Drug pricing

Current understanding

Federal action affecting prescription-drug prices — Medicare negotiation, PBM rules, transparency.

Evidence log

• 2026-11-09 — Medicare and Medicaid Programs; CY 2027 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program: CY 2027 Physician Fee Schedule final rule: CMS finalized Medicare prescription drug inflation rebate rules, advancing the previously logged proposal to final status and updating manufacturer rebate obligations without specifying drug-level rebates or beneficiary cost-sharing changes in this finding. (novelty: 4)
• 2026-11-09 — Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program: CMS issued a final rule codifying permanent standards and operational procedures for Medicare drug-price negotiation under the Inflation Reduction Act, including treatment of fixed-combination formulations, advancing the previously logged proposal to final status without specifying individual patient savings in the finding. (novelty: 4)
• 2026-10-29 — To amend title XXVII of the Public Health Service Act to ensure the equitable treatment of covered entities and pharmacies participating in the 340B drug discount program, and for other purposes.: 2026 — House bill to amend PHSA Title XXVII for ‘equitable treatment of covered entities and pharmacies’ in the 340B drug-discount program (introduced, referred to committee): title signals intent to rebalance 340B participant treatment but no substantive mechanism disclosed and no legal effect yet. (novelty: 2)
• 2026-10-22 — Protecting Consumer Access to Generic Drugs Act of 2026: 2026 — Protecting Consumer Access to Generic Drugs Act of 2026 (House, introduced): referred to Energy and Commerce and Judiciary committees; title indicates generic-drug access protections (likely pay-for-delay or patent-abuse related given dual Judiciary referral), with no substantive mechanism disclosed at introduction. (novelty: 2)
• 2026-10-20 — Medicare Program; Implementation of Sections 6219, 6220, and 6224 of the Consolidated Appropriations Act, 2026: 2026 — CMS Proposed Rule implementing CAA 2026 §6224: would add new accountability requirements for pharmacy benefit managers operating in Medicare Part D, building on prior PBM compensation RFI. (novelty: 3)
• 2026-11-02 — Improving Transparency Into Pharmacy Benefit Manager Fee Disclosure: 2026 — DOL final rule on PBM/broker/consultant compensation disclosure to fiduciaries of large self-insured ERISA group health plans: requires reporting of direct and indirect compensation so plan sponsors can evaluate reasonableness of PBM fees, a transparency change limited to the self-insured employer segment. (novelty: 3)
• 2026-07-14 — Cure Hepatitis C Act of 2026: 2026 — Cure Hepatitis C Act of 2026 (introduced): would authorize HHS to negotiate a five-year bulk-purchase contract for hepatitis C antivirals covering multiple federal and state patient populations, a subscription/‘Netflix’-style federal procurement model distinct from Medicare price negotiation or Medicaid rebates. (novelty: 3)
• 2026-10-02 — Global Benchmark for Efficient Drug Pricing (GLOBE) Model: 2026 — GLOBE Model (final rule): CMS launches a mandatory demonstration applying a new ‘global benchmark’ methodology to calculate Part B drug inflation rebates, intended to reduce costs for traditional Medicare and the program while preserving care quality. (novelty: 3)
• 2026-04-16 — Ensuring Access to Lower-Cost Medicines for Seniors Act: 2026 — Ensuring Access to Lower-Cost Medicines for Seniors Act (introduced): fleshes out the bill’s substantive mechanism — mandating Part D formulary inclusion and utilization-management parity for generics/biosimilars vs. brand-name drugs plus specified cost-sharing tiers, aimed at ensuring formulary design preserves lower-cost alternatives’ price advantage. (novelty: 3)
• 2026-04-16 — Medication Competition Act: 2026 — Medication Competition Act (S.4332, 119th Congress, introduced): read twice and referred to Senate HELP Committee; title suggests drug-competition policy but no substantive mechanism disclosed at referral. (novelty: 2) (novelty: 2)
