Alternatives to Prevent Addiction In the Nation Act or the Alternatives to PAIN Act
This bill reduces cost-sharing and prohibits the imposition of certain utilization requirements under the Medicare prescription drug benefit for certain non-opioid pain management drugs.
Specifically, the bill requires such drugs to be covered without a deductible and to be placed on the lowest cost-sharing tier (if any). The bill also prohibits the imposition of prior authorization requirements (i.e., requiring prior approval from a plan) or step therapy requirements (i.e., requiring the use of alternative drugs before a drug is covered under a plan) with respect to such drugs.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 475 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 475
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 SENATE OF THE UNITED STATES
February 6 (legislative day, February 5), 2025
Mr. Tillis (for himself, Mr. Kelly, Mrs. Capito, Mr. Kaine, Mrs. Britt,
Mrs. Shaheen, Mr. Budd, Mr. Coons, Mr. Cornyn, Mr. Booker, Mr. Moran,
Mr. Bennet, Mr. Banks, Mr. Padilla, Mr. Daines, Mr. Warner, and Mrs.
Hyde-Smith) 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 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), 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)
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 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 plan prior to the furnishing of
a drug.''.
<all>
Introduced in Senate
Read twice and referred to the Committee on Finance.
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