Protecting Seniors Through Immunization Act of 2019

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Brazil Biologics Regulations ---BSUFA ---Canada Biologics Regulations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Implementation of CREATES Act of 2019 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6206: Pandemic Response and Emergency Preparedness (PREP) Act of 2020 ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Drug Supply Chain Management ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Adult Immunization Education ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Maternal Immunization ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program

Client expense: $3,320,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Lobbying Issues Description: Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; community-based public health interventions, and substance misuse/behavioral health issues. Specific Legislation: 1.Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2.Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act and Pandemic and All-Hazards Preparedness and Advancing Innovation Act (Public Law 113-5, 116-22) 3.Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 4.Implementation of Every Student Succeeds Act (Public Law 114-95) 5.Implementation of the Comprehensive Addition and Recovery Act (Public Law 114-98) 6.Midnight Rules Relief Act (S.34/H.R. 21) 7.Regulations from the Executive in Need of Scrutiny Act (S. 21/H.R. 26) 8.Regulatory Accountability Act (S.951/H.R. 5/H.R. 45/H.Res.33) 9.Searching for and Cutting Regulations that are Unnecessarily Burdensome (SCRUB) Act (H.R. 998) 10.Regulatory Integrity Act (H.R. 1004) 11.OIRA Insight, Reform, and Accountability Act (S. 676/H.R. 1009) 12.A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026 (S.Con.Res. 3) 13.American Health Care Act (H.R. 1628/H.Res. 228) 14.Ozone Standards Implementation Act (S. 263/H.R. 806) 15.Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the final rule of the Bureau of Land Management relating to "Waste Prevention, Production Subject to Royalties, and Resource Conservation" (S.J. Res. 11/H.J.Res.36) 16.Common Sense Nutrition Disclosure Act (S. 261/H.R. 772) 17.Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act (H.R. 1840) 18.Preservation of Antibiotics for Medical Treatment Act (H.R. 1587) 19.Preventing Antibiotic Resistance Act (S. 629) 20.Better Care Reconciliation Act (H.R. 1628) and related amendments 21.Public Health Emergency Response Act (S. 196) 22.Recognizing the importance of vaccinations and immunizations in the United States (H.Res.327) 23.Treat and Reduce Obesity Act (S. 830/H.R. 1953) 24.Community Health and Medical Professionals Improve Our Nation (CHAMPION) Act (H.R. 3922) 25.Community Health Investment, Modernization, and Excellence Act of 2017 (S. 1899) 26.Tobacco Tax Equity Act (S. 1837) 27.Healthy Kids Act (S. 1821/H.R. 3921) 28.Implementation of the Drug Quality and Security Act (P.S. 113-54) 29.Continuing Appropriations Act, 2018 and Supplemental Appropriations for Disaster Relief Requirements Act, 2017 (Public Law 115-56) 30.Friendly Airports for Mothers Act (S. 1110/H.R. 2375) 31.Lead-Safe Housing for Kids Act (S. 1583/H.R. 8713) 32.Supporting Working Moms Act (S. 2122/H.R. 3255) 33.Championing Healthy Kids Act (H.R. 3922) 34.Making further continuing appropriations for fiscal year 2018, and for other purposes (Public Law 115-90) 35.An Act to amend the Homeland Security Act of 2002 to require the Secretary of Homeland Security to issue Department of Homeland Security-wide guidance and develop training programs as part of the Department of Homeland Security Blue Campaign, and for other purposes (Public Law 115-96) 36.Tax Cuts and Jobs Act (Public Law 115-97) 37.Pandemic and All-Hazards Preparedness Advancing Innovation Act (P.L. 116-22) 38.Vaccine Access Improvement Act (H.R. 4993) 39.Relief from New Source Performance Standards Act (H.R. 453) 40.Strategies to Address Antimicrobial Resistance (S. 2469) 41.Opioid Quota Reform Act (S. 2535) 42.Hospital Preparedness Program Reauthorization Act (H.R. 4776) 43.Blocking Regulatory Interference from Closing Kilns Act (H.R. 1917) 44.Opioid Crisis Response Act of 2018 (S. 2680) 45.Agriculture and Nutrition Act (H.R. 2) 46.Agriculture Improvement Act (S. 3042) 47.SECURE Act (H.R. 5998) 48.Trauma-Informed Care for Children and Families Act (S. 774) 49.SUPPORT for Patients and Communities Act (H.R. 6) 50.Centers for Disease Control Emergency Response Act (S. 3161) 51.LABEL Opioids Act (S. 3428) 52.Relief from New Source Performance Standards Act (S. 1857) 53.Outdoors for All Act (S. 3499) 54.The MOMMA Act (H.R. 5977) 55.Preventing Maternal Deaths Act (H.R. 1318) 56.Medicare Access to Vaccines Equity Act (not yet introduced) 57.The Support Act (H.R. 6) 58.Climate Change Health Protection and Promotion Act (S. 529) 59.NURSE Act (H.R. 1597) 60.Investing for the People Act (H.R. 2021) 61.Child Care for Working Families Act (H.R. 365/S. 568) 62.FAMILY Act (H.R. 1185/S. 463) 63.Transportation Alternatives Enhancement Act (S. 1098) 64.Lower Health Care Costs Act (S. 1895) 65.LIFT America Act (H.R 2479) 66.Public Health Funding Restoration Act (H.R. 3447/S. 1944) 67.Supporting Older Americans Act of 2020 (HR 4334) 68.Campus Prevention and Recovery Services for Students Act (H.R. 3591) 69.Healthier Students for Stronger Campuses Act (S. 1281) 70.Saving Lives Through Better Data Act (S. 1793) 71.VACCINES Act (H.R. 2862) 72.DISARM Act (H.R. 4100/S. 1712) 73.Community Access, Resources, and Education for Families Act (H.R. 3117) 74.Protecting Seniors Through Immunization Act (S. 1872) 75.Tobacco-Free Youth Act (S. 1541) 76.Tobacco to 21 Act (H.R. 2411/S. 1258) 77.Investing for People Act (H.R. 2021) 78.School Based Health Centers Reauthorization Act (H.R.2075/S.1013) 79.Reversing the Youth Tobacco Epidemic Act of 2019 (H.R. 2339) 80.Social Determinants Accelerator Act (H.R. 4004/S. 2986) 81.Mental Health Professionals Workforce Shortage Loan Repayment Act (H.R. 2431) 82.The UNDERSTAND Act (S. 1323) 83.Americas Transportation Infrastructure Act (S. 2302) 84.Barriers to Suicide Act of 2019 (H.R. 4309) 85.Promoting Physical Activity for Americans Act (S. 1608/H.R. 2891) 86.Public Health Infrastructure Modernization Act of 2019 (H.R. 5321) 87.Supporting Healthy Mothers and Infants Act (H.R. 5249) 88.Lead-Free Future Act (H.R. 4416) 89.Home Visiting to Reduce Maternal Mortality and Morbidity Act (H.R. 4768) 90.Recognizing the anniversary of the eradication of smallpox and the importance of vaccination in the United States and worldwide (H. Res. 592) 91.Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) 92.Families First Coronavirus Response Act (H.R. 6201) 93.Coronavirus Aid, Relief, and Economic Security (CARES) Act (H.R. 748) 94.Connecting Americas Transportation Infrastructure Act (H.R. 5696/S. 3391)) 95.Improving Access to Remote Behavioral Health Treatment Act (S. 2244/H.R. 4131) 96.National Suicide Hotline Designation Act (S. 2661/H.R. 4194) 97.Suicide Prevention Lifeline Improvement Act (H.R. 4564) 98.Campaign to Prevent Suicide Act (H.R. 4585) 99.Medicaid Reentry Act (H.R. 1329) 100.Excellence in Mental Health and Addiction Treatment Expansion Act (S. 824/H.R. 1767) 101.Mental Health Services for Students Act (S. 1122/H.R. 1109) 102.Suicide Training and Awareness Nationally Delivered for Universal Prevention (STANDUP) Act (S. 2492/H.R. 2599) 103.Mental Health Parity Compliance Act (S. 1737/H.R. 3165) 104.Behavioral Health Transparency Act (S. 1576/H.R. 2874) 105.Medicare Mental Health Access Act (S. 2772/H.R. 884) 106.Public Health Emergency Response and Accountability Act (S. 3309) 107.Family Violence Prevention and Services Improvement Act (H.R. 5041) 108.Protecting the Health of Americas Older Adults During COVID-19 and Beyond Act (H.R. 6935) 109.Improving Social Determinants Act (H.R. 6561/S. 4440) 110.Urging the establishment of a United States Commission on Truth, Racial Healing, and Transformation (H.Con.Res.100/S.Con.Res.50) 111.FY 2021 Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations (TBD) 112.Better Tools for Healthy Living Act (S. 1805) 113.The WIC Act (H.R. 6811/S. 2358) 114.Health Equity and Accountability Act (H.R. 6637/S. 4819) 115.Paycheck Protection Program and Health Care Enhancement Act (H.R. 266) 116.The HEROES Act (H.R.6800) 117.Community Solutions for COVID-19 Act (H.R.7077/S.3877) 118.The Black Maternal Health Momnibus Act of 2020 (H.R. 6142) 119.COVID-19 Bias and Anti-Racism Training Act (H.R. 7618/S. 4248) 120.Urging the establishment of a United States Commission on Truth, Racial Healing, and Transformation (H. Con. Res. 100) 121.Community Immunity During COVID-19 Act of 2020 (H.R. 8061) 122.Public Safety Officer Support Act (H.R. 7568) 123.COVID-19 Behavioral Health Support Act (S. 4059) 124.Public Health Workforce Loan Repayment Act (H.R. 6578) 125.Strengthening the Public Health Workforce Act (S. 3737) 126.A resolution declaring racism a public health crisis (S. Res. 655) 127.Pandemic Child Hunger Prevention Act (H.R.7887) 128.Public Health Infrastructure Saves Lives Act (S. 4740) 129.CARE for Families Act (H.R. 3117/S. 3354) 130.Improving Data Collection for Adverse Childhood Experiences Act (H.R. 7689/S. 4980) 131.The STANDUP Act of 2020 (H.R. 7293) 132.The Effective Suicide Screening and Assessment in the Emergency Department Act (H.R. 4861) 133.The Pursuing Equity in Mental Health Act of 2019 (H.R. 5469) 134.The Improving Mental Health Access from the Emergency Department Act (H.R. 2519/S. 1334) 135.The Suicide Prevention Act (H.R. 5619/S. 3198) 136.The Helping Emergency Responders Overcome (HERO) Act (H.R. 1646/S. 3244) 137.The Campaign to Prevent Suicide Act (H.R. 4585) 138.The Maternal Health Immunization Enhancement Act (S. 4690) 139.Pandemic Vaccine Access Improvement Act (Not yet introduced) 140.Moving Forward Act (H.R. 2) 141.Continuing Appropriations Act, 2021 and Other Extensions Act (HR 8319) Coronavirus Response Additional Supplemental Appropriations Act (S. 4320). 142.ETHIC Act (H.R. 8205) 143.Safely Back to School and Work Act (S. 4322) 144.Supporting the goals and ideals of BIPOC Mental Health Awareness Month (H.Res. 1064) 145.COVID-19 Health Disparities Action Act (S. 4262) 146.Protecting American Heroes Act of 2020 (S. 4368) 147.Health STATISTICS Act (H.R. 8080) 148.Maternal Health Quality Improvement Act (H.R. 4995) 149.Helping MOMS Act of 2020 (H.R. 4996) 150.Maternal Immunization Enhancement Act 151.FY2021 Omnibus and COVID Relief and Response Act (P.L. 116-260) 152.Helping Adults Protect Immunity (HAPI) Act (H.R. 4864) 153.Secure Affordable Vaccines Equally (SAVE) for Seniors Act (H.R. 8623) House(s) of Congress and Federal Agencies lobbied during the quarter: House, Senate, Exec Office of Pres, HHS, CDC, FDA, CMS, OMB, DOT, HUD, EPA, NIMH, Education, USDA, DHS, FEMA, and SAMHSA.

