National Aeronautics and Space Administration Authorization Act of 2018

Health disparities Access to clinical trials for underrepresented populations Improving Social Determinants of Health Act (S.104/H.R.379) Comprehensive Breast Reconstruction Act of 2021 (H.R. 469) DIVERSE Trials Act (H.R. 5030/S. 2706) Diverse and Equitable Participation in Clinical Trials (DEPICT) Act (H.R.6584); a bill to direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes CURES 2.0 Act (H.R. 6000) Policies related to cancer survivorship Policies related to medications access in during emergencies Polices related to PBM and drug cost transparency Policies related to COVID-19 vaccination distribution Policies impacting immunocompromised people, including COVID-19 vaccination and monoclonal antibody distribution Policies related to reducing the cost of cancer treatment for patients Policies related to decline in breast cancer screenings during the COVID-19 pandemic Policies related to genetic counseling and screening Policies related to reauthorization of user fees at the Food and Drug Administration (H.R. 7667/ S. 4348) H.R. 7845 NIH Clinical Trial Diversity Act; a bill to direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 8185/S. 4440 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; a bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2023 through 2027 Advanced Research Project Agency-Health Act (H.R.5585) Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT) Pandemics Act (S.3799) Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017 H.R. 9565/S. 5295- Comprehensive Cancer Survivorship Act Policies related to the reauthorization of FDA User Fee Agreements Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017 Policies related to the implementation of the Mammography Quality Standards Act Policies related to administrative actions necessary in breast imaging and breast cancer diagnosis Policies related to the regulation of diagnostic devices Section 1557, Nondiscrimination in Health Programs and Activities (RIN Number 0945-AA17) Request for Information on establishing a National Directory of Healthcare Providers and Services

Client expense: Not reported · Firm income: $40,000

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), 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 H.R.2617 - Consolidated Appropriations Act, 2023

Client expense: $350,000 · 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

Health disparities Access to clinical trials for underrepresented populations Improving Social Determinants of Health Act (S.104/H.R.379) Comprehensive Breast Reconstruction Act of 2021 (H.R. 469) DIVERSE Trials Act (H.R. 5030/S. 2706) Diverse and Equitable Participation in Clinical Trials (DEPICT) Act (H.R.6584); a bill to direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes CURES 2.0 Act (H.R. 6000) Policies related to cancer survivorship Policies related to medications access in during emergencies Polices related to PBM and drug cost transparency Policies related to COVID-19 vaccination distribution Policies impacting immunocompromised people, including COVID-19 vaccination and monoclonal antibody distribution Policies related to reducing the cost of cancer treatment for patients Policies related to decline in breast cancer screenings during the COVID-19 pandemic Policies related to genetic counseling and screening Policies related to reauthorization of user fees at the Food and Drug Administration (H.R. 7667/ S. 4348) H.R. 7845 NIH Clinical Trial Diversity Act; a bill to direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 8185/S. 4440 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; a bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2023 through 2027 Advanced Research Project Agency-Health Act (H.R.5585) Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT) Pandemics Act (S.3799) Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017

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

Support for NASA's commercial crew program; monitor H.R. 3267 / S. 1662, the Commerce, Justice, Science, and Related Agencies Appropriations Act of 2018; H.R. 3354, the Make America Secure and Prosperous Appropriations Act of 2018; and H.R. 5503 / S. 3799, the NASA reauthorization bill.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5503/S. 3799 - National Aeronautics and Space Administration Authorization Act of 2018; all provisions H.R. 6227/S. 3143 - National Quantum Initiative Act; all provisions

