Protect Medical Innovation Act of 2019

H.R. 2207/S. 692 - Protect Medical Innovation Act of 2019 H.R. 1865 - Further Consolidated Appropriations Act, 2020 medical device tax

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

S.692 & H.R.2207 - Protect Medical Innovation Act of 2019 S.503 & H.R.1366 - Responsible Additions & Increases to Sustain Employee Health Benefits Act of 2019 S.684 - Middle Class Health Benefits Tax Repeal Act of 2019

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

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Occupational Safety & Health Administration (OSHA), SENATE, Treasury, Dept of

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 19/S. 3129, Lower Costs, More Cures Act of 2019 H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448/S. 99, Medicare Drug Price Negotiation Act H.R. 748/ S. 3548, Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019 H.R. 1384, Medicare for All Act of 2019 H.R. 1398/S. 172, Health Insurance Tax Relief Act of 2019 H.R. 1425, Patient Protection and Affordable Care Enhancement Act H.R. 1865, Further Consolidated Appropriations Act, 2020 H.R. 1922/S. 1089, Restoring Access to Medication Act of 2019 H.R. 1985, Family Savings for Kids and Seniors Act H.R. 2207, Protect Medical Innovation Act of 2019 H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act H.R. 7617, Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and Human Services, Education, Transportation, Housing, and Urban Development Appropriations Act, 2021 S. 12, Health Savings Act of 2019 S. 61, Safe and Affordable Drugs from Canada Act of 2019 S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 S. 64, Preserve Access to Affordable Generics and Biosimilars Act S. 80, Jobs and Premium Protection Act, including provisions relating to repeal of the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act S. 178, UIGHUR Act of 2019, including provisions relating to substitute amendment regarding COVID-19 relief package S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 S. 344, Hatch-Waxman Integrity Act of 2019 S. 470, Medicare at 50 Act S. 684, Middle Class Health Benefits Tax Repeal Act of 2019 S. 692, Protect Medical Innovation Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 S. 1541, Tobacco-Free Youth Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act S. 3200, Chronic Disease Management Act of 2020 S. 4317, Safeguarding Americas Frontline Employees To Offer Work Opportunities Required to Kickstart the Economy (SAFE TO WORK) Act Potential legislation similar to H.R. 2911/S. 1697, Small Business Healthcare Relief Act (114th Cong.) Proposed regulation on the Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2020 (84 Fed. Reg. 227-321, January 24, 2019) Proposed regulations on Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; interoperability and patient access for Medicare advantage organization and Medicaid managed care plans, state Medicaid agencies, CHIP agencies and CHIP managed care entities, issuers of qualified health plans in the federally-facilitated exchanges and health care providers; supplement and extension of comment period (84 Fed, Reg. 16,834, April 23, 2019) Proposed regulation on Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2021; notice requirement for non-federal governmental plans (85 Fed. Reg. 7,088-7,159, February 6, 2020) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, the Cost Sharing Reduction (CSR) program, the section 9010 Health Insurance Providers Fee or Health Insurance Tax (HIT), 40% excise tax on high-cost employer-sponsored health coverage (Cadillac tax); medical device tax; protect Medicare Part Ds Non-Interference Clause from repeal, proposed rule regarding section 1557; Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; legislation addressing mental health parity; inclusion of prescription drug pricing on 2019 congressional agenda; reauthorization of the Patient Centered Outcomes Research Institute; (PCORI); potential premium reduction/reinsurance program to reduce health insurance premiums; proposals to expand Medicare including Medicare Buy-In and the development of a public option; medical hospital outpatient prospective payment system for CY 2020; drug pricing including most-favored nations proposals, international pricing index, importation and mandatory rebates; potential healthcare pricing proposals, including a medicaid rebate cap, spread pricing, and inflation penalty; comments on Medicare and State Healthcare Programs: fraud and abuse; revisions to safe harbors under the anti-kickback statute, and civil monetary penalty rules regarding beneficiary inducements; comments on Medicare Program; modernizing and clarifying the physician self-referral regulations; comments on CMS proposed Medicaid fiscal accountability regulation; comments on CMS proposed transparency in coverage rule; comments to the U.S. Department of Health and Human Services on the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19, as amended on April 10, 2020 and June 8, 2020 (Declaration), Section 319F-3 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6d); comments to the U.S. Department of Health and Human Services on CMS-2393-P: Medicaid Program; Medicaid fiscal accountability regulation; comments to the U.S. Department of Health and Human Services on the Administrations proposed rule to eliminate drug manufacturer rebates in Part D; transparency in coverage; issues relating to the coronavirus pandemic, including testing, liability protection, and temporary COBRA subsidies; Public Health and Social Services Emergency Fund (PHSSEF); health insurance coverage during the coronavirus pandemic; health legislative priorities for the potential Phase 4 coronavirus relief package; provisions relating to Health Savings Accounts (HSA) and Flexible Spending Arrangements (FSA) in the Coronavirus, Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136); FCCs COVID-19 Telehealth Program; Federal Emergency Management Agencys (FEMA) temporary rule regarding Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use; reform of the World Health Organization (WHO); continued U.S. membership in the World Health Organization Public Readiness and Emergency Preparedness Act (P.L. 109-148, Division C), and COVID -19; potential legislation dealing with COVID-19 liability issues