Client expense: $41,268 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT)

Lobbying Issues Description: Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; community-based public health interventions, and substance misuse/behavioral health issues. Specific Legislation: 1.Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2.Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act and Pandemic and All-Hazards Preparedness and Advancing Innovation Act (Public Law 113-5, 116-22) 3.Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 4.Implementation of Every Student Succeeds Act (Public Law 114-95) 5.Implementation of the Comprehensive Addition and Recovery Act (Public Law 114-98) 6.Midnight Rules Relief Act (S.34/H.R. 21) 7.Regulations from the Executive in Need of Scrutiny Act (S. 21/H.R. 26) 8.Regulatory Accountability Act (S.951/H.R. 5/H.R. 45/H.Res.33) 9.Searching for and Cutting Regulations that are Unnecessarily Burdensome (SCRUB) Act (H.R. 998) 10.Regulatory Integrity Act (H.R. 1004) 11.OIRA Insight, Reform, and Accountability Act (S. 676/H.R. 1009) 12.A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026 (S.Con.Res. 3) 13.American Health Care Act (H.R. 1628/H.Res. 228) 14.Ozone Standards Implementation Act (S. 263/H.R. 806) 15.Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the final rule of the Bureau of Land Management relating to "Waste Prevention, Production Subject to Royalties, and Resource Conservation" (S.J. Res. 11/H.J.Res.36) 16.Common Sense Nutrition Disclosure Act (S. 261/H.R. 772) 17.Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act (H.R. 1840) 18.Preservation of Antibiotics for Medical Treatment Act (H.R. 1587) 19.Preventing Antibiotic Resistance Act (S. 629) 20.Better Care Reconciliation Act (H.R. 1628) and related amendments 21.Public Health Emergency Response Act (S. 196) 22.Recognizing the importance of vaccinations and immunizations in the United States (H.Res.327) 23.Treat and Reduce Obesity Act (S. 830/H.R. 1953) 24.Community Health and Medical Professionals Improve Our Nation (CHAMPION) Act (H.R. 3922) 25.Community Health Investment, Modernization, and Excellence Act of 2017 (S. 1899) 26.Tobacco Tax Equity Act (S. 1837) 27.Healthy Kids Act (S. 1821/H.R. 3921) 28.Implementation of the Drug Quality and Security Act (P.S. 113-54) 29.Continuing Appropriations Act, 2018 and Supplemental Appropriations for Disaster Relief Requirements Act, 2017 (Public Law 115-56) 30.Friendly Airports for Mothers Act (S. 1110/H.R. 2375) 31.Lead-Safe Housing for Kids Act (S. 1583/H.R. 8713) 32.Supporting Working Moms Act (S. 2122/H.R. 3255) 33.Championing Healthy Kids Act (H.R. 3922) 34.Making further continuing appropriations for fiscal year 2018, and for other purposes (Public Law 115-90) 35.An Act to amend the Homeland Security Act of 2002 to require the Secretary of Homeland Security to issue Department of Homeland Security-wide guidance and develop training programs as part of the Department of Homeland Security Blue Campaign, and for other purposes (Public Law 115-96) 36.Tax Cuts and Jobs Act (Public Law 115-97) 37.Pandemic and All-Hazards Preparedness Advancing Innovation Act (P.L. 116-22) 38.Vaccine Access Improvement Act (H.R. 4993) 39.Relief from New Source Performance Standards Act (H.R. 453) 40.Strategies to Address Antimicrobial Resistance (S. 2469) 41.Opioid Quota Reform Act (S. 2535) 42.Hospital Preparedness Program Reauthorization Act (H.R. 4776) 43.Blocking Regulatory Interference from Closing Kilns Act (H.R. 1917) 44.Opioid Crisis Response Act of 2018 (S. 2680) 45.Agriculture and Nutrition Act (H.R. 2) 46.Agriculture Improvement Act (S. 3042) 47.SECURE Act (H.R. 5998) 48.Trauma-Informed Care for Children and Families Act (S. 774) 49.SUPPORT for Patients and Communities Act (H.R. 6) 50.Centers for Disease Control Emergency Response Act (S. 3161) 51.LABEL Opioids Act (S. 3428) 52.Relief from New Source Performance Standards Act (S. 1857) 53.Outdoors for All Act (S. 3499) 54.The MOMMA Act (H.R. 5977) 55.Preventing Maternal Deaths Act (H.R. 1318) 56.Medicare Access to Vaccines Equity Act (not yet introduced) 57.The Support Act (H.R. 6) 58.Climate Change Health Protection and Promotion Act (S. 529) 59.NURSE Act (H.R. 1597) 60.Investing for the People Act (H.R. 2021) 61.Child Care for Working Families Act (H.R. 365/S. 568) 62.FAMILY Act (H.R. 1185/S. 463) 63.Transportation Alternatives Enhancement Act (S. 1098) 64.Lower Health Care Costs Act (S. 1895) 65.LIFT America Act (H.R 2479) 66.Public Health Funding Restoration Act (H.R. 3447/S. 1944) 67.Supporting Older Americans Act of 2020 (HR 4334) 68.Campus Prevention and Recovery Services for Students Act (H.R. 3591) 69.Healthier Students for Stronger Campuses Act (S. 1281) 70.Saving Lives Through Better Data Act (S. 1793) 71.VACCINES Act (H.R. 2862) 72.DISARM Act (H.R. 4100/S. 1712) 73.Community Access, Resources, and Education for Families Act (H.R. 3117) 74.Protecting Seniors Through Immunization Act (S. 1872) 75.Tobacco-Free Youth Act (S. 1541) 76.Tobacco to 21 Act (H.R. 2411/S. 1258) 77.Investing for People Act (H.R. 2021) 78.School Based Health Centers Reauthorization Act (H.R.2075/S.1013) 79.Reversing the Youth Tobacco Epidemic Act of 2019 (H.R. 2339) 80.Social Determinants Accelerator Act (H.R. 4004/S. 2986) 81.Mental Health Professionals Workforce Shortage Loan Repayment Act (H.R. 2431) 82.The UNDERSTAND Act (S. 1323) 83.Americas Transportation Infrastructure Act (S. 2302) 84.Barriers to Suicide Act of 2019 (H.R. 4309) 85.Promoting Physical Activity for Americans Act (S. 1608/H.R. 2891) 86.Public Health Infrastructure Modernization Act of 2019 (H.R. 5321) 87.Supporting Healthy Mothers and Infants Act (H.R. 5249) 88.Lead-Free Future Act (H.R. 4416) 89.Home Visiting to Reduce Maternal Mortality and Morbidity Act (H.R. 4768) 90.Recognizing the anniversary of the eradication of smallpox and the importance of vaccination in the United States and worldwide (H. Res. 592) 91.Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) 92.Families First Coronavirus Response Act (H.R. 6201) 93.Coronavirus Aid, Relief, and Economic Security (CARES) Act (H.R. 748) 94.Connecting Americas Transportation Infrastructure Act (H.R. 5696/S. 3391)) 95.Improving Access to Remote Behavioral Health Treatment Act (S. 2244/H.R. 4131) 96.National Suicide Hotline Designation Act (S. 2661/H.R. 4194) 97.Suicide Prevention Lifeline Improvement Act (H.R. 4564) 98.Campaign to Prevent Suicide Act (H.R. 4585) 99.Medicaid Reentry Act (H.R. 1329) 100.Excellence in Mental Health and Addiction Treatment Expansion Act (S. 824/H.R. 1767) 101.Mental Health Services for Students Act (S. 1122/H.R. 1109) 102.Suicide Training and Awareness Nationally Delivered for Universal Prevention (STANDUP) Act (S. 2492/H.R. 2599) 103.Mental Health Parity Compliance Act (S. 1737/H.R. 3165) 104.Behavioral Health Transparency Act (S. 1576/H.R. 2874) 105.Medicare Mental Health Access Act (S. 2772/H.R. 884) 106.Public Health Emergency Response and Accountability Act (S. 3309) 107.Family Violence Prevention and Services Improvement Act (H.R. 5041) 108.Protecting the Health of Americas Older Adults During COVID-19 and Beyond Act (H.R. 6935) 109.Improving Social Determinants Act (H.R. 6561/S. 4440) 110.Urging the establishment of a United States Commission on Truth, Racial Healing, and Transformation (H.Con.Res.100/S.Con.Res.50) 111.FY 2021 Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations (TBD) 112.Better Tools for Healthy Living Act (S. 1805) 113.The WIC Act (H.R. 6811/S. 2358) 114.Health Equity and Accountability Act (H.R. 6637/S. 4819) 115.Paycheck Protection Program and Health Care Enhancement Act (H.R. 266) 116.The HEROES Act (H.R.6800) 117.Community Solutions for COVID-19 Act (H.R.7077/S.3877) 118.The Black Maternal Health Momnibus Act of 2020 (H.R. 6142) 119.COVID-19 Bias and Anti-Racism Training Act (H.R. 7618/S. 4248) 120.Urging the establishment of a United States Commission on Truth, Racial Healing, and Transformation (H. Con. Res. 100) 121.Community Immunity During COVID-19 Act of 2020 (H.R. 8061) 122.Public Safety Officer Support Act (H.R. 7568) 123.COVID-19 Behavioral Health Support Act (S. 4059) 124.Public Health Workforce Loan Repayment Act (H.R. 6578) 125.Strengthening the Public Health Workforce Act (S. 3737) 126.A resolution declaring racism a public health crisis (S. Res. 655) 127.Pandemic Child Hunger Prevention Act (H.R.7887) 128.Public Health Infrastructure Saves Lives Act (S. 4740) 129.CARE for Families Act (H.R. 3117/S. 3354) 130.Improving Data Collection for Adverse Childhood Experiences Act (H.R. 7689/S. 4980) 131.The STANDUP Act of 2020 (H.R. 7293) 132.The Effective Suicide Screening and Assessment in the Emergency Department Act (H.R. 4861) 133.The Pursuing Equity in Mental Health Act of 2019 (H.R. 5469) 134.The Improving Mental Health Access from the Emergency Department Act (H.R. 2519/S. 1334) 135.The Suicide Prevention Act (H.R. 5619/S. 3198) 136.The Helping Emergency Responders Overcome (HERO) Act (H.R. 1646/S. 3244) 137.The Campaign to Prevent Suicide Act (H.R. 4585) 138.The Maternal Health Immunization Enhancement Act (S. 4690) 139.Pandemic Vaccine Access Improvement Act (Not yet introduced) 140.Moving Forward Act (H.R. 2) 141.Continuing Appropriations Act, 2021 and Other Extensions Act (HR 8319) Coronavirus Response Additional Supplemental Appropriations Act (S. 4320). 142.ETHIC Act (H.R. 8205) 143.Safely Back to School and Work Act (S. 4322) 144.Supporting the goals and ideals of BIPOC Mental Health Awareness Month (H.Res. 1064) 145.COVID-19 Health Disparities Action Act (S. 4262) 146.Protecting American Heroes Act of 2020 (S. 4368) 147.Health STATISTICS Act (H.R. 8080) 148.Maternal Health Quality Improvement Act (H.R. 4995) 149.Helping MOMS Act of 2020 (H.R. 4996) 150.Maternal Immunization Enhancement Act 151.FY2021 Omnibus and COVID Relief and Response Act (P.L. 116-260) 152.Helping Adults Protect Immunity (HAPI) Act (H.R. 4864) 153.Secure Affordable Vaccines Equally (SAVE) for Seniors Act (H.R. 8623) House(s) of Congress and Federal Agencies lobbied during the quarter: House, Senate, Exec Office of Pres, HHS, CDC, FDA, CMS, OMB, DOT, HUD, EPA, NIMH, Education, USDA, DHS, FEMA, and SAMHSA.

