Patient-Centered Outcomes Research Extension Act of 2019

H.R. 3630- No Surprises Act H.R. 2076- Early Detection to Stop Infant Abuse and Prevent Fatalities Act H.R. 2328- Community Health Investment, Modernization, and Excellence Act of 2019 H.R. 3439- PCORI Reauthorization H.R. 3030- Patient-Centered Outcomes Research Extension Act of 2019 H.R. 3666- STRONGER Patents Act 2019 S. 2082- Support Technology and Research for Our Nation's Growth and Economic Resilience Patents Act of 2019 S.2543- Prescription Drug Pricing Reduction Act of 2019 H.R. 4378- Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 H.R. 2507- Newborn Screening Saves Lives Reauthorization Act of 2019 H.R. 2781- EMPOWER for Health Act of 2019 H.R. 4519- Pediatricians Accelerate Childhood Therapies Act of 2019 S. 3023- Pediatricians Accelerate Childhood Therapies Act of 2019 H.R. 3- Lower Drug Cost Now Act of 2019 H.R. 1865- Further Consolidated Appropriations Act, 2020 H.R. 6201-Families First Coronavirus Response Act H.R. 748- CARES Act H.R. 266 Paycheck Protection and Health Care Enhancement Act H.R 7233 KEEP Telehealth Options Act H.R. 7614 Fiscal 2021 Labor-HHS-Education Appropriations H.R. 6800 Health and Economic Recovery Omnibus Emergency Solutions Act S.3985 JUSTICE Act H.R. 7120 Justice in Policing Act S. 4717 Accelerating Kids Access to Care Act H.R. 5900 Accelerating Kids Access to Care Act H.R. 133 Consolidated Appropriations Act, 2021 General issues regarding mental health/ behavioral health, Medicaid, CHIP, and DSH.

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

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

PCORI reauthorization bill, HR 3030; HR 3439 P.L. 111-148/ P.L. 111-152, Affordable Care Act, Title VII Reauthorization/Implementation

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

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

Medicare Access and CHIP Reauthorization Act of 2015 implementation, Medicare physician payment reform, MEDPAC, surgical global payments, ACA implementation, health care reform, health care quality improvement, physician workforce issues, comparative clinical effectiveness research, health information technology, EHR meaningful use, EHR data blocking, Patient-Centered Outcomes Research Institute, MEDCAC, Centers for Medicare & Medicaid Innovation, registry access to Medicare claims data, lung cancer screenings, Agency for Healthcare Research & Quality, graduate medical education, electronic cigarette and cigar regulation, PTAC, meaningful use, congenital heart disease funding, unique device identifiers, medical liability reform, COVID-19 pandemic, tobacco riders in appropriations bills, tobacco regulation in the FDA, price transparency, ECMO coding, Prohibit Smoking in VA Facilities Act (S.2106/HR3700) Resident Physician Shortage Reduction Act (S.348/HR1763), Congenital Heart Futures Reauthorization Act, surprise billing, prior authorization, Women and Lung Cancer Research and Preventive Services Act (S.1107/HR2222), T21 bills, Transcatheter aortic valve replacement (TAVR), Increasing Access to Quality Cardiac Rehabilitation Act (HR.3911), Smoke-Free Schools Act of 2019 (HR.4019/S.1832), Protection for Veterans Burn Pits Exposure Act (HR.4086), The Coronavirus Aid, Relief, and Economic Security Act (H.R.748), Coronavirus Provider Protection Act (H.R.7059), Resident Physician Shortage Reduction Act of 2019 (S. 348/H.R. 1763), Quit Because of COVID-19 Act (H.R.7286), Tobacco to 21 Act (S.1258/H.R.2411), The Local Chamber, Tourism, and 501(c)(6) Protection Act (H.R.6697), Immediate Relief for Rural Facilities and Providers Act (S.3559/H.R.6365), Reversing the Youth Tobacco Epidemic Act of 2019 (H.R.2339), Vaccines Act of 2019 (H.R.2862), Investment in Tomorrow's Pediatric Health Care Workforce Act (S.2443), Protecting People from Surprise Medical Bills Act (H.R.3502), Stopping Appealing Flavors in E-Cigarettes for Kids Act (H.R.1498), Resident Education Deferred Interest (REDI) Act (H.R.1554), Improving Access to Medicare Coverage Act (H.R.1682), Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2019 (H.R.1854), Women & Lung Cancer Research & Preventive Services Act (H.R.2222), Prevent BLEEDing Act of 2019 (H.R.2550), Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) for Health Act (H.R.2781), PCORI Reauthorization (H.R.3030), Improving Seniors Timely Access to Care Act (H.R.3107), Keep Physicians Serving Patients Act (H.R.3302), Stopping Appealing Flavors in E-Cigarettes for Kids Act (S.655), Improving Access to Medicare Coverage Act (S.753)

Client expense: $143,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), 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), Medicare Payment Advisory Commission (MedPAC), SENATE, Social Security Administration (SSA)

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

PCORI reauthorization bill, HR 3030; HR 3439 P.L. 111-148/ P.L. 111-152, Affordable Care Act, Title VII Reauthorization/Implementation

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

H.R. 3630- No Surprises Act H.R. 2076- Early Detection to Stop Infant Abuse and Prevent Fatalities Act H.R. 2328- Community Health Investment, Modernization, and Excellence Act of 2019 H.R. 3439- PCORI Reauthorization H.R. 3030- Patient-Centered Outcomes Research Extension Act of 2019 H.R. 3666- STRONGER Patents Act 2019 S. 2082- Support Technology and Research for Our Nation's Growth and Economic Resilience Patents Act of 2019 S.2543- Prescription Drug Pricing Reduction Act of 2019 H.R. 4378- Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 H.R. 2507- Newborn Screening Saves Lives Reauthorization Act of 2019 H.R. 2781- EMPOWER for Health Act of 2019 H.R. 4519- Pediatricians Accelerate Childhood Therapies Act of 2019 S. 3023- Pediatricians Accelerate Childhood Therapies Act of 2019 H.R. 3- Lower Drug Cost Now Act of 2019 H.R. 1865- Further Consolidated Appropriations Act, 2020 H.R. 6201-Families First Coronavirus Response Act H.R. 748- CARES Act H.R. 266 Paycheck Protection and Health Care Enhancement Act H.R 7233 KEEP Telehealth Options Act H.R. 7614 Fiscal 2021 Labor-HHS-Education Appropriations H.R. 6800 Health and Economic Recovery Omnibus Emergency Solutions Act S.3985 JUSTICE Act H.R. 7120 Justice in Policing Act S. 4717 Accelerating Kids Access to Care Act H.R. 5900 Accelerating Kids Access to Care Act General issues regarding mental health/ behavioral health, Medicaid, CHIP, and DSH.

