Alternatives to PAIN Act

This Act may be cited as the Alternatives to Prevent Addiction In the Nation Act or the Alternatives to PAIN Act.

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.

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:

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.

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.

(E) ; and

(2) in subsection (c), by adding at the end the following new paragraph:

The coverage is provided in accordance with subsection (b)(10).

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:

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.