Title: BIOSIM Act
Policy area: Health

Summary:
Bolstering Innovative Options to Save Immediately on Medicines Act or the BIOSIM Act
This bill increases Medicare payments for biosimilars for five years. The bill applies to biosimilars for which the average sales price or wholesale acquisition cost is less than that of the reference biological product, as specified.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4455 Introduced in House (IH)]

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116th CONGRESS
  1st Session
                                H. R. 4455

   To amend title XVIII of the Social Security Act to provide for a 
   temporary payment increase under the Medicare program for certain 
biosimilar biological products to encourage the development and use of 
                             such products.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 20, 2019

 Mr. Schrader (for himself and Mr. Gianforte) introduced the following 
 bill; which was referred to the Committee on Energy and Commerce, and 
  in addition to the Committee on Ways and Means, 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

_______________________________________________________________________

                                 A BILL


 
   To amend title XVIII of the Social Security Act to provide for a 
   temporary payment increase under the Medicare program for certain 
biosimilar biological products to encourage the development and use of 
                             such products.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Bolstering Innovative Options to 
Save Immediately on Medicines Act'' or the ``BIOSIM Act''.

SEC. 2. TEMPORARY INCREASE IN MEDICARE PART B PAYMENT FOR CERTAIN 
              BIOSIMILAR BIOLOGICAL PRODUCTS.

    Section 1847A(b)(8) of the Social Security Act (42 U.S.C. 1395w-
3a(b)(8)) is amended--
            (1) by redesignating subparagraphs (A) and (B) as clauses 
        (i) and (ii), respectively, and moving the margin of each such 
        redesignated clause 2 ems to the right;
            (2) by striking ``product.--The amount'' and inserting the 
        following: ``product.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                amount''; and
            (3) by adding at the end the following new subparagraph:
                    ``(B) Temporary payment increase.--
                            ``(i) In general.--In the case of a 
                        qualifying biosimilar biological product that 
                        is furnished during the applicable 5-year 
                        period for such product, the amount specified 
                        in this paragraph for such product with respect 
                        to such period is the sum determined under 
                        subparagraph (A), except that clause (ii) of 
                        such subparagraph shall be applied by 
                        substituting `8 percent' for `6 percent'.
                            ``(ii) Applicable 5-year period.--For 
                        purposes of clause (i), the applicable 5-year 
                        period for a biosimilar biological product is--
                                    ``(I) in the case of such a product 
                                for which payment was made under this 
                                paragraph as of December 31, 2019, the 
                                5-year period beginning on January 1, 
                                2020; and
                                    ``(II) in the case of such a 
                                product for which payment is first made 
                                under this paragraph during a calendar 
                                quarter during the period beginning 
                                January 1, 2020, and ending December 
                                31, 2024, the 5-year period beginning 
                                on the first day of such calendar 
                                quarter during which such payment is 
                                first made.
                            ``(iii) Qualifying biosimilar biological 
                        product defined.--For purposes of this 
                        subparagraph, the term `qualifying biosimilar 
                        biological product' means a biosimilar 
                        biological product described in paragraph 
                        (1)(C) with respect to which--
                                    ``(I) in the case of a product 
                                described in clause (ii)(I), the 
                                average sales price is not more than 
                                the average sales price for the 
                                reference biological product; and
                                    ``(II) in the case of a product 
                                described in clause (ii)(II), the 
                                wholesale acquisition cost is not more 
                                than the wholesale acquisition cost for 
                                the reference biological product''.
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