The PLASMA Act (S 694) modifies Medicare Part D drug discount rules for plasma-derived products - biological drugs made from human blood plasma. It establishes a phased reduction in the discount rate these drugs must offer to Medicare beneficiaries, starting at 99% of the negotiated price in 2026 and gradually decreasing to 80% by 2032. This affects manufacturers of plasma-derived drugs covered under Medicare Part D and beneficiaries who meet specific out-of-pocket cost thresholds. The bill excludes certain low-income beneficiaries and small manufacturers from these provisions. The policy change directly alters how drug costs are calculated for these specific medications under Medicare.
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.
The 340B ACCESS Act strengthens oversight of the 340B Drug Pricing Program, which allows safety-net hospitals and clinics to purchase outpatient drugs at discounted prices. The bill clarifies who qualifies as a "patient" for 340B discounts, establishes new requirements for hospital child sites and contract pharmacies, and mandates that covered entities implement sliding fee scales to ensure patient affordability based on income. It creates a claims data clearinghouse to prevent duplicate Medicaid discounts and requires covered entities to report detailed data about drug dispensing. These changes aim to ensure 340B discounts reach intended patients while preventing program misuse and ensuring transparency.
This bill would add pharmacist services to Medicare Part B coverage for beneficiaries, specifically covering pharmacist-led testing and treatment for illnesses like flu, COVID-19, or strep throat during public health emergencies. It defines covered services as those performed under state law, often requiring collaboration with a physician, and sets payment at 80% of the lesser of the actual charge or 85% of physician payment rates. Pharmacists would be prohibited from balance billing for these services, ensuring Medicare beneficiaries pay only their standard copayment. The changes would take effect January 1, 2026.
The Protect Medicaid Act (S 523) prohibits federal Medicaid funds from covering administrative costs for health benefits provided to unauthorized immigrants. It directly affects states that currently offer Medicaid-like benefits to noncitizens ineligible due to immigration status, requiring them to fund these administrative costs themselves. The bill amends the Social Security Act to explicitly ban such federal spending and mandates an Inspector General report detailing how states separate costs, ensure compliance, and finance these programs (e.g., via provider taxes). The report must also analyze drug pricing impacts when unauthorized immigrants receive covered medications through Medicaid or 340B programs. This is a procedural change restricting federal funding, not altering eligibility for Medicaid benefits.
Treat and Reduce Obesity Act of 2025 This bill expands Medicare coverage of intensive behavioral therapy for obesity. Specifically, the bill allows coverage for therapy that is provided by (1) a physician who is not a primary care physician; or (2) other health care providers (e.g., physician assistants and nurse practitioners) and approved counseling programs, if provided upon a referral from, and in coordination with, a physician or primary care practitioner. Currently, such therapy is covered only if provided by a primary care practitioner. The bill also allows coverage under Medicare's prescription drug benefit of drugs used for the treatment of obesity or for weight loss management for individuals who are overweight.