• 2025-05-01 — Affordable and Safe Prescription Drug Importation Act of 2025: 2025 — Affordable and Safe Prescription Drug Importation Act of 2025 (introduced): would require HHS to permit importation of qualifying prescription drugs and biologics from Canada, UK, Switzerland, and EU states without a prior HHS safety/cost certification, and would authorize personal-use imports via licensed foreign pharmacies filling U.S. prescriptions. (novelty: 3) (novelty: 3)
• 2026-07-27 — American Patients First Act of 2026: 2026 — American Patients First Act of 2026 (HR9972, 119th Congress, introduced): referred to House Energy and Commerce and Ways and Means committees; title echoes prior drug-pricing framing but no substantive mechanism disclosed at referral. (novelty: 2)
• 2026-07-21 — Prices on the Wall Act of 2026: 2026 — Prices on the Wall Act of 2026 (HR9390) ordered to be reported as amended by a 24–21 committee vote, advancing a drug price-transparency vehicle out of committee. (novelty: 2)
• 2026-07-21 — Lower Costs, More Transparency Act of 2026: 2026 — Lower Costs, More Transparency Act of 2026 (HR9393) ordered to be reported in the nature of a substitute by unanimous 45–0 committee vote; scope includes drug cost/transparency policy though substantive mechanisms not disclosed at this stage. (novelty: 2)
• 2025-12-18 — American Affordability Act of 2025: 2025 — American Affordability Act of 2025 (HR6900, 119th Congress, introduced): referred to House Ways and Means, Education and Workforce, and Energy and Commerce committees; broad affordability vehicle with no substantive drug-pricing mechanism disclosed at referral. (novelty: 2) (novelty: 2)
• 2026-07-28 — Medication Affordability and Patent Integrity Act: 2026 — Medication Affordability and Patent Integrity Act (S2658, 119th Congress): placed on Senate Legislative Calendar under General Orders; title suggests addressing medication affordability and pharmaceutical patent integrity, though substantive mechanism not disclosed at this stage. (novelty: 2)
• 2026-07-21 — Affordable Prescriptions for Patients Act: 2026 — Affordable Prescriptions for Patients Act (introduced): would cap how many patents a biologic reference-product manufacturer may assert against a biosimilar applicant—especially those filed more than four years after approval—subject to a good-cause exception, aiming to reduce biologic patent thickets that delay biosimilar competition and price relief. (novelty: 2) (novelty: 2)
• 2025-06-24 — Cancer Drug Parity Act of 2025: 2025 — Cancer Drug Parity Act of 2025 (HR4101, introduced): would require health plans to apply comparable patient cost-sharing to orally administered and intravenously administered anticancer drugs, targeting the pharmacy-benefit vs medical-benefit cost differential faced by oral chemotherapy patients. (novelty: 2) (novelty: 2)
• 2026-07-21 — A bill to amend the Public Health Service Act to streamline the review of biosimilar biological products.: 2026-07-21 — S5059 (introduced): would streamline PHSA biosimilar review pathways, with potential downstream implications for biosimilar market entry and price competition against reference biologics; no specific mechanism disclosed at introduction. (novelty: 2)
• 2026-07-15 — Drug Deal Disclosure Act: 2026 — Drug Deal Disclosure Act (HR9699, 119th Congress, introduced): referred to House Energy and Commerce, Ways and Means, and Budget committees; title suggests pharmaceutical drug-deal disclosure/transparency requirements, but no legislative text or mechanism disclosed at introduction. (novelty: 2)
• 2026-04-21 — Drug Deal Disclosure Act: 2026 — Drug Deal Disclosure Act (S4355, 119th Congress, introduced): referred to Senate HELP Committee; title suggests drug-deal transparency/disclosure requirements, but no legislative text or mechanism disclosed at introduction. (novelty: 2)
• 2026-07-21 — Novartis Pharmaceuticals Corporation v. Robert Kennedy, Jr.: 2026-07-21 — Novartis Pharmaceuticals Corporation v. Robert Kennedy, Jr.: D.C. Circuit issued an appellate opinion in pharma-vs-HHS litigation involving Novartis; only case caption and date disclosed, with substantive holdings and implications for federal drug pricing programs not yet detailed. (novelty: 2)
