FriendSHIP Act

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

Client expense: $380,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

Implementation of PL 114-255, 21st Century Cures Act Ensuring Patient Access to Critical Breakthrough Products (H.R.4043) Transitional Coverage for Emerging Technologies (TCET) rule Policies promoting medical innovation Heart Valve Disease Awareness Implementation of PL-115-201, FDA Reauthorization Act of 2017 Cybersecurity for Healthcare Industry FDA Reauthorization for 2022/FDA User Fees Coronavirus Preparedness and Response Provisions (PHE) Health Equity Issues (Diversity in Clinical Trials) H.R.6000 Cures 2.0 Act HR 5394 Registry Access to Medicare Claims Data includes Coverage with Evidence Development provisions H.R. 1193, The Cardiovascular Advances in Research and Opportunities Legacy Act CAROL Act Inspection Modernization Emerging Signals Shortage Reporting S.3799 PREVENTS Pandemic Act Coverage with Evidence Development

Client expense: $310,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

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

Implementation of PL 114-255, 21st Century Cures Act Ensuring Patient Access to Critical Breakthrough Products (H.R.4043) Transitional Coverage for Emerging Technologies (TCET) rule Policies promoting medical innovation Heart Valve Disease Awareness Implementation of PL-115-201, FDA Reauthorization Act of 2017 Cybersecurity for Healthcare Industry FDA Reauthorization for 2022/FDA User Fees Coronavirus Preparedness and Response Provisions (PHE) Health Equity Issues (Diversity in Clinical Trials) H.R.6000 Cures 2.0 Act HR 5394 Registry Access to Medicare Claims Data includes Coverage with Evidence Development provisions H.R. 1193, The Cardiovascular Advances in Research and Opportunities Legacy Act CAROL Act Inspection Modernization Emerging Signals Shortage Reporting S.3799 PREVENTS Pandemic Act Coverage with Evidence Development

Client expense: $330,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

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

Implementation of PL 114-255, 21st Century Cures Act Ensuring Patient Access to Critical Breakthrough Products (H.R.4043) Medicare Coverage for Innovative Technologies (MCIT) rule Policies promoting medical innovation Heart Valve Disease Awareness Implementation of PL-115-201, FDA Reauthorization Act of 2017 Cybersecurity for Healthcare Industry FDA Reauthorization for 2022/FDA User Fees Coronavirus Preparedness and Response Provisions Health Equity Issues (Diversity in Clinical Trials) H.R.6000 Cures 2.0 Act HR 5394 Registry Access to Medicare Claims Data includes Coverage with Evidence Development provisions H.R. 1193, The Cardiovascular Advances in Research and Opportunities Legacy Act CAROL Act Inspection Modernization Emerging Signals Shortage Reporting S.3799 PREVENTS Pandemic Act Coverage with Evidence Development

Client expense: $260,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE