Index for HR3962: Affordable Health Care for America Act

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) In general.—Section 1847A of the Social Security Act (42 U.S.C. 1395w–3a) is amended—

(1) in subsection (b)(1)—

(A) in subparagraph (A), by striking “or” at the end;

(B) in subparagraph (B), by striking the period at the end and inserting “; or”; and

(C) by adding at the end the following new subparagraph:

“(C) in the case of one or more interchangeable biological products (as defined in subsection (c)(6)(I)) and their reference biological product (as defined in subsection (c)(6)(J)), which shall be included in the same billing and payment code, the sum of—

“(i) the average sales price as determined using the methodology described in paragraph (6) applied to such interchangeable and reference products for all National Drug Codes assigned to such products in the same manner as such paragraph (6) is applied to multiple source drugs; and

“(ii) 6 percent of the amount determined under clause (i);

“(D) in the case of a biosimilar biological product (as defined in subsection (c)(6)(H)), the sum of—

“(i) the average sales price as determined using the methodology described in paragraph (4) applied to such biosimilar biological product for all National Drug Codes assigned to such product in the same manner as such paragraph (4) is applied to a single source drug; and

“(ii) 6 percent of the amount determined under paragraph (4) or the amount determined under subparagraph (C)(ii), as the case may be, for the reference biological product (as defined in subsection (c)(6)(J)); or

“(E) in the case of a reference biological product for both an interchangeable biological product and a biosimilar product, the amount determined in subparagraph (C).”; and

(2) in subsection (c)(6)—

(A) by amending subparagraph (D)(i) to read as follows:

“(i) a biological, including a reference biological product for a biosimilar product, but excluding—

“(I) a biosimilar biological product;

“(II) an interchangeable biological product;

“(III) a reference biological product for an interchangeable biological product; and

“(IV) a reference biological product for both an interchangeable biological product and a biosimilar product; or”; and

(B) by adding at the end the following new subparagraphs:

“(H) BIOSIMILAR BIOLOGICAL PRODUCT.—The term ‘biosimilar biological product’ means a biological product licensed as a biosimilar biological product under section 351(k) of the Public Health Service Act.

“(I) INTERCHANGEABLE BIOLOGICAL PRODUCT.—The term ‘interchangeable biological product’ means a biological product licensed as an interchangeable biological product under section 351(k) of the Public Health Service Act

“(J) REFERENCE BIOLOGICAL PRODUCT.—The term ‘reference biological product’ means the biological product that is referred to in the application for a biosimilar or interchangeable biological product licensed under section 351(k) of the Public Health Service Act.”.

(b) Effective date.—The amendments made by subsection (a) shall apply to payments for biosimilar biological products, interchangeable biological products, and reference biological products beginning with the first day of the second calendar quarter after the date of the enactment of this Act.