Client expense: $70,000 · Firm income: Not reported

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

H.R. 3630- No Surprises Act H.R. 2076- Early Detection to Stop Infant Abuse and Prevent Fatalities Act H.R. 2328- Community Health Investment, Modernization, and Excellence Act of 2019 H.R. 3439- PCORI Reauthorization H.R. 3030- Patient-Centered Outcomes Research Extension Act of 2019 H.R. 3666- STRONGER Patents Act 2019 S. 2082- Support Technology and Research for Our Nation's Growth and Economic Resilience Patents Act of 2019 S.2543- Prescription Drug Pricing Reduction Act of 2019 H.R. 4378- Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 H.R. 2507- Newborn Screening Saves Lives Reauthorization Act of 2019 H.R. 2781- EMPOWER for Health Act of 2019 H.R. 4519- Pediatricians Accelerate Childhood Therapies Act of 2019 S. 3023- Pediatricians Accelerate Childhood Therapies Act of 2019 H.R. 3- Lower Drug Cost Now Act of 2019 H.R. 1865- Further Consolidated Appropriations Act, 2020 H.R. 6201-Families First Coronavirus Response Act H.R. 748- CARES Act H.R. 266 Paycheck Protection and Health Care Enhancement Act H.R 7233 KEEP Telehealth Options Act H.R. 7614 Fiscal 2021 Labor-HHS-Education Appropriations H.R. 6800 Health and Economic Recovery Omnibus Emergency Solutions Act S.3985 JUSTICE Act H.R. 7120 Justice in Policing Act S. 4717 Accelerating Kids Access to Care Act H.R. 5900 Accelerating Kids Access to Care Act General issues regarding mental health/ behavioral health, Medicaid, CHIP, and DSH.

Client expense: $70,000 · Firm income: Not reported

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

Medicare Access and CHIP Reauthorization Act of 2015 implementation, Medicare physician payment reform, MEDPAC, surgical global payments, ACA implementation, health care reform, health care quality improvement, physician workforce issues, comparative clinical effectiveness research, health information technology, EHR meaningful use, EHR data blocking, Patient-Centered Outcomes Research Institute, MEDCAC, Centers for Medicare & Medicaid Innovation, registry access to Medicare claims data, lung cancer screenings, Agency for Healthcare Research & Quality, graduate medical education, electronic cigarette and cigar regulation, PTAC, meaningful use, congenital heart disease funding, unique device identifiers, medical liability reform, tobacco riders in appropriations bills, tobacco regulation in the FDA, price transparency, ECMO coding, Prohibit Smoking in VA Facilities Act (S.2106/HR3700) Resident Physician Shortage Reduction Act (S.348/HR1763), Congenital Heart Futures Reauthorization Act, surprise billing, prior authorization, Women and Lung Cancer Research and Preventive Services Act (S.1107/HR2222), T21 bills, Transcatheter aortic valve replacement (TAVR), Increasing Access to Quality Cardiac Rehabilitation Act (HR.3911), Smoke-Free Schools Act of 2019 (HR.4019/S.1832), Protection for Veterans Burn Pits Exposure Act (HR.4086), The Coronavirus Aid, Relief, and Economic Security Act (H.R.748), Coronavirus Provider Protection Act (H.R.7059), Resident Physician Shortage Reduction Act of 2019 (S. 348/H.R. 1763), Quit Because of COVID-19 Act (H.R.7286), Tobacco to 21 Act (S.1258/H.R.2411), The Local Chamber, Tourism, and 501(c)(6) Protection Act (H.R.6697), Immediate Relief for Rural Facilities and Providers Act (S.3559/H.R.6365), Reversing the Youth Tobacco Epidemic Act of 2019 (H.R.2339), Vaccines Act of 2019 (H.R.2862), Investment in Tomorrow's Pediatric Health Care Workforce Act (S.2443), Protecting People from Surprise Medical Bills Act (H.R.3502), Stopping Appealing Flavors in E-Cigarettes for Kids Act (H.R.1498), Resident Education Deferred Interest (REDI) Act (H.R.1554), Improving Access to Medicare Coverage Act (H.R.1682), Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2019 (H.R.1854), Women & Lung Cancer Research & Preventive Services Act (H.R.2222), Prevent BLEEDing Act of 2019 (H.R.2550), Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) for Health Act (H.R.2781), PCORI Reauthorization (H.R.3030), Improving Seniors Timely Access to Care Act (H.R.3107), Keep Physicians Serving Patients Act (H.R.3302), Stopping Appealing Flavors in E-Cigarettes for Kids Act (S.655), Improving Access to Medicare Coverage Act (S.753)

Client expense: $186,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), 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), Medicare Payment Advisory Commission (MedPAC), SENATE, Social Security Administration (SSA)

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

H.R. 3630- No Surprises Act H.R. 2076- Early Detection to Stop Infant Abuse and Prevent Fatalities Act H.R. 2328- Community Health Investment, Modernization, and Excellence Act of 2019 H.R. 3439- PCORI Reauthorization H.R. 3030- Patient-Centered Outcomes Research Extension Act of 2019 H.R. 3666- STRONGER Patents Act 2019 S. 2082- Support Technology and Research for Our Nation's Growth and Economic Resilience Patents Act of 2019 S.2543- Prescription Drug Pricing Reduction Act of 2019 H.R. 4378- Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 H.R. 2507- Newborn Screening Saves Lives Reauthorization Act of 2019 H.R. 2781- EMPOWER for Health Act of 2019 H.R. 4519- Pediatricians Accelerate Childhood Therapies Act of 2019 S. 3023- Pediatricians Accelerate Childhood Therapies Act of 2019 H.R. 3- Lower Drug Cost Now Act of 2019 H.R. 1865- Further Consolidated Appropriations Act, 2020 H.R. 6201-Families First Coronavirus Response Act H.R. 748- CARES Act H.R. 266 Paycheck Protection and Health Care Enhancement Act H.R 7233 KEEP Telehealth Options Act H.R. 7614 Fiscal 2021 Labor-HHS-Education Appropriations H.R. 6800 Health and Economic Recovery Omnibus Emergency Solutions Act General issues regarding mental health/ behavioral health, Medicaid, CHIP, and DSH.