• 2025-11-20 — Lowering Drug Costs for American Families Act: 2025 — Lowering Drug Costs for American Families Act (HR6166, 119th Congress, introduced): referred to House Energy and Commerce, Ways and Means, and Education and Workforce committees; broad drug-cost reduction vehicle with no substantive mechanism disclosed at introduction. (novelty: 2)
• 2026-03-05 — PrEP Access and Coverage Act of 2026: 2026 — PrEP Access and Coverage Act of 2026 (HR7853, introduced): would expand coverage of HIV PrEP drugs across federal health programs, with implications for beneficiary out-of-pocket costs; no specific pricing mechanism disclosed at introduction. (novelty: 2) (novelty: 2)
• 2025-12-04 — HELP Copays Act: 2026 — HELP Copays Act (HR6423, introduced): referred to House Energy and Commerce and Ways and Means committees; addresses patient copay burdens with implications for out-of-pocket drug cost-sharing (no substantive mechanism disclosed at introduction). (novelty: 2) (novelty: 2)
• 2026-07-15 — Pharmaceutical Investment Oversight and Accountability Act: 2024 — Pharmaceutical Investment Oversight and Accountability Act (S4987, introduced): would establish federal oversight and accountability requirements for pharmaceutical-sector investments; no substantive mechanism disclosed at introduction. (novelty: 2)
• 2026-07-15 — Health Care Price Certainty for All Americans Act: 2026 — Health Care Price Certainty for All Americans Act (HR9645) ordered to be reported in the nature of a substitute by a 25–15 committee vote, advancing healthcare price-certainty policy at the committee stage. (novelty: 2)
• 2025-06-10 — Protecting Health Care for All Patients Act of 2025: 2025 — Protecting Health Care for All Patients Act of 2025 (introduced): would bar federal and federally funded health programs from using QALY-based thresholds in coverage or reimbursement determinations, constraining value-assessment methodologies that inform drug pricing and formulary decisions. (novelty: 3)
• 2026-07-16 — Medicare and Medicaid Programs; CY 2027 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program: 2026 — CY 2027 Physician Fee Schedule Proposed Rule: proposes to codify the Medicare Prescription Drug Inflation Rebate Program (IRA 2022) rules governing manufacturer rebates for Part B and Part D drugs whose prices rise faster than inflation. (novelty: 2) (novelty: 2)
• 2026-06-23 — SLASH Prices Act: 2026-06-23 — SLASH Prices Act (HR9371, 119th Congress) introduced with sponsor introductory remarks; no substantive mechanism disclosed at introduction. (novelty: 2)
• 2025-01-03 — Rural 340B Access Act of 2025: 2025 — Rural 340B Access Act of 2025 (introduced): would extend 340B drug pricing program eligibility to rural emergency hospitals, allowing them to purchase outpatient drugs at HRSA-set discounted ceiling prices. (novelty: 2) (novelty: 2)
• 2026-03-27 — Ensuring Access to Lower-Cost Medicines for Seniors Act of 2026.: 2026-03 — Ensuring Access to Lower-Cost Medicines for Seniors Act of 2026 (HR8143, introduced): referred to House Energy and Commerce and Ways and Means; would expand seniors’ access to lower-cost medicines (no substantive detail public at introduction). (novelty: 2)
• 2025-09-18 — Military Construction and Veterans Affairs, Agriculture, and Legislative Branch Appropriations Act, 2026: 2026 — HR3944 (Military Construction and Veterans Affairs, Agriculture, and Legislative Branch Appropriations Act, 2026, introduced): consolidated FY2026 appropriations vehicle providing funding for FDA operations that support drug approval, safety, and market oversight, without new drug-pricing policy mechanisms. (novelty: 2)
• 2026-06-24 — Medicare Cost Cap Act of 2026: 2026 — Medicare Cost Cap Act of 2026 (S4886, introduced): Senate bill referred to Finance Committee proposing Medicare cost caps, potentially affecting beneficiary drug cost exposure. (novelty: 2)