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

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Citizenship & Immigration Services (BCIS), Bureau of Industry and Security (BIS), Bureau of Reclamation, Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 19/S. 3129, Lower Costs, More Cures Act of 2019 H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448/S. 99, Medicare Drug Price Negotiation Act H.R. 748/ S. 3548, Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019 H.R. 1384, Medicare for All Act of 2019 H.R. 1398/S. 172, Health Insurance Tax Relief Act of 2019 H.R. 1425, Patient Protection and Affordable Care Enhancement Act H.R. 1865, Further Consolidated Appropriations Act, 2020 H.R. 1922/S. 1089, Restoring Access to Medication Act of 2019 H.R. 1985, Family Savings for Kids and Seniors Act H.R. 2207, Protect Medical Innovation Act of 2019 H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act H.R. 7617, Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and Human Services, Education, Transportation, Housing, and Urban Development Appropriations Act, 2021 S. 12, Health Savings Act of 2019 S. 61, Safe and Affordable Drugs from Canada Act of 2019 S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 S. 64, Preserve Access to Affordable Generics and Biosimilars Act S. 80, Jobs and Premium Protection Act, including provisions relating to repeal of the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act S. 178, UIGHUR Act of 2019, including provisions relating to substitute amendment regarding COVID-19 relief package S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 S. 344, Hatch-Waxman Integrity Act of 2019 S. 470, Medicare at 50 Act S. 684, Middle Class Health Benefits Tax Repeal Act of 2019 S. 692, Protect Medical Innovation Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 S. 1541, Tobacco-Free Youth Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act S. 3200, Chronic Disease Management Act of 2020 S. 4317, Safeguarding Americas Frontline Employees To Offer Work Opportunities Required to Kickstart the Economy (SAFE TO WORK) Act Potential legislation similar to H.R. 2911/S. 1697, Small Business Healthcare Relief Act (114th Cong.) Proposed regulation on the Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2020 (84 Fed. Reg. 227-321, January 24, 2019) Proposed regulations on Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; interoperability and patient access for Medicare advantage organization and Medicaid managed care plans, state Medicaid agencies, CHIP agencies and CHIP managed care entities, issuers of qualified health plans in the federally-facilitated exchanges and health care providers; supplement and extension of comment period (84 Fed, Reg. 16,834, April 23, 2019) Proposed regulation on Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2021; notice requirement for non-federal governmental plans (85 Fed. Reg. 7,088-7,159, February 6, 2020) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, the Cost Sharing Reduction (CSR) program, the section 9010 Health Insurance Providers Fee or Health Insurance Tax (HIT), 40% excise tax on high-cost employer-sponsored health coverage (Cadillac tax); medical device tax; protect Medicare Part Ds Non-Interference Clause from repeal, proposed rule regarding section 1557; Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; legislation addressing mental health parity; inclusion of prescription drug pricing on 2019 congressional agenda; reauthorization of the Patient Centered Outcomes Research Institute; (PCORI); potential premium reduction/reinsurance program to reduce health insurance premiums; proposals to expand Medicare including Medicare Buy-In and the development of a public option; medical hospital outpatient prospective payment system for CY 2020; drug pricing including most-favored nations proposals, international pricing index, importation and mandatory rebates; potential healthcare pricing proposals, including a medicaid rebate cap, spread pricing, and inflation penalty; comments on Medicare and State Healthcare Programs: fraud and abuse; revisions to safe harbors under the anti-kickback statute, and civil monetary penalty rules regarding beneficiary inducements; comments on Medicare Program; modernizing and clarifying the physician self-referral regulations; comments on CMS proposed Medicaid fiscal accountability regulation; comments on CMS proposed transparency in coverage rule; comments to the U.S. Department of Health and Human Services on the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19, as amended on April 10, 2020 and June 8, 2020 (Declaration), Section 319F-3 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6d); comments to the U.S. Department of Health and Human Services on CMS-2393-P: Medicaid Program; Medicaid fiscal accountability regulation; comments to the U.S. Department of Health and Human Services on the Administrations proposed rule to eliminate drug manufacturer rebates in Part D; transparency in coverage; issues relating to the coronavirus pandemic, including testing, liability protection, and temporary COBRA subsidies; Public Health and Social Services Emergency Fund (PHSSEF); health insurance coverage during the coronavirus pandemic; health legislative priorities for the potential Phase 4 coronavirus relief package; provisions relating to Health Savings Accounts (HSA) and Flexible Spending Arrangements (FSA) in the Coronavirus, Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136); FCCs COVID-19 Telehealth Program; Federal Emergency Management Agencys (FEMA) temporary rule regarding Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use; reform of the World Health Organization (WHO); continued U.S. membership in the World Health Organization Public Readiness and Emergency Preparedness Act (P.L. 109-148, Division C), and COVID -19; potential legislation dealing with COVID-19 liability issues

