Maddy summaryThe ORPHAN Cures Act amends the Drug Price Negotiation Program under the Social Security Act to clarify how orphan drugs (medications for rare diseases affecting fewer than 200,000 people in the U.S.) are treated. It ensures that periods when a drug was designated as an orphan drug are excluded from the time calculation used to determine when the drug can no longer be excluded from price negotiations. The bill also updates the definition to allow a single drug to be designated for multiple rare diseases, rather than just one. This change provides clearer rules for manufacturers and the government regarding orphan drug exclusions in the program.
Rep. Scott H. Peters
Sponsored bills
Maddy summaryThe Maintaining Investments in New Innovation Act (HR 5547) extends the exclusivity period for certain advanced drugs from 7 to 11 years. It defines an "advanced drug product" as a drug using genetically targeted technology to change how genes work, such as drugs that suppress or activate gene function. The bill amends the Social Security Act to update the definition of "qualifying single source drug" to include these advanced therapies with the longer exclusivity period. This change directly affects drug manufacturers developing such advanced therapies and influences Medicare's drug coverage rules by delaying generic competition for these specific treatments.
Maddy summaryHR 5376, the Share the Savings with Seniors Act, changes Medicare Part D drug cost-sharing rules for specific chronic medications starting in 2025. It limits what seniors pay for certain chronic care drugs (like anticoagulants, blood glucose regulators, and respiratory medications) by capping pre-deductible costs at the drug's net price and requiring coinsurance after the deductible to be based on that net price. This directly affects Medicare Part D beneficiaries taking these defined chronic medications. The bill aims to reduce out-of-pocket costs by tying payment limits to the negotiated drug price rather than list price or other benchmarks.
Maddy summaryThis bill expands Medicare coverage to include home infusion treatment for people with Alpha-1 Antitrypsin Deficiency Disorder, a genetic condition causing lung and liver damage. It specifically covers "augmentation therapy" (a standard treatment using Alpha-1 Proteinase Inhibitor) when administered in a patient's home by qualified providers. Medicare will pay 80% of the cost for intravenous kits and up to 2 hours of nursing care during these home infusions, starting January 1, 2025. The change directly affects Medicare beneficiaries with this condition who require home-based treatment and their qualified home infusion providers.
Maddy summaryThe LIFT the BAR Act removes barriers preventing lawfully present noncitizens from accessing federal benefits like food assistance, Medicaid, and school meals. It repeals specific 1996 welfare law provisions that excluded noncitizens and updates terminology to replace "alien" with "noncitizen" throughout federal law. The bill expands eligibility to include noncitizens in categories such as Deferred Action for Childhood Arrivals (DACA) recipients, individuals with special immigrant juvenile status, and those with pending U-visa applications. This change ensures more noncitizens lawfully present in the U.S. can access essential services without being denied based on immigration status.
Maddy summaryThis bill requires Medicare to cover genetic counseling services provided by licensed genetic counselors at 85% of the physician payment rate. It defines "genetic counselor" as a state-licensed professional (or meeting federal criteria in non-licensing states) and mandates a new billing modifier for these services starting January 1, 2024. Medicare beneficiaries seeking genetic counseling would gain expanded access to these services under this coverage. The policy change applies to services furnished on or after the effective date, with implementation via interim rule.
Maddy summaryHR 3561, the PATIENT Act of 2023, requires hospitals, health insurance plans, and pharmacy benefit managers to publicly disclose detailed pricing information for healthcare services and drugs. Hospitals must publish standard charges for 300+ shoppable services, including gross charges, payer-specific negotiated rates, and discounted cash prices, with updates required annually. Health plans must provide real-time information on in-network rates, cost sharing, deductibles, and prior authorization requirements for covered services. The bill establishes enforcement mechanisms, including civil monetary penalties for non-compliance, with fines ranging from $300 per day for small hospitals to $5 million for large hospitals that fail to comply with the transparency requirements.
Maddy summaryHR 3589, the Affordability is Access Act of 2023, requires health insurance plans to cover FDA-approved over-the-counter birth control without cost-sharing (like copays or deductibles). It directly affects millions of people who use contraception, particularly low-income individuals and those in areas with limited access to reproductive health services ("contraceptive deserts"). The bill clarifies that existing insurance coverage rules under the Affordable Care Act apply to over-the-counter contraceptives, and directs the FDA to expedite reviews for over-the-counter status. Retailers must not block access to these products but may refuse sales if payment isn’t provided.
Maddy summaryThe FAMILY Act (HR 3481) would establish a national paid family and medical leave insurance program administered by the Social Security Administration. Eligible workers would receive wage replacement benefits (up to 85% of average earnings, with a maximum of $4,000 monthly) for up to 60 caregiving days per 12-month benefit period for qualifying reasons like caring for a sick family member, personal serious health conditions, or responding to domestic violence. The program would be funded through 0.2% payroll taxes from employees and employers (with self-employed individuals paying 0.4%), with benefits coordinated with existing state programs. The law includes protections against employer retaliation for taking leave and requires employers to maintain health coverage during leave periods.
Maddy summaryThis bill would add acupuncture services to Medicare coverage for beneficiaries, specifically defining "qualified acupuncturist services" as those provided by state-licensed acupuncturists or physicians trained in acupuncture. It establishes payment rules allowing these services to be billed under the physician fee schedule, included in hospital inpatient billing, and provided under a doctor's supervision. The bill requires the Secretary of Health and Human Services to set standards for non-licensed practitioners, mirroring nationally recognized certification. It would take effect 270 days after enactment, expanding access to acupuncture for Medicare-covered seniors.