STEVEN LAPIERRE

2023 Reauthorization of the Federal Aviation Administration - Limitations on aircraft transportation of lithium batteries. House, Senate, Pipeline & Hazardous Materials Safety Admin (PHMSA) Interim Final Rule (IFR) HM 224I. -Issued by PHMSA to revise Hazardous Materials Regulations for lithium cells & batteries transported by aircraft.

American Innovation and R&D Competitiveness Act of 2023 (H.R. 2673), Build It in America Act (H.R. 3938), & American Innovation and Jobs Act (S.866): Research and Development (R&D) Expensing - advocacy for legislation to return to pre-2022 R&D expensing rules. OECD 2 Pillar Framework Implementation- International tax provisions specifically regarding the global minimum tax, including the Defending American Jobs and Investment Act (H.R. 3665) legislation regarding extraterritorial taxation. H.R.7024 - Tax Relief for American Families and Workers Act of 2024: Research and Development (R&D) Expensing - advocacy for legislation to return to pre-2022 R&D expensing rules

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. PFAS-Free Procurement Act of 2023 (S.2283) and Draft Legislation from Sens. Carper and Capito to improve the mitigation and remediation of PFAS contamination.

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. 2024 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 device's 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 & 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 2023 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. FY 2025 Inpatient Prospective Payment System Proposed Rule: Changes to the New Tech Add-On Payment (NTAP) application and acceptance process, including clarification of deadlines and eligibility requirements. Patient Access to Innovative New Technologies Act of 2024 (PAINT Act) (H.R. 7939)- legislation to change the frequency of review of medical devices applying for New Tech Add-On Payments (NTAP). National Plan to End Parkinsons Act (S.1064/H.R. 8585) (Public Law 118-66) - Legislation requiring the Department of Health and Human Services (HHS) to form a public private partnership (Parkinsons Advisory Committee) and to implement a project to support research into prevention, diagnosis, and treatment options for Parkinsons Disease. The Advancing Research for Chronic Pain Act (S.2922/H.R.7164) - this bill would require the Centers for Disease Control and Prevention (CDC) to analyze and regularly publish key population health data on chronic pain which will help guide future policy and research priorities to better treat and manage this disease impacting more than 50 million Americans.

Medical device procurement and supply chain resilience. Ensuring VHA patient access to Med Tech as VHA manages supply chain and upgrades its medical surgery and prosthetics procurement contracting. EPA Rulemaking Restricting use of Ethylene Oxide (EtO) to sterilize medical devices. Advocacy efforts to educate lawmakers on the importance of EtO sterilization and need for VA/DOD to assess potential impact of proposed EPA rules on troop readiness and veteran/military personnel health care. Pain management - working to increase veteran access to multidisciplinary and multimodal pain management to provide for effective non-opioid treatment alternatives.

Sen. Schumer's "SAFE" Innovative Framework and Sens. Thune and Klobuchar's AI Research, Innovation and Accountability Act of 2023 (S.3312) - advocacy and education efforts to ensure that FDA retains regulatory authority over artificial intelligence used in medical devices to avoid any harmful regulations that could impair patient access to devices or hinder innovation. American Privacy Rights Act of 2024 (H.R. 8818) - advocacy for inclusion of an exemption for biomedical research that is compliant with an existing regulatory framework for human subjects research to avoid unintended conflicts and burdens; advocacy for inclusion of an exemption for information maintained by an entity that meets the definition of Health Care Provider under HIPAA to prevent unintended negative impacts on patient care, and avoid unnecessary lawsuits for uses and disclosures of patient data that are enabled under HIPAA and critical to a functioning healthcare system.

BOSTON SCIENTIFIC CORPORATION

BOSTON SCIENTIFIC CORPORATION

BOSTON SCIENTIFIC CORPORATION