The 340B PATIENTS Act of 2025 clarifies that drug manufacturers must offer discounted prices under the 340B program to covered entities - such as community health centers, hospitals, and clinics - regardless of how or where drugs are dispensed, including through contracted pharmacies. It prohibits manufacturers from imposing restrictions on covered entities, such as limiting delivery locations, requiring extra data, or restricting how discounted drugs are used. The bill also establishes civil penalties for violations, including daily fines of up to $2 million, and allows covered entities to file claims for breaches of these rules. This ensures that covered entities can continue using contract pharmacies to access specialty drugs for patients with chronic or serious conditions.
This bill targets pharmaceutical companies that extend patent protection for the same drug through multiple overlapping patents, a practice sometimes called "evergreening." It creates a presumption that companies must disclaim patent term for subsequent patents covering the same drug after the first patent expires, unless they prove the patents cover truly distinct inventions. The bill also requires the U.S. Patent Office to review its processes to prevent issuing such overlapping patents and report findings within a year. This directly affects pharmaceutical companies holding multiple patents for single drugs and aims to reduce artificial extensions of drug exclusivity, potentially lowering costs for consumers and insurers.
This bill requires the FDA to disclose whether a generic drug's inactive ingredients match those in the brand-name reference drug. It mandates that, upon request from a generic drug applicant, the FDA must confirm if the drugs are "qualitatively and quantitatively the same" in inactive ingredients or specify which ingredients differ and by how much. The policy directly affects generic drug manufacturers seeking FDA approval for their products. This change increases transparency in the drug approval process by providing clear, specific information to applicants about ingredient equivalence.
This bill, S 2770 (Share the Savings with Seniors Act), changes Medicare Part D drug coverage for seniors taking specific chronic medications. It requires that for covered chronic care drugs (like blood glucose regulators, anticoagulants, and certain inhalers), beneficiaries pay no more than the drug’s actual negotiated price (net price) for costs below the deductible, and coinsurance above the deductible must be based on that net price. The rules apply to plan years starting January 1, 2027, directly affecting Medicare Part D enrollees using drugs in the defined categories. The bill clarifies that cost-sharing for these drugs cannot exceed the negotiated price, aiming to reduce out-of-pocket costs for seniors on long-term medications.
The Providing Veterans Essential Medications Act requires the Department of Veterans Affairs to reimburse State homes or provide medications directly for certain high-cost drugs used by veterans in State-run nursing homes. A medication is defined as high-cost if its price (including a 3% fee) exceeds 8.5% of the VA's monthly payment for the veteran's care at that home. This applies specifically to State homes that provide such medications to veterans under VA contracts. The bill ensures veterans receive essential medications without financial burden on the State homes, using clear cost thresholds to determine eligibility.
This bill requires Medicare drug plan sponsors and Medicare Advantage plans to pay long-term care pharmacies (pharmacies serving nursing homes and assisted living facilities) a mandatory $30 supply fee per prescription in 2026, increasing annually in 2027 based on inflation. The fee must be paid separately from existing reimbursements for drug costs or dispensing, and sponsors face $10,000 penalties for non-payment. The government will later reimburse sponsors for these fees through subsidies, paid within 18 months after each plan year. The bill also directs a GAO study on pharmacy payment sustainability in Medicare Part D, focusing on rural access and cost analysis. It directly affects long-term care pharmacies and Medicare drug plan sponsors, aiming to ensure uninterrupted pharmacy services for nursing home residents.
HR 5133, the Patients’ Right to Know Their Medication Act of 2025, requires drug manufacturers to provide standardized printed patient medication information (PMI) with each prescription dispensed in non-hospital settings. This PMI must include clear, plain-language details on drug name, usage instructions, warnings, side effects, storage, disposal, and interactions - formatted consistently with readable text and graphics. The bill directly affects patients receiving prescriptions, ensuring they get accessible, non-promotional printed information to improve safety and reduce errors. The FDA would establish regulations within one year of enactment, mandating that manufacturers include this standardized PMI on prescription drug packaging.
HR 3595, the Safe Prescribing Through Reporting Act of 2025, requires healthcare providers to share certain records about prescribing or dispensing medications for substance use disorder with state prescription drug monitoring programs (PDMPs), but only when state law already mandates such reporting. This bill does not create new reporting requirements but ensures federal law aligns with existing state rules. It directly affects healthcare providers (like doctors and pharmacists) who prescribe or dispense medications for addiction treatment, as they must comply with their state's PDMP reporting rules. The key provision amends federal law to clarify that such disclosures are permissible under applicable state law.
HR 2554, the Lower Drug Costs for Families Act, modifies how Medicare calculates rebates for prescription drugs under Parts B and D. It changes the base year for rebate calculations from 2021 to 2016, which would increase rebates to Medicare by accounting for higher drug price growth since 2016. The bill also adjusts how "commercial market" drug units are counted for rebates, excluding units paid for through Medicaid or other programs. These changes apply to Medicare Part B drugs starting in 2026 and Part D drugs starting in 2025, directly affecting drug manufacturers and Medicare's rebate payments.
The Bipartisan Health Insurance Affordability Act extends and modifies premium tax credit rules to make health insurance more affordable for people with household incomes up to 700% of the poverty line, with specific provisions for different income tiers. The bill requires pharmacy benefit managers to pass through 100% of rebates to health plans, establishes transparency requirements for drug pricing, and creates mechanisms to prevent fraud in health insurance exchanges. It also extends the annual open enrollment period for 2026 and allows qualified Exchange enrollees to establish health savings accounts, with options to prepay annual premiums or direct part of their premium tax credit into a health savings account.
