ABORTION ; Including carrying pregnancy to term and parenting child, carrying pregnancy to term and placing child for adoption, miscarriage and
Index of Sec 2529. ...ABSENTEEISM rates ; Assessment of number of education days gained by students as result of seasonal vaccinations based on
Index of Sec 2524. ...ACADEMIC day when school in session and established network of support and access to services with backup health providers when school or SBHC closed ; SBHC providing onsite access during
Index of Sec 2511. ...CONTRACT with academic institution or other entity to conduct independent evaluation of demonstration programing funded under subsection ; Secretary entering into
Index of Sec 2553. ...EDUCATION and training organizations jointly administered by health care providers and health care labor organizations or other organizations representing staff nurses and frontline health care workers working in collaboration with accredited schools of nursing and academic institutions ; Providing training programs through
Index of Sec 2521. ...ASSOCIATE'S, bachelor's or advanced nursing degree programs or specialty training or certification programs ; Entities carrying out or overseeing programs carried out with assistance provided under section demonstrating collaboration with accredited schools of nursing including community colleges and other academic institutions providing
Index of Sec 2521. ...ASSOCIATE'S, bachelor's or advanced nursing degree programs or specialty training or certification programs for nurses to carry out innovative nursing programs meeting needs of bedside nursing and health care providers ; Collaboration with accredited schools of nursing including community colleges and other academic institutions providing
Index of Sec 2521. ...HEALTH worker programs receiving funds under section to collaborate with academic institutions ; Secretary encouraging community
Index of Sec 2530. ...ACCESSIBILITY standards being consistent with guidelines issued under subsection ; Prescribing regulations in accessible format as necessary to carry out provisions of Act and sectioning 504 of Act including
Index of Sec 2592. ...ACCOUNT in determining whether manufacturer deemed to meet requirements of section 340b(a) of Public Health Service Act 42 USC 256b(a) and section 1927(a)(5) of Social Security Act 42 USC 1396r-8(a)(5) ; Amendments making by subtitle to be effective and taken into
Index of Sec 2503. ...ACCOUNT established on behalf of beneficiary with beneficiary's cash daily benefit ; Crediting
Index of Sec 2581. ...ACTUARIAL analysis of 75-year costs of program ensuring solvency throughout ; Secretary establishing premiums to be paid by enrollees for year based on
Index of Sec 2581. ...ACTUARIAL opinion certifying that techniques and methodologies used generally accepted within actuarial profession and assumptions and cost estimates used being reasonable ;
Index of Sec 2581. ...ACTUARIAL profession and assumptions and cost estimates used being reasonable ; Actuarial opinion certifying that techniques and methodologies used generally accepted within
Index of Sec 2581. ...ACTUARIAL science, economics and other relevant disciplines as determined by Secretary ; Family caregivers of individuals requiring servicing and supporting to maintain independence at home or another residential setting of choice in community, individuals with expertise in long-term care or disability insurance,
Index of Sec 2581. ...FRAUD or abuse ; Recommendations for administrative or legislative action as Secretary determining being necessary to improve program or preventing occurrence of
Index of Sec 2581. ...ADMINISTRATIVE expenses under section 3203(b)(2) ; Advocacy servicing and advising and assistance counseling services under paragraphs and subsection to be included as
Index of Sec 2581. ...ADMINISTRATIVE expenses related to Fund and investment under subsection ; Paying
Index of Sec 2581. ...ADMINISTRATIVE staff on weekends or otherwise providing urgent care alternative to emergency department ; Expanding capacity to provide care at provider participating in community-based collaborative care network hiring new clinical or
Index of Sec 2534. ...ABORTION ; Including carrying pregnancy to term and parenting child, carrying pregnancy to term and placing child for adoption, miscarriage and
Index of Sec 2529. ...ALCOHOL treatment programs, nutrition and physical activity programs ; Additional counseling for at-risk mothers including smoking cesations programs, drug treatment programs,
Index of Sec 2532. ...PROTEIN, allergenic product ; Paragraph, so designated, inserting
Index of Sec 2575. ...AMBULANCE diversion status and coordination of tracking with regional communications and hospital destination decisions ; Emergency department capacity, on-call specialist coverage,
Index of Sec 2553. ...ANALYTIC files allowing for pooling and analysis of data from disparate data environments, electronic health records and other data deemed appropriate by Secretary ; Standardizing
Index of Sec 2571. ...ANTITRUST law relating to settlement agreements unsettled ; State of
Index of Sec 2573. ...APPOINTMENTS or following up care instructions ; Providing for followup outreach to remind patients of
Index of Sec 2534. ...ASSESSMENT ; Designing services and operations of nurse-managed health center for populations based on
Index of Sec 2512. ...ASSESSMENT, interventions, services, treatment and supports for children and adults with autism ; Convening experts from multiple interdiscipations training programs, individuals with autism and families of individuals to discuss and make recommendations with regard to training issues related to
Index of Sec 2527. ...ASSESSMENT ; Entity establishing steering committee to provide input on
Index of Sec 2535. ...ASSESSMENT, diagnosis, treatment and management of pain ; Evaluating adequacy of assessment, diagnosis, treatment and management of acute and chronic pain in general population and identified racial ethnic, gender, aging and other demographic groups to be disproportionately affected by inadequacies in
Index of Sec 2561. ...ASSESSMENT and crisis planning ; Person-centered treatment planning or similar processes including risk
Index of Sec 2513. ...ASSESSMENT and diagnosis including risk assessment ;
Index of Sec 2513. ...ASSESSMENT and treatment ; Providing resources reducing disparities in access to appropriate diagnosis,
Index of Sec 2563. ...ASSESSMENT of device safety and effectiveness ; Other data as Secretary deeming necessary to permit postmarket
Index of Sec 2571. ...ASSESSMENT of feasibility of using existing Federal and private insurance funding in establishing multistate ;
Index of Sec 2524. ...ASSESSMENT of overweight and obesity problem in community including extent of problem and factors contributing to problem ; Entity conducting or conducting
Index of Sec 2535. ...ASSESSMENT of utility of employing elementary schools and secondary schools as part of multistate ;
Index of Sec 2524. ...ASSESSMENT, diagnosis, treatment and management of acute and chronic pain in general population and identified racial ethnic, gender, aging and other demographic groups to be disproportionately affected by inadequacies in assessment, diagnosis, treatment and management of pain ; Evaluating adequacy of
Index of Sec 2561. ...ASSESSMENT ; Assessment and diagnosis including risk
Index of Sec 2513. ...ASSESSMENT and provision of supports and services ; Serving as research-based resource for Federal and State policymakers on information concerning provision of training and technical assistance for
Index of Sec 2527. ...ASSESSMENT methods and new treatments to improve pain care ; Gaps in basic and clinical research on symptoms and causes of pain and potential
Index of Sec 2561. ...ASSOCIATE'S, bachelor's or advanced nursing degree programs or specialty training or certification programs ; Entities carrying out or overseeing programs carried out with assistance provided under section demonstrating collaboration with accredited schools of nursing including community colleges and other academic institutions providing
Index of Sec 2521. ...ASSOCIATE'S, bachelor's or advanced nursing degree programs or specialty training or certification programs for nurses to carry out innovative nursing programs meeting needs of bedside nursing and health care providers ; Collaboration with accredited schools of nursing including community colleges and other academic institutions providing
Index of Sec 2521. ...AT-risk teens in State ; Describing State's proposal addressing needs of
Index of Sec 2526. ...ALCOHOL treatment programs, nutrition and physical activity programs ; Additional counseling for at-risk mothers including smoking cesations programs, drug treatment programs,
Index of Sec 2532. ...AT-risk mothers in rural areas ; Establishing rural outreach program to provide care to
Index of Sec 2532. ...ATTORNEYS' fees or imposing caps on damages ; Law not limiting
Index of Sec 2531. ...AUTHORIZATION contained in section remaining available ; Sums appropriated under
Index of Sec 2581. ...AUTISM ; Continuing education, technical assistance and information for purpose of improving services rendered to children and adults with autism and families to address unmet needs related to
Index of Sec 2527. ...AUTISM ; Continuing education, technical assistance and information for purpose of improving services rendered to children and adults with autism and families to address unmet needs related to
Index of Sec 2527. ...AUTISM and related developmental disabilities fully to participate in society and achieving good quality-of-life outcomes ; Support community-based family and individual services and enabling individuals with
Index of Sec 2527. ...AUTISM ; Collecting data on outcomes of training and technical assistance programs to meet statewide needs for expansion of services to children and adults with
Index of Sec 2527. ...AUTISM ; Convening experts from multiple interdiscipations training programs, individuals with autism and families of individuals to discuss and make recommendations with regard to training issues related to assessment, interventions, services, treatment and supports for children and adults with
Index of Sec 2527. ...AUTISM ; Term interventions meaning educational methods and positive behavioral support strategies designed to improve or ameliorate symptoms associated with
Index of Sec 2527. ...AUTISM to live more independently in communities ; Term servicing means servicing to assist individuals with
Index of Sec 2527. ...AUTISM ; Term treatments meaning health services designed to improve or ameliorate symptoms associated with
Index of Sec 2527. ...AUTISM and families to address unmet needs related to autism ; Continuing education, technical assistance and information for purpose of improving services rendered to children and adults with
Index of Sec 2527. ...AUTISM and families as part of program to ensure that individualand family-centered approach used ; Including individuals with
Index of Sec 2527. ...AUTISM and families to address unmet needs related to autism ; Continuing education, technical assistance and information for purpose of improving services rendered to children and adults with
Index of Sec 2527. ...AUTISM and families including seamless transitions between education and health systems across lifespan ; Working to develop comprehensive systems of supports and services for individuals with
Index of Sec 2527. ...ASSESSMENT, interventions, services, treatment and supports for children and adults with autism ; Convening experts from multiple interdiscipations training programs, individuals with autism and families of individuals to discuss and make recommendations with regard to training issues related to
Index of Sec 2527. ...AUTISM and families ; Minority institutions demonstrated capacity to meet requirements of section and providing services to individuals with
Index of Sec 2527. ...AUTISM meaning autism spectrum disorder or related developmental disability ; Term
Index of Sec 2527. ...AUTISM spectrum disorder or related developmental disability ; Term autism meaning
Index of Sec 2527. ...AUTOMATIC enrollment ; Allowing for individual's employer to deduct premium for spouse described in subsection being not subject to
Index of Sec 2581. ...BACHELOR'S or advanced nursing degree programs or specialty training or certification programs ; Entities carrying out or overseeing programs carried out with assistance provided under section demonstrating collaboration with accredited schools of nursing including community colleges and other academic institutions providing associate's,
Index of Sec 2521. ...BACHELOR'S or advanced nursing degree programs or specialty training or certification programs for nurses to carry out innovative nursing programs meeting needs of bedside nursing and health care providers ; Collaboration with accredited schools of nursing including community colleges and other academic institutions providing associate's,
Index of Sec 2521. ...BEHAVIORAL health centers ; Paragraph, striking community mental health centers and inserting federally qualified
Index of Sec 2513. ...BEHAVIORAL health centers as meeting criteria specified in subsection ; Federally qualified
Index of Sec 2513. ...BEHAVIORAL health services ; Subsection, striking community mental health services and inserting
Index of Sec 2513. ...AUTISM ; Term interventions meaning educational methods and positive behavioral support strategies designed to improve or ameliorate symptoms associated with
Index of Sec 2527. ...PAYMENT of cash benefit for beneficiary into Life Independence Account established by Secretary on behalf of eligible beneficiary ; Secretary establishing procedures for administering provision of benefits to eligible beneficiaries under Class Independence Benefit Plan including
Index of Sec 2581. ...HOSPITAL, nursing facility, intermediate care facility for mentally retarded or institution for mental diseases ; Beneficiary being patient in
Index of Sec 2581. ...BENEFICIARY'S cash benefits by authorized representative of eligible beneficiary on whose behalf ; Secretary establishing procedures to allow access to
Index of Sec 2581. ...FUNCTIONAL status of beneficiary before end of 12-month benefit period to be included in determination of applicable annual benefit paid to eligible beneficiary ; Increase or decrease as result of change in
Index of Sec 2581. ...HEALTH care benefits or assistance ; Other health care benefits For which beneficiary being eligible under Medicaid or other federally funded program providing
Index of Sec 2581. ...INFORMATION regarding ; Agreement entered under subsection requiring entity to assign advice and assistance counselor providing eligible beneficiary with
Index of Sec 2581. ...BENEFICIARY'S eligibility for receipt of benefits under other Federal ; Benefits paid to eligible beneficiary under Class program to be disregarded for purposes of determining or continuing
Index of Sec 2581. ...BENEFICIARY'S care and Medicaid providing secondary coverage for care ; Beneficiary retaining amount equal to 5 percent of beneficiary's daily or weekly cash benefit and remainder of benefit to be applied toward facility's cost of providing
Index of Sec 2581. ...BENEFICIARY'S daily or weekly cash benefit and remainder of daily or weekly cash benefit to be applied toward cost to State of providing assistance and Medicaid providing secondary coverage for remainder of costs incurred in providing assistance ; Beneficiary retaining amount equal to 50 percent of
Index of Sec 2581. ...BENEFICIARY'S daily or weekly cash benefit and remainder of daily or weekly cash benefit to be applied toward cost to State of providing assistance and Medicaid providing secondary coverage for remainder of costs incurred in providing assistance ; Beneficiary retaining amount equal to 50 percent of
Index of Sec 2581. ...BENEFICIARY meaning individual being active enrollee in Class program ; Term eligible
Index of Sec 2581. ...BENEFICIARY'S continued eligibility for receipt of benefits ; Recertifying by submission of medical evidence
Index of Sec 2581. ...BENEFICIARY'S daily or weekly cash benefit under subclause only if State home and community-based waiver under section 1115 of Social Security Act or subsection or section 1915 of Act or State plan amendment under subsection of section not including waiver of requirements of section 1902(a)(1) of Social Security Act or section 1902(a) of Act and State offers at minimum case management services, personal care services, habilitation services and respite care waiver or State plan amendment ; State to be paid remainder of
Index of Sec 2581. ...BENEFICIARY'S cash daily benefit ; Crediting account established on behalf of beneficiary with
Index of Sec 2581. ...BENEFICIARY'S care and Medicaid providing secondary coverage for care ; Beneficiary retaining amount equal to 5 percent of beneficiary's daily or weekly cash benefit and remainder of benefit to be applied toward facility's cost of providing
Index of Sec 2581. ...BENEFICIARY'S cash benefits by authorized representative of eligible beneficiary on whose behalf ; Secretary establishing procedures to allow access to
Index of Sec 2581. ...BENEFICIARY'S eligibility for receipt of benefits under other Federal ; Benefits paid to eligible beneficiary under Class program to be disregarded for purposes of determining or continuing
Index of Sec 2581. ...EDUCATION, services and treatment ; Age, biological and sociocultural contexts including prevention programs, public and professional
Index of Sec 2588. ...CLINICAL practice protocols and conduct of research into patient outcomes, delivery of health care services, quality of care and access to health care ; Age, biological and sociocultural contexts including development of evidence reports and
Index of Sec 2588. ...BIOLOGICAL product licensed under subsection bearing name ; Secretary ensuring that labeling and packaging of
Index of Sec 2575. ...BIOLOGICAL product being biosimilar to reference product based upon data derived ;
Index of Sec 2575. ...BIOLOGICAL product being highly similar to reference product notwithstanding minor differences in clinically inactive components ; Analytical studies demonstrating that
Index of Sec 2575. ...BIOLOGICAL product ; Clinical study or studies being sufficient to demonstrate safety, purity and potency in 1 or more appropriate conditions of use For which reference product licensed and intended to be used and licensure being sought for
Index of Sec 2575. ...BIOLOGICAL product previously approved for reference product ; Condition or conditions of use prescribed, recommended or suggested in labeling proposed for
Index of Sec 2575. ...BIOLOGICAL product continuing to be safe ; Facility in which biological product manufactured, processed, packed or holding meeting standards designed to assure that
Index of Sec 2575. ...BIOLOGICAL product ; Including additional information in support of application including publicly available information with respect to reference product or another
Index of Sec 2575. ...BIOLOGICAL product meeting standards described in paragraph ; Application submitted under subsection including information demonstrating that
Index of Sec 2575. ...BIOLOGICAL product ; Secretary determining that information submitted in application being sufficient to show that
Index of Sec 2575. ...BIOLOGICAL product to be interchangeable with reference product if Secretary determining that information submitted in application being sufficient to show ; Secretary determining
Index of Sec 2575. ...BIOLOGICAL product not to be evaluated against more than 1 reference product ;
Index of Sec 2575. ...BIOLOGICAL product under subsection unless Secretary determining to be no increased risk to security or health of public from licensing biological product under subsection ; Secretary not licensing
Index of Sec 2575. ...BIOLOGICAL product to be approved as interchangeable for reference product ; 1 year after first commercial marketing of first interchangeable biosimilar
Index of Sec 2575. ...BIOLOGICAL product ; Final court decision on patents in suit in action instituted under subsection against applicant submitting application for first approved interchangeable biosimilar
Index of Sec 2575. ...BIOLOGICAL product ; Dismissal withor without prejudice of action instituted under subsection against applicant submitting application for first approved interchangeable biosimilar
Index of Sec 2575. ...BIOLOGICAL product if applicant submitting application sued under subsection and litigation being still ongoing within 42-month period ; 42 months after approval of first interchangeable biosimilar
Index of Sec 2575. ...BIOLOGICAL product if applicant submitting application not sued under subsection ; 18 months after approval of first interchangeable biosimilar
Index of Sec 2575. ...BIOLOGICAL product being reference product ; Subsequent application filed by same sponsor or manufacturer of
Index of Sec 2575. ...BIOLOGICAL product not resulting in change in safety, purity or potency ; Modification to structure of
Index of Sec 2575. ...BIOLOGICAL product meeting standards described in paragraph ; Criteria that Secretary using to determine whether
Index of Sec 2575. ...BIOLOGICAL product being subject of application under subsection ; Biosimilar product meaning
Index of Sec 2575. ...BIOLOGICAL product being highly similar to reference product notwithstanding minor differences in clinically inactive components ;
Index of Sec 2575. ...BIOLOGICAL product being shown to meet standards described in subsection ; Reference to
Index of Sec 2575. ...BIOLOGICAL product evaluated in application submitted under subsection ; Term reference product meaning single biological product licensed under subsection against
Index of Sec 2575. ...BIOLOGICAL product to be submitted under section 351 of Public Health Service Act 42 USC 262 ; Application for
Index of Sec 2575. ...BIOLOGICAL product to be submitted under section 505 of Federal Food, Drug ; Application for
Index of Sec 2575. ...BIOLOGICAL product in product class being subject of application approved under section 505 not later than date of enactment of Act ; Biological product in product class For which
Index of Sec 2575. ...BIOLOGICAL product not to be submitted under section 505 of Federal Food, Drug and Cosmetic Act 21 USC 355 ; Application for
Index of Sec 2575. ...BIOLOGICAL product under section 351 on date being 10 years after date of enactment of Act ; Approved application for biological product under section 505 of Federal Food, Drug and Cosmetic Act 21 USC 355 to be deemed to be license for
Index of Sec 2575. ...BIOLOGICAL product having meaning given term under section 351 of Public Health Service Act 42 USC 262 ; Term
Index of Sec 2575. ...BIOLOGICAL product claimed in patent or use of which claimed in patent before expiration of patent ; Statement described in subparagraph provided in connection with application to obtain license to engage in commercial manufacture, use or sale of
Index of Sec 2577. ...BIOLOGICAL product and reference product utilizing same mechanism or mechanisms of action for condition or conditions of use prescribed, recommended or suggested in proposed labeling ;
Index of Sec 2575. ...BIOLOGICAL product and reference product being not greater than risk of using reference product without ; Risk in terms of safety or diminished efficacy of alternating or switching between use of
Index of Sec 2575. ...BIOLOGICAL product receiving determination of interchangeability for condition of use ; Review of application submitted under subsection relying on same reference product For which prior
Index of Sec 2575. ...BIOLOGICAL product evaluated in application submitted under subsection ; Term reference product meaning single biological product licensed under subsection against
Index of Sec 2575. ...BIOLOGICAL products licensed under subsection following evaluation against reference product ; Reference product and other
Index of Sec 2575. ...BIOLOGICAL products licensed under subsection in same manner as authority applying to biological products licensed under subsection ; Authority of Secretary with respect to risk evaluation and mitigation strategies under Federal Food, Drug and Cosmetic Act applying to
Index of Sec 2575. ...BIOLOGICAL products containing dangerous ingredients ; Restrictions on
Index of Sec 2575. ...BIOLOGICAL products ; Fees relating to BIOSIMILAR
Index of Sec 2576. ...BIOLOGY, chemistry, physiology, mathematics, nutrition and other courses deemed appropriate by Secretary to prepare students for associate or bachelor's degree programs in health professions or bachelor's degree programs in health professions-related majors ; Including curricula in
Index of Sec 2533. ...BIOSIMILAR to reference product based upon data derived ; Biological product being
Index of Sec 2575. ...BIOLOGICAL product ; Final court decision on patents in suit in action instituted under subsection against applicant submitting application for first approved interchangeable biosimilar
Index of Sec 2575. ...BIOLOGICAL product ; Dismissal withor without prejudice of action instituted under subsection against applicant submitting application for first approved interchangeable biosimilar
Index of Sec 2575. ...BIOLOGICAL product to be approved as interchangeable for reference product ; 1 year after first commercial marketing of first interchangeable biosimilar
Index of Sec 2575. ...BIOLOGICAL product if applicant submitting application sued under subsection and litigation being still ongoing within 42-month period ; 42 months after approval of first interchangeable biosimilar
Index of Sec 2575. ...BIOLOGICAL product if applicant submitting application not sued under subsection ; 18 months after approval of first interchangeable biosimilar
Index of Sec 2575. ...BIOLOGICAL product being subject of application under subsection ; Biosimilar product meaning
Index of Sec 2575. ...BIOSIMILAR product ; Reference product sponsor providing to applicant list of relevant patents owned by reference product sponsor or respect of which reference product sponsor having right to commence action of infringement or otherwise interest in patent as patent concerns
Index of Sec 2575. ...BIOSIMILAR product and requesting Secretary not to grant final approval of application before date of expiration of noticed patent ; Applicant not commencing marketing of
Index of Sec 2575. ...BIOSIMILAR product applicant under subsection and reference product sponsor entering into agreement described in subparagraph ;
Index of Sec 2575. ...BIOSIMILAR product applicant under subsection and reference product sponsor or 2 or more biosimilar product applicants under subsection regarding manufacture or sale ; Agreement between
Index of Sec 2575. ...BIOSIMILAR product being subject of application described in subparagraph ; Biosimilar product being subject of application or
Index of Sec 2575. ...BIOSIMILAR product and production ; Applicant providing reference product sponsor with copy of application and information concerning
Index of Sec 2575. ...BIOSIMILAR product in method of treatment indicated in application ; Use, sale or offer for sale within United States or importation into United States of biosimilar product or materials used in manufacture of biosimilar product or due to use of
Index of Sec 2575. ...BIOSIMILAR product ; Information including detailed description of
Index of Sec 2575. ...BIOSIMILAR product in method of treatment indicated in application ; Use, sale or offer for sale within United States or importation into United States of biosimilar product or materials used in manufacture of biosimilar product or due to use of
Index of Sec 2575. ...BIOSIMILAR product applicants submitting application under subsection for biosimilar products with same reference product and entering into agreement described in subparagraph ; 2 or more
Index of Sec 2575. ...BIOSIMILAR product applicants under subsection regarding manufacture or sale ; Agreement between biosimilar product applicant under subsection and reference product sponsor or 2 or more
Index of Sec 2575. ...BIOSIMILAR product in method of treatment indicated in application ; Use, sale or offer for sale within United States or importation into United States of biosimilar product or materials used in manufacture of biosimilar product or due to use of
Index of Sec 2575. ...BIOSIMILAR products with same reference product and entering into agreement described in subparagraph ; 2 or more biosimilar product applicants submitting application under subsection for
Index of Sec 2575. ...BIOSIMILAR product in treatment indicated in application ; Biosimilar product or use of
Index of Sec 2575. ...BIOSIMILAR product in treatment indicated in application not infringing patent ; Biosimilar product or use of
Index of Sec 2575. ...CALORIC intake in context of total daily diet ; Succinct statement concerning suggested daily
Index of Sec 2572. ...CALORIC intake designed to enable public to understand significance of nutrition information provided on menu board ; Succinct statement concerning suggested daily
Index of Sec 2572. ...CALORIES contained in standard menu item as usually prepared and offered for sale ; Number of
Index of Sec 2572. ...CALORIES contained in article ; Vending machine operator providing sign in close proximity to article of food or selection button including clear and conspicuous statement disclosing number of
Index of Sec 2572. ...CANCER hospital excluded from Medicare prospective payment system pursuant to section 1886(d)(1)(b)(v) of Social Security Act meeting requirements of subparagraph ; Children's hospital excluded from Medicare prospective payment system pursuant to section 1886(d)(1)(b)( iii of Social Security Act or free-standing
Index of Sec 2501. ...CAPITAL or operating expenses ; Financial support to be demonstrated by State or political subdivision funding for trauma center's
Index of Sec 2551. ...CAREER centers, community-based organizations, community colleges and accredited schools of nursing ; Labor organizations including joint labor-management training programs and including representatives from local governments worker investment agency one-stop
Index of Sec 2521. ...CAREER ladder to nursing for incumbent ancillary health care workers ; Addressing projected shortage of nurses by funding comprehensive programs to create
Index of Sec 2521. ...CAREER ladder programs ; Provision of paid leave time and continued health coverage to incumbent health care workers to allow participation in nursing
Index of Sec 2521. ...CAREER ladders to educate incumbent health care workers to become nurses ; Carrying out programs providing education and training to establish nursing
Index of Sec 2521. ...CAREER opportunities for community health workers ; Recommendations regarding training to enhance
Index of Sec 2530. ...ACTUARIAL science, economics and other relevant disciplines as determined by Secretary ; Family caregivers of individuals requiring servicing and supporting to maintain independence at home or another residential setting of choice in community, individuals with expertise in long-term care or disability insurance,
Index of Sec 2581. ...CAREGIVERS with respect ; Secretary designing public awareness campaign under section to educate consumers, patients, families and other
Index of Sec 2563. ...CATASTROPHIC event ; Need of financial assistance following natural disaster or other
Index of Sec 2551. ...CATASTROPHIC event ; Geographic location substantially affected by natural disaster or other
Index of Sec 2551. ...CERTIFICATION ; Materials filed with Federal Trade Commission and Department of Justice under section 1112 of subtitle B of title XI of Medicare Prescription Drug, Improvement and Modernization Act of 2003 with respect to agreement referenced in
Index of Sec 2573. ...CERTIFICATION as following ; Chief executive officer or company official responsible for negotiating agreement required to be filed by subparagraph including in filing under paragraph
Index of Sec 2575. ...CERTIFICATION program ; Provision of paid release time for staff nurses to enable to obtain bachelor of science in nursing degree, other advanced nursing degrees, specialty training or
Index of Sec 2521. ...CERTIFICATION programs ; Entities carrying out or overseeing programs carried out with assistance provided under section demonstrating collaboration with accredited schools of nursing including community colleges and other academic institutions providing associate's, bachelor's or advanced nursing degree programs or specialty training or
Index of Sec 2521. ...CERTIFICATION programs and establishing incentives for nurses to assume nurse faculty positions on part-time or full-time basis ; Carrying out programs assisting nurses in obtaining advanced degrees and completing specialty training or
Index of Sec 2521. ...CERTIFICATION programs for nurses to carry out innovative nursing programs meeting needs of bedside nursing and health care providers ; Collaboration with accredited schools of nursing including community colleges and other academic institutions providing associate's, bachelor's or advanced nursing degree programs or specialty training or
Index of Sec 2521. ...CHARGEBACKS for drugs ; Manufacturers and wholesalers using identification system developed by Secretary for purposes of facilitating ordering, purchasing and delivery of covered drugs under section including processing of
Index of Sec 2502. ...CHARGEBACKS for drugs ; Universal and standardized identification system by which covered entity site to be identified by manufacturers, distributors, covered entities and Secretary for purposes of facilitating ordering, purchasing and delivery of covered drugs under section including processing of
Index of Sec 2502. ...CHEMISTRY, physiology, mathematics, nutrition and other courses deemed appropriate by Secretary to prepare students for associate or bachelor's degree programs in health professions or bachelor's degree programs in health professions-related majors ; Including curricula in biology,
Index of Sec 2533. ...ABORTION ; Including carrying pregnancy to term and parenting child, carrying pregnancy to term and placing child for adoption, miscarriage and
Index of Sec 2529. ...CHRONIC care management ; Requiring services provided by community-based collaborative care network to include support services appropriate to meet health needs of low-income populations in network's community including
Index of Sec 2534. ...CHRONIC conditions by teaching more effective management techniques focusing on individual self-care and patient-driven decisionmaking ; Term wellness services meaning health-related service or intervention designed to reduce identifiable health risks and increase healthy behaviors intended to prevent onset of disease or lessening impact of existing
Index of Sec 2512. ...CHRONIC conditions ; Developing or strengthening activities related to providing coordinated care for individuals with
Index of Sec 2534. ...CHRONIC conditions to reduce severity ; Managing
Index of Sec 2534. ...CHRONIC conditions in various populations including comparison of prevalence in general population versus in population of individuals with inadequate health insurance coverage ; Prevalence of certain
Index of Sec 2534. ...DISSEMINATION and implementation of pharmacist-delivered MTM services ; Chronic disease groups and other stakeholders involved with research,
Index of Sec 2528. ...CHRONIC diseases including pulations conditions ; High percentage of residents suffering from
Index of Sec 2530. ...ASSESSMENT, diagnosis, treatment and management of pain ; Evaluating adequacy of assessment, diagnosis, treatment and management of acute and chronic pain in general population and identified racial ethnic, gender, aging and other demographic groups to be disproportionately affected by inadequacies in
Index of Sec 2561. ...CIVIL action ; Penalty to be recovered in
Index of Sec 2575. ...EDUCATION and clinical care in United States ; Establishing agenda for action public and private sectors reducing barriers and significantly improving state of pain care research,
Index of Sec 2561. ...CLINICAL opportunities through collaborative programs between staff nurse organizations, health care providers and accredited schools of nursing ; Increasing capacity for educating nurses by increasing nurse faculty and
Index of Sec 2521. ...CLINICAL practice protocols and conduct of research into patient outcomes, delivery of health care services, quality of care and access to health care ; Age, biological and sociocultural contexts including development of evidence reports and
Index of Sec 2588. ...ASSESSMENT methods and new treatments to improve pain care ; Gaps in basic and clinical research on symptoms and causes of pain and potential
Index of Sec 2561. ...BIOLOGICAL product ; Clinical study or studies being sufficient to demonstrate safety, purity and potency in 1 or more appropriate conditions of use For which reference product licensed and intended to be used and licensure being sought for
Index of Sec 2575. ...CLINICAL trials and analysis of data by sex in accordance with needs identified ; Make annual estimates of funds needed to monitor
Index of Sec 2588. ...COGNITIVE impairment ; Individual requiring substantial supervision to protect individual from threats to health and safety due to substantial
Index of Sec 2581. ...COMMERCE prohibited under section 5 of Federal Trade Commission Act and enforced by Federal Trade Commission in same manner ; Violation of subparagraph to be treated as unfair and deceptive act or practice and unfair method of competition or affecting interstate
Index of Sec 2573. ...BIOLOGICAL product to be approved as interchangeable for reference product ; 1 year after first commercial marketing of first interchangeable biosimilar
Index of Sec 2575. ...BIOLOGICAL product claimed in patent or use of which claimed in patent before expiration of patent ; Statement described in subparagraph provided in connection with application to obtain license to engage in commercial manufacture, use or sale of
Index of Sec 2577. ...COMPARATIVE analysis of laws ; Reports containing sufficient documentation regarding effectiveness of laws to enable objective
Index of Sec 2531. ...COMPENSATION from patients ; Practitioner not for provision of services receiving
Index of Sec 2586. ...COMPENSATION or continued health coverage to staff nurses desiring to work full or part-time in faculty position ; Provision of paid release time, incentive
Index of Sec 2521. ...COMPENSATION authority ; Functions exercised by Office on Women's Health of Public Health Service prior to date of enactment of section including personnel and
Index of Sec 2588. ...LABOR organization ; Providing waging and benefiting to nurses being competitive for market or collectively bargained with
Index of Sec 2521. ...COMPETITIVE basis to eligible entities to enable entities to carry out training for individuals to attain or advance in health care occupations ; Awarding National Health Workforce Online Training Grants on
Index of Sec 2591. ...COMPETITIVE grants to eligible entities to support demonstration programs ; Secretary awarding not fewer than 4 multiyear contracts or
Index of Sec 2553. ...COMPLIANCE by manufacturers with requirements of section in order to prevent overcharges and other violations of discounted pricing requirements specified in section ; Secretary providing for improvements in
Index of Sec 2502. ...COMPLIANCE by covered entities with requirements of section in order to prevent diversion and violations of duplicate discount provision and other requirements under subsection ; Secretary providing for improvements in
Index of Sec 2502. ...COMPLIANCE ; Imposition of monetary penalty to be insufficient reasonably to ensure
Index of Sec 2502. ...COMPLIANCE with guidelines established under subsection ; Secretary monitoring community health worker programs identified in approved applications under section and determining whether programs in
Index of Sec 2530. ...COMPLIANCE with section ; Secretary submitting to Congress annual report on progress States making in enacting and implementing alternative medical liability laws in
Index of Sec 2531. ...COMPLIANCE and granting other equitable relief as court in discretion determining necessary or appropriate ; Order
Index of Sec 2575. ...CONSUMER making order selection ; Term menu or menu board meaning primary writing of restaurant or other similar retail food establishment from which
Index of Sec 2572. ...CAREGIVERS with respect ; Secretary designing public awareness campaign under section to educate consumers, patients, families and other
Index of Sec 2563. ...MEDICAL device manufacturers and pharmaceutical companies ; Secretary consulting with organizations representing patients in pain and other consumers, employers, physicians including physicians specializing in pain care, other pain management professionals,
Index of Sec 2563. ...CONTRACT with academic institution or other entity to conduct independent evaluation of demonstration programing funded under subsection ; Secretary entering into
Index of Sec 2553. ...CONTRACT or grant under subsection to eligible entity proposing demonstration program to design, implement and evaluate emergency medical system ; Secretary awarding
Index of Sec 2553. ...CONTRACT or grant described in subsection submitting to Secretary application at timing and mannering as Secretary requiring ; Eligible entity seeking
Index of Sec 2553. ...CONTRACT or grant under subsection ; Respect to costs of activities to be carried out year with
Index of Sec 2553. ...CONTRACT or grant being eligible entity involved agreeing to make available non-Federal contributions toward ; Condition for receipt of
Index of Sec 2553. ...CONTRACT or grant described in subsection submitting to Secretary report containing results of evaluation of program ; Recipient of
Index of Sec 2553. ...CONTRACT or linkages with other programs ; Make available to individuals served by center through
Index of Sec 2513. ...CONTRACT to be carried out in partnership with accredited health professions schooling ; Activities under grant or
Index of Sec 2533. ...CONTRACT recipient demonstrating to Secretary's satisfaction ; Secretary renewing grant or contract award under section only if grant or
Index of Sec 2535. ...CONTRACT under section to entity only if entity demonstrating to Secretary's satisfaction ; Secretary awarding grant or
Index of Sec 2535. ...CONTRACT ; Entity's program funded through grant or
Index of Sec 2535. ...CONTRACT to carry out activities supported by grant or contract ; Secretary awarding grant or contract to eligible entity under section only if entity agreeing to provide amount equal to $1 for $9 provided through grant or
Index of Sec 2535. ...CONTRACT under section to entity only if entity demonstrating to satisfaction of Secretary ; Secretary awarding grant or
Index of Sec 2535. ...CONTRACT under section to entity only if entity demonstrating to satisfaction of Secretary ; Secretary awarding grant or
Index of Sec 2535. ...CONTRACT to be expended only to supplement and not ; Funds received through grant or
Index of Sec 2535. ...CONTRACT under section to be used to assist patients and families to navigate health care-related programs and activities and achieving one or more of following goals ; Amounts received as grant or
Index of Sec 2537. ...CONTRACTS ; Employment or consulting
Index of Sec 2575. ...CONTRACTS or grants described in subsection to eligible entity serving medically underserved population ; Secretary giving priority for award of
Index of Sec 2553. ...CONTRACTS to public agencies and private nonprofit organizations to assist with development and implementation of public awareness campaign under section ; Secretary making awards of grants, cooperative agreements and
Index of Sec 2563. ...CONTRACTS ; Maintaining linkages and possible entering into formal
Index of Sec 2513. ...CONTRACTS to eligible entities for purpose of funding development of performance measures assessing use and effectiveness of medication therapy management services ; Secretary awarding grants or
Index of Sec 2528. ...COMPETITIVE grants to eligible entities to support demonstration programs ; Secretary awarding not fewer than 4 multiyear contracts or
Index of Sec 2553. ...CONTRACTS awarded under section ; Secretary submitting to Congress annual report on program of grants and
Index of Sec 2535. ...CONTRACT award under section only if grant or contract recipient demonstrating to Secretary's satisfaction ; Secretary renewing grant or
Index of Sec 2535. ...CONTRIBUTIONS to be made directly or donations from public or private entities or provided through cash equivalent of paid release time provided to incumbent worker students ;
Index of Sec 2521. ...CONTRIBUTIONS toward ; Secretary not making grant under section unless applicant involved agreeing to make available non-Federal
Index of Sec 2521. ...CONTRIBUTIONS in accordance with subsection ; Agreement to make available non-Federal
Index of Sec 2553. ...CONTRIBUTIONS toward ; Condition for receipt of contract or grant being eligible entity involved agreeing to make available non-Federal
Index of Sec 2553. ...CONTRIBUTIONS ; Secretary of Education requiring recipients of grants under subsection to provide matching funds from non-Federal sources and permitting recipients to match funds in whole or part with in-kind
Index of Sec 2536. ...CONTRIBUTIONS required in subparagraph in cash or kind ; Non-Federal
Index of Sec 2521. ...CONTRIBUTIONS required in paragraph in cash or kind ; Non-Federal
Index of Sec 2553. ...CONVICTION of criminal offense or connection with verdict or finding described in section 202(x)(1)(a)( ii of Social Security Act ; Confining in jail, prison, other penal institution or correctional facility or court order pursuant to
Index of Sec 2581. ...CONVICTION of criminal offense or connection with verdict or finding described in section 202(x)(1)(a)( ii of Social Security Act ; Confining in jail, prison, other penal institution or correctional facility or court order pursuant to
Index of Sec 2581. ...CRIMINAL offense or connection with verdict or finding described in section 202(x)(1)(a)( ii of Social Security Act ; Confining in jail, prison, other penal institution or correctional facility or court order pursuant to conviction of
Index of Sec 2581. ...DATABANKS and registries ; Reports data to appropriate Federal and State
Index of Sec 2553. ...COMMERCE prohibited under section 5 of Federal Trade Commission Act and enforced by Federal Trade Commission in same manner ; Violation of subparagraph to be treated as unfair and deceptive act or practice and unfair method of competition or affecting interstate
Index of Sec 2573. ...ECONOMIC outcomes including demographic characteristics ; Identify and evaluating other factors impacting clinical and
Index of Sec 2528. ...ASSESSMENT, diagnosis, treatment and management of pain ; Evaluating adequacy of assessment, diagnosis, treatment and management of acute and chronic pain in general population and identified racial ethnic, gender, aging and other demographic groups to be disproportionately affected by inadequacies in
Index of Sec 2561. ...HEALTH facilities ; Matter preceding subparagraph, inserting dental and mental
Index of Sec 2555. ...DENTAL ; Subparagraph of section 653(b)(4) of Post-Katrina Emergency Management Reform Act of 2006 amended by striking public health and medical and inserting public health, medical and
Index of Sec 2556. ...DENTAL ; Section 319f(a)(5)(b) 42 USC 247d-6(a)(5)(b) amended by striking public health or medical and inserting public health, medical or
Index of Sec 2555. ...DEPRESSION or postpartum psychosis ; Term postpartum condition meaning postpartum
Index of Sec 2529. ...HEALTH professionals ; Weight scales, mammography equipment, x-ray machines and other equipment commonly used for diagnostic or examination purposes by
Index of Sec 2592. ...DIAGNOSTIC techniques ; Development of improved screening and
Index of Sec 2529. ...DIET ; Succinct statement concerning suggested daily caloric intake in context of total daily
Index of Sec 2572. ...DIETARY practices ; Disclosing for purpose of providing information to assist consumers in maintaining healthy
Index of Sec 2572. ...DISABILITIES receiving equal access to aspects of health care delivery system ; Including provisions ensuring that individuals with
Index of Sec 2592. ...DISABILITIES fully to participate in society and achieving good quality-of-life outcomes ; Support community-based family and individual services and enabling individuals with autism and related developmental
Index of Sec 2527. ...DISABILITY self-management, supported employment, supported housing services, therapeutic foster care services, multisystemic therapy and other evidence-based practices as Secretary requiring ; Assertive community treatment, family psychoeducation,
Index of Sec 2513. ...DISABILITY and enrollees and beneficiaries received services from entity or another entity ; Entity reporting number of active enrollees and beneficiaries provided with assistance by age,
Index of Sec 2581. ...DISABILITY ; Term autism meaning autism spectrum disorder or related developmental
Index of Sec 2527. ...ACTUARIAL science, economics and other relevant disciplines as determined by Secretary ; Family caregivers of individuals requiring servicing and supporting to maintain independence at home or another residential setting of choice in community, individuals with expertise in long-term care or disability insurance,
Index of Sec 2581. ...DISCHARGE from hospital, facility or institution ; Planning to discharge from hospital, facility or institution or 60 days from date of
Index of Sec 2581. ...DISCLOSURE under section 552 of title 5, United States Code and no ; Information or documentary material filed with Assistant Attorney General or Federal Trade Commission pursuant to paragraph to be exempt from
Index of Sec 2575. ...DISCLOSURE of ceiling prices or data used to calculate ceiling price ; Other provision of law prohibiting
Index of Sec 2502. ...DISCLOSURE of nutrient in written form required under subclause ; Secretary requiring
Index of Sec 2572. ...DISCLOSURE ; Provision of access to covered entities and State Medicaid agencies through Internet website of Department of Health and Human Services or contractor to applicable ceiling prices for covered drugs as calculated and verified by Secretary in manner ensuring protection of privileged pricing data from unauthorized
Index of Sec 2502. ...DISCLOSURES of type required under section 403(q)(5)(h) of Federal Food, Drug and Cosmetic Act and expressly preempted under section 403a(a)(4) of Act ; Provision establishing or continuing into effect nutrient content
Index of Sec 2572. ...DISCLOSURES including nutrient databases ; Restaurant or similar retail food establishment to have reasonable basis for nutrient content
Index of Sec 2572. ...DISENROLL from program during annual disenrollment period established by Secretary and form and manner as Secretary establishing ; Individual only to be permitted to
Index of Sec 2581. ...DISENROLLMENT period established by Secretary and form and manner as Secretary establishing ; Individual only to be permitted to disenroll from program during annual
Index of Sec 2581. ...DISPARATE data environments, electronic health records and other data deemed appropriate by Secretary ; Standardizing analytic files allowing for pooling and analysis of data from
Index of Sec 2571. ...DISTRIBUTION and care of routine community patients ; Promoting regional partnerships and more effective emergency medical systems in order to enhance appropriate triage,
Index of Sec 2552. ...COMPARATIVE analysis of laws ; Reports containing sufficient documentation regarding effectiveness of laws to enable objective
Index of Sec 2531. ...DOWNGRADATION ; Operating in rural areas where trauma care availability significantly decreaseing if center forced to close or downgrade service and substantial costs contributing to likelihood of closure or
Index of Sec 2551. ...DRUG being made available to other purchaser at price ; Covered entity covered drugs for purchase below applicable ceiling price if
Index of Sec 2502. ...DRUG ; Price for covered drug subject to agreement representing maximum price covered entities permissibly to be required to pay for
Index of Sec 2502. ...DRUG to be manufactured under ANDA involved and subject of patent infringement claim ;
Index of Sec 2573. ...DRUG to be manufactured under ANDA involved and subject of patent infringement claim ; Right to market
Index of Sec 2573. ...DRUG ; Other statutory exclusivity preventing marketing of
Index of Sec 2573. ...DRUG ; Waiver of patent infringement claim for damages based on prior marketing of
Index of Sec 2573. ...DRUG to be manufactured under ANDA infringing patent ; Including in complaint filed with court of law ANDA or
Index of Sec 2573. ...DRUG manufacturers ; Purpose of section to provide additional means to effectuate intent of 1984 Act by enhancing competition in pharmaceutical market by stopping agreements between brand name and generic
Index of Sec 2573. ...DRUG under section ; Term ANDA meaning abbreviated new drug application for approval of new
Index of Sec 2573. ...DRUG exceeding maximum applicable price under subsection or knowingly violating other provision of section or withholding or providing false information to Secretary or covered entities under section ; Applying to manufacturer with agreement under section and not exceeding $100,000 for instanceing where manufacturer knowingly charging covered entity price for purchase of
Index of Sec 2502. ...DRUG application for approval of new drug under section ; Term ANDA meaning abbreviated new
Index of Sec 2573. ...DRUG subject to agreement representing maximum price covered entities permissibly to be required to pay for drug ; Price for covered
Index of Sec 2502. ...ALCOHOL treatment programs, nutrition and physical activity programs ; Additional counseling for at-risk mothers including smoking cesations programs, drug treatment programs,
Index of Sec 2532. ...ECONOMIC outcomes including demographic characteristics ; Identify and evaluating other factors impacting clinical and
Index of Sec 2528. ...ECONOMICS and other relevant disciplines as determined by Secretary ; Family caregivers of individuals requiring servicing and supporting to maintain independence at home or another residential setting of choice in community, individuals with expertise in long-term care or disability insurance, actuarial science,
Index of Sec 2581. ...EDUCATION to nursing and creating A pipeline to nursing ; Sec 2521, comprehensive Programs to provide
Index of Sec 2521. ...EDUCATION and training organizations jointly administered by health care providers and health care labor organizations or other organizations representing staff nurses and frontline health care workers working in collaboration with accredited schools of nursing and academic institutions ; Providing training programs through
Index of Sec 2521. ...EDUCATION to nurses and creating pipeline to nursing for incumbent ancillary health care workers wishing to advance careers and otherwise carrying out purposes of section ; Secretary of Labor establishing partnership grant program to award grants to eligible entities to carry out comprehensive programs to provide
Index of Sec 2521. ...CAREER ladders to educate incumbent health care workers to become nurses ; Carrying out programs providing education and training to establish nursing
Index of Sec 2521. ...AUTISM and families to address unmet needs related to autism ; Continuing education, technical assistance and information for purpose of improving services rendered to children and adults with
Index of Sec 2527. ...AUTISM and families to address unmet needs related to autism ; Continuing education, technical assistance and information for purpose of improving services rendered to children and adults with
Index of Sec 2527. ...EDUCATION and training designed to enhance understanding and appropriate use of medications by patient, caregiver and other authorized representative ; Providing
Index of Sec 2528. ...EDUCATION including complete information concerning postpartum conditions including symptoms ; Ensuring that
Index of Sec 2529. ...EDUCATION among employers, patients, health care providers, regulators and third-party payors ; Lack of understanding and
Index of Sec 2561. ...EDUCATION and clinical care in United States ; Establishing agenda for action public and private sectors reducing barriers and significantly improving state of pain care research,
Index of Sec 2561. ...EDUCATION and training ; Establishing short-range and long-range goals and objectives within Centers for women's health and coordinate with other appropriate offices on activities within Centers relating to prevention, research,
Index of Sec 2588. ...EDUCATION and health systems across lifespan ; Working to develop comprehensive systems of supports and services for individuals with autism and families including seamless transitions between
Index of Sec 2527. ...ABSENTEEISM rates ; Assessment of number of education days gained by students as result of seasonal vaccinations based on
Index of Sec 2524. ...EDUCATION to improve patient care and safety ; Providing for improving quality of nursing
Index of Sec 2521. ...EDUCATION ; Section not to be construed to preempt or limit State law regarding parental involvement and decisionmaking in children's
Index of Sec 2526. ...EDUCATION ; Establishing short-range and long-range goals and objectives within Department of Health and Human Services and coordinate with other appropriate offices on activities within Department relating to disease prevention, health promotion, service delivery, research and public and health care professional
Index of Sec 2588. ...EDUCATION, services and treatment ; Age, biological and sociocultural contexts including prevention programs, public and professional
Index of Sec 2588. ...EDUCATION in appropriate use of health care ; Facilitating exchange of information regarding matters relating to health information, health promotion, preventive health services, research advances and
Index of Sec 2588. ...CAREER and education choices ; Mechanism for searching and comparing training and educational options for specific health care occupations to facilitate informed
Index of Sec 2590. ...EDUCATION fellowship in trauma or trauma-related specialties including neurological surgery ; 1 graduate medical
Index of Sec 2551. ...EDUCATION outreach and awareness campaign described in subsection ; Secretary establishing and implementing national pain care
Index of Sec 2563. ...EDUCATION program or programs selected from registry developed under subsection to be used to address risks in priority populations ; Identify evidence-based
Index of Sec 2526. ...EDUCATION program described in subsection ; Secretary establishing program consisting of making granting to State submiting application in accordance with subsection for evidence-based
Index of Sec 2526. ...EDUCATION programs ; Intensive summer institutes continuing
Index of Sec 2527. ...EDUCATION programs ; Demonstrating experience in implementing and operating online worker skills training and
Index of Sec 2591. ...EDUCATION programs to reduce teen pregnancy or sexually transmitted diseases ; Amounts received by State under section to be used to conduct or support evidence-based
Index of Sec 2526. ...WOMEN and infants ; Educational and clinical services to promote healthy pregnancies, full term births and healthy infancies delivered to
Index of Sec 2532. ...HEALTH Care Labor Market and related educational and training opportunities ; Sec 2590, Web Site on
Index of Sec 2590. ...HEALTH care labor market and related educational and training opportunities ;
Index of Sec 2590. ...EDUCATIONAL agencies for purpose of reducing student-to-school nurse ratio in public elementary and secondary schools ; Secretary of Education making demonstration grants to eligible local
Index of Sec 2536. ...EDUCATIONAL agencies demonstrating greatest need for new or additional nursing services among children in public elementary and secondary schools served by agency in part by providing information on current ratios of students to school nurses ; Secretary of Education giving special consideations to applications submitted by high-need local
Index of Sec 2536. ...EDUCATIONAL agency described in section 6211(b)(1) of Elementary and Secondary Education Act of 1965 20 USC 7345(b)(1) ; Term rural local educational agency meaning eligible local
Index of Sec 2524. ...EDUCATIONAL agency in which student-to-school nurse ratio in public elementary and secondary schools served by agency being 750 or more students to every school nurse ; Term eligible local educational agency meaning local
Index of Sec 2536. ...EDUCATIONAL agency having meaning given to term in section 9101 of Elementary and Secondary Education Act of 1965 20 USC 7801 ; Term local
Index of Sec 2533. ...EDUCATIONAL agency having meaning given to term in section 9101 of Elementary and Secondary Education Act of 1965 ; Term local
Index of Sec 2535. ...EDUCATIONAL agency and secondary school having meanings given to terms in section 9101 of Elementary and Secondary Education Act of 1965 20 USC 7801 ; Terms elementary school, local
Index of Sec 2536. ...EDUCATIONAL agency meaning local educational agency ; Term high-need local
Index of Sec 2536. ...EDUCATIONAL institution receiving grant under paragraph using grant ; Postsecations
Index of Sec 2591. ...EDUCATIONAL institutions and other workforce training organizations ; Grantees under paragraph conducting outreach activities to disseminate information about program and results to workforce investment boards, local governments,
Index of Sec 2591. ...EDUCATIONAL institutions to provide services described in paragraph ; Secretary awarding one or more grants to eligible postsecations
Index of Sec 2591. ...AUTISM ; Term interventions meaning educational methods and positive behavioral support strategies designed to improve or ameliorate symptoms associated with
Index of Sec 2527. ...CAREER and education choices ; Mechanism for searching and comparing training and educational options for specific health care occupations to facilitate informed
Index of Sec 2590. ...MEDICAL data and inserting transmission and electronic archival of medical data ; Subparagraph, striking transmission of