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

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

H.R. 3630- No Surprises Act H.R. 2076- Early Detection to Stop Infant Abuse and Prevent Fatalities Act H.R. 2328- Community Health Investment, Modernization, and Excellence Act of 2019 H.R. 3439- PCORI Reauthorization H.R. 3030- Patient-Centered Outcomes Research Extension Act of 2019 H.R. 3666- STRONGER Patents Act 2019 S. 2082- Support Technology and Research for Our Nation's Growth and Economic Resilience Patents Act of 2019 S.2543- Prescription Drug Pricing Reduction Act of 2019 H.R. 4378- Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 H.R. 2507- Newborn Screening Saves Lives Reauthorization Act of 2019 H.R. 2781- EMPOWER for Health Act of 2019 H.R. 4519- Pediatricians Accelerate Childhood Therapies Act of 2019 S. 3023- Pediatricians Accelerate Childhood Therapies Act of 2019 H.R. 3- Lower Drug Cost Now Act of 2019 H.R. 1865- Further Consolidated Appropriations Act, 2020 H.R. 6201-Families First Coronavirus Response Act H.R. 748- CARES Act H.R. 266 Paycheck Protection and Health Care Enhancement Act H.R 7233 KEEP Telehealth Options Act H.R. 7614 Fiscal 2021 Labor-HHS-Education Appropriations H.R. 6800 Health and Economic Recovery Omnibus Emergency Solutions Act General issues regarding mental health/ behavioral health, Medicaid, CHIP, and DSH.

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

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

PCORI reauthorization bill, HR 3030; HR 3439 P.L. 111-148/ P.L. 111-152, Affordable Care Act, Title VII Reauthorization/Implementation

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

FY 2021 funding for the National Institutes of Health (NIH) and Health Resources Services Administration (HRSA); Title VII and Title VII health professions funding S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R.3630 - No Surprises Act ("surprise billing" legislation) H.R. 3439 / H.R. 3030 - Patient-Centered Outcomes Research Institute - Protecting Access to Information for Effective and Necessary Treatment (PATIENT) Act of 2019 (H.R. 3439) and H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 2328 - Medicaid Disproportionate Share Payments - the Community Health Investment, Modernization, and Excellence Act of 2019 H.R. 1763 / S. 348 - Resident Physician Shortage Reduction Act of 2019 340B Drug Pricing Program The Health Resources and Services Administration (HRSA), Organ Procurement and Transplantation Network: Proposal to Eliminate the use of DSA and Region in kidney allocation policy Centers for Medicare & Medicaid Services proposed Radiation Oncology Alternative Payment Model

Client expense: $245,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense Intelligence Agency (DIA), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Science & Technology Policy (OSTP), SENATE, State, Dept of (DOS), Vice President of the U.S., 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

H.R. 3630- No Surprises Act H.R. 2076- Early Detection to Stop Infant Abuse and Prevent Fatalities Act H.R. 2328- Community Health Investment, Modernization, and Excellence Act of 2019 H.R. 3439- PCORI Reauthorization H.R. 3030- Patient-Centered Outcomes Research Extension Act of 2019 H.R. 3666- STRONGER Patents Act 2019 S. 2082- Support Technology and Research for Our Nation's Growth and Economic Resilience Patents Act of 2019 S.2543- Prescription Drug Pricing Reduction Act of 2019 H.R. 4378- Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 H.R. 2507- Newborn Screening Saves Lives Reauthorization Act of 2019 H.R. 2781- EMPOWER for Health Act of 2019 H.R. 4519- Pediatricians Accelerate Childhood Therapies Act of 2019 S. 3023- Pediatricians Accelerate Childhood Therapies Act of 2019 H.R. 3- Lower Drug Cost Now Act of 2019 H.R. 1865- Further Consolidated Appropriations Act, 2020 H.R. 6201-Families First Coronavirus Response Act H.R. 748- CARES Act General issues regarding mental health/ behavioral health, Medicaid, CHIP, and DSH.

Client expense: $90,000 · Firm income: Not reported

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

PCORI reauthorization bill, HR 3030; HR 3439 P.L. 111-148/ P.L. 111-152, Affordable Care Act, Title VII Reauthorization/Implementation

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

S106; S192; HR1943; HR1983; HR 2328, - National Health Service Corps: Medical Student Debt Relief and Rural and Under-served area access. S 304; HR 2815; HR 2328 - Teaching Health Center GME Re-authorization: Increased, extended THCGME funding. HR 1358 - GME Reform: Allow the establishment of new family physician residencies. HR 2740 - HHS FY 2020 Appropriations; Women's Health Research: AAFP funding priorities. Increased funding for women's health research. HR 3030 - Patient Centered Outcomes Research Institute reauthorization: Patient-centered, primary care research, AHRQ funding. No Bill No. - Obesity Drug Study: Responding to GAO inquiry on AAFP policy on obesity drugs. No Bill No. - Rural Health: Improved access to quality care for rural populations. No Bill No. - Teaching Health Center GME funding/Training the Next Generation of Primary Care Doctors Act. No Bill No. - Title VII Primary Care training Enhancement Grants: Support for family medicine training. No Bill No. - AHRQ Center for Primary Care Research: Primary Care research at AHRQ.

Client expense: $997,393 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

S106; S192; HR1943; HR1983; HR 2328, - National Health Service Corps: Medical Student Debt Relief and Rural and Under-served area access. S 289 - Rural Physician Workforce Protection Act: GME reform to support rural residency training. S 304; HR 2815; HR 2328 - Teaching Health Center GME Re-authorization: Increased, extended THCGME funding. S 2372 Rural Moms Act: Supported a rural maternal health bill and urged members to support it. HR 2328 Community Health Investment, and Modernization, and Excellence Act: Also, THCGME, along with Community Health Centers, National Health Service Corps, and Medicaid Funding for the Territories. HR 2328 - Reauthorizing and Extending America's Community Health Act: Support for key primary care extenders, Patient-Centered Outcomes Research Initiative, Independence at Home, Medicaid for the Territories. HR 2740 - HHS FY 2020 Appropriations; Women's Health Research: AAFP funding priorities. Increased funding for women's health research. HR 2774 - Primary Care Patient Protection Act: Create a Primary Care benefit in high deductible health plans. HR 2895 - Conrad State 30 & Physician Access Act: Expand J-1 visa waiver program for medical residents. HR 3030 - Patient Centered Outcomes Research Institute reauthorization: Patient-centered, primary care research, AHRQ funding. HR 3107 - Prior Authorization: Improve healthcare access and reduce administrative burden. HR 3436 - Chronic Care Management: to remove cost-sharing responsibilities for chronic care management services under the medicare plan. No Bill No. - Obesity Drug Study: Responding to GAO inquiry on AAFP policy on obesity drugs. No Bill No. - Opioid prescribing guideline: Responding to FDA inquiry on opioid prescribing guidelines. No Bill No. - Healthcare Coverage for All: Retaining ACA coverage gains and expanding coverage. No Bill No. - Administrative Burden: Reduced administrative burden on family physicians. No Bill No. - Rural Health: Improved access to quality care for rural populations. No Bill No. - Primary Care Investment: Increased spending on primary care. No Bill No. - Congressional Primary Care Caucus: 116th Congress Membership in the bipartisan CPCC. No Bill No. - Insurance network adequacy to avoid "surprise medical bills": protecting patients and families from unanticipated medical bills. No Bill No. - Comment on the definition of Health Literacy: Health Literacy for all patients. No Bill No. - Administrative Simplification: Suggestions to reduce burdens for FPs. No Bill No. - Nondiscrimination in health plans: Healthcare for all. No Bill No. - Patient access to effective drugs: Opioid Issues. No. Bill No. - Telehealth for low-income consumers: Access to high speed internet. No Bill No. - Access to Medicaid Services: Need for higher payment to ensure access to primary care. No Bill No. - 2020 proposed outpatient perspective payment system: Site of service neutrality and transparency in hospital charges. No Bill No. - Lower Health Care Costs Act/Surprise Billing: Support for vaccines, maternal health, transparency, and reducing administrative burdens. Also, support for reauthorizing the Teaching Health Center GME (THCGME) program, along with Community Health Centers and National Health Service Corps. No Bill No. - Teaching Health Center GME funding/Training the Next Generation of Primary Care Doctors Act. No Bill No. - Tobacco Use Prevention: Urged support for Reversing the Youth Tobacco Epidemic Act, Safe Kids Act, and Tobacco to 21 bill. No Bill No. - Surprise Billing: Shared letter on surprise billing. No Bill No. - Drug Prices: Recommendations for various biologic and insulin drug pricing bills. No Bill No. - Congressional Primary Care Caucus: 116th Congress Membership in the bipartisan CPCC.

