The SECURE 340B Act strengthens oversight of the drug discount program for safety-net health care providers by establishing clearer definitions for patients and prescribing providers, requiring detailed record-keeping to prove a legitimate patient relationship. The bill introduces strict rules for contract pharmacies, mandating that manufacturers cannot restrict discounts based on their use and requiring full transparency on where these drugs are dispensed. It also expands eligibility for child sites of covered entities while imposing a new community need standard based on geographic vulnerability scores to prevent abuse. To improve program integrity, the legislation creates a centralized data clearinghouse to track claims and prevent duplicate discounts, while simultaneously prohibiting discriminatory practices by insurance companies and pharmacy benefit managers against covered entities. Finally, the Act authorizes new user fees and additional funding for the Health Resources and Services Administration to support expanded audits and enforcement activities.
The CHECK Act of 2026 requires healthcare intermediaries, such as pharmacy benefit managers and third-party administrators, to provide group health plans with quarterly, detailed reports on their pricing formulas, rebates, and fees without charge. This legislation also mandates that these providers supply specific data on alternative payment models and prohibits contract clauses that delay or restrict access to this financial information. Additionally, the bill expands transparency for patients by requiring health plans to send itemized explanations of benefits within 45 days of a payment request and obligating healthcare providers to issue itemized bills that include plain language descriptions, billing codes, and charity care information. These new reporting and billing requirements are designed to help plans verify costs and enable patients to better understand their medical expenses. Non-compliance with these disclosure rules could result in civil penalties of up to $100,000 per day for service providers and up to $10,000 per instance for healthcare facilities.
The Modernizing Opioid Treatment Access Act 2.0 of 2026 allows specific addiction medicine specialists to prescribe methadone for opioid use disorder to be dispensed directly through pharmacies, rather than requiring patients to attend traditional treatment clinics. This change permits these qualified doctors to use telemedicine for patient care and requires that the methadone be in a liquid or dispersible tablet form. While the bill maintains existing clinic-based treatment options, it streamlines access by removing the need for pharmacies to obtain separate registrations to dispense the medication. The law also mandates that patients sign informed consent forms explaining how privacy rules differ between clinic and pharmacy settings, and it requires the Drug Enforcement Administration to report on the program's progress to Congress every year.
This bill requires hospitals, laboratories, imaging centers, and ambulatory surgical centers to publicly post detailed price lists for their services, including standard charges, negotiated rates, and discounted cash prices, starting in 2027. It also mandates that private health insurance plans provide consumers with cost-sharing estimates and publish quarterly data on payment rates to doctors and pharmacies beginning in 2029. Additionally, the legislation requires Medicare Advantage and prescription drug plan sponsors to report ownership details for providers and pharmacies they control, while establishing civil penalties for entities that fail to comply with these transparency rules.
The Preserving Patient Access Act requires health insurance plans to grant special enrollment periods when they remove a doctor from their network or stop covering a specific prescription drug that a patient has used recently. Under this bill, Medicare Advantage and individual market plans must allow individuals to join or switch plans within the same year if their current provider becomes out-of-network after a visit within the last two years or if a covered medication is dropped from the formulary within the last six months. These protections apply to both Medicare Advantage plans and private individual market plans, ensuring that patients can maintain access to their preferred doctors and medications without waiting for the annual open enrollment window. The changes are scheduled to take effect for plan years beginning on or after January 1, 2027.
The Modernizing Opioid Treatment Access Act 2.0 of 2026 allows licensed addiction medicine specialists to prescribe methadone for opioid use disorder to be dispensed directly through pharmacies, rather than requiring patients to visit traditional treatment clinics. Under this bill, these practitioners must use electronic prescribing and can only dispense liquid or dispersible tablet formulations, while pharmacies do not need separate registration to handle these prescriptions. The law also permits telemedicine for maintenance or detoxification treatment and requires doctors to obtain informed consent from patients regarding how privacy protections differ between clinic and pharmacy settings. Additionally, the Attorney General can revoke a doctor's registration if a state requests it, and the Drug Enforcement Administration must report annually on the number of registered providers and pharmacies involved in the program.
The Fair Care Act of 2026 is a comprehensive legislative proposal designed to lower health care costs and improve access by modernizing health savings accounts, expanding insurance coverage options, and increasing transparency in the health care market. The bill directly affects individuals, employers, health insurance issuers, hospitals, and pharmaceutical manufacturers through provisions that allow unused premium tax credits to be deposited into savings accounts, introduce new "copper" insurance plans, and require greater price transparency for hospitals and pharmacy benefit managers. Key mechanisms include the repeal of the employer health insurance mandate, the establishment of a federal reinsurance pool for high-risk individuals, the creation of a conditional approval pathway for drugs treating rare and serious diseases, and the imposition of congressional review procedures for major Food and Drug Administration rules. Additionally, the legislation seeks to promote competition by banning anticompetitive contract terms, regulating co-pay contributions from drug manufacturers, and enforcing stricter price reporting requirements for shoppable medical procedures.
The Access to Innovative Treatments Act of 2026 changes how Medicare reviews decisions to deny or limit coverage for new drugs and biological products. It requires the Medicare administrator to start a review within 90 days of a request, includes a 30-day period for public comments, and mandates a final decision within 120 days that must address those comments. The bill also prevents Medicare from applying old coverage rules to newly approved or licensed drugs if those rules would contradict the current approval. Additionally, it stops prescription drug plans from using outdated coverage decisions to deny payment for new medications. These changes directly affect Medicare beneficiaries, drug manufacturers, and the Medicare program administrators.
The Prior Authorization Reform for Autoimmune and Blood Disorders Act requires group health plans and health insurers to cover specific medications for autoimmune diseases, hemophilia, and Von Willebrand disease without restricting how they are administered. To improve access, the bill limits prior authorization requirements for these drugs to no more than once every 12 months, unless the medication is short-term, classified as an opioid or benzodiazepine, or carries a specific government-mandated risk management strategy. These rules apply to plans governed by federal laws including ERISA, the Public Health Service Act, and the Internal Revenue Code, with coverage beginning for plan years starting on or after January 1, 2027.
This bill creates a new federal commission to set maximum prices for all approved prescription drugs, including insulin and vaccines, starting in 2027. The commission would determine these "fair prices" by considering manufacturing costs, therapeutic benefits, and prices in other countries, while the Health and Human Services Secretary would publish the final prices that drug makers must charge. Manufacturers that sell drugs above these set prices would face significant fines, and the bill grants the government the authority to bypass patent protections to increase drug production if domestic supply is insufficient.