Index of Sec 2523. ...ELECTRONIC exchange and use in certified electronic health records of unique device identifier for covered device ; Hit Policy Committee established under section 3002 of Public Health Service Act 42 USC 300jj-12 recommending to head of Office of National Coordinator for Health Information Technology standards, implementation specifications and certification criteria for
Index of Sec 2571. ...ELECTRONIC exchange and use in certified electronic health records of unique device identifier for covered device referred in paragraph ; Secretary of Health and Human Services adopting standards, implementation specifications and certification criteria for
Index of Sec 2571. ...INFLUENZA vaccination Centers ; Demonstration Program using elementary and secondary Schools as
Index of Sec 2524. ...SCHOOL nurses ; Secretary awarding grants to eligible partnerships to be used to provide influenza vaccinations to children in elementary and secondary schools in coordination with
Index of Sec 2524. ...EDUCATIONAL agencies for purpose of reducing student-to-school nurse ratio in public elementary and secondary schools ; Secretary of Education making demonstration grants to eligible local
Index of Sec 2536. ...INFORMATION on current ratios of students to school nurses ; Secretary of Education giving special consideations to applications submitted by high-need local educational agencies demonstrating greatest need for new or additional nursing services among children in public elementary and secondary schools served by agency in part by providing
Index of Sec 2536. ...SCHOOL nurse ; Term eligible local educational agency meaning local educational agency in which student-to-school nurse ratio in public elementary and secondary schools served by agency being 750 or more students to every
Index of Sec 2536. ...HEALTH department or another health organization defined by Secretary as eligible to submit application and one or more elementary and secondary schools ; Term eligible partnership meaning local public
Index of Sec 2524. ...ELEMENTARY school and secondary school having meanings given terms in section 9101 of Elementary and Secondary Education Act of 1965 20 USC 7801 ; Terms
Index of Sec 2524. ...EDUCATIONAL agency and secondary school having meanings given to terms in section 9101 of Elementary and Secondary Education Act of 1965 20 USC 7801 ; Terms elementary school, local
Index of Sec 2536. ...ELEMENTARY schools and secondary schools as influenza vaccination centers ; Awarding grants to eligible partnerships to carry out demonstration programs designed to test feasibility of using Nation's
Index of Sec 2524. ...ELEMENTARY schools and secondary schools as part of multistate ; Assessment of utility of employing
Index of Sec 2524. ...ELIGIBILITY under programs and receiving services or other benefits of programs ; Assisting individuals in establishing
Index of Sec 2530. ...ELIGIBILITY for benefits ; 5-year vesting period for
Index of Sec 2581. ...ELIGIBILITY for receipt of Benefits ; Requirement to recertify
Index of Sec 2581. ...ELIGIBILITY for receipt of benefits ; Recertifying by submission of medical evidence beneficiary's continued
Index of Sec 2581. ...ELIGIBILITY for certain institutionalizeding Enrollees planning to Discharge ; Presumptive
Index of Sec 2581. ...ELIGIBILITY for another grant described in section ; Acquisition of grant under section 1241(b) not precluding trauma center's
Index of Sec 2551. ...ELIGIBILITY assessments of active enrollees applying for receipt of benefits ; Designating entity to serve as Eligibility Assessment System by providing for
Index of Sec 2581. ...ELIGIBILITY determination process as certified by licensed health care practitioner ; Secretary promulgating regulations to develop expedited nationally equitable
Index of Sec 2581. ...ELIGIBILITY requirements ; Community-based collaborative care network described in subsection being consortium of health care providers with joint governance structure providing comprehensive range of coordinated and integrated health care services for low-income patient populations or medically underserved communities and complying with applicable minimum
Index of Sec 2534. ...LABOR-management training funds as provided under section 302(c)(6) of Labor Management Relations Act, 1947 29 USC 186(c)(6) ; Health care entity jointly administered by health care employer and labor union representing health care employees of employer and carries out activities using
Index of Sec 2521. ...TRAINING programs ; State, local and private resources in order to expand participation of businesses, employees and individuals in
Index of Sec 2591. ...SUBJECT in capacity as employer to obligation under division A of Act and amendments making by division applicable to persons in capacity as employer ;
Index of Sec 2585. ...LABOR-management training funds as provided under section 302(c)(6) of Labor Management Relations Act, 1947 29 USC 186(c)(6) ; Health care entity jointly administered by health care employer and labor union representing health care employees of employer and carries out activities using
Index of Sec 2521. ...HEALTH care employees of employer and carries out activities using labor-management training funds as provided under section 302(c)(6) of Labor Management Relations Act, 1947 29 USC 186(c)(6) ; Health care entity jointly administered by health care employer and labor union representing
Index of Sec 2521. ...HEALTH care providers, regulators and third-party payors ; Lack of understanding and education among employers, patients,
Index of Sec 2561. ...MEDICAL device manufacturers and pharmaceutical companies ; Secretary consulting with organizations representing patients in pain and other consumers, employers, physicians including physicians specializing in pain care, other pain management professionals,
Index of Sec 2563. ...EMPLOYMENT, supported housing services, therapeutic foster care services, multisystemic therapy and other evidence-based practices as Secretary requiring ; Assertive community treatment, family psychoeducation, disability self-management, supported
Index of Sec 2513. ...CONTRACTS ; Employment or consulting
Index of Sec 2575. ...EMPLOYMENT ; Reporting for work at individual's usual place of employment or another location to which individual required to travel because of individual's
Index of Sec 2581. ...EMPLOYMENT or another location to which individual required to travel because of individual's employment ; Reporting for work at individual's usual place of
Index of Sec 2581. ...EMPLOYMENT obligations ; Sec 2585, States failing to adhere to certain
Index of Sec 2585. ...HEALTH ; Ethical and policy issues relating to women's
Index of Sec 2588. ...ASSESSMENT, diagnosis, treatment and management of pain ; Evaluating adequacy of assessment, diagnosis, treatment and management of acute and chronic pain in general population and identified racial ethnic, gender, aging and other demographic groups to be disproportionately affected by inadequacies in
Index of Sec 2561. ...NATURAL history of conditions and differences among racial and ethnic groups with respect to conditions ; Epidemiological studies to address frequency and
Index of Sec 2529. ...ETIOLOGY and causes of conditions ; Basic research concerning
Index of Sec 2529. ...DRUG ; Other statutory exclusivity preventing marketing of
Index of Sec 2573. ...CERTIFICATION as following ; Chief executive officer or company official responsible for negotiating agreement required to be filed by subparagraph including in filing under paragraph
Index of Sec 2575. ...EXPENDITURES attributable to aggregate cash benefit received by beneficiary during preceding year ; Submitting records of
Index of Sec 2581. ...ELEMENTARY schools and secondary schools as influenza vaccination centers ; Awarding grants to eligible partnerships to carry out demonstration programs designed to test feasibility of using Nation's
Index of Sec 2524. ...BEHAVIORAL health professionals being participants program and plan to work in field of mental and behavioral health ; Providing financial assistance to mental and
Index of Sec 2522. ...BEHAVIORAL health professionals being participants programming and plan to teach in field of mental and behavioral health ; Providing financial assistance in form of traineeships and fellowships to mental and
Index of Sec 2522. ...CATASTROPHIC event ; Need of financial assistance following natural disaster or other
Index of Sec 2551. ...DISSEMINATION of information developed as result of projects ; Providing for evaluations of projects carried out with financial assistance provided under paragraph and
Index of Sec 2588. ...FINANCIAL consequences resulting if pain being not appropriately assessed, diagnosed, treated or managed ; Societal and
Index of Sec 2563. ...FINANCIAL coordination among providers of care in community ; Information sharing and clinical and
Index of Sec 2534. ...FINANCIAL independence and live in community through new financing strategy for community living assistance services and supports ; Maintaining personal and
Index of Sec 2581. ...FINANCIAL interest ; Entity ensuring that active enrollee or beneficiary informed of
Index of Sec 2581. ...CAPITAL or operating expenses ; Financial support to be demonstrated by State or political subdivision funding for trauma center's
Index of Sec 2551. ...FINANCIAL support of State or political subdivision involved for activities to be funded through grant for fiscal year during that payments being made to center under grant ; Giving preference to application submitted by applicant demonstrating
Index of Sec 2551. ...FINANCIAL support for purposes of preferential treatment under subsection ; State funding derived from Federal support not constituting State or local
Index of Sec 2551. ...FINANCIAL sustainability ; Submitting to Secretary plan for achieving long-term
Index of Sec 2528. ...FINANCIAL sustainability of emergency care system ; Methods of assuring long-term
Index of Sec 2553. ...FINANCING mechanism ; Address institutional bias by providing
Index of Sec 2581. ...FINANCING strategy for community living assistance services and supports ; Maintaining personal and financial independence and live in community through new
Index of Sec 2581. ...FISCAL year ; Amounts appropriated to carry out that section for
Index of Sec 2522. ...FISCAL year ; Amount appropriated to carry out that section for
Index of Sec 2526. ...FISCAL year ; Amounts making available to State through grant under section for
Index of Sec 2526. ...FISCAL year only if State agreeing to provide amount equal to $1 for $4 provided through grant to carry out activities supported by grant ; Secretary awarding grant to State under section for
Index of Sec 2526. ...FISCAL year to make grant to national organization with demonstrated capacity for providing training and technical assistance ; Secretary reserving 2 percent of amount appropriated to carry out that subsection for
Index of Sec 2527. ...FISCAL year ; Funds received through grant under section for
Index of Sec 2532. ...FISCAL year during that payments being made to center under grant ; Giving preference to application submitted by applicant demonstrating financial support of State or political subdivision involved for activities to be funded through grant for
Index of Sec 2551. ...FISCAL year For which trauma center applying to receive grant or geographic areas where growth in demand for trauma services exceeding capacity ; Providing trauma care in geographic area in which availability of trauma care significantly decreasing as result of trauma center in area permanently ceasing participation in system described in section 1241(c)(1) as of date occurring during 2-year period preceding
Index of Sec 2551. ...FISCAL year under section 1245 ; Total amount appropriated for
Index of Sec 2551. ...FISCAL year ; Amount appropriated to carry out that section for
Index of Sec 2553. ...FISCAL year ; Total number of eligible beneficiaries during
Index of Sec 2581. ...FISCAL year ; Total amount of cash benefits provided during
Index of Sec 2581. ...FISCAL year ; Description of instances of fraud or abuse identified during
Index of Sec 2581. ...FISCAL year ; Excepting that Secretary waiving requirement for center and authorizing center to receive payments for 1 additional
Index of Sec 2551. ...FISCAL year and next 2 fiscal years ; Report to Congress not later than first day of April of year on operation and status of Class Independence Fund during preceding fiscal year and expected operation and status during current
Index of Sec 2581. ...FISCAL year ; Next 2 fiscal years and projected over 75-year period beginning with current
Index of Sec 2581. ...FISCAL year For which appropriations Act providing that amounts in fund under paragraph being available with respect to practitioners ; Applying with respect to volunteer practitioners beginning with first
Index of Sec 2586. ...FISCAL year and expected operation and status during current fiscal year and next 2 fiscal years ; Report to Congress not later than first day of April of year on operation and status of Class Independence Fund during preceding
Index of Sec 2581. ...FISCAL years ; Period during that trauma center receiving payments under grant under section 1241(b)(1) for 3
Index of Sec 2551. ...FISCAL years ; Report to Congress not later than first day of April of year on operation and status of Class Independence Fund during preceding fiscal year and expected operation and status during current fiscal year and next 2
Index of Sec 2581. ...FISCAL year ; Next 2 fiscal years and projected over 75-year period beginning with current
Index of Sec 2581. ...FISCAL year 2001 and following through period and inserting projects for fiscal year 2010 ; Subsection, striking projects for
Index of Sec 2523. ...FISCAL year 2010 ; Subsection, striking projects for fiscal year 2001 and following through period and inserting projects for
Index of Sec 2523. ...FISCAL year 2011 ; Subsection, striking authorized and following through period and inserting authorized to be appropriated $70,000,000 for
Index of Sec 2525. ...FISCAL year limitation ; Amounts holding in Fund appropriated and remaining available without
Index of Sec 2581. ...FOOD described in subclause ; Excepting for
Index of Sec 2572. ...FOOD offering sign ; Place adjacent to
Index of Sec 2572. ...FOOD establishment being not part of chain with 20 or more locations doing business under same name and offering for sale substantially same menu items unless restaurant or similar retail food establishment complying with voluntary provision of nutrition information requirements under section 403(q)(5)(h)( ix ; Section 403a(a)(4) of Federal Food, Drug and Cosmetic Act 21 USC 343-1(a)(4) amended by striking excepting requirement for nutrition labeling of food being exempt under subclause or section 403(q)(5)(a) and inserting excepting that paragraph not applying to food offered for sale in restaurant or similar retail
Index of Sec 2572. ...CALORIES contained in article ; Vending machine operator providing sign in close proximity to article of food or selection button including clear and conspicuous statement disclosing number of
Index of Sec 2572. ...FOOD being standard menu item offered for sale in restaurant or similar retail food establishment being part of chain with 20 or more locations doing business under same name and offering for sale substantially same menu items ; Case of
Index of Sec 2572. ...FOOD on display and visible to customers ; Case of food selling at salad bar, buffet line, cafeteria line or similar self-service facility and self-service beverages or
Index of Sec 2572. ...FOOD selling from vending machine ; Case of article of
Index of Sec 2572. ...FOOD or component of food ; Applying to State or local requirement respecting statement in labeling of food providing for warning concerning safety of
Index of Sec 2572. ...FOOD being part of cusations market test appearing on menu for less than 90 days ; Other
Index of Sec 2572. ...FOOD on display and visible to customers ; Case of food selling at salad bar, buffet line, cafeteria line or similar self-service facility and self-service beverages or
Index of Sec 2572. ...FOOD service workers, variations in ingredients and other factors ; Considering standardization of recipes and methods of preparation, reasonable variation in serving size and formulation of menu items, space on menus and menu boards, inadvertent human error, training of
Index of Sec 2572. ...CREDIT courses ; Developing mechanisms to provide training and technical assistance including for-
Index of Sec 2527. ...FRAUD and abuse under program ; Regulations including provisions to prevent
Index of Sec 2581. ...FRAUD and abuse in Class program ; Inspector General of Department of Health and Human Services submitting annual report to Secretary and Congress relating to overall progress of Class program and existence of waste,
Index of Sec 2581. ...FRAUD or abuse ; Conflicts of interest and not misusing benefits paid on behalf of beneficiaries or otherwise engaging in
Index of Sec 2581. ...FISCAL year ; Description of instances of fraud or abuse identified during
Index of Sec 2581. ...FRAUD or abuse ; Recommendations for administrative or legislative action as Secretary determining being necessary to improve program or preventing occurrence of
Index of Sec 2581. ...FUNCTIONAL ability and not more than 6 ; Benefit amount being varied based on scale of
Index of Sec 2581. ...FUNCTIONAL limitation described in section 3203(a)(1)(c) expected to last for continuous period of more than 90 days ; Date described in subparagraph being date on which individual determined to have
Index of Sec 2581. ...FUNCTIONAL limitation described in following clauses expected to last for continuous period of more than 90 days ; Individual having
Index of Sec 2581. ...HEALTH and functional status of patient receiving MTM services ; Performing or obtaining necessary assessments of
Index of Sec 2528. ...FUNCTIONAL status of beneficiary before end of 12-month benefit period to be included in determination of applicable annual benefit paid to eligible beneficiary ; Increase or decrease as result of change in
Index of Sec 2581. ...PUBLIC awareness campaign under section in educating general public with respect to matters described in subsection ; Secretary preparing and submitting to Congress report evaluating effectiveness of
Index of Sec 2563. ...GENERAL policies followed in managing Class Independence Fund and recommending changes in policies ; Reviewing
Index of Sec 2581. ...GENERAL policy in administration of Class program established under title and formulation of regulations under title including with respect ; Class Independence Advisory Council advising Secretary on matters of
Index of Sec 2581. ...ASSESSMENT, diagnosis, treatment and management of pain ; Evaluating adequacy of assessment, diagnosis, treatment and management of acute and chronic pain in general population and identified racial ethnic, gender, aging and other demographic groups to be disproportionately affected by inadequacies in
Index of Sec 2561. ...GENERAL population versus in population of individuals with inadequate health insurance coverage ; Prevalence of certain chronic conditions in various populations including comparison of prevalence in
Index of Sec 2534. ...GENERAL statements of policy with respect to practices prohibited under paragraph ; Rules including interpretive rules and
Index of Sec 2573. ...GENERIC competitors making reverse payments ; Intent of 1984 Act subverted by certain settlement agreements between brand companies and potential
Index of Sec 2573. ...GENERIC drugs when preserving incentives for innovation ; Drug Price Competition and patenting Term Restoration Act enacted with intent of facilitating early entry of
Index of Sec 2573. ...GENERIC drugs ; 67 percent of prescriptions dispensed in United States being
Index of Sec 2573. ...GENERIC drugs contrary to free competition and interests of consumers ; Settlement agreements unduly delaying marketing of low-cost
Index of Sec 2573. ...GENERIC drugs ; Limit, delay or otherwise preventing competition from
Index of Sec 2573. ...GENERIC drugs ; Beginning 2 years after date of enactment of Act and year for period of 4 years Comptroller General conducting studying on litigation in United States courting during period beginning 5 years prior to date of enactment of Act relating to patent infringement claims involving
Index of Sec 2573. ...GEOGRAPHIC area served by Coordinated Care Network ; Federally qualified health centers of Social Security Act 42 USC 1395x( aa located in
Index of Sec 2534. ...GEOGRAPHIC area where growth in demand for trauma services exceeding capacity ;
Index of Sec 2551. ...FISCAL year For which trauma center applying to receive grant or geographic areas where growth in demand for trauma services exceeding capacity ; Providing trauma care in geographic area in which availability of trauma care significantly decreasing as result of trauma center in area permanently ceasing participation in system described in section 1241(c)(1) as of date occurring during 2-year period preceding
Index of Sec 2551. ...GEOGRAPHIC area ; Incurring substantial uncompensated care costs in amount rendering center unable to continue participation in system and results in significant decrease in availability of trauma care in
Index of Sec 2551. ...GEOGRAPHIC areas where growth in demand for trauma services exceeding capacity ; Providing trauma care in geographic area in which availability of trauma care significantly decreasing as result of trauma center in area permanently ceasing participation in system described in section 1241(c)(1) as of date occurring during 2-year period preceding fiscal year For which trauma center applying to receive grant or
Index of Sec 2551. ...GEOGRAPHIC areas and populations to be served by network and including following ; Criteria varying based on needs of
Index of Sec 2534. ...GEOGRAPHIC coverage in rural or medically underserved areas of State or States in which entity located ; Eligible entity demonstrating broad
Index of Sec 2523. ...CATASTROPHIC event ; Geographic location substantially affected by natural disaster or other
Index of Sec 2551. ...GEOGRAPHY ; Report on populations using trauma care centering and including aggregate patient data on income, race, ethnicity and
Index of Sec 2551. ...GOVERNANCE requirements under section 330 of Public Health Service Act 42 USC 254b ; Participation in community-based collaborative care network not affecting federally qualified health centers' obligation to comply with
Index of Sec 2534. ...GOVERNANCE structure of community-based collaborative care network in manner so being clear why decisions to be made and decisionmaking process of network including appropriate representation of participating entities ; Including description of organizational and joint
Index of Sec 2534. ...ELIGIBILITY requirements ; Community-based collaborative care network described in subsection being consortium of health care providers with joint governance structure providing comprehensive range of coordinated and integrated health care services for low-income patient populations or medically underserved communities and complying with applicable minimum
Index of Sec 2534. ...GUIDANCE regarding effective strategies to promote positive health behaviors within family ; Educating and providing
Index of Sec 2530. ...GUIDANCE ; Secretary establishing process through public providing Secretary with input regarding priorities for issuing
Index of Sec 2575. ...GUIDANCE including description ;
Index of Sec 2575. ...DRUGGING Administration ; Other reasonable means coding of Federal Regulations or related guidance of Food and
Index of Sec 2572. ...GUIDANCE ; Secretary providing public opportunity to comment on proposed guidance issued under subparagraph before issuing final
Index of Sec 2575. ...GUIDANCE under subparagraph not precluding review of application submitted under subsection ; Issuance of
Index of Sec 2575. ...GUIDANCE describing methodologies and options available to covered entities for billing covered drugs to State Medicaid agencies in manner avoiding duplicate discounts pursuant to subsection ; Development of more detailed
Index of Sec 2502. ...GUIDANCE issued under subparagraph before issuing final guidance ; Secretary providing public opportunity to comment on proposed
Index of Sec 2575. ...GUIDANCE document under clause ; Secretary issuing subsequent guidance document under subparagraph to modify or reverse
Index of Sec 2575. ...GUIDANCE document ; Clause not to be construed to require Secretary to approve product with respect to which Secretary not indicating in
Index of Sec 2575. ...GUIDANCE document under clause ; Secretary issuing subsequent guidance document under subparagraph to modify or reverse
Index of Sec 2575. ...HABILITATION services and respite care waiver or State plan amendment ; State to be paid remainder of beneficiary's daily or weekly cash benefit under subclause only if State home and community-based waiver under section 1115 of Social Security Act or subsection or section 1915 of Act or State plan amendment under subsection of section not including waiver of requirements of section 1902(a)(1) of Social Security Act or section 1902(a) of Act and State offers at minimum case management services, personal care services,
Index of Sec 2581. ...HEALTH and mental health services ; Communities or populations in which children and adolescents having difficulty accessing
Index of Sec 2511. ...HEALTH professionals in accordance with State and local laws and regulations ; Providing comprehensive primary health services during school hours to children and adolescents by
Index of Sec 2511. ...HEALTH professionals ; Direct access to client-centered services offered by advanced practice nurses, other nurses, physicians, physician assistants or other qualified
Index of Sec 2512. ...CHRONIC conditions by teaching more effective management techniques focusing on individual self-care and patient-driven decisionmaking ; Term wellness services meaning health-related service or intervention designed to reduce identifiable health risks and increase healthy behaviors intended to prevent onset of disease or lessening impact of existing
Index of Sec 2512. ...HEALTH professional shortage area as designated under section 332 ;
Index of Sec 2530. ...HEALTH professionals ; Weight scales, mammography equipment, x-ray machines and other equipment commonly used for diagnostic or examination purposes by
Index of Sec 2592. ...COGNITIVE impairment ; Individual requiring substantial supervision to protect individual from threats to health and safety due to substantial
Index of Sec 2581. ...HEALTH and wellness services including services for tobacco cesations ;
Index of Sec 2513. ...HEALTH or health-related social services to individuals being underserved with respect to services ; Experience in providing
Index of Sec 2530. ...HEALTH providers when school or SBHC closed ; SBHC providing onsite access during academic day when school in session and established network of support and access to services with backup
Index of Sec 2511. ...HEALTH with fewer hospitalizations and emergency room visits than similar patients not enrolled in program ; Including evaluation whether enrollees maintained better
Index of Sec 2528. ...HEALTH professionals ; Conducting study on barriers experienced by veterans received training as medical personnel when serving in Armed Forces of United States and seeking to become licensed or certified in State as civilian
Index of Sec 2554. ...HEALTH workers ; Grants awarded under subsection to be used to support community
Index of Sec 2530. ...HEALTH workers to enable workers to provide authorized program services ; Containing assurance program providing training and supervision to community
Index of Sec 2530. ...HEALTH worker program receiving funds under grant providing services in cultural context ; Community
Index of Sec 2530. ...HEALTH worker programs receiving funds under section to collaborate with academic institutions ; Secretary encouraging community
Index of Sec 2530. ...HEALTH worker programs receiving funding under section to implement outcome-based payment system ; Secretary encouraging community
Index of Sec 2530. ...COMPLIANCE with guidelines established under subsection ; Secretary monitoring community health worker programs identified in approved applications under section and determining whether programs in
Index of Sec 2530. ...HEALTH worker programs identified in approved applications under section with respect to planning, developing and operating programs under grant ; Secretary providing technical assistance to community
Index of Sec 2530. ...HEALTH worker programs developed or assisted under section ; Recommendations for sustaining community
Index of Sec 2530. ...HEALTH workers ; Recommendations regarding training to enhance career opportunities for community
Index of Sec 2530. ...HEALTH worker programs receiving funds under grant ; Applicant evaluating effectiveness of community
Index of Sec 2530. ...HEALTH and prenatal care ; Educating, guiding and providing home visitation services regarding maternal
Index of Sec 2530. ...DENTAL ; Section 319f(a)(5)(b) 42 USC 247d-6(a)(5)(b) amended by striking public health or medical and inserting public health, medical or
Index of Sec 2555. ...DENTAL ; Subparagraph of section 653(b)(4) of Post-Katrina Emergency Management Reform Act of 2006 amended by striking public health and medical and inserting public health, medical and
Index of Sec 2556. ...HEALTH and functional status of patient receiving MTM services ; Performing or obtaining necessary assessments of
Index of Sec 2528. ...HEALTH workers informing individuals about availability of safety net and primary care providers available through community-based collaborative care network ; Using neighborhood
Index of Sec 2534. ...HEALTH professionals available in community network serving ; Addressing appropriate minimum scope of work consistent with setting of network and
Index of Sec 2534. ...DENTAL ; Section 319f(a)(5)(b) 42 USC 247d-6(a)(5)(b) amended by striking public health or medical and inserting public health, medical or
Index of Sec 2555. ...DENTAL ; Subparagraph of section 653(b)(4) of Post-Katrina Emergency Management Reform Act of 2006 amended by striking public health and medical and inserting public health, medical and
Index of Sec 2556. ...HEALTH ; Requiring manufacturers of devices to submit information to registry if deemed necessary by Secretary to protect public
Index of Sec 2571. ...HEALTH of students on learning ; Including evaluation of effectiveness of program in improving student-to-school nurse ratios described in subsection and evaluation of impact of resulting enhanced
Index of Sec 2536. ...BIOLOGICAL product under subsection ; Secretary not licensing biological product under subsection unless Secretary determining to be no increased risk to security or health of public from licensing
Index of Sec 2575. ...HEALTH or nutrition within community in which individual residing ; Term community health worker meaning individual promoting
Index of Sec 2530. ...HEALTH workers under programs funded under section and assuring cost-effectiveness of programs ; Secretary establishing guidelines for assuring quality of training and supervision of community
Index of Sec 2530. ...HEALTH professional shortage area ; Eligible entity being health care provider in health care network furnishing services in medically underserved area or
Index of Sec 2523. ...HEALTH workers ; Secretary authorized to award grants to eligible entities to promote positive health behaviors for populations in medically underserved communities through use of community
Index of Sec 2530. ...HEALTH behaviors and outcomes ; Sec 2530, Grants to promote positive
Index of Sec 2530. ...HEALTH behaviors and outcomes ; Sec 399v, Grants to promote positive
Index of Sec 2530. ...HEALTH behaviors for populations in medically underserved communities through use of community health workers ; Secretary authorized to award grants to eligible entities to promote positive
Index of Sec 2530. ...HEALTH behaviors within family ; Educating and providing guidance regarding effective strategies to promote positive
Index of Sec 2530. ...HEALTH benefits in population ; Secretary determining that information relating to use of product in pediatric population producing
Index of Sec 2575. ...HEALTH care providers and accredited schools of nursing ; Increasing capacity for educating nurses by increasing nurse faculty and clinical opportunities through collaborative programs between staff nurse organizations,
Index of Sec 2521. ...HEALTH care labor organizations or other organizations representing staff nurses and frontline health care workers working in collaboration with accredited schools of nursing and academic institutions ; Providing training programs through education and training organizations jointly administered by health care providers and
Index of Sec 2521. ...HEALTH care employees of employer and carries out activities using labor-management training funds as provided under section 302(c)(6) of Labor Management Relations Act, 1947 29 USC 186(c)(6) ; Health care entity jointly administered by health care employer and labor union representing
Index of Sec 2521. ...HEALTH Care Employer described in subsection c ; Additional requirements for
Index of Sec 2521. ...HEALTH care providers ; Collaboration with accredited schools of nursing including community colleges and other academic institutions providing associate's, bachelor's or advanced nursing degree programs or specialty training or certification programs for nurses to carry out innovative nursing programs meeting needs of bedside nursing and
Index of Sec 2521. ...HEALTH care network furnishing services in medically underserved area or health professional shortage area ; Eligible entity being health care provider in
Index of Sec 2523. ...HEALTH care providers ; Enhancing community residents' ability effectively to communicate with
Index of Sec 2530. ...HEALTH care in State ; Amounts received by State as incentive payment under section to be used to improve
Index of Sec 2531. ...HEALTH care providers to coordinate efforts so ; Encouraging
Index of Sec 2534. ...HEALTH care providers participating in community-based collaborative care network proposed by applicant and reason ; Identify
Index of Sec 2534. ...HEALTH care provider from reimbursement under title XVIII, XIX or XXI of Social Security Act with respect to services otherwise reimbursable under title ; Participation in community-based collaborative care network not disqualifying
Index of Sec 2534. ...HEALTH care providers, regulators and third-party payors ; Lack of understanding and education among employers, patients,
Index of Sec 2561. ...HEALTH care ; Age, biological and sociocultural contexts including development of evidence reports and clinical practice protocols and conduct of research into patient outcomes, delivery of health care services, quality of care and access to
Index of Sec 2588. ...HEALTH care provider training ; Establishing short-range and long-range goals and objectives within Health Resources and servicing Administration for women's health and coordinate with other appropriate offices on activities within Administration relating to
Index of Sec 2588. ...HEALTH care plans covered by Affordable Health Care for America Act meet requirements of Americans with Disabilities Act and sectioning 504 ; Ensuring that health care providers and
Index of Sec 2592. ...HEALTH care workers ; Addressing projected shortage of nurses by funding comprehensive programs to create career ladder to nursing for incumbent ancillary
Index of Sec 2521. ...HEALTH care workers wishing to advance careers and otherwise carrying out purposes of section ; Secretary of Labor establishing partnership grant program to award grants to eligible entities to carry out comprehensive programs to provide education to nurses and creating pipeline to nursing for incumbent ancillary
Index of Sec 2521. ...HEALTH care ; Facilitating exchange of information regarding matters relating to health information, health promotion, preventive health services, research advances and education in appropriate use of
Index of Sec 2588. ...ELIGIBILITY requirements ; Community-based collaborative care network described in subsection being consortium of health care providers with joint governance structure providing comprehensive range of coordinated and integrated health care services for low-income patient populations or medically underserved communities and complying with applicable minimum
Index of Sec 2534. ...HEALTH care across settings including health care institutions ; Coordination of delivery of
Index of Sec 2522. ...HEALTH care workers or staff nurses and direct care health care workers or staff nurses having direct input as to leadership of organization ; One or more organizations representing interests of direct care
Index of Sec 2521. ...DRUGGING Administration for use in pediatric populations ; Program under section not restricting discretion of health care provider to administer influenza vaccine approved by Food and
Index of Sec 2524. ...HEALTH care workers working in collaboration with accredited schools of nursing and academic institutions ; Providing training programs through education and training organizations jointly administered by health care providers and health care labor organizations or other organizations representing staff nurses and frontline
Index of Sec 2521. ...CAREER ladder programs ; Provision of paid leave time and continued health coverage to incumbent health care workers to allow participation in nursing
Index of Sec 2521. ...HEALTH care workers to become nurses ; Carrying out programs providing education and training to establish nursing career ladders to educate incumbent
Index of Sec 2521. ...HEALTH care workers to participate in programs ; Providing stipends for release time and continued health care coverage to enable incumbent
Index of Sec 2521. ...HEALTH care workers to become nurses or established effective programs or pilots to increase nurse faculty ; Demonstrating success in upgrading incumbent
Index of Sec 2521. ...HEALTH care provider prescribing reference product ; Biological product to be substituted for reference product without intervention of
Index of Sec 2575. ...HEALTH care practitioner ; Secretary promulgating regulations to develop expedited nationally equitable eligibility determination process as certified by licensed
Index of Sec 2581. ...HEALTH care spending ; Prescription drugs making up 10 percent of national
Index of Sec 2573. ...EDUCATION ; Establishing short-range and long-range goals and objectives within Department of Health and Human Services and coordinate with other appropriate offices on activities within Department relating to disease prevention, health promotion, service delivery, research and public and health care professional
Index of Sec 2588. ...HEALTH care agencies and community-based programs and organizations in order to increase access to quality health care services ; Educating and referring underserved populations to appropriate
Index of Sec 2530. ...HEALTH care benefits or assistance ; Other health care benefits For which beneficiary being eligible under Medicaid or other federally funded program providing
Index of Sec 2581. ...HEALTH care benefits For which beneficiary being eligible under Medicaid or other federally funded program providing health care benefits or assistance ; Other
Index of Sec 2581. ...HEALTH care coverage to enable incumbent health care workers to participate in programs ; Providing stipends for release time and continued
Index of Sec 2521. ...HEALTH care decisions ; Injury or illness causing individual to be unable to make
Index of Sec 2581. ...HEALTH care decisions ; Injury or illness causing individual to be unable to make
Index of Sec 2581. ...HEALTH care delivery system characterized by effective collaboration ; Developing efficient and sustainable infrastructure for
Index of Sec 2534. ...HEALTH care delivery system ; Including provisions ensuring that individuals with disabilities receiving equal access to aspects of
Index of Sec 2592. ...HEALTH care employees of employer and carries out activities using labor-management training funds as provided under section 302(c)(6) of Labor Management Relations Act, 1947 29 USC 186(c)(6) ; Health care entity jointly administered by health care employer and labor union representing
Index of Sec 2521. ...HEALTH care entity whose mission to provide access to comprehensive primary health care services ; Nonprofit
Index of Sec 2511. ...EXPENDITURES ; Past decade being one of fastest growing segments of health care
Index of Sec 2573. ...HEALTH care field ; Information on types of jobs projected in high demand in
Index of Sec 2590. ...HEALTH care institutions ; Coordination of delivery of health care across settings including
Index of Sec 2522. ...HEALTH Care Labor Market and related educational and training opportunities ; Sec 2590, Web Site on
Index of Sec 2590. ...HEALTH care needs of vulnerable populations ; Supporting teaching programs addressing
Index of Sec 2522. ...HEALTH care network furnishing services in medically underserved area or health professional shortage area ; Eligible entity being health care provider in
Index of Sec 2523. ...HEALTH care occupations ; Awarding National Health Workforce Online Training Grants on competitive basis to eligible entities to enable entities to carry out training for individuals to attain or advance in
Index of Sec 2591. ...HEALTH care occupations including ; Entity providing online workforce training for individuals seeking to attain or advance in
Index of Sec 2591. ...CAREER and education choices ; Mechanism for searching and comparing training and educational options for specific health care occupations to facilitate informed
Index of Sec 2590. ...HEALTH care plans covered by Affordable Health Care for America Act meet requirements of Americans with Disabilities Act and sectioning 504 ; Ensuring that health care providers and
Index of Sec 2592. ...HEALTH care resources ; Eligible entity agreeing to use grant to promote greater efficiency in use of
Index of Sec 2523. ...HEALTH care services over nonclinical uses ; Eligible entity providing plan for coordinating system use by eligible entities and prioritizing use of grant funds for
Index of Sec 2523. ...HEALTH care services ; Nonprofit health care entity whose mission to provide access to comprehensive primary
Index of Sec 2511. ...HEALTH care services as required under subsection ; Failing to provide comprehensive range of coordinated and integrated
Index of Sec 2534. ...ELIGIBILITY requirements ; Community-based collaborative care network described in subsection being consortium of health care providers with joint governance structure providing comprehensive range of coordinated and integrated health care services for low-income patient populations or medically underserved communities and complying with applicable minimum
Index of Sec 2534. ...HEALTH care services ; Secretary defining criteria for evaluating whether services offered by community-based collaborative care network qualifying as comprehensive range of coordinated and integrated
Index of Sec 2534. ...HEALTH care services, quality of care and access to health care ; Age, biological and sociocultural contexts including development of evidence reports and clinical practice protocols and conduct of research into patient outcomes, delivery of
Index of Sec 2588. ...HEALTH care services ; Educating and referring underserved populations to appropriate health care agencies and community-based programs and organizations in order to increase access to quality
Index of Sec 2530. ...HEALTH center controlled network as defined by section 330(e)(1)(c) of Public Health Service Act ;
Index of Sec 2534. ...HEALTH center ; Other activities for planning, developing or operating nurse-managed
Index of Sec 2512. ...HEALTH center ; Assessing needs of medically underserved populations proposed to be served by nurse-managed
Index of Sec 2512. ...ASSESSMENT ; Designing services and operations of nurse-managed health center for populations based on
Index of Sec 2512. ...HEALTH center providing ; Secretary awarding grant under subsection to entity only if entity assuring that nurse-managed
Index of Sec 2512. ...HEALTH center having meaning given to term in section 801 ; Term nurse-managed
Index of Sec 2512. ...HEALTH centers participating in community-based collaborative care network not to be required to provide services beyond Federal Health Center scope of project approved by hrss ; Federally qualified
Index of Sec 2534. ...HEALTH centers to assist centers in meeting requirements of section ; Secretary providing technical and other assistance to nurse-managed
Index of Sec 2512. ...GEOGRAPHIC area served by Coordinated Care Network ; Federally qualified health centers of Social Security Act 42 USC 1395x( aa located in
Index of Sec 2534. ...HEALTH centers ; Nothing in section to be construed to expand medical malpractice liability protection under Federal Tort Claims acting for Section 330-funded federally qualified
Index of Sec 2534. ...HEALTH center program consisting of awarding grants to entities under subsection ; Secretary establishing nurse-managed
Index of Sec 2512. ...HEALTH center's operations ; Entity establishing community advisory committee composed of individuals to provide input into nurse-managed
Index of Sec 2512. ...GOVERNANCE requirements under section 330 of Public Health Service Act 42 USC 254b ; Participation in community-based collaborative care network not affecting federally qualified health centers' obligation to comply with
Index of Sec 2534. ...HEALTH clinic ; Term school-based health clinic meaning
Index of Sec 2511. ...HEALTH clinic meaning health clinic ; Term school-based
Index of Sec 2511. ...HEALTH clinics ; Secretary establishing school-based health clinic program consisting of awarding grants to eligible entities to support operation of school-based
Index of Sec 2511. ...HEALTH clinic program consisting of awarding grants to eligible entities to support operation of school-based health clinics ; Secretary establishing school-based
Index of Sec 2511. ...CAREER ladder programs ; Provision of paid leave time and continued health coverage to incumbent health care workers to allow participation in nursing
Index of Sec 2521. ...HEALTH coverage to staff nurses desiring to work full or part-time in faculty position ; Provision of paid release time, incentive compensation or continued
Index of Sec 2521. ...HEALTH department or another health organization defined by Secretary as eligible to submit application and one or more elementary and secondary schools ; Term eligible partnership meaning local public
Index of Sec 2524. ...HEALTH department submitting proposal to Secretary ; Term eligible entity meaning State, county, city, territorial or tribal
Index of Sec 2532. ...HEALTH disparities ; Eligible entity demonstrating project to be funded through grant addressing
Index of Sec 2523. ...HEALTH disparities having meaning given term in section 3171 ; Term
Index of Sec 2523. ...HEALTH disparities having meaning given to term in section 3171 of Public Health Service Act as added by section 2301 ; Term
Index of Sec 2537. ...BENEFICIAL health effect in judgment of Secretary and including Ways to enhance Children's Activity and Nutrition program and curriculum of National Institutes of Health ; Term evidence-based means methodologically sounding research demonstrating
Index of Sec 2535. ...HEALTH measures and evaluation methodologies ; Evaluating effectiveness and efficiency of trauma care center activities using standard public
Index of Sec 2551. ...CHRONIC care management ; Requiring services provided by community-based collaborative care network to include support services appropriate to meet health needs of low-income populations in network's community including
Index of Sec 2534. ...HEALTH needs of communities served by SBHCS ; Operational and administrative support and provision of information to SBHCS of variety of resources available under title and resources to be best used to meet
Index of Sec 2511. ...HEALTH centers ; Operational and administrative support and provision of information to nurse-managed health centers regarding various resources available under section and resources besting to be used to meet health needs of communities served by nurse-managed
Index of Sec 2512. ...HEALTH organization defined by Secretary as eligible to submit application and one or more elementary and secondary schools ; Term eligible partnership meaning local public health department or another
Index of Sec 2524. ...HEALTH policy accurately to evaluate and address threat of diseases ; Report providing information necessary to enhance
Index of Sec 2587. ...HEALTH problems prevalent in medically underserved communities ; Educating, guiding and providing outreach in community setting regarding
Index of Sec 2530. ...HEALTH profession meaning profession of member of health workforce as added by section 2261 ; Term
Index of Sec 2533. ...HEALTH professions, specialties and subspecialties ; Term interdiscipations meaning collaboration across
Index of Sec 2522. ...HEALTH professions ; Establishing health sciences training program consisting of awarding granting and contracting under subsection to prepare secondary school students for careers in
Index of Sec 2533. ...HEALTH professions-related majors ; Including curricula in biology, chemistry, physiology, mathematics, nutrition and other courses deemed appropriate by Secretary to prepare students for associate or bachelor's degree programs in health professions or bachelor's degree programs in
Index of Sec 2533. ...HEALTH professions ; Programs to increase awareness of careers in
Index of Sec 2533. ...HEALTH professions or bachelor's degree programs in health professions-related majors ; Including curricula in biology, chemistry, physiology, mathematics, nutrition and other courses deemed appropriate by Secretary to prepare students for associate or bachelor's degree programs in
Index of Sec 2533. ...HEALTH professions schooling ; Activities under grant or contract to be carried out in partnership with accredited
Index of Sec 2533. ...HEALTH professions training Program clearinghouse ; Online
Index of Sec 2591. ...HEALTH professions school including accredited school or program of psychology ; Accredited
Index of Sec 2522. ...EDUCATION ; Establishing short-range and long-range goals and objectives within Department of Health and Human Services and coordinate with other appropriate offices on activities within Department relating to disease prevention, health promotion, service delivery, research and public and health care professional
Index of Sec 2588. ...EDUCATION in appropriate use of health care ; Facilitating exchange of information regarding matters relating to health information, health promotion, preventive health services, research advances and
Index of Sec 2588. ...HEALTH records of unique device identifier for covered device ; Hit Policy Committee established under section 3002 of Public Health Service Act 42 USC 300jj-12 recommending to head of Office of National Coordinator for Health Information Technology standards, implementation specifications and certification criteria for electronic exchange and use in certified electronic
Index of Sec 2571. ...HEALTH records of unique device identifier for covered device referred in paragraph ; Secretary of Health and Human Services adopting standards, implementation specifications and certification criteria for electronic exchange and use in certified electronic
Index of Sec 2571. ...HEALTH records and other data deemed appropriate by Secretary ; Standardizing analytic files allowing for pooling and analysis of data from disparate data environments, electronic
Index of Sec 2571. ...HEALTH resources and servicing administration office of women's health ;
Index of Sec 2588. ...CHRONIC conditions by teaching more effective management techniques focusing on individual self-care and patient-driven decisionmaking ; Term wellness services meaning health-related service or intervention designed to reduce identifiable health risks and increase healthy behaviors intended to prevent onset of disease or lessening impact of existing
Index of Sec 2512. ...HEALTH professions ; Establishing health sciences training program consisting of awarding granting and contracting under subsection to prepare secondary school students for careers in
Index of Sec 2533. ...HEALTH services with appropriate school personnel and other community providers co-located at school ; SBHC to be integrated into school environment and coordinating
Index of Sec 2511. ...HEALTH services on prepaid basis ; Entity providing
Index of Sec 2511. ...HEALTH Services ; Regulations regarding reimbursement for
Index of Sec 2511. ...HEALTH services on prepaid basis ; Entity providing
Index of Sec 2512. ...AUTISM ; Term treatments meaning health services designed to improve or ameliorate symptoms associated with
Index of Sec 2527. ...HEALTH services ; Access and appropriately using
Index of Sec 2534. ...HEALTH services on prepaid basis ; Entity providing
Index of Sec 2535. ...HEALTH services and medical effectiveness research for issues of particular concern to women ; Establishing short-range and long-range goals and objectives within Agency for research important to women's health and coordinate with other appropriate offices on activities within Agency relating to
Index of Sec 2588. ...HEALTH services and health-related social services under Federal ; Describing plans to enhance capacity of individuals to utilize
Index of Sec 2530. ...HEALTH infrastructure for children and adolescents ; Term medically underserved children and adolescents meaning population of children and adolescents being residents of area designated by Secretary as area with shortage of personal health services and
Index of Sec 2511. ...HEALTH services and supports and assisting States in developing comprehensive State workforce development plan with respect to workforce ; Making recommendations to other Federal entities regarding appropriate and effective means of identifying, promoting and implementing investments in direct care workforce necessary to meet growing demand for long-term
Index of Sec 2589. ...HEALTH services meaning core servicing offered by SBHCS ; Term comprehensive primary
Index of Sec 2511. ...HEALTH professionals in accordance with State and local laws and regulations ; Providing comprehensive primary health services during school hours to children and adolescents by
Index of Sec 2511. ...HEALTH services and eliminating duplicative care ; Including preventive
Index of Sec 2530. ...EDUCATION in appropriate use of health care ; Facilitating exchange of information regarding matters relating to health information, health promotion, preventive health services, research advances and
Index of Sec 2588. ...HEALTH services in section 330(b)(1) ; Term comprehensive primary care services having meaning given to term required primary
Index of Sec 2512. ...HEALTH services ; Entity receiving funds under title V of Social Security Act for provision of
Index of Sec 2501. ...HEALTH status and reducing long-term complications and costs ; Including screening and counseling in order to improve
Index of Sec 2534. ...HEALTH workforce as added by section 2261 ; Term health profession meaning profession of member of
Index of Sec 2533. ...HEALTH ; Agency for healthcare Research and quality activities regarding women's
Index of Sec 2588. ...HOME or another residential setting of choice in community ; Her independence at
Index of Sec 2581. ...ACTUARIAL science, economics and other relevant disciplines as determined by Secretary ; Family caregivers of individuals requiring servicing and supporting to maintain independence at home or another residential setting of choice in community, individuals with expertise in long-term care or disability insurance,
Index of Sec 2581. ...HOME and community-based waiver authorized for State under section 1115 of Social Security Act or subsection or section 1915 of acting or State plan amendment under subsection of section ; Term home and community-based services meaning services to be offered under
Index of Sec 2581. ...HABILITATION services and respite care waiver or State plan amendment ; State to be paid remainder of beneficiary's daily or weekly cash benefit under subclause only if State home and community-based waiver under section 1115 of Social Security Act or subsection or section 1915 of Act or State plan amendment under subsection of section not including waiver of requirements of section 1902(a)(1) of Social Security Act or section 1902(a) of Act and State offers at minimum case management services, personal care services,
Index of Sec 2581. ...HOME and community-based services meaning services to be offered under home and community-based waiver authorized for State under section 1115 of Social Security Act or subsection or section 1915 of acting or State plan amendment under subsection of section ; Term
Index of Sec 2581. ...HOME or community organization located in neighborhood in which participant residing ; Term community setting meaning
Index of Sec 2530. ...HEALTH and prenatal care ; Educating, guiding and providing home visitation services regarding maternal
Index of Sec 2530. ...HOSPITAL as defined by section 1886(d)(1)(b) of Social Security Act ; Hospital being subsection
Index of Sec 2501. ...HOSPITAL described in subparagraph ;
Index of Sec 2501. ...HOSPITAL or nursing facility or institution for mental diseases and receiving medical assistance under Medicaid ; Patient in
Index of Sec 2581. ...DISCHARGE from hospital, facility or institution ; Planning to discharge from hospital, facility or institution or 60 days from date of
Index of Sec 2581. ...HOSPITAL, nursing facility, intermediate care facility for mentally retarded or institution for mental diseases ; Beneficiary being patient in
Index of Sec 2581. ...HOSPITAL, nursing facility, intermediate care facility for mentally retarded or institution for mental diseases ; Beneficiary receiving assistance under Medicaid for Pace program services being patient in
Index of Sec 2581. ...HOSPITAL and interfacility decisions and relevant outcomes of hospital care ; Containing information sufficient to evaluate key elements of prehospital care, hospital destination decisions, including initial
Index of Sec 2553. ...CANCER hospital excluded from Medicare prospective payment system pursuant to section 1886(d)(1)(b)(v) of Social Security Act meeting requirements of subparagraph ; Children's hospital excluded from Medicare prospective payment system pursuant to section 1886(d)(1)(b)( iii of Social Security Act or free-standing
Index of Sec 2501. ...HOSPITAL as defined by section 1886(d)(1)(b) of Social Security Act ; Hospital being subsection
Index of Sec 2501. ...HOSPITAL care ; Containing information sufficient to evaluate key elements of prehospital care, hospital destination decisions, including initial hospital and interfacility decisions and relevant outcomes of
Index of Sec 2553. ...HOSPITAL and interfacility decisions and relevant outcomes of hospital care ; Containing information sufficient to evaluate key elements of prehospital care, hospital destination decisions, including initial
Index of Sec 2553. ...HOSPITAL destination decisions ; Emergency department capacity, on-call specialist coverage, ambulance diversion status and coordination of tracking with regional communications and
Index of Sec 2553. ...HOSPITAL resources including inpatient bed capacity ; Allowing for tracking of prehospital and
Index of Sec 2553. ...HOSPITALIZATIONS and emergency room visits than similar patients not enrolled in program ; Including evaluation whether enrollees maintained better health with fewer
Index of Sec 2528. ...HOUSING assistance programs or supplemental nutrition assistance program established under Food and Nutrition Act of 2008 ; XVI, XVIII, XIX or XXI of Social Security Act under laws administered by Secretary of Veterans Affairs under low-income
Index of Sec 2581. ...HOUSING services, therapeutic foster care services, multisystemic therapy and other evidence-based practices as Secretary requiring ; Assertive community treatment, family psychoeducation, disability self-management, supported employment, supported
Index of Sec 2513. ...IDENTIFICATION of amounts used for patient care services ; Including
Index of Sec 2534. ...CHARGEBACKS for drugs ; Manufacturers and wholesalers using identification system developed by Secretary for purposes of facilitating ordering, purchasing and delivery of covered drugs under section including processing of
Index of Sec 2502. ...CHARGEBACKS for drugs ; Universal and standardized identification system by which covered entity site to be identified by manufacturers, distributors, covered entities and Secretary for purposes of facilitating ordering, purchasing and delivery of covered drugs under section including processing of
Index of Sec 2502. ...HEALTH on date of enactment of section ; Director of Office assuming authority for development, implementation, administration and evaluation of projects carried out through Health Resources and servicing Administration relating to women's
Index of Sec 2588. ...IMPLEMENTATION of item ; Secretary publishing notice in Federal Register specifying terms and conditions for
Index of Sec 2572. ...DISSEMINATION and implementation of pharmacist-delivered MTM services ; Chronic disease groups and other stakeholders involved with research,
Index of Sec 2528. ...IMPLEMENTATION of registry under section 519(g) of Federal Food, Drug and Cosmetic Act as added by paragraphing without regard whether final regulations to establish and operate registry promulgated by date ; Secretary of Health and Human Services establishing and beginning
Index of Sec 2571. ...IMPLEMENTATION of public awareness campaign under section ; Secretary making awards of grants, cooperative agreements and contracts to public agencies and private nonprofit organizations to assist with development and
Index of Sec 2563. ...IMPLEMENTATION ; Developing systems and products allowing for interventions, services, treatments and supports to be evaluated for fidelity of
