[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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