S. 4323

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4323 Introduced in Senate (IS)]

<DOC>

119th CONGRESS
2d Session
S. 4323

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

April 16 (legislative day, April 14), 2026

Mr. Lankford (for himself and Ms. Hassan) 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, 2028, 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, 2028, 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, 2028, 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).''.
<all>