EPA Rulemaking Restricting Ethylene Oxide (ETO) - Proposed rulemaking to place more-stringent limits on emissions and institute new monitoring requirements for ethylene oxide (ETO). Advocacy efforts include educating lawmakers on the importance of ETO in the sterilization of medical devices and potential shortages of sterile medical devices if EPA's proposed changes are enacted.
Ensuring Patient Access to Critical Breakthrough Products Act of 2025(H.R. 5343 and S.1717) - Legislation to create automatic CMS coverage for devices approved via FDA's breakthrough pathway. (CMS rulemaking for Transitional Coverage of Emerging Technologies (TCET) - advocacy for a new, voluntary Transitional Coverage of Emerging Technologies (TCET) pathway that provides national Medicare coverage for Breakthrough-designated technologies, beginning on the date of FDA market authorization.) The Patient Access to Innovative New Technologies Act (PAINT Act) -- proposed legislation that aims to expand access to new medical technologies by improving the Medicare New Technology Add-on Payment (NTAP) program. It would create a single deadline for products in an alternative pathway, ensure breakthrough devices are eligible for conditional approval under NTAP, and prevent disruption in Medicare beneficiaries' access to new treatments. 2025 Reauthorization of the SUPPORT for Patients and Communities Act - Advocacy for reauthorization of the SUPPORT Act, specifically for FDA approved alternative treatments for Chronic Pain, and medical devices role to address the opioid epidemic. Starting work on the Food and Drug Omnibus Reform Act of 2026 (Public Law 117-328) - advocacy efforts on Medical Device User Fee Amendments (MDUFA) reauthorization, riders, and device shortages. Reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) (Public Law 109-417) - advocacy on risk mitigation plans and voluntary shortage reporting related to medical device supply chains and advocacy for medical research and to foster a new era of medical innovation and prepare for future pandemics and promote health equity. Support passage of the Radiation Oncology Case Rate (ROCR) Value Based Payment Program Act of 2025 - Senate (S. 1031) & (H.R. 2120). This legislation would increase access to patient care, enhance the quality of cancer treatments, encourage innovation, reduce disparities for rural and underserved patients, and lower patient costs by saving Medicare about $200 million over 10 years. The WISeR Model (Wasteful and Inappropriate Service Reduction Model) - Advocacy efforts on inclusions in CMS' WISeR model, which is aimed at reducing inappropriate care and preventing improper payments under Medicare Part B by refining prior authorization processes for traditional fee-for-service Medicare.
Medical device procurement and supply chain resiliency. Ensuring VHA patient access to Med Tech as VHA manages supply chain and upgrades its medical surgery and prosthetics procurement contracting. Pain management - working to increase veteran access to multidisciplinary and multimodal pain management to provide for effective non-opioid treatment alternatives, specifically H.R.6835. VA Authorization Bill of 2025- Specifically, H.R. 6549 The VA Contracting and Procurement Act. This bill would reform VAs contracting process by modernizing medical implant acquisition and consolidating billing for surgical procedures to enhance delivery of care to veterans. FY2027 Appropriations: Advocacy efforts on including report language in Labor-HHS to advance non-opioid, evidence-based pain management and in VA/DoD accounts to support modernization of procurement processes, including a transparent product add cycle and a streamlined single purchase order mechanism. Take Care of American Veterans Act: Specifically advocating for modernizing the VA's prosthetics and implant procurement program by increasing resources, expanding clinical and procurement expertise, and requiring implementation of a nationwide electronic ordering system.
OECD 2 Pillar Framework Implementation - International tax provisions specifically regarding the global minimum tax, including the Defending American Jobs Act (H.R. 591) and the Unfair Tax Prevention Act (H.R.2423), legislation regarding extraterritorial taxation and completion/implementation of the G7 side-by-side agreement.
Supply Chain - advocacy efforts on topics that could potentially impact the medical device supply chain such as decisions made by the United States House Select Committee on Strategic Competition between the United States and the Chinese Communist Party, outbound investments, raw materials, components, export controls, and shortage/supply chain resiliency reporting regulations. Submitted comments for the U.S. Dept of Commerce's investigation to determine the effects on the national security of imports of medical equipment including medical devices. Discussed the unique aspects and critical contributions of the U.S. medical technology sector as related to tariffs and other trade measures on imported medical devices and components and our support for policies that do not harm domestic manufacturing and global competition in the sector.
Issues related to the U.S. House discussion draft of the Great American AI Act (GAAIA) - Advocacy and education efforts on the importance of FDA retaining regulatory authority over AI used in medical devices, and on redundant or potentially harmful regulations that could impair patient access to devices or hinder innovation. Issues related to SECURE Data Act (H.R. 8413) - Advocacy for the inclusion of healthcare-related carveouts with exemptions for HIPAA covered entities and business associates, health records, and certain clinical research and patient-safety data. Also, advocacy for the inclusion of language preempting state frameworks by establishing a single federal standard.
Issues related to FY2027 National Defense Authorization Act (NDAA) (S. 4784 & H.R. 8800) - Advocacy efforts on right to repair (RTR) proposals impacting servicing and repair of medical devices. Specifically, the Reform of Technical Data and Software Rights to Support Competition, Sustainment, and Readiness (section 861 of H.R. 8800), the Modifications to Technical Data Rights (section 804 of S. 4784), and other provisions related to healthcare and proprietary data.