Client expense: $997,393 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

HR 2740 - HHS FY 2020 Appropriations; Women's Health Research: AAFP funding priorities. Increased funding for women's health research. HR 3030 - Patient Centered Outcomes Research Institute reauthorization: Patient-centered, primary care research, AHRQ funding. No Bill No. - Obesity Drug Study: Responding to GAO inquiry on AAFP policy on obesity drugs. No Bill No. - Opioid prescribing guideline: Responding to FDA inquiry on opioid prescribing guidelines. Evidence Based opioid prescribing guidelines. No Bill No. - Opioid Use Disorder Treatment GME: Medication-assisted treatment training. HR 2328 - Reauthorizing and Extending America's Community Health Act: Support for key primary care extenders, Patient-Centered Outcomes Research Initiative, Independence at Home, Medicaid for the Territories. No Bill No. - AHRQ Center for Primary Care Research: Primary Care research at AHRQ.

Client expense: $997,393 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

S. 73: End Taxpayer Subsidies for Drug Ads Act; all provisions. S. 348/H.R. 1763: Support the Resident Physician Shortage Reduction Act of 2019; all provisions. S. 427 / H.R. 1058: Autism CARES Act of 2019; all provisions. S. 948/ H.R. 2895: Conrad State 30 and Physician Access Reauthorization Act; all provisions. S. 1384: Prescription Drug Rebate Reform Act of 2019; all provisions. S. 1391 / H.R. 2296: FAIR Accountability and Innovative Research Drug Pricing Act; all provisions. S. 3032: Cannabidiol and Marijuana Research Expansion Act; all provisions. H.R. 1155: Preventing Unkind and Painful Procedures and Experiments on Respected Species Act of 2019; all provisions. H.R. 2113: Prescription Drug STAR Act: Sections 2 and 5 H.R. 2279: Safe Step Act; all provisions. H.R. 3030: Patient-Centered Outcomes Research Extension Act of 2019; all provisions. H.R. 3439: Protecting Access to Information for Effective and Necessary Treatment (PATIENTS) Act of 2019; all provisions. Supporting policies to address prescription drug costs, including improving drug pricing transparency and eliminating or reducing direct-to-consumer advertising. Funding for the National Neurological Conditions Surveillance System and opposing certain expansions to this program. Research into firearm morbidity and mortality prevention at CDC, fetal tissue research, and the NIH including the BRAIN Initiative. Funding for Congressionally Directed Medical Research Programs at the DoD. Raising budget caps to avoid sequestration. Policy to address surprise medical billing. Promoting interoperability in electronic health records.

Client expense: $350,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

H.R. 2740, FY 2020 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations bill, funding for the National Institutes of Health (NIH) and Health Resources Services Administration (HRSA); Title VII and Title VII health professions funding S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R.3630 - No Surprises Act ("surprise billing" legislation) H.R. 3439 / H.R. 3030 - Patient-Centered Outcomes Research Institute - Protecting Access to Information for Effective and Necessary Treatment (PATIENT) Act of 2019 (H.R. 3439) and H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 2328 - Medicaid Disproportionate Share Payments - the Community Health Investment, Modernization, and Excellence Act of 2019 H.R. 1763 / S. 348 - Resident Physician Shortage Reduction Act of 2019 340B Drug Pricing Program The Health Resources and Services Administration (HRSA), Organ Procurement and Transplantation Network: Proposal to Eliminate the use of DSA and Region in kidney allocation policy Centers for Medicare & Medicaid Services proposed Radiation Oncology Alternative Payment Model

Client expense: $245,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Education, Dept of, HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Science Foundation (NSF), SENATE, Vice President of the U.S., White House Office

Appropriations for NIH PCORI Reuathorization -H.R. 3030, the Patient-Centered Outcomes Research Extension Act of 2019 PEPFAR

Client expense: $5,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Appropriations for NIH PCORI Reauthorization - H.R. 3030, the "Patient-Centered Outcomes Research Extension Act of 2019"

Client expense: $5,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Agency for Healthcare Research and Quality Public Health Services Act, Title VII re-authorization; HR2781 Council on Graduate Medical Education HRSA Primary Care Medicine and Dentistry Advisory Committee Affordable Care Act Implementation Teaching Health Centers GME Program S. 192, S.304, S.1191, HR2815, HR2328, HR4378 Continuing Appropriations Act 2020, and Health Extenders Act of 2019 National Health Service Corps; HR2328 Patient Centered Outcomes Research Institute/PCOR Trust Fund; HR3030, HR3439

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), President of the U.S., SENATE, Veterans Affairs, Dept of (VA)