Client expense: $36,974 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT)

Legislation and policies relating to: Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Reauthorization of funding for the Childrens Health Insurance Program Reauthorization of the Child Nutrition Act Section 2706 of the ACA regarding provider non-discrimination Policies related to health insurance market stabilization Policies affecting nurse practitioner education and workforce Definition, evaluation and enforcement of essential health benefits and provider network adequacy Health information technology and electronic health records Mental health services and violence prevention Human and child trafficking Palliative Care and Hospice Education and Training Act (H.R. 647/S. 2080) Title VIII Nursing Workforce Reauthorization Act of 2019 (H.R. 728/S. 1399) Coronavirus Aid, Relief, and Economic Security (CARES) Act (H.R. 748/S.3548) Emergency Medical Services for Children Program Reauthorization Act of 2019 (H.R. 776/S. 1173) End Surprise Billing Act of 2019 (H.R. 861) Fairness for Breastfeeding Mothers Act (H.R. 866/S. 528) Heroes Act (H.R. 925) Mental Health Access Improvement Act of 2019 (H.R. 945) Mental Health Services for Students Act of 2019 (H.R. 1109) Workplace Violence Prevention for Health Care and Social Service Workers Act (H.R. 1309) Competitive Health Insurance Reform Act of 2020 (H.R. 1418) Patient Protection and Affordable Care Enhancement Act (H.R. 1425) Healthy Families Act (H.R. 1784/S. 840) Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act (H.R. 1897) School-Based Health Centers Reauthorization Act of 2019 (H.R. 2075/S. 1013) Scarlett's Sunshine on Sudden Unexpected Death Act (H.R. 2271/S. 1130) Easy MAT for Opioid Addiction Act (H.R. 2281) Community Health Investment, Modernization, and Excellence Act of 2019 (H.R. 2328) Newborn Screening Saves Lives Reauthorization Act of 2019 (H.R. 2507) Pregnant Workers Fairness Act (H.R. 2694) Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) for Health Act of 2019 (H.R. 2781) Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 (H.R. 2862) Physical Activities Recommendations for Americans Act of 2019 (H.R. 2891) Safe Cribs Act of 2019 (H.R. 3170) Safe Sleep for Babies Act of 2019 (H.R. 3172) Pathways to Health Careers Act (H.R. 3398) Chronic Care Management Improvement Act (H.R. 3436) No Surprises Act (H.R. 3630) Midwives for Maximizing Optimal Maternity Services (Midwives for MOMS) Act of 2019 (H.R. 3849) Social Determinants Accelerator Act of 2019 (H.R. 4004/S. 2986) Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019 (H.R. 3328/H.R. 4100/S. 1712) Effective Suicide Screening and Assessment in the Emergency Department Act of 2019 (H.R. 4861/S. 3006) United States Public Health Service Modernization Act of 2019 (H.R. 4870/S. 2629) Medication Access and Training Expansion (MATE) Act of 2019 (H.R. 4974) Maternal Health Quality Improvement Act of 2019 (H.R. 4995) Helping Medicaid Offer Maternity Services (MOMS) Act of 2019 (H.R. 4996) Protecting Seniors Through Immunization Act of 2019 (H.R. 5076/S. 1872) Pursuing Equity in Mental Health Act of 2019 (H.R. 5469) Primary and Behavioral Health Care Access Act (H.R. 5575) Ban Surprise Billing Act (H.R. 5800) Consumer Protections Against Surprise Medical Bills Act of 2020 (H.R. 5826) Black Maternal Health Momnibus Act of 2020 (H.R. 6142/S. 3424) Families First Coronavirus Response Act (H.R. 6201) Take Responsibility for Workers and Families Act (H.R. 6379) Health Care at Home Act (H.R. 6644) COVID-19 Mental Health Research Act (H.R. 6645) HEROES Act (H.R. 6800) Child Care Is Essential Act (H.R. 7027) Ensuring Children and Child Care Workers Are Safe Act of 2020 (H.R. 7079) Child Care for Economic Recovery Act (H.R. 7327) Protect Telehealth Access Act (H.R. 7391) Protecting Access to Post-COVID-19 Telehealth Act of 2020 (H.R. 7663) Community and Public Health Programs Extension Act (S. 192) National Nurse Act of 2019 (S. 696/H.R. 1597) Excellence in Mental Health and Addiction Treatment Expansion Act (S. 824/H.R. 1767) Nursing Where It's Needed Act (S. 1045) Promoting Physical Activity for Americans Act (S. 1608) Lower Health Care Costs Act (S. 1895) National Suicide Hotline Designation Act (S. 2661) Child Care Protection Improvement Act of 2019 (S. 2683) CONNECT for Health Act of 2019(S. 2741/H.R. 4932) CAPTA Reauthorization Act of 2019 (S. 2971) Suicide Prevention Act (S. 3198/H.R. 5619) Eliminating Abusive and Rampant Neglect of Interactive Technologies (EARN IT) Act of 2020 (S. 3398) Tele-Mental Health Improvement Act (S. 3792) Coronavirus Mental Health and Addiction Assistance Act of 2020 (S. 3825/H.R. 6999) Mental and Behavioral Health Connectivity Act (S. 3999) Future Advancement of Academic Nursing (FAAN) Act (S. 4396/H.R. 7945) Safe Authorization for Vaccines during Emergencies (SAVE) Act (S. 4427) Pioneering Antimicrobial Subscriptions to End Up surging Resistance (PASTEUR) Act of 2020 (S. 4760)

Client expense: Not reported · Firm income: $24,000

Government targets: Bureau of Alcohol Tobacco Firearms & Explosives, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, Veterans Affairs, Dept of (VA), Vice President of the U.S., White House Office

Additional Coronavirus Health Care Relief. S. 178, H.R. 925, S. 4108, H.R. 6539 and H.R. 6800: Proposals to increase the Medicaid federal medical assistance percentage (FMAP), expand Medicare coverage for COVID related services, increase FMAP funding specifically for Medicaid home and community-based services; improve nursing home oversight, provide funding for COVID testing; ensure tele-visitation for nursing home residents, and eliminate cost sharing for COVID treatment. COVID Drug Database. H.R. 7288 and S. 4539, the Taxpayer Research and Coronavirus Knowledge Act of 2020: Proposals to require a single user-friendly database of federal biomedical investments in COVID-19 vaccines, drugs, therapies, medical devices, or other products. COVID Drug Pricing. H.R. 7296, the Make Medications Affordable by Preventing Pandemic Price-gouging Act: Proposals to prohibit pharmaceutical companies from exclusive licensing of drugs used to treat or prevent COVID-19. Health Care Extenders. H.R. 8337, the Continuing Appropriations Act, 2021: Proposals to extend the Medicaid Money Follows the Person Program which provides states money to keep seniors in their homes; and extend spousal impoverishment protections in Medicaid to long term care services provided in the home. Infection Control in Nursing Homes. H.R. 6698 and S. 3644, the Quality Care for Nursing Home Residents and Workers During COVID-19 Act: Proposal to authorize $500 million for states to establish expert strike teams for resident and worker safety to be deployed within 72 hours of 3+ confirmed or suspected COVID-19 cases in a facility. Medicare Coverage of Vaccines. H.R. 5076 and S. 1872, the Protecting Seniors Through Immunization Act of 2019: Proposals to expand Medicare to cover all adult vaccines recommended by the Advisory Committee on Immunization Practices without any cost-sharing for Part D. Medicare Enrollment. H.R. 2477, the BENES Act of 2020, changes the Medicare general enrollment period to October 15-December 31, and requires coverage to begin on the first day of the month following enrollment. (The general enrollment period has been January 1-March 31, and coverage begins July 1.) Medicare Enrollment. H.R. 2564, Medicare Enrollment Protection Act: Proposal to bill creates a special Medicare enrollment period for individuals enrolled in, or transitioning out of, continuation coverage under the Consolidated Omnibus Budget Reconciliation Act (COBRA) -a federal law that allows an individual to maintain health coverage following loss of coverage due to termination of employment or another qualifying event. Medicare Enrollment. The Consolidated Appropriations Act of 2021 (P.L. 116-260): Proposal to extending funding for enrollment assistance to help low-income seniors access the Medicare Prescription Drug Program Part D Low-Income Subsidy. Medicare Telehealth. Proposal to support efforts at Center for Medicare and Medicaid Services to continue access to telehealth during the COVID pandemic. Nursing Home Telehealth Visitation. H.R. 6487 and S. 3517, the ACCESS Act: Proposal requiring that residents have access to telehealth visitation during the pandemic. Medical Expense Deduction. The Consolidated Appropriations Act of 2021 (P.L. 116-260): Proposal to include a permanent extension of the 7.5 percent threshold for the medical expense deduction. Medicare Structure. Letter to Biden Transition team. Proposals to modify Medicare including changing to premium support model, lowering the eligibility age, furthering privatization of the program, adding hearing dental and vision coverage. Medicare Prescription Drugs: Letter to Biden transition team. Proposals to allow Medicare to negotiate prices with drug makers, cap prices at inflation in Part B and D, cap beneficiary out-of-pocket costs in Part D. Drug Pricing. Letter to Biden transition team. Proposals to allow generics to come to market earlier by limiting brand manufacturers ability to pay generics to delay entering the market. Short Term Care Coverage. H.R. 1682, Improving Access to Medicare Coverage Act of 2019: Proposal to amend title XVIII of the Social Security Act to count a period of receipt of outpatient observation services in a hospital toward satisfying the 3-day inpatient hospital stay requirement for coverage of skilled nursing facility services under Medicare, and for other purposes.

