Breakthrough Pathway - 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 Public Law 115-271 SUPPORT for Patients and Communities Act - Specifically, advocacy for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic. HR 1580 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for certain interventional pain therapies to be conducted via telehealth 2023 Physician Fee Schedule - educating Members of Congress on unintended consequences of CMS's proposed update to labor inputs and how they impact medical services with high supply costs relative to labor 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. Food & Drug Administration: advocacy efforts on MDUFA, riders & device shortages Food & Drug Amendments of 2022 (H.R. 7667) - Medical Device User Fee Amendments (MDUFA V) once every five year reauthorization of the medical device user fee amendments MDUFA V Riders - device shortages, emerging signals, charge protocols & cybersecurity. Medical Device Supply Chain: USICA (S.1260) and Endless Frontier Act (HR2731) and Implementation of CARES Act -- Semiconductor and raw materials shortages, device shortage reporting, resilient supply chain, domestic incentives and Buy America proposals. USICA: United States Innovation & Competition Act of 2021 (S.1260) - advocacy to establish a $29 billion fund at the National Science Foundation to fund research in the areas of AI and medical technology CURES 2.0 Act (H.R. 6000)- 21st Century Cures Act 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 PREVENT Pandemics Act (S.3799) - advocacy on risk mitigation plans and voluntary shortage reporting related to medical device supply chains America COMPETES Act of 2022 (H.R. 4521) - advocacy to establish a $29 billion fund at the National Science Foundation to fund research in the areas of AI and medical technology FY 2023 Agriculture Appropriations Bill (House) - FDA Funding FY 2023 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2023 Labor HHS Appropriations Bill (House) - Report language encouraging CMS to extend expiring New Technology Add-On Payments (NTAPs) & Transitional Pass-Through Payments (TPTs) expiring during Public Health Emergency for an additional year FY 2023 Labor HHS Appropriations Bill (Senate) - Report language encouraging CMS to extend expiring New Technology Add-On Payments (NTAPs) & Transitional Pass-Through Payments (TPTs) expiring during Public Health Emergency for an additional year Implementation of task force recommendations 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. National Pain Strategy - Encouraging adaption of the NIH's National Pain Strategy Medial device supply chain procurement - VHA patient access to Med Technology as VHA migrates to new sourcing methodology Implementation of Comprehensive Addiction and Recovery Act (CARA) law to improve the quality of Pain Care provided to veterans. 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 United States-Mexico-Canada Agreement (USMCA) - Supporting passage of updated agreement to reflect current trade investment environment for Medical Devices Countries specific market access issues - India price controls and China market access issues Tariffs Limitations on aircraft transportation of lithium batteries H.R. 4, S. 1405, and Public Law 115-254 - Federal Aviation Administration Re-authorization Act of 2018 - 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 Coronavirus Response and Relief Supplemental Appropriations Act, 2021, (CRRSA) Public Law 116-260 - Advocacy to secure medical device supply chain & prevent device shortages HR 5 the Equality Act - to prohibit discrimination on the basis of sex, gender identity, and sexual orientation in a wide variety of areas including public accommodations and facilities, education, federal funding, employment, housing, credit, and the jury system. Build Back Better Act (BBB) (H.R. 5376 & Senate Reconciliation Bill) - International tax provisions specifically changes to GILTI (Global Intangible Low-Taxed Income), interest deductions, and R&D expense deductibility USICA: United States Innovation & Competition Act of 2021 (S.1260) - advocacy for the inclusion of legislation to return to pre-2022 R&D expensing rules
HCR - Health Issues BUD - Budget/Appropriations VET - Veterans TRD - Trade (domestic/foreign) TRA - Transportation LBR - Labor Issues/Antitrust/Workplace TAX - Taxation/Internal Revenue Code
136 - Centers For Medicare and Medicaid Services (CMS) 2 - HOUSE OF REPRESENTATIVES 18 - Office of Management & Budget (OMB) 1 - SENATE 2 - HOUSE OF REPRESENTATIVES 1 - SENATE 2 - HOUSE OF REPRESENTATIVES 1 - SENATE 2 - HOUSE OF REPRESENTATIVES 1 - SENATE 2 - HOUSE OF REPRESENTATIVES 1 - SENATE 2 - HOUSE OF REPRESENTATIVES 1 - SENATE 2 - HOUSE OF REPRESENTATIVES 1 - SENATE
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