SMART Prices Act

To amend title XVIII of the Social Security Act to strengthen the drug pricing reforms in the Inflation Reduction Act. 1. Short title This Act may be cited as the Strengthening Medicare and Reducing Taxpayer Prices Act SMART Prices Act 2. Repeal of the Medicare part D noninterference clause Section 1860D–11 of the Social Security Act ( 42 U.S.C. 1395w–111 3. Improvements to the Medicare Drug Price Negotiation Program (a) Acceleration of the selection of negotiation-Eligible drugs (1) In general Section 1192(a) of the Social Security Act ( 42 U.S.C. 1320f–1(a) (A) in paragraph (1)— (i) by striking 10 20 (ii) by inserting and (B) by striking paragraph (2) and redesignating paragraph (3) as paragraph (2); (C) in paragraph (2), as redesignated by subparagraph (B) of this paragraph— (i) by striking 2028, 15 negotiation-eligible drugs 2027 or a subsequent year, 40 negotiation-eligible drugs (ii) by striking ; and (D) by striking paragraph (4). (2) Conforming amendments Section 1192 of the Social Security Act ( 42 U.S.C. 1320f–1 (A) in subsection (b)(2)— (i) in the paragraph heading, by striking and 2027 (ii) by striking and with respect to the initial price applicability year 2027 (B) in subsection (d)(1), in the matter preceding subparagraph (A), by striking or 2027 (b) Improvements to the definition of qualifying single source drug Section 1192(e)(1) of the Social Security Act ( 42 U.S.C. 1320f–1(e)(1) (1) in subparagraph (A)(ii), by striking 7 years 3 years (2) in subparagraph (B)(ii), by striking 11 years 3 years (c) Improvement to the ceiling for maximum fair price Section 1194(c)(3) of the Social Security Act ( 42 U.S.C. 1320f–3(c)(3) (1) in subparagraph (A), by striking 75 percent 76 percent (2) in subparagraph (B), by striking 65 percent 55 percent (3) in subparagraph (C), by striking 40 percent 30 percent

Summary: Strengthening Medicare And Reducing Taxpayer Prices Act or the SMART Prices Act This bill modifies requirements of the Medicare Drug Price Negotiation Program and makes other changes with respect to the prices of prescription drugs under Medicare. Current law requires the Centers for Medicare & Medicaid Services (CMS) to negotiate maximum prices for brand-name drugs that do not have other generic equivalents and that account for the greatest Medicare spending. The CMS must negotiate the prices of 10 drugs that are covered under the Medicare prescription drug benefit in 2026, 15 drugs that are covered under the Medicare prescription drug benefit in 2027, 15 drugs that are covered under the Medicare prescription drug benefit or under Medicare medical services in 2028, and 20 drugs that are covered under the Medicare prescription drug benefit or under Medicare medical services in 2029 and each year thereafter. The bill requires the CMS to negotiate the prices of 20 drugs under the Medicare prescription drug benefit in 2026 and 40 drugs under the Medicare prescription drug benefit or under Medicare medical services in 2027 and each year thereafter. It also (1) shortens the required period of market approval from 7 years and 11 years for drugs and biologics, respectively, to 3 years; and (2) modifies the ceiling for the maximum fair price for short-, extended-, and long-monopoly drugs. The bill also repeals provisions that prohibit the CMS from interfering in negotiations between drug manufacturers, pharmacies, and PDP sponsors (i.e., noninterference clause).