Index of Sec 2527. ...CERTIFICATION criteria for electronic exchange and use in certified electronic health records of unique device identifier for covered device ; Hit Policy Committee established under section 3002 of Public Health Service Act 42 USC 300jj-12 recommending to head of Office of National Coordinator for Health Information Technology standards, implementation specifications and
Index of Sec 2571. ...CERTIFICATION criteria for electronic exchange and use in certified electronic health records of unique device identifier for covered device referred in paragraph ; Secretary of Health and Human Services adopting standards, implementation specifications and
Index of Sec 2571. ...BIOSIMILAR product in method of treatment indicated in application ; Use, sale or offer for sale within United States or importation into United States of biosimilar product or materials used in manufacture of biosimilar product or due to use of
Index of Sec 2575. ...COMPLIANCE ; Imposition of monetary penalty to be insufficient reasonably to ensure
Index of Sec 2502. ...CONTRIBUTIONS ; Secretary of Education requiring recipients of grants under subsection to provide matching funds from non-Federal sources and permitting recipients to match funds in whole or part with in-kind
Index of Sec 2536. ...INCENTIVE Grants regarding coordination among States ;
Index of Sec 2523. ...HEALTH care in State ; Amounts received by State as incentive payment under section to be used to improve
Index of Sec 2531. ...INCENTIVE payment under section ; Secretary providing technical assistance to States applying or receiving
Index of Sec 2531. ...INCOME meaning student, age 5 through 19, eligible for free or reduced-price lunch under National School Lunch Act 42 USC 1751 et seq ; Term low-
Index of Sec 2524. ...INCOME to receive efficient and higher quality care and gaining entry and receiving services from comprehensive system of care ; Including uninsured and low-
Index of Sec 2534. ...INCOME individuals and families ; Providing mechanisms for improving quality and efficiency of care for low-
Index of Sec 2534. ...INCOME individuals ; Including capability to provide broadest range of services to low-
Index of Sec 2534. ...ELIGIBILITY requirements ; Community-based collaborative care network described in subsection being consortium of health care providers with joint governance structure providing comprehensive range of coordinated and integrated health care services for low-income patient populations or medically underserved communities and complying with applicable minimum
Index of Sec 2534. ...INCOME patients as demonstrated by meeting criteria in section 1923(b)(1) of Social Security Act ; Safety net hospital providing services to high volume of low-
Index of Sec 2534. ...INCOME and uninsured patients ; Other type of provider specified by Secretary having desire to serve low-
Index of Sec 2534. ...GEOGRAPHY ; Report on populations using trauma care centering and including aggregate patient data on income, race, ethnicity and
Index of Sec 2551. ...HOUSING assistance programs or supplemental nutrition assistance program established under Food and Nutrition Act of 2008 ; XVI, XVIII, XIX or XXI of Social Security Act under laws administered by Secretary of Veterans Affairs under low-income
Index of Sec 2581. ...INCOME from investments ; Including additional amounts derived as
Index of Sec 2581. ...INCOME to Class Independence Fund for year projected to be insufficient with respect to 20-year period begining with year ; Monthly premiums and
Index of Sec 2581. ...CHRONIC care management ; Requiring services provided by community-based collaborative care network to include support services appropriate to meet health needs of low-income populations in network's community including
Index of Sec 2534. ...INDIVIDUALAND family-centered approach used ; Including individuals with autism and families as part of program to ensure that
Index of Sec 2527. ...INFANT mortality in United States in past 3 years ; Secretary giving preference to eligible entities proposing to serve 15 counties or groups of counties with highest rates of
Index of Sec 2532. ...INFANT mortality pilot program funded under section ;
Index of Sec 2532. ...INFANT mortality pilot program ; Entitying that receiving grant under subsection submitting report to Secretary detailing
Index of Sec 2532. ...INFANT mortality pilot programs ; Awarding grants to eligible entities to create, implement and oversee
Index of Sec 2532. ...INFANT mortality pilot programs funded through section ;
Index of Sec 2532. ...INFLUENZA vaccination Centers ; Demonstration Program using elementary and secondary Schools as
Index of Sec 2524. ...INFLUENZA vaccination centers ; Awarding grants to eligible partnerships to carry out demonstration programs designed to test feasibility of using Nation's elementary schools and secondary schools as
Index of Sec 2524. ...INFLUENZA vaccination rates for school-aged children including whether school-based vaccination assists in achieving recommendations of Advisory Committee on Immunization Practices ; Comparing to national average
Index of Sec 2524. ...INFLUENZA vaccinations ; State Medicaid agencies, State insurance agencies and private insurers to carry out program consisting of awarding grants under subsection to ensure that children having coverage for reasonable and cusations expenses relating to
Index of Sec 2524. ...INFLUENZA vaccinations to children in elementary and secondary schools in coordination with school nurses ; Secretary awarding grants to eligible partnerships to be used to provide
Index of Sec 2524. ...INFLUENZA vaccinations ; Eligible partnerships receiving grant using funds to purchase and administer
Index of Sec 2524. ...INFLUENZA vaccinations as following ; Eligible partnerships receiving grant under section ensuring maximum number of children access
Index of Sec 2524. ...INFLUENZA vaccine administered outside of physician's office in school or other related setting ; Including costs of purchasing and administering vaccine incurred when
Index of Sec 2524. ...INFLUENZA vaccine for children not covered through other federally funded programs or private insurance ; Extent to which payment of costs of purchasing or administering
Index of Sec 2524. ...INFLUENZA vaccine ; Children being eligible under other federally funded programs for payment of costs of purchasing or administering
Index of Sec 2524. ...DRUGGING Administration for use in pediatric populations ; Program under section not restricting discretion of health care provider to administer influenza vaccine approved by Food and
Index of Sec 2524. ...INFORMATION on Internet Web site of Department of Health and Human Services relating to section ; Development of procedures to enable and require covered entities to update annually
Index of Sec 2502. ...INFORMATION as Secretary ; Submitting application at time and containing
Index of Sec 2511. ...INFORMATION as Secretary requiring ; Eligible partnership desiring grant under section submitting application to Secretary at time and containing
Index of Sec 2524. ...ASSESSMENT and provision of supports and services ; Serving as research-based resource for Federal and State policymakers on information concerning provision of training and technical assistance for
Index of Sec 2527. ...INFORMATION, support services and resources and strategies designed to enhance patient adherence with therapeutic regimens ; Providing
Index of Sec 2528. ...INFORMATION ; Reports required under paragraph including
Index of Sec 2532. ...FINANCIAL coordination among providers of care in community ; Information sharing and clinical and
Index of Sec 2534. ...INFORMATION as specified by Secretary ; Community-based collaborative care network described in subsection submitting to Secretary application in form and manner and containing
Index of Sec 2534. ...INFORMATION ; Evaluation including
Index of Sec 2534. ...INFORMATION on current ratios of students to school nurses ; Secretary of Education giving special consideations to applications submitted by high-need local educational agencies demonstrating greatest need for new or additional nursing services among children in public elementary and secondary schools served by agency in part by providing
Index of Sec 2536. ...INFORMATION on number of trauma cases treated by center and extent to which center incuring uncompensated costs in providing trauma care ; Center maintaining
Index of Sec 2551. ...HOSPITAL and interfacility decisions and relevant outcomes of hospital care ; Containing information sufficient to evaluate key elements of prehospital care, hospital destination decisions, including initial
Index of Sec 2553. ...INFORMATION contained in report making under subsection ;
Index of Sec 2553. ...INFORMATION included in registry as described in subparagraph ; Validating methods for analyzing patient safety and outcomes data from multiple sources and linking data with
Index of Sec 2571. ...INFORMATION from public and private sources identified under paragraph ;
Index of Sec 2571. ...INFORMATION in registry ; Link data obtained under clause with
Index of Sec 2571. ...INFORMATION respecting covered device including claims data ; Term data refering to
Index of Sec 2571. ...INFORMATION to registry device ; Requiring manufacturers of devices to submit
Index of Sec 2571. ...HEALTH ; Requiring manufacturers of devices to submit information to registry if deemed necessary by Secretary to protect public
Index of Sec 2571. ...INFORMATION and comprehensive ; Establishing procedures to permit public access to information in registry in manner and form protecting patient privacy and proprations
Index of Sec 2571. ...INFORMATION described in subclauses ; Restaurant or similar retail food establishment disclosing
Index of Sec 2572. ...FOOD establishments ; Information required to be disclosed by restaurants and retail
Index of Sec 2572. ...DIETARY practices ; Disclosing for purpose of providing information to assist consumers in maintaining healthy
Index of Sec 2572. ...INFORMATION from agreements ; Modernization Act of 2003 21 USC 355 note or unaggregated
Index of Sec 2573. ...INFORMATION demonstrating ; Application submitted under subsection including
Index of Sec 2575. ...BIOLOGICAL product meeting standards described in paragraph ; Application submitted under subsection including information demonstrating that
Index of Sec 2575. ...BIOLOGICAL product ; Secretary determining that information submitted in application being sufficient to show that
Index of Sec 2575. ...INFORMATION submitted in application being sufficient to show ; Secretary determining biological product to be interchangeable with reference product if Secretary determining that
Index of Sec 2575. ...INFORMATION in application submitted under subsection ;
Index of Sec 2575. ...HEALTH benefits in population ; Secretary determining that information relating to use of product in pediatric population producing
Index of Sec 2575. ...INFORMATION ; Entity receiving confidential information pursuant to subsection designating one or more individuals to receive
Index of Sec 2575. ...BIOSIMILAR product ; Information including detailed description of
Index of Sec 2575. ...INFORMATION specified in subparagraph ; Applicant sending to individual designated by interested third party
Index of Sec 2575. ...INFORMATION pursuant to clause ; 90 days of date of receiving
Index of Sec 2575. ...INFORMATION regarding ; Agreement entered under subsection requiring entity to assign advice and assistance counselor providing eligible beneficiary with
Index of Sec 2581. ...INFORMATION about programing established under Assistive Technology Act of 1998 and services offered under programs ;
Index of Sec 2581. ...INFORMATION about ; Entity providing
Index of Sec 2581. ...HEALTH policy accurately to evaluate and address threat of diseases ; Report providing information necessary to enhance
Index of Sec 2587. ...HEALTH care field ; Information on types of jobs projected in high demand in
Index of Sec 2590. ...INFORMATION on training and educational opportunities within region for type of jobs described in paragraph ;
Index of Sec 2590. ...EDUCATIONAL institutions and other workforce training organizations ; Grantees under paragraph conducting outreach activities to disseminate information about program and results to workforce investment boards, local governments,
Index of Sec 2591. ...INFORMATION and evaluation ; Secretary using not more than 7 percent of funds appropriated to carry out that section for providing technical assistance to grantees holding meetings, developing of tools, disseminating of
Index of Sec 2534. ...DISCLOSURE under section 552 of title 5, United States Code and no ; Information or documentary material filed with Assistant Attorney General or Federal Trade Commission pursuant to paragraph to be exempt from
Index of Sec 2575. ...DISCLOSURE of information or documentary material to body of Congress or duly authorized committee or subcommittee of Congress ; Nothing in subparagraph preventing
Index of Sec 2575. ...INFORMATION regarding covered entities listed on Web site described in clause ; Development of procedures for Secretary to verify accuracy of
Index of Sec 2502. ...BIOLOGICAL product ; Including additional information in support of application including publicly available information with respect to reference product or another
Index of Sec 2575. ...INFORMATION described in item ; Prominent, clear and conspicuous statement regarding availability of
Index of Sec 2572. ...INFORMATION regarding Secretary's previous determination ; Including publicly available
Index of Sec 2575. ...BIOLOGICAL product ; Including additional information in support of application including publicly available information with respect to reference product or another
Index of Sec 2575. ...INFORMATION provided on menu ; Significance of caloric
Index of Sec 2572. ...INFORMATION concerning postpartum conditions including symptoms ; Ensuring that education including complete
Index of Sec 2529. ...INFORMATION used to calculate ceiling price as determined necessary to administer requirements of program under section ; Component
Index of Sec 2502. ...INFORMATION, searchable by workforce region ; Secretary of Labor establishing and maintaining Web site to serve as comprehensive source of
Index of Sec 2590. ...INFORMATION pursuant to subsection designating one or more individuals to receive information ; Entity receiving confidential
Index of Sec 2575. ...INFORMATION from applicant ; Identify 1 patent and designating individual executing agreement in accordance with paragraph to receive confidential
Index of Sec 2575. ...CONFIDENTIALITY of information received pursuant to subsection and using information solely for purposes authorized by subsection ; Regulations requiring individual to take reasonable steps to maintain
Index of Sec 2575. ...BIOSIMILAR product and production ; Applicant providing reference product sponsor with copy of application and information concerning
Index of Sec 2575. ...INFORMATION from reports received under paragraph ; Using data and
Index of Sec 2521. ...INFORMATION required to be provided under clause ; 60 days of date of receipt of
Index of Sec 2575. ...INFORMATION about ; Documenting care delivered and communicating essential
Index of Sec 2528. ...EDUCATION in appropriate use of health care ; Facilitating exchange of information regarding matters relating to health information, health promotion, preventive health services, research advances and
Index of Sec 2588. ...INFORMATION to Secretary or covered entities under section ; Applying to manufacturer with agreement under section and not exceeding $100,000 for instanceing where manufacturer knowingly charging covered entity price for purchase of drug exceeding maximum applicable price under subsection or knowingly violating other provision of section or withholding or providing false
Index of Sec 2502. ...INFORMATION including with respect to loan forgiveness ; Financial aid
Index of Sec 2590. ...INFORMATION ; Agreement described in paragraph requiring that manufacturer furnishing Secretary with reports on quarterly basis including following
Index of Sec 2502. ...EDUCATION in appropriate use of health care ; Facilitating exchange of information regarding matters relating to health information, health promotion, preventive health services, research advances and
Index of Sec 2588. ...INFORMATION of individual to government agencies ; Nothing in section requiring provider to report individually identifiable
Index of Sec 2534. ...INFORMATION on device in registry not providing useful information on safety or effectiveness ; Secretary by order exempt class III device from provisions of subsection if Secretary concluding that inclusion of
Index of Sec 2571. ...INFORMATION ; Prevalent language spoken based on latest Census
Index of Sec 2590. ...INFORMATION submitted pursuant to subparagraph with patient safety and outcomes data obtained under paragraph ; Permitting linkage of
Index of Sec 2571. ...INFORMATION required under clauses and subparagraph ; Nutrition
Index of Sec 2572. ...HEALTH needs of communities served by SBHCS ; Operational and administrative support and provision of information to SBHCS of variety of resources available under title and resources to be best used to meet
Index of Sec 2511. ...HEALTH centers regarding various resources available under section and resources besting to be used to meet health needs of communities served by nurse-managed health centers ; Operational and administrative support and provision of information to nurse-managed
Index of Sec 2512. ...INFORMATION as necessary to facilitate postmarket assessments of device safety and effectiveness and notification of device risks ; Requiring covered device manufacturers to submit other
Index of Sec 2571. ...INFORMATION Secretary determining appropriate ; Establishing requirements for regular and timely reports to Secretary concerning adverse event trends, adverse event patterns, incidence and prevalence of adverse events and other
Index of Sec 2571. ...INFORMATION in connection with safety of device under section ; Respect to entitying that submiting or required to submit safety report or other
Index of Sec 2571. ...DISSEMINATION of information developed as result of projects ; Providing for evaluations of projects carried out with financial assistance provided under paragraph and
Index of Sec 2588. ...INFORMATION and comprehensive ; Providing public access to data and analysis collected or developed through registry in manner and form protecting patient privacy and proprations
Index of Sec 2571. ...INFORMATION and comprehensive ; Establishing procedures to permit public access to information in registry in manner and form protecting patient privacy and proprations
Index of Sec 2571. ...INFORMATION ; Grantees under paragraph collecting and report
Index of Sec 2591. ...INFORMATION not to be construed to reflect necessarily conclusion by entity or Secretary ; Report or
Index of Sec 2571. ...INFORMATION provided on menu board ; Succinct statement concerning suggested daily caloric intake designed to enable public to understand significance of nutrition
Index of Sec 2572. ...AUTISM and families to address unmet needs related to autism ; Continuing education, technical assistance and information for purpose of improving services rendered to children and adults with
Index of Sec 2527. ...AUTISM and families to address unmet needs related to autism ; Continuing education, technical assistance and information for purpose of improving services rendered to children and adults with
Index of Sec 2527. ...INFORMATION on safety or effectiveness ; Secretary by order exempt class III device from provisions of subsection if Secretary concluding that inclusion of information on device in registry not providing useful
Index of Sec 2571. ...INFORMATION at point of purchase ; Not permitting prospective purchaser to examine Nutrition Facts panelling before purchasing article or not otherwise providing visible nutrition
Index of Sec 2572. ...COMPLIANCE with section as Secretary requiring ; State submitting application at time and containing information and assurance of
Index of Sec 2526. ...INFORMATION requirements under section 403(q)(5)(h)( ix ; Section 403a(a)(4) of Federal Food, Drug and Cosmetic Act 21 USC 343-1(a)(4) amended by striking excepting requirement for nutrition labeling of food being exempt under subclause or section 403(q)(5)(a) and inserting excepting that paragraph not applying to food offered for sale in restaurant or similar retail food establishment being not part of chain with 20 or more locations doing business under same name and offering for sale substantially same menu items unless restaurant or similar retail food establishment complying with voluntary provision of nutrition
Index of Sec 2572. ...INFRINGEMENT of patenting or filed patent application, extension, reissuance, renewal, division, continations, continations in part, reexamination, patent term restoration, patent of addition or extension ; Term patent infringement meaning
Index of Sec 2573. ...INFRINGEMENT of relevant patent ; Owns relevant patent or right to commence or participate in action for
Index of Sec 2575. ...INFRINGEMENT ; Interested third party owns or respect of which interested third party having right to commence or participate in action for
Index of Sec 2575. ...INFRINGEMENT involving Reference product Sponsor ; Action for
Index of Sec 2575. ...BIOSIMILAR product ; Reference product sponsor providing to applicant list of relevant patents owned by reference product sponsor or respect of which reference product sponsor having right to commence action of infringement or otherwise interest in patent as patent concerns
Index of Sec 2575. ...GENERIC drugs ; Beginning 2 years after date of enactment of Act and year for period of 4 years Comptroller General conducting studying on litigation in United States courting during period beginning 5 years prior to date of enactment of Act relating to patent infringement claims involving
Index of Sec 2573. ...FINANCING mechanism ; Address institutional bias by providing
Index of Sec 2581. ...INSURANCE funding in establishing multistate ; Assessment of feasibility of using existing Federal and private
Index of Sec 2524. ...HEALTH insurance including State Children's Health Insurance Program under title XXI of Social Security Act ; Educating and providing outreach regarding enrollment in
Index of Sec 2530. ...INSURANCE ; Extent to which payment of costs of purchasing or administering influenza vaccine for children not covered through other federally funded programs or private
Index of Sec 2524. ...INFLUENZA vaccinations ; State Medicaid agencies, State insurance agencies and private insurers to carry out program consisting of awarding grants under subsection to ensure that children having coverage for reasonable and cusations expenses relating to
Index of Sec 2524. ...HEALTH insurance coverage ; Prevalence of certain chronic conditions in various populations including comparison of prevalence in general population versus in population of individuals with inadequate
Index of Sec 2534. ...INSURANCE Program for purchasing community living assistance Services and Support ; Sec 2581, establishment of national VOLUNTARY
Index of Sec 2581. ...INSURANCE program for purchasing community living assistance services and supports in order ; Purpose of title to establish national voluntary
Index of Sec 2581. ...EDUCATION programs ; Intensive summer institutes continuing
Index of Sec 2527. ...INTERCHANGEABILITY for condition of use ; Review of application submitted under subsection relying on same reference product For which prior biological product receiving determination of
Index of Sec 2575. ...BEHAVIORAL health training program consisting of awarding granting and contracting under subsection ; Secretary establishing interdiscipations mental and
Index of Sec 2522. ...ASSESSMENT, interventions, services, treatment and supports for children and adults with autism ; Convening experts from multiple interdiscipations training programs, individuals with autism and families of individuals to discuss and make recommendations with regard to training issues related to
Index of Sec 2527. ...HEALTH professions, specialties and subspecialties ; Term interdiscipations meaning collaboration across
Index of Sec 2522. ...INTEREST ; Other activities to increase
Index of Sec 2533. ...INTEREST on amount specified in subparagraph ; Amount representing
Index of Sec 2551. ...BIOSIMILAR product ; Reference product sponsor providing to applicant list of relevant patents owned by reference product sponsor or respect of which reference product sponsor having right to commence action of infringement or otherwise interest in patent as patent concerns
Index of Sec 2575. ...INTEREST in relevant patent after date on which reference product sponsor providing list required by clause to applicant ; Reference product sponsor issued or acquiring
Index of Sec 2575. ...INTEREST in relevant patent after date on which interested third party providing list required by clause ; Issuing or acquiring
Index of Sec 2575. ...FRAUD or abuse ; Conflicts of interest and not misusing benefits paid on behalf of beneficiaries or otherwise engaging in
Index of Sec 2581. ...INTEREST between entity and active enrollee or beneficiary ; Entity established operating procedures designed to avoid or minimize conflicts of
Index of Sec 2581. ...GENERAL statements of policy with respect to practices prohibited under paragraph ; Rules including interpretive rules and
Index of Sec 2573. ...HEALTH and identify needs regarding coordination of activities including intramural and extramural multidiscipations activities ; Monitoring Department of Health and Human Services' offices, agencies and regional activities regarding women's
Index of Sec 2588. ...JURISDICTION in performance of functions transferred under paragraph ; Federal agency or official or court of competent
Index of Sec 2588. ...LABOR market and related educational and training opportunities ; Health care
Index of Sec 2590. ...LABOR organization ; Providing waging and benefiting to nurses being competitive for market or collectively bargained with
Index of Sec 2521. ...CAREER centers, community-based organizations, community colleges and accredited schools of nursing ; Labor organizations including joint labor-management training programs and including representatives from local governments worker investment agency one-stop
Index of Sec 2521. ...HEALTH care workers working in collaboration with accredited schools of nursing and academic institutions ; Providing training programs through education and training organizations jointly administered by health care providers and health care labor organizations or other organizations representing staff nurses and frontline
Index of Sec 2521. ...LABOR-management training funds as provided under section 302(c)(6) of Labor Management Relations Act, 1947 29 USC 186(c)(6) ; Health care entity jointly administered by health care employer and labor union representing health care employees of employer and carries out activities using
Index of Sec 2521. ...CAREER centers, community-based organizations, community colleges and accredited schools of nursing ; Labor organizations including joint labor-management training programs and including representatives from local governments worker investment agency one-stop
Index of Sec 2521. ...LABOR-management training fund administering program involved ; Contributions to joint
Index of Sec 2521. ...LABOR-management training fund or other jointly administered program ; Payment of tuition assistance managed by joint
Index of Sec 2521. ...LEGISLATIVE action as Board of Trustees determining to be appropriate ; Board of Trustees including in report provided in subparagraph recommendations for
Index of Sec 2581. ...COMPLIANCE with section ; Secretary submitting to Congress annual report on progress States making in enacting and implementing alternative medical liability laws in
Index of Sec 2531. ...BIOLOGICAL product ; Clinical study or studies being sufficient to demonstrate safety, purity and potency in 1 or more appropriate conditions of use For which reference product licensed and intended to be used and licensure being sought for
Index of Sec 2575. ...LICENSURE rates ; Increasing number of graduating nurses and improved nurse graduation and
Index of Sec 2521. ...LICENSURE tests and requirements ; Providing assistance in preparing and meeting nursing
Index of Sec 2521. ...HEALTH centers ; Nothing in section to be construed to expand medical malpractice liability protection under Federal Tort Claims acting for Section 330-funded federally qualified
Index of Sec 2534. ...HEALTH professionals ; Weight scales, mammography equipment, x-ray machines and other equipment commonly used for diagnostic or examination purposes by
Index of Sec 2592. ...ADDICTION medicine ; Social work, marriage and family therapy, professional mental health or substance abuse counseling or
Index of Sec 2522. ...HEALTH professions or bachelor's degree programs in health professions-related majors ; Including curricula in biology, chemistry, physiology, mathematics, nutrition and other courses deemed appropriate by Secretary to prepare students for associate or bachelor's degree programs in
Index of Sec 2533. ...MEDICAL Technicians ; Assisting Veterans with military emergency medical training to become State-licensed or certified emergency
Index of Sec 2554. ...MEDICAL Technicians ; Assisting Veterans with military emergency medical training to become State-licensed or certified emergency
Index of Sec 2554. ...MEDICAL technicians ; Secretary establishing program consisting of awarding grants to States to assist veterans received and completed military emergency medical training when serving in Armed Forces of United States to become State-licensed or certified emergency
Index of Sec 2554. ...MEDICAL technicians as following ; Amounts received as grant under section to be used to assist veterans described in subsection to become State-licensed or certified emergency
Index of Sec 2554. ...MEDICAL assistance under Medicaid ; Patient in hospital or nursing facility or institution for mental diseases and receiving
Index of Sec 2581. ...MEDICAL Care ; Sec 2553, Pilot Programs to improve emergency
Index of Sec 2553. ...MEDICAL care including right to accept or refuse medical or surgical treatment and right to formulate advance directives or other written instructions recognized under State law ; Nothing in preceding sentence preventing eligible beneficiary from using cash benefits paid into Life Independence Account for obtaining assistance with decisionmaking concerning
Index of Sec 2581. ...MEDICAL care including right to accept or refuse medical or surgical treatment and right to formulate advance directives or other written instructions recognized under State law ; Available assistance with decisionmaking concerning
Index of Sec 2581. ...MEDICAL data and inserting transmission and electronic archival of medical data ; Subparagraph, striking transmission of
Index of Sec 2523. ...MEDICAL device manufacturers and pharmaceutical companies ; Secretary consulting with organizations representing patients in pain and other consumers, employers, physicians including physicians specializing in pain care, other pain management professionals,
Index of Sec 2563. ...MEDICAL dispatch ; Coordinating approach to emergency medical system access throughout region including 9-1-1 public safety answering points and emergency
Index of Sec 2553. ...MEDICAL effectiveness research for issues of particular concern to women ; Establishing short-range and long-range goals and objectives within Agency for research important to women's health and coordinate with other appropriate offices on activities within Agency relating to health services and
Index of Sec 2588. ...MEDICAL intervention being different for women or reasonable evidence indicating that factors or types to be different for women ; Factors of medical risk or type of
Index of Sec 2588. ...MEDICAL care including right to accept or refuse medical or surgical treatment and right to formulate advance directives or other written instructions recognized under State law ; Nothing in preceding sentence preventing eligible beneficiary from using cash benefits paid into Life Independence Account for obtaining assistance with decisionmaking concerning
Index of Sec 2581. ...MEDICAL care including right to accept or refuse medical or surgical treatment and right to formulate advance directives or other written instructions recognized under State law ; Available assistance with decisionmaking concerning
Index of Sec 2581. ...MEDICAL system ; Secretary awarding contract or grant under subsection to eligible entity proposing demonstration program to design, implement and evaluate emergency
Index of Sec 2553. ...DISTRIBUTION and care of routine community patients ; Promoting regional partnerships and more effective emergency medical systems in order to enhance appropriate triage,
Index of Sec 2552. ...MEDICAL dispatch ; Coordinating approach to emergency medical system access throughout region including 9-1-1 public safety answering points and emergency
Index of Sec 2553. ...HEALTH-related programs and activities ; Medical-legal partnerships to assist patients and families to navigate
Index of Sec 2537. ...ADDICTION medicine ; Social work, marriage and family therapy, professional mental health or substance abuse counseling or
Index of Sec 2522. ...BEHAVIORAL health training program consisting of awarding granting and contracting under subsection ; Secretary establishing interdiscipations mental and
Index of Sec 2522. ...BEHAVIORAL health professionals being participants program and plan to work in field of mental and behavioral health ; Providing financial assistance to mental and
Index of Sec 2522. ...BEHAVIORAL health professionals planning to teach in field of mental and behavioral health ; Planning, developing, operating or participating in accredited program for training of mental and
Index of Sec 2522. ...BEHAVIORAL health professionals being participants programming and plan to teach in field of mental and behavioral health ; Providing financial assistance in form of traineeships and fellowships to mental and
Index of Sec 2522. ...MENTAL diseases having meanings given terms for purposes of Medicaid ; Intermediate care facility for mentally retarded and institution for
Index of Sec 2581. ...MEDICAL assistance under Medicaid ; Patient in hospital or nursing facility or institution for mental diseases and receiving
Index of Sec 2581. ...MENTAL diseases ; Nursing facility, intermediate care facility for mentally retarded or institution for
Index of Sec 2581. ...MENTAL diseases ; Beneficiary being patient in hospital, nursing facility, intermediate care facility for mentally retarded or institution for
Index of Sec 2581. ...MENTAL diseases ; Beneficiary receiving assistance under Medicaid for Pace program services being patient in hospital, nursing facility, intermediate care facility for mentally retarded or institution for
Index of Sec 2581. ...HEALTH servicing administration ; Substance Abuse and mental
Index of Sec 2588. ...ADDICTION medicine ; Social work, marriage and family therapy, professional mental health or substance abuse counseling or
Index of Sec 2522. ...BEHAVIORAL health centers ; Paragraph, striking community mental health centers and inserting federally qualified
Index of Sec 2513. ...HEALTH clinic ; Community clinic including mental
Index of Sec 2534. ...HEALTH consequences for WOMEN of resolving A pregnancy ; Sense of congress regarding longitudinal Study of relative mental
Index of Sec 2529. ...HEALTH consequences for women of resolving pregnancy in various ways ; Director of National Institute of Mental Health conducting nationally representative longitudinal study on relative mental
Index of Sec 2529. ...HEALTH services ; Entity receiving funds under subpart I of part B of title XIX of Public Health Service Act for provision of community mental
Index of Sec 2501. ...HEALTH services ; Communities or populations in which children and adolescents having difficulty accessing health and mental
Index of Sec 2511. ...BEHAVIORAL health services ; Subsection, striking community mental health services and inserting
Index of Sec 2513. ...HEALTH services including 24-hour mobile crisis teams ; Crisis mental
Index of Sec 2513. ...MENTAL illness and substance abuse to be evidence-based ; Medication management and integrated treatment for
Index of Sec 2513. ...MENTAL diseases having meanings given terms for purposes of Medicaid ; Intermediate care facility for mentally retarded and institution for
Index of Sec 2581. ...MENTAL diseases ; Nursing facility, intermediate care facility for mentally retarded or institution for
Index of Sec 2581. ...MENTAL diseases ; Beneficiary being patient in hospital, nursing facility, intermediate care facility for mentally retarded or institution for
Index of Sec 2581. ...MENTAL diseases ; Beneficiary receiving assistance under Medicaid for Pace program services being patient in hospital, nursing facility, intermediate care facility for mentally retarded or institution for
Index of Sec 2581. ...MENTORSHIP programs assisting newly graduated nurses in adjusting to working at bedside to ensure retention postgraduation and ongoing programs to support nurse retention ; Carrying out orientation and
Index of Sec 2521. ...MEDICAL Technicians ; Assisting Veterans with military emergency medical training to become State-licensed or certified emergency
Index of Sec 2554. ...MEDICAL Technicians ; Assisting Veterans with military emergency medical training to become State-licensed or certified emergency
Index of Sec 2554. ...MEDICAL technicians ; Secretary establishing program consisting of awarding grants to States to assist veterans received and completed military emergency medical training when serving in Armed Forces of United States to become State-licensed or certified emergency
Index of Sec 2554. ...COMPLIANCE ; Imposition of monetary penalty to be insufficient reasonably to ensure
Index of Sec 2502. ...MORATORIUM on new enrollments ; Adjusting monthly premiums or imposing temporary
Index of Sec 2581. ...MULTISYSTEMIC therapy and other evidence-based practices as Secretary requiring ; Assertive community treatment, family psychoeducation, disability self-management, supported employment, supported housing services, therapeutic foster care services,
Index of Sec 2513. ...CATASTROPHIC event ; Need of financial assistance following natural disaster or other
Index of Sec 2551. ...CATASTROPHIC event ; Geographic location substantially affected by natural disaster or other
Index of Sec 2551. ...NATURAL history of conditions and differences among racial and ethnic groups with respect to conditions ; Epidemiological studies to address frequency and
Index of Sec 2529. ...HEALTH-related programs and activities ; Medical-legal partnerships to assist patients and families to navigate
Index of Sec 2537. ...HEALTH care-related programs and activities and achieving one or more of following goals ; Amounts received as grant or contract under section to be used to assist patients and families to navigate
Index of Sec 2537. ...HEALTH care-related programs and activities ; Whose primary mission to assist patients and families navigate
Index of Sec 2537. ...NEUROLOGICAL surgery ; 1 graduate medical education fellowship in trauma or trauma-related specialties including
Index of Sec 2551. ...NONCLINICAL uses ; Eligible entity providing plan for coordinating system use by eligible entities and prioritizing use of grant funds for health care services over
Index of Sec 2523. ...NONPROFIT entities to establish new trauma centers in urban areas with substantial degree of trauma resulting from violent crimes ; Grants to local governments and public or private
Index of Sec 2551. ...NONPROFIT entity or consortium of entities located in United States or territory ; Term eligible entity meaning public or private
Index of Sec 2530. ...NONPROFIT organizations including equal participation from industry including public or private employers ; State training partnership program consisting of
Index of Sec 2521. ...IMPLEMENTATION of public awareness campaign under section ; Secretary making awards of grants, cooperative agreements and contracts to public agencies and private nonprofit organizations to assist with development and
Index of Sec 2563. ...NUTRITION and physical activity programs ; Additional counseling for at-risk mothers including smoking cesations programs, drug treatment programs, alcohol treatment programs,
Index of Sec 2532. ...HEALTH professions or bachelor's degree programs in health professions-related majors ; Including curricula in biology, chemistry, physiology, mathematics, nutrition and other courses deemed appropriate by Secretary to prepare students for associate or bachelor's degree programs in
Index of Sec 2533. ...HEALTH or nutrition within community in which individual residing ; Term community health worker meaning individual promoting
Index of Sec 2530. ...NUTRITION and increased physical activity ; Planning evidence-based programs for prevention of overweight and obesity among children and families through improved
Index of Sec 2535. ...NUTRITION assistance program established under Food and Nutrition Act of 2008 ; XVI, XVIII, XIX or XXI of Social Security Act under laws administered by Secretary of Veterans Affairs under low-income housing assistance programs or supplemental
Index of Sec 2581. ...FOOD being exempt under subclause or section 403(q)(5)(a) and inserting excepting that paragraph not applying to food offered for sale in restaurant or similar retail food establishment being not part of chain with 20 or more locations doing business under same name and offering for sale substantially same menu items unless restaurant or similar retail food establishment complying with voluntary provision of nutrition information requirements under section 403(q)(5)(h)( ix ; Section 403a(a)(4) of Federal Food, Drug and Cosmetic Act 21 USC 343-1(a)(4) amended by striking excepting requirement for nutrition labeling of
Index of Sec 2572. ...OBESITY ; Measurable progress in preventing overweight and
Index of Sec 2535. ...NUTRITION and increased physical activity ; Planning evidence-based programs for prevention of overweight and obesity among children and families through improved
Index of Sec 2535. ...OBESITY prevention program consisting of awarding granting and contracting under subsection ; Secretary establishing community-based overweight and
Index of Sec 2535. ...OF-life outcomes ; Support community-based family and individual services and enabling individuals with autism and related developmental disabilities fully to participate in society and achieving good quality-
Index of Sec 2527. ...AMBULANCE diversion status and coordination of tracking with regional communications and hospital destination decisions ; Emergency department capacity, on-call specialist coverage,
Index of Sec 2553. ...OUTPATIENT drugs through group purchasing organization or other group purchasing arrangement ; Paragraph not obtaining covered
Index of Sec 2501. ...OUTPATIENT programs ; Treatment and referral to continuum of services including emergency psychiatric care, community support programs, inpatient care and
Index of Sec 2511. ...PARASITIC diseases identified as Chagas disease ; Including neglected
Index of Sec 2587. ...HEALTH professions schooling ; Activities under grant or contract to be carried out in partnership with accredited
Index of Sec 2533. ...PARTNERSHIP of 1 or more States and 1 or more local governments ; Term eligible entity meaning State or
Index of Sec 2553. ...PARTNERSHIP demonstrating community support and including ; Entity to be community
Index of Sec 2535. ...INFORMATION as Secretary requiring ; Eligible partnership desiring grant under section submitting application to Secretary at time and containing
Index of Sec 2524. ...HEALTH department or another health organization defined by Secretary as eligible to submit application and one or more elementary and secondary schools ; Term eligible partnership meaning local public
Index of Sec 2524. ...PARTNERSHIP meaning entity ; Term medical-legal
Index of Sec 2537. ...EDUCATION to nurses and creating pipeline to nursing for incumbent ancillary health care workers wishing to advance careers and otherwise carrying out purposes of section ; Secretary of Labor establishing partnership grant program to award grants to eligible entities to carry out comprehensive programs to provide
Index of Sec 2521. ...NONPROFIT organizations including equal participation from industry including public or private employers ; State training partnership program consisting of
Index of Sec 2521. ...PATENT ; Including in complaint filed with court of law ANDA or drug to be manufactured under ANDA infringing
Index of Sec 2573. ...PATENT ; Relevant patent meaning
Index of Sec 2575. ...BIOSIMILAR product ; Reference product sponsor providing to applicant list of relevant patents owned by reference product sponsor or respect of which reference product sponsor having right to commence action of infringement or otherwise interest in patent as patent concerns
Index of Sec 2575. ...PATENT identified under clause or subparagraph or clause or subparagraph ;
Index of Sec 2575. ...PATENT identified under clause or subparagraph or clause or subparagraph ; Not later than 45 days after date on which
Index of Sec 2575. ...PATENT ; Biosimilar product or use of biosimilar product in treatment indicated in application not infringing
Index of Sec 2575. ...PATENT infringed prior to date applicable under subsection ; Brought within 60 days of date of receipt of statement under paragraph and court in which action commenced determining
Index of Sec 2575. ...PATENT ; Subparagraph, striking or
Index of Sec 2577. ...PATENT before expiration of patent ; Statement described in subparagraph provided in connection with application to obtain license to engage in commercial manufacture, use or sale of biological product claimed in patent or use of which claimed in
Index of Sec 2577. ...PATENT of addition or extension ; Term patent infringement meaning infringement of patenting or filed patent application, extension, reissuance, renewal, division, continations, continations in part, reexamination, patent term restoration,
Index of Sec 2573. ...INFRINGEMENT of relevant patent ; Owns relevant patent or right to commence or participate in action for
Index of Sec 2575. ...PATENT before expiration of patent ; Statement described in subparagraph provided in connection with application to obtain license to engage in commercial manufacture, use or sale of biological product claimed in patent or use of which claimed in
Index of Sec 2577. ...PATENT ; Statement described in subparagraph provided in connection with application to obtain license to engage in commercial manufacture, use or sale of biological product claimed in patent or use of which claimed in patent before expiration of
Index of Sec 2577. ...INFORMATION from applicant ; Identify 1 patent and designating individual executing agreement in accordance with paragraph to receive confidential
Index of Sec 2575. ...PATENT ; Applicant not commencing marketing of biosimilar product and requesting Secretary not to grant final approval of application before date of expiration of noticed
Index of Sec 2575. ...PATENT meaning patent ; Relevant
Index of Sec 2575. ...PATENT ; Owns relevant patent or right to commence or participate in action for infringement of relevant
Index of Sec 2575. ...PATENT after date on which reference product sponsor providing list required by clause to applicant ; Reference product sponsor issued or acquiring interest in relevant
Index of Sec 2575. ...PATENT after date on which interested third party providing list required by clause ; Issuing or acquiring interest in relevant
Index of Sec 2575. ...PATENT to be infringed ; Explaining in writing sponsor or interested third party believing relevant
Index of Sec 2575. ...PATENT identified by reference product sponsor under clause or paragraph or interested third party under clause or paragraph ; Action for infringement concerning relevant
Index of Sec 2575. ...PATENT application, extension, reissuance, renewal, division, continations, continations in part, reexamination, patent term restoration, patent of addition or extension ; Term patent infringement meaning infringement of patenting or filed
Index of Sec 2573. ...GENERIC drugs ; Number of patent challenges initiated by manufacturers of
Index of Sec 2573. ...BIOSIMILAR product ; Reference product sponsor providing to applicant list of relevant patents owned by reference product sponsor or respect of which reference product sponsor having right to commence action of infringement or otherwise interest in patent as patent concerns
Index of Sec 2575. ...INFRINGEMENT meaning infringement of patenting or filed patent application, extension, reissuance, renewal, division, continations, continations in part, reexamination, patent term restoration, patent of addition or extension ; Term patent
Index of Sec 2573. ...INFRINGEMENT claim ; Unlawful for person to directly or indirectly party to agreement resolving or settling patent
Index of Sec 2573. ...INFRINGEMENT claim in which value received by ANDA filer including no more ; Subparagraph not prohibiting resolution or settlement of patent
Index of Sec 2573. ...INFRINGEMENT claim ; Drug to be manufactured under ANDA involved and subject of patent
Index of Sec 2573. ...INFRINGEMENT claim ; Right to market drug to be manufactured under ANDA involved and subject of patent
Index of Sec 2573. ...INFRINGEMENT claim meaning allegation making to ANDA filer ; Term patent
Index of Sec 2573. ...DRUG ; Waiver of patent infringement claim for damages based on prior marketing of
Index of Sec 2573. ...PATENT of addition or extension ; Term patent infringement meaning infringement of patenting or filed patent application, extension, reissuance, renewal, division, continations, continations in part, reexamination, patent term restoration,
Index of Sec 2573. ...PAYMENT ; Nothing in section to be construed to require
Index of Sec 2530. ...PAYMENT of monthly premiums by individual enrolled in Class program not to have employer electing to deduct and withhold premiums in accordance with subparagraph ; Secretary establishing alternative procedures for
Index of Sec 2581. ...PAYMENT of cash benefit satisfying following requirements ;
Index of Sec 2581. ...PAYMENT of cash benefit for beneficiary into Life Independence Account established by Secretary on behalf of eligible beneficiary ; Secretary establishing procedures for administering provision of benefits to eligible beneficiaries under Class Independence Benefit Plan including
Index of Sec 2581. ...INFLUENZA vaccine for children not covered through other federally funded programs or private insurance ; Extent to which payment of costs of purchasing or administering
Index of Sec 2524. ...INFLUENZA vaccine ; Children being eligible under other federally funded programs for payment of costs of purchasing or administering
Index of Sec 2524. ...PAYMENT before end of 12-month period in which benefits accrued ; Failure of beneficiary to elect under paragraph to receive benefits as lump-sum
Index of Sec 2581. ...PAYMENTS being made to center under grant ; Giving preference to application submitted by applicant demonstrating financial support of State or political subdivision involved for activities to be funded through grant for fiscal year during that
Index of Sec 2551. ...PAYMENTS under grant ; Center first receiving
Index of Sec 2551. ...FISCAL years ; Period during that trauma center receiving payments under grant under section 1241(b)(1) for 3
Index of Sec 2551. ...PAYMENTS to Class Independence Fund on basis of estimates by Secretary and certified to Secretary of Treasury of amounts collected in accordance with section ; Amount deposited pursuant to paragraph to be transferred in monthly
Index of Sec 2581. ...PAYMENTS into Fund under sections 3204(f) and 3205(c)(5)(c)( ii and remaining after investment of amounts under subsection ; Secretary of Treasury serving as managing Trustee of Fund Fund consisting of amounts derived from
Index of Sec 2581. ...PAYMENTS of more than 3 months occurred during period begining on date of individual's enrollment and ends on date of determination ; Lapse in premium
Index of Sec 2581. ...PAYMENTS ; Intent of 1984 Act subverted by certain settlement agreements between brand companies and potential generic competitors making reverse
Index of Sec 2573. ...PAYMENT system ; Secretary encouraging community health worker programs receiving funding under section to implement outcome-based
Index of Sec 2530. ...CANCER hospital excluded from Medicare prospective payment system pursuant to section 1886(d)(1)(b)(v) of Social Security Act meeting requirements of subparagraph ; Children's hospital excluded from Medicare prospective payment system pursuant to section 1886(d)(1)(b)( iii of Social Security Act or free-standing
Index of Sec 2501. ...HEALTH benefits in population ; Secretary determining that information relating to use of product in pediatric population producing
Index of Sec 2575. ...PEDIATRIC populations ; Program under section not restricting discretion of health care provider to administer influenza vaccine approved by Food and drugging Administration for use in
Index of Sec 2524. ...CONVICTION of criminal offense or connection with verdict or finding described in section 202(x)(1)(a)( ii of Social Security Act ; Confining in jail, prison, other penal institution or correctional facility or court order pursuant to
Index of Sec 2581. ...PERIODIC audits and request periodic spending reports of community-based collaborative care networks under community-based collaborative care network program ; Secretary conducting
Index of Sec 2534. ...PERIODIC audits and request periodic spending reports of community-based collaborative care networks under community-based collaborative care network program ; Secretary conducting
Index of Sec 2534. ...PERSONNEL, asseal and liabilities of Emergency Care Coordination Center to be transferred to Emergency Care Coordination Center established under section 2816(a) of Public Health Service Act ; Functions,
Index of Sec 2552. ...HEALTH professionals ; Conducting study on barriers experienced by veterans received training as medical personnel when serving in Armed Forces of United States and seeking to become licensed or certified in State as civilian
Index of Sec 2554. ...PHARMACEUTICAL companies ; Secretary consulting with organizations representing patients in pain and other consumers, employers, physicians including physicians specializing in pain care, other pain management professionals, medical device manufacturers and
Index of Sec 2563. ...DRUG manufacturers ; Purpose of section to provide additional means to effectuate intent of 1984 Act by enhancing competition in pharmaceutical market by stopping agreements between brand name and generic
Index of Sec 2573. ...PHYSICAL activity ; Planning evidence-based programs for prevention of overweight and obesity among children and families through improved nutrition and increased
Index of Sec 2535. ...ALCOHOL treatment programs, nutrition and physical activity programs ; Additional counseling for at-risk mothers including smoking cesations programs, drug treatment programs,
Index of Sec 2532. ...HEALTH professions or bachelor's degree programs in health professions-related majors ; Including curricula in biology, chemistry, physiology, mathematics, nutrition and other courses deemed appropriate by Secretary to prepare students for associate or bachelor's degree programs in
Index of Sec 2533. ...DISCHARGE from hospital, facility or institution ; Planning to discharge from hospital, facility or institution or 60 days from date of
Index of Sec 2581. ...ASSESSMENT and crisis planning ; Person-centered treatment planning or similar processes including risk
Index of Sec 2513. ...PLANNING to Discharge ; Presumptive eligibility for certain institutionalizeding Enrollees
Index of Sec 2581. ...PLANNING services ; Entity providing counseling or
Index of Sec 2581. ...PLANNING services ; Entity providing counseling or
Index of Sec 2581. ...CAPITAL or operating expenses ; Financial support to be demonstrated by State or political subdivision funding for trauma center's
Index of Sec 2551. ...FISCAL year during that payments being made to center under grant ; Giving preference to application submitted by applicant demonstrating financial support of State or political subdivision involved for activities to be funded through grant for
Index of Sec 2551. ...HEALTH infrastructure for children and adolescents ; Term medically underserved children and adolescents meaning population of children and adolescents being residents of area designated by Secretary as area with shortage of personal health services and
Index of Sec 2511. ...HEALTH insurance coverage ; Prevalence of certain chronic conditions in various populations including comparison of prevalence in general population versus in population of individuals with inadequate
Index of Sec 2534. ...HEALTH benefits in population ; Secretary determining that information relating to use of product in pediatric population producing
Index of Sec 2575. ...CONTRACTS or grants described in subsection to eligible entity serving medically underserved population ; Secretary giving priority for award of
Index of Sec 2553. ...TRAINING initiatives and providing access to training modules and technical assistance practices and other materials developed by grantees ; Developing Web portal providing linkages to individual
Index of Sec 2527. ...POSSESSION ; Term medically underserved community meaning community identified by State, United States territory or
Index of Sec 2530. ...POSTGRADUATION and ongoing programs to support nurse retention ; Carrying out orientation and mentorship programs assisting newly graduated nurses in adjusting to working at bedside to ensure retention
Index of Sec 2521. ...NOTIFICATION of device risks ; Requiring covered device manufacturers to submit other information as necessary to facilitate postmarket assessments of device safety and effectiveness and
Index of Sec 2571. ...POSTMARKET safety and outcomes data on covered device ; Secretary establishing national medical device registry to facilitate analysis of
Index of Sec 2571. ...POVERTY line ; Not less than 20 percent of children served by agency from families with incomes below
Index of Sec 2536. ...PREFERENTIAL treatment under subsection ; State funding derived from Federal support not constituting State or local financial support for purposes of
Index of Sec 2551. ...PREGNANCY in various ways ; Director of National Institute of Mental Health conducting nationally representative longitudinal study on relative mental health consequences for women of resolving
Index of Sec 2529. ...PREGNANCY ; Sense of congress regarding longitudinal Study of relative mental health consequences for WOMEN of resolving A
Index of Sec 2529. ...PREGNANCY ; Healthy Teen initiative to prevent Teen
Index of Sec 2526. ...PREGNANCY ; Healthy Teen initiative to prevent Teen
Index of Sec 2526. ...PREGNANCY or sexually transmitted diseases ; Amounts received by State under section to be used to conduct or support evidence-based education programs to reduce teen
Index of Sec 2526. ...HOSPITAL and interfacility decisions and relevant outcomes of hospital care ; Containing information sufficient to evaluate key elements of prehospital care, hospital destination decisions, including initial
Index of Sec 2553. ...HEALTH and prenatal care ; Educating, guiding and providing home visitation services regarding maternal
Index of Sec 2530. ...CONSUMER making order selection ; Term menu or menu board meaning primary writing of restaurant or other similar retail food establishment from which
Index of Sec 2572. ...PRIMARY care ; Vulnerable patient populations seeking and obtaining
Index of Sec 2534. ...PRIMARY care providers available through community-based collaborative care network ; Using neighborhood health workers informing individuals about availability of safety net and
Index of Sec 2534. ...PRIMARY care provider responsible for managing that patient's care ; Requiring networks to assign patient of network to
Index of Sec 2534. ...PRIMARY care services and wellness services ; Training and technical assistance related to provision of comprehensive
Index of Sec 2512. ...HEALTH services in section 330(b)(1) ; Term comprehensive primary care services having meaning given to term required primary
Index of Sec 2512. ...HEALTH care-related programs and activities ; Whose primary mission to assist patients and families navigate
Index of Sec 2537. ...PRIMARY service area ; Risk of closing or operating in area where closing occurring within
Index of Sec 2551. ...CONVICTION of criminal offense or connection with verdict or finding described in section 202(x)(1)(a)( ii of Social Security Act ; Confining in jail, prison, other penal institution or correctional facility or court order pursuant to
Index of Sec 2581. ...PRIVACY and security law as defined in section 3009(a)(2) ; Consistent with HIPAA
Index of Sec 2534. ...INFORMATION and comprehensive ; Providing public access to data and analysis collected or developed through registry in manner and form protecting patient privacy and proprations
Index of Sec 2571. ...INFORMATION and comprehensive ; Establishing procedures to permit public access to information in registry in manner and form protecting patient privacy and proprations
Index of Sec 2571. ...PRIVACY requirements of section 264 of Health Insurance Portability and Accountability Act of 1996 42 USC 1320d-2 note and section 444 of General Education Provisions acting 20 USC 1232g ; Secretary ensuring that program under section adhering to confidentiality and
Index of Sec 2524. ...ADDICTION medicine ; Social work, marriage and family therapy, professional mental health or substance abuse counseling or
Index of Sec 2522. ...PROFESSIONAL shortage area ; Eligible entity being health care provider in health care network furnishing services in medically underserved area or health
