HR 6423, the HELP Copays Act, requires health insurance plans and coverage to count financial assistance from non-profits or drug manufacturers toward patient cost-sharing limits like deductibles and copayments. This directly affects patients enrolled in health insurance who receive such assistance for prescription drugs, ensuring the help they get reduces their out-of-pocket costs faster. The bill amends key health laws to mandate that these payments are included when calculating whether a patient has met their deductible or copayment threshold. The change applies to all prescription drugs, including specialty drugs and those subject to prior authorization, but does not alter how insurers manage drug access through tools like step therapy. It takes effect for plan years starting in 2026.
HR 7871 (MVP Act) updates Medicaid drug rebate rules to allow manufacturers to report multiple "best price points" for drugs sold under outcome-based payment arrangements, requiring these arrangements to be offered to all states. It clarifies how average manufacturer price is calculated for such drugs and exempts certain outcome-linked payments from anti-kickback laws. The bill also mandates a GAO study to assess whether these arrangements improve patient access, lower costs, and reduce disparities in drug coverage. This affects Medicaid programs nationwide, drug manufacturers, and patients receiving covered outpatient drugs under Medicaid.
This bill creates a legal safe harbor for generic drug manufacturers, protecting them from patent infringement lawsuits when they market drugs for unpatented uses. It specifically shields companies that submit abbreviated drug applications (like 505(j) applications) and avoid referencing patented conditions of use in their labeling, promotion, or marketing. The key provision ensures that describing a generic drug as therapeutically equivalent to a brand-name product - without referencing the patented use - does not constitute infringement of method-of-use patents. This directly affects generic drug companies and brand-name pharmaceutical firms, clarifying that certain labeling practices (called "skinny labels") are legally permissible under patent law.
Protecting Pharmacies in Medicaid Act This bill provides funds beginning in FY2026 for the Centers for Medicare & Medicaid Services to survey retail and non-retail pharmacies (e.g., mail-order pharmacies) to determine average prices of covered outpatient drugs under Medicaid. Pharmacies that fail to participate in the surveys are subject to civil penalties. The bill additionally provides funds for FY2026 for the Office of the Inspector General of the Department of Health and Human Services to study the results of the survey and report accordingly to Congress. The bill also requires pass-through pricing models, and prohibits spread-pricing, for payment arrangements with pharmacy benefit managers under Medicaid.
This bill repeals two specific provisions from the 2023 "Trump Sick Tax Act" (Public Law 119-21) that affected Medicaid and drug pricing. It restores previous Medicaid cost-sharing rules under Title XIX of the Social Security Act and reverts changes to orphan drug exclusions under the Drug Price Negotiation Program (Title XI). These changes directly affect Medicaid beneficiaries and pharmaceutical manufacturers by returning to the pre-2023 policy framework for cost-sharing and drug pricing negotiations. The bill does not create new programs but reverses specific cost-related provisions enacted in 2023.
This bill, S 2756 (Affordable Inhalers and Nebulizers Act of 2025), sets a $15 monthly cost cap for specified inhaler products used to treat asthma and COPD under private insurance, Medicare Part B, and Medicare Part D plans. It requires insurers to cover these products without deductibles and counts any cost-sharing toward the annual out-of-pocket maximum. The bill also creates a new program to pay for these products for uninsured individuals starting in 2026, with providers agreeing not to bill patients more than $15 per month. It directly affects patients with asthma or COPD who rely on prescribed inhalers or nebulizers, ensuring predictable, low-cost access to these essential treatments.
S 475, the Alternatives to PAIN Act, changes Medicare Part D coverage to make non-opioid pain management drugs more accessible and affordable for beneficiaries. It requires Medicare plans to cover qualifying non-opioid pain drugs without deductibles and place them on the lowest cost-sharing tier (meaning patients pay the least out-of-pocket) starting in 2026. The bill also prohibits plans from requiring step therapy (forcing patients to try opioids first) or prior authorization for these specific drugs. Qualifying drugs must treat acute pain (like post-surgery), not work on opioid receptors, have no equivalent alternatives, and meet cost thresholds. This directly affects Medicare Part D beneficiaries needing pain management and the plans that cover them.
HR 3222, the SMART Health Care Act, aims to improve Medicare efficiency and affordability. It requires Medicare Advantage plans to use two years of diagnostic data for risk adjustment starting in 2026, affecting how these plans are funded. The bill also implements site-neutral payments for outpatient services (ending exceptions after 2025) and mandates that covered entities provide Medicare patients with drugs at the purchase price minus discounts, with public reporting of pricing data. These changes directly impact Medicare Advantage insurers, hospitals, outpatient departments, and drug providers, focusing on cost control and transparency.
The Access to Birth Control Act (S 2302) requires pharmacies to provide contraception without delay when available and to help customers obtain it if out of stock - either by referring to another pharmacy or expediting an order. It prohibits pharmacies from intimidating customers, misrepresenting availability, breaching confidentiality, or refusing to return valid prescriptions for contraception. Exceptions allow pharmacists to decline service only if a prescription is missing, the customer cannot pay, or they use professional clinical judgment. Violations may result in civil penalties of up to $1,000 per day or private lawsuits by affected individuals.
This bill temporarily allows doctors to prescribe and dispense certain Medicare-covered medications directly to seniors in their offices from 2026 to 2030, under specific conditions. It requires prior in-person visits, limits dispensing to group practices, and mandates billing through the physician’s practice. The bill also directs the GAO to study whether physician-owned pharmacies are becoming common and how such arrangements might affect prescribing. It directly affects seniors receiving Medicare Part D drugs and physician practices participating in these arrangements. The exception expires in 2030, with no changes to Medicare Part D program rules.
