ISAAC FORDJOUR

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 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. Medical Device User Fee Amendments (MDUFA V) - once every five year reauthorization of the medical device user fee amendments USICA - 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 - 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

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 CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services 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: Implementation of CARES Act and Endless Frontiers Act -- Device Shortages, Resilient Supply Chain, Domestic Incentives and Buy America Medical Device User Fee Amendments (MDUFA V) - once every five year reauthorization of the medical device user fee amendments USICA - 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 - 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

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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. 2020 proposed OPPS rule - Telehealth and C-APC changes for Interspinous Decompression HR 1580 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Coronavirus Response and Relief Supplemental Appropriations Act, 2021, (CRRSA) Public Law 116-260: Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency 2021 Proposed CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services 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: Implementation of CARES Act and Endless Frontiers Act -- Device Shortages, Resilient Supply Chain, Domestic Incentives and Buy America

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. Medical Device User Fee Amendments (MDUFA V) - once every five year reauthorization of the medical device user fee amendments USICA - 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

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. Medical Device User Fee Amendments (MDUFA V) - once every five year reauthorization of the medical device user fee amendments USICA - 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

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 CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 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. Medical Device User Fee Amendments (MDUFA V) - once every five year reauthorization of the medical device user fee amendments USICA - 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 - 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

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.

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.

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.

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) - International tax provisions specifically changes to GILTI (Global Intangible Low-Taxed Income), interest deductions, and R&D expense deductibility

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. Medical Device User Fee Amendments (MDUFA V) - once every five year reauthorization of the medical device user fee amendments USICA - 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

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. Medical Device User Fee Amendments (MDUFA V) - once every five year reauthorization of the medical device user fee amendments USICA - 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

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 CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 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. Medical Device User Fee Amendments (MDUFA V) - once every five year reauthorization of the medical device user fee amendments USICA - 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 - 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

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

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

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

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

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

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

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

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

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act- Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule- Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Yet-to-be released COVID Stimulus Bill (House & Senate):Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act - Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule - Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Yet-to-be released COVID Stimulus Bill (House & Senate): Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency 2021 Proposed CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services S4473/HR7956 Critical Medical Infrastructure Right to Repair Act of 2020 - To allow non-manufacturer repair technicians to maintain and repair essential medical equipment during the COVID-19 pandemic, and temporarily suspend restrictions.

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act - Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule - Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Coronavirus Response and Relief Supplemental Appropriations Act, 2021, (CRRSA) Public Law 116-260: Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency 2021 Proposed CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services S4473/HR7956 Critical Medical Infrastructure Right to Repair Act of 2020 - To allow non-manufacturer repair technicians to maintain and repair essential medical equipment during the COVID-19 pandemic, and temporarily suspend restrictions. 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.

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act- Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule- Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain.

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act- Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule- Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain.

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act- Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule- Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Yet-to-be released COVID Stimulus Bill (House & Senate):Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act - Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule - Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Coronavirus Response and Relief Supplemental Appropriations Act, 2021, (CRRSA) Public Law 116-260: Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency 2021 Proposed CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services S4473/HR7956 Critical Medical Infrastructure Right to Repair Act of 2020 - To allow non-manufacturer repair technicians to maintain and repair essential medical equipment during the COVID-19 pandemic, and temporarily suspend restrictions. 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.

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act - Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule - Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Yet-to-be released COVID Stimulus Bill (House & Senate): Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency 2021 Proposed CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services S4473/HR7956 Critical Medical Infrastructure Right to Repair Act of 2020 - To allow non-manufacturer repair technicians to maintain and repair essential medical equipment during the COVID-19 pandemic, and temporarily suspend restrictions.

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.

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.

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.

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.

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act- Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule- Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Yet-to-be released COVID Stimulus Bill (House & Senate):Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act - Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule - Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Coronavirus Response and Relief Supplemental Appropriations Act, 2021, (CRRSA) Public Law 116-260: Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency 2021 Proposed CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services S4473/HR7956 Critical Medical Infrastructure Right to Repair Act of 2020 - To allow non-manufacturer repair technicians to maintain and repair essential medical equipment during the COVID-19 pandemic, and temporarily suspend restrictions. 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.

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act - Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule - Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Yet-to-be released COVID Stimulus Bill (House & Senate): Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency 2021 Proposed CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services S4473/HR7956 Critical Medical Infrastructure Right to Repair Act of 2020 - To allow non-manufacturer repair technicians to maintain and repair essential medical equipment during the COVID-19 pandemic, and temporarily suspend restrictions.

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act- Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule- Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain.

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act - Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule - Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Coronavirus Response and Relief Supplemental Appropriations Act, 2021, (CRRSA) Public Law 116-260: Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency 2021 Proposed CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services S4473/HR7956 Critical Medical Infrastructure Right to Repair Act of 2020 - To allow non-manufacturer repair technicians to maintain and repair essential medical equipment during the COVID-19 pandemic, and temporarily suspend restrictions. 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.

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act - Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule - Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Yet-to-be released COVID Stimulus Bill (House & Senate): Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency 2021 Proposed CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services S4473/HR7956 Critical Medical Infrastructure Right to Repair Act of 2020 - To allow non-manufacturer repair technicians to maintain and repair essential medical equipment during the COVID-19 pandemic, and temporarily suspend restrictions.

