[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2129 Introduced in Senate (IS)]

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118th CONGRESS
  1st Session
                                S. 2129

To amend title XVIII of the Social Security Act to require PDP sponsors 
   of a prescription drug plan and Medicare Advantage organizations 
offering an MA-PD 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 SENATE OF THE UNITED STATES

                             June 22, 2023

 Mr. Lankford (for himself and Mr. Menendez) introduced the following 
  bill; which was read twice and referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
To amend title XVIII of the Social Security Act to require PDP sponsors 
   of a prescription drug plan and Medicare Advantage organizations 
offering an MA-PD 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''.

SEC. 2. REQUIREMENTS FOR PDP SPONSORS OF PRESCRIPTION DRUG PLANS AND 
              MEDICARE ADVANTAGE ORGANIZATIONS OFFERING MA-PD PLANS 
              UNDER PART D OF THE MEDICARE PROGRAM THAT USE 
              FORMULARIES.

    (a) In General.--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 subparagraphs:
                    ``(J) Required inclusion of certain generic drugs 
                and biosimilar biological products.--
                            ``(i) In general.--Subject to the 
                        succeeding provisions of this subparagraph, 
                        with respect to a plan year beginning on or 
                        after January 1, 2025, the following rules 
                        shall apply:
                                    ``(I) If the formulary includes a 
                                part D reference drug, the formulary 
                                shall include each part D generic drug 
                                of such part D reference drug for which 
                                the wholesale acquisition cost is less 
                                than the wholesale acquisition cost of 
                                such part D reference drug.
                                    ``(II) If the formulary includes a 
                                part D reference biological product, 
                                the formulary shall include at least 
                                one part D biosimilar biological of 
                                such part D reference biological 
                                product for which the wholesale 
                                acquisition cost is less than the 
                                wholesale acquisition cost of such part 
                                D reference biological product (if one 
                                or more such part D biosimilar 
                                biologicals is available).
                            ``(ii) Determinations and implementation.--
                        Determinations of part D generic drugs and part 
                        D biosimilar biological products described in 
                        subclauses (I) and (II) of clause (i) and 
                        implementation of formulary requirements under 
                        clause (i) shall be made by PDP sponsors 
                        offering prescription drug plans in accordance 
                        with uniform requirements established by the 
                        Secretary (by program instruction or 
                        otherwise), which shall provide for such 
                        determinations to be made as of specified dates 
                        (in the case of determinations during a plan 
                        year, on a quarterly basis), and for any 
                        associated formulary changes to be implemented 
                        promptly thereafter (in accordance with 
                        timeframes specified by the Secretary). Such 
                        uniform requirements shall also specify 
                        circumstances under which a part D generic drug 
                        or part D biosimilar biological product shall 
                        be deemed for purposes of subclauses (I) and 
                        (II) of clause (i) to have a lower wholesale 
                        acquisition cost than its part D reference drug 
                        or part D reference biological product (so as 
                        to require its inclusion on formularies), 
                        including where no wholesale acquisition cost 
                        is published for such part D reference drug or 
                        part D reference biological product or the part 
                        D reference drug or part D reference biological 
                        product is not available for purchase by the 
                        PDP sponsor (or its network pharmacies) from 
                        its manufacturer at the published wholesale 
                        acquisition cost.
                            ``(iii) Prohibition on certain limits on 
                        access.--The PDP sponsor offering the 
                        prescription drug plan may not impose limits on 
                        access to a part D generic drug required to be 
                        included on the formulary under clause (i)(I) 
                        or a part D biosimilar biological product 
                        required to be included on the formulary under 
                        clause (i)(II), including through prior 
                        authorization, utilization management, or step 
                        therapy, that are more restrictive than any 
                        such limits imposed on access to the part D 
                        reference drug of such part D generic drug or 
                        part D reference biological product of such 
                        part D biosimilar biological product, 
                        respectively, or that otherwise have the effect 
                        of giving preferred status to such part D 
                        reference drug or part D reference biological 
                        product over such part D generic drug or part D 
                        biosimilar biological product, respectively.
                            ``(iv) Definitions.--In this subparagraph 
                        and subparagraph (K):
                                    ``(I) Part d biosimilar biological 
                                product.--The term `part D biosimilar 
                                biological product' means a covered 
                                part D drug that is a biosimilar 
                                biological product (as defined in 
                                section 1847A(c)(6)(H)).
                                    ``(II) Part d generic drug.--The 
                                term `part D generic drug' means a 
                                covered part D drug that is approved 
                                under section 505(j) of the Federal 
                                Food, Drug, and Cosmetic Act.
                                    ``(III) Part d reference biological 
                                product.--The term `part D reference 
                                biological product' means a covered 
                                part D drug that is a reference 
                                biological product (as defined in 
                                section 1847A(c)(6)(I)).
                                    ``(IV) Part d reference drug.--The 
                                term `part D reference drug' means, 
                                with respect to a part D generic drug, 
                                a covered part D drug that is 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 part D generic 
                                drug under such section.
                                    ``(V) Wholesale acquisition cost.--
                                The term `wholesale acquisition cost' 
                                has the meaning given such term in 
                                section 1847A(c)(6)(B).
                    ``(K) Cost-sharing tiering requirements with 
                respect to part d generic drugs and part d biosimilar 
                biological products.--
                            ``(i) Generic drug and biosimilar 
                        biological product cost-sharing tier.--With 
                        respect to a plan year beginning on or after 
                        January 1, 2025, if the PDP sponsor offering 
                        the prescription drug plan applies tiered cost-
                        sharing (through copayment or coinsurance 
                        tiers) to covered part D drugs on a formulary, 
                        the PDP sponsor shall--
                                    ``(I) have at least one cost-
                                sharing tier on the formulary that only 
                                includes part D generic drugs and part 
                                D biosimilar biological products; and
                                    ``(II) with respect to each cost-
                                sharing tier described in subclause (I) 
                                on the formulary, either apply no cost-