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

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Citizenship & Immigration Services (BCIS), Bureau of Industry and Security (BIS), Bureau of Reclamation, Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

H.R. 2207/S. 692 - Protect Medical Innovation Act of 2019 medical device tax H.R. 1865 - Further Consolidated Appropriations Act, 2020

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

H.R. 2207/S.692 - Protect Medical Innovation Act of 2019 no specific bill, tariff and trade policies H.R. 1865 - Further Consolidated Appropriations Act, 2020

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 2207/S. 692 - Protect Medical Innovation Act of 2019 H.R. 1865 - Further Consolidated Appropriations Act, 2020

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

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

S.692 & H.R.2207 - Protect Medical Innovation Act of 2019 S.503 & H.R.1366 - Responsible Additions & Increases to Sustain Employee Health Benefits Act of 2019 S.684 - Middle Class Health Benefits Tax Repeal Act of 2019

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

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Occupational Safety & Health Administration (OSHA), SENATE, Treasury, Dept of

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 19/S. 3129, Lower Costs, More Cures Act of 2019 H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448/S. 99, Medicare Drug Price Negotiation Act H.R. 748/ S. 3548, Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019 H.R. 1384, Medicare for All Act of 2019 H.R. 1398/S. 172, Health Insurance Tax Relief Act of 2019 H.R. 1425, Patient Protection and Affordable Care Enhancement Act H.R. 1865, Further Consolidated Appropriations Act, 2020 H.R. 1922/S. 1089, Restoring Access to Medication Act of 2019 H.R. 1985, Family Savings for Kids and Seniors Act H.R. 2207, Protect Medical Innovation Act of 2019 H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act S. 12, Health Savings Act of 2019 S. 61, Safe and Affordable Drugs from Canada Act of 2019 S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 S. 64, Preserve Access to Affordable Generics and Biosimilars Act S. 80, Jobs and Premium Protection Act, including provisions relating to repeal of the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 S. 344, Hatch-Waxman Integrity Act of 2019 S. 470, Medicare at 50 Act S. 684, Middle Class Health Benefits Tax Repeal Act of 2019 S. 692, Protect Medical Innovation Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 S. 1541, Tobacco-Free Youth Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act S. 3200, Chronic Disease Management Act of 2020 Potential legislation similar to H.R. 2911/S. 1697, Small Business Healthcare Relief Act (114th Cong.) Proposed regulation on the Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2020 (84 Fed. Reg. 227-321, January 24, 2019) Proposed regulations on Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; interoperability and patient access for Medicare advantage organization and Medicaid managed care plans, state Medicaid agencies, CHIP agencies and CHIP managed care entities, issuers of qualified health plans in the federally-facilitated exchanges and health care providers; supplement and extension of comment period (84 Federal Register 16,834, April 23, 2019) Proposed regulations on Medicare modernizing and clarifying physician self-referral regulations (84 Fed. Reg. 55,766-55,847, October 17, 2019) Proposed regulation on Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2021; notice requirement for non-federal governmental plans (85 Fed. Reg. 7,088-7,159, February 6, 2020) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, the Cost Sharing Reduction (CSR) program, the section 9010 Health Insurance Providers Fee or Health Insurance Tax (HIT), 40% excise tax on high-cost employer-sponsored health coverage (Cadillac tax); medical device tax; protect Medicare Part Ds Non-Interference Clause from repeal, proposed rule regarding section 1557; Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; legislation addressing mental health parity; inclusion of prescription drug pricing on 2019 congressional agenda; reauthorization of the Patient Centered Outcomes Research Institute; (PCORI); potential premium reduction/reinsurance program to reduce health insurance premiums; medical hospital outpatient prospective payment system for CY 2020; drug pricing; potential healthcare pricing proposals, including a medicaid rebate cap, spread pricing, and inflation penalty; comments on Medicare and State Healthcare Programs: fraud and abuse; revisions to safe harbors under the anti-kickback statute, and civil monetary penalty rules regarding beneficiary inducements; comments on Medicare Program; modernizing and clarifying the physician self-referral regulations; comments on CMS proposed Medicaid fiscal accountability regulation; comments on CMS proposed transparency in coverage rule; comments on HHS notice of benefit and payment parameters for 2021; transparency in coverage; Medicaid fiscal accountability regulations; issues relating to the coronavirus pandemic, including testing, liability protection, and temporary COBRA subsidies; Public Health and Social Services Emergency Fund (PHSSEF); health insurance coverage during the coronavirus pandemic; health legislative priorities for the potential Phase 4 coronavirus relief package; provisions relating to Health Savings Accounts (HSA) and Flexible Spending Arrangements (FSA) in the Coronavirus, Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136); FCCs COVID-19 Telehealth Program; Federal Emergency Management Agencys (FEMA) temporary rule regarding Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use