Client expense: $180,000 · Firm income: Not reported

Government targets: Administration on Aging, 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), Justice, Dept of (DOJ), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Social Security Administration (SSA), Treasury, Dept of, U.S. Postal Service (USPS)

Medicare payment issues including the Independent Payment Advisory Board (IPAB) and Medicaid issues. Medicare Part D. 101 drug pricing. S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019. Vaccine legislation; H.R. 5076, S. 1872. Policies impacting U.S. address to the Covid-19 pandemic, including H.R. 604 Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No: 116-123.; H. R . 6201 Families First Coronavirus Response Act, Public Law No: 116-127; and H. R. 748 CARES Act, Public Law No: 116-136. Education regarding Executive Orders impacting drug pricing including Medicare rebate reform, the 340 B program, "buy America" proposals, and proposals to impose "most favored nation" pricing on Medicare Part B and D. H.R. 133, Consolidated Appropriations Act, 2021, Public Law No: 116-260.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

- H.R. 863 - DXM Abuse Prevention Act of 2019, regarding all provisions - S. 726 - Personal Care Products Safety Act, regarding all provisions - Issues related to the regulation of over-the-counter drugs - Issues related to cosmetic regulatory reform - Issues related to cosmetic animal testing - Issues related to biosimilars - Issues related to maternal mortality - Issues related to contact lens safety - Issues related to medical product communications - Issues related to medical product review - Issues related to ingredient safety - Issues related to diversity in clinical trials - Issues related to health care pricing transparency - Issues related to peripheral artery disease - H.R. 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - Issues related to drug importation - S. 2543, "Prescription Drug Pricing Reduction Act of 2019", regarding all provisions - H.R. 19, "Lower Costs, More Cures Act of 2019", regarding all provisions - H.R. 748/ S. 3458, "'Coronavirus Aid, Relief, and. Economic Security Act'', regarding all provisions - H.R. 6074, "Coronavirus Preparedness and Response Supplemental Appropriations Act", regarding all provisions - H.R. 6201, "Families First Coronavirus Response Act", regarding all provisions - H.R. 3975, the Contact Lens Prescription Verification Modernization Act, regarding all provisions - H.R. 5663, the Safeguarding Therapeutics Act, regarding all provisions - Issues related to counterfeit health care goods - S. 3468, Preventing Essential Medical Device Shortages Act of 2020 - Issues related to counterfeit medical devices and combination products and authority to destroy counterfeit medical products - Issues related to reporting medical device shortages - Issues related to pandemic response - S. 2740, "Over the Counter Monograph Safety, Innovation, and Reform Act of 2019", regarding all provisions - H.R. 5279, "Cosmetic Safety Enhancement Act", regarding all provisions - H.R. 4296, "Safe Cosmetics and Personal Care Products Act of 2019", regarding all provisions - Issues related to social determinants of health - H.R. 5076/S. 1872, "Protecting Seniors Through Immunization", regarding all provisions - H.R.6062, "To amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes", regarding all provisions. - H.R.6952, "To direct the President to appoint a Medical Supplies Response Coordinator to coordinate the efforts of the Federal Government regarding the supply and distribution of certain supplies and equipment relating to COVID-19", regarding all provisions - S.3942, "Securing America's Medical Supply Chain and Advancing the Production of Life Saving Medicines Act", regarding all provisions - S.3945, "Bring Entrepreneurial Advancements To Consumers Here In North America Act", regarding all provisions - S.3780, "HOME Act", regarding all provisions - S.3781, "PART Act", regarding all provisions - Issues related to diversity in clinical trials - Issues related to 340B - S.4613, The Contact Lens Rule Modernization Act, regarding all provisions - H.R.3107, "Improving Seniors Timely Access to Care Act of 2019, regarding all provisions - Executive Order 13948: Lowering Drug Prices by Putting America First - Executive Order 13939: Lowering Prices for Patients by Eliminating Kickbacks to Middlemen - Executive Order 13938: Increasing Drug Importation To Lower Prices for American Patients - Executive Order 13937: Access to Affordable Life-Saving Medications -H.R.133 - Consolidated Appropriations Act, 2021, including legislation regarding average sales price (ASP) reporting requirements for certain hyaluronic acid (HA) products that are classified as devices, but reimbursed as drugs under Medicare Part B

Client expense: $1,450,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Prescription drug coverage and payment policies; S. 1872/H.R. 5076, Protecting Seniors Through Immunization Act; Medical innovation issues.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 a Provisions related to prescription drug pricing and access H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6258: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity H.R. 6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavi-rus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act H.R. 7296: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency H.R. 7647: To provide for a COVID-19-related delay regarding annual limitation on cost-sharing for group health plans and individual and small group health insurance coverage - Provisions related to accumulator adjustment programs H.R. 7838: To provide for certain temporary waivers with respect to the 340B drug discount program due to the COVID-19 public health emergency, and for other purposes - Provisions related to the 340B drug discount program H.R. 8894: To repeal the authority of the Food and Drug Administration to require that drugs be dispensed only upon prescription, and for other purposes - Provisions related to FDA authority and prescription drugs H.R. 8920: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections - Provisions related to anti-microbial resistant and prescription drug development S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 658: Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act - Provisions related to accelerated approval S. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1712: DISARM Act of 2019 - Provisions related to antimicrobial drug development S. 1872/H.R. 5075: Protecting Seniors Through Immunization Act S. 4864/H.R. 8725: HAPI Act; Medicaid financial barriers S. 1619/H.R. 2862: VACCINES Act CMSS. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity CMS rule on Value Based Payment purchasing, 85 FR 37286, CMS-2482-P, provisions related to the definition of line-extension drugs. S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing CBD DSHEA 2.0 S. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Corona-virus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals S. 3872: Promising Pathway Act - Provisions related to FDA provisional approval pathways Transparency policy issues S. 3932: A bill to direct the Secretary of Defense to carry out a pilot program under the TRICARE pharmacy benefits program - Provisions related to DoD TRICARE pharmacy benefits program S. 4010: A bill to amend the Federal Food, Drug, and Cosmetic Act to make permanent the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases - Provisions related to priority review vouchers S. 4427: SAVE Act - Provisions related to the FDA drug approval process S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls S. 4760: The PASTEUR Act - Provisions related to anti-microbial resistant and prescription drug development Proclamation Suspending Entry of Aliens Who Present a Risk to the U.S. Labor Market Following the Coronavirus Outbreak (June 22, 2020) Department of Homeland Security cybersecurity policy issues HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program reform and policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues FDA mandatoruy recall authority policy issues Pharmaceutical supply chain policy issues COVID-19 policy issues Final Rule; Importation of Prescription Drugs (RIN 0910-AI45) Executive Order 13951, An America-First Healthcare Plan (September 24, 2020) Executive Order 13950, Combating Race and Sex Stereotyping (September 22, 2020) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues Executive Order 13944, Combating Public Health Emergencies and Strengthening Na- tional Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13939, Lowering Drug Prices for Patients by Eliminating Kickbacks to Middlemen (July 24, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Proposed Rule: Implementation of Executive Order 13937, Executive Order on Access to Affordable Life-Saving Medications (RIN 0906-AB25) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Final Rule: 340B Drug Pricing Program; Administrative Dispute Resolution Regulation (RIN 0906-AB26) Amendments to HHS Covid-19 Declaration

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---COVID-19 Pricing-Related Provisions ---Immunization information systems ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---In-Home Administration of Part B Drugs ---Patient Cost-Sharing and Smoothing ---Preventive Monoclonal Antibody Coverage Drug Pricing ---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.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Executive Order on Lowering Drug Prices by Putting America First (Most Favored Nation, or MFN, EO) ---General ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---International Pricing Index Proposal ---Most Favored Nation (MFN) Model interim final rule (MFN Rule) Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---Executive Order on Lowering Drug Prices by Putting America First (Most Favored Nation, or MFN, EO) ---In-Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Most Favored Nation (MFN) Model interim final rule (MFN Rule) ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019

Client expense: $3,180,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Institutes of Health (NIH), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.7661: Coronavirus Emerging Growth Companies (EGC) Extension Act of 2020 ---H.R.8080: Health STATISTICS Act of 2020 ---S.4317: SAFE TO WORK Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Immunization information systems ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---In-Home Administration of Part B Drugs ---Operation Warp Speed ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 declaration coverage for private sector procurement ---Preventive Monoclonal Antibody Coverage Diversity & Inclusion Drug Evaluation and Review ---COVID-19 Lessons Learned ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs Drug Importation ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---General Drug Manufacturing, Quality & Distribution ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.7767: To amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment ---Drug Shortages ---Executive Order on Buy American Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 Drug Pricing ---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.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Executive Order on Lowering Drug Prices by Putting America First (Most Favored Nation, or MFN, EO) ---General ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---International Pricing Index Proposal ---Most Favored Nation (MFN) Model interim final rule (MFN Rule) Funding for Antimicrobial Resistance Programs ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---S.4760:Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Health Resources and Services Administration (HRSA) - Countermeasures Injury Compensation Program (CICP) ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Funding for National Institutes of Health ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Orphan Drug Issues ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Rare Pediatric Disease Priority Review ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Reimbursement and Coverage of Innovative Products ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---Executive Order on Increasing Drug Importation to Lower Prices for American Patients ---Executive Order on Lowering Drug Prices by Putting America First (Most Favored Nation, MFN EO) ---In-Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccine Injury Compensation Program Tax ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019 Vaccines and Infectious Diseases ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Adult Immunization Education ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Maternal Immunization ---Operation Warp Speed ---Preventive Monoclonal Antibody Coverage ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety

Client expense: $3,180,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Institutes of Health (NIH), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Additional Coronavirus Health Care Relief. S. 178, H.R. 925, S. 4108, H.R. 6539 and H.R. 6800: Proposals to increase the Medicaid federal medical assistance percentage (FMAP), expand Medicare coverage for COVID related services, increase FMAP funding specifically for Medicaid home and community-based services; improve nursing home oversight, provide funding for COVID testing; ensure tele-visitation for nursing home residents, and eliminate cost sharing for COVID treatment. COVID Drug Database. H.R. 7288 and S. 4539, the Taxpayer Research and Coronavirus Knowledge Act of 2020: Proposals to require a single user-friendly database of federal biomedical investments in COVID-19 vaccines, drugs, therapies, medical devices, or other products. COVID Drug Pricing. H.R. 7296, the Make Medications Affordable by Preventing Pandemic Price-gouging Act: Proposals to prohibit pharmaceutical companies from exclusive licensing of drugs used to treat or prevent COVID-19. Health Care Extenders. H.R. 8337, the Continuing Appropriations Act, 2021: Proposals to extend the Medicaid Money Follows the Person Program which provides states money to keep seniors in their homes; and extend spousal impoverishment protections in Medicaid to long term care services provided in the home. Infection Control in Nursing Homes. H.R. 6698 and S. 3644, the Quality Care for Nursing Home Residents and Workers During COVID-19 Act: Proposal to authorize $500 million for states to establish expert strike teams for resident and worker safety to be deployed within 72 hours of 3+ confirmed or suspected COVID-19 cases in a facility. Medicare Coverage of Vaccines. H.R. 5076 and S. 1872, the Protecting Seniors Through Immunization Act of 2019: Proposals to expand Medicare to cover all adult vaccines recommended by the Advisory Committee on Immunization Practices without any cost-sharing for Part D. Medicare Enrollment. H.R. 2477, the BENES Act of 2020, changes the Medicare general enrollment period to October 15-December 31, and requires coverage to begin on the first day of the month following enrollment. (The general enrollment period has been January 1-March 31, and coverage begins July 1.) Medicare Enrollment. H.R. 2564, Medicare Enrollment Protection Act: Proposal to bill creates a special Medicare enrollment period for individuals enrolled in, or transitioning out of, continuation coverage under the Consolidated Omnibus Budget Reconciliation Act (COBRA) -a federal law that allows an individual to maintain health coverage following loss of coverage due to termination of employment or another qualifying event. Medicare Enrollment. The Consolidated Appropriations Act of 2021 (P.L. 116-260): Proposal to extending funding for enrollment assistance to help low-income seniors access the Medicare Prescription Drug Program Part D Low-Income Subsidy. Medicare Telehealth. Proposal to support efforts at Center for Medicare and Medicaid Services to continue access to telehealth during the COVID pandemic. Nursing Home Telehealth Visitation. H.R. 6487 and S. 3517, the ACCESS Act: Proposal requiring that residents have access to telehealth visitation during the pandemic. Medical Expense Deduction. The Consolidated Appropriations Act of 2021 (P.L. 116-260): Proposal to include a permanent extension of the 7.5 percent threshold for the medical expense deduction. Medicare Structure. Letter to Biden Transition team. Proposals to modify Medicare including changing to premium support model, lowering the eligibility age, furthering privatization of the program, adding hearing dental and vision coverage. Medicare Prescription Drugs: Letter to Biden transition team. Proposals to allow Medicare to negotiate prices with drug makers, cap prices at inflation in Part B and D, cap beneficiary out-of-pocket costs in Part D. Drug Pricing. Letter to Biden transition team. Proposals to allow generics to come to market earlier by limiting brand manufacturers ability to pay generics to delay entering the market. Short Term Care Coverage. H.R. 1682, Improving Access to Medicare Coverage Act of 2019: Proposal to amend title XVIII of the Social Security Act to count a period of receipt of outpatient observation services in a hospital toward satisfying the 3-day inpatient hospital stay requirement for coverage of skilled nursing facility services under Medicare, and for other purposes.