S 289, HR 1358 - Physician Workforce/GME Reform: Increasing the number of family medicine residency slots; GME reform to support rural residency training; correct rotator problems. S 304; S 1191; HR 2815; HR 2328 - Teaching Health Center GME Re-authorization: Support for increased, extended THCGME funding. S106; S192; S 962; HR1943; HR1983; HR 2328, - National Health Service Corps: Medical Student Debt Relief and Rural and Under-served area access. S. 1895 - Surprise medical billing: Eliminate barriers to patient access to primary care, fund THCGME program. HR 3; S 2543 - Drug pricing legislation: Support THGME, primary care in HDHP, Medicare and Medicaid. HR 2339 - Nicotine usage: Urged support for reversing the youth tobacco epidemic, tobacco 21 and the vaping flavors ban. HR 2694 - Pregnant workers Fairness Act: AAFP signed a joint letter supporting HR 2694. HR 2774 - Primary Care Patient Protection Act: Create a Primary Care benefit in high deductible health plans. HR 2774, S 2793, HR 5575 - Primary Care Benefit: establish standard primary care benefit in private health insurance plans. HR 3030; HR 1965 - Patient Centered Outcomes Research Institute reauthorization: Evidence based primary care research. HR 3107 - Administrative Burden/Prior Authorization: Reduce administrative burden. HR 4995; 4996 - Maternal Health: AAFP supported maternal health bills to expand medicaid access and bolster training and best practices. No Bill No. - Advisory Committee Training in Primary Care Medicine and Dentistry: Title VII Primary Care Training and Enhancement Grants. No Bill No. - Rural Health: Improved access to quality care for rural populations. No Bill No. - Insurance network adequacy to avoid "surprise medical bills": protecting patients and families from unanticipated medical bills. No Bill No. - Primary Care Investment: Increased spending on primary care. No Bill No. - Congressional Primary Care Caucus: 116th Congress Membership in the bipartisan CPCC. No Bill No. - AHRQ Center for Primary Care Research: Primary Care research at AHRQ. No Bill No. - Primary Care Innovation: Increased awareness of primary care payment and delivery. No Bill No. - Rural Access Issues: How to increase supply of PCP's in rural areas. No Bill No. - RFI on opioid addiction and access to medication-assisted treatment: Chronic pain management. No Bill No. - Confidentiality of Substance Use Disorder: Opioid issues. No Bill No. - 2020 National Vaccine plan: How to improve vaccination rates. No Bill No. - Concerns with EO provisions on scope of practice. No Bill No. - Concerns with flavored e-cigarettes: Youth e-cig epidemic. No Bill No. - Revising two screening code descriptors: Depression and alcohol misuse screening descriptors. No Bill No. - Fraud and safe harbors in medicare: How to address safe harbors in payment models. No Bill No. - Modernizing self-referral laws: How to improve Stark for payment model arrangements. No Bill No. - Lower Health Care Costs Act/Surprise Billing: Support for vaccines, maternal health, transparency, and reducing administrative burdens. Also, support for reauthorizing the Teaching Health Center GME (THCGME) program, along with Community Health Centers and National Health Service Corps. No Bill No. - Medicare Payment: Educated staff about the Medicare Physician Fee Schedule's E&M code increase.

Client expense: $1,218,792 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), 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), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

S 289 - Rural Physician Workforce Protection Act: GME reform to support rural residency training. S106; S192; S 962; HR1943; HR1983; HR 2328, - National Health Service Corps: Medical Student Debt Relief and Rural and Under-served area access. S 304; S 1191; HR 2815; HR 2328 - Teaching Health Center GME Re-authorization: Support for increased, extended THCGME funding. HR 3; S 2543 - Drug pricing legislation: Support THGME, primary care in HDHP, Medicare and Medicaid. HR 3030; HR 1965 - Patient Centered Outcomes Research Institute reauthorization: Evidence based primary care research. HR 2740; HR 1865- HHS FY 2020 Appropriations; Women's Health Research: AAFP spending priorities. Increased funding for women's health research. No Bill No. - Advisory Committee Training in Primary Care Medicine and Dentistry: Title VII Primary Care Training and Enhancement Grants. No Bill No. - Rural Health: Improved access to quality care for rural populations. No Bill No. - AHRQ Center for Primary Care Research: Primary Care research at AHRQ. No Bill No. - HRSA Title VII funding: Title VII Primary Care training Enhancement Grants.

Client expense: $1,218,792 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), 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), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

HR 3030; HR 1965 - Patient Centered Outcomes Research Institute reauthorization: Evidence based primary care research.

Client expense: $1,218,792 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), 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), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

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

S. 116, Modernizing Obstetric Medicine Standards Act of 2019 (MOMS Act) (Gillibrand)-maternal health S. 916, Mothers and Offspring Mortality and Morbidity Awareness Act (MOMMAs Act) (Durbin) -maternal health S. 1012, The Protecting Jessica Grubbs Legacy Act (Capito) - confidential sharing of substance use disorder information S. 1770, Resilience Investment, Support, and Expansion from Trauma Act (RISE from Trauma Act) (Durbin) - trauma care S. 1895, Lower Health Care Costs Act (Alexander-Murray) - surprise medical billing, prescription drug prices, transparency, public health initiatives, exchange of health information, mental health parity, pharmacy benefit manager (PBM) issues, provider directories, disclosure of proprietary information S. 2408, Telehealth Across State Lines Act of 2019 (Blackburn)- telehealth S. 2741, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019 (Schatz) - telehealth S. 2885, Stop Marketing and Revealing the Wearables and Trackers Consumer Health Data Act (Cassidy) - consumer health information S. 2897, Patient-Centered Outcomes Research Institute Reauthorization Act (Warner) - PCORI funding S. 2986, Social Determinants Accelerator Act of 2019 (Young) - Social Determinants of Health H.R. 506, Hospital Competition Act (Banks) - hospital consolidation H.R. 525, Strengthening the Health Care Fraud Prevention Task Force Act (Walden) - codification of Healthcare Fraud Prevention Partnership H.R. 861, End Surprise Billing Act (Doggett) - surprise medical bills H.R. 1395, Youth Mental Health Services Act (Roe) - mental health for students H.R. 1409, Transparency in All Health Care Pricing Act (Perlmutter) - transparency in health care pricing H.R. 1897, Mothers and Offspring Mortality and Morbidity Awareness Act (MOMMAs Act) (Kelly) -maternal health H.R. 2062, Overdose Prevention and Patient Safety Act (Blumenauer) - confidential sharing of substance use disorder information H.R. 2740, HHS Appropriations (DeLauro) - funding for HHS programs and agencies H.R. 3030, Patient-Centered Outcomes Research Extension Act (DeGette) - PCORI reauthorization H.R. 3180, Resilience Investment, Support, and Expansion from Trauma Act (RISE from Trauma Act) (Davis) -trauma care H.R. 3439, Protecting Access to Information for Effective & Necessary Treatment and Services Act (Beyer) - PCORI reauthorization H.R. 4004, Social Determinants Accelerator Act of 2019 (Bustos)- social determinants of health H.R. 4040, Protecting Access to Spinal Surgeries Act (Lewis)- site neutral IPPS payments H.R. 4215, Excellence in Maternal Health Act of 2019 (Bucshon)- maternal health H.R. 4336, Easy Enrollment Act of 2019 (Bera)- aligning enrollment for exchange plans with tax returns H.R. 4768, Home Visiting to Reduce Maternal Mortality and Morbidity Act (David) - maternal health H.R. 4900, Telehealth Across State Lines Act of 2019 (Roe) - telehealth H.R. 4932, Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2019 (Thompson) - telehealth H.R. 4995, Maternal Health Quality Improvement Act of 2019 (Engel) - maternal health outcomes H.R. 5190, STAR Act (Harder) - telemedicine assistance for rural health clinics and health centers H.R. 5257, Telehealth Expansion Act of 2019 (Cox) - establish FCC telehealth program H.R. 5473, Enhance Access to Support Essential Behavioral Health Services Act (Bilirakis) - telehealth Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers including the health plan identifier, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues relating to similarly sized subscriber group (SSSG) and MLR requirements under the FEHBP; implementation of the health savings account provisions of the Medicare Act; issues related to Medicare Secondary Payer requirements; issues related to Patient-Centered Outcomes Research Institute (PCORI) re-authorization; issues related to health care price transparency; issues related to all payor claims databases; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital and provider consolidation; issues related to trauma-informed care; issues related to medical management; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; prescription drug pricing; telemedicine; rural health; issues related to Managed Long Term Services and Supports (MLTSS); issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; issues relating to surprise medical bills; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues relating to the annual fee on health insurance providers; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; NQF reauthorization; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to caregivers; and other issues relating to health care reform implementation.

