The 340B ACCESS Act strengthens oversight of the 340B Drug Pricing Program, which allows safety-net hospitals and clinics to purchase outpatient drugs at discounted prices. The bill clarifies who qualifies as a "patient" for 340B discounts, establishes new requirements for hospital child sites and contract pharmacies, and mandates that covered entities implement sliding fee scales to ensure patient affordability based on income. It creates a claims data clearinghouse to prevent duplicate Medicaid discounts and requires covered entities to report detailed data about drug dispensing. These changes aim to ensure 340B discounts reach intended patients while preventing program misuse and ensuring transparency.
This bill would add pharmacist services to Medicare Part B coverage for beneficiaries, specifically covering pharmacist-led testing and treatment for illnesses like flu, COVID-19, or strep throat during public health emergencies. It defines covered services as those performed under state law, often requiring collaboration with a physician, and sets payment at 80% of the lesser of the actual charge or 85% of physician payment rates. Pharmacists would be prohibited from balance billing for these services, ensuring Medicare beneficiaries pay only their standard copayment. The changes would take effect January 1, 2026.
Treat and Reduce Obesity Act of 2025 This bill expands Medicare coverage of intensive behavioral therapy for obesity. Specifically, the bill allows coverage for therapy that is provided by (1) a physician who is not a primary care physician; or (2) other health care providers (e.g., physician assistants and nurse practitioners) and approved counseling programs, if provided upon a referral from, and in coordination with, a physician or primary care practitioner. Currently, such therapy is covered only if provided by a primary care practitioner. The bill also allows coverage under Medicare's prescription drug benefit of drugs used for the treatment of obesity or for weight loss management for individuals who are overweight.
The Combating Illicit Xylazine Act places xylazine - a veterinary sedative increasingly found in illicit drug mixtures - into Schedule III of the Controlled Substances Act, subjecting it to federal regulation as a controlled substance. It specifically allows veterinary use without requiring registration of the ultimate user (e.g., pet owners or veterinarians) if xylazine is dispensed by a registered veterinarian or pharmacy with a vet prescription and used for animals owned by the user, under their care, or in authorized animal programs. The bill provides a one-year delay for labeling and packaging requirements and a 60-day delay for registration and recordkeeping for veterinary use to ease implementation. Additionally, it adds xylazine to the Arcos tracking system for controlled substances and mandates two congressional reports on illicit use prevalence within 18 months and 4 years of enactment.
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.
The Fair Prescription Drug Prices for Americans Act would cap the U.S. list price for prescription drugs and biological products at the average price in Canada, France, Germany, Italy, Japan, and the United Kingdom. Drug manufacturers must annually report U.S. and international prices to the Health and Human Services Secretary, who calculates the six-country average. If a U.S. price exceeds this average, manufacturers face a civil penalty of 10 times the price difference per unit sold. The bill directly targets drug pricing practices without altering drug approval processes or insurance coverage.
This bill, S 641 (Safe and Affordable Drugs from Canada Act of 2025), would allow U.S. individuals to import certain prescription drugs from Canada under specific conditions. It requires drugs to come from FDA-certified Canadian pharmacies, match U.S.-approved drugs in active ingredients and form, be for personal use (not resale) in 90-day quantities, and include a U.S. physician's prescription. The bill excludes controlled substances, biologics, infused drugs, and other high-risk medications. It directly affects U.S. patients seeking lower-cost prescriptions who meet these criteria. The FDA would establish the certification process for Canadian pharmacies within 180 days of enactment.
The HELP Copays Act requires that financial assistance from non-profit organizations or prescription drug manufacturers counts toward patients' annual out-of-pocket cost-sharing limits (like deductibles and copays) for certain prescription drugs. It directly affects individuals enrolled in group health plans or individual insurance who receive such assistance, ensuring payments from these sources reduce their total out-of-pocket spending. The bill amends key healthcare laws to include these payments in calculating cost-sharing thresholds, specifically for specialty drugs and drugs subject to utilization management (like prior authorization). It takes effect for plan years beginning in 2026 and does not change how utilization management tools are applied.
HR 2553, the Capping Prescription Costs Act of 2025, limits out-of-pocket costs for prescription drugs under health insurance. It sets a $2,000 annual cap per individual or $4,000 per family for covered prescriptions starting in 2026, with annual adjustments based on the medical care CPI. The bill applies directly to people with employer-sponsored group health plans, individual health insurance plans, and plans covered under the Affordable Care Act. It requires insurers and plan sponsors to ensure cost-sharing for prescriptions does not exceed these limits, effective for plan years beginning January 1, 2026.
HR 7391, the Community Health Center Drug Pricing Protection Act, requires that Federally Qualified Health Centers (FQHCs) pay the discounted 340B ceiling price for covered drugs **at the time of purchase**, not later through rebates or adjustments. This directly affects FQHCs, which rely on 340B discounts to provide affordable care to low-income patients. The bill amends the Public Health Service Act to prohibit manufacturers from entering agreements where FQHCs initially pay more than the ceiling price, with later reimbursement. It takes effect immediately upon enactment for all new drug purchases and applies to existing agreements starting then.