Client expense: $12,300,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Citizenship & Immigration Services (BCIS), Bureau of Industry and Security (BIS), Bureau of Labor Statistics (BLS), Bureau of Reclamation, Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

Medical Device User Fee Act - S.692 Medical Device Access and Innovation Protection Act - section 710 requiring FDA to report on third-party servicing of medical devices. H.R. 1362, Medical Innovation Never Stops Act - All provisions 3rd Party Service regulation - H.R.2118/Medical Device Servicing Safety and Accountability Act (115th Congress) Cybersecurity Artificial Intelligence issues relating to medical devices Information blocking rule from ONC (21st Century Cures Act Sec 4004) Population Health and Connected Care Issues FDA guidance on device re-manufacturing FDA device approval - 510(k) and PMA processes GPO administrative fees Aging in place - connected care and remote patient monitoring HR 2669 - Medical Device Safety Act (all provisions) Healthcare Data Privacy Issues related to COVID-19 pandemic response Capabilities related to COVID-19 pandemic and disaster response and planning Defense Production Act implementation Supply chain legislative proposals Issues related to production and procurement of ventilators

Client expense: $470,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Office of the Vice President of the United States, SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

H.R. 2207/S. 692 - Protect Medical Innovation Act of 2019 H.R. 1865 - Further Consolidated Appropriations Act, 2020

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

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

H.R. 2207/S.692 - Protect Medical Innovation Act of 2019 no specific bill, tariff and trade policies H.R. 1865 - Further Consolidated Appropriations Act, 2020

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

In support of the Protect Medical Innovation Act of 2019 (HR 2207/S 692)

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

Government targets: Centers For Disease Control & Prevention (CDC), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Small Business Administration (SBA), Treasury, Dept of, White House Office

H.R. 2207/S. 692 - Protect Medical Innovation Act of 2019 medical device tax H.R. 1865 - Further Consolidated Appropriations Act, 2020

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

S.692 & H.R.2207 - Protect Medical Innovation Act of 2019 S.503 & H.R.1366 - Responsible Additions & Increases to Sustain Employee Health Benefits Act of 2019 S.684 - Middle Class Health Benefits Tax Repeal Act of 2019

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

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), SENATE, Treasury, Dept of

Medical Device User Fee Act - S.692 Medical Device Access and Innovation Protection Act - section 710 requiring FDA to report on third-party servicing of medical devices. H.R. 1362, Medical Innovation Never Stops Act - All provisions Healthy aging / frail elderly proposal 3rd Party Service regulation - H.R.2118/Medical Device Servicing Safety and Accountability Act (115th Congress) Cybersecurity Artificial Intelligence issues relating to medical devices PL 115-271: SUPPORT for Patients and Communities Act - Implementation of various provisions, including opioid package and ultrasound nerve blocking as an alternative to opioids Information blocking rule from ONC (21st Century Cures Act Sec 4004) Population Health and Connected Care Issues FDA guidance on device re-manufacturing FDA device approval - 510(k) and PMA processes GPO administrative fees Aging in place - connected care and remote patient monitoring HR 2669 - Medical Device Safety Act (all provisions) Possibility of establishing Congressional Sleep Health Caucus Healthcare Data Privacy NPRM on Anti-Kickback Safe Harbor Provision Issues related to COVID-19 pandemic response Capabilities related to COVID-19 pandemic and disaster response and planning Defense Production Act implementation Supply chain legislative proposals Issues related to production and procurement of ventilators

