[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2846 Introduced in House (IH)]
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117th CONGRESS
1st Session
H. R. 2846
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
April 26, 2021
Mr. McKinley (for himself, Ms. Kuster, Mr. Tonko, Mr. Carter of
Georgia, Ms. Bass, and Ms. Matsui) 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 2021''.
SEC. 2. REQUIREMENTS FOR PDP SPONSORS OF PRESCRIPTION DRUG 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:
``(I) 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, 2022, the
formulary shall include--
``(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) each covered biosimilar
biological product 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 prior
authorization, utilization management, 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 giving preferred
status 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) Reference biological
product.--The term `reference
biological product' has the meaning
given such term in section
1847A(c)(6)(I).
``(IV) 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.
``(V) Wholesale acquisition cost.--
The term `wholesale acquisition cost'
has the meaning given such term in
section 1847A(c)(6)(B).
``(J) Cost-sharing tiering requirements with
respect to covered generic drugs and covered biosimilar
biological products.--
``(i) Generic drug cost-sharing tier.--With
respect to a plan year beginning on or after
January 1, 2022, the PDP sponsor offering the
prescription drug plan shall--
``(I) have at least one cost-
sharing tier on the formulary that only
includes covered generic drugs and
covered biosimilar biological products;
and
``(II) apply a cost-sharing
requirement with respect to each cost-
sharing tier described in subclause (I)
on the formulary that is meaningfully
lesser than the lowest cost-sharing
requirement applicable with respect to
any cost-sharing tier on such formulary
that includes a brand drug (referred to
in this subparagraph as the `lowest
brand drug cost-sharing tier').
``(ii) Specialty generic drug cost-sharing
tier.--With respect to a plan year beginning on
or after January 1, 2022, if the PDP sponsor
offering the prescription drug plan has a cost-
sharing tier for specialty brand drugs on the
formulary, the PDP sponsor shall--
``(I) have a cost-sharing tier on
such formulary that only includes
covered generic drugs and covered
biosimilar biological products--
``(aa) for which the
wholesale acquisition cost is
greater than a threshold
specified by the Secretary; and
``(bb) with respect to
which the reference drug for
such a covered generic drug or
the reference biological
product for such a covered
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 cost-sharing
requirement with respect to the cost-
sharing tier required for the formulary
under subclause (I) that is
meaningfully lesser than the cost-
sharing requirement applicable with
respect to the cost-sharing tier for
specialty brand drugs on such
formulary.
``(iii) Placement of certain generic drugs
and biosimilar biological products.--Each
covered generic drug and each covered
biosimilar biological product required to be
included on the formulary under subparagraph
(I)(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) Definitions.--In this subparagraph:
``(I) Brand drug.--The term `brand
drug' means a covered part D drug that
is a drug described in section 1860D-
2(e)(1)(A) and approved under section
505(c) of the Federal Food, Drug, and
Cosmetic Act.
``(II) Meaningfully lesser.--The
term `meaningfully lesser' means--
``(aa) for purposes of
subclause (II) of clause (i),
such a lesser cost-sharing
requirement that the Secretary
determines will likely
significantly incentivize the
utilization of covered generic
drugs and covered biosimilar
biological products on a cost-
sharing tier described in
subclause (I) of such clause on
a formulary over covered part D
drugs on the lowest brand drug
cost-sharing tier on such
formulary; and
``(bb) for purposes of
subclause (II) of clause (ii),
such a lesser cost-sharing
requirement that the Secretary
determines will likely
significantly incentivize the
utilization of covered generic
drugs and covered biosimilar
biological products on the
cost-sharing tier required for
the formulary under subclause
(I) of such clause over covered
part D drugs on the cost-
sharing tier for specialty
brand drugs on such formulary.
``(III) Specialty brand drug.--The
term `specialty brand drug' means a
brand drug for which the wholesale
acquisition cost is greater than a
threshold specified by the
Secretary.''.
(b) Conforming Amendment.--Section 1860D-2(b)(2)(B) of the Social
Security Act (42 U.S.C. 1395w-102(b)(2)(B)) is amended by inserting
before the period the following: ``and section 1860D-4(b)(3)(J)''.
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