Client expense: $170,000 · Firm income: Not reported

Government targets: Administration on Aging, 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), Justice, Dept of (DOJ), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Social Security Administration (SSA), Treasury, Dept of, U.S. Postal Service (USPS)

Medicare Part D Program; S.1872/H.R.5076, Protecting Seniors Through Immunization Act of 2019.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Part D cost sharing and quality measures for vaccines; S. 1872/H.R. 5076, Protecting Seniors Through Immunization Act; Medicare reimbursement for vaccine education, counseling and administration; S.4705 Maternal Immunization Coverage Act; S. 4690 Maternal Immunization Enhancement Act; H.R.8623 /S. 4825 Ensuring Access to COVID-19 Vaccines for Seniors Act; S.4864 /H.R.8725 Helping Adults Protect Immunity (HAPI) Act S.4469 - 116th Congress.

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

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

Lobbying Issues Description: Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; community-based public health interventions, and substance misuse/behavioral health issues. Specific Legislation: 1.Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2.Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act and Pandemic and All-Hazards Preparedness and Advancing Innovation Act (Public Law 113-5, 116-22) 3.Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111-296) 4.Implementation of Every Student Succeeds Act (Public Law 114-95) 5.Implementation of the Comprehensive Addition and Recovery Act (Public Law 114-98) 6.Midnight Rules Relief Act (S.34/H.R. 21) 7.Regulations from the Executive in Need of Scrutiny Act (S. 21/H.R. 26) 8.Regulatory Accountability Act (S.951/H.R. 5/H.R. 45/H.Res.33) 9.Searching for and Cutting Regulations that are Unnecessarily Burdensome (SCRUB) Act (H.R. 998) 10.Regulatory Integrity Act (H.R. 1004) 11.OIRA Insight, Reform, and Accountability Act (S. 676/H.R. 1009) 12.A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026 (S.Con.Res. 3) 13.American Health Care Act (H.R. 1628/H.Res. 228) 14.Ozone Standards Implementation Act (S. 263/H.R. 806) 15.Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the final rule of the Bureau of Land Management relating to "Waste Prevention, Production Subject to Royalties, and Resource Conservation" (S.J. Res. 11/H.J.Res.36) 16.Common Sense Nutrition Disclosure Act (S. 261/H.R. 772) 17.Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act (H.R. 1840) 18.Preservation of Antibiotics for Medical Treatment Act (H.R. 1587) 19.Preventing Antibiotic Resistance Act (S. 629) 20.Better Care Reconciliation Act (H.R. 1628) and related amendments 21.Public Health Emergency Response Act (S. 196) 22.Recognizing the importance of vaccinations and immunizations in the United States (H.Res.327) 23.Treat and Reduce Obesity Act (S. 830/H.R. 1953) 24.Community Health and Medical Professionals Improve Our Nation (CHAMPION) Act (H.R. 3922) 25.Community Health Investment, Modernization, and Excellence Act of 2017 (S. 1899) 26.Tobacco Tax Equity Act (S. 1837) 27.Healthy Kids Act (S. 1821/H.R. 3921) 28.Implementation of the Drug Quality and Security Act (P.S. 113-54) 29.Continuing Appropriations Act, 2018 and Supplemental Appropriations for Disaster Relief Requirements Act, 2017 (Public Law 115-56) 30.Friendly Airports for Mothers Act (S. 1110/H.R. 2375) 31.Lead-Safe Housing for Kids Act (S. 1845) 32.Supporting Working Moms Act (S. 2122/H.R. 3255) 33.Championing Healthy Kids Act (H.R. 3922) 34.Making further continuing appropriations for fiscal year 2018, and for other purposes (Public Law 115-90) 35.An Act to amend the Homeland Security Act of 2002 to require the Secretary of Homeland Security to issue Department of Homeland Security-wide guidance and develop training programs as part of the Department of Homeland Security Blue Campaign, and for other purposes (Public Law 115-96) 36.Tax Cuts and Jobs Act (Public Law 115-97) 37.Pandemic and All-Hazards Preparedness Advancing Innovation Act (S. 2852/H.R. 6378/H.R. 7328/S. 1379/H.R. 269) 38.Vaccine Access Improvement Act (H.R. 4993) 39.Relief from New Source Performance Standards Act (H.R. 453) 40.Strategies to Address Antimicrobial Resistance (S. 2469) 41.Opioid Quota Reform Act (S. 2535) 42.Hospital Preparedness Program Reauthorization Act (H.R. 4776) 43.Blocking Regulatory Interference from Closing Kilns Act (H.R. 1917) 44.Opioid Crisis Response Act of 2018 (S. 2680) 45.Agriculture and Nutrition Act (H.R. 2) 46.Agriculture Improvement Act (S. 3042) 47.SECURE Act (H.R. 5998) 48.Trauma-Informed Care for Children and Families Act (S. 774) 49.SUPPORT for Patients and Communities Act (H.R. 6) 50.Centers for Disease Control Emergency Response Act (S. 3161) 51.LABEL Opioids Act (S. 3428) 52.Relief from New Source Performance Standards Act (S. 1857) 53.Outdoors for All Act (S. 3499) 54.The MOMMA Act (H.R. 5977) 55.Preventing Maternal Deaths Act (H.R. 1318) 56.Medicare Access to Vaccines Equity Act (not yet introduced) 57.The Support Act (H.R. 6) 58.Climate Change Health Protection and Promotion Act (S. 529) 59.NURSE Act (H.R. 1597) 60.Investing for the People Act (H.R. 2021) 61.Child Care for Working Families Act (H.R. 365/S. 568) 62.FAMILY Act (H.R. 1185/S. 463) 63.Transportation Alternatives Enhancement Act (S. 1098) 64.Lower Health Care Costs Act (S. 1895) 65.LIFT America Act (H.R 2479) 66.Public Health Funding Restoration Act (H.R. 3447/S. 1944) 67.Supporting Older Americans Act of 2020 (HR 4334) 68.Campus Prevention and Recovery Services for Students Act (H.R. 3591) 69.Healthier Students for Stronger Campuses Act (S. 1281) 70.Saving Lives Through Better Data Act (S. 1793) 71.VACCINES Act (H.R. 2862) 72.DISARM Act (H.R. 4100/S. 1712) 73.Community Access, Resources, and Education for Families Act (H.R. 3117) 74.Protecting Seniors Through Immunization Act (S. 1872) 75.Tobacco-Free Youth Act (S. 1541) 76.Tobacco to 21 Act (H.R. 2411/S. 1258) 77.Investing for People Act (H.R. 2021) 78.School Based Health Centers Reauthorization Act (H.R.2075/S.1013) 79.Reversing the Youth Tobacco Epidemic Act of 2019 (H.R. 2339) 80.Social Determinants Accelerator Act (H.R. 4004/S. 2986) 81.Mental Health Professionals Workforce Shortage Loan Repayment Act (H.R. 2431) 82.The UNDERSTAND Act (S. 1323) 83.Americas Transportation Infrastructure Act (S. 2302) 84.Barriers to Suicide Act of 2019 (H.R. 4309) 85.Promoting Physical Activity for Americans Act (S. 1608/H.R. 2891) 86.Public Health Infrastructure Modernization Act of 2019 (H.R. 5321) 87.Supporting Healthy Mothers and Infants Act (H.R. 5249) 88.Lead-Free Future Act (H.R. 4416) 89.Home Visiting to Reduce Maternal Mortality and Morbidity Act (H.R. 4768) 90.Recognizing the anniversary of the eradication of smallpox and the importance of vaccination in the United States and worldwide (H. Res. 592) 91.Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) 92.Families First Coronavirus Response Act (H.R. 6201) 93.Coronavirus Aid, Relief, and Economic Security (CARES) Act (H.R. 748) 94.Connecting Americas Transportation Infrastructure Act (H.R. 5696/S. 3391)) 95.Improving Access to Remote Behavioral Health Treatment Act (S. 2244/H.R. 4131) 96.National Suicide Hotline Designation Act (S. 2661/H.R. 4194) 97.Suicide Prevention Lifeline Improvement Act (H.R. 4564) 98.Campaign to Prevent Suicide Act (H.R. 4585) 99.Medicaid Reentry Act (H.R. 1329) 100.Excellence in Mental Health and Addiction Treatment Expansion Act (S. 824/H.R. 1767) 101.Mental Health Services for Students Act (S. 1122/H.R. 1109) 102.Suicide Training and Awareness Nationally Delivered for Universal Prevention (STANDUP) Act (S. 2492/H.R. 2599) 103.Mental Health Parity Compliance Act (S. 1737/H.R. 3165) 104.Behavioral Health Transparency Act (S. 1576/H.R. 2874) 105.Medicare Mental Health Access Act (S. 2772/H.R. 884) 106.Public Health Emergency Response and Accountability Act (S. 3309) 107.Family Violence Prevention and Services Improvement Act (H.R. 5041) 108.Protecting the Health of Americas Older Adults During COVID-19 and Beyond Act (H.R. 6935) 109.Improving Social Determinants Act (H.R. 6561/S. 4440) 110.Urging the establishment of a United States Commission on Truth, Racial Healing, and Transformation (H.Con.Res.100) 111.FY 2021 Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations (TBD) 112.Better Tools for Healthy Living Act (S. 1805) 113.The WIC Act (H.R. 6811/S. 2358) 114.Health Equity and Accountability Act (H.R. 6637) 115.Paycheck Protection Program and Health Care Enhancement Act (H.R. 266) 116.The HEROES Act (H.R.6800) 117.Community Solutions for COVID-19 Act (H.R.7077/S.3877) 118.The Black Maternal Health Momnibus Act of 2020 (H.R. 6142) 119.COVID-19 Bias and Anti-Racism Training Act (H.R. 7618/S. 4248) 120.Urging the establishment of a United States Commission on Truth, Racial Healing, and Transformation (H. Con. Res. 100) 121.Community Immunity During COVID-19 Act of 2020 (H.R. 8061) 122.Public Safety Officer Support Act (H.R. 7568) 123.COVID-19 Behavioral Health Support Act (S. 4059) 124.Public Health Workforce Loan Repayment Act (H.R. 6578) 125.Strengthening the Public Health Workforce Act (S. 3737) 126.A resolution declaring racism a public health crisis (S. Res. 655) 127.Pandemic Child Hunger Prevention Act (H.R.7887) 128.Public Health Infrastructure Saves Lives Act (S. 4740) 129.CARE for Families Act (H.R. 3117/S. 3354) 130.Improving Data Collection for Adverse Childhood Experiences Act (H.R. 7689) 131.The STANDUP Act of 2020 (H.R. 7293) 132.The Effective Suicide Screening and Assessment in the Emergency Department Act (H.R. 4861) 133.The Pursuing Equity in Mental Health Act of 2019 (H.R. 5469) 134.The Improving Mental Health Access from the Emergency Department Act (H.R. 2519/S. 1334) 135.The Suicide Prevention Act (H.R. 5619/S. 3198) 136.The Helping Emergency Responders Overcome (HERO) Act (H.R. 1646/S. 3244) 137.The Campaign to Prevent Suicide Act (H.R. 4585) 138.The Maternal Health Immunization Enhancement Act (S. 4690) 139.Pandemic Vaccine Access Improvement Act (Not yet introduced) 140.Moving Forward Act (H.R. 2) 141.Continuing Appropriations Act, 2021 and Other Extensions Act (HR 8319) Coronavirus Response Additional Supplemental Appropriations Act (S. 4320). 142.ETHIC Act (H.R. 8205) 143.Safely Back to School and Work Act (S. 4322) 144.Supporting the goals and ideals of BIPOC Mental Health Awareness Month (H.Res. 1064) 145.COVID-19 Health Disparities Action Act (S. 4262) 146.Protecting American Heroes Act of 2020 (S. 4368) 147.Health STATISTICS Act (H.R. 8080) House(s) of Congress and Federal Agencies lobbied during the quarter: House, Senate, Exec Office of Pres, HHS, CDC, FDA, CMS, OMB, DOT, HUD, EPA, NIMH, Education, USDA, DHS, FEMA, and SAMHSA.