Client expense: $2,340,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

S. 1384/ H.R. 3805: Prescription Drug Rebate Reform Act of 2019; all provisions. S. 1391 / H.R. 2296: FAIR Accountability and Innovative Research Drug Pricing Act; all provisions. S. 2387: We Protect American Investment in Drugs (PAID) Act; all provisions. S.2443: Investment in Tomorrow's Pediatric Health Care Workforce Act; all provisions. S. 2546 / H.R. 2279: Safe Step Act; all provisions. H.R. 1865: Further Consolidated Appropriations Act, 2020; priorities within this package around outlined below. H.R. 2781: Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) for Health Act, section 4. H.R. 3030: Patient-Centered Outcomes Research Extension Act of 2019; all provisions. H.R. 3439: Protecting Access to Information for Effective and Necessary Treatment (PATIENTS) Act of 2019; all provisions. H.R. 3502, Protecting People from Surprise Medical Bills Act; all provisions. Supporting policies to address prescription drug costs, including improving drug pricing transparency and eliminating or reducing direct-to-consumer advertising. Funding for the National Neurological Conditions Surveillance System and opposing certain expansions to this program. Research into firearm morbidity and mortality prevention at CDC, fetal tissue research, and the NIH including the BRAIN Initiative. Funding for Congressionally Directed Medical Research Programs at the DoD. Lifting the federal ban restricting HHS from studying a Universal Patient Identifier. Policy to address surprise medical billing. Promoting interoperability in electronic health records

Client expense: $250,000 · Firm income: Not reported

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

Administration proposals relating to biomedical research, health care reform and Medicaid funding. H.R. 1763 and S. 348: Resident Physician Shortage Reduction Act of 2019 A bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions, and for other purposes (ALL). H.R. 1554: Resident Education Deferred Interest Act To amend the Higher Education Act of 1965 to provide for interest-free deferment on student loans for borrowers serving in a medical or dental internship or residency program (ALL). H.R. 3030: Patient-Centered Outcomes Research Extension Act of 2019 To amend the Internal Revenue Code of 1986 and title XI of the Social Security Act to extend appropriations and transfers to the Patient-Centered Outcomes Research Trust Fund and to extend certain health insurance fees for such transfers (ALL). S. 2897: Patient-Centered Outcomes Research Institute Reauthorization Act A bill to amend title XI of the Social Security Act to reauthorize the Patient-Centered Outcomes Research Institute, and for other purposes (ALL).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3, Lower Drug Costs Now Act of 2019 H.R. 19, 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. 684, Middle Class Health Benefits Tax Repeal Act of 2019 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 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. 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 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 revisions to safe harbors under the anti-kickback statute (84 Fed. Reg. 55,694-55,765, October 17, 2019) Proposed regulations on Medicare modernizing and clarifying physician self-referral regulations (84 Fed. Reg. 55766-55,847, October 17, 2019) 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

Client expense: $16,900,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), 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), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), 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

H.R. 3630- No Surprises Act H.R. 2076- Early Detection to Stop Infant Abuse and Prevent Fatalities Act H.R. 2328- Community Health Investment, Modernization, and Excellence Act of 2019 H.R. 3439- PCORI Reauthorization H.R. 3030- Patient-Centered Outcomes Research Extension Act of 2019 H.R. 3666- STRONGER Patents Act 2019 S. 2082- Support Technology and Research for Our Nation's Growth and Economic Resilience Patents Act of 2019 S.2543- Prescription Drug Pricing Reduction Act of 2019 H.R. 4378- Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 H.R. 2507- Newborn Screening Saves Lives Reauthorization Act of 2019 H.R. 2781- EMPOWER for Health Act of 2019 H.R. 4519- Pediatricians Accelerate Childhood Therapies Act of 2019 S. 3023- Pediatricians Accelerate Childhood Therapies Act of 2019 H.R. 3- Lower Drug Cost Now Act of 2019 H.R. 1865- Further Consolidated Appropriations Act, 2020 General issues regarding mental health/ behavioral health, Medicaid, CHIP, and DSH.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Expressed support for repealing cuts to the Medicaid Disproportionate Share Hospital program Expressed support for reauthorization of the Patient-Centered Outcomes Trust Fund and the Patient-Centered Outcomes Research Extension Act of 2019 (H.R. 3030) Discussed proposals to prevent surprise medical billing S.1895 - Lower Health Care Costs Act Expresses support for proposals to lower drug prices for patients, including HR. 3, the Elijah E. Cumming Lower Drug Costs Now Act, S. 2543, the Discussed the availability of marijuana for public health research Discussed reforms to the NIH, FDA and CMS that could be included in a new 21st Century Cures Act Requested letters of support for grant renewal for Sheridan Health Services

Client expense: $141,686 · Firm income: Not reported

Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, Veterans Affairs, Dept of (VA)

PCORI reauthorization bill, HR 3030; HR 3439 P.L. 111-148/ P.L. 111-152, Affordable Care Act, Title VII Reauthorization/Implementation