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act - Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule - Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Coronavirus Response and Relief Supplemental Appropriations Act, 2021, (CRRSA) Public Law 116-260: Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency 2021 Proposed CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services S4473/HR7956 Critical Medical Infrastructure Right to Repair Act of 2020 - To allow non-manufacturer repair technicians to maintain and repair essential medical equipment during the COVID-19 pandemic, and temporarily suspend restrictions. 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.

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act - Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule - Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes HR 5833 to Amend Title XVIII of the Social Security Act - Allows psychological evaluation required for preauthorization for certain interventional pain therapies to be conducted via telehealth Public Law 116-136 Coronavirus Aid Relief & Economic Security (CARES) Act - Legislation to support businesses of all sizes, cash support for citizens, and monetary relief for health care providers & hospitals, telehealth expansion. Specifically, advocacy for funding to help health providers offset expenses and lost revenue related to the pandemic; medical device shortages reporting for public health emergencies, grants for COVID-19 medical countermeasures; and air transport provisions to maintain medical device supply chain. Yet-to-be released COVID Stimulus Bill (House & Senate): Emergency waiver to increase the frequency of application review of CMS's New Tech Add-on Payment program during the Public Health Emergency 2021 Proposed CMS OPPS Rule - Requesting that CMS not finalized new prior authorization requirements in Medicare Part A. 2021 Proposed Physician Fee Schedule - Adding telehealth services approved for use during the Public Health Emergency to the list of permanently authorized telehealth services S4473/HR7956 Critical Medical Infrastructure Right to Repair Act of 2020 - To allow non-manufacturer repair technicians to maintain and repair essential medical equipment during the COVID-19 pandemic, and temporarily suspend restrictions.

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

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

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 Yet-to-be released COVID Stimulus Bill (House & Senate)- Advocacy to secure medical device supply chain & prevent device shortages

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.

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

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.

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 Yet-to-be released COVID Stimulus Bill (House & Senate)- Advocacy to secure medical device supply chain & prevent device shortages

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

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act- Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule- Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes

Public Law 115-97 - Implementation of Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition, base erosion, International Tax Reform Provisions, and tax Extender Provisions S.692 Protect Medical Innovation Act of 2019 - Bill to repeal the 2.3% Medical Device Tax HR 2207 - House companion bill to repeal the 2.3% Medical Device Tax HR 1865 Further Consolidated Appropriations Act, 2020 - House end of year spending bill which included repeal of the 2.3% Medical Device Tax

Public Law 115-97 - Implementation of Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition, base erosion, International Tax Reform Provisions, and tax Extender Provisions S.692 Protect Medical Innovation Act of 2019 - Bill to repeal the 2.3% Medical Device Tax HR 2207 - House companion bill to repeal the 2.3% Medical Device Tax HR 1865 Further Consolidated Appropriations Act, 2020 - House end of year spending bill which included repeal of the 2.3% Medical Device Tax

Public Law 115-97 - Implementation of Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition, base erosion, International Tax Reform Provisions, and tax Extender Provisions S.692 Protect Medical Innovation Act of 2019 - Bill to repeal the 2.3% Medical Device Tax HR 2207 - House companion bill to repeal the 2.3% Medical Device Tax

Public Law 115-97 - Implementation of Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition, base erosion, International Tax Reform Provisions, and tax Extender Provisions S.692 Protect Medical Innovation Act of 2019 - Bill to repeal the 2.3% Medical Device Tax HR 2207 - House companion bill to repeal the 2.3% Medical Device Tax

Public Law 115-97 - Implementation of Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition, base erosion, International Tax Reform Provisions, and tax Extender Provisions S.692 Protect Medical Innovation Act of 2019 - Bill to repeal the 2.3% Medical Device Tax HR 2207 - House companion bill to repeal the 2.3% Medical Device Tax

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act- Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule- Telehealth and C-APC changes for Interspinous Decompression

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act- Modifications to legislation to streamline access to medical device interventions by employing telehealth 2020 proposed OPPS rule- Telehealth and C-APC changes for Interspinous Decompression Labor HHS bill HR 1865 - Advocacy for C-APC changes

FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction 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 3417 Better Act- Modifications to legislation to streamline access to medical device interventions by employing telehealth

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.

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.

Public Law 115-97 - Implementation of Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition, base erosion, International Tax Reform Provisions, and tax Extender Provisions S.692 Protect Medical Innovation Act of 2019 - Bill to repeal the 2.3% Medical Device Tax HR 2207 - House companion bill to repeal the 2.3% Medical Device Tax

Public Law 115-97 - Implementation of Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition, base erosion, International Tax Reform Provisions, and tax Extender Provisions S.692 Protect Medical Innovation Act of 2019 - Bill to repeal the 2.3% Medical Device Tax HR 2207 - House companion bill to repeal the 2.3% Medical Device Tax HR 1865 Further Consolidated Appropriations Act, 2020 - House end of year spending bill which included repeal of the 2.3% Medical Device Tax

Public Law 115-97 - Implementation of Comprehensive/Corporate Tax Reform - Includes lower corporate tax rate, research credit transition, base erosion, International Tax Reform Provisions, and tax Extender Provisions S.692 Protect Medical Innovation Act of 2019 - Bill to repeal the 2.3% Medical Device Tax HR 2207 - House companion bill to repeal the 2.3% Medical Device Tax