                                sharing requirement or a copayment that 
                                is--
                                            ``(aa) in the case where 
                                        the lowest branded drug tier of 
                                        such formulary bases cost-
                                        sharing on a copayment amount, 
                                        an amount at least $20 lower 
                                        than the copayment for such 
                                        lowest branded drug tier (but 
                                        in no case may such copayment 
                                        amount be less than zero); or
                                            ``(bb) in the case where 
                                        the lowest branded drug tier of 
                                        such formulary bases cost-
                                        sharing on a coinsurance 
                                        percentage, an amount at least 
                                        $20 lower than the actuarially 
                                        expected average cost-sharing 
                                        amount payable for the covered 
                                        part D drugs included on such 
                                        lowest branded drug tier, 
                                        determined using processes and 
                                        methods established under 
                                        section 1860D-11(c) (but in no 
                                        case may such copayment amount 
                                        be less than zero).
                            ``(ii) Specialty generic drug and 
                        biosimilar biological product cost-sharing 
                        tier.--With respect to a plan year beginning on 
                        or after January 1, 2025, if the PDP sponsor 
                        offering the prescription drug plan has a 
                        specialty tier, the PDP sponsor shall--
                                    ``(I) have a second specialty tier 
                                on such formulary that only includes 
                                part D generic drugs and part D 
                                biosimilar biological products--
                                            ``(aa) for which the cost 
                                        (as defined by the Secretary) 
                                        is greater than a cost 
                                        threshold specified by the 
                                        Secretary; and
                                            ``(bb) with respect to 
                                        which the part D reference drug 
                                        for such a part D generic drug 
                                        or the part D reference 
                                        biological product for such a 
                                        part D biosimilar biological 
                                        product is either included on a 
                                        cost-sharing tier on such 
                                        formulary with a cost-sharing 
                                        requirement that is greater 
                                        than the cost-sharing 
                                        requirement applied under 
                                        subclause (II), or excluded 
                                        from such formulary; and
                                    ``(II) apply a coinsurance cost-
                                sharing requirement with respect to the 
                                cost-sharing tier required for the 
                                formulary under subclause (I) that is 
                                at least 5 percentage points lower than 
                                the coinsurance percentage applicable 
                                to any other specialty tier of the 
                                formulary.
                            ``(iii) Placement of certain generic drugs 
                        and biosimilar biological products.--Each part 
                        D generic drug and each part D biosimilar 
                        biological product required to be included on 
                        the formulary under subparagraph (J)(i) shall 
                        be included either on a cost-sharing tier 
                        described in clause (i)(I) or, if applicable, 
                        the cost-sharing tier required for the 
                        formulary under clause (ii)(I).
                            ``(iv) Application.--
                                    ``(I) In general.--The requirements 
                                under clauses (i) through (iii) shall, 
                                subject to the requirements under 
                                section 1860D-14, apply after the 
                                individual has satisfied any deductible 
                                under subsections (a)(2)(A)(i) or 
                                (b)(1) of section 1860D-2.
                                    ``(II) Limitation.--The Secretary 
                                shall not approve any benefit design 
                                for a prescription drug plan or an MA-
                                PD plan to which the requirements of 
                                this subparagraph apply if such benefit 
                                design has any deductible applicable to 
                                any part D generic drug or part D 
                                biosimilar biological product unless 
                                such deductible, or a greater 
                                deductible, also applies to all other 
                                covered part D drugs on the formulary 
                                of such plan (subject to the 
                                requirements under section 1860D-14), 
                                except for lesser or zero deductibles 
                                applicable only to particular types of 
                                covered part D drugs which the 
                                Secretary determines warrant favorable 
                                cost-sharing when such lesser or zero 
                                deductibles are also applicable to part 
                                D generic drugs and part D biosimilar 
                                biological products of the given type.
                            ``(v) Definitions.--In this subparagraph:
                                    ``(I) Brand drug.--The term `brand 
                                drug' means a covered part D drug that 
                                is approved under section 505(c) of the 
                                Federal Food, Drug, and Cosmetic Act or 
                                licensed under section 351(a) of the 
                                Public Health Service Act.
                                    ``(II) Lowest branded drug tier.--
                                The term `lowest branded drug tier' 
                                means the cost-sharing tier of a 
                                formulary which includes at least 1 
                                brand drug and provides for the lowest 
                                level of cost sharing applicable to any 
                                such tier, as determined by the 
                                Secretary.
                                    ``(III) Specialty tier.--The term 
                                `specialty tier' means a cost-sharing 
                                tier consisting only of covered part D 
                                drugs that have a cost (as defined by 
                                the Secretary) which equals or exceeds 
                                an applicable cost threshold 
                                established by the Secretary for high-
                                cost covered part D drugs to be 
                                eligible for inclusion on such cost-
                                sharing tier.''.
    (b) Conforming Amendments.--Section 1860D-2 of the Social Security 
Act (42 U.S.C. 1395w-102) is amended--
            (1) in subsection (b)(2)--
                    (A) in subparagraph (A), by striking ``and 
                paragraphs (8) and (9)'' and inserting ``, paragraphs 
                (8) and (9), and section 1860D-4(b)(3)(K)''; and
                    (B) in subparagraph (B), by inserting before the 
                period the following: ``and section 1860D-4(b)(3)(K)''; 
                and
            (2) in subsection (c), by adding at the end the following 
        new paragraph:
            ``(7) Treatment of cost-sharing for part d generic drugs 
        and part d biosimilar biological products.--The coverage is 
        provided in accordance with section 1860D-4(b)(3)(K).''.
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