Index of Sec 2523. ...PROFESSIONAL shortage area as designated under section 332 ; Health
Index of Sec 2530. ...DISCLOSURE ; Provision of access to covered entities and State Medicaid agencies through Internet website of Department of Health and Human Services or contractor to applicable ceiling prices for covered drugs as calculated and verified by Secretary in manner ensuring protection of privileged pricing data from unauthorized
Index of Sec 2502. ...INFORMATION agreeing to other terms or conditions regarding handling or use of confidential information ; Court imposing protective order governing use or handling of confidential information or party providing confidential
Index of Sec 2575. ...PROTEIN, allergenic product ; Paragraph, so designated, inserting
Index of Sec 2575. ...CALORIES contained in article ; Vending machine operator providing sign in close proximity to article of food or selection button including clear and conspicuous statement disclosing number of
Index of Sec 2572. ...OUTPATIENT programs ; Treatment and referral to continuum of services including emergency psychiatric care, community support programs, inpatient care and
Index of Sec 2511. ...DISABILITY self-management, supported employment, supported housing services, therapeutic foster care services, multisystemic therapy and other evidence-based practices as Secretary requiring ; Assertive community treatment, family psychoeducation,
Index of Sec 2513. ...PSYCHOLOGY ; Not less than 15 percent to be used for training programs in
Index of Sec 2522. ...PSYCHOLOGY ; Accredited health professions school including accredited school or program of
Index of Sec 2522. ...PSYCHOSIS ; Term postpartum condition meaning postpartum depression or postpartum
Index of Sec 2529. ...NONPROFIT organizations including equal participation from industry including public or private employers ; State training partnership program consisting of
Index of Sec 2521. ...CONTRIBUTIONS to be made directly or donations from public or private entities or provided through cash equivalent of paid release time provided to incumbent worker students ;
Index of Sec 2521. ...NONPROFIT entity or consortium of entities located in United States or territory ; Term eligible entity meaning public or private
Index of Sec 2530. ...EDUCATIONAL agencies for purpose of reducing student-to-school nurse ratio in public elementary and secondary schools ; Secretary of Education making demonstration grants to eligible local
Index of Sec 2536. ...INFORMATION on current ratios of students to school nurses ; Secretary of Education giving special consideations to applications submitted by high-need local educational agencies demonstrating greatest need for new or additional nursing services among children in public elementary and secondary schools served by agency in part by providing
Index of Sec 2536. ...SCHOOL nurse ; Term eligible local educational agency meaning local educational agency in which student-to-school nurse ratio in public elementary and secondary schools served by agency being 750 or more students to every
Index of Sec 2536. ...NONPROFIT entities to establish new trauma centers in urban areas with substantial degree of trauma resulting from violent crimes ; Grants to local governments and public or private
Index of Sec 2551. ...EDUCATION and clinical care in United States ; Establishing agenda for action public and private sectors reducing barriers and significantly improving state of pain care research,
Index of Sec 2561. ...PUBLIC awareness campaign under section in educating general public with respect to matters described in subsection ; Secretary preparing and submitting to Congress report evaluating effectiveness of
Index of Sec 2563. ...INFORMATION from public and private sources identified under paragraph ;
Index of Sec 2571. ...GUIDANCE issued under subparagraph before issuing final guidance ; Secretary providing public opportunity to comment on proposed
Index of Sec 2575. ...INFORMATION and comprehensive ; Providing public access to data and analysis collected or developed through registry in manner and form protecting patient privacy and proprations
Index of Sec 2571. ...INFORMATION and comprehensive ; Establishing procedures to permit public access to information in registry in manner and form protecting patient privacy and proprations
Index of Sec 2571. ...IMPLEMENTATION of public awareness campaign under section ; Secretary making awards of grants, cooperative agreements and contracts to public agencies and private nonprofit organizations to assist with development and
Index of Sec 2563. ...CAREGIVERS with respect ; Secretary designing public awareness campaign under section to educate consumers, patients, families and other
Index of Sec 2563. ...PUBLIC awareness campaign required by section ; Designing and implementing
Index of Sec 2563. ...PUBLIC awareness campaign under section ; Secretary making awards of grants, cooperative agreements and contracts to public agencies and private nonprofit organizations to assist with development and implementation of
Index of Sec 2563. ...PUBLIC awareness campaign under section in educating general public with respect to matters described in subsection ; Secretary preparing and submitting to Congress report evaluating effectiveness of
Index of Sec 2563. ...PUBLIC comment ; Designating benefit plan as Class Independence Benefit Plan Secretary publishing designation along with details of plan and reasons for selection by Secretary in final rule allowing for period of
Index of Sec 2581. ...PUBLIC entities State proposing to work including schools and community-based and faith-based organizations ; Listing private and
Index of Sec 2526. ...EDUCATIONAL agency ; Including one or more public schools located in rural local
Index of Sec 2524. ...PULATIONS conditions ; High percentage of residents suffering from chronic diseases including
Index of Sec 2530. ...BIOLOGICAL product ; Clinical study or studies being sufficient to demonstrate safety, purity and potency in 1 or more appropriate conditions of use For which reference product licensed and intended to be used and licensure being sought for
Index of Sec 2575. ...PURITY or potency ; Modification to structure of biological product not resulting in change in safety,
Index of Sec 2575. ...CANCER hospital excluded from Medicare prospective payment system pursuant to section 1886(d)(1)(b)(v) of Social Security Act meeting requirements of subparagraph ; Children's hospital excluded from Medicare prospective payment system pursuant to section 1886(d)(1)(b)( iii of Social Security Act or free-standing
Index of Sec 2501. ...GUIDANCE describing methodologies and options available to covered entities for billing covered drugs to State Medicaid agencies in manner avoiding duplicate discounts pursuant to subsection ; Development of more detailed
Index of Sec 2502. ...SAFETY and outcomes data obtained under paragraph ; Permitting linkage of information submitted pursuant to subparagraph with patient
Index of Sec 2571. ...INFORMATION ; Entity receiving confidential information pursuant to subsection designating one or more individuals to receive
Index of Sec 2575. ...INFORMATION pursuant to clause ; 90 days of date of receiving
Index of Sec 2575. ...DISCLOSURE under section 552 of title 5, United States Code and no ; Information or documentary material filed with Assistant Attorney General or Federal Trade Commission pursuant to paragraph to be exempt from
Index of Sec 2575. ...CONVICTION of criminal offense or connection with verdict or finding described in section 202(x)(1)(a)( ii of Social Security Act ; Confining in jail, prison, other penal institution or correctional facility or court order pursuant to
Index of Sec 2581. ...PAYMENTS to Class Independence Fund on basis of estimates by Secretary and certified to Secretary of Treasury of amounts collected in accordance with section ; Amount deposited pursuant to paragraph to be transferred in monthly
Index of Sec 2581. ...NATURAL history of conditions and differences among racial and ethnic groups with respect to conditions ; Epidemiological studies to address frequency and
Index of Sec 2529. ...ASSESSMENT, diagnosis, treatment and management of pain ; Evaluating adequacy of assessment, diagnosis, treatment and management of acute and chronic pain in general population and identified racial ethnic, gender, aging and other demographic groups to be disproportionately affected by inadequacies in
Index of Sec 2561. ...RAPID cycle process improvement concepts in use in other Federal programs implemented MTM services ; Secretary determining whether possible to incorporate
Index of Sec 2528. ...REBATES, discounts or other price concessions provided by manufacturers to other purchasers subsequent to sale of covered drugs to covered entities reported to Secretary ;
Index of Sec 2502. ...REBATES, discounts or other price concessions having effect of lowering applicable ceiling price for relevant quarter for drugs involved ; Appropriate credits and refunds issued to covered entities if
Index of Sec 2502. ...REBATES, discounts and other price concessions provided by manufacturers to other purchasers subsequent to sale of covered drugs to covered entities ;
Index of Sec 2502. ...NOTIFICATION required under subsection ; Assistance with respect to annual recertification and
Index of Sec 2581. ...REENROLLS in Class program 90-day period and end of 5-year period begining with first month For which individual failed to pay monthly premium required to maintain individual's enrollment in program ;
Index of Sec 2581. ...REENROLLS in Class program after end of 5-year period described in subparagraph ;
Index of Sec 2581. ...HEALTH and identify needs regarding coordination of activities including intramural and extramural multidiscipations activities ; Monitoring Department of Health and Human Services' offices, agencies and regional activities regarding women's
Index of Sec 2588. ...DISTRIBUTION and care of routine community patients ; Promoting regional partnerships and more effective emergency medical systems in order to enhance appropriate triage,
Index of Sec 2552. ...REGIONAL services, supports and providers including schools ; Other community or
Index of Sec 2513. ...REGISTRY developed under subsection to be used to address risks in priority populations ; Identify evidence-based education program or programs selected from
Index of Sec 2526. ...INFORMATION on safety or effectiveness ; Secretary by order exempt class III device from provisions of subsection if Secretary concluding that inclusion of information on device in registry not providing useful
Index of Sec 2571. ...REGISTRY as described in subparagraph ; Validating methods for analyzing patient safety and outcomes data from multiple sources and linking data with information included in
Index of Sec 2571. ...INFORMATION and comprehensive ; Providing public access to data and analysis collected or developed through registry in manner and form protecting patient privacy and proprations
Index of Sec 2571. ...REGISTRY ; Link data obtained under clause with information in
Index of Sec 2571. ...HEALTH ; Requiring manufacturers of devices to submit information to registry if deemed necessary by Secretary to protect public
Index of Sec 2571. ...INFORMATION and comprehensive ; Establishing procedures to permit public access to information in registry in manner and form protecting patient privacy and proprations
Index of Sec 2571. ...REGISTRY promulgated by date ; Secretary of Health and Human Services establishing and beginning implementation of registry under section 519(g) of Federal Food, Drug and Cosmetic Act as added by paragraphing without regard whether final regulations to establish and operate
Index of Sec 2571. ...REGISTRY of trauma cases in accordance with guidelines developed by American College of Surgeons ; Center establishing and operating
Index of Sec 2551. ...POSTMARKET safety and outcomes data on covered device ; Secretary establishing national medical device registry to facilitate analysis of
Index of Sec 2571. ...REGISTRY device ; Requiring manufacturers of devices to submit information to
Index of Sec 2571. ...REGULATORY authority or modifying ; Nothing in section and amendments making by section to be construed as establishing
Index of Sec 2588. ...PSYCHIATRIC rehabilitation services including skills ;
Index of Sec 2513. ...TITLE ; Participation in community-based collaborative care network not disqualifying health care provider from reimbursement under title XVIII, XIX or XXI of Social Security Act with respect to services otherwise reimbursable under
Index of Sec 2534. ...HEALTH Services ; Regulations regarding reimbursement for
Index of Sec 2511. ...REIMBURSEMENT under title XVIII, XIX or XXI of Social Security Act with respect to services otherwise reimbursable under title ; Participation in community-based collaborative care network not disqualifying health care provider from
Index of Sec 2534. ...REIMBURSEMENT for services and other benefits ; Supervision and materials needed effectively to deliver services described in subsection
Index of Sec 2530. ...PATENT of addition or extension ; Term patent infringement meaning infringement of patenting or filed patent application, extension, reissuance, renewal, division, continations, continations in part, reexamination, patent term restoration,
Index of Sec 2573. ...HEALTH consequences for WOMEN of resolving A pregnancy ; Sense of congress regarding longitudinal Study of relative mental
Index of Sec 2529. ...HEALTH consequences for women of resolving pregnancy in various ways ; Director of National Institute of Mental Health conducting nationally representative longitudinal study on relative mental
Index of Sec 2529. ...REORGANIZATION or transfer approved by Act of Congress ; Federal office of women's health or Federal appointive position with primary responsibility over women's health issues in existence on date of enactment of section not to be terminated, reorganized or powers or duties transferred unless termination,
Index of Sec 2588. ...HEALTH consequences for women of resolving pregnancy in various ways ; Director of National Institute of Mental Health conducting nationally representative longitudinal study on relative mental
Index of Sec 2529. ...BENEFICIARY'S cash benefits by authorized representative of eligible beneficiary on whose behalf ; Secretary establishing procedures to allow access to
Index of Sec 2581. ...RESIDENTIAL setting of choice in community ; Her independence at home or another
Index of Sec 2581. ...ACTUARIAL science, economics and other relevant disciplines as determined by Secretary ; Family caregivers of individuals requiring servicing and supporting to maintain independence at home or another residential setting of choice in community, individuals with expertise in long-term care or disability insurance,
Index of Sec 2581. ...RESPONSIBILITY for SBHC administration, operations and oversight ; SBHC sponsoring facility assuming
Index of Sec 2511. ...FOOD establishment being part of chain with 20 or more locations doing business under same name and offering for sale substantially same menu items ; Case of food being standard menu item offered for sale in restaurant or similar retail
Index of Sec 2572. ...FOOD establishment disclosing in clear and conspicuous manner ; Restaurant or similar retail
Index of Sec 2572. ...DISCLOSURES including nutrient databases ; Restaurant or similar retail food establishment to have reasonable basis for nutrient content
Index of Sec 2572. ...CONSUMER making order selection ; Term menu or menu board meaning primary writing of restaurant or other similar retail food establishment from which
Index of Sec 2572. ...FOOD establishment being not part of chain with 20 or more locations doing business under same name and offering for sale substantially same menu items unless restaurant or similar retail food establishment complying with voluntary provision of nutrition information requirements under section 403(q)(5)(h)( ix ; Section 403a(a)(4) of Federal Food, Drug and Cosmetic Act 21 USC 343-1(a)(4) amended by striking excepting requirement for nutrition labeling of food being exempt under subclause or section 403(q)(5)(a) and inserting excepting that paragraph not applying to food offered for sale in restaurant or similar retail
Index of Sec 2572. ...FOOD establishment described in section 403(q)(5)(h)(i) of Act ; Excepting as provided in section 403(q)(5)(h)( ix of Federal Food, Drug and Cosmetic Act to apply to restaurant or similar retail food establishment other than restaurant or similar retail
Index of Sec 2572. ...FOOD establishment or vending machine operator not subject to requirements of clause electing to be subject to requirements of clause as specified by Secretary by regulation ; Authorized official of restaurant or similar retail
Index of Sec 2572. ...FOOD establishment being part of chain with 20 or more locations doing business under same name and offering for sale substantially same menu items ; Case of food being standard menu item offered for sale in restaurant or similar retail
Index of Sec 2572. ...FOOD establishment disclosing in clear and conspicuous manner ; Restaurant or similar retail
Index of Sec 2572. ...DISCLOSURES including nutrient databases ; Restaurant or similar retail food establishment to have reasonable basis for nutrient content
Index of Sec 2572. ...FOOD establishment or vending machine operator not subject to requirements of clause electing to be subject to requirements of clause as specified by Secretary by regulation ; Authorized official of restaurant or similar retail
Index of Sec 2572. ...CONSUMER making order selection ; Term menu or menu board meaning primary writing of restaurant or other similar retail food establishment from which
Index of Sec 2572. ...FOOD establishment being not part of chain with 20 or more locations doing business under same name and offering for sale substantially same menu items unless restaurant or similar retail food establishment complying with voluntary provision of nutrition information requirements under section 403(q)(5)(h)( ix ; Section 403a(a)(4) of Federal Food, Drug and Cosmetic Act 21 USC 343-1(a)(4) amended by striking excepting requirement for nutrition labeling of food being exempt under subclause or section 403(q)(5)(a) and inserting excepting that paragraph not applying to food offered for sale in restaurant or similar retail
Index of Sec 2572. ...FOOD establishment described in section 403(q)(5)(h)(i) of Act ; Excepting as provided in section 403(q)(5)(h)( ix of Federal Food, Drug and Cosmetic Act to apply to restaurant or similar retail food establishment other than restaurant or similar retail
Index of Sec 2572. ...FOOD establishments ; Information required to be disclosed by restaurants and retail
Index of Sec 2572. ...PRIMARY service area ; Risk of closing or operating in area where closing occurring within
Index of Sec 2551. ...BIOLOGICAL product and reference product being not greater than risk of using reference product without ; Risk in terms of safety or diminished efficacy of alternating or switching between use of
Index of Sec 2575. ...MEDICAL intervention being different for women or reasonable evidence indicating that factors or types to be different for women ; Factors of medical risk or type of
Index of Sec 2588. ...BIOLOGICAL product under subsection ; Secretary not licensing biological product under subsection unless Secretary determining to be no increased risk to security or health of public from licensing
Index of Sec 2575. ...GEOGRAPHIC coverage in rural or medically underserved areas of State or States in which entity located ; Eligible entity demonstrating broad
Index of Sec 2523. ...RURAL areas ; Establishing rural outreach program to provide care to at-risk mothers in
Index of Sec 2532. ...DOWNGRADATION ; Operating in rural areas where trauma care availability significantly decreaseing if center forced to close or downgrade service and substantial costs contributing to likelihood of closure or
Index of Sec 2551. ...EDUCATIONAL agency ; Including one or more public schools located in rural local
Index of Sec 2524. ...EDUCATIONAL agency described in section 6211(b)(1) of Elementary and Secondary Education Act of 1965 20 USC 7345(b)(1) ; Term rural local educational agency meaning eligible local
Index of Sec 2524. ...AT-risk mothers in rural areas ; Establishing rural outreach program to provide care to
Index of Sec 2532. ...RURAL referral center under section 1886(d)(5)(c) of Social Security Act ; Entity classified as
Index of Sec 2501. ...SAFE ; Facility in which biological product manufactured, processed, packed or holding meeting standards designed to assure that biological product continuing to be
Index of Sec 2575. ...BIOLOGICAL product ; Clinical study or studies being sufficient to demonstrate safety, purity and potency in 1 or more appropriate conditions of use For which reference product licensed and intended to be used and licensure being sought for
Index of Sec 2575. ...PURITY or potency ; Modification to structure of biological product not resulting in change in safety,
Index of Sec 2575. ...SAFETY and effectiveness ; Ordering or performing laboratory assessments and evaluating response of patient to therapy including
Index of Sec 2528. ...INFORMATION included in registry as described in subparagraph ; Validating methods for analyzing patient safety and outcomes data from multiple sources and linking data with
Index of Sec 2571. ...SAFETY and outcomes data obtained under paragraph ; Permitting linkage of information submitted pursuant to subparagraph with patient
Index of Sec 2571. ...SAFETY of device under section ; Respect to entitying that submiting or required to submit safety report or other information in connection with
Index of Sec 2571. ...FOOD or component of food ; Applying to State or local requirement respecting statement in labeling of food providing for warning concerning safety of
Index of Sec 2572. ...SAFETY or effectiveness ; Secretary by order exempt class III device from provisions of subsection if Secretary concluding that inclusion of information on device in registry not providing useful information on
Index of Sec 2571. ...SAFETY ; Providing for improving quality of nursing education to improve patient care and
Index of Sec 2521. ...MEDICAL dispatch ; Coordinating approach to emergency medical system access throughout region including 9-1-1 public safety answering points and emergency
Index of Sec 2553. ...BIOLOGICAL product and reference product being not greater than risk of using reference product without ; Risk in terms of safety or diminished efficacy of alternating or switching between use of
Index of Sec 2575. ...PRIMARY care providers available through community-based collaborative care network ; Using neighborhood health workers informing individuals about availability of safety net and
Index of Sec 2534. ...HOSPITAL providing services to high volume of low-income patients as demonstrated by meeting criteria in section 1923(b)(1) of Social Security Act ; Safety net
Index of Sec 2534. ...INFORMATION in connection with safety of device under section ; Respect to entitying that submiting or required to submit safety report or other
Index of Sec 2571. ...SALARY or benefits ; Obtaining leave from bedside position to assume full or part-time position as adjunct or full-time faculty without loss of
Index of Sec 2521. ...HEALTH clinic program consisting of awarding grants to eligible entities to support operation of school-based health clinics ; Secretary establishing school-based
Index of Sec 2511. ...HEALTH providers when school or SBHC closed ; SBHC providing onsite access during academic day when school in session and established network of support and access to services with backup
Index of Sec 2511. ...SCHOOL ; SBHC to be integrated into school environment and coordinating health services with appropriate school personnel and other community providers co-located at
Index of Sec 2511. ...SCHOOL or other related setting ; Including costs of purchasing and administering vaccine incurred when influenza vaccine administered outside of physician's office in
Index of Sec 2524. ...SCHOOL-based vaccination assists in achieving recommendations of Advisory Committee on Immunization Practices ; Comparing to national average influenza vaccination rates for school-aged children including whether
Index of Sec 2524. ...SCHOOL or SBHC closed ; SBHC providing onsite access during academic day when school in session and established network of support and access to services with backup health providers when
Index of Sec 2511. ...SCHOOL of nursing and pipeline for nursing programs ; Increased number of incumbent workers entering accredited
Index of Sec 2521. ...HEALTH clinics ; Secretary establishing school-based health clinic program consisting of awarding grants to eligible entities to support operation of school-based
Index of Sec 2511. ...SCHOOL having meanings given terms in section 9101 of Elementary and Secondary Education Act of 1965 20 USC 7801 ; Terms elementary school and secondary
Index of Sec 2524. ...HEALTH professions ; Establishing health sciences training program consisting of awarding granting and contracting under subsection to prepare secondary school students for careers in
Index of Sec 2533. ...SCHOOL having meanings given to terms in section 9101 of Elementary and Secondary Education Act of 1965 20 USC 7801 ; Terms elementary school, local educational agency and secondary
Index of Sec 2536. ...HEALTH clinic meaning health clinic ; Term school-based
Index of Sec 2511. ...HEALTH services with appropriate school personnel and other community providers co-located at school ; SBHC to be integrated into school environment and coordinating
Index of Sec 2511. ...HEALTH professionals in accordance with State and local laws and regulations ; Providing comprehensive primary health services during school hours to children and adolescents by
Index of Sec 2511. ...SCHOOL nurse ; Term eligible local educational agency meaning local educational agency in which student-to-school nurse ratio in public elementary and secondary schools served by agency being 750 or more students to every
Index of Sec 2536. ...SCHOOL nurses ; Secretary awarding grants to eligible partnerships to be used to provide influenza vaccinations to children in elementary and secondary schools in coordination with
Index of Sec 2524. ...PERSONNEL and other community providers co-located at school ; SBHC to be integrated into school environment and coordinating health services with appropriate school
Index of Sec 2511. ...SCHOOL State science standards ; Graduating high or significantly improved percentage of students exhibited mastery in secondary
Index of Sec 2533. ...SCHOOL years ; Eligible partnerships receiving grant administering demonstration program funded through section over period of 2 consecutive
Index of Sec 2524. ...EDUCATION programs to reduce teen pregnancy or sexually transmitted diseases ; Amounts received by State under section to be used to conduct or support evidence-based
Index of Sec 2526. ...ALCOHOL treatment programs, nutrition and physical activity programs ; Additional counseling for at-risk mothers including smoking cesations programs, drug treatment programs,
Index of Sec 2532. ...SOCIAL ; Developing and implement standardized systems for improved access, utilization and quality of
Index of Sec 2532. ...SOCIAL services and other services as proposed by network ; Transportation, language services, enrollment counselors,
Index of Sec 2534. ...HEALTH-related social services under Federal ; Describing plans to enhance capacity of individuals to utilize health services and
Index of Sec 2530. ...HEALTH-related social services to individuals being underserved with respect to services ; Experience in providing health or
Index of Sec 2530. ...ADDICTION medicine ; Social work, marriage and family therapy, professional mental health or substance abuse counseling or
Index of Sec 2522. ...SOLVENCY throughout ; Secretary establishing premiums to be paid by enrollees for year based on actuarial analysis of 75-year costs of program ensuring
Index of Sec 2581. ...SOLVENCY ; Recalculating premium if required for Program
Index of Sec 2581. ...FOOD service workers, variations in ingredients and other factors ; Considering standardization of recipes and methods of preparation, reasonable variation in serving size and formulation of menu items, space on menus and menu boards, inadvertent human error, training of
Index of Sec 2572. ...ASSESSMENT ; Entity establishing steering committee to provide input on
Index of Sec 2535. ...SUBJECT in capacity as employer to obligation under division A of Act and amendments making by division applicable to persons in capacity as employer ;
Index of Sec 2585. ...SUBJECT of application under subsection ; Biosimilar product meaning biological product being
Index of Sec 2575. ...SUBJECT of application described in subparagraph ; Biosimilar product being subject of application or biosimilar product being
Index of Sec 2575. ...SUBJECT of application approved under section 505 not later than date of enactment of Act ; Biological product in product class For which biological product in product class being
Index of Sec 2575. ...BIOSIMILAR product being subject of application described in subparagraph ; Biosimilar product being subject of application or
Index of Sec 2575. ...SUBSPECIALTIES ; Term interdiscipations meaning collaboration across health professions, specialties and
Index of Sec 2522. ...SURVEILLANCE activities of Secretary authorized by chapter ; Other postmarket device
Index of Sec 2571. ...SUSTAINABILITY of Class program ; Council determining best balances pricing and benefiting to meet enrollees' needs in actuarially sound manner when optimizing probability of long-term
Index of Sec 2581. ...TAX under section 3101(a) or 3201(a) of Internal Revenue Code of 1986 ; Receiving wages on which imposing
Index of Sec 2581. ...CHRONIC conditions by teaching more effective management techniques focusing on individual self-care and patient-driven decisionmaking ; Term wellness services meaning health-related service or intervention designed to reduce identifiable health risks and increase healthy behaviors intended to prevent onset of disease or lessening impact of existing
Index of Sec 2512. ...HEALTH care needs of vulnerable populations ; Supporting teaching programs addressing
Index of Sec 2522. ...TELEHEALTH networks ; Awarding grants under subsection for projects involving
Index of Sec 2523. ...TELEHEALTH resource centers ; Awarding grants under subsection for projects involving
Index of Sec 2523. ...IMPLEMENTATION of telehealth services ; Eligible entity having record of success in provision of technical assistance to providers serving medically underserved communities or populations in establishment and
Index of Sec 2523. ...TELEHEALTH services at national ; Eligible entity having demonstrated record of collaborating and sharing expertise with providers of
Index of Sec 2523. ...TELEHEALTH systems ; Eligible entity agreeing to use grant to establish or develop plans for
Index of Sec 2523. ...TELEHEALTH technology ; Developing projects to use
Index of Sec 2523. ...TITLE ; Participation in community-based collaborative care network not disqualifying health care provider from reimbursement under title XVIII, XIX or XXI of Social Security Act with respect to services otherwise reimbursable under
Index of Sec 2534. ...TITLE ; Term Class program meaning program established under
Index of Sec 2581. ...TITLE ; Secretary developing 3 actuarially sound benefit plans as alternatives for consideations for designation by Secretary as Class Independence Benefit Plan under which eligible beneficiaries receiving benefits under
Index of Sec 2581. ...TITLE to be construed as requiring active enrollee to continue to satisfy subparagraph or subsection in order to maintain enrollment in Class program ; Nothing in
Index of Sec 2581. ...PROHIBITING benefits paid under Class Independence Benefit Plan from used to compensate family caregiver for providing community living assistance services and supports to eligible beneficiary ; Nothing in title to be construed as
Index of Sec 2581. ...TITLE including with respect ; Class Independence Advisory Council advising Secretary on matters of general policy in administration of Class program established under title and formulation of regulations under
Index of Sec 2581. ...TITLE ; Secretary promulgating regulations as necessary to carry out Class program in accordance with
Index of Sec 2581. ...HEALTH needs of communities served by SBHCS ; Operational and administrative support and provision of information to SBHCS of variety of resources available under title and resources to be best used to meet
Index of Sec 2511. ...INSURANCE program for purchasing community living assistance services and supports in order ; Purpose of title to establish national voluntary
Index of Sec 2581. ...TITLE 42, section 121.3 or 121.4 of title 9 or section 331.3 of title 7, Code of Federal Regulations ; Containing selecting agent or toxin listed in section 73.3 or 73.4 of
Index of Sec 2575. ...TITLE 5, United States Code and no ; Information or documentary material filed with Assistant Attorney General or Federal Trade Commission pursuant to paragraph to be exempt from disclosure under section 552 of
Index of Sec 2575. ...TITLE 7, Code of Federal Regulations ; Containing selecting agent or toxin listed in section 73.3 or 73.4 of title 42, section 121.3 or 121.4 of title 9 or section 331.3 of
Index of Sec 2575. ...TITLE and formulation of regulations under title including with respect ; Class Independence Advisory Council advising Secretary on matters of general policy in administration of Class program established under
Index of Sec 2581. ...HEALTH services ; Entity receiving funds under title V of Social Security Act for provision of
Index of Sec 2501. ...CERTIFICATION ; Materials filed with Federal Trade Commission and Department of Justice under section 1112 of subtitle B of title XI of Medicare Prescription Drug, Improvement and Modernization Act of 2003 with respect to agreement referenced in
Index of Sec 2573. ...TITLE XIX of Social Security Act ; Term Medicaid meaning program established under
Index of Sec 2581. ...HEALTH services ; Entity receiving funds under subpart I of part B of title XIX of Public Health Service Act for provision of community mental
Index of Sec 2501. ...TITLE XVIII, XIX or XXI of Social Security Act with respect to services otherwise reimbursable under title ; Participation in community-based collaborative care network not disqualifying health care provider from reimbursement under
Index of Sec 2534. ...TITLE XXI of Social Security Act ; Educating and providing outreach regarding enrollment in health insurance including State Children's Health Insurance Program under
Index of Sec 2530. ...SCHOOL nurse ratio in public elementary and secondary schools served by agency being 750 or more students to every school nurse ; Term eligible local educational agency meaning local educational agency in which student-to-
Index of Sec 2536. ...SCHOOL nurse ratio in public elementary and secondary schools ; Secretary of Education making demonstration grants to eligible local educational agencies for purpose of reducing student-to-
Index of Sec 2536. ...HEALTH of students on learning ; Including evaluation of effectiveness of program in improving student-to-school nurse ratios described in subsection and evaluation of impact of resulting enhanced
Index of Sec 2536. ...TOBACCO cesations ; Health and wellness services including services for
Index of Sec 2513. ...BEHAVIORAL health professionals being participants programming and plan to teach in field of mental and behavioral health ; Providing financial assistance in form of traineeships and fellowships to mental and
Index of Sec 2522. ...EDUCATION and training designed to enhance understanding and appropriate use of medications by patient, caregiver and other authorized representative ; Providing
Index of Sec 2528. ...EDUCATION and training ; Establishing short-range and long-range goals and objectives within Centers for women's health and coordinate with other appropriate offices on activities within Centers relating to prevention, research,
Index of Sec 2588. ...HEALTH and coordinate with other appropriate offices on activities within Administration relating to health care provider training ; Establishing short-range and long-range goals and objectives within Health Resources and servicing Administration for women's
Index of Sec 2588. ...INFORMATION on training and educational opportunities within region for type of jobs described in paragraph ;
Index of Sec 2590. ...PRIMARY care services and wellness services ; Training and technical assistance related to provision of comprehensive
Index of Sec 2512. ...CREDIT courses ; Developing mechanisms to provide training and technical assistance including for-
Index of Sec 2527. ...ASSESSMENT and provision of supports and services ; Serving as research-based resource for Federal and State policymakers on information concerning provision of training and technical assistance for
Index of Sec 2527. ...AUTISM ; Collecting data on outcomes of training and technical assistance programs to meet statewide needs for expansion of services to children and adults with
Index of Sec 2527. ...TRAINING curricula and training methods recommended by Panel ; Assistant Secretary establishing 3-year demonstration program in 4 States to pilot and evaluate effectiveness of competencies articulated by Panel and
Index of Sec 2589. ...TRAINING funds as provided under section 302(c)(6) of Labor Management Relations Act, 1947 29 USC 186(c)(6) ; Health care entity jointly administered by health care employer and labor union representing health care employees of employer and carries out activities using labor-management
Index of Sec 2521. ...TRAINING initiatives and providing access to training modules and technical assistance practices and other materials developed by grantees ; Developing Web portal providing linkages to individual
Index of Sec 2527. ...ASSESSMENT, interventions, services, treatment and supports for children and adults with autism ; Convening experts from multiple interdiscipations training programs, individuals with autism and families of individuals to discuss and make recommendations with regard to training issues related to
Index of Sec 2527. ...TRAINING methods recommended by Panel ; Assistant Secretary establishing 3-year demonstration program in 4 States to pilot and evaluate effectiveness of competencies articulated by Panel and training curricula and
Index of Sec 2589. ...TRAINING modules and technical assistance practices and other materials developed by grantees ; Developing Web portal providing linkages to individual training initiatives and providing access to
Index of Sec 2527. ...HEALTH care labor organizations or other organizations representing staff nurses and frontline health care workers working in collaboration with accredited schools of nursing and academic institutions ; Providing training programs through education and training organizations jointly administered by health care providers and
Index of Sec 2521. ...TRAINING organizations ; Grantees under paragraph conducting outreach activities to disseminate information about program and results to workforce investment boards, local governments, educational institutions and other workforce
Index of Sec 2591. ...TRAINING organizations ; Disseminating best practices identified by National Health Workforce Online Training Grant Program to other workforce
Index of Sec 2591. ...TRAINING program jointly administered ; Entity operating
Index of Sec 2521. ...EDUCATION and training organizations jointly administered by health care providers and health care labor organizations or other organizations representing staff nurses and frontline health care workers working in collaboration with accredited schools of nursing and academic institutions ; Providing training programs through
Index of Sec 2521. ...CAREER centers, community-based organizations, community colleges and accredited schools of nursing ; Labor organizations including joint labor-management training programs and including representatives from local governments worker investment agency one-stop
Index of Sec 2521. ...PSYCHOLOGY ; Not less than 15 percent to be used for training programs in
Index of Sec 2522. ...ASSESSMENT, interventions, services, treatment and supports for children and adults with autism ; Convening experts from multiple interdiscipations training programs, individuals with autism and families of individuals to discuss and make recommendations with regard to training issues related to
Index of Sec 2527. ...TRAINING programs ; State, local and private resources in order to expand participation of businesses, employees and individuals in
Index of Sec 2591. ...SOCIAL services and other services as proposed by network ; Transportation, language services, enrollment counselors,
Index of Sec 2534. ...TRIBAL organization under Indian Self-Determination and Education Assistance Act ; Program administered by Indian Health Service or Bureau of Indian Affairs or operated by Indian tribe or
Index of Sec 2511. ...TUITION assistance with preference for dedicated cohort classes in community colleges, universities and accredited schools of nursing with supportive services including tutoring and counseling ; Providing
Index of Sec 2521. ...LABOR-management training fund or other jointly administered program ; Payment of tuition assistance managed by joint
Index of Sec 2521. ...UNDERTAKEN with funds reserved under section 402a(c)(1) for Common Fund or otherwise available for initiatives ; Consulations with Division of Program Coordination, Planning and Strategic Initiatives developing and submitting to Director of NIH recommendations on appropriate pain research initiatives to be
Index of Sec 2562. ...VACCINATION of children 5 through 19 years of age ; Program under section to be designed to administer vaccines consistent with recommendations of Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices for annual
Index of Sec 2524. ...SCHOOL-based vaccination assists in achieving recommendations of Advisory Committee on Immunization Practices ; Comparing to national average influenza vaccination rates for school-aged children including whether
Index of Sec 2524. ...INFLUENZA vaccine administered outside of physician's office in school or other related setting ; Including costs of purchasing and administering vaccine incurred when
Index of Sec 2524. ...VENDING machine ; Case of article of food selling from
Index of Sec 2572. ...CALORIES contained in article ; Vending machine operator providing sign in close proximity to article of food or selection button including clear and conspicuous statement disclosing number of
Index of Sec 2572. ...VENDING machines ; Operating by person engaged in business of owning or operating 20 or more
Index of Sec 2572. ...BIOLOGICAL product ; Dismissal withor without prejudice of action instituted under subsection against applicant submitting application for first approved interchangeable biosimilar
Index of Sec 2575. ...PREGNANCY in various ways ; Director of National Institute of Mental Health conducting nationally representative longitudinal study on relative mental health consequences for women of resolving
Index of Sec 2529. ...WOMEN and infants ; Educational and clinical services to promote healthy pregnancies, full term births and healthy infancies delivered to
Index of Sec 2532. ...WOMEN or reasonable evidence indicating that factors or types to be different for women ; Factors of medical risk or type of medical intervention being different for
Index of Sec 2588. ...WOMEN ; Establishing short-range and long-range goals and objectives within Agency for research important to women's health and coordinate with other appropriate offices on activities within Agency relating to health services and medical effectiveness research for issues of particular concern to
Index of Sec 2588. ...HEALTH ; Ethical and policy issues relating to women's
Index of Sec 2588. ...HEALTH ; Agency for healthcare Research and quality activities regarding women's
Index of Sec 2588. ...HEALTH ; Activities regarding women's
Index of Sec 2588. ...CLINICAL practice protocols and conduct of research into patient outcomes, delivery of health care services, quality of care and access to health care ; Age, biological and sociocultural contexts including development of evidence reports and
Index of Sec 2588. ...HEALTH ; Purpose of carrying out section 927 regarding women's
Index of Sec 2588. ...HEALTH on date of enactment of section ; Director of Office assuming authority for development, implementation, administration and evaluation of projects carried out through Health Resources and servicing Administration relating to women's
Index of Sec 2588. ...EDUCATION and training ; Establishing short-range and long-range goals and objectives within Centers for women's health and coordinate with other appropriate offices on activities within Centers relating to prevention, research,
Index of Sec 2588. ...HEALTH and coordinate with other appropriate offices on activities within Agency relating to health services and medical effectiveness research for issues of particular concern to women ; Establishing short-range and long-range goals and objectives within Agency for research important to women's
Index of Sec 2588. ...HEALTH and coordinate with other appropriate offices on activities within Administration relating to health care provider training ; Establishing short-range and long-range goals and objectives within Health Resources and servicing Administration for women's
Index of Sec 2588. ...HEALTH and identify needs regarding coordination of activities including intramural and extramural multidiscipations activities ; Monitoring Department of Health and Human Services' offices, agencies and regional activities regarding women's
Index of Sec 2588. ...HEALTH or respect to activities carried out through Department of Health and Human Services on date of enactment of section ; Nothing in section to be construed to limit authority of Secretary of Health and Human Services with respect to women's
Index of Sec 2588. ...HEALTH ; Health resources and servicing administration office of women's
Index of Sec 2588. ...HEALTH issues in existence on date of enactment of section not to be terminated, reorganized or powers or duties transferred unless termination, reorganization or transfer approved by Act of Congress ; Federal office of women's health or Federal appointive position with primary responsibility over women's
Index of Sec 2588. ...EDUCATION, services and treatment ; Age, biological and sociocultural contexts including prevention programs, public and professional
Index of Sec 2588. ...HEALTH issues in existence on date of enactment of section not to be terminated, reorganized or powers or duties transferred unless termination, reorganization or transfer approved by Act of Congress ; Federal office of women's health or Federal appointive position with primary responsibility over women's
Index of Sec 2588. ...HEALTH programs and policies with private sector ; Coordinate efforts to promote women's
Index of Sec 2588. ...CONTRIBUTIONS to be made directly or donations from public or private entities or provided through cash equivalent of paid release time provided to incumbent worker students ;
Index of Sec 2521. ...HEALTH or nutrition within community in which individual residing ; Term community health worker meaning individual promoting
Index of Sec 2530. ...HEALTH workers under programs funded under section and assuring cost-effectiveness of programs ; Secretary establishing guidelines for assuring quality of training and supervision of community
Index of Sec 2530. ...FOOD service workers, variations in ingredients and other factors ; Considering standardization of recipes and methods of preparation, reasonable variation in serving size and formulation of menu items, space on menus and menu boards, inadvertent human error, training of
Index of Sec 2572. ...HEALTH care workers or staff nurses having direct input as to leadership of organization ; One or more organizations representing interests of direct care health care workers or staff nurses and direct care
Index of Sec 2521. ...CAREER centers, community-based organizations, community colleges and accredited schools of nursing ; Labor organizations including joint labor-management training programs and including representatives from local governments worker investment agency one-stop
Index of Sec 2521. ...WORKER program receiving funds under grant providing services in cultural context ; Community health
Index of Sec 2530. ...WORKER programs receiving funds under grant ; Applicant evaluating effectiveness of community health
Index of Sec 2530. ...WORKER programs receiving funds under section to collaborate with academic institutions ; Secretary encouraging community health
Index of Sec 2530. ...PAYMENT system ; Secretary encouraging community health worker programs receiving funding under section to implement outcome-based
Index of Sec 2530. ...COMPLIANCE with guidelines established under subsection ; Secretary monitoring community health worker programs identified in approved applications under section and determining whether programs in
Index of Sec 2530. ...WORKER programs identified in approved applications under section with respect to planning, developing and operating programs under grant ; Secretary providing technical assistance to community health
Index of Sec 2530. ...WORKER programs developed or assisted under section ; Recommendations for sustaining community health
Index of Sec 2530. ...EDUCATION programs ; Demonstrating experience in implementing and operating online worker skills training and
Index of Sec 2591. ...1st Session |
To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes.
Mr. Dingell (for himself, Mr. Rangel, Mr. Waxman, Mr. George Miller of California, Mr. Stark, Mr. Pallone, and Mr. Andrews) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, Oversight and Government Reform, and the Budget, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
(a) Expansion of Covered Entities Receiving Discounted Prices.—Section 340B(a)(4) (42 U.S.C. 256b(a)(4)) is amended by adding at the end the following:
“(M) A children’s hospital excluded from the Medicare prospective payment system pursuant to section 1886(d)(1)(B)(iii) of the Social Security Act, or a free-standing cancer hospital excluded from the Medicare prospective payment system pursuant to section 1886(d)(1)(B)(v) of the Social Security Act that would meet the requirements of subparagraph (L), including the disproportionate share adjustment percentage requirement under clause (ii) of such subparagraph, if the hospital were a subsection (d) hospital as defined by section 1886(d)(1)(B) of the Social Security Act.
“(N) An entity that is a critical access hospital (as determined under section 1820(c)(2) of the Social Security Act).
“(O) An entity receiving funds under title V of the Social Security Act (relating to maternal and child health) for the provision of health services.
“(P) An entity receiving funds under subpart I of part B of title XIX of the Public Health Service Act (relating to comprehensive mental health services) for the provision of community mental health services.
“(Q) An entity receiving funds under subpart II of such part B (relating to the prevention and treatment of substance abuse) for the provision of treatment services for substance abuse.
“(R) An entity that is a Medicare-dependent, small rural hospital (as defined in section 1886(d)(5)(G)(iv) of the Social Security Act).
“(S) An entity that is a sole community hospital (as defined in section 1886(d)(5)(D)(iii) of the Social Security Act).
“(T) An entity that is classified as a rural referral center under section 1886(d)(5)(C) of the Social Security Act.”.
(b) Prohibition on Group Purchasing Arrangements.—Section 340B(a) (42 U.S.C. 256b(a)) is amended—
(A) by adding “and” at the end of clause (i);
(B) by striking “; and” at the end of clause (ii) and inserting a period; and
(C) by striking clause (iii); and
(2) in paragraph (5), by redesignating subparagraphs (C) and (D) as subparagraphs (D) and (E), respectively, and by inserting after subparagraph (B) the following:
“(C) PROHIBITING USE OF GROUP PURCHASING ARRANGEMENTS.—A hospital described in subparagraph (L), (M), (N), (R), (S), or (T) of paragraph (4) shall not obtain covered outpatient drugs through a group purchasing organization or other group purchasing arrangement.”.
(a) Integrity Improvements.—Section 340B (42 U.S.C. 256b) is amended—
(1) by striking subsections (c) and (d); and
(2) by inserting after subsection (b) the following: “(c) Improvements in Program Integrity.— “(1) MANUFACTURER COMPLIANCE.— “(A) IN GENERAL.—From amounts appropriated under paragraph (4), the Secretary shall provide for improvements in compliance by manufacturers with the requirements of this section in order to prevent overcharges and other violations of the discounted pricing requirements specified in this section. “(B) IMPROVEMENTS.—The improvements described in subparagraph (A) shall include the following: “(i) The establishment of a process to enable the Secretary to verify the accuracy of ceiling prices calculated by manufacturers under subsection (a)(1) and charged to covered entities, which shall include the following: “(I) Developing and publishing, through an appropriate policy or regulatory issuance, standards and methodology for the calculation of ceiling prices under such subsection. “(II) Comparing regularly the ceiling prices calculated by the Secretary with the quarterly pricing data that is reported by manufacturers to the Secretary. “(III) Conducting periodic monitoring of sales transactions to covered entities. “(IV) Inquiring into any discrepancies between ceiling prices and manufacturer pricing data that may be identified and taking, or requiring manufacturers to take, corrective action in response to such discrepancies, including the issuance of refunds pursuant to the procedures set forth in clause (ii).
“(ii) The establishment of procedures for the issuance of refunds to covered entities by manufacturers in the event that the Secretary finds there has been an overcharge, including the following:
“(I) Submission to the Secretary by manufacturers of an explanation of why and how the overcharge occurred, how the refunds will be calculated, and to whom the refunds will be issued.
“(II) Oversight by the Secretary to ensure that the refunds are issued accurately and within a reasonable period of time.
“(iii) Notwithstanding any other provision of law prohibiting the disclosure of ceiling prices or data used to calculate the ceiling price, the provision of access to covered entities and State Medicaid agencies through an Internet website of the Department of Health and Human Services or contractor to the applicable ceiling prices for covered drugs as calculated and verified by the Secretary in a manner that ensures protection of privileged pricing data from unauthorized disclosure.
“(iv) The development of a mechanism by which—
“(I) rebates, discounts, or other price concessions provided by manufacturers to other purchasers subsequent to the sale of covered drugs to covered entities are reported to the Secretary; and
“(II) appropriate credits and refunds are issued to covered entities if such rebates, discounts, or other price concessions have the effect of lowering the applicable ceiling price for the relevant quarter for the drugs involved.
“(v) In addition to authorities under section 1927(b)(3) of the Social Security Act, the Secretary may conduct audits of manufacturers and wholesalers to ensure the integrity of the program under this section, including audits on the market price of covered drugs.
“(vi) The establishment of a requirement that manufacturers and wholesalers use the identification system developed by the Secretary for purposes of facilitating the ordering, purchasing, and delivery of covered drugs under this section, including the processing of chargebacks for such drugs.
“(vii) The imposition of sanctions in the form of civil monetary penalties, which—
“(I) shall be assessed according to standards and procedures established in regulations to be promulgated by the Secretary within one year of the date of the enactment of the Affordable Health Care for America Act; and
“(II) shall apply to any manufacturer with an agreement under this section and shall not exceed $100,000 for each instance where a manufacturer knowingly charges a covered entity a price for purchase of a drug that exceeds the maximum applicable price under subsection (a)(1) or that knowingly violates any other provision of this section, or withholds or provides false information to the Secretary or to covered entities under this section.
“(2) COVERED ENTITY COMPLIANCE.—
“(A) IN GENERAL.—From amounts appropriated under paragraph (4), the Secretary shall provide for improvements in compliance by covered entities with the requirements of this section in order to prevent diversion and violations of the duplicate discount provision and other requirements under subsection (a)(5).
“(B) IMPROVEMENTS.—The improvements described in subparagraph (A) shall include the following:
“(i) The development of procedures to enable and require covered entities to update at least annually the information on the Internet Web site of the Department of Health and Human Services relating to this section.
“(ii) The development of procedures for the Secretary to verify the accuracy of information regarding covered entities that is listed on the Web site described in clause (i).
“(iii) The development of more detailed guidance describing methodologies and options available to covered entities for billing covered drugs to State Medicaid agencies in a manner that avoids duplicate discounts pursuant to subsection (a)(5)(A).
“(iv) The establishment of a single, universal, and standardized identification system by which each covered entity site can be identified by manufacturers, distributors, covered entities, and the Secretary for purposes of facilitating the ordering, purchasing, and delivery of covered drugs under this section, including the processing of chargebacks for such drugs.
“(v) The imposition of sanctions in the form of civil monetary penalties, which—
“(I) shall be assessed according to standards and procedures established in regulations promulgated by the Secretary;
“(II) shall not exceed $5,000 for each violation; and
“(III) shall apply to any covered entity that knowingly violates subparagraph (a)(5)(B) or knowingly violates any other provision of this section.
“(vi) The exclusion of a covered entity from participation in the program under this section, for a period of time to be determined by the Secretary, in cases in which the Secretary determines, in accordance with standards and procedures established in regulations, that—
“(I) a violation of a requirement of this section was repeated and knowing; and
“(II) imposition of a monetary penalty would be insufficient to reasonably ensure compliance.
“(vii) The referral of matters as appropriate to the Food and Drug Administration, the Office of Inspector General of Department of Health and Human Services, or other Federal agencies.
“(3) ADMINISTRATIVE DISPUTE RESOLUTION PROCESS.—From amounts appropriated under paragraph (4), the Secretary may establish and implement an administrative process for the resolution of the following:
“(A) Claims by covered entities that manufacturers have violated the terms of their agreement with the Secretary under subsection (a)(1).
“(B) Claims by manufacturers that covered entities have violated subsection (a)(5)(A) or (a)(5)(B).
“(4) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this subsection, such sums as may be necessary for fiscal year 2011 and each succeeding fiscal year.”.
(1) Section 340B(a) (42 U.S.C. 256b(a)) is amended—
(A) by adding at the end of paragraph (1) the following: “Such agreement shall require that the manufacturer offer each covered entity covered drugs for purchase at or below the applicable ceiling price if such drug is made available to any other purchaser at any price. Such agreement shall require that, if the supply of a covered drug is insufficient to meet demand, then the manufacturer may utilize an allocation method that is reported in writing to the Secretary and does not discriminate on the basis of the price paid by covered entities or on any other basis related to an entity’s participation in the program under this section. Notwithstanding any other provision of law, if the Secretary requests a manufacturer to enter into a new or amended agreement under this section that complies with current law and if the manufacturer opts not to sign the new or amended agreement, then any existing agreement between the manufacturer and the Secretary under this section is deemed to no longer meet the requirements of this section for purposes of this section and section 1927 of the Social Security Act.”; and
(B) by adding at the end the following paragraph:
“(11) QUARTERLY REPORTS.—An agreement described in paragraph (1) shall require that the manufacturer furnish the Secretary with reports on a quarterly basis that include the following information:
“(A) The price for each covered drug subject to the agreement that, according to the manufacturer, represents the maximum price that covered entities may permissibly be required to pay for the drug (referred to in this section as the ‘ceiling price’).
“(B) The component information used to calculate the ceiling price as determined necessary to administer the requirements of the program under this section.
“(C) Rebates, discounts, and other price concessions provided by manufacturers to other purchasers subsequent to the sale of covered drugs to covered entities.”.
(2) Section 1927(a)(5) of the Social Security Act (42 U.S.C. 1396r–8(a)(5)) is amended by striking subparagraph (D).
(a) In general.—The amendments made by this subtitle shall take effect on the date of the enactment of this Act, and sections 2501, 2502(a)(1), and 2502(b)(2) shall apply to drugs dispensed on or after such date.
