Rep. Richard Hudson

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.

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 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 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 summaryThis bill regulates pharmacy benefit managers (PBMs) working with Medicare Part D prescription drug plans. It prohibits PBMs from earning income based on drug prices or rebates (requiring flat fees instead), mandates equal reimbursement for all network pharmacies, and requires PBMs to report how much of drug rebates they pass through to Medicare plans. The law also mandates annual compliance certifications and requires the government to publish aggregated transparency data (without revealing specific plan details) starting in 2024. These changes directly affect Medicare Part D plans and the seniors who rely on them for prescription drug coverage.

Maddy summaryHR 2707, the MADE in America Act, creates a 25-30% federal tax credit for manufacturers producing specific health products (including drugs, medical devices, personal protective equipment, and diagnostic tools) in designated "distressed zones." These zones are census tracts with over 30% poverty rates that are also designated as qualified opportunity zones. The credit applies to wages paid to employees working in these zones and qualified production costs (like equipment and materials), increasing to 30% if most employees reside locally. It directly affects pharmaceutical and medical device manufacturers operating in eligible low-income areas, aiming to incentivize domestic production of critical health products.

Maddy summaryHR 2667, the "Fighting Trade Cheats Act of 2023," increases penalties for importers who commit customs fraud or gross negligence. It triples civil penalties for fraudulent violations (to three times the domestic value) and raises gross negligence penalties to ten times, while adding five-year import bans for fraud and two-year bans for gross negligence. The bill also allows U.S. businesses, unions, or trade groups harmed by such violations to sue violators in federal court for triple damages, attorney fees, and injunctions against further imports. Additionally, it excludes violators and their affiliated companies from the Importer of Record program, with special rules to block shell companies evading customs laws. This directly affects importers who violate customs laws and U.S. businesses competing with those imports.

Maddy summaryThis bill would require Medicare to cover FDA-approved blood tests that screen for multiple cancers simultaneously (like breast, lung, or colorectal cancer) for beneficiaries. It directly affects Medicare recipients aged 65+ who could access these new screenings once per year, without prior authorization. The key provision adds "multi-cancer early detection screening tests" to Medicare's covered services under Part B, defining them as blood tests analyzing cell-free DNA, while maintaining existing coverage for standard screenings like mammograms. The bill does not change current coverage for individual cancer screenings but ensures Medicare keeps pace with new medical technology.

Maddy summaryThis bill modifies Medicare's rules for clinical laboratory testing to reduce administrative burdens. It requires the use of statistically valid sampling (instead of full reporting) for "widely available" tests - defined as tests costing under $1,000 per test with over 100 labs performing them - to determine payment rates starting in 2026. The bill also delays reporting deadlines until 2027, updates how labs are defined for payment purposes, and adds annual payment increase caps (2.5% for common tests in 2024-2025, rising to 5% by 2028). These changes directly affect Medicare-participating labs, particularly independent and hospital-based labs conducting common tests.

Maddy summaryThis bill expands Medicare Part B coverage to include specific pharmacist services, directly affecting Medicare beneficiaries and pharmacists who provide these services. It adds new coverage for pharmacist evaluations and treatments related to certain illnesses (like COVID-19, flu, or strep throat) and public health emergencies, requiring payment at 80% of the lesser of actual charge or 85% of physician payment rates (100% during emergencies). The bill also prohibits balance billing for these services, ensuring beneficiaries pay only the standard Medicare copayment. These changes aim to improve access to pharmacist care during health crises while aligning payment with existing physician service frameworks.