Client expense: $450,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Office of the Vice President of the United States, SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 19/S. 3129, Lower Costs, More Cures Act of 2019 H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019 H.R. 448/S. 99, Medicare Drug Price Negotiation Act H.R. 748, Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019 H.R. 1384, Medicare for All Act of 2019 H.R. 1398/S. 172, Health Insurance Tax Relief Act of 2019 H.R. 1865, Further Consolidated Appropriations Act, 2020 H.R. 1922/S. 1089, Restoring Access to Medication Act of 2019 H.R. 1985, Family Savings for Kids and Seniors Act H.R. 2207, Protect Medical Innovation Act of 2019 H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act S. 12, Health Savings Act of 2019 S. 61, Safe and Affordable Drugs from Canada Act of 2019 S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 S. 64, Preserve Access to Affordable Generics and Biosimilars Act S. 80, Jobs and Premium Protection Act, including provisions relating to repeal of the annual fee on health insurance providers enacted by the Patient Protection and Affordable Care Act S. 340, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 S. 344, Hatch-Waxman Integrity Act of 2019 S. 470, Medicare at 50 Act S. 684, Middle Class Health Benefits Tax Repeal Act of 2019 S. 692, Protect Medical Innovation Act of 2019 S. 1416, Affordable Prescriptions for Patients Act of 2019 S. 1541, Tobacco-Free Youth Act S. 1895, Lower Health Care Costs Act S. 1948, Chronic Disease Management Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019 S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act S. 3200, Chronic Disease Management Act of 2020 S. 3548, Coronavirus Aid, Relief, and Economic Security Act or the CARES Act Potential legislation similar to H.R. 2911/S. 1697, Small Business Healthcare Relief Act (114th Cong.) Proposed regulation on the Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2020 (84 Fed. Reg. 227-321, January 24, 2019) Proposed regulations on Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; interoperability and patient access for Medicare advantage organization and Medicaid managed care plans, state Medicaid agencies, CHIP agencies and CHIP managed care entities, issuers of qualified health plans in the federally-facilitated exchanges and health care providers; supplement and extension of comment period (84 Federal Register 16,834, April 23, 2019) Proposed regulations on transparency in health insurance coverage (84 Fed. Reg. 65,464-65,523, November 27, 2019) Proposed regulations on Medicare modernizing and clarifying physician self-referral regulations (84 Fed. Reg. 55,766-55,847, October 17, 2019) Proposed regulation on Patient Protection and Affordable Care Act; HHS notice of benefit and payment parameters for 2021; notice requirement for non-federal governmental plans (85 Fed. Reg. 7,088-7,159, February 6, 2020) Proposed regulation on Medicare and Medicaid Programs; Contract Year 2021 and 2022 Policy and technical changes to the Medicare Advantage Program, Medicare prescription drug benefit program, Medicaid program, Medicare cost plan program, and programs of all-inclusive care for the elderly (85 Fed. Reg. 9,002-9,260, February 18, 2020) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business, the Small Business Tax Credit, section 1332 waivers, section 1557 on nondiscrimination, caps on compensation deductibility required under section 9014, incompleteness or inaccuracy of cost impact analysis, lack of quantified benefit analysis, and need for empirical data sources on which to base costs and benefits, the Cost Sharing Reduction (CSR) program, the section 9010 Health Insurance Providers Fee or Health Insurance Tax (HIT), 40% excise tax on high-cost employer-sponsored health coverage (Cadillac tax); medical device tax; protect Medicare Part Ds Non-Interference Clause from repeal, proposed rule regarding section 1557; Public Health Services Act (P.L.78-410), Internal Revenue Code and the Employee Retirement Income Security Act (ERISA) (P.L. 93-406), regarding regulatory process and legislative corrections to ERISA preemption, changes to Medicare Advantage and Parts B, C, and D, including rebates and non-interference with prescription drug prices, entitlement reform, health information technology, telemedicine services in Medicare, and coordination and disease management programs; association health plans; importation of foreign pharmaceuticals into the United States and preemptive authority of federal food and drug regulations; balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; legislation addressing mental health parity; inclusion of prescription drug pricing on 2019 congressional agenda; reauthorization of the Patient Centered Outcomes Research Institute; potential premium reduction/reinsurance program to reduce health insurance premiums; medical hospital outpatient prospective payment system for CY 2020; drug pricing; potential healthcare pricing proposals, including a medicaid rebate cap, spread pricing, and inflation penalty; comments on Medicare and State Healthcare Programs: fraud and abuse; revisions to safe harbors under the anti-kickback statute, and civil monetary penalty rules regarding beneficiary inducements; comments on Medicare Program; modernizing and clarifying the physician self-referral regulations; comments on CMS proposed Medicaid fiscal accountability regulation; comments on CMS proposed transparency in coverage rule; comments on HHS notice of benefit and payment parameters for 2021; Medicaid fiscal accountability regulations; transparency on coverage; issues relating to the coronavirus pandemic

