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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5461 Introduced in House (IH)]

<DOC>

118th CONGRESS
  1st Session
                                H. R. 5461

To amend title XVIII of the Social Security Act to require PDP sponsors 
 of a prescription drug plan under part D of the Medicare program that 
    use a formulary to include certain generic drugs and biosimilar 
     biological products on such formulary, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                           September 14, 2023

Ms. Kuster (for herself, Mrs. Miller-Meeks, Ms. Matsui, and Mr. Dunn of 
   Florida) 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 require PDP sponsors 
 of a prescription drug plan under part D of the Medicare program that 
    use a formulary to include certain generic drugs and biosimilar 
     biological products on such formulary, and for other purposes.

    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 ``Ensuring Access to Lower-Cost 
Medicines for Seniors Act of 2023''.

SEC. 2. REQUIREMENTS FOR PDP SPONSORS OF PRESCRIPTION DRUG PLANS UNDER 
              PART D OF THE MEDICARE PROGRAM THAT USE FORMULARIES.

    Section 1860D-4(b)(3) of the Social Security Act (42 U.S.C. 1395w-
104(b)(3)) is amended by adding at the end the following new 
subparagraph:
                    ``(J) Required inclusion of certain generic drugs 
                and biosimilar biological products.--
                            ``(i) In general.--With respect to a plan 
                        year beginning on or after January 1, 2024, the 
                        formulary shall include in a preferred position 
                        relative to the reference drug--
                                    ``(I) each covered generic drug for 
                                which the wholesale acquisition cost is 
                                less than the wholesale acquisition 
                                cost of the reference drug of such 
                                covered generic drug; and
                                    ``(II) at least two covered 
                                biosimilar biological products for 
                                which the wholesale acquisition cost is 
                                less than the wholesale acquisition 
                                cost of the reference biological 
                                product of such covered biosimilar 
                                biological product.
                            ``(ii) Prohibition on certain limits on 
                        access.--The PDP sponsor offering the 
                        prescription drug plan may not impose limits on 
                        access to a covered generic drug required to be 
                        included on the formulary under clause (i)(I) 
                        or a covered biosimilar biological product 
                        required to be included on the formulary under 
                        clause (i)(II), including through utilization 
                        management techniques such as prior 
                        authorization, or step therapy, that are more 
                        restrictive than any such limits imposed on 
                        access to the reference drug of such covered 
                        generic drug or reference biological product of 
                        such covered biosimilar biological product, 
                        respectively, or that otherwise have the effect 
                        of limiting the availability to enrollees of 
                        such covered generic drug or covered biosimilar 
                        biological product relative to such reference 
                        drug or reference biological product over such 
                        covered generic drug or covered biosimilar 
                        biological product, respectively.
                            ``(iii) Definitions.--In this subparagraph 
                        and subparagraph (J):
                                    ``(I) Covered biosimilar biological 
                                product.--The term `covered biosimilar 
                                biological product' means a covered 
                                part D drug that is a biosimilar 
                                biological product (as defined in 
                                section 1847A(c)(6)(H)).
                                    ``(II) Covered generic drug.--The 
                                term `covered generic drug' means a 
                                covered part D drug that is a drug 
                                described in section 1860D-2(e)(1)(A) 
                                and approved under section 505(j) of 
                                the Federal Food, Drug, and Cosmetic 
                                Act.
                                    ``(III) Preferred position.--The 
                                term `preferred position' means a 
                                product is placed on a more favorable 
                                formulary tier and has lower patient 
                                out-of-pocket costs than the 
                                corresponding reference drug or 
                                reference biological product.
                                    ``(IV) Reference biological 
                                product.--The term `reference 
                                biological product' has the meaning 
                                given such term in section 
                                1847A(c)(6)(I).
                                    ``(V) Reference drug.--The term 
                                `reference drug' means, with respect to 
                                a covered generic drug, the listed drug 
                                (as described in clause (i) of section 
                                505(j)(2)(A) of the Federal Food, Drug, 
                                and Cosmetic Act) that is referred to 
                                in the abbreviated application for such 
                                covered generic drug under such 
                                section.
                                    ``(VI) Wholesale acquisition 
                                cost.--The term `wholesale acquisition 
                                cost' has the meaning given such term 
                                in section 1847A(c)(6)(B).''.
                                 <all>
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