(b) Effectiveness.—The amendments made by this subtitle shall be effective, and shall be taken into account in determining whether a manufacturer is deemed to meet the requirements of section 340B(a) of the Public Health Service Act (42 U.S.C. 256b(a)), and of section 1927(a)(5) of the Social Security Act (42 U.S.C. 1396r–8(a)(5)), notwithstanding any other provision of law.
(a) In general.—Part Q of title III (42 U.S.C. 280h et seq.) is amended by adding at the end the following:
“(a) Program.—The Secretary shall establish a school-based health clinic program consisting of awarding grants to eligible entities to support the operation of school-based health clinics (referred to in this section as ‘SBHCs’).
“(b) Eligibility.—To be eligible for a grant under this section, an entity shall—
“(1) be an SBHC (as defined in subsection (l)(3)); and
“(2) submit an application at such time, in such manner, and containing such information as the Secretary may require, including at a minimum—
“(A) evidence that the applicant meets all criteria necessary to be designated as an SBHC;
“(B) evidence of local need for the services to be provided by the SBHC;
“(i) SBHC services will be provided in accordance with Federal, State, and local laws;
“(ii) the SBHC has established and maintains collaborative relationships with other health care providers in the catchment area of the SBHC;
“(iii) the SBHC will provide onsite access during the academic day when school is in session and has an established network of support and access to services with backup health providers when the school or SBHC is closed;
“(iv) the SBHC will be integrated into the school environment and will coordinate health services with appropriate school personnel and other community providers co-located at the school; and
“(v) the SBHC sponsoring facility assumes all responsibility for the SBHC administration, operations, and oversight; and
“(D) such other information as the Secretary may require.
“(c) Use of funds.—Funds awarded under a grant under this section—
“(A) providing training related to the provision of comprehensive primary health services and additional health services;
“(B) the management and operation of SBHC programs, including through subcontracts; and
“(C) the payment of salaries for health professionals and other appropriate SBHC personnel; and
“(2) may not be used to provide abortions.
“(d) Consideration of need.—In determining the amount of a grant under this section, the Secretary shall take into consideration—
“(1) the financial need of the SBHC;
“(2) State, local, or other sources of funding provided to the SBHC; and
“(3) other factors as determined appropriate by the Secretary.
“(e) Preferences.—In awarding grants under this section, the Secretary shall give preference to SBHCs that have a demonstrated record of service to at least one of the following:
“(1) A high percentage of medically underserved children and adolescents.
“(2) Communities or populations in which children and adolescents have difficulty accessing health and mental health services.
“(3) Communities with high percentages of children and adolescents who are uninsured, underinsured, or eligible for medical assistance under Federal or State health benefits programs (including titles XIX and XXI of the Social Security Act).
“(f) Matching requirement.—The Secretary may award a grant to an SBHC under this section only if the SBHC agrees to provide, from non-Federal sources, an amount equal to 20 percent of the amount of the grant (which may be provided in cash or in kind) to carry out the activities supported by the grant.
“(g) Supplement, not supplant.—The Secretary may award a grant to an SBHC under this section only if the SBHC demonstrates to the satisfaction of the Secretary that funds received through the grant will be expended only to supplement, and not supplant, non-Federal and Federal funds otherwise available to the SBHC for operation of the SBHC (including each activity described in paragraph (1) or (2) of subsection (c)).
“(h) Payor of last resort.—The Secretary may award a grant to an SBHC under this section only if the SBHC demonstrates to the satisfaction of the Secretary that funds received through the grant will not be expended for any activity to the extent that payment has been made, or can reasonably be expected to be made—
“(1) under any insurance policy;
“(2) under any Federal or State health benefits program (including titles XIX and XXI of the Social Security Act); or
“(3) by an entity which provides health services on a prepaid basis.
“(i) Regulations regarding reimbursement for health services.—The Secretary shall issue regulations regarding the reimbursement for health services provided by SBHCs to individuals eligible to receive such services through the program under this section, including reimbursement under any insurance policy or any Federal or State health benefits program (including titles XIX and XXI of the Social Security Act).
“(j) Technical Assistance.—The Secretary shall provide (either directly or by grant or contract) technical and other assistance to SBHCs to assist such SBHCs to meet the requirements of this section. Such assistance may include fiscal and program management assistance, training in fiscal and program management, operational and administrative support, and the provision of information to the SBHCs of the variety of resources available under this title and how those resources can be best used to meet the health needs of the communities served by the SBHCs.
“(k) Evaluation; report.—The Secretary shall—
“(1) develop and implement a plan for evaluating SBHCs and monitoring quality performances under the awards made under this section; and
“(2) submit to the Congress on an annual basis a report on the program under this section.
“(l) Definitions.—In this section:
“(1) COMPREHENSIVE PRIMARY HEALTH SERVICES.—The term ‘comprehensive primary health services’ means the core services offered by SBHCs, which—
“(i) comprehensive health assessments, diagnosis, and treatment of minor, acute, and chronic medical conditions and referrals to, and followup for, specialty care; and
“(ii) mental health assessments, crisis intervention, counseling, treatment, and referral to a continuum of services including emergency psychiatric care, community support programs, inpatient care, and outpatient programs; and
“(B) may include additional services, such as oral health, social, and age-appropriate health education services, including nutritional counseling.
“(2) MEDICALLY UNDERSERVED CHILDREN AND ADOLESCENTS.—The term ‘medically underserved children and adolescents’ means a population of children and adolescents who are residents of an area designated by the Secretary as an area with a shortage of personal health services and health infrastructure for such children and adolescents.
“(3) SCHOOL-BASED HEALTH CLINIC.—The term ‘school-based health clinic’ means a health clinic that—
“(A) is located in, or is adjacent to, a school facility of a local educational agency;
“(B) is organized through school, community, and health provider relationships;
“(C) is administered by a sponsoring facility;
“(D) provides comprehensive primary health services during school hours to children and adolescents by health professionals in accordance with State and local laws and regulations, established standards, and community practice; and
“(E) does not perform abortion services.
“(4) SPONSORING FACILITY.—The term ‘sponsoring facility’ is—
“(A) a hospital;
“(B) a public health department;
“(C) a community health center;
“(D) a nonprofit health care entity whose mission is to provide access to comprehensive primary health care services;
“(E) a local educational agency; or
“(F) a program administered by the Indian Health Service or the Bureau of Indian Affairs or operated by an Indian tribe or a tribal organization under the Indian Self-Determination and Education Assistance Act, a Native Hawaiian entity, or an urban Indian program under title V of the Indian Health Care Improvement Act.
“(m) Authorization of appropriations.—For purposes of carrying out this section, there are authorized to be appropriated $50,000,000 for fiscal year 2011 and such sums as may be necessary for each of fiscal years 2012 through 2015.”.
(b) Effective date.—The Secretary of Health and Human Services shall begin awarding grants under section 399Z–1 of the Public Health Service Act, as added by subsection (a), not later than July 1, 2010, without regard to whether or not final regulations have been issued under section 399Z–1(i) of such Act.
(c) Termination of study.—Section 2(b) of the Health Care Safety Net Act of 2008 (42 U.S.C. 254b note) is amended by striking paragraph (2) (relating to a school-based health center study).
Title III (42 U.S.C. 241 et seq.) is amended by adding at the end the following:
“(a) Program.—The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall establish a nurse-managed health center program consisting of awarding grants to entities under subsection (b).
“(b) Grant.—The Secretary shall award grants to entities—
“(1) to plan and develop a nurse-managed health center; or
“(2) to operate a nurse-managed health center.
“(c) Use of funds.—Amounts received as a grant under subsection (b) may be used for activities including the following:
“(1) Purchasing or leasing equipment.
“(2) Training and technical assistance related to the provision of comprehensive primary care services and wellness services.
“(3) Other activities for planning, developing, or operating, as applicable, a nurse-managed health center.
“(d) Assurances applicable to both planning and operation grants.—
“(1) IN GENERAL.—The Secretary may award a grant under this section to an entity only if the entity demonstrates to the Secretary’s satisfaction that—
“(A) nurses, in addition to managing the center, will be adequately represented as providers at the center; and
“(B) not later than 90 days after receiving the grant, the entity will establish a community advisory committee composed of individuals, a majority of whom are being served by the center, to provide input into the nurse-managed health center’s operations.
“(2) MATCHING REQUIREMENT.—The Secretary may award a grant under this section to an entity only if the entity agrees to provide, from non-Federal sources, an amount equal to 20 percent of the amount of the grant (which may be provided in cash or in kind) to carry out the activities supported by the grant.
“(3) PAYOR OF LAST RESORT.—The Secretary may award a grant under this section to an entity only if the entity demonstrates to the satisfaction of the Secretary that funds received through the grant will not be expended for any activity to the extent that payment has been made, or can reasonably be expected to be made—
“(A) under any insurance policy;
“(B) under any Federal or State health benefits program (including titles XIX and XXI of the Social Security Act); or
“(C) by an entity which provides health services on a prepaid basis.
“(4) MAINTENANCE OF EFFORT.—The Secretary may award a grant under this section to an entity only if the entity demonstrates to the satisfaction of the Secretary that—
“(A) funds received through the grant will be expended only to supplement, and not supplant, non-Federal and Federal funds otherwise available to the entity for the activities to be funded through the grant; and
“(B) with respect to such activities, the entity will maintain expenditures of non-Federal amounts for such activities at a level not less than the lesser of such expenditures maintained by the entity for the fiscal year preceding the fiscal year for which the entity receives the grant.
“(e) Additional assurance for planning grants.—The Secretary may award a grant under subsection (b)(1) to an entity only if the entity agrees—
“(1) to assess the needs of the medically underserved populations proposed to be served by the nurse-managed health center; and
“(2) to design services and operations of the nurse-managed health center for such populations based on such assessment.
“(f) Additional assurance for operation grants.—The Secretary may award a grant under subsection (b)(2) to an entity only if the entity assures that the nurse-managed health center will provide—
“(1) comprehensive primary care services, wellness services, and other health care services deemed appropriate by the Secretary;
“(2) care without respect to insurance status or income of the patient; and
“(3) direct access to client-centered services offered by advanced practice nurses, other nurses, physicians, physician assistants, or other qualified health professionals.
“(g) Technical assistance.—The Secretary shall provide (either directly or by grant or contract) technical and other assistance to nurse-managed health centers to assist such centers in meeting the requirements of this section. Such assistance may include fiscal and program management assistance, training in fiscal and program management, operational and administrative support, and the provision of information to nurse-managed health centers regarding the various resources available under this section and how those resources can best be used to meet the health needs of the communities served by nurse-managed health centers.
“(h) Report.—The Secretary shall submit to the Congress an annual report on the program under this section.
“(i) Definitions.—In this section:
“(1) COMPREHENSIVE PRIMARY CARE SERVICES.—The term ‘comprehensive primary care services’ has the meaning given to the term ‘required primary health services’ in section 330(b)(1).
“(2) MEDICALLY UNDERSERVED POPULATION.—The term ‘medically underserved population’ has the meaning given to such term in section 330(b)(3).
“(3) NURSE-MANAGED HEALTH CENTER.—The term ‘nurse-managed health center’ has the meaning given to such term in section 801.
“(4) WELLNESS SERVICES.—The term ‘wellness services’ means any health-related service or intervention, not including primary care, which is designed to reduce identifiable health risks and increase healthy behaviors intended to prevent the onset of disease or lessen the impact of existing chronic conditions by teaching more effective management techniques that focus on individual self-care and patient-driven decisionmaking.
“(j) Authorization of appropriations.—To carry out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2011 through 2015.”.
Section 1913 (42 U.S.C. 300x–3) is amended—
(1) in subsection (a)(2)(A), by striking “community mental health services” and inserting “behavioral health services (of the type offered by federally qualified behavioral health centers consistent with subsection (c)(3))”;
(A) by striking paragraph (1) and inserting the following:
“(1) services under the plan will be provided only through appropriate, qualified community programs (which may include federally qualified behavioral health centers, child mental health programs, psychosocial rehabilitation programs, mental health peer-support programs, and mental health primary consumer-directed programs); and”; and
(B) in paragraph (2), by striking “community mental health centers” and inserting “federally qualified behavioral health centers”; and
(3) by striking subsection (c) and inserting the following: “(c) Criteria for federally qualified behavioral health centers.— “(1) IN GENERAL.—The Administrator shall certify, and recertify at least every 5 years, federally qualified behavioral health centers as meeting the criteria specified in this subsection. “(2) REGULATIONS.—Not later than 18 months after the date of the enactment of the Affordable Health Care for America Act, the Administrator shall issue final regulations for certifying centers under paragraph (1). “(3) CRITERIA.—The criteria referred to in subsection (b)(2) are that the center performs each of the following: “(A) Provide services in locations that ensure services will be available and accessible promptly and in a manner which preserves human dignity and assures continuity of care. “(B) Provide services in a mode of service delivery appropriate for the target population. “(C) Provide individuals with a choice of service options where there is more than one efficacious treatment. “(D) Employ a core staff of clinical staff that is multidisciplinary and culturally and linguistically competent. “(E) Provide services, within the limits of the capacities of the center, to any individual residing or employed in the service area of the center. “(F) Provide, directly or through contract, to the extent covered for adults in the State Medicaid plan and for children in accordance with section 1905(r) of the Social Security Act regarding early and periodic screening, diagnosis, and treatment, each of the following services: “(i) Screening, assessment, and diagnosis, including risk assessment. “(ii) Person-centered treatment planning or similar processes, including risk assessment and crisis planning. “(iii) Outpatient clinic mental health services, including screening, assessment, diagnosis, psychotherapy, substance abuse counseling, medication management, and integrated treatment for mental illness and substance abuse which shall be evidence-based (including cognitive behavioral therapy, dialectical behavioral therapy, motivational interviewing, and other such therapies which are evidence-based). “(iv) Outpatient clinic primary care services, including screening and monitoring of key health indicators and health risk (including screening for diabetes, hypertension, and cardiovascular disease and monitoring of weight, height, body mass index (BMI), blood pressure, blood glucose or HbA1C, and lipid profile). “(v) Crisis mental health services, including 24-hour mobile crisis teams, emergency crisis intervention services, and crisis stabilization. “(vi) Targeted case management (services to assist individuals gaining access to needed medical, social, educational, and other services and applying for income security and other benefits to which they may be entitled). “(vii) Psychiatric rehabilitation services including skills training, assertive community treatment, family psychoeducation, disability self-management, supported employment, supported housing services, therapeutic foster care services, multisystemic therapy, and such other evidence-based practices as the Secretary may require. “(viii) Peer support and counselor services and family supports.
“(G) Maintain linkages, and where possible enter into formal contracts with, inpatient psychiatric facilities and substance abuse detoxification and residential programs.
“(H) Make available to individuals served by the center, directly, through contract, or through linkages with other programs, each of the following:
“(i) Adult and youth peer support and counselor services.
“(ii) Family support services for families of children with serious mental disorders.
“(iii) Other community or regional services, supports, and providers, including schools, child welfare agencies, juvenile and criminal justice agencies and facilities, housing agencies and programs, employers, and other social services.
“(iv) Onsite or offsite access to primary care services.
“(v) Enabling services, including outreach, transportation, and translation.
“(vi) Health and wellness services, including services for tobacco cessation.”.
(a) Purposes.—It is the purpose of this section to authorize grants to—
(1) address the projected shortage of nurses by funding comprehensive programs to create a career ladder to nursing (including certified nurse assistants, licensed practical nurses, licensed vocational nurses, and registered nurses) for incumbent ancillary health care workers;
(2) increase the capacity for educating nurses by increasing both nurse faculty and clinical opportunities through collaborative programs between staff nurse organizations, health care providers, and accredited schools of nursing; and
(3) provide training programs through education and training organizations jointly administered by health care providers and health care labor organizations or other organizations representing staff nurses and frontline health care workers, working in collaboration with accredited schools of nursing and academic institutions.
(b) Grants.—Not later than 6 months after the date of the enactment of this Act, the Secretary of Labor (referred to in this section as the “Secretary”) shall establish a partnership grant program to award grants to eligible entities to carry out comprehensive programs to provide education to nurses and create a pipeline to nursing for incumbent ancillary health care workers who wish to advance their careers, and to otherwise carry out the purposes of this section.
(c) Eligibility.—To be eligible for a grant under this section, an entity shall be—
(1) a health care entity that is jointly administered by a health care employer and a labor union representing the health care employees of the employer and that carries out activities using labor-management training funds as provided for under section 302(c)(6) of the Labor Management Relations Act, 1947 (29 U.S.C. 186(c)(6));
(2) an entity that operates a training program that is jointly administered by—
(A) one or more health care providers or facilities, or a trade association of health care providers; and
(B) one or more organizations which represent the interests of direct care health care workers or staff nurses and in which the direct care health care workers or staff nurses have direct input as to the leadership of the organization;
(3) a State training partnership program that consists of nonprofit organizations that include equal participation from industry, including public or private employers, and labor organizations including joint labor-management training programs, and which may include representatives from local governments, worker investment agency one-stop career centers, community-based organizations, community colleges, and accredited schools of nursing; or
(4) a school of nursing (as defined in section 801 of the Public Health Service Act (42 U.S.C. 296)).
(d) Additional requirements for health care employer described in subsection (c).—To be eligible for a grant under this section, a health care employer described in subsection (c) shall demonstrate that it—
(1) has an established program within its facility to encourage the retention of existing nurses;
(2) provides wages and benefits to its nurses that are competitive for its market or that have been collectively bargained with a labor organization; and
(3) supports programs funded under this section through 1 or more of the following:
(A) The provision of paid leave time and continued health coverage to incumbent health care workers to allow their participation in nursing career ladder programs, including certified nurse assistants, licensed practical nurses, licensed vocational nurses, and registered nurses.
(B) Contributions to a joint labor-management training fund which administers the program involved.
(C) The provision of paid release time, incentive compensation, or continued health coverage to staff nurses who desire to work full- or part-time in a faculty position.
(D) The provision of paid release time for staff nurses to enable them to obtain a bachelor of science in nursing degree, other advanced nursing degrees, specialty training, or certification program.
(E) The payment of tuition assistance which is managed by a joint labor-management training fund or other jointly administered program.
(A) IN GENERAL.—The Secretary may not make a grant under this section unless the applicant involved agrees, with respect to the costs to be incurred by the applicant in carrying out the program under the grant, to make available non-Federal contributions (in cash or in kind under subparagraph (B)) toward such costs in an amount equal to not less than $1 for each $1 of Federal funds provided in the grant. Such contributions may be made directly or through donations from public or private entities, or may be provided through the cash equivalent of paid release time provided to incumbent worker students.
(B) DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBUTION.—Non-Federal contributions required in subparagraph (A) may be in cash or in kind (including paid release time), fairly evaluated, including equipment or services (and excluding indirect or overhead costs). Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(2) REQUIRED COLLABORATION.—Entities carrying out or overseeing programs carried out with assistance provided under this section shall demonstrate collaboration with accredited schools of nursing which may include community colleges and other academic institutions providing associate’s, bachelor's, or advanced nursing degree programs or specialty training or certification programs.
(f) Use of funds.—Amounts awarded to an entity under a grant under this section shall be used for the following:
(1) To carry out programs that provide education and training to establish nursing career ladders to educate incumbent health care workers to become nurses (including certified nurse assistants, licensed practical nurses, licensed vocational nurses, and registered nurses). Such programs shall include one or more of the following:
(A) Preparing incumbent workers to return to the classroom through English-as-a-second-language education, GED education, precollege counseling, college preparation classes, and support with entry level college classes that are a prerequisite to nursing.
(B) Providing tuition assistance with preference for dedicated cohort classes in community colleges, universities, and accredited schools of nursing with supportive services including tutoring and counseling.
(C) Providing assistance in preparing for and meeting all nursing licensure tests and requirements.
(D) Carrying out orientation and mentorship programs that assist newly graduated nurses in adjusting to working at the bedside to ensure their retention postgraduation, and ongoing programs to support nurse retention.
(E) Providing stipends for release time and continued health care coverage to enable incumbent health care workers to participate in these programs.
(2) To carry out programs that assist nurses in obtaining advanced degrees and completing specialty training or certification programs and to establish incentives for nurses to assume nurse faculty positions on a part-time or full-time basis. Such programs shall include one or more of the following:
(A) Increasing the pool of nurses with advanced degrees who are interested in teaching by funding programs that enable incumbent nurses to return to school.
(B) Establishing incentives for advanced degree bedside nurses who wish to teach in nursing programs so they can obtain a leave from their bedside position to assume a full- or part-time position as adjunct or full-time faculty without the loss of salary or benefits.
(C) Collaboration with accredited schools of nursing which may include community colleges and other academic institutions providing associate’s, bachelor's, or advanced nursing degree programs, or specialty training or certification programs, for nurses to carry out innovative nursing programs which meet the needs of bedside nursing and health care providers.
(g) Preference.—In awarding grants under this section the Secretary shall give preference to programs that—
(1) provide for improving nurse retention;
(2) provide for improving the diversity of the new nurse graduates to reflect changes in the demographics of the patient population;
(3) provide for improving the quality of nursing education to improve patient care and safety;
(4) have demonstrated success in upgrading incumbent health care workers to become nurses or which have established effective programs or pilots to increase nurse faculty; or
(5) are modeled after or affiliated with such programs described in paragraph (4).
(1) PROGRAM EVALUATIONS.—An entity that receives a grant under this section shall annually evaluate, and submit to the Secretary a report on, the activities carried out under the grant and the outcomes of such activities. Such outcomes may include—
(A) an increased number of incumbent workers entering an accredited school of nursing and in the pipeline for nursing programs;
(B) an increasing number of graduating nurses and improved nurse graduation and licensure rates;
(C) improved nurse retention;
(D) an increase in the number of staff nurses at the health care facility involved;
(E) an increase in the number of nurses with advanced degrees in nursing;
(F) an increase in the number of nurse faculty;
(G) improved measures of patient quality (which may include staffing ratios of nurses, patient satisfaction rates, and patient safety measures); and
(H) an increase in the diversity of new nurse graduates relative to the patient population.
(2) GENERAL REPORT.—Not later than 2 years after the date of the enactment of this Act, and annually thereafter, the Secretary of Labor shall, using data and information from the reports received under paragraph (1), submit to the Congress a report concerning the overall effectiveness of the grant program carried out under this section.
(i) Authorization of appropriations.—There are authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years 2011 through 2015.
Part E of title VII (42 U.S.C. 294n et seq.) is amended by adding at the end the following:
“(a) Program.—The Secretary, acting through the Administrator of the Health Resources and Services Administration and in consultation with the Administrator of the Substance Abuse and Mental Health Services Administration, shall establish an interdisciplinary mental and behavioral health training program consisting of awarding grants and contracts under subsection (b).
“(b) Support and development of mental and behavioral health training programs.—The Secretary shall make grants to, or enter into contracts with, eligible entities—
“(1) to plan, develop, operate, or participate in an accredited professional training program for mental and behavioral health professionals to promote—
“(A) interdisciplinary training; and
“(B) coordination of the delivery of health care within and across settings, including health care institutions, community-based settings, and the patient’s home;
“(2) to provide financial assistance to mental and behavioral health professionals, who are participants in any such program, and who plan to work in the field of mental and behavioral health;
“(3) to plan, develop, operate, or participate in an accredited program for the training of mental and behavioral health professionals who plan to teach in the field of mental and behavioral health; and
“(4) to provide financial assistance in the form of traineeships and fellowships to mental and behavioral health professionals who are participants in any such program and who plan to teach in the field of mental and behavioral health.
“(c) Eligibility.—To be eligible for a grant or contract under subsection (b), an entity shall be—
“(1) an accredited health professions school, including an accredited school or program of psychology, psychiatry, social work, marriage and family therapy, professional mental health or substance abuse counseling, or addiction medicine;
“(2) an accredited public or nonprofit private hospital;
“(3) a public or private nonprofit entity; or
“(4) a consortium of 2 or more entities described in paragraphs (1) through (3).
“(d) Preference.—In awarding grants or contracts under this section, the Secretary shall give preference to entities that have a demonstrated record of at least one of the following:
“(1) Training a high or significantly improved percentage of health professionals who serve in underserved communities.
“(2) Supporting teaching programs that address the health care needs of vulnerable populations.
“(3) Training individuals who are from disadvantaged backgrounds (including racial and ethnic minorities underrepresented among mental and behavioral health professionals).
“(4) Training individuals who serve geriatric populations with an emphasis on underserved elderly.
“(5) Training individuals who serve pediatric populations with an emphasis on underserved children.
“(e) Report.—The Secretary shall submit to the Congress an annual report on the program under this section.
“(f) Definition.—In this section:
“(1) The term ‘interdisciplinary’ means collaboration across health professions, specialties, and subspecialties, which may include public health, nursing, allied health, dietetics or nutrition, and appropriate health specialties.
“(2) The term ‘mental and behavioral health professional’ means an individual training or practicing—
“(A) in psychology; general, geriatric, child or adolescent psychiatry; social work; marriage and family therapy; professional mental health or substance abuse counseling; or addiction medicine; or
“(B) another mental and behavioral health specialty, as deemed appropriate by the Secretary.
“(g) Authorization of appropriations.—To carry out this section, there is authorized to be appropriated $60,000,000 for each of fiscal years 2011 through 2015. Of the amounts appropriated to carry out this section for a fiscal year, not less than 15 percent shall be used for training programs in psychology.”.
(a) Telehealth network and telehealth resource centers grant programs.—Section 330I (42 U.S.C. 254c–14) is amended—
(A) by striking paragraph (3) (relating to frontier communities); and
(B) by inserting after paragraph (2) the following:
“(3) HEALTH DISPARITIES.—The term ‘health disparities’ has the meaning given such term in section 3171.”;
(A) in subparagraph (B), by striking “and” at the end;
(B) in subparagraph (C), by striking the period at the end and inserting “; and”; and
(C) by adding at the end the following:
“(D) reduce health disparities.”;
(3) in subsection (f)(1)(B)(iii)—
(A) in subclause (VII), by inserting “, including skilled nursing facilities” before the period at the end;
(B) in subclause (IX), by inserting “, including county mental health and public mental health facilities” before the period at the end; and
(C) by adding at the end the following:
“(XIII) Renal dialysis facilities.”;
(4) by amending subsection (i) to read as follows: “(1) TELEHEALTH NETWORKS.—In awarding grants under subsection (d)(1) for projects involving telehealth networks, the Secretary shall give preference to eligible entities meeting at least one of the following: “(A) NETWORK.—The eligible entity is a health care provider in, or proposing to form, a health care network that furnishes services in a medically underserved area or a health professional shortage area. “(B) BROAD GEOGRAPHIC COVERAGE.—The eligible entity demonstrates broad geographic coverage in the rural or medically underserved areas of the State or States in which the entity is located. “(C) HEALTH DISPARITIES.—The eligible entity demonstrates how the project to be funded through the grant will address health disparities. “(D) LINKAGES.—The eligible entity agrees to use the grant to establish or develop plans for telehealth systems that will link rural hospitals and rural health care providers to other hospitals, health care providers, and patients. “(E) EFFICIENCY.—The eligible entity agrees to use the grant to promote greater efficiency in the use of health care resources. “(F) VIABILITY.—The eligible entity demonstrates the long-term viability of projects through— “(i) availability of non-Federal funding sources; or “(ii) institutional and community support for the telehealth network.
“(G) SERVICES.—The eligible entity provides a plan for coordinating system use by eligible entities and prioritizes use of grant funds for health care services over nonclinical uses.
“(2) TELEHEALTH RESOURCE CENTERS.—In awarding grants under subsection (d)(2) for projects involving telehealth resource centers, the Secretary shall give preference to eligible entities meeting at least one of the following:
“(A) PROVISION OF A BROAD RANGE OF SERVICES.—The eligible entity has a record of success in the provision of a broad range of telehealth services to medically underserved areas or populations.
“(B) PROVISION OF TELEHEALTH TECHNICAL ASSISTANCE.—The eligible entity has a record of success in the provision of technical assistance to providers serving medically underserved communities or populations in the establishment and implementation of telehealth services.
“(C) COLLABORATION AND SHARING OF EXPERTISE.—The eligible entity has a demonstrated record of collaborating and sharing expertise with providers of telehealth services at the national, regional, State, and local levels.”;
(5) in subsection (j)(2)(B), by striking “such projects for fiscal year 2001” and all that follows through the period and inserting “such projects for fiscal year 2010.”;
(A) in subparagraph (E)(i), by striking “transmission of medical data” and inserting “transmission and electronic archival of medical data”; and
(B) by amending subparagraph (F) to read as follows:
“(F) developing projects to use telehealth technology to—
“(i) facilitate collaboration between health care providers;
“(ii) promote telenursing services; or
“(iii) promote patient understanding and adherence to national guidelines for chronic disease and self-management of such conditions;”;
(7) in subsection (q), by striking “Not later than September 30, 2005” and inserting “Not later than 1 year after the date of the enactment of the Affordable Health Care for America Act, and annually thereafter”;
(8) by striking subsection (r);
(9) by redesignating subsection (s) as subsection (r); and
(10) in subsection (r) (as so redesignated)—
(i) by striking “and” before “such sums”; and
(ii) by inserting “, $10,000,000 for fiscal year 2011, and such sums as may be necessary for each of fiscal years 2012 through 2015” before the semicolon; and
(i) by striking “and” before “such sums”; and
(ii) by inserting “, $10,000,000 for fiscal year 2011, and such sums as may be necessary for each of fiscal years 2012 through 2015” before the period.
(b) Telemedicine; incentive grants regarding coordination among States.—Subsection (b) of section 330L (42 U.S.C. 254c–18) is amended by inserting “, $10,000,000 for fiscal year 2011, and such sums as may be necessary for each of fiscal years 2012 through 2015” before the period at the end.
(a) Purpose.—The Secretary of Health and Human Services in consultation with the Secretary of Education, shall award grants to eligible partnerships to carry out demonstration programs designed to test the feasibility of using the Nation’s elementary schools and secondary schools as influenza vaccination centers.
(b) In general.—The Secretary shall coordinate with the Secretary of Labor, the Secretary of Education, State Medicaid agencies, State insurance agencies, and private insurers to carry out a program consisting of awarding grants under subsection (c) to ensure that children have coverage for all reasonable and customary expenses related to influenza vaccinations, including the costs of purchasing and administering the vaccine incurred when influenza vaccine is administered outside of the physician’s office in a school or other related setting.
(1) GRANTS.—From amounts appropriated pursuant to subsection (l), the Secretary shall award grants to eligible partnerships to be used to provide influenza vaccinations to children in elementary and secondary schools, in coordination with school nurses, school health care programs, community health care providers, State insurance agencies, or private insurers.
(2) ACIP RECOMMENDATIONS.—The program under this section shall be designed to administer vaccines consistent with the recommendations of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) for the annual vaccination of all children 5 through 19 years of age.
(3) PARTICIPATION VOLUNTARY.—Participation by a school or an individual shall be voluntary.
(d) Use of funds.—Eligible partnerships receiving a grant under this section shall ensure the maximum number of children access influenza vaccinations as follows:
(1) COVERED CHILDREN.—To the extent to which payment of the costs of purchasing or administering the influenza vaccine for children is not covered through other federally funded programs or through private insurance, eligible partnerships receiving a grant shall use funds to purchase and administer influenza vaccinations.
(2) CHILDREN COVERED BY OTHER FEDERAL PROGRAMS.—For children who are eligible under other federally funded programs for payment of the costs of purchasing or administering the influenza vaccine, eligible partnerships receiving a grant shall not use funds provided under this section for such costs.
(3) CHILDREN COVERED BY PRIVATE HEALTH INSURANCE.—For children who have private insurance, eligible partnerships receiving a grant shall offer assistance in accessing coverage for vaccinations administered through the program under this section.
(e) Privacy.—The Secretary shall ensure that the program under this section adheres to confidentiality and privacy requirements of section 264 of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note) and section 444 of the General Education Provisions Act (20 U.S.C. 1232g; commonly referred to as the “Family Educational Rights and Privacy Act of 1974”).
(f) Application.—An eligible partnership desiring a grant under this section shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require.
(g) Duration.—Eligible partnerships receiving a grant shall administer a demonstration program funded through this section over a period of 2 consecutive school years.
(h) Choice of vaccine.—The program under this section shall not restrict the discretion of a health care provider to administer any influenza vaccine approved by the Food and Drug Administration for use in pediatric populations.
(i) Awards.—The Secretary shall award—
(1) a minimum of 10 grants in 10 different States to eligible partnerships that each include one or more public schools serving primarily low-income students; and
(2) a minimum of 5 grants in 5 different States to eligible partnerships that each include one or more public schools located in a rural local educational agency.
(j) Report.—Not later than 90 days following the completion of the program under this section, the Secretary shall submit to the Committees on Education and Labor, Energy and Commerce, and Appropriations of the House of Representatives and to the Committees on Health, Education, Labor, and Pensions and Appropriations of the Senate a report on the results of the program. The report shall include—
(1) an assessment of the influenza vaccination rates of school-age children in localities where the program is implemented, compared to the national average influenza vaccination rates for school-aged children, including whether school-based vaccination assists in achieving the recommendations of the Advisory Committee on Immunization Practices;
(2) an assessment of the utility of employing elementary schools and secondary schools as a part of a multistate, community-based pandemic response program that is consistent with existing Federal and State pandemic response plans;
(3) an assessment of the feasibility of using existing Federal and private insurance funding in establishing a multistate, school-based vaccination program for seasonal influenza vaccination;
(4) an assessment of the number of education days gained by students as a result of seasonal vaccinations based on absenteeism rates;
(5) a determination of whether the program under this section—
(A) increased vaccination rates in the participating localities; and
(B) was implemented for sufficient time for gathering enough valid data; and
(6) a recommendation on whether the program should be continued, expanded, or terminated.
(k) Definitions.—In this section:
(1) ELIGIBLE PARTNERSHIP.—The term “eligible partnership” means a local public health department, or another health organization defined by the Secretary as eligible to submit an application, and one or more elementary and secondary schools.
(2) ELEMENTARY SCHOOL.—The terms “elementary school” and “secondary school” have the meanings given such terms in section 9101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801).
(3) LOW-INCOME.—The term “low-income” means a student, age 5 through 19, eligible for free or reduced-price lunch under the National School Lunch Act (42 U.S.C. 1751 et seq.).
(4) RURAL LOCAL EDUCATIONAL AGENCY.—The term “rural local educational agency” means an eligible local educational agency described in section 6211(b)(1) of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7345(b)(1)).
(5) SECRETARY.—Except as otherwise specified, the term “Secretary” means the Secretary of Health and Human Services.
(l) Authorization of appropriations.—To carry out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2011 through 2015.
Section 1509 of the Public Health Service Act (42 U.S.C. 300n–4a) is amended—
(A) by striking the heading and inserting “In general.—”; and
(B) in the matter preceding paragraph (1), by striking “may make grants” and all that follows through “purpose” and inserting the following: “may make grants to such States for the purpose”; and
(2) in subsection (d)(1), by striking “there are authorized” and all that follows through the period and inserting “there are authorized to be appropriated $70,000,000 for fiscal year 2011, $73,500,000 for fiscal year 2012, $77,000,000 for fiscal year 2013, $81,000,000 for fiscal year 2014, and $85,000,000 for fiscal year 2015.”.
Part B of title III (42 U.S.C. 243 et seq.) is amended by inserting after section 317T the following:
“(a) Program.—To the extent and in the amount of appropriations made in advance in appropriations Acts, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish a program consisting of making grants, in amounts determined under subsection (c), to each State that submits an application in accordance with subsection (d) for an evidence-based education program described in subsection (b).
“(b) Use of funds.—Amounts received by a State under this section shall be used to conduct or support evidence-based education programs (directly or through grants or contracts to public or private nonprofit entities, including schools and community-based and faith-based organizations) to reduce teen pregnancy or sexually transmitted diseases.
“(c) Distribution of funds.—The Director shall, for fiscal year 2011 and each subsequent fiscal year, make a grant to each State described in subsection (a) in an amount equal to the product of—
“(1) the amount appropriated to carry out this section for the fiscal year; and
“(2) the percentage determined for the State under section 502(c)(1)(B)(ii) of the Social Security Act.
“(d) Application.—To seek a grant under this section, a State shall submit an application at such time, in such manner, and containing such information and assurance of compliance with this section as the Secretary may require. At a minimum, an application shall to the satisfaction of the Secretary—
“(1) describe how the State’s proposal will address the needs of at-risk teens in the State;
“(2) identify the evidence-based education program or programs selected from the registry developed under subsection (g) that will be used to address risks in priority populations;
“(3) describe how the program or programs will be implemented and any adaptations to the evidence-based model that will be made;
“(4) list any private and public entities with whom the State proposes to work, including schools and community-based and faith-based organizations, and demonstrate their capacity to implement the proposed program or programs; and
“(5) identify an independent entity that will evaluate the impact of the program or programs.
“(1) REQUIREMENT.—As a condition on receipt of a grant under this section, a State shall agree—
“(A) to arrange for an independent evaluation of the impact of the programs to be conducted or supported through the grant; and
“(B) submit reports to the Secretary on such programs and the results of evaluation of such programs.
“(2) FUNDING LIMITATION.—Of the amounts made available to a State through a grant under this section for any fiscal year, not more than 10 percent may be used for such evaluation.
“(f) Rule of construction.—This section shall not be construed to preempt or limit any State law regarding parental involvement and decisionmaking in children’s education.
“(g) Registry of eligible programs.—The Secretary shall develop not later than 180 days after the date of the enactment of the Affordable Health Care for America Act, and periodically update thereafter, a publicly available registry of programs described in subsection (b) that, as determined by the Secretary—
“(1) meet the definition of the term ‘evidence-based’ in subsection (i);
“(2) are medically and scientifically accurate; and
“(3) provide age-appropriate information.
“(h) Matching funds.—The Secretary may award a grant to a State under this section for a fiscal year only if the State agrees to provide, from non-Federal sources, an amount equal to $1 (in cash or in kind) for each $4 provided through the grant to carry out the activities supported by the grant.
“(i) Definition.—In this section, the term ‘evidence-based’ means based on a model that has been found, in methodologically sound research—
“(1) to delay initiation of sex;
“(2) to decrease number of partners;
“(3) to reduce teen pregnancy;
“(4) to reduce sexually transmitted infection rates; or
“(5) to improve rates of contraceptive use.
“(j) Authorization of appropriations.—To carry out this section, there is authorized to be appropriated $50,000,000 for each of fiscal years 2011 through 2015.”.
Title I of the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (42 U.S.C. 15001 et seq.) is amended by adding at the end the following:
“(a) Grants and technical assistance.—
“(A) IN GENERAL.—The Secretary, in consultation with the Interagency Autism Coordinating Committee, shall award multiyear grants to eligible entities to provide individuals (including parents and health, allied health, vocational, and educational professionals) with interdisciplinary training, continuing education, technical assistance, and information for the purpose of improving services rendered to children and adults with autism, and their families, to address unmet needs related to autism.
“(B) ELIGIBLE ENTITY.—To be eligible to receive a grant under this subsection, an entity shall be—
“(i) a University Center for Excellence in Developmental Disabilities Education, Research, and Service; or
“(ii) a comparable interdisciplinary education, research, and service entity.
“(C) APPLICATION REQUIREMENTS.—An entity that desires to receive a grant for a program under this paragraph shall submit to the Secretary an application—
“(i) demonstrating that the entity has capacity to—
“(I) provide training and technical assistance in evidence-based practices to evaluate, and provide effective interventions, services, treatments, and supports to, children and adults with autism and their families;
“(II) include individuals with autism and their families as part of the program to ensure that an individual- and family-centered approach is used;
“(III) share and disseminate materials and practices that are developed for, and evaluated to be effective in, the provision of training and technical assistance; and
“(IV) provide training, technical assistance, interventions, services, treatments, and supports under this subsection statewide.
“(ii) providing assurances that the entity will—
“(I) provide trainees under this subsection with an appropriate balance of interdisciplinary academic and community-based experiences; and
“(II) provide to the Secretary, in the manner prescribed by the Secretary, data regarding the number of individuals who have benefitted from, and outcomes of, the provision of training and technical assistance under this subsection;
“(iii) providing assurances that training, technical assistance, dissemination of information, and services under this subsection will be—
“(I) consistent with the goals of this Act, the Americans with Disabilities Act of 1990, the Individuals with Disabilities Education Act, and the Elementary and Secondary Education Act of 1965; and
“(II) conducted in coordination with relevant State agencies, institutions of higher education, and service providers; and
“(iv) containing such other information and assurances as the Secretary may require.
“(D) USE OF FUNDS.—A grant received under this subsection shall be used to provide individuals (including parents and health, allied health, vocational, and educational professionals) with interdisciplinary training, continuing education, technical assistance, and information for the purpose of improving services rendered to children and adults with autism, and their families, to address unmet needs related to autism. Such training, education, assistance, and information shall include each of the following:
“(i) Training health, allied health, vocational, and educational professionals to identify, evaluate the needs of, and develop interventions, services, treatments, and supports for, children and adults with autism.
“(ii) Developing model services and supports that demonstrate evidence-based practices.
“(iii) Developing systems and products that allow for the interventions, services, treatments, and supports to be evaluated for fidelity of implementation.
“(iv) Working to expand the availability of evidence-based, lifelong interventions; educational, employment, and transition services; and community supports.
“(v) Providing statewide technical assistance in collaboration with relevant State agencies, institutions of higher education, autism advocacy groups, and community-based service providers.
“(vi) Working to develop comprehensive systems of supports and services for individuals with autism and their families, including seamless transitions between education and health systems across the lifespan.
“(vii) Promoting training, technical assistance, dissemination of information, supports, and services.
“(viii) Developing mechanisms to provide training and technical assistance, including for-credit courses, intensive summer institutes, continuing education programs, distance based programs, and Web-based information dissemination strategies.
“(ix) Promoting activities that support community-based family and individual services and enable individuals with autism and related developmental disabilities to fully participate in society and achieve good quality-of-life outcomes.
“(x) Collecting data on the outcomes of training and technical assistance programs to meet statewide needs for the expansion of services to children and adults with autism.
“(E) AMOUNT OF GRANTS.—The amount of a grant to any entity for a fiscal year under this section shall be not less than $250,000.
“(2) TECHNICAL ASSISTANCE.—The Secretary shall reserve 2 percent of the amount appropriated to carry out this subsection for a fiscal year to make a grant to a national organization with demonstrated capacity for providing training and technical assistance to—
“(A) assist in national dissemination of specific information, including evidence-based best practices, from interdisciplinary training programs, and when appropriate, other entities whose findings would inform the work performed by entities awarded grants;
“(B) compile and disseminate strategies and materials that prove to be effective in the provision of training and technical assistance so that the entire network can benefit from the models, materials, and practices developed in individual centers;
“(C) assist in the coordination of activities of grantees under this subsection;
“(D) develop a Web portal that will provide linkages to each of the individual training initiatives and provide access to training modules, promising training, and technical assistance practices and other materials developed by grantees;
“(E) serve as a research-based resource for Federal and State policymakers on information concerning the provision of training and technical assistance for the assessment, and provision of supports and services for, children and adults with autism;
“(F) convene experts from multiple interdisciplinary training programs, individuals with autism, and the families of such individuals to discuss and make recommendations with regard to training issues related to assessment, interventions, services, treatment, and supports for children and adults with autism; and
“(H) undertake any other functions that the Secretary determines to be appropriate.
“(3) AUTHORIZATION OF APPROPRIATIONS.—To carry out this subsection, there are authorized to be appropriated $17,000,000 for fiscal year 2011 and such sums as may be necessary for each of fiscal years 2012 through 2015.
“(b) Expansion of the number of University Centers for Excellence in Developmental Disabilities Education, Research, and Service.—
“(1) GRANTS.—To provide for the establishment of up to 4 new University Centers for Excellence in Developmental Disabilities Education, Research, and Service, the Secretary shall award up to 4 grants to institutions of higher education.
“(2) APPLICABLE PROVISIONS.—Except for subsection (a)(3), the provisions of subsection (a) shall apply with respect to grants under this subsection to the same extent and in the same manner as such provisions apply with respect to grants under subsection (a).
“(3) PRIORITY.—In awarding grants under this subsection, the Secretary shall give priority to applicants that—
“(A) are minority institutions that have demonstrated capacity to meet the requirements of this section and provide services to individuals with autism and their families; or
“(B) are located in a State with one or more underserved populations.
“(4) AUTHORIZATION OF APPROPRIATIONS.—To carry out this subsection, there is authorized to be appropriated $2,000,000 for each of fiscal years 2011 through 2015.
“(c) Definitions.—In this section:
“(1) The term ‘autism’ means an autism spectrum disorder or a related developmental disability.
“(2) The term ‘interventions’ means educational methods and positive behavioral support strategies designed to improve or ameliorate symptoms associated with autism.
“(3) The term ‘minority institution’ has the meaning given to such term in section 365 of the Higher Education Act of 1965.
“(4) The term ‘services’ means services to assist individuals with autism to live more independently in their communities.
“(5) The term ‘treatments’ means health services, including mental health services, designed to improve or ameliorate symptoms associated with autism.
“(6) The term ‘University Center for Excellence in Developmental Disabilities Education, Research, and Service’ means a University Center for Excellence in Development Disabilities Education, Research, and Service that has been or is funded through subtitle D or subsection (b).”.
(a) In general.—The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Director of the Agency for Health Care Research and Quality, shall establish a program to provide grants to eligible entities to implement medication management services (referred to in this section as “MTM services”) provided by licensed pharmacists, as a part of a collaborative, multidisciplinary, interprofessional approach to the treatment of chronic diseases for targeted individuals, to improve the quality of care and reduce overall cost in the treatment of such diseases. The Secretary shall commence the grant program not later than May 1, 2011.
(b) Eligible entities.—To be eligible to receive a grant under subsection (a), an entity shall—
(1) provide a setting appropriate for MTM services, as recommended by the experts described in subsection (e);
(2) submit to the Secretary a plan for achieving long-term financial sustainability;
(3) where applicable, submit a plan for coordinating MTM services with other local providers and where applicable, through or in collaboration with the Medicare Medical Home Pilot program as established by section 1866F of the Social Security Act, as added by section 1302(a) of this Act;
(4) submit a plan for meeting the requirements under subsection (c); and
(5) submit to the Secretary such other information as the Secretary may require.
(c) MTM services to targeted individuals.—The MTM services provided with the assistance of a grant awarded under subsection (a) shall, as allowed by State law (including applicable collaborative pharmacy practice agreements), include—
(1) performing or obtaining necessary assessments of the health and functional status of each patient receiving such MTM services;
(2) formulating a medication treatment plan according to therapeutic goals agreed upon by the prescriber and the patient or caregiver or authorized representative of the patient;
(3) selecting, initiating, modifying, recommending changes to, or administering medication therapy;
(4) monitoring, which may include access to, ordering, or performing laboratory assessments, and evaluating the response of the patient to therapy, including safety and effectiveness;
(5) performing an initial comprehensive medication review to identify, resolve, and prevent medication-related problems, including adverse drug events, quarterly targeted medication reviews for ongoing monitoring, and additional followup interventions on a schedule developed collaboratively with the prescriber;
(6) documenting the care delivered and communicating essential information about such care (including a summary of the medication review) and the recommendations of the pharmacist to other appropriate health care providers of the patient in a timely fashion;
(7) providing education and training designed to enhance the understanding and appropriate use of the medications by the patient, caregiver, and other authorized representative;
(8) providing information, support services, and resources and strategies designed to enhance patient adherence with therapeutic regimens;
(9) coordinating and integrating MTM services within the broader health care management services provided to the patient; and
(10) such other patient care services as are allowed under the scopes of practice for pharmacists for purposes of other Federal programs.
(d) Targeted individuals.—MTM services provided by licensed pharmacists under a grant awarded under subsection (a) shall be offered to targeted individuals who—
(1) take 4 or more prescribed medications (including over-the-counter and dietary supplements);
(2) take any high-risk medications;
(3) have 2 or more chronic diseases, as identified by the Secretary; or
(4) have undergone a transition of care, or other factors, as determined by the Secretary, that are likely to create a high risk of medication-related problems.
(e) Consultation with experts.—In designing and implementing MTM services provided under grants awarded under subsection (a), the Secretary shall consult with Federal, State, private, public-private, and academic entities, pharmacy and pharmacist organizations, health care organizations, consumer advocates, chronic disease groups, and other stakeholders involved with the research, dissemination, and implementation of pharmacist-delivered MTM services, as the Secretary determines appropriate. The Secretary, in collaboration with this group, shall determine whether it is possible to incorporate rapid cycle process improvement concepts in use in other Federal programs that have implemented MTM services.
(f) Reporting to the Secretary.—An entity that receives a grant under subsection (a) shall submit to the Secretary a report that describes and evaluates, as requested by the Secretary, the activities carried out under subsection (c), including quality measures, as determined by the Secretary.
(g) Evaluation and report.—The Secretary shall submit to the relevant committees of Congress a report which shall—
(1) assess the clinical effectiveness of pharmacist-provided services under the MTM services program, as compared to usual care, including an evaluation of whether enrollees maintained better health with fewer hospitalizations and emergency room visits than similar patients not enrolled in the program;
(2) assess changes in overall health care resource of targeted individuals;
(3) assess patient and prescriber satisfaction with MTM services;
(4) assess the impact of patient-cost-sharing requirements on medication adherence and recommendations for modifications;
(5) identify and evaluate other factors that may impact clinical and economic outcomes, including demographic characteristics, clinical characteristics, and health services use of the patient, as well as characteristics of the regimen, pharmacy benefit, and MTM services provided; and
(6) evaluate the extent to which participating pharmacists who maintain a dispensing role have a conflict of interest in the provision of MTM services, and if such conflict is found, provide recommendations on how such a conflict might be appropriately addressed.
(h) Grant To fund development of performance measures.—The Secretary may award grants or contracts to eligible entities for the purpose of funding the development of performance measures that assess the use and effectiveness of medication therapy management services.
(a) Expansion and intensification of activities.—
(1) CONTINUATION OF ACTIVITIES.—The Secretary is encouraged to expand and intensify activities on postpartum conditions.
(2) PROGRAMS FOR POSTPARTUM CONDITIONS.—In carrying out paragraph (1), the Secretary is encouraged to continue research to expand the understanding of the causes of, and treatments for, postpartum conditions, including conducting and supporting the following:
(A) Basic research concerning the etiology and causes of the conditions.
(B) Epidemiological studies to address the frequency and natural history of the conditions and the differences among racial and ethnic groups with respect to the conditions.
(C) The development of improved screening and diagnostic techniques.
(D) Clinical research for the development and evaluation of new treatments.
(E) Information and education programs for health professionals and the public, which may include a coordinated national campaign that—
(i) is designed to increase the awareness and knowledge of postpartum conditions;
(ii) may include public service announcements through television, radio, and other means; and
(I) raising awareness about screening;
(II) educating new mothers and their families about postpartum conditions to promote earlier diagnosis and treatment; and
(III) ensuring that such education includes complete information concerning postpartum conditions, including its symptoms, methods of coping with the illness, and treatment resources.
(1) STUDY.—The Secretary shall conduct a study on the benefits of screening for postpartum conditions.
(2) REPORT.—Not later than 2 years after the date of the enactment of this Act, the Secretary shall complete the study required by paragraph (1) and submit a report to the Congress on the results of such study.
(c) Sense of Congress regarding longitudinal study of relative mental health consequences for women of resolving a pregnancy.—
(1) SENSE OF CONGRESS.—It is the sense of the Congress that the Director of the National Institute of Mental Health may conduct a nationally representative longitudinal study (during the period of fiscal years 2011 through 2020) on the relative mental health consequences for women of resolving a pregnancy (intended and unintended) in various ways, including carrying the pregnancy to term and parenting the child, carrying the pregnancy to term and placing the child for adoption, miscarriage, and having an abortion. This study may assess the incidence, timing, magnitude, and duration of the immediate and long-term mental health consequences (positive or negative) of these pregnancy outcomes.