Client expense: $36,974 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT)

Legislation and policies relating to: Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Reauthorization of funding for the Childrens Health Insurance Program Reauthorization of the Child Nutrition Act Section 2706 of the ACA regarding provider non-discrimination Policies related to health insurance market stabilization Policies affecting nurse practitioner education and workforce Definition, evaluation and enforcement of essential health benefits and provider network adequacy Health information technology and electronic health records Mental health services and violence prevention Human and child trafficking Palliative Care and Hospice Education and Training Act (H.R. 647/S. 2080) Title VIII Nursing Workforce Reauthorization Act of 2019 (H.R. 728/S. 1399) Coronavirus Aid, Relief, and Economic Security (CARES) Act (H.R. 748/S.3548) Emergency Medical Services for Children Program Reauthorization Act of 2019 (H.R. 776/S. 1173) End Surprise Billing Act of 2019 (H.R. 861) Fairness for Breastfeeding Mothers Act (H.R. 866/S. 528) Mental Health Access Improvement Act of 2019 (H.R. 945) Workplace Violence Prevention for Health Care and Social Service Workers Act (H.R. 1309) Patient Protection and Affordable Care Enhancement Act (H.R. 1425) Healthy Families Act (H.R. 1784/S. 840) Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act (H.R. 1897) School-Based Health Centers Reauthorization Act of 2019 (H.R. 2075/S. 1013) Scarlett's Sunshine on Sudden Unexpected Death Act (H.R. 2271/S. 1130) Community Health Investment, Modernization, and Excellence Act of 2019 (H.R. 2328) Newborn Screening Saves Lives Reauthorization Act of 2019 (H.R. 2507) Pregnant Workers Fairness Act (H.R. 2694) Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) for Health Act of 2019 (H.R. 2781) Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 (H.R. 2862) Physical Activities Recommendations for Americans Act of 2019 (H.R. 2891) Safe Cribs Act of 2019 (H.R. 3170) Safe Sleep for Babies Act of 2019 (H.R. 3172) Pathways to Health Careers Act (H.R. 3398) Chronic Care Management Improvement Act (H.R. 3436) No Surprises Act (H.R. 3630) Midwives for Maximizing Optimal Maternity Services (Midwives for MOMS) Act of 2019 (H.R. 3849) Social Determinants Accelerator Act of 2019 (H.R. 4004/S. 2986) Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019 (H.R. 3328/H.R. 4100/S. 1712) Effective Suicide Screening and Assessment in the Emergency Department Act of 2019 (H.R. 4861/S. 3006) United States Public Health Service Modernization Act of 2019 (H.R. 4870/S. 2629) Medication Access and Training Expansion (MATE) Act of 2019 (H.R. 4974) Maternal Health Quality Improvement Act of 2019 (H.R. 4995) Helping Medicaid Offer Maternity Services (MOMS) Act of 2019 (H.R. 4996) Protecting Seniors Through Immunization Act of 2019 (H.R. 5076/S. 1872) Pursuing Equity in Mental Health Act of 2019 (H.R. 5469) Primary and Behavioral Health Care Access Act (H.R. 5575) Ban Surprise Billing Act (H.R. 5800) Consumer Protections Against Surprise Medical Bills Act of 2020 (H.R. 5826) Black Maternal Health Momnibus Act of 2020 (H.R. 6142/S. 3424) Families First Coronavirus Response Act (H.R. 6201) Take Responsibility for Workers and Families Act (H.R. 6379) Health Care at Home Act (H.R. 6644) COVID-19 Mental Health Research Act (H.R. 6645) HEROES Act (H.R. 6800) Child Care Is Essential Act (H.R. 7027) Ensuring Children and Child Care Workers Are Safe Act of 2020 (H.R. 7079) Child Care for Economic Recovery Act (H.R. 7327) Protect Telehealth Access Act (H.R. 7391) Protecting Access to Post-COVID-19 Telehealth Act of 2020 (H.R. 7663) Community and Public Health Programs Extension Act (S. 192) National Nurse Act of 2019 (S. 696/H.R. 1597) Excellence in Mental Health and Addiction Treatment Expansion Act (S. 824/H.R. 1767) Nursing Where It's Needed Act (S. 1045) Promoting Physical Activity for Americans Act (S. 1608) Lower Health Care Costs Act (S. 1895) National Suicide Hotline Designation Act (S. 2661) Child Care Protection Improvement Act of 2019 (S. 2683) CONNECT for Health Act of 2019(S. 2741/H.R. 4932) CAPTA Reauthorization Act of 2019 (S. 2971) Suicide Prevention Act (S. 3198/H.R. 5619) Eliminating Abusive and Rampant Neglect of Interactive Technologies (EARN IT) Act of 2020 (S. 3398) Tele-Mental Health Improvement Act (S. 3792) Coronavirus Mental Health and Addiction Assistance Act of 2020 (S. 3825/H.R. 6999) Future Advancement of Academic Nursing (FAAN) Act (S. 4396/H.R. 7945) Safe Authorization for Vaccines during Emergencies (SAVE) Act (S. 4427)

Client expense: Not reported · Firm income: $24,000

Government targets: Bureau of Alcohol Tobacco Firearms & Explosives, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, Veterans Affairs, Dept of (VA), Vice President of the U.S., White House Office

Additional Coronavirus Health Care Relief. S. 178, H.R 925, S. 4108, H.R. 6539 and H.R. 6800: Proposals to increase the federal medical assistance percentage (FMAP), expand Medicare coverage for COVID related services, increase FMAP funding specifically for home and community based services; improve nursing home oversight, provide funding for COVID testing; ensure tele visitation for nursing home residents, and eliminate cost sharing for COVID treatment. COVID Drug Database. H.R. 7288 and S. 4539, the Taxpayer Research and Coronavirus Knowledge Act of 2020: Proposals to require a single user-friendly database of federal biomedical investments in COVID-19 vaccines, drugs, therapies, medical devices, or other products. COVID Drug Pricing. H.R. 7296, the Make Medications Affordable by Preventing Pandemic Price-gouging Act: Proposals to prohibit pharmaceutical companies from exclusive licensing of drugs used to treat or prevent COVID-19. Health care extenders. H.R. 8337, the Continuing Appropriations Act, 2021: Proposals to extend Money Follows the Person Program which provides states money to keep seniors in their homes; extend spousal impoverishment protections in Medicaid to long term care services provided in the home. Infection Control in Nursing Homes. H.R. 6698 and S. 3644, the Quality Care for Nursing Home Residents and Workers During COVID-19 Act: Proposal to authorize $500 million for states to establish expert strike teams for resident and worker safety to be deployed within 72 hours of 3+ confirmed or suspected COVID-19 cases in a facility. Medicare Coverage of Vaccines. H.R. 5076 and S. 1872, the Protecting Seniors Through Immunization Act of 2019: Proposals to expand Medicare to cover all adult vaccines recommended by the Advisory Committee on Immunization Practices without any cost-sharing for Part D. Medicare Part B premiums. The Continuing Appropriations Act, 2021 and Other Extensions Act (P.L. 116-159). Proposal to freeze the Medicare Part B standard monthly premium to a fee equal to 25% percent of the difference between the 2020 amount and the preliminary monthly actuarial rate for 2021. Medicare Telehealth. Proposal to support efforts at Center for Medicare and Medicaid Services to continue access to telehealth during the COVID pandemic. Nursing Home Telehealth Visitation. H.R. 6487 and S. 3517, the ACCESS Act: Proposal requiring that residents have access to telehealth visitation during the pandemic.

Client expense: $200,000 · Firm income: Not reported

Government targets: Administration on Aging, 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), Justice, Dept of (DOJ), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Social Security Administration (SSA), Treasury, Dept of, U.S. Postal Service (USPS)

H.R.34: 21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---Executive Order on Affordable Life-saving Medications ---H.R. 7614: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Reimbursement and Coverage of Innovative Products ---Executive order on Lowering Drug Prices by Putting America First Drug Importation ---Executive Order on Increasing Drug Importation to Lower Prices for American Patients Antibiotic & Diagnostic Tax Credit Asia Pacific Economic Cooperation Forum ---Biologics Regulations ---Intellectual Property Issues Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---H.R. 748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.4100/S.1712: DISARM Act of 2019 ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---S.4231: Preparing for the Next Pandemic Act of 2020 ---Strategic National Stockpile ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---H.R.7556: To amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. ---H.R.7555: To amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---Implementation of the Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Executive Order on Buy American ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Biodefense Strategy ---Senate HELP Pandemic Preparedness White Paper ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---Biosimilar Copay ---BSUFA ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.7917: IGNITE American Innovation Act ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.4775: The Delivering Immediate Relief to America's Families, Schools and Small Business Act ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Coverage for Covid Tx ---Drug Supply Chain Management ---Funding for Countermeasure Injury Compensation Program ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---H.R.7269/S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management ---Executive Order on Buy American Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous prices (FLAT) prices Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.2387: Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---H.R.7614: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---CMMI Authority ---Executive Order on Buy American ---Executive Order on Access to Affordable Life-saving Medications ---Executive Order on Increasing Drug Importation to Lower Prices for American Patients ---Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen ---General ---International Pricing Index Proposal ---Most Favored Nation Executive Order ---Proposed Federal Price Caps on COVID-19 Therapeutics and Vaccines Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---S. 1624: Health, Economic Assistance, Liability Protection, and Schools (HEALS) Act ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---S.4760:Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 8337: Continuing Appropriations Act, 2021 and other Extensions Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 ---S. 1624: Health, Economic Assistance, Liability Protection, and Schools (HEALS) Act ---Health Defense Operations Funding Designation ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---H.R.7556: To amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. ---H.R.7555: To amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. ---H.R.7537: Infectious Disease Therapies Research and Innovation Act Funding for FDA ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R. 8337: Continuing Appropriations Act, 2021 and other Extensions Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 8337: Continuing Appropriations Act, 2021 and other Extensions Act of 2020 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R. 8337: Continuing Appropriations Act, 2021 and other Extensions Act of 2020 ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---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.3: Lower Drug Costs Now Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---Executive Order on Lowering Drug Prices by Putting America First ---Executive Order on Access to Affordable Life-Saving Medications ---Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen ---In-Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-UK Trade Agreement ---Digital Trade ---IP Provisions ---Market Access ---Regulatory Harmonization Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 ---S.4509: Vaccine And Coverage Certainty (VACC) Act ---Adult Immunization Education ---Countermeasure Injury Compensation Program ---Implementation of the Families First Coronavirus Response Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Maternal Immunization ---Operation Warp Speed/ACTIV ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine and Anti-Microbial Resistance Product Development and Incentives