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE

S.1399, H.R. 728 Title VIII Nursing Workforce Reauthorization Act of 2019; H.R. 3030 Patient-Centered Outcomes Research Extension Act of 2019.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2740, FY 2020 Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations bill, funding for the National Institutes of Health (NIH) and Health Resources Services Administration (HRSA); Title VII and Title VII health professions funding S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R.3630 - No Surprises Act ("surprise billing" legislation) H.R. 3439 / H.R. 3030 - Patient-Centered Outcomes Research Institute - Protecting Access to Information for Effective and Necessary Treatment (PATIENT) Act of 2019 (H.R. 3439) and H.R. 3030, Patient-Centered Outcomes Research Extension Act of 2019 H.R. 2328 - Medicaid Disproportionate Share Payments - the Community Health Investment, Modernization, and Excellence Act of 2019 H.R. 1763 / S. 348 - Resident Physician Shortage Reduction Act of 2019 340B Drug Pricing Program The Health Resources and Services Administration (HRSA), Organ Procurement and Transplantation Network: Proposal to Eliminate the use of DSA and Region in kidney allocation policy Centers for Medicare & Medicaid Services proposed Radiation Oncology Alternative Payment Model

Client expense: $245,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Education, Dept of, HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Science Foundation (NSF), SENATE, Vice President of the U.S., White House Office

Appropriations for NIH PCORI Reauthorization - H.R. 3030, the "Patient-Centered Outcomes Research Extension Act of 2019"

Client expense: $5,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Appropriations for NIH PCORI Reuathorization -H.R. 3030, the Patient-Centered Outcomes Research Extension Act of 2019 PEPFAR

Client expense: $5,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 73: End Taxpayer Subsidies for Drug Ads Act; all provisions. S. 1384: Prescription Drug Rebate Reform Act of 2019; all provisions. S. 1391 / H.R. 2296: FAIR Accountability and Innovative Research Drug Pricing Act; all provisions. S.1622, Stopping Overdoses of Fentanyl Analogues Act; all provisions. S.2546 / H.R. 2279: Safe Step Act; all provisions. H.R. 2471: Healthcare Extension and Accessibility for Developmentally Disabled and Underserved Population Act of 2019; all provisions. H.R. 3030: Patient-Centered Outcomes Research Extension Act of 2019; all provisions. H.R. 3439: Protecting Access to Information for Effective and Necessary Treatment (PATIENTS) Act of 2019; all provisions. HR 3502, Protecting People from Surprise Medical Bills Act; all provisions. Authorizing and funding the pediatric loan repayment program. Supporting policies to address prescription drug costs, including improving drug pricing transparency and eliminating or reducing direct-to-consumer advertising. Funding for the National Neurological Conditions Surveillance System and opposing certain expansions to this program. Research into firearm morbidity and mortality prevention at CDC, fetal tissue research, and the NIH including the BRAIN Initiative. Funding for Congressionally Directed Medical Research Programs at the DoD. Raising budget caps to avoid sequestration. Policy to address surprise medical billing. Promoting interoperability in electronic health records.

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

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

S106; S192; HR1943; HR1983; HR 2328, - National Health Service Corps: Medical Student Debt Relief and Rural and Under-served area access. S 304; HR 2815; HR 2328 - Teaching Health Center GME Re-authorization: Increased, extended THCGME funding. HR 1358 - GME Reform: Allow the establishment of new family physician residencies. HR 2740 - HHS FY 2020 Appropriations; Women's Health Research: AAFP funding priorities. Increased funding for women's health research. HR 3030 - Patient Centered Outcomes Research Institute reauthorization: Patient-centered, primary care research, AHRQ funding. No Bill No. - Obesity Drug Study: Responding to GAO inquiry on AAFP policy on obesity drugs. No Bill No. - Rural Health: Improved access to quality care for rural populations. No Bill No. - Teaching Health Center GME funding/Training the Next Generation of Primary Care Doctors Act. No Bill No. - Title VII Primary Care training Enhancement Grants: Support for family medicine training. No Bill No. - AHRQ Center for Primary Care Research: Primary Care research at AHRQ.

Client expense: $997,393 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

HR 2740 - HHS FY 2020 Appropriations; Women's Health Research: AAFP funding priorities. Increased funding for women's health research. HR 3030 - Patient Centered Outcomes Research Institute reauthorization: Patient-centered, primary care research, AHRQ funding. No Bill No. - Obesity Drug Study: Responding to GAO inquiry on AAFP policy on obesity drugs. No Bill No. - Opioid prescribing guideline: Responding to FDA inquiry on opioid prescribing guidelines. Evidence Based opioid prescribing guidelines. No Bill No. - Opioid Use Disorder Treatment GME: Medication-assisted treatment training. HR 2328 - Reauthorizing and Extending America's Community Health Act: Support for key primary care extenders, Patient-Centered Outcomes Research Initiative, Independence at Home, Medicaid for the Territories. No Bill No. - AHRQ Center for Primary Care Research: Primary Care research at AHRQ.

