[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3064 Introduced in Senate (IS)]
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119th CONGRESS
1st Session
S. 3064
To amend title XVIII of the Social Security Act to ensure appropriate
access to non-opioid pain management drugs for chronic pain conditions
under part D of the Medicare program.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
October 28, 2025
Mr. Daines (for himself and Ms. Cantwell) 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 for chronic pain conditions
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 ``Relief of Chronic Pain Act of
2025''.
SEC. 2. APPROPRIATE COST-SHARING FOR QUALIFYING NON-OPIOID CHRONIC 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 ``and (9)'' and inserting
``(9), and (10)'';
(B) in paragraph (2)(A), in the matter preceding
clause (i), by striking ``and (9)'' and inserting
``(9), and (10)''; and
(C) by adding at the end the following new
paragraph:
``(10) Treatment of cost-sharing for qualifying non-opioid
chronic 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 chronic 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 chronic pain management
drugs.--In this paragraph, the term `qualifying non-
opioid chronic pain management drug' means a non-opioid
drug or biological product--
``(i) that has a label indication approved
by the Food and Drug Administration to treat
chronic pain or a chronic pain condition (as
defined in subparagraph (C));
``(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.
``(C) Chronic pain condition.--In this paragraph,
the term `chronic pain condition' means the following
conditions, each characterized by pain persisting for a
period of greater than 3 months:
``(i) Diabetic peripheral neuropathic pain.
``(ii) Endometriosis.
``(iii) Fibromyalgia.
``(iv) Musculoskeletal pain.
``(v) Neuropathic pain.
``(vi) Post-herpetic neuralgia.
``(vii) Trigeminal neuralgia.''; and
(2) in subsection (c), by adding at the end the following
new paragraph:
``(7) Treatment of cost-sharing for qualifying non-opioid
chronic 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 chronic
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 CHRONIC 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 new paragraph:
``(8) Prohibition on use of step therapy and prior
authorization for qualifying non-opioid chronic 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 chronic 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.''.
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