Client expense: $3,170,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Home Administration of Part B Drugs ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---International Pricing Index Proposal ---H.R.7614: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Reimbursement and Coverage of Innovative Products ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020

Client expense: $3,170,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Part D cost sharing and quality measures for vaccines; S. 1872/H.R. 5076, Protecting Seniors Through Immunization Act; Medicare reimbursement for vaccine education, counseling and administration; S. 4705 A bill to amend title XIX requiring coverage under Medicaid of vaccines for pregnant women; S. 4690 A bill to increase vaccination rates among pregnant women enrolled in Medicaid or CHIP, and for other purposes.

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

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

Prescription drug coverage and payment policies; S. 1872/H.R. 5076, Protecting Seniors Through Immunization Act; Medical innovation issues.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- H.R. 863 - DXM Abuse Prevention Act of 2019, regarding all provisions - S. 726 - Personal Care Products Safety Act, regarding all provisions - Issues related to the regulation of over-the-counter drugs - Issues related to cosmetic regulatory reform - Issues related to cosmetic animal testing - Issues related to biosimilars - Issues related to maternal mortality - Issues related to contact lens safety - Issues related to medical product communications - Issues related to medical product review - Issues related to ingredient safety - Issues related to diversity in clinical trials - Issues related to health care pricing transparency - Issues related to peripheral artery disease - H.R. 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - Issues related to drug importation - S. 2543, "Prescription Drug Pricing Reduction Act of 2019", regarding all provisions - H.R. 19, "Lower Costs, More Cures Act of 2019", regarding all provisions - H.R. 748/ S. 3458, "'Coronavirus Aid, Relief, and. Economic Security Act'', regarding all provisions - H.R. 6074, "Coronavirus Preparedness and Response Supplemental Appropriations Act", regarding all provisions - H.R. 6201, "Families First Coronavirus Response Act", regarding all provisions - H.R. 3975, the Contact Lens Prescription Verification Modernization Act, regarding all provisions - H.R. 5663, the Safeguarding Therapeutics Act, regarding all provisions - Issues related to counterfeit health care goods - S. 3468, Preventing Essential Medical Device Shortages Act of 2020 - Issues related to counterfeit medical devices and combination products and authority to destroy counterfeit medical products - Issues related to reporting medical device shortages - Issues related to pandemic response - S. 2740, "Over the Counter Monograph Safety, Innovation, and Reform Act of 2019", regarding all provisions - H.R. 5279, "Cosmetic Safety Enhancement Act", regarding all provisions - H.R. 4296, "Safe Cosmetics and Personal Care Products Act of 2019", regarding all provisions - Issues related to social determinants of health - H.R. 5076/S. 1872, "Protecting Seniors Through Immunization", regarding all provisions - H.R.6062, "To amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes", regarding all provisions. - H.R.6952, "To direct the President to appoint a Medical Supplies Response Coordinator to coordinate the efforts of the Federal Government regarding the supply and distribution of certain supplies and equipment relating to COVID-19", regarding all provisions - S.3942, "Securing America's Medical Supply Chain and Advancing the Production of Life Saving Medicines Act", regarding all provisions - S.3945, "Bring Entrepreneurial Advancements To Consumers Here In North America Act", regarding all provisions - S.3780, "HOME Act", regarding all provisions - S.3781, "PART Act", regarding all provisions - Issues related to diversity in clinical trials - Issues related to 340B - S.4613, The Contact Lens Rule Modernization Act, regarding all provisions - H.R.3107, "Improving Seniors Timely Access to Care Act of 2019, regarding all provisions - Executive Order 13948: Lowering Drug Prices by Putting America First - Executive Order 13939: Lowering Prices for Patients by Eliminating Kickbacks to Middlemen - Executive Order 13938: Increasing Drug Importation To Lower Prices for American Patients - Executive Order 13937: Access to Affordable Life-Saving Medications

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Medicare payment issues including the Independent Payment Advisory Board (IPAB) and Medicaid issues. Medicare Part D. 101 drug pricing. S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019. Vaccine legislation; H.R. 5076, S. 1872. Policies impacting U.S. address to the Covid-19 pandemic, including H.R. 604 Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No: 116-123.; H. R . 6201 Families First Coronavirus Response Act, Public Law No: 116-127; and H. R. 748 CARES Act, Public Law No: 116-136. Education regarding Executive Orders impacting drug pricing including Medicare rebate reform, the 340 B program, "buy America" proposals, and proposals to impose "most favored nation" pricing on Medicare Part B and D.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Medicare Part D Program; S.1872/H.R.5076, Protecting Seniors Through Immunization Act of 2019.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and policies relating to: Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Reauthorization of funding for the Childrens Health Insurance Program Reauthorization of the Child Nutrition Act Section 2706 of the ACA regarding provider non-discrimination Policies related to health insurance market stabilization Policies affecting nurse practitioner education and workforce Definition, evaluation and enforcement of essential health benefits and provider network adequacy Health information technology and electronic health records Mental health services and violence prevention Human and child trafficking Palliative Care and Hospice Education and Training Act (H.R. 647/S. 2080) Title VIII Nursing Workforce Reauthorization Act of 2019 (H.R. 728/S. 1399) Coronavirus Aid, Relief, and Economic Security (CARES) Act (H.R. 748/S.3548) Emergency Medical Services for Children Program Reauthorization Act of 2019 (H.R. 776/S. 1173) End Surprise Billing Act of 2019 (H.R. 861) Fairness for Breastfeeding Mothers Act (H.R. 866/S. 528) Mental Health Access Improvement Act of 2019 (H.R. 945) Workplace Violence Prevention for Health Care and Social Service Workers Act (H.R. 1309) Patient Protection and Affordable Care Enhancement Act (H.R. 1425) Healthy Families Act (H.R. 1784/S. 840) Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act (H.R. 1897) Community Health Investment, Modernization, and Excellence Act of 2019 (H.R. 2328) Newborn Screening Saves Lives Reauthorization Act of 2019 (H.R. 2507) Pregnant Workers Fairness Act (H.R. 2694) Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) for Health Act of 2019 (H.R. 2781) Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 (H.R. 2862) Physical Activities Recommendations for Americans Act of 2019 (H.R. 2891) Safe Cribs Act of 2019 (H.R. 3170) Safe Sleep for Babies Act of 2019 (H.R. 3172) Pathways to Health Careers Act (H.R. 3398) Chronic Care Management Improvement Act (H.R. 3436) No Surprises Act (H.R. 3630) Social Determinants Accelerator Act of 2019 (H.R. 4004/S. 2986) United States Public Health Service Modernization Act of 2019 (H.R. 4870/S. 2629) Maternal Health Quality Improvement Act of 2019 (H.R. 4995) Helping Medicaid Offer Maternity Services (MOMS) Act of 2019 (H.R. 4996) Protecting Seniors Through Immunization Act of 2019 (H.R. 5076/S. 1872) Pursuing Equity in Mental Health Act of 2019 (H.R. 5469) Primary and Behavioral Health Care Access Act (H.R. 5575) Ban Surprise Billing Act (H.R. 5800) Consumer Protections Against Surprise Medical Bills Act of 2020 (H.R. 5826) Black Maternal Health Momnibus Act of 2020 (H.R. 6142/S. 3424) Families First Coronavirus Response Act (H.R. 6201) Take Responsibility for Workers and Families Act (H.R. 6379) Health Care at Home Act (H.R. 6644) COVID-19 Mental Health Research Act (H.R. 6645) HEROES Act (H.R. 6800) Protect Telehealth Access Act (H.R. 7391) Community and Public Health Programs Extension Act (S. 192) National Nurse Act of 2019 (S. 696/H.R. 1597) Excellence in Mental Health and Addiction Treatment Expansion Act (S. 824/H.R. 1767) Nursing Where It's Needed Act (S. 1045) Promoting Physical Activity for Americans Act (S. 1608) Lower Health Care Costs Act (S. 1895) Child Care Improvement Act of 2019 (S. 2683) CONNECT for Health Act of 2019(S. 2741/H.R. 4932) CAPTA Reauthorization Act of 2019 (S. 2971) Suicide Prevention Act (S. 3198/H.R. 5619) Eliminating Abusive and Rampant Neglect of Interactive Technologies (EARN IT) Act of 2020 (S. 3398) Tele-Mental Health Improvement Act (S. 3792) Coronavirus Mental Health and Addiction Assistance Act of 2020 (S. 3825/H.R. 6999)

Client expense: Not reported · Firm income: $24,000

Government targets: Bureau of Alcohol Tobacco Firearms & Explosives, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, Veterans Affairs, Dept of (VA), Vice President of the U.S., White House Office