Client expense: $997,393 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

S106; S192; HR1943; HR1983; HR 2328, - National Health Service Corps: Medical Student Debt Relief and Rural and Under-served area access. S 289 - Rural Physician Workforce Protection Act: GME reform to support rural residency training. S 304; HR 2815; HR 2328 - Teaching Health Center GME Re-authorization: Increased, extended THCGME funding. S 2372 Rural Moms Act: Supported a rural maternal health bill and urged members to support it. HR 2328 Community Health Investment, and Modernization, and Excellence Act: Also, THCGME, along with Community Health Centers, National Health Service Corps, and Medicaid Funding for the Territories. HR 2328 - Reauthorizing and Extending America's Community Health Act: Support for key primary care extenders, Patient-Centered Outcomes Research Initiative, Independence at Home, Medicaid for the Territories. HR 2740 - HHS FY 2020 Appropriations; Women's Health Research: AAFP funding priorities. Increased funding for women's health research. HR 2774 - Primary Care Patient Protection Act: Create a Primary Care benefit in high deductible health plans. HR 2895 - Conrad State 30 & Physician Access Act: Expand J-1 visa waiver program for medical residents. HR 3030 - Patient Centered Outcomes Research Institute reauthorization: Patient-centered, primary care research, AHRQ funding. HR 3107 - Prior Authorization: Improve healthcare access and reduce administrative burden. HR 3436 - Chronic Care Management: to remove cost-sharing responsibilities for chronic care management services under the medicare plan. No Bill No. - Obesity Drug Study: Responding to GAO inquiry on AAFP policy on obesity drugs. No Bill No. - Opioid prescribing guideline: Responding to FDA inquiry on opioid prescribing guidelines. No Bill No. - Healthcare Coverage for All: Retaining ACA coverage gains and expanding coverage. No Bill No. - Administrative Burden: Reduced administrative burden on family physicians. No Bill No. - Rural Health: Improved access to quality care for rural populations. No Bill No. - Primary Care Investment: Increased spending on primary care. No Bill No. - Congressional Primary Care Caucus: 116th Congress Membership in the bipartisan CPCC. No Bill No. - Insurance network adequacy to avoid "surprise medical bills": protecting patients and families from unanticipated medical bills. No Bill No. - Comment on the definition of Health Literacy: Health Literacy for all patients. No Bill No. - Administrative Simplification: Suggestions to reduce burdens for FPs. No Bill No. - Nondiscrimination in health plans: Healthcare for all. No Bill No. - Patient access to effective drugs: Opioid Issues. No. Bill No. - Telehealth for low-income consumers: Access to high speed internet. No Bill No. - Access to Medicaid Services: Need for higher payment to ensure access to primary care. No Bill No. - 2020 proposed outpatient perspective payment system: Site of service neutrality and transparency in hospital charges. No Bill No. - Lower Health Care Costs Act/Surprise Billing: Support for vaccines, maternal health, transparency, and reducing administrative burdens. Also, support for reauthorizing the Teaching Health Center GME (THCGME) program, along with Community Health Centers and National Health Service Corps. No Bill No. - Teaching Health Center GME funding/Training the Next Generation of Primary Care Doctors Act. No Bill No. - Tobacco Use Prevention: Urged support for Reversing the Youth Tobacco Epidemic Act, Safe Kids Act, and Tobacco to 21 bill. No Bill No. - Surprise Billing: Shared letter on surprise billing. No Bill No. - Drug Prices: Recommendations for various biologic and insulin drug pricing bills. No Bill No. - Congressional Primary Care Caucus: 116th Congress Membership in the bipartisan CPCC.

Client expense: $997,393 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

S. 116, Modernizing Obstetric Medicine Standards Act of 2019 (MOMS Act) (Gillibrand)-maternal health S. 916, Mothers and Offspring Mortality and Morbidity Awareness Act (MOMMAs Act) (Durbin) -maternal health S. 1012, The Protecting Jessica Grubbs Legacy Act (Capito) - confidential sharing of substance use disorder information S. 1770, Resilience Investment, Support, and Expansion from Trauma Act (RISE from Trauma Act) (Durbin) - trauma care S. 1895, Lower Health Care Costs Act (Alexander-Murray) - surprise medical billing, prescription drug prices, transparency, public health initiatives, exchange of health information, mental health parity, pharmacy benefit manager (PBM) issues, provider directories, disclosure of proprietary information S. 2408, Telehealth Across State Lines Act of 2019 (Blackburn)- telehealth H.R. 506, Hospital Competition Act (Banks) - hospital consolidation H.R. 525, Strengthening the Health Care Fraud Prevention Task Force Act (Walden) - codification of Healthcare Fraud Prevention Partnership H.R. 861, End Surprise Billing Act (Doggett) - surprise medical bills H.R. 1395, Youth Mental Health Services Act (Roe) - mental health for students H.R. 1409, Transparency in All Health Care Pricing Act (Perlmutter) - transparency in health care pricing H.R. 1897, Mothers and Offspring Mortality and Morbidity Awareness Act (MOMMAs Act) (Kelly) -maternal health H.R. 2062, Overdose Prevention and Patient Safety Act (Blumenauer) - confidential sharing of substance use disorder information H.R. 2740, HHS Appropriations (DeLauro) - funding for HHS programs and agencies H.R. 3030, Patient-Centered Outcomes Research Extension Act (DeGette) - PCORI reauthorization H.R. 3180, Resilience Investment, Support, and Expansion from Trauma Act (RISE from Trauma Act) (Davis) -trauma care H.R. 3439, Protecting Access to Information for Effective & Necessary Treatment and Services Act (Beyer) - PCORI reauthorization H.R. 4004, Social Determinants Accelerator Act of 2019 (Bustos)- social determinants of health H.R. 4040, Protecting Access to Spinal Surgeries Act (Lewis)- site neutral IPPS payments H.R. 4215, Excellence in Maternal Health Act of 2019 (Bucshon)- maternal health H.R. 4336, Easy Enrollment Act of 2019 (Bera)- aligning enrollment for exchange plans with tax returns Regulatory Issues: HIPAA administrative simplification issues, including standards for privacy, security, and electronic transactions and code sets (including ICD-10), identifiers including the health plan identifier, enforcement; cybersecurity; FEHBP enrollment data clearinghouse initiative, the enrollment reconciliation process, and a related OPM reimbursement factor for records that cannot be reconciled; issues relating to health insurance plan participation in FEHBP, including contract requirements; issues relating to similarly sized subscriber group (SSSG) and MLR requirements under the FEHBP; implementation of the health savings account provisions of the Medicare Act; issues related to Medicare Secondary Payer requirements; issues related to Patient-Centered Outcomes Research Institute (PCORI) re-authorization; issues related to health care price transparency; issues related to all payor claims databases; issues related to implementation of the National Health Information Infrastructure; electronic health records, personal health records, and similar technologies; issues relating to market consolidation; issues related to hospital and provider consolidation; issues related to trauma-informed care; issues related to medical management; issues relating to quality improvement; issues relating to the national health data stewardship; issues relating to hospital outpatient measurement and reporting; prescription drug pricing; issues related to the collection of race and ethnicity data; issues related to medical loss ratios; reference pricing; review of rates for reasonableness; preexisting condition insurance plans; issues relating to antitrust; issues relating to surprise medical bills; accountable care organizations; provider non-discrimination; coverage of preventive services; contraceptive coverage; pre-existing condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; issues relating to the annual fee on health insurance providers; health plan automatic enrollment requirements; issues related to qualified health plans including certification and rate filing templates; health insurance market rules; reinsurance, risk corridors, and risk adjustment; dependent coverage; summary of benefits and coverage disclosures; benefit and payment parameters; essential health benefits, actuarial value, and accreditation; NQF reauthorization; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations; issues related to supplemental products; issues related to HIPAA excepted benefits; issues related to short term limited duration products; issues related to the federally-facilitated marketplaces (i.e., Exchanges/formerly referred to as the web portal); issues related to business continuity in relation to pandemics or natural events (e.g., hurricane, tornado, etc.); issues related to association health plans; issues related to cost-sharing reductions (CSRs); issues related to the refundable credit for coverage under a qualified health plan; issues related to small employer group size; issues related to Certificate of Public Advantage; issues relating to veterans health care; issues relating to family caregivers; and other issues relating to health care reform implementation.

Client expense: $2,110,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Treasury, Dept of, White House Office