Ensuring Patient Access to Critical Breakthrough Products Act of 2023(H.R. 1691) - Legislation to create automatic CMS coverage for devices approved via FDA's breakthrough pathway. 2025 Reauthorization of the SUPPORT for Patients and Communities Act (Public Law 115-271)- 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. 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. Implementation of the Food and Drug Omnibus Reform Act of 2022 (Public Law 117-328) - advocacy efforts on Medical Device User Fee Amendments (MDUFA) reauthorization, riders, and device shortages. Implementation of the Chips and Science Act (Public Law 117-167) - advocacy to establish a $29 billion fund at the National Science Foundation to fund research in the areas of AI and medical technology. Additional efforts on semiconductor and raw materials shortages, device shortage reporting, resilient supply chain, domestic incentives and Buy America proposals. 21st Century Cures Act 2.0 (CURES 2.0) - legislation to advance medical research and to foster a new era of medical innovation and prepare for future pandemics and promote health equity. 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. FY2025 Impatient Payment System Proposed Rule: Changes to the New Tech Add-On Payment (NTAP) application and acceptance process, including clarification of deadlines and eligibility requirements. 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.
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.
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. H.R. 1990 American Innovation and R&D Competitiveness Act of 2025. H.R. 1 (and Senate Amendment 2360) The One Big Beautiful Bill Act- Maintaining the International Tax regime as established in the 2017 TCJA legislation. Policies include proposed changes to GILTI, specifically Country by Country Reporting, the Section 250 deduction, Roundtripping, Section 899, and to return to pre-2022 R&D expensing rules.
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.
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.
Senate Armed Services Committees Draft National Defense Authorization Act (NDAA) of Fiscal Year 2026 Warrior Right to Repair Act of 2025 Proposal- If enacted this legislation would enforce an expansive right to repair (RTR) policy on any businesses that contract with the Department of Defense. We are engaging in advocacy efforts towards the removal of this provision from the Senate bill in conference and to keep it out of the House Armed Services Committees NDAA legislation. We are educating lawmakers on the critical role of the Food and Drug Administration in maintaining product safety and effectiveness throughout the device lifecycle, and the potential risks associated with third-party servicing of medical technologies.