Client expense: $15,770,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Citizenship & Immigration Services (BCIS), Bureau of Industry and Security (BIS), Bureau of Labor Statistics (BLS), Bureau of Reclamation, Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Council of Economic Advisers (CEA), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Motor Carrier Safety Administration, Federal Reserve System, Federal Trade Commission (FTC), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

Implementation of PL 114-255, 21st Century Cures Act Implementation of PL-111-148, PPACA Ensuring Patient Access to Critical Breakthrough Products Policies promoting medical innovation Heart Valve Disease Awareness Implementation of PL-115-201, FDA Reauthorization Act of 2017 H.R. 2207 Protect Medical Innovation (Device Tax Repeal) S. 692 (Medical Device Tax Repeal) Implementation of PL 114-10, MACRA Cybersecurity for Healthcare Industry FDA Reauthorization for 2022/FDA User Fees H.R. 6074/S. 3548 Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020

Client expense: $340,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

H.R. 6074/S. 3548 Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 S. 692 (Medical Device Tax Repeal) H.R. 2207 Protect Medical Innovation (Device Tax Repeal)

Client expense: $340,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

In support of the Protect Medical Innovation Act of 2019 (HR 2207/S 692)

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

Government targets: Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, White House Office

Issues related to the repeal of the medical device excise tax, including S.692 and H. R. 2207, the Protect Medical Innovation Act of 2019, and H. R. 1865, the Further Consolidated Appropriations Act of 2020.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to medical device excise tax (Protect Medical Innovation Act, S. 692/H.R. 2207); flexible spending account limits and treasury rulings on rollovers; RAISE Act (H.R. 1366/S. 503); tax policy proposals and implementation of comprehensive tax reform, including small business tax issues, pass-throughs, student loan interest deduction, higher education tax credits and benefits, dental faculty loan repayment assistance (H.R. 996/S. 359), ACA tax implementation; and student loan debt on medical professional small business owners. Middle Class Health Benefits Tax Repeal Act of 2019 (H.R. 748). Policy issues related to tax, small business and the federal response to the COVID-19 virus.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to medical device tax repeal (Protect Medical Innovation Act, H.R. 2207/S. 692) and expanded use of flexible spending accounts, health savings accounts, and association health plans (H.R. 2294/S. 1170), market stabilization efforts, issues related to oral health care, and health care workforce issues. Responsible Additions and Increases to Sustain Employee Health Benefits Act of 2019 (H.R. 1366/S. 503). Legislation to repeal Affordable Care Act limits on flexible spending accounts. Issues related to small business health care providers, including the Small Business Health Account Act. Ensuring Lasting Smiles Act (H.R. 1379/S. 560). FY 2021 Labor-HHS-Education appropriations; Policy issues related to health care and the federal response to the COVID-19 virus.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medical Device tax Repeal (S. 692), Corporate Tax, health provider funding

Client expense: $100,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Internal Revenue Service (IRS), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

H.R. 2207/S. 692 - Protect Medical Innovation Act of 2019 H.R. 1865 - Further Consolidated Appropriations Act, 2020

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

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

Legislative and regulatory services related to tax reform, PL 115-97 Tax Cuts and Jobs Act and S.692, Protect Medical Innovation Act of 2019, H.R. 2207, Protect Medical Innovation Act of 2019, and H.R. 748, Coronavirus Aid, Relief, and Economic Security (CARES) Act.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2207/S.692 - Protect Medical Innovation Act of 2019 no specific bill, tariff and trade policies H.R. 1865 - Further Consolidated Appropriations Act, 2020

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 2207/S. 692 - Protect Medical Innovation Act of 2019 medical device tax H.R. 1865 - Further Consolidated Appropriations Act, 2020

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Support for S. 692 - Protection Medical Innovation Act of 2019. Support for H.R. 2207 - To amend the Internal Revenue Code of 1986 to repeal the excise tax on medical devices.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medical device tax repeal, servicing of medical imaging equipment, cybersecurity; servicing of medical devices, cybersecurity; Medical device tax repeal (S. 692) Equitable Payment for Radiopharmaceuticals in the Medicare Outpatient Setting, Medicare National Coverage Determinations; Device tax, focused ultrasound;

Client expense: $510,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Energy, Dept of, Federal Energy Regulatory Commission (FERC), HOUSE OF REPRESENTATIVES, Intl Trade Administration (ITA), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), U.S. Trade Representative (USTR)

