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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7142 Introduced in House (IH)]
<DOC>
118th CONGRESS
2d Session
H. R. 7142
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
January 30, 2024
Mrs. Miller-Meeks (for herself and Mr. Cardenas) 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; FINDINGS.
(a) Short Title.--This Act may be cited as the ``Alternatives to
Prevent Addiction In the Nation Act'' or the ``Alternatives to PAIN
Act''.
(b) Findings.--Congress finds the following:
(1) In 2019, approximately 10 million people misused
prescription opioids.
(2) 3 million U.S. citizens and 16 million individuals
worldwide have had or currently suffer from opioid use disorder
(OUD).
(3) In 2021, the number of overdose deaths involving
opioids was 10 times the number in 1999, and overdoses
involving opioids killed more than 80,000 people in 2021 alone.
(4) Most Medicare beneficiaries are prescribed opioids to
manage post-surgical pain.
(5) Data from 2017 indicates that, of those prescribed an
abundance of opioids, 90% did not properly dispose of the
extra.
(6) A combination of opioid overreliance, improper storage,
and easy access to opioids can worsen the addiction crisis.
(7) 1 study from 2019 found that among young people
misusing opioids, over 55% obtained them from friends or
relatives.
(8) Some individuals require opioids to manage their
condition including for chronic pain and palliative care.
(9) Nothing should interfere with the ability of a health
care provider to prescribe or administer a course of treatment
that is medically appropriate.
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), by striking ``paragraphs
(8) and (9)'' and inserting ``paragraphs (8), (9), and
(10)'';
(B) in paragraph (2)--
(i) in subparagraph (A), by striking
``paragraphs (8) and (9)'' and inserting
``paragraphs (8), (9), and (10)'';
(ii) in subparagraph (C)(i), in the matter
preceding subclause (I), by striking ``and
(9)'' and inserting ``, (9), and (10)''; and
(iii) in subparagraph (D)(i), in the matter
preceding subclause (I), by striking ``and
(9)'' and inserting ``, (9), and (10)'';
(C) in paragraph (3)(A), in the matter preceding
clause (i), by striking ``and (9)'' and inserting
``(9), and (10)'';
(D) in paragraph (4)(A)(i), by striking
``paragraphs (8) and (9),'' and inserting ``paragraphs
(8), (9), and (10),''; and
(E) 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, 2025, 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) that is not a schedule I, II, or
III controlled substance;
``(iv) 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) which is sold or marketed in
the United States; and
``(v) 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)'';
(2) in paragraph (2)--
(A) in subparagraph (B), by striking ``Subject to
paragraphs (8) and (9)'' and inserting ``Subject to
paragraphs (8), (9), and (10)'';
(B) in subparagraph (D), by striking ``Subject to
paragraph (6)'' and inserting ``Subject to paragraphs
(6) and (7)''; and
(C) in subparagraph (E), by striking ``Subject to
paragraph (6)'' and inserting ``Subject to paragraphs
(6) and (7)''; and
(3) by adding at the end the following new paragraph:
``(7) No application of cost-sharing or deductible for
qualifying non-opioid pain management drugs.--For plan years
beginning on or after January 1, 2025, 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 of the Social Security Act (42 U.S.C. 1395w-104) is
amended in subsection (c) by adding at the end the following paragraph:
``(7) Prohibition on use of step therapy and prior
authorization for qualifying non-opioid pain management
drugs.--
``(A) In general.--A prescription drug plan may
not, with respect to a qualifying non-opioid pain
management drug 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.
``(D) Qualifying non-opioid pain management
drugs.--In this paragraph, the term `qualifying non-
opioid pain management drug' has the meaning given that
term in section 1860D-2(b)(10)(B).''.
SEC. 4. RULE OF CONSTRUCTION.
Nothing in the amendments made by this Act may be construed to
limit or interfere with the authority of a health care provider to
prescribe or administer any legally marketed drug to a patient for any
condition or disease within a legitimate health care practitioner-
patient relationship.
<all>
Introduced in House
Introduced in House
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.
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.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
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