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 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services 2022 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 2021 CMS Final Rule "Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary"- advocacy for a new, voluntary Medicare Coverage of Innovative Technology (MCIT) pathway that provides four years of national Medicare coverage for Breakthrough-designated technologies, beginning on the date of FDA market authorization. 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. Food & Drug Administration: advocacy efforts on MDUFA, riders & device shortages Medical Device User Fee Amendments (MDUFA V) - once every five year reauthorization of the medical device user fee amendments 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 2022 Agriculture Appropriations Bill (House) - FDA Funding FY 2022 Agriculture Appropriations Bill (Senate) - FDA Funding FY 2022 Labor HHS Appropriations Bill (House) - Collection of Pain Care Statistics & HHS public awareness campaign on pain management best practices FY 2022 Labor HHS Appropriations Bill (Senate) - Collection of Pain Care Statistics & HHS public awareness campaign on pain management best practices 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 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. 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 Build Back Better Act (BBB) (H.R. 5376) - 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) LBR - Labor Issues/Antitrust/Workplace TRA - Transportation 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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