(2) REPORT.—Beginning not later than 3 years after the date of the enactment of this Act, and periodically thereafter for the duration of the study, such Director may prepare and submit to the Congress reports on the findings of the study.
(d) Definitions.—In this section:
(1) The term “postpartum condition” means postpartum depression or postpartum psychosis.
(2) The term “Secretary” means the Secretary of Health and Human Services.
(e) Authorization of appropriations.—For the purpose of carrying out this section, in addition to any other amounts authorized to be appropriated for such purpose, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2011 through 2013.
Part P of title III (42 U.S.C. 280g et seq.) is amended by adding at the end the following:
“(a) Grants Authorized.—The Secretary, in collaboration with the Director of the Centers for Disease Control and Prevention and other Federal officials determined appropriate by the Secretary, is authorized to award grants to eligible entities to promote positive health behaviors for populations in medically underserved communities through the use of community health workers.
“(b) Use of Funds.—Grants awarded under subsection (a) shall be used to support community health workers—
“(1) to educate, guide, and provide outreach in a community setting regarding health problems prevalent in medically underserved communities, especially racial and ethnic minority populations;
“(2) to educate, guide, and provide experiential learning opportunities that target behavioral risk factors including—
“(A) poor nutrition;
“(B) physical inactivity;
“(C) being overweight or obese;
“(D) tobacco use;
“(E) alcohol and substance use;
“(F) injury and violence;
“(G) risky sexual behavior;
“(H) untreated mental health problems;
“(I) untreated dental and oral health problems; and
“(J) understanding informed consent;
“(3) to educate and provide guidance regarding effective strategies to promote positive health behaviors within the family;
“(4) to educate and provide outreach regarding enrollment in health insurance including the State Children’s Health Insurance Program under title XXI of the Social Security Act, Medicare under title XVIII of such Act, and Medicaid under title XIX of such Act;
“(5) to educate and refer underserved populations to appropriate health care agencies and community-based programs and organizations in order to increase access to quality health care services, including preventive health services, and to eliminate duplicative care; or
“(6) to educate, guide, and provide home visitation services regarding maternal health and prenatal care.
“(1) IN GENERAL.—Each eligible entity that desires to receive a grant under subsection (a) shall submit an application to the Secretary, at such time, in such manner, and accompanied by such information as the Secretary may require.
“(2) CONTENTS.—Each application submitted pursuant to paragraph (1) shall—
“(A) describe the activities for which assistance is sought under this section;
“(B) contain an assurance that, with respect to each community health worker program receiving funds under the grant, such program will provide training and supervision to community health workers to enable such workers to provide authorized program services;
“(C) contain an assurance that the applicant will evaluate the effectiveness of community health worker programs receiving funds under the grant;
“(D) contain an assurance that each community health worker program receiving funds under the grant will provide services in the cultural context most appropriate for the individuals served by the program;
“(E) contain a plan to document and disseminate project descriptions and results to other States and organizations as identified by the Secretary; and
“(F) describe plans to enhance the capacity of individuals to utilize health services and health-related social services under Federal, State, and local programs by—
“(i) assisting individuals in establishing eligibility under the programs and in receiving the services or other benefits of the programs; and
“(ii) providing other services as the Secretary determines to be appropriate, that may include transportation and translation services.
“(d) Priority.—In awarding grants under subsection (a), the Secretary shall give priority to applicants that—
“(1) propose to target geographic areas—
“(A) with a high percentage of residents who are eligible for health insurance but are uninsured or underinsured;
“(B) with a high percentage of residents who suffer from chronic diseases including pulmonary conditions, hypertension, heart disease, mental disorders, diabetes, and asthma; and
“(C) with a high infant mortality rate;
“(2) have experience in providing health or health-related social services to individuals who are underserved with respect to such services; and
“(3) have documented community activity and experience with community health workers.
“(e) Collaboration With Academic Institutions.—The Secretary shall encourage community health worker programs receiving funds under this section to collaborate with academic institutions, especially those that graduate a disproportionate number of health and health care students from underrepresented racial and ethnic minority backgrounds. Nothing in this section shall be construed to require such collaboration.
“(f) Evidence-Based Interventions.—The Secretary shall encourage community health worker programs receiving funding under this section to implement an outcome-based payment system that rewards community health workers for connecting underserved populations with the most appropriate services at the most appropriate time. Nothing in this section shall be construed to require such payment.
“(g) Quality Assurance and Cost Effectiveness.—The Secretary shall establish guidelines for assuring the quality of the training and supervision of community health workers under the programs funded under this section and for assuring the cost-effectiveness of such programs.
“(h) Monitoring.—The Secretary shall monitor community health worker programs identified in approved applications under this section and shall determine whether such programs are in compliance with the guidelines established under subsection (g).
“(i) Technical Assistance.—The Secretary may provide technical assistance to community health worker programs identified in approved applications under this section with respect to planning, developing, and operating programs under the grant.
“(1) IN GENERAL.—Not later than 4 years after the date on which the Secretary first awards grants under subsection (a), the Secretary shall submit to Congress a report regarding the grant project.
“(2) CONTENTS.—The report required under paragraph (1) shall include the following:
“(A) A description of the programs for which grant funds were used.
“(B) The number of individuals served under such programs.
“(i) the effectiveness of such programs;
“(ii) the cost of such programs; and
“(iii) the impact of the programs on the health outcomes of the community residents.
“(D) Recommendations for sustaining the community health worker programs developed or assisted under this section.
“(E) Recommendations regarding training to enhance career opportunities for community health workers.
“(k) Definitions.—In this section:
“(1) COMMUNITY HEALTH WORKER.—The term ‘community health worker’ means an individual who promotes health or nutrition within the community in which the individual resides—
“(A) by serving as a liaison between communities and health care agencies;
“(B) by providing guidance and social assistance to community residents;
“(C) by enhancing community residents’ ability to effectively communicate with health care providers;
“(D) by providing culturally and linguistically appropriate health or nutrition education;
“(E) by advocating for individual and community health, including oral and mental, or nutrition needs; and
“(F) by providing referral and followup services or otherwise coordinating care.
“(2) COMMUNITY SETTING.—The term ‘community setting’ means a home or a community organization located in the neighborhood in which a participant resides.
“(3) MEDICALLY UNDERSERVED COMMUNITY.—The term ‘medically underserved community’ means a community identified by a State, United States territory or possession, or federally recognized Indian tribe—
“(A) that has a substantial number of individuals who are members of a medically underserved population, as defined by section 330(b)(3); and
“(B) a significant portion of which is a health professional shortage area as designated under section 332.
“(4) SUPPORT.—The term ‘support’ means the provision of training, supervision, and materials needed to effectively deliver the services described in subsection (b), reimbursement for services, and other benefits.
“(5) ELIGIBLE ENTITY.—The term ‘eligible entity’ means a public or private nonprofit entity (including a State or public subdivision of a State, a public health department, or a federally qualified health center), or a consortium of any of such entities, located in the United States or territory thereof.
“(l) Authorization of Appropriations.—There is authorized to be appropriated to carry out this section $30,000,000 for each of fiscal years 2011 through 2015.”.
(a) Incentive payments for medical liability reform.—
(1) IN GENERAL.—To the extent and in the amounts made available in advance in appropriations Acts, the Secretary shall make an incentive payment, in an amount determined by the Secretary, to each State that has an alternative medical liability law in compliance with this section.
(2) DETERMINATION BY SECRETARY.—The Secretary shall determine that a State has an alternative medical liability law in compliance with this section if the Secretary is satisfied that—
(A) the State enacted the law after the date of the enactment of this Act and is implementing the law;
(B) the law is effective; and
(C) the contents of the law are in accordance with paragraph (4).
(3) CONSIDERATIONS FOR DETERMINING EFFECTIVENESS.—In determining whether an alternative medical liability law is effective under paragraph (2)(B), the Secretary shall consider whether the law—
(A) makes the medical liability system more reliable through prevention of, or prompt and fair resolution of, disputes;
(B) encourages the disclosure of health care errors; and
(C) maintains access to affordable liability insurance.
(4) CONTENTS OF ALTERNATIVE MEDICAL LIABILITY LAW.—The contents of an alternative liability law are in accordance with this paragraph if—
(A) the litigation alternatives contained in the law consist of certificate of merit, early offer, or both; and
(B) the law does not limit attorneys’ fees or impose caps on damages.
(b) Use of Incentive Payments.—Amounts received by a State as an incentive payment under this section shall be used to improve health care in that State.
(c) Technical assistance.—The Secretary may provide technical assistance to the States applying for or receiving an incentive payment under this section.
(d) Reports.—Beginning not later than one year after the date of the enactment of this Act, the Secretary shall submit to the Congress an annual report on the progress States have made in enacting and implementing alternative medical liability laws in compliance with this section. Such reports shall contain sufficient documentation regarding the effectiveness of such laws to enable an objective comparative analysis of such laws.
(e) Definition.—In this section—
(1) the term “Secretary” means the Secretary of Health and Human Services; and
(2) the term “State” includes the several States, District of Columbia, the Commonwealth of Puerto Rico, and each other territory or possession of the United States.
(f) Authorization of appropriations.—There are authorized to be appropriated to carry out this section such sums as may be necessary, to remain available until expended.
(a) In general.—The Secretary of Health and Human Services (in this section referred to as the “Secretary”), acting through the Director, shall award grants to eligible entities to create, implement, and oversee infant mortality pilot programs.
(b) Period of a grant.—The period of a grant under this section shall be 5 consecutive fiscal years.
(c) Preference.—In awarding grants under this section, the Secretary shall give preference to eligible entities proposing to serve any of the 15 counties or groups of counties with the highest rates of infant mortality in the United States in the past 3 years.
(d) Use of Funds.—Any infant mortality pilot program funded under this section may—
(1) include the development of a plan that identifies the individual needs of each community to be served and strategies to address those needs;
(2) provide outreach to at-risk mothers through programs deemed appropriate by the Director;
(3) develop and implement standardized systems for improved access, utilization, and quality of social, educational, and clinical services to promote healthy pregnancies, full term births, and healthy infancies delivered to women and their infants, such as—
(A) counseling on infant care, feeding, and parenting;
(B) postpartum care;
(C) prevention of premature delivery; and
(D) additional counseling for at-risk mothers, including smoking cessation programs, drug treatment programs, alcohol treatment programs, nutrition and physical activity programs, postpartum depression and domestic violence programs, social and psychological services, dental care, and parenting programs;
(4) establish a rural outreach program to provide care to at-risk mothers in rural areas;
(5) establish a regional public education campaign, including a campaign to—
(A) prevent preterm births; and
(B) educate the public about infant mortality; and
(6) provide for any other activities, programs, or strategies as identified by the community plan.
(e) Limitation.—Of the funds received through a grant under this section for a fiscal year, an eligible entity shall not use more than 10 percent for program evaluation.
(f) Reports on Pilot Programs.—
(1) IN GENERAL.—Not later than 1 year after receiving a grant, and annually thereafter for the duration of the grant period, each entity that receives a grant under subsection (a) shall submit a report to the Secretary detailing its infant mortality pilot program.
(2) CONTENTS OF REPORT.—The reports required under paragraph (1) shall include information such as the methodology of, and outcomes and statistics from, the grantee’s infant mortality pilot program.
(3) EVALUATION.—The Secretary shall use the reports required under paragraph (1) to evaluate, and conduct statistical research on, infant mortality pilot programs funded through this section.
(g) Definitions.—For the purposes of this section:
(1) DIRECTOR.—The term “Director” means the Director of the Centers for Disease Control and Prevention.
(2) ELIGIBLE ENTITY.—The term “eligible entity” means a State, county, city, territorial, or tribal health department that has submitted a proposal to the Secretary that the Secretary deems likely to reduce infant mortality rates within the standard metropolitan statistical area involved.
(3) TRIBAL.—The term “tribal” refers to an Indian tribe, a Tribal organization, or an Urban Indian organization, as such terms are defined in section 4 of the Indian Health Care Improvement Act.
(h) Authorization of appropriations.—To carry out this section, there are authorized to be appropriated $10,000,000 for each of fiscal years 2011 through 2015.
(a) Program.—The Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, and in consultation with the Secretary of Education, may establish a health sciences training program consisting of awarding grants and contracts under subsection (b) to prepare secondary school students for careers in health professions.
(b) Development and implementation of health sciences curricula.—The Secretary may make grants to, or enter into contracts with, eligible entities—
(1) to plan, develop, or implement secondary school health sciences curricula, including curricula in biology, chemistry, physiology, mathematics, nutrition, and other courses deemed appropriate by the Secretary to prepare students for associate’s or bachelor’s degree programs in health professions or bachelor’s degree programs in health professions-related majors; and
(2) to increase the interest of secondary school students in applying to, and enrolling in, accredited associate’s or bachelor’s degree programs in health professions or bachelor’s degree programs in health professions-related majors, including through—
(A) work-study programs;
(B) programs to increase awareness of careers in health professions; and
(C) other activities to increase such interest.
(c) Eligibility.—To be eligible for a grant or contract under subsection (b), an entity shall—
(1) be a local educational agency; and
(2) provide assurances that activities under the grant or contract will be carried out in partnership with an accredited health professions school or program, public or private nonprofit hospital, or public or private nonprofit entity.
(d) Preference.—In awarding grants and contracts under subsection (b), the Secretary shall give preference to entities that have a demonstrated record of at least one of the following:
(1) Graduating a high or significantly improved percentage of students who have exhibited mastery in secondary school State science standards.
(2) Graduating students from disadvantaged backgrounds, including racial and ethnic minorities who are underrepresented in—
(A) associate’s or bachelor’s degree programs in health professions or bachelor’s degree programs in health professions-related majors; or
(B) health professions.
(e) Report.—The Secretary shall submit to the Congress an annual report on the program carried out under this section.
(f) Definitions.—In this section:
(1) The term “health profession” means the profession of any member of the health workforce, as defined in section 764(i) of the Public Health Service Act, as added by section 2261.
(2) The term “local educational agency” has the meaning given to the term in section 9101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801).
(3) The term “secondary school”—
(A) means a secondary school, as defined in section 9101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801); and
(B) includes any such school that is a middle school.
(4) The term “Secretary” means the Secretary of Health and Human Services except as otherwise specified.
(g) Authorization of appropriations.—To carry out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2011 through 2015.
(a) Purpose.—The purpose of this subtitle is to establish and provide assistance to community-based collaborative care networks—
(1) to develop or strengthen coordination of services to allow all individuals, including the uninsured and low-income, to receive efficient and higher quality care and to gain entry into and receive services from a comprehensive system of care;
(2) to develop efficient and sustainable infrastructure for a health care delivery system characterized by effective collaboration, information sharing, and clinical and financial coordination among providers of care in the community;
(3) to develop or strengthen activities related to providing coordinated care for individuals with chronic conditions; and
(4) to reduce the use of emergency departments, inpatient and other expensive resources of hospitals and other providers.
(b) Creation of the Community-Based Collaborative Care Network Program.—Part D of title III (42 U.S.C. 254b et seq.), as amended, is further amended by inserting after subpart XII the following new subpart:
“(a) In general.—The Secretary may award grants to eligible entities for the purpose of establishing model projects to accomplish the following goals:
“(1) To reduce unnecessary use of items and services furnished in emergency departments of hospitals (especially to ensure that individuals without health insurance coverage or with inadequate health insurance coverage do not use the services of such department instead of the services of a primary care provider) through methods such as—
“(A) screening individuals who seek emergency department services for possible eligibility under relevant governmental health programs or for subsidies under such programs; and
“(B) providing such individuals referrals for followup care and chronic condition care.
“(2) To manage chronic conditions to reduce their severity, negative health outcomes, and expense.
“(3) To encourage health care providers to coordinate their efforts so that the most vulnerable patient populations seek and obtain primary care.
“(4) To provide more comprehensive and coordinated care to vulnerable low-income individuals and individuals without health insurance coverage or with inadequate coverage.
“(5) To provide mechanisms for improving both quality and efficiency of care for low-income individuals and families, with an emphasis on those most likely to remain uninsured despite the existence of government programs to make health insurance more affordable.
“(6) To increase preventive services, including screening and counseling, to those who would otherwise not receive such screening, in order to improve health status and reduce long-term complications and costs.
“(7) To ensure the availability of community-wide safety net services, including emergency and trauma care.
“(b) Eligibility and grantee selection.—
“(1) APPLICATION.—A community-based collaborative care network described in subsection (d) shall submit to the Secretary an application in such form and manner and containing such information as specified by the Secretary. Such information shall at least—
“(A) identify the health care providers participating in the community-based collaborative care network proposed by the applicant and, if a provider designated in paragraph (d)(1)(B) is not included, the reason such provider is not so included;
“(B) include a description of how the providers plan to collaborate to provide comprehensive and integrated care for low-income individuals, including uninsured and underinsured individuals;
“(C) include a description of the organizational and joint governance structure of the community-based collaborative care network in a manner so that it is clear how decisions will be made, and how the decisionmaking process of the network will include appropriate representation of the participating entities;
“(D) define the geographic areas and populations that the network intends to serve;
“(E) define the scope of services that the network intends to provide and identify any reasons why such services would not include a suggested core service identified by the Secretary under paragraph (3);
“(F) demonstrate the network’s ability to meet the requirements of this section; and
“(G) provide assurances that grant funds received shall be used to support the entire community-based collaborative care network.
“(A) IN GENERAL.—The Secretary shall select community-based collaborative care networks to receive grants from applications submitted under paragraph (1) on the basis of quality of the proposal involved, geographic diversity (including different States and regions served and urban and rural diversity), and the number of low-income and uninsured individuals that the proposal intends to serve.
“(B) PRIORITY.—The Secretary shall give priority to proposals from community-based collaborative care networks that—
“(i) include the capability to provide the broadest range of services to low-income individuals; and
“(ii) include providers that currently serve a high volume of low-income individuals.
“(C) RENEWAL.—In subsequent years, based on the performance of grantees, the Secretary may provide renewal grants to prior year grant recipients.
“(3) SUGGESTED CORE SERVICES.—For purposes of paragraph (1)(E), the Secretary shall develop a list of suggested core patient and core network services to be provided by a community-based collaborative care network. The Secretary may select a community-based collaborative care network under paragraph (2), the application of which does not include all such services, if such application provides a reasonable explanation why such services are not proposed to be included, and the Secretary determines that the application is otherwise high quality.
“(4) TERMINATION AUTHORITY.—The Secretary may terminate selection of a community-based collaborative care network under this section for good cause. Such good cause shall include a determination that the network—
“(A) has failed to provide a comprehensive range of coordinated and integrated health care services as required under subsection (d)(2);
“(B) has failed to meet reasonable quality standards;
“(C) has misappropriated funds provided under this section; or
“(D) has failed to make progress toward accomplishing goals set out in subsection (a).
“(1) USE BY GRANTEES.—Grant funds are provided to community-based collaborative care networks to carry out the following activities:
“(A) Assist low-income individuals without adequate health care coverage to—
“(i) access and appropriately use health services;
“(ii) enroll in applicable public or private health insurance programs;
“(iii) obtain referrals to and see a primary care provider in case such an individual does not have a primary care provider; and
“(iv) obtain appropriate care for chronic conditions.
“(B) Improve heath care by providing case management, application assistance, and appropriate referrals such as through methods to—
“(i) create and meaningfully use a health information technology network to track patients across collaborative providers;
“(ii) perform health outreach, such as by using neighborhood health workers who may inform individuals about the availability of safety net and primary care providers available through the community-based collaborative care network;
“(iii) provide for followup outreach to remind patients of appointments or follow-up care instructions;
“(iv) provide transportation to individuals to and from the site of care;
“(v) expand the capacity to provide care at any provider participating in the community-based collaborative care network, including telehealth, hiring new clinical or administrative staff, providing access to services after-hours, on weekends, or otherwise providing an urgent care alternative to an emergency department; and
“(vi) provide a primary care provider or medical home for each network patient.
“(C) Provide direct patient care services as described in their application and approved by the Secretary.
“(2) GRANT FUNDS TO HRSA GRANTEES.—The Secretary may limit the percent of grant funding that may be spent on direct care services provided by grantees of programs administered by the Health Resources and Services Administration (in this section referred to as ‘HRSA’) or impose other requirements on HRSA grantees participating in a community-based collaborative care network as may be necessary for consistency with the requirements of such programs.
“(3) RESERVATION OF FUNDS FOR NATIONAL PROGRAM PURPOSES.—The Secretary may use not more than 7 percent of funds appropriated to carry out this section for providing technical assistance to grantees, obtaining assistance of experts and consultants, holding meetings, developing of tools, disseminating of information, and evaluation.
“(d) Community-Based collaborative care networks.—
“(A) DESCRIPTION.—A community-based collaborative care network described in this subsection is a consortium of health care providers with a joint governance structure that provides a comprehensive range of coordinated and integrated health care services for low-income patient populations or medically underserved communities (whether or not such individuals receive benefits under title XVIII, XIX, or XXI of the Social Security Act, private or other health insurance or are uninsured or underinsured) and that complies with any applicable minimum eligibility requirements that the Secretary may determine appropriate.
“(B) REQUIRED INCLUSION.—Each such network shall include the following providers that serve the community (unless such provider does not exist within the community, declines or refuses to participate, or places unreasonable conditions on their participation)—
“(i) A safety net hospital that provides services to a high volume of low-income patients, as demonstrated by meeting the criteria in section 1923(b)(1) of the Social Security Act, or other similar criteria determined by the Secretary; and
“(ii) All Federally qualified health centers (as defined in section 1861(aa) of the Social Security Act (42 U.S.C. 1395x(aa))) located in the geographic area served by the Coordinated Care Network;
“(C) ADDITIONAL INCLUSIONS.—Each such network may include any of the following additional providers:
“(i) A hospital, including a critical access hospital (as defined in section 1820(c)(2) of the Social Security Act (42 U.S.C. 1395i–4(c)(2))).
“(ii) A county or municipal department of health.
“(iii) A rural health clinic or a rural health network (as defined in sections 1861(aa) and 1820(d) of the Social Security Act, respectively (42 U.S.C. 1395x(aa), 1395i–4(d))).
“(iv) A community clinic, including a mental health clinic, substance abuse clinic, or a reproductive health clinic.
“(v) A health center controlled network as defined by section 330(e)(1)(C) of the Public Health Service Act
“(vi) A private practice physician or group practice.
“(vii) A nurse or physician assistant or group practice.
“(viii) An adult day care center.
“(ix) A home health provider.
“(x) Any other type of provider specified by the Secretary, which has a desire to serve low-income and uninsured patients.
“(i) Nothing in this section shall prohibit a single entity from qualifying as community-based collaborative care network so long as such single entity meets the criteria of a community-based collaborative care network. If the network does not include the providers referenced in clauses (i) and (ii) of subparagraph (B) of this paragraph, the application must explain the reason pursuant to subsection (b)(1)(A).
“(ii) Participation in a community-based collaborative care network shall not affect Federally qualified health centers’ obligation to comply with the governance requirements under section 330 of the Public Health Service Act (42 U.S.C. 254b).
“(iii) Federally qualified health centers participating in a community-based collaborative care network may not be required to provide services beyond their Federal Health Center scope of project approved by HRSA.
“(iv) Nothing in this section shall be construed to expand medical malpractice liability protection under the Federal Tort Claims Act for Section 330-funded Federally qualified health centers.
“(2) COMPREHENSIVE RANGE OF COORDINATED AND INTEGRATED HEALTH CARE SERVICES.—The Secretary shall define criteria for evaluating whether the services offered by a community-based collaborative care network qualify as a comprehensive range of coordinated and integrated health care services. Such criteria may vary based on the needs of the geographic areas and populations to be served by the network and may include the following:
“(A) Requiring community-based collaborative care networks to include at least the suggested core services identified under subsection (b)(3), or whichever subset of the suggested core services is applicable to a particular network.
“(B) Requiring such networks to assign each patient of the network to a primary care provider responsible for managing that patient’s care.
“(C) Requiring the services provided by a community-based collaborative care network to include support services appropriate to meet the health needs of low-income populations in the network’s community, which may include chronic care management, nutritional counseling, transportation, language services, enrollment counselors, social services and other services as proposed by the network.
“(D) Providing that the services provided by a community-based collaborative care network may also include long-term care services and other services not specified in this subsection.
“(E) Providing for the approval by the Secretary of a scope of community-based collaborative care network services for each network that addresses an appropriate minimum scope of work consistent with the setting of the network and the health professionals available in the community the network serves.
“(3) CLARIFICATION.—Participation in a community-based collaborative care network shall not disqualify a health care provider from reimbursement under title XVIII, XIX, or XXI of the Social Security Act with respect to services otherwise reimbursable under such title. Nothing in this section shall prevent a community-based collaborative care network that is otherwise eligible to contract with Medicare, a private health insurer, or any other appropriate entity to provide care under Medicare, under health insurance coverage offered by the insurer, or otherwise.
“(1) GRANTEE REPORTS.—Beginning in the third year following an initial grant, each community-based collaborative care network shall submit to the Secretary, with respect to each year the grantee has received a grant, an evaluation on the activities carried out by the community-based collaborative care network under the community-based collaborative care network program and shall include—
“(A) the number of people served;
“(B) the most common health problems treated;
“(C) any reductions in emergency department use;
“(D) any improvements in access to primary care;
“(E) an accounting of how amounts received were used, including identification of amounts used for patient care services as may be required for HRSA grantees; and
“(F) to the extent requested by the Secretary, any quality measures or any other measures specified by the Secretary.
“(2) PROGRAM REPORTS.—The Secretary shall submit to Congress an annual evaluation (beginning not later than 6 months after the first reports under paragraph (1) are submitted) on the extent to which emergency department use was reduced as a result of the activities carried out by the community-based collaborative care network under the program. Each such evaluation shall also include information on—
“(A) the prevalence of certain chronic conditions in various populations, including a comparison of such prevalence in the general population versus in the population of individuals with inadequate health insurance coverage;
“(B) demographic characteristics of the population of uninsured and underinsured individuals served by the community-based collaborative care network involved; and
“(C) the conditions of such individuals for whom services were requested at such emergency departments of participating hospitals.
“(3) AUDIT AUTHORITY.—The Secretary may conduct periodic audits and request periodic spending reports of community-based collaborative care networks under the community-based collaborative care network program.
“(f) Clarification.—Nothing in this section requires a provider to report individually identifiable information of an individual to government agencies, unless the individual consents, consistent with HIPAA privacy and security law, as defined in section 3009(a)(2).
“(g) Authorization of appropriations.—There are authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years 2011 through 2015.”.
Part Q of title III (42 U.S.C. 280h et seq.) is amended by inserting after section 399W the following:
“(a) Program.—The Secretary shall establish a community-based overweight and obesity prevention program consisting of awarding grants and contracts under subsection (b).
“(b) Grants.—The Secretary shall award grants to, or enter into contracts with, eligible entities—
“(1) to plan evidence-based programs for the prevention of overweight and obesity among children and their families through improved nutrition and increased physical activity; or
“(2) to implement such programs.
“(c) Eligibility.—To be eligible for a grant or contract under subsection (b), an entity shall be a community partnership that demonstrates community support and includes—
“(1) a broad cross section of stakeholders, such as—
“(A) hospitals, health care systems, community health centers, or other health care providers;
“(B) universities, local educational agencies, or childcare providers;
“(C) State, local, and tribal health departments;
“(D) State, local, and tribal park and recreation departments;
“(E) employers; and
“(F) health insurance companies;
“(2) residents of the community; and
“(3) representatives of public and private entities that have a history of working within and serving the community.
“(1) IN GENERAL.—The period of a grant or contract under this section shall be 5 years, subject to renewal under paragraph (2).
“(2) RENEWAL.—At the end of each fiscal year, the Secretary may renew a grant or contract award under this section only if the grant or contract recipient demonstrates to the Secretary’s satisfaction that the recipient has made appropriate, measurable progress in preventing overweight and obesity.
“(1) IN GENERAL.—The Secretary may award a grant or contract under this section to an entity only if the entity demonstrates to the Secretary’s satisfaction that—
“(A) not later than 90 days after receiving the grant or contract, the entity will establish a steering committee to provide input on the assessment of, and recommendations on improvements to, the entity’s program funded through the grant or contract; and
“(B) the entity has conducted or will conduct an assessment of the overweight and obesity problem in its community, including the extent of the problem and factors contributing to the problem.
“(2) MATCHING REQUIREMENT.—The Secretary may award a grant or contract to an eligible entity under this section only if the entity agrees to provide, from non-Federal sources, an amount equal to $1 (in cash or in kind) for each $9 provided through the grant or contract to carry out the activities supported by the grant or contract.
“(3) PAYOR OF LAST RESORT.—The Secretary may award a grant or contract under this section to an entity only if the entity demonstrates to the satisfaction of the Secretary that funds received through the grant or contract will not be expended for any activity to the extent that payment has been made, or can reasonably be expected to be made—
“(A) under any insurance policy;
“(B) under any Federal or State health benefits program (including titles XIX and XXI of the Social Security Act); or
“(C) by an entity which provides health services on a prepaid basis.
“(4) MAINTENANCE OF EFFORT.—The Secretary may award a grant or contract under this section to an entity only if the entity demonstrates to the satisfaction of the Secretary that—
“(A) funds received through the grant or contract will be expended only to supplement, and not supplant, non-Federal and Federal funds otherwise available to the entity for the activities to be funded through the grant or contract; and
“(B) with respect to such activities, the entity will maintain expenditures of non-Federal amounts for such activities at a level not less than the lesser of such expenditures maintained by the entity for the fiscal year preceding the fiscal year for which the entity receives the grant or contract.
“(f) Preferences.—In awarding grants and contracts under this section, the Secretary shall give preference to eligible entities that—
“(1) will serve communities with high levels of overweight and obesity and related chronic diseases; or
“(2) will plan or implement activities for the prevention of overweight and obesity in school or workplace settings.
“(g) Report.—The Secretary shall submit to the Congress an annual report on the program of grants and contracts awarded under this section.
“(h) Definitions.—In this section:
“(1) The term ‘evidence-based’ means that methodologically sound research has demonstrated a beneficial health effect in the judgment of the Secretary and includes the Ways to Enhance Children’s Activity and Nutrition (We Can) program and curriculum of the National Institutes of Health.
“(2) The term ‘local educational agency’ has the meaning given to the term in section 9101 of the Elementary and Secondary Education Act of 1965.
“(i) Authorization of appropriations.—To carry out this section, there are authorized to be appropriated $10,000,000 for fiscal year 2011 and such sums as may be necessary for each of fiscal years 2012 through 2015.”.
(1) IN GENERAL.—The Secretary of Education, in consultation with the Secretary of Health and Human Services and the Director of the Centers for Disease Control and Prevention, may make demonstration grants to eligible local educational agencies for the purpose of reducing the student-to-school nurse ratio in public elementary and secondary schools.
(2) SPECIAL CONSIDERATION.—In awarding grants under this section, the Secretary of Education shall give special consideration to applications submitted by high-need local educational agencies that demonstrate the greatest need for new or additional nursing services among children in the public elementary and secondary schools served by the agency, in part by providing information on current ratios of students to school nurses.
(3) MATCHING FUNDS.—The Secretary of Education may require recipients of grants under this subsection to provide matching funds from non-Federal sources, and shall permit the recipients to match funds in whole or in part with in-kind contributions.
(b) Report.—Not later than 24 months after the date on which assistance is first made available to local educational agencies under this section, the Secretary of Education shall submit to the Congress a report on the results of the demonstration grant program carried out under this section, including an evaluation of the effectiveness of the program in improving the student-to-school nurse ratios described in subsection (a) and an evaluation of the impact of any resulting enhanced health of students on learning.
(c) Definitions.—For purposes of this section:
(1) The terms “elementary school”, “local educational agency”, and “secondary school” have the meanings given to those terms in section 9101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801).
(2) The term “eligible local educational agency” means a local educational agency in which the student-to-school nurse ratio in the public elementary and secondary schools served by the agency is 750 or more students to every school nurse.
(3) The term “high-need local educational agency” means a local educational agency—
(A) that serves not fewer than 10,000 children from families with incomes below the poverty line; or
(B) for which not less than 20 percent of the children served by the agency are from families with incomes below the poverty line.
(4) The term “nurse” means a licensed nurse, as defined under State law.
(d) Authorization of Appropriations.—To carry out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2011 through 2015.
(a) In general.—The Secretary shall establish a nationwide demonstration project consisting of—
(1) awarding grants to, and entering into contracts with, medical-legal partnerships to assist patients and their families to navigate health-related programs and activities; and
(2) evaluating the effectiveness of such partnerships.
(b) Use of funds.—Amounts received as a grant or contract under this section shall be used to assist patients and their families to navigate health care-related programs and activities and thereby achieve one or more of the following goals:
(1) Enhancing access to health care services.
(2) Improving health outcomes for low-income individuals.
(3) Reducing health disparities.
(4) Enhancing wellness and prevention of chronic conditions.
(c) Prohibition.—No funds under this section may be used—
(1) for any medical malpractice or other civil action or proceeding; or
(2) to assist individuals who are not lawfully present in the United States.
(d) Report.—Not later than 5 years after the date of the enactment of this Act, the Secretary shall submit a report to the Congress on the results of the demonstration project under this section. Such report shall include the following:
(1) A description of the extent to which medical-legal partnerships funded through this section achieved the goals described in subsection (b).
(2) Recommendations on the possibility of extending or expanding the demonstration project.
(e) Definitions.—In this section:
(1) The term “health disparities” has the meaning given to the term in section 3171 of the Public Health Service Act, as added by section 2301.
(2) The term “medical-legal partnership” means an entity—
(A) that is a collaboration between—
(i) a community health center, public hospital, children’s hospital, or other provider of health care services to a significant number of low-income beneficiaries; and
(ii) one or more attorneys; and
(B) whose primary mission is to assist patients and their families navigate health care-related programs and activities.
(3) The term “Secretary” means the Secretary of Health and Human Services.
(f) Authorization of appropriations.—To carry out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2011 through 2015.
(a) Grants for trauma care centers.—Section 1241 (42 U.S.C. 300d–41) is amended to read as follows:
“(a) In general.—The Secretary shall establish a trauma center program consisting of awarding grants under section (b).
“(b) Grants.—The Secretary shall award grants as follows:
“(1) EXISTING CENTERS.—Grants to public, private nonprofit, Indian Health Service, Indian tribal, and urban Indian trauma centers—
“(A) to further the core missions of such centers; or
“(B) to provide emergency relief to ensure the continued and future availability of trauma services by trauma centers—
“(i) at risk of closing or operating in an area where a closing has occurred within their primary service area; or
“(ii) in need of financial assistance following a natural disaster or other catastrophic event, such as a terrorist attack.
“(2) NEW CENTERS.—Grants to local governments and public or private nonprofit entities to establish new trauma centers in urban areas with a substantial degree of trauma resulting from violent crimes.
“(c) Minimum Qualifications of Trauma Centers.—
“(1) PARTICIPATION IN TRAUMA CARE SYSTEM OPERATING UNDER CERTAIN PROFESSIONAL GUIDELINES.—
“(A) LIMITATION.—Subject to subparagraph (B), the Secretary may not award a grant to an existing trauma center under this section unless the center is a participant in a trauma care system that substantially complies with section 1213.
“(B) EXEMPTION.—Subparagraph (A) shall not apply to trauma centers that are located in States with no existing trauma care system.
“(2) DESIGNATION.—The Secretary may not award a grant under this section to an existing trauma center unless the center is—
“(A) verified as a trauma center by the American College of Surgeons; or
“(B) designated as a trauma center by the applicable State health or emergency medical services authority.”.
(b) Considerations in making grants.—Section 1242 (42 U.S.C. 300d–42) is amended to read as follows:
“(1) IN GENERAL.—In awarding grants under section 1241(b)(1)(A), the Secretary shall—
“(A) reserve a minimum of 25 percent of the amount allocated for such grants for level III and level IV trauma centers in rural or underserved areas;
“(B) reserve a minimum of 25 percent of the amount allocated for such grants for level I and level II trauma centers in urban areas; and
“(C) give preference to any application made by a trauma center—
“(i) in a geographic area where growth in demand for trauma services exceeds capacity;
“(ii) that demonstrates the financial support of the State or political subdivision involved;
“(iii) that has at least 1 graduate medical education fellowship in trauma or trauma-related specialties, including neurological surgery, surgical critical care, vascular surgery, and spinal cord injury, for which demand is exceeding supply; or
“(iv) that demonstrates a substantial commitment to serving vulnerable populations.
“(2) FINANCIAL SUPPORT.—For purposes of paragraph (1)(C)(ii), financial support may be demonstrated by State or political subdivision funding for the trauma center’s capital or operating expenses (including through State trauma regional advisory coordination activities, Medicaid funding designated for trauma services, or other governmental funding). State funding derived from Federal support shall not constitute State or local financial support for purposes of preferential treatment under this subsection.
“(3) USE OF FUNDS.—The recipient of a grant under section 1241(b)(1)(A) shall carry out, consistent with furthering the core missions of the center, one or more of the following activities:
“(A) Providing 24-hour-a-day, 7-day-a-week trauma care availability.
“(B) Reducing overcrowding related to throughput of trauma patients.
“(C) Enhancing trauma surge capacity.
“(D) Ensuring physician and essential personnel availability.
“(E) Trauma education and outreach.
“(F) Coordination with local and regional trauma care systems.
“(G) Such other activities as the Secretary may deem appropriate.
“(b) Emergency awards; new centers.—In awarding grants under paragraphs (1)(B) and (2) of section 1241(b), the Secretary shall—
“(1) give preference to any application submitted by an applicant that demonstrates the financial support (in accordance with subsection (a)(2)) of the State or political subdivision involved for the activities to be funded through the grant for each fiscal year during which payments are made to the center under the grant; and
“(2) give preference to any application submitted for a trauma center that—
“(A) is providing or will provide trauma care in a geographic area in which the availability of trauma care has either significantly decreased as a result of a trauma center in the area permanently ceasing participation in a system described in section 1241(c)(1) as of a date occurring during the 2-year period preceding the fiscal year for which the trauma center is applying to receive a grant, or in geographic areas where growth in demand for trauma services exceeds capacity;
“(B) will, in providing trauma care during the 1-year period beginning on the date on which the application for the grant is submitted, incur substantial uncompensated care costs in an amount that renders the center unable to continue participation in such system and results in a significant decrease in the availability of trauma care in the geographic area;
“(C) operates or will operate in rural areas where trauma care availability will significantly decrease if the center is forced to close or downgrade service and substantial costs are contributing to a likelihood of such closure or downgradation;
“(D) is in a geographic location substantially affected by a natural disaster or other catastrophic event such as a terrorist attack; or
“(E) will establish a new trauma service in an urban area with a substantial degree of trauma resulting from violent crimes.
“(c) Designations of Levels of Trauma Centers in Certain States.—In the case of a State which has not designated 4 levels of trauma centers, any reference in this section to—
“(1) a level I or level II trauma center is deemed to be a reference to a trauma center within the highest 2 levels of trauma centers designated under State guidelines; and
“(2) a level III or IV trauma center is deemed to be a reference to a trauma center not within such highest 2 levels.”.
(c) Certain agreements.—Section 1243 (42 U.S.C. 300d–43) is amended to read as follows:
“(a) Commitment regarding continued participation in trauma care system.—The Secretary may not award a grant to an applicant under section 1241(b) unless the applicant agrees that—
“(1) the trauma center involved will continue participation, or in the case of a new center will participate, in the system described in section 1241(c)(1), except as provided in section 1241(c)(1)(B), throughout the grant period beginning on the date that the center first receives payments under the grant; and
“(2) if the agreement made pursuant to paragraph (1) is violated by the center, the center will be liable to the United States for an amount equal to the sum of—
“(A) the amount of assistance provided to the center under section 1241; and
“(B) an amount representing interest on the amount specified in subparagraph (A).
“(b) Maintenance of financial support.—With respect to activities for which funds awarded through a grant under section 1241 are authorized to be expended, the Secretary may not award such a grant unless the applicant agrees that, during the period in which the trauma center involved is receiving payments under the grant, the center will maintain access to trauma services at levels not less than the levels for the prior year, taking into account—
“(1) reasonable volume fluctuation that is not caused by intentional trauma boundary reduction;
“(2) downgrading of the level of services; and
“(3) whether such center diverts its incoming patients away from such center 5 percent or more of the time during which the center is in operation over the course of the year.
“(c) Trauma care registry.—The Secretary may not award a grant to a trauma center under section 1241(b)(1) unless the center agrees that—
“(1) not later than 6 months after the date on which the center submits a grant application to the Secretary, the center will establish and operate a registry of trauma cases in accordance with guidelines developed by the American College of Surgeons; and
“(2) in carrying out paragraph (1), the center will maintain information on the number of trauma cases treated by the center and, for each such case, the extent to which the center incurs uncompensated costs in providing trauma care.”.
(d) General provisions.—Section 1244 (42 U.S.C. 300d–44) is amended to read as follows:
“(a) Limitation on duration of support.—The period during which a trauma center receives payments under a grant under section 1241(b)(1) shall be for 3 fiscal years, except that the Secretary may waive such requirement for the center and authorize the center to receive such payments for 1 additional fiscal year.
“(b) Eligibility.—The acquisition of, or eligibility for, a grant under section 1241(b) shall not preclude a trauma center’s eligibility for another grant described in such section.
“(c) Funding distribution.—Of the total amount appropriated for a fiscal year under section 1245—
“(1) 90 percent shall be used for grants under paragraph (1)(A) of section 1241(b); and
“(2) 10 percent shall be used for grants under paragraphs (1)(B) and (2) of section 1241(b).
“(d) Report.—Beginning 2 years after the date of the enactment of the Affordable Health Care for America Act, and every 2 years thereafter, the Secretary shall biennially—
“(1) report to Congress on the status of the grants made pursuant to section 1241;
“(2) evaluate and report to Congress on the overall financial stability of trauma centers in the United States;
“(3) report on the populations using trauma care centers and include aggregate patient data on income, race, ethnicity, and geography; and
“(4) evaluate the effectiveness and efficiency of trauma care center activities using standard public health measures and evaluation methodologies.”.
(e) Authorization of appropriations.—Section 1245 (42 U.S.C. 300d–45) is amended to read as follows:
“(a) In general.—For the purpose of carrying out this part, there are authorized to be appropriated $100,000,000 for fiscal year 2011, and such sums as may be necessary for each of fiscal years 2012 through 2015. Such authorization of appropriations is in addition to any other authorization of appropriations or amounts that are available for such purpose.
“(b) Reallocation.—The Secretary shall reallocate for grants under section 1241(b)(1)(A) any funds appropriated for grants under paragraph (1)(B) or (2) of section 1241(b), but not obligated due to insufficient applications eligible for funding.”.
(a) In general.—Subtitle B of title XXVIII (42 U.S.C. 300hh–10 et seq.) is amended by adding at the end the following:
“(a) Emergency Care Coordination Center.—
“(1) ESTABLISHMENT.—The Secretary shall establish, within the Office of the Assistant Secretary for Preparedness and Response, an Emergency Care Coordination Center (in this section referred to as the ‘Center’), to be headed by a director.
“(2) DUTIES.—The Secretary, acting through the Director of the Center, in coordination with the Federal Interagency Committee on Emergency Medical Services, shall—
“(A) promote and fund research in emergency medicine and trauma health care;
“(B) promote regional partnerships and more effective emergency medical systems in order to enhance appropriate triage, distribution, and care of routine community patients; and
“(C) promote local, regional, and State emergency medical systems’ preparedness for and response to public health events.
“(b) Council of Emergency Care.—
“(1) ESTABLISHMENT.—The Secretary, acting through the Director of the Center, shall establish a Council of Emergency Care to provide advice and recommendations to the Director on carrying out this section.
“(2) COMPOSITION.—The Council shall be comprised of employees of the departments and agencies of the Federal Government who are experts in emergency care and management.
“(1) SUBMISSION.—Not later than 12 months after the date of the enactment of the Affordable Health Care for America Act, the Secretary shall submit to the Congress an annual report on the activities carried out under this section.
“(2) CONSIDERATIONS.—In preparing a report under paragraph (1), the Secretary shall consider factors including—
“(A) emergency department crowding and boarding; and
“(B) delays in care following presentation.
“(d) Authorization of appropriations.—To carry out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2011 through 2015.”.
(b) Functions, personnel, assets, liabilities, and administrative actions.—All functions, personnel, assets, and liabilities of, and administrative actions applicable to, the Emergency Care Coordination Center, as in existence on the day before the date of the enactment of this Act, shall be transferred to the Emergency Care Coordination Center established under section 2816(a) of the Public Health Service Act, as added by subsection (a).
Part B of title III (42 U.S.C. 243 et seq.) is amended by inserting after section 314 the following:
(a) In general.—Part B of title III (42 U.S.C. 243 et seq.), as amended, is amended by inserting after section 315 the following:
“SEC. 315A. Assisting veterans with military emergency medical training to become State-licensed or certified emergency medical technicians (EMTs).
“(a) Program.—The Secretary shall establish a program consisting of awarding grants to States to assist veterans who received and completed military emergency medical training while serving in the Armed Forces of the United States to become, upon their discharge or release from active duty service, State-licensed or certified emergency medical technicians.
“(b) Use of funds.—Amounts received as a grant under this section may be used to assist veterans described in subsection (a) to become State-licensed or certified emergency medical technicians as follows:
“(1) Providing training.
“(2) Providing reimbursement for costs associated with—
“(A) training; or
“(B) applying for licensure or certification.
“(3) Expediting the licensing or certification process.
“(c) Eligibility.—To be eligible for a grant under this section, a State shall demonstrate to the Secretary’s satisfaction that the State has a shortage of emergency medical technicians.
“(d) Report.—The Secretary shall submit to the Congress an annual report on the program under this section.
“(e) Authorization of appropriations.—To carry out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2011 through 2015.”.
(b) GAO study and report.—The Comptroller General of the United States shall—
(1) conduct a study on the barriers experienced by veterans who received training as medical personnel while serving in the Armed Forces of the United States and, upon their discharge or release from active duty service, seek to become licensed or certified in a State as civilian health professionals; and
(2) not later than 2 years after the date of the enactment of this Act, submit to the Congress a report on the results of such study, including recommendations on whether the program established under section 315A of the Public Health Service Act, as added by subsection (a), should be expanded to assist veterans seeking to become licensed or certified in a State as health providers other than emergency medical technicians.
(a) National health security strategy.—Section 2802(b)(3) (42 U.S.C. 300hh–1(b)(3)) is amended—
(1) in the matter preceding subparagraph (A), by inserting “dental and” before “mental health facilities”; and
(2) in subparagraph (D), by inserting “and dental” after “medical”.
(b) All-Hazards public health and medical response curricula and training.—Section 319F(a)(5)(B) (42 U.S.C. 247d–6(a)(5)(B)) is amended by striking “public health or medical” and inserting “public health, medical, or dental”.
(a) National response framework.—Paragraph (6) of section 2 of the Homeland Security Act of 2002 (6 U.S.C. 101) is amended by inserting “and dental” after “emergency medical”.
(b) National preparedness system.—Subparagraph (B) of section 653(b)(4) of the Post-Katrina Emergency Management Reform Act of 2006 (6 U.S.C. 753(b)(4)) is amended by striking “public health and medical” and inserting “public health, medical, and dental”.
(c) Chief Medical Officer.—Paragraph (5) of section 516(c) of the Homeland Security Act of 2002 (6 U.S.C. 321e(c)) is amended by striking “medical community” and inserting “medical and dental communities”.
(a) Convening.—Not later than June 30, 2011, the Secretary of Health and Human Services shall seek to enter into an agreement with the Institute of Medicine of the National Academies to convene a Conference on Pain (in this section referred to as “the Conference”).
(b) Purposes.—The purposes of the Conference shall be to—
(1) increase the recognition of pain as a significant public health problem in the United States;
(2) evaluate the adequacy of assessment, diagnosis, treatment, and management of acute and chronic pain in the general population, and in identified racial, ethnic, gender, age, and other demographic groups that may be disproportionately affected by inadequacies in the assessment, diagnosis, treatment, and management of pain;
(3) identify barriers to appropriate pain care, including—
(A) lack of understanding and education among employers, patients, health care providers, regulators, and third-party payors;
(B) barriers to access to care at the primary, specialty, and tertiary care levels, including barriers—
(i) specific to those populations that are disproportionately undertreated for pain;
(ii) related to physician concerns over regulatory and law enforcement policies applicable to some pain therapies; and
(iii) attributable to benefit, coverage, and payment policies in both the public and private sectors; and
(C) gaps in basic and clinical research on the symptoms and causes of pain, and potential assessment methods and new treatments to improve pain care; and
(4) establish an agenda for action in both the public and private sectors that will reduce such barriers and significantly improve the state of pain care research, education, and clinical care in the United States.
(c) Other appropriate entity.—If the Institute of Medicine declines to enter into an agreement under subsection (a), the Secretary of Health and Human Services may enter into such agreement with another appropriate entity.
(d) Report.—A report summarizing the Conference’s findings and recommendations shall be submitted to the Congress not later than June 30, 2012.
(e) Authorization of appropriations.—For the purpose of carrying out this section, there is authorized to be appropriated $500,000 for each of fiscal years 2011 and 2012.
Part B of title IV (42 U.S.C. 284 et seq.) is amended by adding at the end the following:
“(1) IN GENERAL.—The Director of NIH is encouraged to continue and expand, through the Pain Consortium, an aggressive program of basic and clinical research on the causes of and potential treatments for pain.
“(2) ANNUAL RECOMMENDATIONS.—Not less than annually, the Pain Consortium, in consultation with the Division of Program Coordination, Planning, and Strategic Initiatives, shall develop and submit to the Director of NIH recommendations on appropriate pain research initiatives that could be undertaken with funds reserved under section 402A(c)(1) for the Common Fund or otherwise available for such initiatives.
“(3) DEFINITION.—In this subsection, the term ‘Pain Consortium’ means the Pain Consortium of the National Institutes of Health or a similar trans-National Institutes of Health coordinating entity designated by the Secretary for purposes of this subsection.
“(b) Interagency pain research coordinating committee.—
“(1) ESTABLISHMENT.—The Secretary shall establish not later than 1 year after the date of the enactment of this section and as necessary maintain a committee, to be known as the Interagency Pain Research Coordinating Committee (in this section referred to as the ‘Committee’), to coordinate all efforts within the Department of Health and Human Services and other Federal agencies that relate to pain research.
“(A) IN GENERAL.—The Committee shall be composed of the following voting members:
“(i) Not more than 7 voting Federal representatives as follows:
“(I) The Director of the Centers for Disease Control and Prevention.
“(II) The Director of the National Institutes of Health and the directors of such national research institutes and national centers as the Secretary determines appropriate.
“(III) The heads of such other agencies of the Department of Health and Human Services as the Secretary determines appropriate.
“(IV) Representatives of other Federal agencies that conduct or support pain care research and treatment, including the Department of Defense and the Department of Veterans Affairs.
“(ii) Twelve additional voting members appointed under subparagraph (B).
“(B) ADDITIONAL MEMBERS.—The Committee shall include additional voting members appointed by the Secretary as follows:
“(i) Six members shall be appointed from among scientists, physicians, and other health professionals, who—
“(I) are not officers or employees of the United States;
“(II) represent multiple disciplines, including clinical, basic, and public health sciences;
“(III) represent different geographical regions of the United States; and
“(IV) are from practice settings, academia, manufacturers, or other research settings.
“(ii) Six members shall be appointed from members of the general public, who are representatives of leading research, advocacy, and service organizations for individuals with pain-related conditions.
