HR 4623, the Plain Prescription Prices Act, requires drug companies to include the current list price for a typical 30-day supply or treatment course in all direct-to-consumer television ads for prescription drugs covered by Medicare (Part D) or Medicaid. This applies to ads aired on broadcast, cable, streaming, or satellite TV. The bill mandates that the displayed price must be truthful and reflect the list price as of the first day of the quarter the ad runs. The goal is to provide consumers with clear, upfront pricing information when viewing drug advertisements.
HR 3546, the Prescription Drug Price Relief Act of 2025, directs the Secretary of Health and Human Services to determine if brand-name drug prices are "excessive" by comparing U.S. prices to median prices in Canada, the UK, Germany, France, and Japan, or by evaluating factors like patient population size, drug value, and R&D costs. If a price is deemed excessive, the bill automatically voids the manufacturer’s government-granted drug exclusivity (like patent protections) and allows any company to produce generic versions using the original drug data. New manufacturers must pay a reasonable royalty (capped at IRS average rates for pharma) and sell the drug at a price below the "excessive" level. The bill also requires drug manufacturers to submit detailed annual pricing reports with penalties for non-compliance and creates a public database tracking all excessive price determinations and licensing activity.
HR 5278, the Affordable Inhalers and Nebulizers Act of 2025, limits out-of-pocket costs for patients using prescription inhalers and nebulizers to treat asthma and chronic obstructive pulmonary disease (COPD). The bill requires private health insurance plans, Medicare Part B and Part D, and new payment programs to cover these products with no deductible and a maximum cost of $15 per 30-day supply. It directly affects patients with asthma or COPD who rely on covered inhalers, nebulizers, and related equipment like spacers. The law applies to all specified inhaler products (including medications and administration equipment) and takes effect for plan years beginning January 1, 2026.
Affordable and Safe Prescription Drug Importation Act of 2025 This bill expands the categories of prescription drugs that may be imported into the United States and the countries from which such drugs may be imported. Current law allows the Department of Health and Human Services (HHS) to authorize importation of certain eligible prescription drugs from Canada if HHS certifies that doing so would pose no additional risk to public health and safety, among other requirements. HHS long declined to make the requisite certification, citing safety concerns (e.g., contamination, counterfeiting), but ultimately made the certification in 2020 and has since approved one state plan to import drugs. The bill removes the certification requirement and requires HHS to issue regulations that permit importation of qualifying prescription drugs from the United Kingdom, Switzerland, and member states of the European Union, in addition to Canada. After one year, if HHS determines that importation of drugs from these countries has been conducted safely, HHS may authorize importation from other countries that meet certain requirements. The bill also expands the types of prescription drugs eligible for importation to include, for example, biologics such as insulin. Further, the bill allows individuals to use an eligible licensed foreign pharmacy to fill a U.S.-issued prescription for a qualifying drug for personal use. Currently, an individual seeking to import a prescription drug generally must acquire a waiver from HHS. Finally, the bill imposes criminal penalties for websites that sell counterfeit drugs or dispense drugs without a required prescription.
This bill requires Medicare Advantage and prescription drug plans to reimburse the Department of Veterans Affairs (VA) for health care services provided to veterans enrolled in those plans, including outpatient care, prescription drugs, and inpatient services. It establishes a new process for the VA to recover costs from Medicare plans, requiring these plans to respond to reimbursement claims within 45 days and face penalties for non-compliance, including triple damages for willful violations. The law modifies existing VA authority to recover costs for non-service-connected disabilities by clarifying recovery procedures and requiring Medicare plans to coordinate benefits with VA care. The provisions apply to Medicare plan years beginning January 1, 2026, and directly affect Medicare Advantage organizations and prescription drug plan sponsors that serve veterans. This policy change ensures veterans receive full benefits without double payments by requiring Medicare plans to reimburse the VA for services they cover.
The Protect Beneficiaries from Middlemen Act (HR 5197) limits out-of-pocket costs for Medicare Part D beneficiaries on prescription drugs. Starting in 2027, the bill caps the amount a beneficiary pays for a month’s supply of a covered drug (after meeting the deductible but before reaching the out-of-pocket threshold) at either the drug’s average net price (actual cost to the plan after rebates) or the pharmacy’s standard cash price (what a patient would pay without insurance), whichever is lower. This applies to all Medicare Part D drug plans and aims to prevent beneficiaries from paying more than the drug’s actual cost. The bill also requires a GAO report by January 2029 to evaluate compliance and enforcement of these cost-sharing limits.
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.
This bill requires drug manufacturers to pay rebates to Medicare when their "selected drugs" (cancer and complex therapies subject to negotiated maximum fair prices) are used. Manufacturers must calculate rebates based on the difference between current Medicare payment rates (ASP+6) and new negotiated rates (MFP+6), covering the gap for beneficiaries. This lowers patient coinsurance from the current 20% of ASP+6 to 20% of MFP+6 for these specific drugs during the negotiated price period. The rebates are paid to the Medicare trust fund and apply to Medicare Part B beneficiaries using these drugs, directly affecting drug manufacturers and patients covered under Medicare Part B.
This bill amends training requirements for healthcare professionals who prescribe controlled substances. It expands the list of approved organizations that can provide required training to include the American Academy of Family Physicians, American Podiatric Medical Association, Academy of General Dentistry, and American Optometric Association. The key change adds these groups to the list of entities authorized to develop or deliver training materials for prescribers. This directly affects doctors, dentists, podiatrists, and other licensed prescribers who handle medications like opioids. The law updates existing provisions without changing the core training mandate.
Preserving Patient Access to Home Infusion Act This bill specifically includes pharmacy services and home infusion drugs that are administered without a pump as part of covered home infusion therapy under Medicare. The bill also allows nurses and physician assistants to establish and review the plan of care for home infusion therapy, and it specifies that payment may be made regardless of whether a practitioner is physically present in the home at the time the drug is administered.
