The PBM Reform Act of 2025 aims to increase transparency and fairness in pharmacy benefit manager (PBM) operations within Medicare Part D and Medicaid programs. The bill requires Medicare Part D plans to allow any pharmacy meeting standard terms to join their networks, establishes "essential retail pharmacies" in underserved areas (with limited pharmacy access), and mandates detailed reporting on drug pricing, rebates, and reimbursement rates. It creates a process for pharmacies to report PBM violations of reasonable contract terms and prohibits "spread pricing" in Medicaid, where PBMs retain the difference between what they pay pharmacies and what they charge plans. These provisions aim to improve pharmacy access for Medicare beneficiaries and ensure fairer reimbursement practices for pharmacies.
HR 6509, the SAFE Drugs Act of 2025, limits how often pharmacies and healthcare providers can create custom drug formulations that copy standard medications. It restricts compounding any drug essentially identical to a commercially available product to no more than 20 times per month for individual patients. The bill also requires pharmacies compounding such drugs for out-of-state patients more than 20 times monthly to report details to the FDA, while exempting hospital pharmacies. These changes aim to improve safety oversight of non-standard drug compounding by setting clear limits and reporting rules.
HR 3375, the Fair Prescription Drug Prices for Americans Act, sets a cap on the U.S. list price for prescription drugs and biological products, limiting it to the average price charged in Canada, France, Germany, Italy, Japan, and the United Kingdom. Drug manufacturers must annually report U.S. and international list prices to the Health and Human Services Secretary, who calculates the average price for each drug. Manufacturers violating the price cap face civil penalties equal to 10 times the price difference per unit sold in the U.S. The bill directly affects drug manufacturers by restricting U.S. pricing and imposing financial penalties for noncompliance.
HR 6652, the "U.S. Vets of the FAS Act," requires the Department of Veterans Affairs (VA) to provide telehealth services and mail-order pharmacy deliveries to veterans residing in the Freely Associated States (FAS) - which include the Marshall Islands, Micronesia, and Palau. The bill mandates the VA to establish agreements with FAS governments within one year of enactment and begin offering these services within the same timeframe. It also modifies travel payment rules to require VA to cover beneficiary travel costs starting one year after enactment. The VA must report quarterly on implementation progress and costs to Congress until agreements are finalized and services launched. This bill directly affects veterans in FAS territories and VA operations related to their healthcare access.
HR 44, the Rural 340B Access Act of 2025, would expand eligibility for the federal 340B drug discount program to include specific rural emergency hospitals. It directly affects rural emergency hospitals owned or operated by state/local governments, non-profits with governmental powers, or private non-profits with contracts to serve low-income patients. The bill amends the law to formally add these hospitals as "covered entities" under the 340B program, allowing them to purchase discounted drugs. This change would enable these facilities to access the same drug discounts previously available to other safety-net providers.
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.
