[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1227 Introduced in House (IH)]
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119th CONGRESS
1st Session
H. R. 1227
To amend title XVIII of the Social Security Act to ensure appropriate
access to non-opioid pain management drugs under part D of the Medicare
program.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 12, 2025
Mrs. Miller-Meeks (for herself, Ms. Barragan, Mr. Kelly of
Pennsylvania, and Mr. Panetta) 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 ensure appropriate
access to non-opioid pain management drugs under part D of the Medicare
program.
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 ``Alternatives to Prevent Addiction In
the Nation Act'' or the ``Alternatives to PAIN Act''.
SEC. 2. APPROPRIATE COST-SHARING FOR QUALIFYING NON-OPIOID PAIN
MANAGEMENT DRUGS UNDER MEDICARE PART D.
(a) Medicare Part D.--Section 1860D-2 of the Social Security Act
(42 U.S.C. 1395w-102) is amended--
(1) in subsection (b)--
(A) in paragraph (1)(A), in the matter preceding
clause (i), by striking ``paragraphs (8) and (9)'' and
inserting ``paragraphs (8), (9), and (10)'';
(B) in paragraph (2)(A), in the matter preceding
clause (i), in subparagraph (A), by striking
``paragraphs (8) and (9)'' and inserting ``paragraphs
(8), (9), and (10)''; and
(C) by adding at the end the following new
paragraph:
``(10) Treatment of cost-sharing for qualifying non-opioid
pain management drugs.--
``(A) In general.--For plan years beginning on or
after January 1, 2026, with respect to a covered part D
drug that is a qualifying non-opioid pain management
drug (as defined in subparagraph (B))--
``(i) the deductible under paragraph (1)
shall not apply; and
``(ii) such drug shall be placed on the
lowest cost-sharing tier, if any, for purposes
of determining the maximum co-insurance or
other cost-sharing for such drug.
``(B) Qualifying non-opioid pain management
drugs.--In this paragraph, the term `qualifying non-
opioid pain management drug' means a drug or biological
product--
``(i) that has a label indication approved
by the Food and Drug Administration to reduce
postoperative pain or any other form of acute
pain;
``(ii) that does not act upon the body's
opioid receptors;
``(iii) for which there is no other drug or
product that is--
``(I) rated as therapeutically
equivalent (under the Food and Drug
Administration's most recent
publication of `Approved Drug Products
with Therapeutic Equivalence
Evaluations'); and
``(II) sold or marketed in the
United States; and
``(iv) for which the wholesale acquisition
cost (as defined in section 1847A(c)(6)(B)),
for a monthly supply does not exceed the
monthly specialty-tier cost threshold as
determined by the Secretary from time to
time.''; and
(2) in subsection (c), by adding at the end the following
new paragraph:
``(7) Treatment of cost-sharing for qualifying non-opioid
pain management drugs.--The coverage is provided in accordance
with subsection (b)(10).''.
(b) Conforming Amendments to Cost-Sharing for Low-Income
Individuals.--Section 1860D-14(a) of the Social Security Act (42 U.S.C.
1395w-114(a)) is amended--
(1) in paragraph (1)(D), in each of the clauses (ii) and
(iii), by striking ``Subject to paragraph (6)'' and inserting
``Subject to paragraphs (6) and (7)''; and
(2) by adding at the end the following new paragraph:
``(7) Treatment of cost-sharing or deductible for
qualifying non-opioid pain management drugs.--For plan years
beginning on or after January 1, 2026, with respect to a
covered part D drug that is a qualifying non-opioid pain
management drug (as defined in section 1860D-2(b)(10)(B))--
``(A) the deductible under section 1860D-2(b)(1)
shall not apply; and
``(B) such drug shall be placed on the lowest cost-
sharing tier, if any, for purposes of determining the
maximum co-insurance or other cost-sharing for such
drug.''.
SEC. 3. PROHIBITION ON THE USE OF STEP THERAPY AND PRIOR AUTHORIZATION
FOR QUALIFYING NON-OPIOID PAIN MANAGEMENT DRUGS UNDER
MEDICARE PART D.
Section 1860D-4(c) of the Social Security Act (42 U.S.C. 1395w-
104(c)) is amended--
(1) by redesignating paragraph (6), as added by section
50354 of division E of the Bipartisan Budget Act of 2018
(Public Law 115-123), as paragraph (7); and
(2) by adding at the end the following new paragraph:
``(8) Prohibition on use of step therapy and prior
authorization for qualifying non-opioid pain management
drugs.--
``(A) In general.--For plan years beginning on or
after January 1, 2026, a prescription drug plan or an
MA-PD plan may not, with respect to a qualifying non-
opioid pain management drug (as defined in section
1860D-2(b)(10)(B)) for which coverage is provided under
such plan, impose any--
``(i) step therapy requirement under which
an individual enrolled under such plan is
required to use an opioid prior to receiving
such drug; or
``(ii) prior authorization requirement.
``(B) Step therapy.--In this paragraph, the term
`step therapy' means a drug therapy utilization
management protocol or program that requires use of an
alternative, preferred prescription drug or drugs
before the plan approves coverage for the non-preferred
drug therapy prescribed.
``(C) Prior authorization.--In this paragraph, the
term `prior authorization' means any requirement to
obtain approval from a prescription drug plan prior to
the furnishing of a drug.''.
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