Issues related to the repeal of the medical device excise tax, including S.692 and H. R. 2207, the Protect Medical Innovation Act of 2019.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medical imaging reimbursement Wireless Medical Telemetry Ultrasound Reimbursement Cyber Security S. 692 - A bill to amend the Internal Revenue Code of 1986 to repeal the excise tax on medical devices Department of Energy Medical Isotopes Development Appropriations Diagnostic radiopharmaceutical payment reform Medical Device Servicing

Client expense: $1,220,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Natl Aeronautics & Space Administration (NASA), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

Medical device tax; tax issues; Implementation of the Tax Cuts and Jobs Act (P.L. 115-97); Repeal of medical device tax; H.R. 2207, S. 692 Protecting Medical Innovation Act of 2019.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Public Law 115-97, Tax Cuts and Jobs Act Implementation S.692 / H.R. 2207, Protect Medical Innovation Act of 2019

Client expense: $1,860,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Highway Traffic Safety Administration (NHTSA), Patent & Trademark Office (PTO), Pipeline & Hazardous Materials Safety Administration, SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

S.692 / H.R. 2207, Protect Medical Innovation Act of 2019 S.518 / H.R.1948, Lymphedema Treatment Act S. 1895, Lower Health Care Costs Act

Client expense: $1,860,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Highway Traffic Safety Administration (NHTSA), Patent & Trademark Office (PTO), Pipeline & Hazardous Materials Safety Administration, SENATE, Transportation, Dept of (DOT), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

H.R. 3301, Taxpayer Certainty and Disaster Tax Relief Act of 2019, Sec. 145. Look-thru rule for related controlled foreign corporations. H.R. 2207/S.692, Protect Medical Innovation Act of 2019 (Repeal of medical device tax) all sections.

Client expense: $220,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Natl Highway Traffic Safety Administration (NHTSA), SENATE, U.S. Trade Representative (USTR)

S.692 & H.R.2207 - Protect Medical Innovation Act of 2019 S.503 & H.R.1366 - Responsible Additions & Increases to Sustain Employee Health Benefits Act of 2019 S.684 & H.R.748 - Middle Class Health Benefits Tax Repeal Act of 2019

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), SENATE

Legislation to repeal the 2.3%$ excise tax on medical devices, the Protect Medical Innovation act of 2019 (S. 692 contained in the Further Consolidated Appropriations Act, PL 116-94)

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

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, SENATE

Support proposals to repeal the Medical Device Tax, including S. 692 / H.R. 2207, the Protect Medical Innovation Act of 2019, and H.R. 1865, the Further Consolidated Appropriations Act, 2020.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 692, Protect Medical Innovation Act, to repeal the excise tax on medical devices H.R.1865, the Further Consolidated Appropriations Act, 2020, repeal medical device excise tax, repeal ACA Cadillac tax H.R. 2207, the Protect Medical Innovation Act of 2019, to amend the Internal Revenue Code of 1986 to repeal the excise tax on medical devices

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

S. 692, Protect Medical Innovation Act, to repeal the excise tax on medical devices H.R.1865, the Further Consolidated Appropriations Act, 2020, repeal medical device excise tax, repeal ACA Cadillac tax H.R. 2207, the Protect Medical Innovation Act of 2019, to amend the Internal Revenue Code of 1986 to repeal the excise tax on medical devices

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Medical device excise tax H.R.2207 and S.692 (Protect Medical Innovation Act of 2019), all provisions H.R. 1865 (Further Consolidated Appropriations Act, 2020), Division N, Title I, Section 501, regarding medical device excise tax

