Rep. Mike Kelly

Maddy summaryThe PILLS Act creates tax credits to encourage domestic production of generic drugs and biosimilars. It provides a production credit (up to 35% of value added for final drug production) for manufacturers producing eligible drugs in the U.S., with additional bonus credits for domestically sourced materials. The bill also establishes a 25% investment credit for qualified facilities building new production capacity, with both credits phasing out after 2029 and terminating for new construction after 2027. These provisions directly affect U.S. pharmaceutical manufacturers of generic drugs and biosimilars, aiming to increase domestic supply of these medications.

Maddy summaryThis bill amends Medicare, Medicaid, and private insurance rules to improve coverage for drugs treating rare diseases (defined as conditions affecting 200,000 or fewer people in the U.S.). It requires coverage for rare disease drug uses supported by peer-reviewed medical literature and not listed as contraindicated in FDA labeling or medical reference guides. Private insurers must provide expedited review processes for denials of such drugs. The changes apply 30 days after enactment, affecting insurers and patients seeking coverage for rare disease treatments.

Maddy summaryThe Veterans HSA Access Act of 2023 changes IRS rules to allow veterans who receive certain veterans benefits (like disability compensation) but do not have a service-connected disability to contribute to health savings accounts (HSAs). This removes a current barrier preventing these veterans from using HSAs to pay for qualified medical expenses. The policy change applies to tax years starting after December 31, 2025, meaning it will take effect in 2026. It directly affects veterans with non-service-connected health issues who currently cannot use HSAs despite qualifying for other veterans' benefits.

Maddy summaryThis bill, HR 5796, prohibits the Department of Health and Human Services from implementing a proposed rule requiring minimum staffing levels in nursing homes. It creates an advisory panel of 15 members - including rural nursing home staff and experts - to study workforce shortages and report on access barriers for seniors, especially in rural areas. The panel must submit an initial report within 60 days, analyzing staffing challenges and recommending solutions to strengthen the nursing home workforce. These provisions directly aim to prevent nursing home closures (like the 129 that occurred in 2022) that threaten rural seniors’ access to care.

Maddy summaryHR 5777 amends the tax code to clarify that employees using specific on-site clinic services at work are not considered covered by a health plan for health savings account (HSA) eligibility. The bill defines "qualified items and services" to include physical exams, immunizations, preventive care for chronic conditions, drug testing, and hearing/vision screenings provided at employer-operated clinics. This allows employees to access these services without losing their ability to contribute to an HSA. The change applies to taxable years beginning after the bill's enactment.

Maddy summaryThis bill requires health insurance plans (both private and Medicare) to cover routine patient costs for children with rare pediatric diseases participating in approved clinical trials, even when care is provided by non-network providers. Specifically, it mandates that insurers apply the same copay or coinsurance rate for non-participating providers as they would for in-network providers during clinical trial participation. The law expands the definition of "routine costs" to include consultation and referral services related to these trials and updates Medicare coverage rules to align with this requirement. These changes apply to plans beginning January 1, 2024, directly affecting families of children with rare pediatric cancers enrolled in qualifying clinical trials.

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 requires Medicare to improve transparency in its national coverage decision process for medical treatments and devices. It mandates that Medicare (through the Secretary of Health and Human Services) must determine within 30 days if a submission is a complete request for a coverage decision, and if not, provide specific feedback on missing information. Complete requests must be posted publicly on a government website within two business days, and annual reports must include the time between submission and the point when the request was deemed complete. This directly affects healthcare providers, pharmaceutical companies, and medical device manufacturers seeking Medicare coverage for new treatments.

Maddy summaryThis bill clarifies that Medicare must cover external infusion pumps and associated non-self-administrable drugs as durable medical equipment (DME) when specific criteria are met. It directly affects Medicare beneficiaries requiring home infusion therapy for drugs that must be prepared just before use, administered by a healthcare professional, or labeled for external pump use at least monthly. Key provisions require the drug's FDA labeling to specify external pump administration, safe home delivery by qualified suppliers, and preparation/administration requirements. The bill mandates Medicare coverage under existing rules (LCD L33794) for qualifying treatments, effective upon enactment or FDA approval, whichever is later.

Maddy summaryThis bill modifies tax rules for vaccines by adding new vaccines to the list of taxable vaccines under federal law. Specifically, it includes any vaccine placed on the Vaccine Injury Table under the Public Health Service Act, which determines eligibility for compensation for vaccine-related injuries. Manufacturers and distributors will need to account for these vaccines under the tax code once HHS adds them to the injury compensation list. The change affects tax reporting for these specific vaccines but does not alter vaccine access, costs, or the injury compensation program itself.