“(C) NONVOTING MEMBERS.—The Committee shall include such nonvoting members as the Secretary determines to be appropriate.
“(3) CHAIRPERSON.—The voting members of the Committee shall select a chairperson from among such members. The selection of a chairperson shall be subject to the approval of the Director of NIH.
“(4) MEETINGS.—The Committee shall meet at the call of the chairperson of the Committee or upon the request of the Director of NIH, but in no case less often than once each year.
“(5) DUTIES.—The Committee shall—
“(A) develop a summary of advances in pain care research supported or conducted by the Federal agencies relevant to the diagnosis, prevention, and treatment of pain and diseases and disorders associated with pain;
“(B) identify critical gaps in basic and clinical research on the symptoms and causes of pain;
“(C) make recommendations to ensure that the activities of the National Institutes of Health and other Federal agencies, including the Department of Defense and the Department of Veteran Affairs, are free of unnecessary duplication of effort;
“(D) make recommendations on how best to disseminate information on pain care; and
“(E) make recommendations on how to expand partnerships between public entities, including Federal agencies, and private entities to expand collaborative, crosscutting research.
“(6) REVIEW.—The Secretary shall review the necessity of the Committee at least once every 2 years.”.
Part B of title II (42 U.S.C. 238 et seq.) is amended by adding at the end the following:
“(a) Establishment.—Not later than 12 months after the date of the enactment of this section, the Secretary shall establish and implement a national pain care education outreach and awareness campaign described in subsection (b).
“(b) Requirements.—The Secretary shall design the public awareness campaign under this section to educate consumers, patients, their families, and other caregivers with respect to—
“(1) the incidence and importance of pain as a national public health problem;
“(2) the adverse physical, psychological, emotional, societal, and financial consequences that can result if pain is not appropriately assessed, diagnosed, treated, or managed;
“(3) the availability, benefits, and risks of all pain treatment and management options;
“(4) having pain promptly assessed, appropriately diagnosed, treated, and managed, and regularly reassessed with treatment adjusted as needed;
“(5) the role of credentialed pain management specialists and subspecialists, and of comprehensive interdisciplinary centers of treatment expertise;
“(6) the availability in the public, nonprofit, and private sectors of pain management-related information, services, and resources for consumers, employers, third-party payors, patients, their families, and caregivers, including information on—
“(A) appropriate assessment, diagnosis, treatment, and management options for all types of pain and pain-related symptoms; and
“(B) conditions for which no treatment options are yet recognized; and
“(7) other issues the Secretary deems appropriate.
“(c) Consultation.—In designing and implementing the public awareness campaign required by this section, the Secretary shall consult with organizations representing patients in pain and other consumers, employers, physicians including physicians specializing in pain care, other pain management professionals, medical device manufacturers, and pharmaceutical companies.
“(1) LEAD OFFICIAL.—The Secretary shall designate one official in the Department of Health and Human Services to oversee the campaign established under this section.
“(2) AGENCY COORDINATION.—The Secretary shall ensure the involvement in the public awareness campaign under this section of the Surgeon General of the Public Health Service, the Director of the Centers for Disease Control and Prevention, and such other representatives of offices and agencies of the Department of Health and Human Services as the Secretary determines appropriate.
“(e) Underserved areas and populations.—In designing the public awareness campaign under this section, the Secretary shall—
“(1) take into account the special needs of geographic areas and racial, ethnic, gender, age, and other demographic groups that are currently underserved; and
“(2) provide resources that will reduce disparities in access to appropriate diagnosis, assessment, and treatment.
“(f) Grants and contracts.—The Secretary may make awards of grants, cooperative agreements, and contracts to public agencies and private nonprofit organizations to assist with the development and implementation of the public awareness campaign under this section.
“(g) Evaluation and Report.—Not later than the end of fiscal year 2012, the Secretary shall prepare and submit to the Congress a report evaluating the effectiveness of the public awareness campaign under this section in educating the general public with respect to the matters described in subsection (b).
“(h) Authorization of appropriations.—For purposes of carrying out this section, there are authorized to be appropriated $2,000,000 for fiscal year 2011 and $4,000,000 for each of fiscal years 2012 and 2015.”.
(1) IN GENERAL.—Section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is amended—
(A) by redesignating subsection (g) as subsection (h); and
(B) by inserting after subsection (f) the following:
“(g) (1)(A) The Secretary shall establish a national medical device registry (in this subsection referred to as the ‘registry’) to facilitate analysis of postmarket safety and outcomes data on each covered device.
“(B) In this subsection, the term ‘covered device’—
“(i) shall include each class III device; and
“(ii) may include, as the Secretary determines appropriate and specifies in regulation, a class II device that is life-supporting or life-sustaining.
“(C) Notwithstanding subparagraph (B)(i), the Secretary may by order exempt a class III device from the provisions of this subsection if the Secretary concludes that inclusion of information on the device in the registry will not provide useful information on safety or effectiveness.
“(2) In developing the registry, the Secretary shall, in consultation with the Commissioner of Food and Drugs, the Administrator of the Centers for Medicare & Medicaid Services, the Administrator of the Agency for Healthcare Research and Quality, the head of the Office of the National Coordinator for Health Information Technology, and the Secretary of Veterans Affairs, determine the best methods for—
“(A) including in the registry, in a manner consistent with subsection (f), appropriate information to identify each covered device by type, model, and serial number or other unique identifier;
“(B) validating methods for analyzing patient safety and outcomes data from multiple sources and for linking such data with the information included in the registry as described in subparagraph (A), including, to the extent feasible, use of—
“(i) data provided to the Secretary under other provisions of this chapter; and
“(ii) information from public and private sources identified under paragraph (3);
“(C) integrating the activities described in this subsection (so as to avoid duplication) with—
“(i) activities under paragraph (3) of section 505(k) (relating to active postmarket risk identification);
“(ii) activities under paragraph (4) of section 505(k) (relating to advanced analysis of drug safety data);
“(iii) other postmarket device surveillance activities of the Secretary authorized by this chapter; and
“(iv) registries carried out by or for the Agency for Healthcare Research and Quality; and
“(D) providing public access to the data and analysis collected or developed through the registry in a manner and form that protects patient privacy and proprietary information and is comprehensive, useful, and not misleading to patients, physicians, and scientists.
“(3)(A) To facilitate analyses of postmarket safety and patient outcomes for covered devices, the Secretary shall, in collaboration with public, academic, and private entities, develop methods to—
“(i) obtain access to disparate sources of patient safety and outcomes data, including—
“(I) Federal health-related electronic data (such as data from the Medicare program under title XVIII of the Social Security Act or from the health systems of the Department of Veterans Affairs);
“(II) private sector health-related electronic data (such as pharmaceutical purchase data and health insurance claims data); and
“(III) other data as the Secretary deems necessary to permit postmarket assessment of device safety and effectiveness; and
“(ii) link data obtained under clause (i) with information in the registry.
“(B) In this paragraph, the term ‘data’ refers to information respecting a covered device, including claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of data from disparate data environments, electronic health records, and any other data deemed appropriate by the Secretary.
“(4) The Secretary shall promulgate regulations for establishment and operation of the registry under paragraph (1). Such regulations—
“(A)(i) in the case of covered devices that are sold on or after the date of the enactment of this subsection, shall require manufacturers of such devices to submit information to the registry, including, for each such device, the type, model, and serial number or, if required under subsection (f), other unique device identifier; and
“(ii) in the case of covered devices that are sold before such date, may require manufacturers of such devices to submit such information to the registry, if deemed necessary by the Secretary to protect the public health;
“(B) shall establish procedures—
“(i) to permit linkage of information submitted pursuant to subparagraph (A) with patient safety and outcomes data obtained under paragraph (3); and
“(ii) to permit analyses of linked data;
“(C) may require covered device manufacturers to submit such other information as is necessary to facilitate postmarket assessments of device safety and effectiveness and notification of device risks;
“(D) shall establish requirements for regular and timely reports to the Secretary, which shall be included in the registry, concerning adverse event trends, adverse event patterns, incidence and prevalence of adverse events, and other information the Secretary determines appropriate, which may include data on comparative safety and outcomes trends; and
“(E) shall establish procedures to permit public access to the information in the registry in a manner and form that protects patient privacy and proprietary information and is comprehensive, useful, and not misleading to patients, physicians, and scientists.
“(5)(A) The Secretary shall promulgate final regulations under paragraph (4) not later than 36 months after the date of the enactment of this subsection.
“(B) Before issuing the notice of proposed rulemaking preceding the final regulations described in subparagraph (A), the Secretary shall hold a public hearing before an advisory committee on the issue of which class II devices to include in the definition of covered devices.
“(C) The Secretary shall include in any regulation under this subsection an explanation demonstrating that the requirements of such regulation—
“(i) do not duplicate other Federal requirements; and
“(ii) do not impose an undue burden on device manufacturers.
“(6) With respect to any entity that submits or is required to submit a safety report or other information in connection with the safety of a device under this section (and any release by the Secretary of that report or information), such report or information shall not be construed to reflect necessarily a conclusion by the entity or the Secretary that the report or information constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or otherwise caused or contributed to a death, serious injury, or serious illness. Such an entity need not admit, and may deny, that the report or information submitted by the entity constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or caused or contributed to a death, serious injury, or serious illness.
“(7) To carry out this subsection, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2011 and 2012.”.
(2) EFFECTIVE DATE.—The Secretary of Health and Human Services shall establish and begin implementation of the registry under section 519(g) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph (1), by not later than the date that is 36 months after the date of the enactment of this Act, without regard to whether or not final regulations to establish and operate the registry have been promulgated by such date.
(3) CONFORMING AMENDMENT.—Section 303(f)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(1)(B)(ii)) is amended by striking “519(g)” and inserting “519(h)”.
(b) Electronic exchange and use in certified electronic health records of unique device identifiers.—
(1) RECOMMENDATIONS.—The HIT Policy Committee established under section 3002 of the Public Health Service Act (42 U.S.C. 300jj–12) shall recommend to the head of the Office of the National Coordinator for Health Information Technology standards, implementation specifications, and certification criteria for the electronic exchange and use in certified electronic health records of a unique device identifier for each covered device (as defined under section 519(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)).
(2) STANDARDS, IMPLEMENTATION CRITERIA, AND CERTIFICATION CRITERIA.—The Secretary of Health and Human Services, acting through the head of the Office of the National Coordinator for Health Information Technology, shall adopt standards, implementation specifications, and certification criteria for the electronic exchange and use in certified electronic health records of a unique device identifier for each covered device referred to in paragraph (1), if such an identifier is required by section 519(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) for the device.
(c) Unique device identification system.—The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue proposed regulations to implement section 519(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) not later than 6 months after the date of the enactment of this Act.
(a) Technical amendments.—Section 403(q)(5)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)(A)) is amended—
(1) in subclause (i), by inserting “except as provided in clause (H)(ii)(III),” after “(i)” ; and
(2) in subclause (ii), by inserting “except as provided in clause (H)(ii)(III),” after “(ii)” .
(b) Labeling requirements.—Section 403(q)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)) is amended by adding at the end the following:
“(H) Restaurants, retail food establishments, and vending machines.—
“(i) GENERAL REQUIREMENTS FOR RESTAURANTS AND SIMILAR RETAIL FOOD ESTABLISHMENTS.—Except for food described in subclause (vii), in the case of food that is a standard menu item that is offered for sale in a restaurant or similar retail food establishment that is part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering for sale substantially the same menu items, the restaurant or similar retail food establishment shall disclose the information described in subclauses (ii) and (iii).
“(ii) INFORMATION REQUIRED TO BE DISCLOSED BY RESTAURANTS AND RETAIL FOOD ESTABLISHMENTS.—Except as provided in subclause (vii), the restaurant or similar retail food establishment shall disclose in a clear and conspicuous manner—
“(I)(aa) in a nutrient content disclosure statement adjacent to the name of the standard menu item, so as to be clearly associated with the standard menu item, on the menu listing the item for sale, the number of calories contained in the standard menu item, as usually prepared and offered for sale; and
“(bb) a succinct statement concerning suggested daily caloric intake, as specified by the Secretary by regulation and posted prominently on the menu and designed to enable the public to understand, in the context of a total daily diet, the significance of the caloric information that is provided on the menu;
“(II)(aa) in a nutrient content disclosure statement adjacent to the name of the standard menu item, so as to be clearly associated with the standard menu item, on the menu board, including a drive-through menu board, the number of calories contained in the standard menu item, as usually prepared and offered for sale; and
“(bb) a succinct statement concerning suggested daily caloric intake, as specified by the Secretary by regulation and posted prominently on the menu board, designed to enable the public to understand, in the context of a total daily diet, the significance of the nutrition information that is provided on the menu board;
“(III) in a written form, available on the premises of the restaurant or similar retail establishment and to the consumer upon request, the nutrition information required under clauses (C) and (D) of subparagraph (1); and
“(IV) on the menu or menu board, a prominent, clear, and conspicuous statement regarding the availability of the information described in item (III).
“(iii) SELF-SERVICE FOOD AND FOOD ON DISPLAY.—Except as provided in subclause (vii), in the case of food sold at a salad bar, buffet line, cafeteria line, or similar self-service facility, and for self-service beverages or food that is on display and that is visible to customers, a restaurant or similar retail food establishment shall place adjacent to each food offered a sign that lists calories per displayed food item or per serving.
“(iv) REASONABLE BASIS.—For the purposes of this clause, a restaurant or similar retail food establishment shall have a reasonable basis for its nutrient content disclosures, including nutrient databases, cookbooks, laboratory analyses, and other reasonable means, as described in section 101.10 of title 21, Code of Federal Regulations (or any successor regulation) or in a related guidance of the Food and Drug Administration.
“(v) MENU VARIABILITY AND COMBINATION MEALS.—The Secretary shall establish by regulation standards for determining and disclosing the nutrient content for standard menu items that come in different flavors, varieties, or combinations, but which are listed as a single menu item, such as soft drinks, ice cream, pizza, doughnuts, or children's combination meals, through means determined by the Secretary, including ranges, averages, or other methods.
“(vi) ADDITIONAL INFORMATION.—If the Secretary determines that a nutrient, other than a nutrient required under subclause (ii)(III), should be disclosed for the purpose of providing information to assist consumers in maintaining healthy dietary practices, the Secretary may require, by regulation, disclosure of such nutrient in the written form required under subclause (ii)(III).
“(vii) NONAPPLICABILITY TO CERTAIN FOOD.—
“(I) IN GENERAL.—Subclauses (i) through (vi) do not apply to—
“(aa) items that are not listed on a menu or menu board (such as condiments and other items placed on the table or counter for general use);
“(bb) daily specials, temporary menu items appearing on the menu for less than 60 days per calendar year, or custom orders; or
“(cc) such other food that is part of a customary market test appearing on the menu for less than 90 days, under terms and conditions established by the Secretary.
“(II) WRITTEN FORMS.—Clause (C) shall apply to any regulations promulgated under subclauses (ii)(III) and (vi).
“(viii) VENDING MACHINES.—In the case of an article of food sold from a vending machine that—
“(I) does not permit a prospective purchaser to examine the Nutrition Facts Panel before purchasing the article or does not otherwise provide visible nutrition information at the point of purchase; and
“(II) is operated by a person who is engaged in the business of owning or operating 20 or more vending machines,
the vending machine operator shall provide a sign in close proximity to each article of food or the selection button that includes a clear and conspicuous statement disclosing the number of calories contained in the article.
“(ix) VOLUNTARY PROVISION OF NUTRITION INFORMATION.—
“(I) IN GENERAL.—An authorized official of any restaurant or similar retail food establishment or vending machine operator not subject to the requirements of this clause may elect to be subject to the requirements of such clause, by registering biannually the name and address of such restaurant or similar retail food establishment or vending machine operator with the Secretary, as specified by the Secretary by regulation.
“(II) REGISTRATION.—Within 120 days of the enactment of this clause, the Secretary shall publish a notice in the Federal Register specifying the terms and conditions for implementation of item (I), pending promulgation of regulations.
“(III) RULE OF CONSTRUCTION.—Nothing in this subclause shall be construed to authorize the Secretary to require an application, review, or licensing process for any entity to register with the Secretary, as described in such item.
“(I) PROPOSED REGULATION.—Not later than 1 year after the date of the enactment of this clause, the Secretary shall promulgate proposed regulations to carry out this clause.
“(II) CONTENTS.—In promulgating regulations, the Secretary shall—
“(aa) consider standardization of recipes and methods of preparation, reasonable variation in serving size and formulation of menu items, space on menus and menu boards, inadvertent human error, training of food service workers, variations in ingredients, and other factors, as the Secretary determines; and
“(bb) specify the format and manner of the nutrient content disclosure requirements under this subclause.
“(III) REPORTING.—The Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a quarterly report that describes the Secretary's progress toward promulgating final regulations under this subparagraph.
“(xi) DEFINITION.—In this clause, the term ‘menu’ or ‘menu board’ means the primary writing of the restaurant or other similar retail food establishment from which a consumer makes an order selection.”.
(c) National uniformity.—Section 403A(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343–1(a)(4)) is amended by striking “except a requirement for nutrition labeling of food which is exempt under subclause (i) or (ii) of section 403(q)(5)(A)” and inserting “except that this paragraph does not apply to food that is offered for sale in a restaurant or similar retail food establishment that is not part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering for sale substantially the same menu items unless such restaurant or similar retail food establishment complies with the voluntary provision of nutrition information requirements under section 403(q)(5)(H)(ix)”.
(d) Rule of construction.—Nothing in the amendments made by this section shall be construed—
(1) to preempt any provision of State or local law, unless such provision establishes or continues into effect nutrient content disclosures of the type required under section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (b)) and is expressly preempted under section 403A(a)(4) of such Act;
(2) to apply to any State or local requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food; or
(3) except as provided in section 403(q)(5)(H)(ix) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (b)), to apply to any restaurant or similar retail food establishment other than a restaurant or similar retail food establishment described in section 403(q)(5)(H)(i) of such Act.
(1) FINDINGS.—The Congress finds the following:
(A) In 1984, the Drug Price Competition and Patent Term Restoration Act (Pub. L. 98–417; in this subsection referred to as the “1984 Act”) was enacted with the intent of facilitating the early entry of generic drugs while preserving incentives for innovation.
(B) Prescription drugs make up 10 percent of national health care spending, but for the past decade have been one of the fastest growing segments of health care expenditures.
(C) Until recently, the 1984 Act was successful in facilitating generic competition to the benefit of consumers and health care payers—although 67 percent of all prescriptions dispensed in the United States are generic drugs, they account for only 20 percent of all expenditures.
(D) In recent years, the intent of the 1984 Act has been subverted by certain settlement agreements between brand companies and their potential generic competitors that make reverse payments, i.e., payments by the brand company to the generic company.
(E) These settlement agreements have unduly delayed the marketing of low-cost generic drugs contrary to free competition and the interests of consumers.
(F) The state of antitrust law relating to such settlement agreements is unsettled.
(2) PURPOSE.—The purpose of this section is to provide an additional means to effectuate the intent of the 1984 Act by enhancing competition in the pharmaceutical market by stopping agreements between brand name and generic drug manufacturers that limit, delay, or otherwise prevent competition from generic drugs.
(b) In general.—Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following:
“(w) Protecting Consumer Access to Generic Drugs.—
“(1) UNFAIR AND DECEPTIVE ACTS AND PRACTICES RELATED TO NEW DRUG APPLICATIONS.—
“(A) CONDUCT PROHIBITED.—It shall be unlawful for any person to directly or indirectly be a party to any agreement resolving or settling a patent infringement claim in which—
“(i) an ANDA filer receives anything of value; and
“(ii) the ANDA filer agrees to limit or forego research, development, manufacturing, marketing, or sales, for any period of time, of the drug that is to be manufactured under the ANDA involved and is the subject of the patent infringement claim.
“(B) EXCEPTIONS.—Notwithstanding subparagraph (A)(i), subparagraph (A) does not prohibit a resolution or settlement of a patent infringement claim in which the value received by the ANDA filer includes no more than—
“(i) the right to market the drug that is to be manufactured under the ANDA involved and is the subject of the patent infringement claim, before the expiration of—
“(I) the patent that is the basis for the patent infringement claim; or
“(II) any other statutory exclusivity that would prevent the marketing of such drug; and
“(ii) the waiver of a patent infringement claim for damages based on prior marketing of such drug.
“(i) IN GENERAL.—A violation of subparagraph (A) shall be treated as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce prohibited under section 5 of the Federal Trade Commission Act and shall be enforced by the Federal Trade Commission in the same manner, by the same means, and with the same jurisdiction as though all applicable terms and provisions of the Federal Trade Commission Act were incorporated into and made a part of this subsection.
“(ii) INAPPLICABILITY.—Subchapter A of chapter VII shall not apply with respect to this subsection.
“(D) DEFINITIONS.—In this subsection:
“(i) AGREEMENT.—The term ‘agreement’ means anything that would constitute an agreement under section 5 of the Federal Trade Commission Act.
“(ii) AGREEMENT RESOLVING OR SETTLING.—The term ‘agreement resolving or settling’, in reference to a patent infringement claim, includes any agreement that is contingent upon, provides a contingent condition for, or is otherwise related to the resolution or settlement of the claim.
“(iii) ANDA.—The term ‘ANDA’ means an abbreviated new drug application for the approval of a new drug under section (j).
“(iv) ANDA FILER.—The term ‘ANDA filer’ means a party that has filed an ANDA with the Food and Drug Administration.
“(v) PATENT INFRINGEMENT.—The term ‘patent infringement’ means infringement of any patent or of any filed patent application, extension, reissuance, renewal, division, continuation, continuation in part, reexamination, patent term restoration, patent of addition, or extension thereof.
“(vi) PATENT INFRINGEMENT CLAIM.—The term ‘patent infringement claim’ means any allegation made to an ANDA filer, whether or not included in a complaint filed with a court of law, that its ANDA or drug to be manufactured under such ANDA may infringe any patent.
“(2) FTC RULEMAKING.—The Federal Trade Commission may, by rule promulgated under section 553 of title 5, United States Code, exempt certain agreements described in paragraph (1) from the requirements of this subsection if the Commission finds such agreements to be in furtherance of market competition and for the benefit of consumers. Consistent with the authority of the Commission, such rules may include interpretive rules and general statements of policy with respect to the practices prohibited under paragraph (1).”.
(c) Notice and Certification of Agreements.—
(1) NOTICE OF ALL AGREEMENTS.—Section 1112(c)(2) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (21 U.S.C. 3155 note) is amended by—
(A) striking “the Commission the” and inserting the following: “the Commission—
“(A) the”;
(B) striking the period at the end and inserting “; and”; and
(C) adding at the end the following:
“(B) any other agreement the parties enter into within 30 days of entering into an agreement covered by subsection (a) or (b).”.
(2) CERTIFICATION OF AGREEMENTS.—Section 1112 of such Act is amended by adding at the end the following: “(d) Certification.—The chief executive officer or the company official responsible for negotiating any agreement required to be filed under subsection (a), (b), or (c) shall execute and file with the Assistant Attorney General and the Commission a certification as follows: ‘I declare under penalty of perjury that the following is true and correct: The materials filed with the Federal Trade Commission and the Department of Justice under section 1112 of subtitle B of title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, with respect to the agreement referenced in this certification: (1) represent the complete, final, and exclusive agreement between the parties; (2) include any ancillary agreements that are contingent upon, provide a contingent condition for, or are otherwise related to, the referenced agreement; and (3) include written descriptions of any oral agreements, representations, commitments, or promises between the parties that are responsive to subsection (a) or (b) of such section 1112 and have not been reduced to writing.’.”.
(1) STUDY.—Beginning 2 years after the date of enactment of this Act, and each year for a period of 4 years thereafter, the Comptroller General shall conduct a study on the litigation in United States courts during the period beginning 5 years prior to the date of enactment of this Act relating to patent infringement claims involving generic drugs, the number of patent challenges initiated by manufacturers of generic drugs, and the number of settlements of such litigation. The Comptroller General shall transmit to Congress a report of the findings of such a study and an analysis of the effect of the amendments made by subsections (b) and (c) on such litigation, whether such amendments have had an effect on the number and frequency of claims settled, and whether such amendments resulted in earlier or delayed entry of generic drugs to market, including whether any harm or benefit to consumers has resulted.
(2) DISCLOSURE OF AGREEMENTS.—Notwithstanding any other law, agreements filed under section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (21 U.S.C. 355 note), or unaggregated information from such agreements, shall be disclosed to the Comptroller General for purposes of the study under paragraph (1) within 30 days of a request by the Comptroller General.
(a) Licensure of Biological Products as Biosimilar or Interchangeable.—Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended—
(1) in subsection (a)(1)(A), by inserting “under this subsection or subsection (k)” after “biologics license”; and
(2) by adding at the end the following: “(k) Licensure of biological products as biosimilar or interchangeable.— “(1) IN GENERAL.—Any person may submit an application for licensure of a biological product under this subsection. “(i) REQUIRED INFORMATION.—An application submitted under this subsection shall include information demonstrating that— “(I) the biological product is biosimilar to a reference product based upon data derived from— “(aa) analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; “(bb) animal studies (including the assessment of toxicity); and “(cc) a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in 1 or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product;
“(II) the biological product and reference product utilize the same mechanism or mechanisms of action for the condition or conditions of use prescribed, recommended, or suggested in the proposed labeling, but only to the extent the mechanism or mechanisms of action are known for the reference product;
“(III) the condition or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product;
“(IV) the route of administration, the dosage form, and the strength of the biological product are the same as those of the reference product; and
“(V) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent.
“(ii) DETERMINATION BY SECRETARY.—The Secretary may determine, in the Secretary's discretion, that an element described in clause (i)(I) is unnecessary in an application submitted under this subsection.
“(iii) ADDITIONAL INFORMATION.—An application submitted under this subsection—
“(I) shall include publicly available information regarding the Secretary’s previous determination that the reference product is safe, pure, and potent; and
“(II) may include any additional information in support of the application, including publicly available information with respect to the reference product or another biological product.
“(B) INTERCHANGEABILITY.—An application (or a supplement to an application) submitted under this subsection may include information demonstrating that the biological product meets the standards described in paragraph (4).
“(3) EVALUATION BY SECRETARY.—Upon review of an application (or a supplement to an application) submitted under this subsection, the Secretary shall license the biological product under this subsection if—
“(A) the Secretary determines that the information submitted in the application (or the supplement) is sufficient to show that the biological product—
“(i) is biosimilar to the reference product; or
“(ii) meets the standards described in paragraph (4), and therefore is interchangeable with the reference product; and
“(B) the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c).
“(4) SAFETY STANDARDS FOR DETERMINING INTERCHANGEABILITY.—Upon review of an application submitted under this subsection or any supplement to such application, the Secretary shall determine the biological product to be interchangeable with the reference product if the Secretary determines that the information submitted in the application (or a supplement to such application) is sufficient to show that—
“(i) is biosimilar to the reference product; and
“(ii) can be expected to produce the same clinical result as the reference product in any given patient; and
“(B) for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.
“(A) ONE REFERENCE PRODUCT PER APPLICATION.—A biological product, in an application submitted under this subsection, may not be evaluated against more than 1 reference product.
“(B) REVIEW.—An application submitted under this subsection shall be reviewed by the division within the Food and Drug Administration that is responsible for the review and approval of the application under which the reference product is licensed.
“(C) RISK EVALUATION AND MITIGATION STRATEGIES.—The authority of the Secretary with respect to risk evaluation and mitigation strategies under the Federal Food, Drug, and Cosmetic Act shall apply to biological products licensed under this subsection in the same manner as such authority applies to biological products licensed under subsection (a).
“(D) RESTRICTIONS ON BIOLOGICAL PRODUCTS CONTAINING DANGEROUS INGREDIENTS.—If information in an application submitted under this subsection, in a supplement to such an application, or otherwise available to the Secretary shows that a biological product—
“(i) is, bears, or contains a select agent or toxin listed in section 73.3 or 73.4 of title 42, section 121.3 or 121.4 of title 9, or section 331.3 of title 7, Code of Federal Regulations (or any successor regulations); or
“(ii) is, bears, or contains a controlled substance in schedule I or II of section 202 of the Controlled Substances Act, as listed in part 1308 of title 21, Code of Federal Regulations (or any successor regulations);
the Secretary shall not license the biological product under this subsection unless the Secretary determines, after consultation with appropriate national security and drug enforcement agencies, that there would be no increased risk to the security or health of the public from licensing such biological product under this subsection.
“(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL PRODUCT.—Upon review of an application submitted under this subsection relying on the same reference product for which a prior biological product has received a determination of interchangeability for any condition of use, the Secretary shall not make a determination under paragraph (4) that the second or subsequent biological product is interchangeable for any condition of use until the earlier of—
“(A) 1 year after the first commercial marketing of the first interchangeable biosimilar biological product to be approved as interchangeable for that reference product;
“(i) a final court decision on all patents in suit in an action instituted under subsection (l)(5) against the applicant that submitted the application for the first approved interchangeable biosimilar biological product; or
“(ii) the dismissal with or without prejudice of an action instituted under subsection (l)(5) against the applicant that submitted the application for the first approved interchangeable biosimilar biological product; or
“(C)(i) 42 months after approval of the first interchangeable biosimilar biological product if the applicant that submitted such application has been sued under subsection (l)(5) and such litigation is still ongoing within such 42-month period; or
“(ii) 18 months after approval of the first interchangeable biosimilar biological product if the applicant that submitted such application has not been sued under subsection (l)(5).
For purposes of this paragraph, the term ‘final court decision’ means a final decision of a court from which no appeal (other than a petition to the United States Supreme Court for a writ of certiorari) has been or can be taken.
“(7) EXCLUSIVITY FOR REFERENCE PRODUCT.—
“(A) EFFECTIVE DATE OF BIOSIMILAR APPLICATION APPROVAL.—Approval of an application under this subsection may not be made effective by the Secretary until the date that is 12 years after the date on which the reference product was first licensed under subsection (a).
“(B) FILING PERIOD.—An application under this subsection may not be submitted to the Secretary until the date that is 4 years after the date on which the reference product was first licensed under subsection (a).
“(C) FIRST LICENSURE.—Subparagraphs (A) and (B) shall not apply to a license for or approval of—
“(i) a supplement for the biological product that is the reference product; or
“(ii) a subsequent application filed by the same sponsor or manufacturer of the biological product that is the reference product (or a licensor, predecessor in interest, or other related entity) for—
“(I) a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength; or
“(II) a modification to the structure of the biological product that does not result in a change in safety, purity, or potency.
“(A) EXCLUSIVITY.—If, before or after licensure of the reference product under subsection (a) of this section, the Secretary determines that information relating to the use of such product in the pediatric population may produce health benefits in that population, the Secretary makes a written request for pediatric studies (which shall include a timeframe for completing such studies), the applicant or holder of the approved application agrees to the request, such studies are completed using appropriate formulations for each age group for which the study is requested within any such timeframe, and the reports thereof are submitted and accepted in accordance with section 505A(d)(3) of the Federal Food, Drug, and Cosmetic Act the period referred to in paragraph (7)(A) of this subsection is deemed to be 12 years and 6 months rather than 12 years.
“(B) EXCEPTION.—The Secretary shall not extend the period referred to in subparagraph (A) of this paragraph if the determination under section 505A(d)(3) of the Federal Food, Drug, and Cosmetic Act is made later than 9 months prior to the expiration of such period.
“(C) APPLICATION OF CERTAIN PROVISIONS.—The provisions of subsections (a), (d), (e), (f), (h), (j), (k), and (l) of section 505A of the Federal Food, Drug, and Cosmetic Act shall apply with respect to the extension of a period under subparagraph (A) of this paragraph to the same extent and in the same manner as such provisions apply with respect to the extension of a period under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act.
“(A) IN GENERAL.—The Secretary may, after opportunity for public comment, issue guidance in accordance, except as provided in subparagraph (B)(i), with section 701(h) of the Federal Food, Drug, and Cosmetic Act with respect to the licensure of a biological product under this subsection. Any such guidance may be general or specific.
“(i) IN GENERAL.—The Secretary shall provide the public an opportunity to comment on any proposed guidance issued under subparagraph (A) before issuing final guidance.
“(ii) INPUT REGARDING MOST VALUABLE GUIDANCE.—The Secretary shall establish a process through which the public may provide the Secretary with input regarding priorities for issuing guidance.
“(C) NO REQUIREMENT FOR APPLICATION CONSIDERATION.—The issuance (or non-issuance) of guidance under subparagraph (A) shall not preclude the review of, or action on, an application submitted under this subsection.
“(D) REQUIREMENT FOR PRODUCT CLASS-SPECIFIC GUIDANCE.—If the Secretary issues product class-specific guidance under subparagraph (A), such guidance shall include a description of—
“(i) the criteria that the Secretary will use to determine whether a biological product is highly similar to a reference product in such product class; and
“(ii) the criteria, if available, that the Secretary will use to determine whether a biological product meets the standards described in paragraph (4).
“(E) CERTAIN PRODUCT CLASSES.—
“(i) GUIDANCE.—The Secretary may indicate in a guidance document that the science and experience, as of the date of such guidance, with respect to a product or product class (not including any recombinant protein) does not allow approval of an application for a license as provided under this subsection for such product or product class.
“(ii) MODIFICATION OR REVERSAL.—The Secretary may issue a subsequent guidance document under subparagraph (A) to modify or reverse a guidance document under clause (i).
“(iii) NO EFFECT ON ABILITY TO DENY LICENSE.—Clause (i) shall not be construed to require the Secretary to approve a product with respect to which the Secretary has not indicated in a guidance document that the science and experience, as described in clause (i), does not allow approval of such an application.
“(10) NAMING.—The Secretary shall ensure that the labeling and packaging of each biological product licensed under this subsection bears a name that uniquely identifies the biological product and distinguishes it from the reference product and any other biological products licensed under this subsection following evaluation against such reference product.
“(l) Patent notices; relationship to final approval.—
“(1) DEFINITIONS.—For the purposes of this subsection, the term—
“(A) ‘biosimilar product’ means the biological product that is the subject of the application under subsection (k);
“(B) ‘relevant patent’ means a patent that—
“(i) expires after the date specified in subsection (k)(7)(A) that applies to the reference product; and
“(ii) could reasonably be asserted against the applicant due to the unauthorized making, use, sale, or offer for sale within the United States, or the importation into the United States of the biosimilar product, or materials used in the manufacture of the biosimilar product, or due to a use of the biosimilar product in a method of treatment that is indicated in the application;
“(C) ‘reference product sponsor’ means the holder of an approved application or license for the reference product; and
“(D) ‘interested third party’ means a person other than the reference product sponsor that owns a relevant patent, or has the right to commence or participate in an action for infringement of a relevant patent.
“(2) HANDLING OF CONFIDENTIAL INFORMATION.—Any entity receiving confidential information pursuant to this subsection shall designate one or more individuals to receive such information. Each individual so designated shall execute an agreement in accordance with regulations promulgated by the Secretary. The regulations shall require each such individual to take reasonable steps to maintain the confidentiality of information received pursuant to this subsection and use the information solely for purposes authorized by this subsection. The obligations imposed on an individual who has received confidential information pursuant to this subsection shall continue until the individual returns or destroys the confidential information, a court imposes a protective order that governs the use or handling of the confidential information, or the party providing the confidential information agrees to other terms or conditions regarding the handling or use of the confidential information.
“(3) PUBLIC NOTICE BY SECRETARY.—Within 30 days of acceptance by the Secretary of an application filed under subsection (k), the Secretary shall publish a notice identifying—
“(A) the reference product identified in the application; and
“(B) the name and address of an agent designated by the applicant to receive notices pursuant to paragraph (4)(B).
“(4) EXCHANGES CONCERNING PATENTS.—
“(A) EXCHANGES WITH REFERENCE PRODUCT SPONSOR.—
“(i) Within 30 days of the date of acceptance of the application by the Secretary, the applicant shall provide the reference product sponsor with a copy of the application and information concerning the biosimilar product and its production. This information shall include a detailed description of the biosimilar product, its method of manufacture, and the materials used in the manufacture of the product.
“(ii) Within 60 days of the date of receipt of the information required to be provided under clause (i), the reference product sponsor shall provide to the applicant a list of relevant patents owned by the reference product sponsor, or in respect of which the reference product sponsor has the right to commence an action of infringement or otherwise has an interest in the patent as such patent concerns the biosimilar product.
“(iii) If the reference product sponsor is issued or acquires an interest in a relevant patent after the date on which the reference product sponsor provides the list required by clause (ii) to the applicant, the reference product sponsor shall identify that patent to the applicant within 30 days of the date of issue of the patent, or the date of acquisition of the interest in the patent, as applicable.
“(B) EXCHANGES WITH INTERESTED THIRD PARTIES.—
“(i) At any time after the date on which the Secretary publishes a notice for an application under paragraph (3), any interested third party may provide notice to the designated agent of the applicant that the interested third party owns or has rights under 1 or more patents that may be relevant patents. The notice shall identify at least 1 patent and shall designate an individual who has executed an agreement in accordance with paragraph (2) to receive confidential information from the applicant.
“(ii) Within 30 days of the date of receiving notice pursuant to clause (i), the applicant shall send to the individual designated by the interested third party the information specified in subparagraph (A)(i), unless the applicant and interested third party otherwise agree.
“(iii) Within 90 days of the date of receiving information pursuant to clause (ii), the interested third party shall provide to the applicant a list of relevant patents which the interested third party owns, or in respect of which the interested third party has the right to commence or participate in an action for infringement.
“(iv) If the interested third party is issued or acquires an interest in a relevant patent after the date on which the interested third party provides the list required by clause (iii), the interested third party shall identify that patent within 30 days of the date of issue of the patent, or the date of acquisition of the interest in the patent, as applicable.
“(C) IDENTIFICATION OF BASIS FOR INFRINGEMENT.—For any patent identified under clause (ii) or (iii) of subparagraph (A) or under clause (iii) or (iv) of subparagraph (B), the reference product sponsor or the interested third party, as applicable—
“(i) shall explain in writing why the sponsor or the interested third party believes the relevant patent would be infringed by the making, use, sale, or offer for sale within the United States, or importation into the United States, of the biosimilar product or by a use of the biosimilar product in treatment that is indicated in the application;
“(ii) may specify whether the relevant patent is available for licensing; and
“(iii) shall specify the number and date of expiration of the relevant patent.
“(D) CERTIFICATION BY APPLICANT CONCERNING IDENTIFIED RELEVANT PATENTS.—Not later than 45 days after the date on which a patent is identified under clause (ii) or (iii) of subparagraph (A) or under clause (iii) or (iv) of subparagraph (B), the applicant shall send a written statement regarding each identified patent to the party that identified the patent. Such statement shall either—
“(i) state that the applicant will not commence marketing of the biosimilar product and has requested the Secretary to not grant final approval of the application before the date of expiration of the noticed patent; or
“(ii) provide a detailed written explanation setting forth the reasons why the applicant believes—
“(I) the making, use, sale, or offer for sale within the United States, or the importation into the United States, of the biosimilar product, or the use of the biosimilar product in a treatment indicated in the application, would not infringe the patent; or
“(II) the patent is invalid or unenforceable.
“(5) ACTION FOR INFRINGEMENT INVOLVING REFERENCE PRODUCT SPONSOR.—If an action for infringement concerning a relevant patent identified by the reference product sponsor under clause (ii) or (iii) of paragraph (4)(A), or by an interested third party under clause (iii) or (iv) of paragraph (4)(B), is brought within 60 days of the date of receipt of a statement under paragraph (4)(D)(ii), and the court in which such action has been commenced determines the patent is infringed prior to the date applicable under subsection (k)(7)(A) or (k)(8), the Secretary shall make approval of the application effective on the day after the date of expiration of the patent that has been found to be infringed. If more than one such patent is found to be infringed by the court, the approval of the application shall be made effective on the day after the date that the last such patent expires.
“(6) NOTIFICATION OF AGREEMENTS.—
“(i) AGREEMENT BETWEEN BIOSIMILAR PRODUCT APPLICANT AND REFERENCE PRODUCT SPONSOR.—If a biosimilar product applicant under subsection (k) and the reference product sponsor enter into an agreement described in subparagraph (B), the applicant and sponsor shall each file the agreement in accordance with subparagraph (C).
“(ii) AGREEMENT BETWEEN BIOSIMILAR PRODUCT APPLICANTS.—If 2 or more biosimilar product applicants submit an application under subsection (k) for biosimilar products with the same reference product and enter into an agreement described in subparagraph (B), the applicants shall each file the agreement in accordance with subparagraph (C).
“(B) SUBJECT MATTER OF AGREEMENT.—An agreement described in this subparagraph—
“(i) is an agreement between the biosimilar product applicant under subsection (k) and the reference product sponsor or between 2 or more biosimilar product applicants under subsection (k) regarding the manufacture, marketing, or sale of—
“(I) the biosimilar product (or biosimilar products) for which an application was submitted; or
“(II) the reference product;
“(ii) includes any agreement between the biosimilar product applicant under subsection (k) and the reference product sponsor or between 2 or more biosimilar product applicants under subsection (k) that is contingent upon, provides a contingent condition for, or otherwise relates to an agreement described in clause (i); and
“(iii) excludes any agreement that solely concerns—
“(I) purchase orders for raw material supplies;
“(II) equipment and facility contracts;
“(III) employment or consulting contracts; or
“(IV) packaging and labeling contracts.
“(i) IN GENERAL.—The text of an agreement required to be filed by subparagraph (A) shall be filed with the Assistant Attorney General and the Federal Trade Commission not later than—
“(I) 10 business days after the date on which the agreement is executed; and
“(II) prior to the date of the first commercial marketing of, for agreements described in subparagraph (A)(i), the biosimilar product that is the subject of the application or, for agreements described in subparagraph (A)(ii), any biosimilar product that is the subject of an application described in such subparagraph.
“(ii) IF AGREEMENT NOT REDUCED TO TEXT.—If an agreement required to be filed by subparagraph (A) has not been reduced to text, the persons required to file the agreement shall each file written descriptions of the agreement that are sufficient to disclose all the terms and conditions of the agreement.
“(iii) CERTIFICATION.—The chief executive officer or the company official responsible for negotiating any agreement required to be filed by subparagraph (A) shall include in any filing under this paragraph a certification as follows: ‘I declare under penalty of perjury that the following is true and correct: The materials filed with the Federal Trade Commission and the Department of Justice under section 351(l)(6) of the Public Health Service Act, with respect to the agreement referenced in this certification: (1) represent the complete, final, and exclusive agreement between the parties; (2) include any ancillary agreements that are contingent upon, provide a contingent condition for, or are otherwise related to, the referenced agreement; and (3) include written descriptions of any oral agreements, representations, commitments, or promises between the parties that are responsive to such section and have not been reduced to writing.’.
“(D) DISCLOSURE EXEMPTION.—Any information or documentary material filed with the Assistant Attorney General or the Federal Trade Commission pursuant to this paragraph shall be exempt from disclosure under section 552 of title 5, United States Code, and no such information or documentary material may be made public, except as may be relevant to any administrative or judicial action or proceeding. Nothing in this subparagraph prevents disclosure of information or documentary material to either body of the Congress or to any duly authorized committee or subcommittee of the Congress.
“(i) CIVIL PENALTY.—Any person that violates a provision of this paragraph shall be liable for a civil penalty of not more than $11,000 for each day on which the violation occurs. Such penalty may be recovered in a civil action—
“(I) brought by the United States; or
“(II) brought by the Federal Trade Commission in accordance with the procedures established in section 16(a)(1) of the Federal Trade Commission Act.
“(ii) COMPLIANCE AND EQUITABLE RELIEF.—If any person violates any provision of this paragraph, the United States district court may order compliance, and may grant such other equitable relief as the court in its discretion determines necessary or appropriate, upon application of the Assistant Attorney General or the Federal Trade Commission.
“(F) RULEMAKING.—The Federal Trade Commission, with the concurrence of the Assistant Attorney General and by rule in accordance with section 553 of title 5, United States Code, consistent with the purposes of this paragraph—
“(i) may define the terms used in this paragraph;
“(ii) may exempt classes of persons or agreements from the requirements of this paragraph; and
“(iii) may prescribe such other rules as may be necessary and appropriate to carry out the purposes of this paragraph.
“(G) SAVINGS CLAUSE.—Any action taken by the Assistant Attorney General or the Federal Trade Commission, or any failure of the Assistant Attorney General or the Commission to take action, under this paragraph shall not at any time bar any proceeding or any action with respect to any agreement between a biosimilar product applicant under subsection (k) and the reference product sponsor, or any agreement between biosimilar product applicants under subsection (k), under any other provision of law, nor shall any filing under this paragraph constitute or create a presumption of any violation of any competition laws.”.
(b) Definitions.—Section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)) is amended—
(1) by striking “In this section, the term ‘biological product’ means” and inserting the following: “In this section:
“(1) The term ‘biological product’ means”;
(2) in paragraph (1), as so designated, by inserting “protein (except any chemically synthesized polypeptide),” after “allergenic product,”; and
(3) by adding at the end the following:
“(2) The term ‘biosimilar’ or ‘biosimilarity’, in reference to a biological product that is the subject of an application under subsection (k), means—
“(A) that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and
“(B) there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.
“(3) The term ‘interchangeable’ or ‘interchangeability’, in reference to a biological product that is shown to meet the standards described in subsection (k)(4), means that the biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.
“(4) The term ‘reference product’ means the single biological product licensed under subsection (a) against which a biological product is evaluated in an application submitted under subsection (k).”.
(c) Products Previously Approved Under Section 505.—
(1) REQUIREMENT TO FOLLOW SECTION 351.—Except as provided in paragraph (2), an application for a biological product shall be submitted under section 351 of the Public Health Service Act (42 U.S.C. 262) (as amended by this Act).
(2) EXCEPTION.—An application for a biological product may be submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) if—
(A) such biological product is in a product class for which a biological product in such product class is the subject of an application approved under such section 505 not later than the date of enactment of this Act; and
(i) has been submitted to the Secretary of Health and Human Services (referred to in this Act as the “Secretary”) before the date of enactment of this Act; or
(ii) is submitted to the Secretary not later than the date that is 10 years after the date of enactment of this Act.
(3) LIMITATION.—Notwithstanding paragraph (2), an application for a biological product may not be submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) if there is another biological product approved under subsection (a) of section 351 of the Public Health Service Act that could be a reference product with respect to such application (within the meaning of such section 351) if such application were submitted under subsection (k) of such section 351.
(4) DEEMED APPROVED UNDER SECTION 351.—An approved application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) shall be deemed to be a license for the biological product under such section 351 on the date that is 10 years after the date of enactment of this Act.
(5) DEFINITIONS.—For purposes of this subsection, the term “biological product” has the meaning given such term under section 351 of the Public Health Service Act (42 U.S.C. 262) (as amended by this Act).
Subparagraph (B) of section 735(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended by inserting “, including licensure of a biological product under section 351(k) of such Act” before the period at the end.
(a) Section 271(e)(2) of title 35, United States Code is amended—
(1) in subparagraph (A), by striking “or” after “patent,”;
(2) in subparagraph (B), by adding “or” after the comma at the end;
(3) by inserting the following after subparagraph (B):
“(C) a statement under section 351(l)(4)(D)(ii) of the Public Health Service Act,”; and
(4) in the matter following subparagraph (C) (as added by paragraph (3)), by inserting before the period the following: “, or if the statement described in subparagraph (C) is provided in connection with an application to obtain a license to engage in the commercial manufacture, use, or sale of a biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent”.
(b) Section 271(e)(4) of title 35, United States Code, is amended by striking “in paragraph (2)” in both places it appears and inserting “in paragraph (2)(A) or (2)(B)”.
(a) Establishment of CLASS program.—The Public Health Service Act (42 U.S.C. 201 et seq.), as amended by section 2301, is amended by adding at the end the following:
“The purpose of this title is to establish a national voluntary insurance program for purchasing community living assistance services and supports in order to—
“(1) provide individuals with functional limitations with tools that will allow them to maintain their personal and financial independence and live in the community through a new financing strategy for community living assistance services and supports;
“(2) establish an infrastructure that will help address the Nation's community living assistance services and supports needs;
“(3) alleviate burdens on family caregivers; and
“(4) address institutional bias by providing a financing mechanism that supports personal choice and independence to live in the community.
“In this title:
“(1) ACTIVE ENROLLEE.—The term ‘active enrollee’ means an individual who is enrolled in the CLASS program in accordance with section 3204 and who has paid any premiums due to maintain such enrollment.
“(2) ACTIVELY EMPLOYED.—The term ‘actively employed’ means an individual who—
“(A) is reporting for work at the individual's usual place of employment or at another location to which the individual is required to travel because of the individual's employment (or in the case of an individual who is a member of the uniformed services, is on active duty and is physically able to perform the duties of the individual's position); and
“(B) is able to perform all the usual and customary duties of the individual's employment on the individual's regular work schedule.
“(3) ACTIVITIES OF DAILY LIVING.—The term ‘activities of daily living’ has the meaning given the term in section 7702B(c)(2)(B) of the Internal Revenue Code of 1986.
“(4) CLASS PROGRAM.—The term ‘CLASS program’ means the program established under this title.
“(5) ELIGIBILITY ASSESSMENT SYSTEM.—The term ‘Eligibility Assessment System’ means the entity designated by the Secretary under section 3205(a)(2)(A)(i).
“(A) IN GENERAL.—The term ‘eligible beneficiary’ means any individual who is an active enrollee in the CLASS program and, as of the date described in subparagraph (B)—
“(i) has paid premiums for enrollment in such program for at least 60 months;
“(ii) has earned, for each calendar year that occurs during the first 60 months for which the individual has paid premiums for enrollment in the program, at least an amount equal to the amount of wages and self-employment income which an individual must have in order to be credited with a quarter of coverage under section 213(d) of the Social Security Act for that year; and
“(iii) has paid premiums for enrollment in such program for at least 24 consecutive months, if a lapse in premium payments of more than 3 months has occurred during the period that begins on the date of the individual's enrollment and ends on the date of such determination.
“(B) DATE DESCRIBED.—For purposes of subparagraph (A), the date described in this subparagraph is the date on which the individual is determined to have a functional limitation described in section 3203(a)(1)(C) that is expected to last for a continuous period of more than 90 days.
“(C) REGULATIONS.—The Secretary shall promulgate regulations specifying exceptions to the minimum earnings requirements under subparagraph (A)(ii) for purposes of being considered an eligible beneficiary for certain populations.
“(7) HOSPITAL; NURSING FACILITY; INTERMEDIATE CARE FACILITY FOR THE MENTALLY RETARDED; INSTITUTION FOR MENTAL DISEASES.—The terms ‘hospital’, ‘nursing facility’, ‘intermediate care facility for the mentally retarded’, and ‘institution for mental diseases’ have the meanings given such terms for purposes of Medicaid.
“(8) CLASS INDEPENDENCE ADVISORY COUNCIL.—The term ‘CLASS Independence Advisory Council’ or ‘Council’ means the Advisory Council established under section 3207 to advise the Secretary.
“(9) CLASS INDEPENDENCE BENEFIT PLAN.—The term ‘CLASS Independence Benefit Plan’ means the benefit plan developed and designated by the Secretary in accordance with section 3203.
“(10) CLASS INDEPENDENCE FUND.—The term ‘CLASS Independence Fund’ or ‘Fund’ means the fund established under section 3206.
“(11) MEDICAID.—The term ‘Medicaid’ means the program established under title XIX of the Social Security Act.
“(12) PROTECTION AND ADVOCACY SYSTEM.—The term ‘Protection and Advocacy System’ means the system for each State established under section 143 of the Developmental Disabilities Assistance and Bill of Rights Act of 2000.