• 2026-06-18 — Request for Information (RFI): Pharmacy Benefit Manager Compensation and Data Collection: 2026 — CMS Request for Information on PBM Compensation and Data Collection: solicits technical input to implement Medicare Part D PBM compensation restrictions and data reporting requirements taking effect in 2028. (novelty: 2)
• 2025-09-11 — Drug Shortage Compounding Patient Access Act of 2025: 2025 — Drug Shortage Compounding Patient Access Act of 2025 (HR5316) introduced: would relax FDA compounding restrictions during shortages (waiving patient-specific and copy-drug limits, extending 503B outsourcing windows to 180 days post-shortage) and require manufacturers of life-sustaining drugs to report demand surges, affecting supply and pricing dynamics for shortage drugs. (novelty: 3) (novelty: 3)
• 2026-05-21 — Transparency in Billing Act of 2026: 2026 — Transparency in Billing Act of 2026 (HR8684) ordered reported as amended by unanimous 34-0 committee vote in the 119th Congress; advances broader healthcare billing transparency requirements that may intersect with prescription drug billing disclosures. (novelty: 2)
• 2025-02-06 — Alternatives to PAIN Act: 2026 — Alternatives to PAIN Act (introduced): would restructure Medicare Part D cost-sharing for non-opioid pain management drugs by eliminating deductibles and mandating lowest-tier placement, effectively lowering beneficiary out-of-pocket costs for these products. (novelty: 3) (novelty: 3)
• 2025-04-03 — Making Insulin Affordable for All Children Act: 2026 — Making Insulin Affordable for All Children Act (HR2636) introduced and referred to House Energy and Commerce, Ways and Means, and Education and Workforce committees; would cap insulin costs for children. (novelty: 2)
• 2026-05-20 — VA National Formulary Act of 2025: 2025 — VA National Formulary Act of 2025 (HR6580) advancing through committee hearings in the 119th Congress; proposes changes to the VA’s national drug formulary system that would affect drug availability and pricing for veterans. (novelty: 2)
• 2026-06-16 — Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program: 2026 — Medicare Drug Price Negotiation Program Proposed Rule: CMS proposes to codify the IRA 2022 negotiation program with new implementing policies, including a modification to the fixed combination drug policy affecting which products fall within a negotiated drug’s scope. (novelty: 3)
• 2026-07-02 — PBM Kickback Prohibition Act: 2026-07-02 — PBM Kickback Prohibition Act (HR7895) placed on the Union Calendar in the 119th Congress, advancing a bill to prohibit kickbacks in pharmacy benefit manager arrangements. (novelty: 2) (novelty: 2)
• 2026-06-25 — Health Data Access, Transparency, and Affordability Act of 2026: 2026 — Health Data Access, Transparency, and Affordability Act of 2026 (HR9228) ordered reported as amended by House committee on an 18-15 vote; addresses health data access and drug affordability. (novelty: 2)
• 2025-07-31 — REMEDY Act: 2025 — REMEDY Act (introduced): would limit the Hatch-Waxman 30-month FDA approval stay to litigation over a single patent selected by the brand-name applicant, curbing multi-patent evergreening that delays generic entry. (novelty: 3) (novelty: 3)
• 2025-04-10 — Prescription Pricing for the People Act of 2025: 2025 — Prescription Pricing for the People Act of 2025 (introduced): would require the FTC to report on anticompetitive practices by PBMs and sole-source drug manufacturers and recommend measures to increase supply chain transparency and consumer savings. (novelty: 2)
• 2025-06-27 — Treat and Reduce Obesity Act of 2025: 2025 — Treat and Reduce Obesity Act of 2025 (introduced): would authorize Medicare Part D coverage of prescription drugs used for chronic weight management, which are currently statutorily excluded. (novelty: 3)
• 2026-03-09 — MVP Act: 2026 — MVP Act (introduced): would codify value-based purchasing arrangements in federal drug pricing, permitting variable best price under Medicaid rebates and carving such sales out of Medicare ASP. (novelty: 3)

Open questions

Related