119-S475

Bill is currently in: Senate
Path to Law
House Senate President

119th CONGRESS

1st Session

S. 475

1. Short title
2. Appropriate cost-sharing for qualifying non-opioid pain management drugs under Medicare part D
3. Prohibition on the use of step therapy and prior authorization for qualifying non-opioid pain management drugs under medicare part D

1. Short title

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

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) Treatment of cost-sharing for qualifying non-opioid pain management drugs - 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) Treatment of cost-sharing for qualifying non-opioid pain management drugs - 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.

(2) Treatment of cost-sharing for qualifying non-opioid pain management drugs - 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) Treatment of cost-sharing or deductible for qualifying non-opioid pain management drugs - 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.

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) Prohibition on use of step therapy and prior authorization for qualifying non-opioid pain management drugs - 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.