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issue: Educate Congress and the administration on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019 S. 2997, Title VII Health Care Workforce Reauthorization Act of 2019 Issue: Support the reauthorization of Health Resources and Services Administrations Title VII health professions workforce programs. P.L 116-94, Further Consolidated Appropriations Act, 2020, Division N P.L. 116-59, Continuing Appropriations Act 2020, and Health Extenders Act of 2019 P.L. 116-69, Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 S.1895, Lower Health Care Costs Act S. 106, H.R. 1983, H.R.2328, Community Health Investment, Modernization, and Excellence Act of 2019 S. 192, Community and Public Health Programs Extension Act S. 692, H.R. 1943, Community Health Center and Primary Care Workforce Expansion Act of 2019 Issue: Support the reauthorization of the National Health Service Corps, Community Health Centers, and Teaching Health Centers mandatory appropriation funds. Issue: Support initiatives of hospitals to promote affordable housing in local communities and eliminate other social determinants of health to improve health equity. Issues: Educate Congress and the administration about academic medicines response to the opioid epidemic. Support funding for training on substance use disorders, pain management, and safe prescribing practices. P.L. 116-94, The Further Consolidated Appropriations Act, 2020, Division N P.L. 116-69, Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 3439, Protecting Access to Information for Effective and Necessary Treatment Act H.R. 2328, Reauthorizing and Extending Americas Community Health (REACH) Act S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act Draft Senate Finance Committee Health Extenders Legislation Issue: Support long-term reauthorization of the Patient Centered Outcomes Research Institute (PCORI) and the Patient Centered Outcomes Research Trust Fund Issue: Oppose restrictions on fetal tissue research. Urge changes to HHS and NIH policy on fetal tissue research. P.L. 116-22, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 Issues: Support the Hospital Preparedness Program and the reauthorization of the Pandemic and All-Hazards Preparedness Act. Support increased funding authorization levels. Issues: Support high-quality affordable health insurance. Support programs and funds for safety-net providers. Issue: Support measures to preserve and strengthen the 340B Drug Pricing Program and oppose efforts to reduce the scope of the program, including instituting a moratorium, increasing reporting requirements on covered entities, and imposing user fees Draft, Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2018 Draft, Diagnostic Accuracy and Innovation Act (DAIA) Issue: Oppose burdensome regulation of Laboratory Developed Tests S. 1895, Lower Health Care Costs Act H.R. 3630, No Surprises Act S. 1531, Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019 H.R. 3502, Protecting People From Surprise Medical Bills Act Issues: Educate Congress on surprise medical bills and price transparency. Support general principles for surprise medical bills draft legislation. Oppose statutory benchmark rate setting. Oppose Senate hospital/insurer contracting provisions and onerous reporting burden. S. 1895, Lower Health Care Costs Act, Title IV Issues: Prescription drug pricing, public health, and health information technology. P.L. 116-94, the Further Consolidated Appropriations Act, 2020, Division N H.R. 2328, Community Health Investment, Modernization, and Excellence Act of 2019 Issue: Support legislation providing stable and predictable funding for quality measurement activities carried out by the National Quality Forum Issue: Development of Enhanced Primary Care Pilot Act proposal Issue: Educate Congress about medical education on nutrition, consent, implicit bias, and maternal health. Issue: Support efforts to address maternal health S. 1416, Affordable Prescriptions for Patients Act S. 1224, H.R. 2374, Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act S. 440, Preserving Access to Cost Effective Drugs Act H.R. 2296 / S.1391, The Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2019 S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act H.R. 2113, Prescription Drug STAR Act US-Mexico-Canada Agreement Issue: Support measures to lower prescription drug cost H.R. 4004, S.2986, Social Determinants Accelerator Act of 2019 Issue: Support grants to address social determinants of health Issue: Support aligning 42 CFR Part 2 regulations with the Health Insurance Portability and Accountability Act (HIPAA) for the purposes of treatment, payment, and healthcare operations. Draft, firearm safety legislation Issue: Support universal background checks, violence prevention programs, extreme risks protection orders, child access safety laws, and reinstating assault weapons ban. H.R. 8, Bipartisan Background Checks Act of 2019 Issue: Support universal background checks Issue: Support nomination of Stephen Hahn, MD, as FDA commissioner. H.R. 1888, Expanding Nutritions Role in Curricula and Healthcare (ENRICH Act) Issue: Support legislation to create or expand nutrition and physical activity curricula. Draft Cures 2.0 Legislation Issue: Support efforts to modernize health care coverage and ensure access to scientific break-throughs through electronic health records, addressing health disparities, harnessing data, and supporting the physician workforce. Issue: Addressing preparedness for influenza. S. 2723, Mitigating Emergency Drug Shortages Act Issue: Support efforts to mitigate drug shortages and develop market-based incentives to help ensure a stable supply of medications critical for patient care Draft Health Equity and Accountability Act Issue: Support programs to improve health equity and address social determinants of health

Client expense: $1,137,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Bureau of Citizenship & Immigration Services (BCIS), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Director of National Intelligence (ODNI), Education, Dept of, Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

H.R. 2207, S. 692, and related bills related to repeal of the medical device excise tax Issues related to the reform of the tax code and tax credits for investors in pre-revenue and start-up medical technology companies.

Client expense: $1,750,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor implementation of The Tax Cut and Jobs Act as it relates to corporate tax reform and the taxation of U.S. multinational corporations. S. 692, Protect Medical Innovation Act of 2019 and H.R. 3301, Taxpayer Certainty and Disaster Tax Relief Act of 2019, as they relate to the medical device tax. H.R. 1865, Further Consolidated Appropriations Act, 2020, as it relates to repeal of the medical device excise tax.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA)