[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6465 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 6465

 To amend title XVIII of the Social Security Act to provide a phase-in 
  for plasma-derived products under the manufacturer discount program.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           November 21, 2023

 Mr. Hudson (for himself, Mr. Murphy, Mr. Davis of North Carolina, and 
 Mr. Nickel) 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 a phase-in 
  for plasma-derived products under the manufacturer discount program.

    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 ``Preserving Life-saving Access to 
Specialty Medicines in America Act'' or the ``PLASMA Act''.

SEC. 2. PHASE-IN FOR PLASMA-DERIVED PRODUCTS UNDER MANUFACTURER 
              DISCOUNT PROGRAM.

    Section 1860D-14C(g)(4) of the Social Security Act (42 U.S.C. 
1395w-114c(g)(4)) is amended--
            (1) in subparagraph (A), in the matter preceding clause 
        (i), by striking ``and (C)'' and inserting ``, (C), and (D)'';
            (2) by redesignating subparagraphs (D) and (E) as 
        subparagraphs (E) and (F), respectively; and
            (3) by inserting after subparagraph (C) the following:
                    ``(D) Phase-in for plasma-derived products.--
                            ``(i) In general.--In the case of an 
                        applicable drug that is a plasma-derived 
                        product (as defined in clause (ii)), and that 
                        is marketed as of the date of enactment of this 
                        subparagraph and dispensed for an applicable 
                        beneficiary, the term `discounted price' means 
                        the specified plasma-derived product percent 
                        (as defined in clause (iii)) of the negotiated 
                        price of the applicable drug of the 
                        manufacturer.
                            ``(ii) Plasma-derived product.--In this 
                        subparagraph, the term `plasma-derived product' 
                        means an applicable drug that is a biological 
                        product that is derived from human whole blood 
                        or plasma.
                            ``(iii) Specified plasma-derived product 
                        percent.--In this subparagraph, the term 
                        `specified plasma-derived product percent' 
                        means, with respect to a year--
                                    ``(I) for an applicable drug that 
                                is as a plasma-derived product 
                                dispensed for an applicable beneficiary 
                                who has not incurred costs, as 
                                determined in accordance with section 
                                1860D-2(b)(4)(C), for covered part D 
                                drugs in the year that are equal to or 
                                exceed the annual out-of-pocket 
                                threshold specified in section 1860D-
                                2(b)(4)(B)(i) for the year, the percent 
                                specified under subparagraph 
                                (B)(iii)(I) for such year; and
                                    ``(II) for an applicable drug that 
                                is as a plasma-derived product 
                                dispensed for an applicable beneficiary 
                                who has incurred costs, as determined 
                                in accordance with section 1860D-
                                2(b)(4)(C), for covered part D drugs in 
                                the year that are equal to or exceed 
                                the annual out-of-pocket threshold 
                                specified in section 1860D-
                                2(b)(4)(B)(i) for the year, the percent 
                                specified under subparagraph 
                                (B)(iii)(II) for such year.''.
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