This bill prohibits "reverse payment" agreements where brand-name drug companies pay generic or biosimilar manufacturers to delay entering the market, which harms competition. It creates a presumption that such agreements are anticompetitive if a generic or biosimilar company receives value in exchange for delaying market entry, with exceptions for standard settlements involving early market entry rights or reasonable litigation expenses. The bill amends the Federal Trade Commission Act to enforce this new prohibition and requires certification of such agreements, aiming to enhance competition and lower drug costs for consumers. This would directly affect brand-name drug companies, generic manufacturers, and biosimilar biological product manufacturers.
This bill requires drug manufacturers to offer Medicare Part D and Part B patients the lowest price they charge in eight specific countries (Canada, Denmark, France, Germany, Italy, Japan, Switzerland, UK), defined as the "most-favored-nation price." It directly affects drug manufacturers not in a special agreement with Medicare and Medicare beneficiaries who use covered drugs. The model, tested for five years starting in 2029, mandates manufacturers to report pricing data and provide discounts to eligible patients and providers. Manufacturers could avoid the requirement by signing an agreement with Medicare before December 2028. The bill aims to align U.S. drug prices with international averages for certain Medicare-covered drugs.
This bill requires pharmacy benefits managers (PBMs) administering prescription drug benefits for federal employee health plans to reimburse pharmacies at specific rates, including the national average drug cost plus a small percentage or $50, whichever is lower. It prohibits PBMs from favoring their own pharmacies, restricting patient choice, or reducing pharmacy payments after claims are processed. The bill establishes $10,000 civil penalties for violations, with debarment from federal health plans after 10 penalties in 10 years. This directly affects PBMs, in-network pharmacies, and federal health benefit plans covering millions of federal employees and their families. The law aims to ensure fair reimbursement practices and maintain pharmacy choice under the Federal Employees Health Benefits Program.
The Patients Before Middlemen Act (S 882) improves pharmacy access for Medicare beneficiaries by requiring prescription drug plans to allow any pharmacy meeting standard contract terms to join their networks. It establishes "essential retail pharmacies" in medically underserved areas or regions with limited pharmacy access (such as rural areas with no other pharmacies within 10 miles), and creates standards for reasonable and relevant contract terms between drug plans and pharmacies. The bill also increases transparency requirements for pharmacy benefit managers, mandating detailed annual reports on drug costs, rebates, and pricing practices, with many provisions taking effect for plan years beginning January 1, 2028.
This bill establishes new requirements for pharmacy benefit managers (PBMs) working with Medicare Part D prescription drug plans and Medicaid programs. It mandates that PBMs pay pharmacies a specific reimbursement amount based on drug acquisition costs plus a fixed fee, pass through manufacturer rebates directly to beneficiaries at the point of sale, and prohibits steering practices that direct patients to specific pharmacies. The bill applies to Medicare Part D plans and Medicaid managed care organizations beginning January 1, 2027, affecting how PBMs interact with pharmacies and handle drug rebates. Violations could result in criminal penalties of up to $1 million or 10 years in prison for willful noncompliance. The bill aims to increase transparency and fairness in pharmacy drug pricing for Medicare and Medicaid beneficiaries.
HR 5031, the *Preserving Patient Access to Long-Term Care Pharmacies Act*, requires Medicare Part D plans and Medicare Advantage plans with drug coverage (MA-PD) to pay long-term care pharmacies an additional supply fee for each specified prescription dispensed to eligible beneficiaries during 2026 ($30) and 2027 (adjusted for inflation). This fee must be paid alongside existing reimbursements for drug costs and dispensing, with a $10,000 penalty for non-payment. The bill also directs the GAO to study long-term care pharmacy payment sustainability under Medicare, analyzing historical payments for brand/generic drugs and dispensing fees. It aims to ensure uninterrupted pharmacy access for Medicare beneficiaries in long-term care settings, particularly in rural areas.
This bill requires the Federal Trade Commission (FTC) to study how pharmacy benefit managers (PBMs) and other intermediaries affect prescription drug prices and competition. Specifically, the FTC must report within one year on whether PBMs charge different prices to pharmacies, steer patients toward pharmacies they own, use pharmacy data for profit, or design formularies to favor expensive drugs. The bill also mandates an interim report within six months and a separate study on sole-source drug manufacturers and enforcement challenges. It does not directly change drug prices or create new regulations, but instead seeks to gather data to inform potential future policy actions. The study focuses on transparency and competition in the pharmaceutical supply chain, with no immediate price-reducing mechanisms.
S 1302, the "Increasing Transparency in Generic Drug Applications Act," requires the FDA to disclose to generic drug applicants whether their proposed drug matches the brand-name reference drug in inactive ingredients (type and amount). If differences exist, the FDA must specify which ingredients differ and the exact quantitative deviations. The bill mandates the FDA issue guidance within one year on how it determines ingredient similarity, including for pH adjusters, after a 60-day public comment period. This directly affects generic drug manufacturers seeking FDA approval by providing clearer, earlier feedback during the application review process.
S 526, the Pharmacy Benefit Manager Transparency Act of 2025, requires pharmacy benefit managers (PBMs) - the middlemen managing drug coverage for health plans - to disclose financial details and stop unfair practices. It prohibits PBMs from keeping price differences between what they charge health plans and pay pharmacies, arbitrarily clawing back payments, or inflating fees to offset government-mandated changes. PBMs must annually report to the FTC and HHS on rebate sharing, fee structures, formulary changes, and reimbursement differences, including whether drug tier shifts were influenced by manufacturers. This directly affects PBMs, pharmacies, health plans, and patients by increasing transparency in drug pricing and reimbursement.
This bill clarifies and strengthens the 340B drug discount program, which allows community health centers, hospitals, and clinics (covered entities) to purchase medications at discounted prices. It explicitly requires drug manufacturers to offer these discounts regardless of where drugs are dispensed (including through contracted pharmacies) and prohibits manufacturers from adding conditions that restrict how covered entities use these discounts - such as limiting delivery locations or demanding extra data. The bill also establishes civil penalties of up to $2 million per day for manufacturers who violate these rules, and allows covered entities to file claims for violations. This directly affects safety-net providers who rely on 340B savings to access specialty drugs (like cancer treatments) for patients in underserved communities.