Client expense: $40,000 · Firm income: Not reported

Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 8, Water Resources Development Act of 2018; climate and coastal observation research; earth observing research H.R. 237, Integrated Coastal and Ocean Observation System Act Amendments of 2017; climate and coastal observation research; earth observing research H.R. 589/S.2503, Department of Energy Research and Innovation Act (P.L. 115-246); climate and coastal observation research; earth observing research H.R. 5503, National Aeronautics and Space Administration Authorization Act of 2018; climate and coastal observation research; earth observing research; funding for research and development programs H.R.5895, Energy and Water, Legislative Branch, and Military Construction and Veterans Affairs Appropriations Act, 2019 (P.L. 115-244); climate and coastal observation research, earth observing research S. 2975, Energy and Water Development and Related Agencies Appropriations Act, 2019; climate and coastal observation research, earth observing research H.R.5952/S. 3072, Commerce, Justice, Science, and Related Agencies Appropriations Act, 2019; climate and coastal observation research; earth observing research; funding for research and development programs H.R. 5961/S. 2976, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019; funding for agriculture research programs H.R. 5996, Coral Reef Conservation Reauthorization Act of 2018; climate and coastal observation research, earth observing research H.R.6147, Interior, Environment, Financial Services and General Government, Agriculture, Rural Development, Food and Drug Administration, and Transportation, Housing and Urban Development Appropriations Act, 2019; climate and coastal observation research, earth observing research S. 3073, Department of the Interior, Environment, and Related Agencies Appropriations Act, 2019; climate and coastal observation research, earth observing research H.R. 6206, Coast Guard Blue Technology Center of Expertise Act; extramural research, research facilities issues HR 6227/S 3143, National Quantum Initiative Act (P.L. 115-368); funding for research and development programs H.R.6229, National Institute of Standards and Technology Reauthorization Act of 2018; climate and coastal observation research; earth observing research H.R. 6562, Finding Orphan-disease Remedies with Anti-Fungal Research and Development Act (the FORWARD Act) of 2018; Valley Fever research issues S. 1425, Coordinated Ocean Monitoring and Research Act; climate and coastal observation research; earth observing research S. 1768/H.R.6650, National Earthquake Hazards Reduction Program Reauthorization Act of 2018 (P.L. 115-307); Earth observation research; earthquake research S.2200, National Integrated Drought Information System Reauthorization Act of 2018; climate and coastal observation research; earth observing research S. 3021, America's Water Infrastructure Act of 2018 (P.L. 115-270); climate and coastal observation research; earth observing research S. 3508, Save Our Seas Act of 2018 (P.L. 115-265); extramural research; research facilities issues S.3799, National Aeronautics and Space Administration Authorization Act of 2018; climate and coastal observation research, earth observing, research and development funding H.R. 5196, Commercial Engagement Through Ocean Technology Act of 2018 (the CENOTE Act of 2018); climate and coastal observation research; earth observing research Graduate student STEM education issues President's FY2020 Budget Request; climate and coastal observation research, earth observing; research funding issues

H.R. 5503, S. 3799, National Aeronautics and Space Administration Authorization Act of 2018, Issues pertaining to NASA science research and missions.

Client expense: Not reported · Firm income: $20,000

Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Natl Aeronautics & Space Administration (NASA), SENATE

Issues pertaining to infrastructure research, workforce development, and research infrastructure. H.R. 5503, S. 3799, National Aeronautics and Space Administration Authorization Act of 2018, Issues pertaining to NASA space technology and aeronautics priorities.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE

H.R. 5503, S. 3799. National Aeronautics and Space Administration Authorization Act of 2018, Issues pertaining to NASA science and space technology priorities. Issues pertaining to microgravity research and development.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE

Issues pertaining to infrastructure research, workforce development, and research infrastructure. Issues pertaining to DOE hydropower. H.R. 5503, S. 3799, National Aeronautics and Space Administration Authorization Act of 2018, Issues pertaining to NASA science research and missions. Issues pertaining to STEM education and the skilled technical workforce.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues pertaining to infrastructure research, workforce development, and research infrastructure. H.R. 5503, S. 3799, National Aeronautics and Space Administration Authorization Act of 2018, Issues pertaining to NASA science research and missions. S. 3617, Government Spectrum Valuation Act of 2018, Issues pertaining to spectrum management.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE

Issues pertaining to infrastructure research, workforce development, and research infrastructure. H.R. 3086, S. 141, Space Weather Research and Forecasting Act, Issues pertaining to space weather research. H.R. 5503, S. 3799, National Aeronautics and Space Administration Authorization Act of 2018, Issues pertaining to NASA science research and missions.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues pertaining to infrastructure research, workforce development, and research infrastructure. H.R. 5503, S. 3799, National Aeronautics and Space Administration Authorization Act of 2018, Issues pertaining to NASA science research and missions. Issues pertaining to the nomination of Kelvin Droegemeier to become Director of the White House Office of Science and Technology Policy.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5503, S. 3799, National Aeronautics and Space Administration Authorization Act of 2018, Issues pertaining to NASA human exploration.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

National Quantum Initiative Act (Public Law 115-368) - support for research Space Weather Research and Forecasting Act (S. 141) - support for research NASA reauthorization (S. 3799) - support for space research NSF reauthorization (no bill number) - support for basic research Combating Sexual Harassment in Science Act of 2018 (H.R. 7031) - provisions to combat harassment in science

Client expense: $80,000 · Firm income: Not reported

Government targets: Education, Dept of, HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), SENATE