“(a) Process for development.—
“(1) IN GENERAL.—The Secretary, in consultation with appropriate actuaries and other experts, shall develop at least 3 actuarially sound benefit plans as alternatives for consideration for designation by the Secretary as the CLASS Independence Benefit Plan under which eligible beneficiaries shall receive benefits under this title. Each of the plan alternatives developed shall be designed to provide eligible beneficiaries with the benefits described in section 3205 consistent with the following requirements:
“(A) PREMIUMS.—Beginning with the first year of the CLASS program, and for each year thereafter, the Secretary shall establish all premiums to be paid by enrollees for the year based on an actuarial analysis of the 75-year costs of the program that ensures solvency throughout such 75-year period.
“(B) VESTING PERIOD.—A 5-year vesting period for eligibility for benefits.
“(C) BENEFIT TRIGGERS.—A benefit trigger for provision of benefits that requires a determination that an individual has a functional limitation, as certified by a licensed health care practitioner, described in any of the following clauses that is expected to last for a continuous period of more than 90 days:
“(i) The individual is determined to be unable to perform at least the minimum number (which may be 2 or 3) of activities of daily living as are required under the plan for the provision of benefits without substantial assistance (as defined by the Secretary) from another individual.
“(ii) The individual requires substantial supervision to protect the individual from threats to health and safety due to substantial cognitive impairment.
“(iii) The individual has a level of functional limitation similar (as determined under regulations prescribed by the Secretary) to the level of functional limitation described in clause (i) or (ii).
“(D) CASH BENEFIT.—Payment of a cash benefit that satisfies the following requirements:
“(i) MINIMUM REQUIRED AMOUNT.—The benefit amount provides an eligible beneficiary with not less than an average of $50 per day (as determined based on the reasonably expected distribution of beneficiaries receiving benefits at various benefit levels).
“(ii) AMOUNT SCALED TO FUNCTIONAL ABILITY.—The benefit amount is varied based on a scale of functional ability, with not less than 2, and not more than 6, benefit level amounts.
“(iii) DAILY OR WEEKLY.—The benefit is paid on a daily or weekly basis.
“(iv) NO LIFETIME OR AGGREGATE LIMIT.—The benefit is not subject to any lifetime or aggregate limit.
“(2) REVIEW AND RECOMMENDATION BY THE CLASS INDEPENDENCE ADVISORY COUNCIL.—The CLASS Independence Advisory Council shall—
“(A) evaluate the alternative benefit plans developed under paragraph (1); and
“(B) recommend for designation as the CLASS Independence Benefit Plan for offering to the public the plan that the Council determines best balances price and benefits to meet enrollees’ needs in an actuarially sound manner, while optimizing the probability of the long-term sustainability of the CLASS program.
“(3) DESIGNATION BY THE SECRETARY.—Not later than October 1, 2012, the Secretary, taking into consideration the recommendation of the CLASS Independence Advisory Council under paragraph (2)(B), shall designate a benefit plan as the CLASS Independence Benefit Plan. The Secretary shall publish such designation, along with details of the plan and the reasons for the selection by the Secretary, in a final rule that allows for a period of public comment.
“(b) Additional premium requirements.—
“(A) IN GENERAL.—Except as provided in subparagraphs (B), (C), (D), and (E), the amount of the monthly premium determined for an individual upon such individual's enrollment in the CLASS program shall remain the same for as long as the individual is an active enrollee in the program.
“(B) RECALCULATED PREMIUM IF REQUIRED FOR PROGRAM SOLVENCY.—
“(i) IN GENERAL.—Subject to clause (ii), if the Secretary determines, based on the most recent report of the Board of Trustees of the CLASS Independence Fund, the advice of the CLASS Independence Advisory Council, and the annual report of the Inspector General of the Department of Health and Human Services, and waste, fraud, and abuse, or such other information as the Secretary determines appropriate, that the monthly premiums and income to the CLASS Independence Fund for a year are projected to be insufficient with respect to the 20-year period that begins with that year, the Secretary shall adjust the monthly premiums for individuals enrolled in the CLASS program as necessary.
“(ii) EXEMPTION FROM INCREASE.—Any increase in a monthly premium imposed as result of a determination described in clause (i) shall not apply with respect to the monthly premium of any active enrollee who—
“(I) has attained age 65;
“(II) has paid premiums for enrollment in the program for at least 20 years; and
“(III) is not actively employed.
“(C) RECALCULATED PREMIUM IF REENROLLMENT AFTER MORE THAN A 3-MONTH LAPSE.—
“(i) IN GENERAL.—The reenrollment of an individual after a 90-day period during which the individual failed to pay the monthly premium required to maintain the individual's enrollment in the CLASS program shall be treated as an initial enrollment for purposes of age-adjusting the premium for enrollment in the program.
“(ii) CREDIT FOR PRIOR MONTHS IF REENROLLED WITHIN 5 YEARS.—An individual who reenrolls in the CLASS program after such a 90-day period and before the end of the 5-year period that begins with the first month for which the individual failed to pay the monthly premium required to maintain the individual's enrollment in the program shall be—
“(I) credited with any months of paid premiums that accrued prior to the individual's lapse in enrollment; and
“(II) notwithstanding the total amount of any such credited months, required to satisfy section 3202(6)(A)(ii) before being eligible to receive benefits.
“(D) PENALTY FOR REENROLLMENT AFTER 5-YEAR LAPSE.—In the case of an individual who reenrolls in the CLASS program after the end of the 5-year period described in subparagraph (C)(ii), the monthly premium required for the individual shall be the age-adjusted premium that would be applicable to an initially enrolling individual who is the same age as the reenrolling individual, increased by the greater of—
“(i) an amount that the Secretary determines is actuarially sound for each month that occurs during the period that begins with the first month for which the individual failed to pay the monthly premium required to maintain the individual's enrollment in the CLASS program and ends with the month preceding the month in which the reenrollment is effective; or
“(ii) 1 percent of the applicable age-adjusted premium for each such month occurring in such period.
“(2) ADMINISTRATIVE EXPENSES.—In determining the monthly premiums for the CLASS program, the Secretary may factor in costs for administering the program, not to exceed—
“(A) in the case of the first 5 years in which the program is in effect under this title, an amount equal to 3 percent of all premiums paid during each such year; and
“(B) in the case of subsequent years, an amount equal to 5 percent of the total amount of all expenditures (including benefits paid) under this title with respect to that year.
“(3) NO UNDERWRITING REQUIREMENTS.—No underwriting (other than on the basis of age in accordance with paragraph (2)) shall be used to—
“(A) determine the monthly premium for enrollment in the CLASS program; or
“(B) prevent an individual from enrolling in the program.
“(1) IN GENERAL.—Subject to paragraph (2), the Secretary shall establish procedures under which each individual described in subsection (c) shall be automatically enrolled in the CLASS program by an employer of such individual under rules similar to the rules of sections 401(k)(13) and 414(w) of the Internal Revenue Code of 1986.
“(2) ALTERNATIVE ENROLLMENT PROCEDURES.—The procedures established under paragraph (1) shall provide for an alternative enrollment process for an individual described in subsection (c) in the case of such an individual—
“(A) who is self-employed;
“(B) who has more than 1 employer;
“(C) whose employer does not elect to participate in the automatic enrollment process established by the Secretary; or
“(D) who is a spouse described in subsection (c)(2) of who is not subject to automatic enrollment.
“(A) IN GENERAL.—The Secretary shall, by regulation, establish procedures to—
“(i) ensure that an individual is not automatically enrolled in the CLASS program by more than 1 employer; and
“(ii) allow for an individual's employer to deduct a premium for a spouse described in subsection (c)(1)(B) who is not subject to automatic enrollment.
“(B) FORM.—Enrollment in the CLASS program shall be made in such manner as the Secretary may prescribe in order to ensure ease of administration.
“(b) Election To Opt-Out.—An individual described in subsection (c) may elect to waive enrollment in the CLASS program at any time in such form and manner as the Secretary shall prescribe.
“(c) Individual described.—For purposes of enrolling in the CLASS program, an individual described in this paragraph is—
“(A) who has attained age 18;
“(B) who receives wages on which there is imposed a tax under section 3101(a) or 3201(a) of the Internal Revenue Code of 1986;
“(C) who is actively employed; and
“(i) a patient in a hospital or nursing facility, an intermediate care facility for the mentally retarded, or an institution for mental diseases and receiving medical assistance under Medicaid; or
“(ii) confined in a jail, prison, other penal institution or correctional facility, or by court order pursuant to conviction of a criminal offense or in connection with a verdict or finding described in section 202(x)(1)(A)(ii) of the Social Security Act; or
“(2) the spouse of an individual described in paragraph (1) and who would be an individual so described but for subparagraph (B) or (C) of that paragraph.
“(d) Rule of construction.—Nothing in this title shall be construed as requiring an active enrollee to continue to satisfy subparagraph (B) or (C) of subsection (c)(1) in order to maintain enrollment in the CLASS program.
“(1) PAYROLL DEDUCTION.—An amount equal to the monthly premium for the enrollment in the CLASS program of an individual shall be deducted from the wages of such individual in accordance with such procedures as the Secretary shall establish for employers who elect to deduct and withhold such premiums on behalf of enrolled employees.
“(2) ALTERNATIVE PAYMENT MECHANISM.—The Secretary shall establish alternative procedures for the payment of monthly premiums by an individual enrolled in the CLASS program who does not have an employer who elects to deduct and withhold premiums in accordance with subparagraph (A).
“(f) Transfer of premiums collected.—
“(1) IN GENERAL.—During each calendar year the Secretary of the Treasury shall deposit into the CLASS Independence Fund a total amount equal, in the aggregate, to 100 percent of the premiums collected during that year.
“(2) TRANSFERS BASED ON ESTIMATES.—The amount deposited pursuant to paragraph (1) shall be transferred in at least monthly payments to the CLASS Independence Fund on the basis of estimates by the Secretary and certified to the Secretary of the Treasury of the amounts collected in accordance with this section. Proper adjustments shall be made in amounts subsequently transferred to the Fund to the extent prior estimates were in excess of, or were less than, actual amounts collected.
“(g) Other enrollment and disenrollment opportunities.—The Secretary shall establish procedures under which—
“(1) an individual who, in the year of the individual's initial eligibility to enroll in the CLASS program, has elected to waive enrollment in the program, is eligible to elect to enroll in the program, in such form and manner as the Secretary shall establish, only during an open enrollment period established by the Secretary that is specific to the individual and that may not occur more frequently than biennially after the date on which the individual first elected to waive enrollment in the program; and
“(2) an individual shall only be permitted to disenroll from the program during an annual disenrollment period established by the Secretary and in such form and manner as the Secretary shall establish.
“(a) Determination of eligibility.—
“(1) APPLICATION FOR RECEIPT OF BENEFITS.—The Secretary shall establish procedures under which an active enrollee shall apply for receipt of benefits under the CLASS Independence Benefit Plan.
“(2) ELIGIBILITY ASSESSMENTS.—
“(A) IN GENERAL.—Not later than January 1, 2012, the Secretary shall—
“(i) designate an entity (other than a service with which the Commissioner of Social Security has entered into an agreement, with respect to any State, to make disability determinations for purposes of title II or XVI of the Social Security Act) to serve as an Eligibility Assessment System by providing for eligibility assessments of active enrollees who apply for receipt of benefits;
“(ii) enter into an agreement with the Protection and Advocacy System for each State to provide advocacy services in accordance with subsection (d); and
“(iii) enter into an agreement with public and private entities to provide advice and assistance counseling in accordance with subsection (e).
“(B) REGULATIONS.—The Secretary shall promulgate regulations to develop an expedited nationally equitable eligibility determination process, as certified by a licensed health care practitioner, an appeals process, and a redetermination process, as certified by a licensed health care practitioner, including whether an applicant is eligible for a cash benefit under the program and if so, the amount of the cash benefit (in accordance the sliding scale established under the plan).
“(C) PRESUMPTIVE ELIGIBILITY FOR CERTAIN INSTITUTIONALIZED ENROLLEES PLANNING TO DISCHARGE.—An active enrollee shall be deemed presumptively eligible if the enrollee—
“(i) has applied for, and attests is eligible for, the maximum cash benefit available under the sliding scale established under the CLASS Independence Benefit Plan;
“(ii) is a patient in a hospital (but only if the hospitalization is for long-term care), nursing facility, intermediate care facility for the mentally retarded, or an institution for mental diseases; and
“(iii) is in the process of, or about to being the process of, planning to discharge from the hospital, facility, or institution, or within 60 days from the date of discharge from the hospital, facility, or institution.
“(D) APPEALS.—The Secretary shall establish procedures under which an applicant for benefits under the CLASS Independence Benefit Plan shall be guaranteed the right to appeal an adverse determination.
“(b) Benefits.—An eligible beneficiary shall receive the following benefits under the CLASS Independence Benefit Plan:
“(1) CASH BENEFIT.—A cash benefit established by the Secretary in accordance with the requirements of section 3203(a)(1)(D) that—
“(A) the first year in which beneficiaries receive the benefits under the plan, is not less than the average dollar amount specified in clause (i) of such section; and
“(B) for any subsequent year, is not less than the average per day dollar limit applicable under this subparagraph for the preceding year, increased by the percentage increase in the consumer price index for all urban consumers (U.S. city average) over the previous year.
“(2) ADVOCACY SERVICES.—Advocacy services in accordance with subsection (d).
“(3) ADVICE AND ASSISTANCE COUNSELING.—Advice and assistance counseling in accordance with subsection (e).
“(4) ADMINISTRATIVE EXPENSES.—Advocacy services and advise and assistance counseling services under paragraphs (2) and (3) of this subsection shall be included as administrative expenses under section 3203(b)(2).
“(1) LIFE INDEPENDENCE ACCOUNT.—
“(A) IN GENERAL.—The Secretary shall establish procedures for administering the provision of benefits to eligible beneficiaries under the CLASS Independence Benefit Plan, including the payment of the cash benefit for the beneficiary into a Life Independence Account established by the Secretary on behalf of each eligible beneficiary.
“(B) USE OF CASH BENEFITS.—Cash benefits paid into a Life Independence Account of an eligible beneficiary shall be used to purchase nonmedical services and supports that the beneficiary needs to maintain his or her independence at home or in another residential setting of their choice in the community, including (but not limited to) home modifications, assistive technology, accessible transportation, homemaker services, respite care, personal assistance services, home care aides, and nursing support. Nothing in the preceding sentence shall prevent an eligible beneficiary from using cash benefits paid into a Life Independence Account for obtaining assistance with decisionmaking concerning medical care, including the right to accept or refuse medical or surgical treatment and the right to formulate advance directives or other written instructions recognized under State law, such as a living will or durable power of attorney for health care, in the case that an injury or illness causes the individual to be unable to make health care decisions.
“(C) ELECTRONIC MANAGEMENT OF FUNDS.—The Secretary shall establish procedures for—
“(i) crediting an account established on behalf of a beneficiary with the beneficiary's cash daily benefit;
“(ii) allowing the beneficiary to access such account through debit cards; and
“(iii) accounting for withdrawals by the beneficiary from such account.
“(D) PRIMARY PAYOR RULES FOR BENEFICIARIES WHO ARE ENROLLED IN MEDICAID.—In the case of an eligible beneficiary who is enrolled in Medicaid, the following payment rules shall apply:
“(i) INSTITUTIONALIZED BENEFICIARY.—If the beneficiary is a patient in a hospital, nursing facility, intermediate care facility for the mentally retarded, or an institution for mental diseases, the beneficiary shall retain an amount equal to 5 percent of the beneficiary's daily or weekly cash benefit (as applicable) (which shall be in addition to the amount of the beneficiary's personal needs allowance provided under Medicaid), and the remainder of such benefit shall be applied toward the facility's cost of providing the beneficiary's care, and Medicaid shall provide secondary coverage for such care.
“(ii) BENEFICIARIES RECEIVING HOME AND COMMUNITY-BASED SERVICES.—
“(I) 50 PERCENT OF BENEFIT RETAINED BY BENEFICIARY.—Subject to subclause (II), if a beneficiary is receiving medical assistance under Medicaid for home and community-based services, the beneficiary shall retain an amount equal to 50 percent of the beneficiary's daily or weekly cash benefit (as applicable), and the remainder of the daily or weekly cash benefit shall be applied toward the cost to the State of providing such assistance (and shall not be used to claim Federal matching funds under Medicaid), and Medicaid shall provide secondary coverage for the remainder of any costs incurred in providing such assistance.
“(II) REQUIREMENT FOR STATE OFFSET.—A State shall be paid the remainder of a beneficiary's daily or weekly cash benefit under subclause (I) only if the State home and community-based waiver under section 1115 of the Social Security Act or subsection (c) or (d) of section 1915 of such Act, or the State plan amendment under subsection (i) of such section does not include a waiver of the requirements of section 1902(a)(1) of the Social Security Act (relating to statewideness) or of section 1902(a)(10)(B) of such Act (relating to comparability) and the State offers at a minimum case management services, personal care services, habilitation services, and respite care under such a waiver or State plan amendment.
“(III) DEFINITION OF HOME AND COMMUNITY-BASED SERVICES.—In this clause, the term ‘home and community-based services’ means any services which may be offered under a home and community-based waiver authorized for a State under section 1115 of the Social Security Act or subsection (c) or (d) of section 1915 of such Act or under a State plan amendment under subsection (i) of such section.
“(iii) BENEFICIARIES ENROLLED IN PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE).—
“(I) IN GENERAL.—Subject to subclause (II), if a beneficiary is receiving medical assistance under Medicaid for PACE program services under section 1934 of the Social Security Act, the beneficiary shall retain an amount equal to 50 percent of the beneficiary's daily or weekly cash benefit (as applicable), and the remainder of the daily or weekly cash benefit shall be applied toward the cost to the State of providing such assistance (and shall not be used to claim Federal matching funds under Medicaid), and Medicaid shall provide secondary coverage for the remainder of any costs incurred in providing such assistance.
“(II) INSTITUTIONALIZED RECIPIENTS OF PACE PROGRAM SERVICES.—If a beneficiary receiving assistance under Medicaid for PACE program services is a patient in a hospital, nursing facility, intermediate care facility for the mentally retarded, or an institution for mental diseases, the beneficiary shall be treated as in institutionalized beneficiary under clause (i).
“(2) AUTHORIZED REPRESENTATIVES.—
“(A) IN GENERAL.—The Secretary shall establish procedures to allow access to a beneficiary's cash benefits by an authorized representative of the eligible beneficiary on whose behalf such benefits are paid.
“(B) QUALITY ASSURANCE AND PROTECTION AGAINST FRAUD AND ABUSE.—The procedures established under subparagraph (A) shall ensure that authorized representatives of eligible beneficiaries comply with standards of conduct established by the Secretary, including standards requiring that such representatives provide quality services on behalf of such beneficiaries, do not have conflicts of interest, and do not misuse benefits paid on behalf of such beneficiaries or otherwise engage in fraud or abuse.
“(3) COMMENCEMENT OF BENEFITS.—Benefits shall be paid to, or on behalf of, an eligible beneficiary beginning with the first month in which an application for such benefits is approved.
“(4) ROLLOVER OPTION FOR LUMP-SUM PAYMENT.—An eligible beneficiary may elect to—
“(A) defer payment of their daily or weekly benefit and to rollover any such deferred benefits from month-to-month, but not from year-to-year; and
“(B) receive a lump-sum payment of such deferred benefits in an amount that may not exceed the lesser of—
“(i) the total amount of the accrued deferred benefits; or
“(ii) the applicable annual benefit.
“(5) PERIOD FOR DETERMINATION OF ANNUAL BENEFITS.—
“(A) IN GENERAL.—The applicable period for determining with respect to an eligible beneficiary the applicable annual benefit and the amount of any accrued deferred benefits is the 12-month period that commences with the first month in which the beneficiary began to receive such benefits, and each 12-month period thereafter.
“(B) INCLUSION OF INCREASED BENEFITS.—The Secretary shall establish procedures under which cash benefits paid to an eligible beneficiary that increase or decrease as a result of a change in the functional status of the beneficiary before the end of a 12-month benefit period shall be included in the determination of the applicable annual benefit paid to the eligible beneficiary.
“(C) RECOUPMENT OF UNPAID, ACCRUED BENEFITS.—
“(i) IN GENERAL.—The Secretary, in coordination with the Secretary of the Treasury, shall recoup any accrued benefits in the event of—
“(I) the death of a beneficiary; or
“(II) the failure of a beneficiary to elect under paragraph (4)(B) to receive such benefits as a lump-sum payment before the end of the 12-month period in which such benefits accrued.
“(ii) PAYMENT INTO CLASS INDEPENDENCE FUND.—Any benefits recouped in accordance with clause (i) shall be paid into the CLASS Independence Fund and used in accordance with section 3206.
“(6) REQUIREMENT TO RECERTIFY ELIGIBILITY FOR RECEIPT OF BENEFITS.—An eligible beneficiary shall periodically, as determined by the Secretary—
“(A) recertify by submission of medical evidence the beneficiary's continued eligibility for receipt of benefits; and
“(B) submit records of expenditures attributable to the aggregate cash benefit received by the beneficiary during the preceding year.
“(7) SUPPLEMENT, NOT SUPPLANT OTHER HEALTH CARE BENEFITS.—Subject to the Medicaid payment rules under paragraph (1)(D), benefits received by an eligible beneficiary shall supplement, but not supplant, other health care benefits for which the beneficiary is eligible under Medicaid or any other Federally funded program that provides health care benefits or assistance.
“(d) Advocacy services.—An agreement entered into under subsection (a)(2)(A)(ii) shall require the Protection and Advocacy System for the State to—
“(1) assign, as needed, an advocacy counselor to each eligible beneficiary that is covered by such agreement and who shall provide an eligible beneficiary with—
“(A) information regarding how to access the appeals process established for the program;
“(B) assistance with respect to the annual recertification and notification required under subsection (c)(6); and
“(C) such other assistance with obtaining services as the Secretary, by regulation, shall require; and
“(2) ensure that the System and such counselors comply with the requirements of subsection (h).
“(e) Advice and assistance counseling.—An agreement entered into under subsection (a)(2)(A)(iii) shall require the entity to assign, as requested by an eligible beneficiary that is covered by such agreement, an advice and assistance counselor who shall provide an eligible beneficiary with information regarding—
“(1) accessing and coordinating long-term services and supports in the most integrated setting;
“(2) possible eligibility for other benefits and services;
“(3) development of a service and support plan;
“(4) information about programs established under the Assistive Technology Act of 1998 and the services offered under such programs;
“(5) available assistance with decisionmaking concerning medical care, including the right to accept or refuse medical or surgical treatment and the right to formulate advance directives or other written instructions recognized under State law, such as a living will or durable power of attorney for health care, in the case that an injury or illness causes the individual to be unable to make health care decisions; and
“(6) such other services as the Secretary, by regulation, may require.
“(f) No effect on eligibility for other benefits.—Benefits paid to an eligible beneficiary under the CLASS program shall be disregarded for purposes of determining or continuing the beneficiary's eligibility for receipt of benefits under any other Federal, State, or locally funded assistance program, including benefits paid under titles II, XVI, XVIII, XIX, or XXI of the Social Security Act, under the laws administered by the Secretary of Veterans Affairs, under low-income housing assistance programs, or under the supplemental nutrition assistance program established under the Food and Nutrition Act of 2008.
“(g) Rule of construction.—Nothing in this title shall be construed as prohibiting benefits paid under the CLASS Independence Benefit Plan from being used to compensate a family caregiver for providing community living assistance services and supports to an eligible beneficiary.
“(h) Protection against conflicts of interest.—The Secretary shall establish procedures to ensure that the Eligibility Assessment System, the Protection and Advocacy System for a State, advocacy counselors for eligible beneficiaries, and any other entities that provide services to active enrollees and eligible beneficiaries under the CLASS program comply with the following:
“(1) If the entity provides counseling or planning services, such services are provided in a manner that fosters the best interests of the active enrollee or beneficiary.
“(2) The entity has established operating procedures that are designed to avoid or minimize conflicts of interest between the entity and an active enrollee or beneficiary.
“(3) The entity provides information about all services and options available to the active enrollee or beneficiary, to the best of its knowledge, including services available through other entities or providers.
“(4) The entity assists the active enrollee or beneficiary to access desired services, regardless of the provider.
“(5) The entity reports the number of active enrollees and beneficiaries provided with assistance by age, disability, and whether such enrollees and beneficiaries received services from the entity or another entity.
“(6) If the entity provides counseling or planning services, the entity ensures that an active enrollee or beneficiary is informed of any financial interest that the entity has in a service provider.
“(7) The entity provides an active enrollee or beneficiary with a list of available service providers that can meet the needs of the active enrollee or beneficiary.
“(a) Establishment of CLASS Independence Fund.—There is established in the Treasury of the United States a trust fund to be known as the ‘CLASS Independence Fund’. The Secretary of the Treasury shall serve as Managing Trustee of such Fund. The Fund shall consist of all amounts derived from payments into the Fund under sections 3204(f) and 3205(c)(5)(C)(ii), and remaining after investment of such amounts under subsection (b), including additional amounts derived as income from such investments. The amounts held in the Fund are appropriated and shall remain available without fiscal year limitation—
“(1) to be held for investment on behalf of individuals enrolled in the CLASS program;
“(2) to pay the administrative expenses related to the Fund and to investment under subsection (b); and
“(3) to pay cash benefits to eligible beneficiaries under the CLASS Independence Benefit Plan.
“(b) Investment of fund balance.—The Secretary of the Treasury shall invest and manage the CLASS Independence Fund in the same manner, and to the same extent, as the Federal Supplementary Medical Insurance Trust Fund may be invested and managed under subsections (c), (d), and (e) of section 1841(d) of the Social Security Act.
“(1) IN GENERAL.—With respect to the CLASS Independence Fund, there is hereby created a body to be known as the Board of Trustees of the CLASS Independence Fund (hereinafter in this section referred to as the ‘Board of Trustees’) composed of the Secretary of the Treasury, the Secretary of Labor, and the Secretary of Health and Human Services, all ex officio, and of two members of the public (both of whom may not be from the same political party), who shall be nominated by the President for a term of 4 years and subject to confirmation by the Senate. A member of the Board of Trustees serving as a member of the public and nominated and confirmed to fill a vacancy occurring during a term shall be nominated and confirmed only for the remainder of such term. An individual nominated and confirmed as a member of the public may serve in such position after the expiration of such member's term until the earlier of the time at which the member's successor takes office or the time at which a report of the Board is first issued under paragraph (2) after the expiration of the member's term. The Secretary of the Treasury shall be the Managing Trustee of the Board of Trustees. The Board of Trustees shall meet not less frequently than once each calendar year. A person serving on the Board of Trustees shall not be considered to be a fiduciary and shall not be personally liable for actions taken in such capacity with respect to the Trust Fund.
“(A) IN GENERAL.—It shall be the duty of the Board of Trustees to do the following:
“(i) Hold the CLASS Independence Fund.
“(ii) Report to the Congress not later than the first day of April of each year on the operation and status of the CLASS Independence Fund during the preceding fiscal year and on its expected operation and status during the current fiscal year and the next 2 fiscal years.
“(iii) Report immediately to the Congress whenever the Board is of the opinion that the amount of the CLASS Independence Fund is not actuarially sound in regards to the projections under section 3203(b)(1)(B)(i).
“(iv) Review the general policies followed in managing the CLASS Independence Fund, and recommend changes in such policies, including necessary changes in the provisions of law which govern the way in which the CLASS Independence Fund is to be managed.
“(B) REPORT.—The report provided for in subparagraph (A)(ii) shall—
“(I) a statement of the assets of, and the disbursements made from, the CLASS Independence Fund during the preceding fiscal year;
“(II) an estimate of the expected income to, and disbursements to be made from, the CLASS Independence Fund during the current fiscal year and each of the next 2 fiscal years;
“(III) a statement of the actuarial status of the CLASS Independence Fund for the current fiscal year, each of the next 2 fiscal years, and as projected over the 75-year period beginning with the current fiscal year; and
“(IV) an actuarial opinion certifying that the techniques and methodologies used are generally accepted within the actuarial profession and that the assumptions and cost estimates used are reasonable; and
“(ii) be printed as a House document of the session of the Congress to which the report is made.
“(C) RECOMMENDATIONS.—If the Board of Trustees determines that enrollment trends and expected future benefit claims on the CLASS Independence Fund are not actuarially sound in regards to the projections under section 3203(b)(1)(B)(i) and are unlikely to be resolved with reasonable premium increases or through other means, the Board of Trustees shall include in the report provided for in subparagraph (A)(ii) recommendations for such legislative action as the Board of Trustees determine to be appropriate, including whether to adjust monthly premiums or impose a temporary moratorium on new enrollments.
“(a) Establishment.—There is hereby created an Advisory Committee to be known as the ‘CLASS Independence Advisory Council’.
“(1) IN GENERAL.—The CLASS Independence Advisory Council shall be composed of not more than 15 individuals, not otherwise in the employ of the United States—
“(A) who shall be appointed by the President without regard to the civil service laws and regulations; and
“(B) a majority of whom shall be representatives of individuals who participate or are likely to participate in the CLASS program, and shall include representatives of older and younger workers, individuals with disabilities, family caregivers of individuals who require services and supports to maintain their independence at home or in another residential setting of their choice in the community, individuals with expertise in long-term care or disability insurance, actuarial science, economics, and other relevant disciplines, as determined by the Secretary.
“(A) IN GENERAL.—The members of the CLASS Independence Advisory Council shall serve overlapping terms of 3 years (unless appointed to fill a vacancy occurring prior to the expiration of a term, in which case the individual shall serve for the remainder of the term).
“(B) LIMITATION.—A member shall not be eligible to serve for more than 2 consecutive terms.
“(3) CHAIR.—The President shall, from time to time, appoint one of the members of the CLASS Independence Advisory Council to serve as the Chair.
“(c) Duties.—The CLASS Independence Advisory Council shall advise the Secretary on matters of general policy in the administration of the CLASS program established under this title and in the formulation of regulations under this title including with respect to—
“(1) the development of the CLASS Independence Benefit Plan under section 3203; and
“(2) the determination of monthly premiums under such plan.
“(d) Application of FACA.—The Federal Advisory Committee Act, other than section 14 of that Act, shall apply to the CLASS Independence Advisory Council.
“(e) Authorization of appropriations.—
“(1) IN GENERAL.—There are authorized to be appropriated to the CLASS Independence Advisory Council to carry out its duties under this section, such sums as may be necessary for fiscal year 2011 and for each fiscal year thereafter.
“(2) AVAILABILITY.—Any sums appropriated under the authorization contained in this section shall remain available, without fiscal year limitation, until expended.
“(a) Regulations.—The Secretary shall promulgate such regulations as are necessary to carry out the CLASS program in accordance with this title. Such regulations shall include provisions to prevent fraud and abuse under the program.
“(b) Annual report.—Beginning January 1, 2014, the Secretary shall submit an annual report to Congress on the CLASS program. Each report shall include the following:
“(1) The total number of enrollees in the program.
“(2) The total number of eligible beneficiaries during the fiscal year.
“(3) The total amount of cash benefits provided during the fiscal year.
“(4) A description of instances of fraud or abuse identified during the fiscal year.
“(5) Recommendations for such administrative or legislative action as the Secretary determines is necessary to improve the program or to prevent the occurrence of fraud or abuse.
“The Inspector General of the Department of Health and Human Services shall submit an annual report to the Secretary and Congress relating to the overall progress of the CLASS program and of the existence of waste, fraud, and abuse in the CLASS program. Each such report shall include findings in the following areas:
“(1) The eligibility determination process.
“(2) The provision of cash benefits.
“(3) Quality assurance and protection against waste, fraud, and abuse.
“(4) Recouping of unpaid and accrued benefits.”.
(b) Conforming amendments to Medicaid.—For conforming provisions amending the Medicaid program, see section 1739.
A State is eligible for Federal funds under the provisions of the Public Health Service Act (42 U.S.C. 201 et seq.) only if the State—
(1) agrees to be subject in its capacity as an employer to each obligation under division A of this Act and the amendments made by such division applicable to persons in their capacity as an employer; and
(2) assures that all political subdivisions in the State will do the same.
(a) In general.—Section 224 (42 U.S.C. 233) is amended—
(A) in the first sentence, by striking “or employee” and inserting “employee, or (subject to subsection (k)(4)) volunteer practitioner”; and
(B) in the second sentence, by inserting “and subsection (k)(4)” after “subject to paragraph (5)”; and
(2) in each of subsections (g), (i), (j), (l), and (m), by striking the term “employee, or contractor” each place such term appears and inserting “employee, volunteer practitioner, or contractor”;
(3) in subsection (g)(1)(H), by striking the term “employee, and contractor” each place such term appears and inserting “employee, volunteer practitioner, and contractor”;
(4) in subsection (l), by striking the term “employee, or any contractor” and inserting “employee, volunteer practitioner, or contractor”; and
(5) in subsections (h)(3) and (k), by striking the term “employees, or contractors” each place such term appears and inserting “employees, volunteer practitioners, or contractors”.
(b) Applicability; definition.—Section 224(k) (42 U.S.C. 233(k)) is amended by adding at the end the following paragraph:
“(4)(A) Subsections (g) through (m) apply with respect to volunteer practitioners beginning with the first fiscal year for which an appropriations Act provides that amounts in the fund under paragraph (2) are available with respect to such practitioners.
“(B) For purposes of subsections (g) through (m), the term ‘volunteer practitioner’ means a practitioner who, with respect to an entity described in subsection (g)(4), meets the following conditions:
“(i) The practitioner is a licensed physician, a licensed clinical psychologist, or other licensed or certified health care practitioner.
“(ii) At the request of such entity, the practitioner provides services to patients of the entity, at a site at which the entity operates or at a site designated by the entity. The weekly number of hours of services provided to the patients by the practitioner is not a factor with respect to meeting conditions under this subparagraph.
“(iii) The practitioner does not for the provision of such services receive any compensation from such patients, from the entity, or from third-party payors (including reimbursement under any insurance policy or health plan, or under any Federal or State health benefits program).”.
Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall report to Congress on the epidemiology of, impact of, and appropriate funding required to address neglected diseases of poverty, including neglected parasitic diseases identified as Chagas disease, cysticercosis, toxocariasis, toxoplasmosis, trichomoniasis, the soil-transmitted helminths, and others. The report should provide the information necessary to enhance health policy to accurately evaluate and address the threat of these diseases.
(a) Health and Human Services office on women's health.—
(1) ESTABLISHMENT.—Part A of title II (42 U.S.C. 202 et seq.) is amended by adding at the end the following:
“(a) Establishment of office.—There is established within the Office of the Secretary, an Office on Women’s Health (referred to in this section as the ‘Office’). The Office shall be headed by a Deputy Assistant Secretary for Women’s Health who may report to the Secretary.
“(b) Duties.—The Secretary, acting through the Office, with respect to the health concerns of women, shall—
“(1) establish short-range and long-range goals and objectives within the Department of Health and Human Services and, as relevant and appropriate, coordinate with other appropriate offices on activities within the Department that relate to disease prevention, health promotion, service delivery, research, and public and health care professional education, for issues of particular concern to women throughout their lifespan;
“(2) provide expert advice and consultation to the Secretary concerning scientific, legal, ethical, and policy issues relating to women’s health;
“(3) monitor the Department of Health and Human Services’ offices, agencies, and regional activities regarding women’s health and identify needs regarding the coordination of activities, including intramural and extramural multidisciplinary activities;
“(4) establish a Department of Health and Human Services Coordinating Committee on Women’s Health, which shall be chaired by the Deputy Assistant Secretary for Women’s Health and composed of senior level representatives from each of the agencies and offices of the Department of Health and Human Services;
“(5) establish a National Women’s Health Information Center to—
“(A) facilitate the exchange of information regarding matters relating to health information, health promotion, preventive health services, research advances, and education in the appropriate use of health care;
“(B) facilitate access to such information;
“(C) assist in the analysis of issues and problems relating to the matters described in this paragraph; and
“(D) provide technical assistance with respect to the exchange of information (including facilitating the development of materials for such technical assistance);
“(6) coordinate efforts to promote women’s health programs and policies with the private sector; and
“(7) through publications and any other means appropriate, provide for the exchange of information between the Office and recipients of grants, contracts, and agreements under subsection (c), and between the Office and health professionals and the general public.
“(c) Grants and contracts regarding duties.—
“(1) AUTHORITY.—In carrying out subsection (b), the Secretary may make grants to, and enter into cooperative agreements, contracts, and interagency agreements with, public and private entities, agencies, and organizations.
“(2) EVALUATION AND DISSEMINATION.—The Secretary shall directly or through contracts with public and private entities, agencies, and organizations, provide for evaluations of projects carried out with financial assistance provided under paragraph (1) and for the dissemination of information developed as a result of such projects.
“(d) Reports.—Not later than 1 year after the date of enactment of this section, and every second year thereafter, the Secretary shall prepare and submit to the appropriate committees of Congress a report describing the activities carried out under this section during the period for which the report is being prepared.”.
(2) TRANSFER OF FUNCTIONS.—There are transferred to the Office on Women’s Health (established under section 229 of the Public Health Service Act, as added by this section), all functions exercised by the Office on Women’s Health of the Public Health Service prior to the date of enactment of this section, including all personnel and compensation authority, all delegation and assignment authority, and all remaining appropriations. All orders, determinations, rules, regulations, permits, agreements, grants, contracts, certificates, licenses, registrations, privileges, and other administrative actions that—
(A) have been issued, made, granted, or allowed to become effective by the President, any Federal agency or official thereof, or by a court of competent jurisdiction, in the performance of functions transferred under this paragraph; and
(B) are in effect at the time this section takes effect, or were final before the date of enactment of this section and are to become effective on or after such date;
shall continue in effect according to their terms until modified, terminated, superseded, set aside, or revoked in accordance with law by the President, the Secretary, or other authorized official, a court of competent jurisdiction, or by operation of law.
(b) Centers for disease control and prevention office of women’s health.—Part A of title III (42 U.S.C. 241 et seq.) is amended by adding at the end the following:
“(a) Establishment.—There is established within the Office of the Director of the Centers for Disease Control and Prevention, an office to be known as the Office of Women’s Health (referred to in this section as the ‘Office’). The Office shall be headed by a director who shall be appointed by the Director of such Centers.
“(b) Purpose.—The Director of the Office shall—
“(1) report to the Director of the Centers for Disease Control and Prevention on the current level of the Centers’ activity regarding women’s health conditions across, where appropriate, age, biological, and sociocultural contexts, in all aspects of the Centers’ work, including prevention programs, public and professional education, services, and treatment;
“(2) establish short-range and long-range goals and objectives within the Centers for women’s health and, as relevant and appropriate, coordinate with other appropriate offices on activities within the Centers that relate to prevention, research, education and training, service delivery, and policy development, for issues of particular concern to women;
“(3) identify projects in women’s health that should be conducted or supported by the Centers;
“(4) consult with health professionals, nongovernmental organizations, consumer organizations, women’s health professionals, and other individuals and groups, as appropriate, on the policy of the Centers with regard to women; and
“(5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s Health (established under section 229(b)(4)).
“(c) Definition.—As used in this section, the term ‘women's health conditions’, with respect to women of all age, ethnic, and racial groups, means diseases, disorders, and conditions—
“(1) unique to, significantly more serious for, or significantly more prevalent in women; and
“(2) for which the factors of medical risk or type of medical intervention are different for women, or for which there is reasonable evidence that indicates that such factors or types may be different for women.”.
(c) Office of women’s health research.—Section 486(a) (42 U.S.C. 287d(a)) is amended by inserting “and who shall report directly to the Director” before the period at the end thereof.
(d) Substance abuse and mental health services administration.—Section 501(f) (42 U.S.C. 290aa(f)) is amended—
(1) in paragraph (1), by inserting “who shall report directly to the Administrator” before the period;
(2) by redesignating paragraph (4) as paragraph (5); and
(3) by inserting after paragraph (3), the following:
“(4) OFFICE.—Nothing in this subsection shall be construed to preclude the Secretary from establishing within the Substance Abuse and Mental Health Administration an Office of Women’s Health.”.
(e) Agency for Healthcare Research and Quality activities regarding women’s health.—Part C of title IX (42 U.S.C. 299c et seq.) is amended—
(1) by redesignating sections 927 and 928 as sections 928 and 929, respectively;
(2) by inserting after section 926 the following:
“(a) Establishment.—There is established within the Office of the Director, an Office of Women’s Health and Gender-Based Research (referred to in this section as the ‘Office’). The Office shall be headed by a director who shall be appointed by the Director of Healthcare and Research Quality.
“(b) Purpose.—The official designated under subsection (a) shall—
“(1) report to the Director on the current Agency level of activity regarding women’s health, across, where appropriate, age, biological, and sociocultural contexts, in all aspects of Agency work, including the development of evidence reports and clinical practice protocols and the conduct of research into patient outcomes, delivery of health care services, quality of care, and access to health care;
“(2) establish short-range and long-range goals and objectives within the Agency for research important to women’s health and, as relevant and appropriate, coordinate with other appropriate offices on activities within the Agency that relate to health services and medical effectiveness research, for issues of particular concern to women;
“(3) identify projects in women’s health that should be conducted or supported by the Agency;
“(4) consult with health professionals, nongovernmental organizations, consumer organizations, women’s health professionals, and other individuals and groups, as appropriate, on Agency policy with regard to women; and
“(5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s Health (established under section 229(b)(4)).”; and
(3) by adding at the end of section 928 (as redesignated by paragraph (1)) the following: “(e) Women’s health.—For the purpose of carrying out section 927 regarding women’s health, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2011 through 2015.”.
(f) Health resources and services administration office of women’s health.—Title VII of the Social Security Act (42 U.S.C. 901 et seq.) is amended by adding at the end the following:
“(a) Establishment.—The Secretary shall establish within the Office of the Administrator of the Health Resources and Services Administration, an office to be known as the Office of Women’s Health. The Office shall be headed by a director who shall be appointed by the Administrator.
“(b) Purpose.—The Director of the Office shall—
“(1) report to the Administrator on the current Administration level of activity regarding women’s health across, where appropriate, age, biological, and sociocultural contexts;
“(2) establish short-range and long-range goals and objectives within the Health Resources and Services Administration for women’s health and, as relevant and appropriate, coordinate with other appropriate offices on activities within the Administration that relate to health care provider training, health service delivery, research, and demonstration projects, for issues of particular concern to women;
“(3) identify projects in women’s health that should be conducted or supported by the bureaus of the Administration;
“(4) consult with health professionals, nongovernmental organizations, consumer organizations, women’s health professionals, and other individuals and groups, as appropriate, on Administration policy with regard to women; and
“(5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s Health (established under section 229(b)(4) of the Public Health Service Act).
“(c) Continued administration of existing programs.—The Director of the Office shall assume the authority for the development, implementation, administration, and evaluation of any projects carried out through the Health Resources and Services Administration relating to women’s health on the date of enactment of this section.
“(d) Definitions.—For purposes of this section:
“(1) ADMINISTRATION.—The term ‘Administration’ means the Health Resources and Services Administration.
“(2) ADMINISTRATOR.—The term ‘Administrator’ means the Administrator of the Health Resources and Services Administration.
“(3) OFFICE.—The term ‘Office’ means the Office of Women’s Health established under this section in the Administration.”.
(g) Food and drug administration office of women’s health.—Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at the end the following:
“(a) Establishment.—There is established within the Office of the Commissioner, an office to be known as the Office of Women’s Health (referred to in this section as the ‘Office’). The Office shall be headed by a director who shall be appointed by the Commissioner of Food and Drugs.
“(b) Purpose.—The Director of the Office shall—
“(1) report to the Commissioner of Food and Drugs on current Food and Drug Administration (referred to in this section as the ‘Administration’) levels of activity regarding women’s participation in clinical trials and the analysis of data by sex in the testing of drugs, medical devices, and biological products across, where appropriate, age, biological, and sociocultural contexts;
“(2) establish short-range and long-range goals and objectives within the Administration for issues of particular concern to women’s health within the jurisdiction of the Administration, including, where relevant and appropriate, adequate inclusion of women and analysis of data by sex in Administration protocols and policies;
“(3) provide information to women and health care providers on those areas in which differences between men and women exist;
“(4) consult with pharmaceutical, biologics, and device manufacturers, health professionals with expertise in women’s issues, consumer organizations, and women’s health professionals on Administration policy with regard to women;
“(5) make annual estimates of funds needed to monitor clinical trials and analysis of data by sex in accordance with needs that are identified; and
“(6) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s Health (established under section 229(b)(4) of the Public Health Service Act).”.
(h) No new regulatory authority.—Nothing in this section and the amendments made by this section may be construed as establishing regulatory authority or modifying any existing regulatory authority.
(i) Limitation on termination.—Notwithstanding any other provision of law, a Federal office of women’s health (including the Office of Research on Women’s Health of the National Institutes of Health) or Federal appointive position with primary responsibility over women’s health issues (including the Associate Administrator for Women’s Services under the Substance Abuse and Mental Health Services Administration) that is in existence on the date of enactment of this section shall not be terminated, reorganized, or have any of its powers or duties transferred unless such termination, reorganization, or transfer is approved by an Act of Congress.
(j) Rule of construction.—Nothing in this section (or the amendments made by this section) shall be construed to limit the authority of the Secretary of Health and Human Services with respect to women’s health, or with respect to activities carried out through the Department of Health and Human Services on the date of enactment of this section.
(a) Amendments to the Older Americans Act of 1965.—
(1) PROMOTION OF DIRECT CARE WORKFORCE.—Section 202(b)(1) of the Older Americans Act of 1965 (42 U.S.C. 3012(b)(1)) is amended by inserting before the semicolon the following: “, and, in carrying out the purposes of this paragraph, shall make recommendations to other Federal entities regarding appropriate and effective means of identifying, promoting, and implementing investments in the direct care workforce necessary to meet the growing demand for long-term health services and supports and of assisting States in developing a comprehensive State workforce development plan with respect to such workforce, including assisting efforts to systematically assess, track, and report on workforce adequacy and capacity”.
(2) PERSONAL CARE ATTENDANT WORKFORCE ADVISORY PANEL.—Section 202 of such Act (42 U.S.C. 3012) is amended by adding at the end the following: “(g)(1) Not later than 90 days after the date of the enactment of this subsection, the Assistant Secretary shall establish a Personal Care Attendant Workforce Advisory Panel to examine and formulate recommendations on— “(A) working conditions and training for workers providing long-term services and supports, including home health aides, certified nurse aides, and personal care attendants; and “(B) other workforce issues related to such workers, including with respect to the adequacy of the number of such workers; the salaries, wages, and benefits of such workers; and access to the services provided by such workers. “(2) The Panel shall include representatives of— “(A) relevant home- and community-based service providers, health care agencies, and facilities (including personal or home care agencies, home health care agencies, nursing homes, assisted living facilities, and residential care facilities); “(B) the disability community, including individuals with disabilities and family caregivers; “(C) the nursing community; “(D) direct care workers (which may include unions and national organizations); “(E) older individuals, including senior individuals and family caregivers; “(F) State and Federal health care entities; and “(G) experts in workforce development and adult learning.
“(3) Within one year after the establishment of the Panel, the Panel shall submit a report to the Assistant Secretary and the Congress on workforce issues related to providing long-term services and supports, including information on core competencies for eligible personal or home care aides necessary to successfully provide long-term services and supports to eligible consumers, as well as recommended training curricula and resources.
“(4) Within 180 days after receipt by the Assistant Secretary of the report under paragraph (3), the Assistant Secretary shall establish a 3-year demonstration program in 4 States to pilot and evaluate the effectiveness of the competencies articulated by the Panel and the training curricula and training methods recommended by the Panel.
“(5) Not later than 1 year after the completion of the demonstration program under paragraph (4), the Assistant Secretary shall submit to the Congress a report containing the results of the evaluations by the Assistant Secretary pursuant to paragraph (4), together with such recommendations for legislation or administrative action as the Assistant Secretary determines appropriate.”.
(b) Authorization of Additional Appropriations for the Family Caregiver Support Program Under the Older Americans Act of 1965.—Section 303(e)(2) of the Older Americans Act of 1965 (42 U.S.C. 3023(e)(2)) is amended by striking “, $173,000,000” and all that follows through “2011”, and inserting “and $250,000,000 for each of fiscal years 2011, 2012, and 2013”.
(a) In General.—The Secretary of Labor, in consultation with the National Center for Health Workforce Analysis, shall establish and maintain a Web site to serve as a comprehensive source of information, searchable by workforce region, on the health care labor market and related educational and training opportunities.
(b) Contents.—The Web site maintained under this section shall include the following:
(1) Information on the types of jobs that are currently or are projected to be in high demand in the health care field, including—
(A) salary information; and
(B) training requirements, such as requirements for educational credentials, licensure, or certification.
(2) Information on training and educational opportunities within each region for the type of jobs described in paragraph (1), including by—
(A) type of provider or program (such as public, private nonprofit, or private for-profit);
(B) duration;
(C) cost (such as tuition, fees, books, laboratory expenses, and other mandatory costs);
(D) performance outcomes (such as graduation rates, job placement, average salary, job retention, and wage progression);
(E) Federal financial aid participation;
(F) average graduate loan debt;
(G) student loan default rates;
(H) average institutional grant aid provided;
(I) Federal and State accreditation information; and
(J) other information determined by the Secretary.
(3) A mechanism for searching and comparing training and educational options for specific health care occupations to facilitate informed career and education choices.
(4) Financial aid information, including with respect to loan forgiveness, loan cancellation, loan repayment, stipends, scholarships, and grants or other assistance authorized by this Act or other Federal or State programs.
(c) Public Accessibility.—The Web site maintained under this section shall—
(1) be publicly accessible;
(2) be user friendly and convey information in a manner that is easily understandable; and
(3) be in English and the second most prevalent language spoken based on the latest Census information.
Section 171 of the Workforce Investment Act of 1998 (29 U.S.C. 2916) is amended by adding at the end the following:
Title V of the Rehabilitation Act of 1973 (29 U.S.C. 791 et seq.) is amended by adding at the end of the following:
“(a) Standards.—Not later than 9 months after the date of enactment of the Affordable Health Care for America Act, the Architectural and Transportation Barriers Compliance Board (Access Board) shall issue guidelines setting forth the minimum technical criteria for new medical diagnostic equipment to be purchased for use in (or in conjunction with) physician’s offices, clinics, emergency rooms, hospitals, and other medical settings. The guidelines shall ensure that such equipment is accessible to, and usable by, individuals with disabilities, including provisions to ensure independent entry to, use of, and exit from the equipment by such individuals to the maximum extent possible.
“(b) Medical diagnostic equipment covered.—The guidelines issued under subsection (a) for medical diagnostic equipment shall apply to new purchases of equipment that includes examination tables, examination chairs (including chairs used for eye examinations or procedures, and dental examinations or procedures), weight scales, mammography equipment, x-ray machines, and other equipment commonly used for diagnostic or examination purposes by health professionals.
“(c) Regulations.—Not later than 6 months after the date of the issuance of the guidelines under subsection (a), each appropriate Federal agency authorized to promulgate regulations under this Act or under the Americans with Disabilities Act shall—
“(1) prescribe regulations in an accessible format as necessary to carry out the provisions of such Act and section 504 of this Act that include accessibility standards that are consistent with the guidelines issued under subsection (a); and
“(2) ensure that health care providers and health care plans covered by the Affordable Health Care for America Act meet the requirements of the Americans with Disabilities Act and section 504, including provisions ensuring that individuals with disabilities receive equal access to all aspects of the health care delivery system.
“(d) Review and amend.—The Architectural and Transportation Barriers Compliance Board (Access Board) shall periodically review and, as appropriate, amend the guidelines as prescribed under subsection (a). Not later than 6 months after the date of the issuance of such revised guidelines, revised regulations consistent with such guidelines shall be promulgated in an accessible format by the appropriate Federal agencies described in subsection (c).”.