The Next GEN Act of 2026 modifies the Drug Price Negotiation Program to include a specific category of medications called engineered cyclic peptides. This change extends the time before these drugs can be negotiated for lower prices from seven years to eleven years. The bill defines these peptides as synthetic, amino acid-based drugs that are self-administered and created using genetic library screening methods. By adjusting the timeline, the legislation directly affects pharmaceutical companies and the government agencies responsible for setting drug prices under the program.
HR 1476, the PLASMA Act, adjusts discount rates for plasma-derived drugs under Medicare Part D starting in 2026. It sets gradually decreasing discount percentages (from 99% down to 90% by 2030) for these specific drugs when beneficiaries reach their annual out-of-pocket spending threshold. The bill directly affects Medicare Part D beneficiaries using plasma-derived biological products (drugs made from human blood or plasma) and the manufacturers of those drugs. Certain drugs for low-income subsidy beneficiaries and small manufacturers are excluded from these discount provisions. The law phases in these changes over several years to align with existing Medicare Part D cost-sharing rules.
HR 1195, the Protect Medicaid Act, prohibits federal Medicaid funds from covering administrative costs related to health benefits provided to unauthorized immigrants who lack lawful immigration status and are ineligible for Medicaid. This directly affects states that currently provide such benefits, requiring them to separate these administrative costs from general Medicaid program expenses. The bill adds a new provision to the Social Security Act clarifying that federal funds cannot be used for these specific administrative costs, while allowing funds for systems designed to enforce this rule. It also mandates an Inspector General report detailing how states separate costs, ensure compliance, finance these programs (e.g., through provider taxes), and the impact on drug pricing for this population.
The EPIC Act of 2025 extends the required time period for negotiating drug prices under the federal program for biologic drugs. It changes the rule so that biologic drug manufacturers must wait at least 11 years after FDA approval before their drug can be included in price negotiations, starting with the 2028 initial price applicability year. This specifically affects biologic drug manufacturers, as the change applies only to biologics (not small-molecule drugs, which already have different rules). The bill modifies Section 1192(e)(1)(A)(ii) of the Social Security Act to implement this longer waiting period. This is a concrete policy change to the timing of drug price negotiations, not a new program or broader policy shift.
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.
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.
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.
This bill exempts certain orally administered drugs from Medicare Part D's manufacturer discount program. Specifically, it excludes drugs that: (1) received FDA approval under the standard new drug application process, and (2) have been granted a narrow CMS exception allowing them to be treated as noninnovator drugs under Medicaid rebates. The exemption applies directly to these specific drugs meeting both criteria, altering how their costs are calculated under Medicare Part D. This change affects drug manufacturers and Medicare beneficiaries by modifying the discount structure for these particular medications.
HR 2197, the "No 340B Savings for Transgender Care Act," prohibits covered entities participating in the federal 340B drug pricing program from using savings from discounted drug purchases to pay for specific transgender healthcare services. The bill amends the Public Health Service Act to ban using 340B savings for sex reassignment surgeries or hormone treatments provided "for the purpose of gender alteration" of transgender individuals. This directly affects hospitals and clinics enrolled in the 340B program, restricting how they allocate funds saved through the program’s discounted drug pricing. The key provision is a targeted restriction on fund usage, not a ban on providing the medical services themselves. The bill focuses on reallocating program savings away from these specific care types.
S 3019, the "No Big Blockbuster Bailouts Act," amends Medicare's drug price negotiation program to change how orphan drugs (treatments for rare diseases) are handled. It raises the revenue threshold from $200 million to $400 million before orphan drugs become subject to price negotiations under Medicare. This directly affects pharmaceutical companies developing drugs solely for rare diseases, as they will face price negotiations only if their annual U.S. revenue exceeds $400 million. The change applies to initial price negotiations starting January 1, 2028.
