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. 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. 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. 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 The Workforce Mobility Act of 2023 (S. 220/ H.R. 731) - prohibits the use of non-compete agreements in the context of commercial enterprises except under certain circumstances. Advocacy to exclude select leaders and employees with access to intellectual property and trade secrets from proposed non-competes ban. FTC Non-Compete Clause Proposed Rulemaking (Matter Number P201200) - proposed rule preventing employers from entering into non-compete clauses with workers and requiring employers to rescind existing non-compete clauses. Advocacy to exclude select leaders and employees with access to intellectual property and trade secrets from FTC's proposed rule. 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. Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Purchase Order Prompt Pay - Ensures the VA pays bills in accordance with the law. Public Law No. 115-407 - Veterans Benefits and Transition Act of 2018 - specifically the inclusion and implementation of Rep. Bergman's VA MedSurg Purchasing Stabilization Act - VA device formulary; requires clinical expertise development VHA Directive 2009-053 - Pain care directive - working to increase veteran access to pain specialists and FDA approved alternative treatments in the VHA Public Law No. 113-146 - Veterans Access, Choice, and Accountability Act: Implementation of law to allow veterans to seek healthcare from non-VA facilities if unable to receive care from the VA in a timely manner. 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 2023 (H.R. 1691) - Legislation to create automatic CMS coverage for devices approved via FDA's breakthrough pathway. House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain. 2023 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 in 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
SCI - Science/Technology ENV - Environment/Superfund TRD - Trade (domestic/foreign) TAX - Taxation/Internal Revenue Code LBR - Labor Issues/Antitrust/Workplace TRA - Transportation VET - Veterans HCR - Health Issues
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