Lobbying Issues Description: Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; community-based public health interventions, and substance misuse/behavioral health issues. Specific Legislation: 1. Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2. Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act and Pandemic and All-Hazards Preparedness and Advancing Innovation Act (Public Law 113-5, 116-22) 3. Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111- 296) 4. Implementation of Every Student Succeeds Act (Public Law 114-95) 5. Implementation of the Comprehensive Addition and Recovery Act (Public Law 114-98) 6. Midnight Rules Relief Act (S.34/H.R. 21) 7. Regulations from the Executive in Need of Scrutiny Act (S. 21/H.R. 26) 8. Regulatory Accountability Act (S.951/H.R. 5/H.R. 45/H.Res.33) 9. Searching for and Cutting Regulations that are Unnecessarily Burdensome (SCRUB) Act (H.R. 998) 10. Regulatory Integrity Act (H.R. 1004) 11. OIRA Insight, Reform, and Accountability Act (S. 676/H.R. 1009) 12. A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026 (S.Con.Res. 3) 13. American Health Care Act (H.R. 1628/H.Res. 228) 14. Ozone Standards Implementation Act (S. 263/H.R. 806) 15. Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the final rule of the Bureau of Land Management relating to "Waste Prevention, Production Subject to Royalties, and Resource Conservation" (S.J. Res. 11/H.J.Res.36) 16. Common Sense Nutrition Disclosure Act (S. 261/H.R. 772) 17. Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act (H.R. 1840) 18. Preservation of Antibiotics for Medical Treatment Act (H.R. 1587) 19. Preventing Antibiotic Resistance Act (S. 629) 20. Better Care Reconciliation Act (H.R. 1628) and related amendments 21. Public Health Emergency Response Act (S. 196) 22. Recognizing the importance of vaccinations and immunizations in the United States (H.Res.327) 23. Treat and Reduce Obesity Act (S. 830/H.R. 1953) 24. Community Health and Medical Professionals Improve Our Nation (CHAMPION) Act (H.R. 3922) 25. Community Health Investment, Modernization, and Excellence Act of 2017 (S. 1899) 26. Tobacco Tax Equity Act (S. 1837) 27. Healthy Kids Act (S. 1821/H.R. 3921) 28. Implementation of the Drug Quality and Security Act (P.S. 113-54) 29. Continuing Appropriations Act, 2018 and Supplemental Appropriations for Disaster Relief Requirements Act, 2017 (Public Law 115-56) 30. Friendly Airports for Mothers Act (S. 1110/H.R. 2375) 31. Lead-Safe Housing for Kids Act (S. 1845) 32. Supporting Working Moms Act (S. 2122/H.R. 3255) 33. Championing Healthy Kids Act (H.R. 3922) 34. Making further continuing appropriations for fiscal year 2018, and for other purposes (Public Law 115-90) 35. An Act to amend the Homeland Security Act of 2002 to require the Secretary of Homeland Security to issue Department of Homeland Security-wide guidance and develop training programs as part of the Department of Homeland Security Blue Campaign, and for other purposes (Public Law 115- 96) 36. Tax Cuts and Jobs Act (Public Law 115-97) 37. Pandemic and All-Hazards Preparedness Advancing Innovation Act (S. 2852/H.R. 6378/H.R. 7328/S. 1379/H.R. 269) 38. Vaccine Access Improvement Act (H.R. 4993) 39. Relief from New Source Performance Standards Act (H.R. 453) 40. Strategies to Address Antimicrobial Resistance (S. 2469) 41. Opioid Quota Reform Act (S. 2535) 42. Hospital Preparedness Program Reauthorization Act (H.R. 4776) 43. Blocking Regulatory Interference from Closing Kilns Act (H.R. 1917) 44. Opioid Crisis Response Act of 2018 (S. 2680) 45. Agriculture and Nutrition Act (H.R. 2) 46. Agriculture Improvement Act (S. 3042) 47. SECURE Act (H.R. 5998) 48. Trauma-Informed Care for Children and Families Act (S. 774) 49. SUPPORT for Patients and Communities Act (H.R. 6) 50. Centers for Disease Control Emergency Response Act (S. 3161) 51. LABEL Opioids Act (S. 3428) 52. Relief from New Source Performance Standards Act (S. 1857) 53. Outdoors for All Act (S. 3499) 54. The MOMMA Act (H.R. 5977) 55. Preventing Maternal Deaths Act (H.R. 1318) 56. Medicare Access to Vaccines Equity Act (not yet introduced) 57. The Support Act (H.R. 6) 58. Climate Change Health Protection and Promotion Act (S. 529) 59. NURSE Act (H.R. 1597) 60. Investing for the People Act (H.R. 2021) 61. Child Care for Working Families Act (H.R. 365/S. 568) 62. FAMILY Act (H.R. 1185/S. 463) 63. Transportation Alternatives Enhancement Act (S. 1098) 64. Lower Health Care Costs Act (S. 1895) 65. LIFT America Act (H.R 2479) 66. Public Health Funding Restoration Act (H.R. 3447/S. 1944) 67. Supporting Older Americans Act of 2020 (HR 4334) 68. Campus Prevention and Recovery Services for Students Act (H.R. 3591) 69. Healthier Students for Stronger Campuses Act (S. 1281) 70. Saving Lives Through Better Data Act (S. 1793) 71. VACCINES Act (H.R. 2862) 72. DISARM Act (H.R. 4100/S. 1712) 73. Community Access, Resources, and Education for Families Act (H.R. 3117) 74. Protecting Seniors Through Immunization Act (S. 1872) 75. Tobacco-Free Youth Act (S. 1541) 76. Tobacco to 21 Act (H.R. 2411/S. 1258) 77. Investing for People Act (H.R. 2021) 78. School Based Health Centers Reauthorization Act (H.R.2075/S.1013) 79. Reversing the Youth Tobacco Epidemic Act of 2019 (H.R. 2339) 80. Social Determinants Accelerator Act (H.R. 4004) 81. Mental Health Professionals Workforce Shortage Loan Repayment Act (H.R. 2431) 82. The UNDERSTAND Act (S. 1323) 83. Americas Transportation Infrastructure Act (S. 2302) 84. Barriers to Suicide Act of 2019 (H.R. 4309) 85. Promoting Physical Activity for Americans Act (S. 1608/H.R. 2891) 86. Public Health Infrastructure Modernization Act of 2019 (H.R. 5321) 87. Supporting Healthy Mothers and Infants Act (H.R. 5249) 88. Lead-Free Future Act (H.R. 4416) 89. Home Visiting to Reduce Maternal Mortality and Morbidity Act (H.R. 4768) 90. Recognizing the anniversary of the eradication of smallpox and the importance of vaccination in the United States and worldwide (H. Res. 592) 91. Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) 92. Families First Coronavirus Response Act (H.R. 6201) 93. Coronavirus Aid, Relief, and Economic Security (CARES) Act (H.R. 748) 94. Connecting Americas Transportation Infrastructure Act (S. 2302) 95. Improving Access to Remote Behavioral Health Treatment Act (S. 2244/H.R. 4131) 96. National Suicide Hotline Designation Act (S. 2661/H.R. 4194) 97. Suicide Prevention Lifeline Improvement Act (H.R. 4564) 98. Campaign to Prevent Suicide Act (H.R. 4585) 99. Medicaid Reentry Act (H.R. 1329) 100. Excellence in Mental Health and Addiction Treatment Expansion Act (S. 824/H.R. 1767) 101. Mental Health Services for Students Act (S. 1122/H.R. 1109) 102. Suicide Training and Awareness Nationally Delivered for Universal Prevention (STANDUP) Act (S. 2492/H.R. 2599) 103. Mental Health Parity Compliance Act (S. 1737/H.R. 3165) 104. Behavioral Health Transparency Act (S. 1576/H.R. 2874) 105. Medicare Mental Health Access Act (S. 2772/H.R. 884) 106. Public Health Emergency Response and Accountability Act (S. 3309) 107. Family Violence Prevention and Services Improvement Act (H.R. 5041) 108. Protecting the Health of Americas Older Adults During COVID-19 and Beyond Act (H.R. 6935) 109. Improving Social Determinants Act (H.R. 6561) 110. Urging the establishment of a United States Commission on Truth, Racial Healing, and Transformation (H.Con.Res.100) 111. FY 2021 Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations (TBD) 112. Better Tools for Healthy Living Act (S. 1805) 113. The WIC Act (S. 2358) 114. Health Equity and Accountability Act (H.R. 6637) 115. Paycheck Protection Program and Health Care Enhancement Act (H.R. 266) 116. The HEROES Act (H.R.6800) 117. Community Solutions for COVID-19 Act (H.R.7077/S.3877) 118. The Black Maternal Health Momnibus Act of 2020 (H.R. 6142) 119. COVID-19 Bias and Anti-Racism Training Act (S.___) 120. Urging the establishment of a United States Commission on Truth, Racial Healing, and Transformation (H. Con. Res. 100) 121. Community Immunity During COVID-19 Act of 2020 (H.R._____) 122. Public Safety Officer Support Act (H.R. 7568) 123. COVID-19 Behavioral Health Support Act (S. 4059) 124. Public Health Workforce Loan Repayment Act (H.R. 6578) 125. Strengthening the Public Health Workforce Act (S. 3737) House(s) of Congress and Federal Agencies lobbied during the quarter: House, Senate, Exec Office of Pres, HHS, CDC, FDA, CMS, OMB, DOT, HUD, EPA, NIMH, Education, USDA, DHS, FEMA, and SAMHSA

Client expense: $32,208 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT)

H.R. 748, CARES Act H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R.1730, Cancer Drug Parity Act of 2019 H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S1872/HR5076, Protecting Seniors Through Immunization Act H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6019: Cure the Coronavirus Act - Provisions related to FDA prescription drug approvals H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6258: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity H.R. 6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavi-rus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act H.R. 6450: Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6457: Disaster and Emergency Pricing Abuse Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6472: COVID-19 Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing HR6711, Medical Supply Transparency and Delivery Act, DPA impact on Rx manufacturers H.R. 6906: Health Care Emergency Guarantee Act - Provisions related to prescription drug access and cost sharing H.R. 7269: To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited provisional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes - Provisions related to FDA provisional approval pathways H.R. 7288: To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development related to COVID-19, and for other purposes - Provisions related to prescription drug research and development and transparency H.R. 7296: To require any COVID-19 drug developed in whole or in part with Federal support to be affordable and accessible by prohibiting monopolies and price gouging, and for other purposes - Provisions related to prescription drug pricing and transparency S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 658: Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act - Provisions related to accelerated approval S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and negotiated rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1712: DISARM Act of 2019 - Provisions related to antimicrobial drug development S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 3162: Affordable Drug Manufacturing Act of 2019 - Provisions related to prescription drug manufacturing S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3439: Lower Health Insurance Deductibles Act - Provisions related to prescription drug pricing and insurance plan design S. 3432: Securing America's Medicine Cabinet Act of 2020 - Provisions related to advanced manufacturing and prescription drugs S. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Corona-virus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals S3780, HOME Act S. 3872: Promising Pathway Act - Provisions related to FDA provisional approval pathways Transparency policy issues S. 3932: A bill to direct the Secretary of Defense to carry out a pilot program under the TRICARE pharmacy benefits program - Provisions related to DoD TRICARE pharmacy benefits program S. 4010: A bill to amend the Federal Food, Drug, and Cosmetic Act to make permanent the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases - Provisions related to priority review vouchers H.R. 7288: Taxpayer Research and Coronavirus Knowledge (TRACK) Act of 2020 - Provisions related to database of federal biomedical investment information for COVID-19 H.R. 7296: Make Medicines Affordable by Preventing Pandemic Pricegouging (MMAPPP) Act of 2020 Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 (discussion draft) Proclamation Suspending Entry of Aliens Who Present a Risk to the U.S. Labor Market Following the Coronavirus Outbreak (June 22, 2020) Department of Homeland Security cybersecurity policy issues HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors FDA modernization policy issues PDUFA policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients CARES ACT-Monograph Reform Support for Arthritis Caucus

Client expense: $870,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

Prescription drug coverage and payment policies; S. 1872/H.R. 5076, Protecting Seniors Through Immunization Act; Medical innovation issues.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Home Administration of Part B Drugs ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Reimbursement and Coverage of Innovative Products ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020

Client expense: $3,320,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Brazil Biologics Regulations ---BSUFA ---Canada Biologics Regulations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Implementation of CREATES Act of 2019 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6206: Pandemic Response and Emergency Preparedness (PREP) Act of 2020 ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Drug Supply Chain Management ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Adult Immunization Education ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Maternal Immunization ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program

Client expense: $3,320,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

- H.R. 863 - DXM Abuse Prevention Act of 2019, regarding all provisions - S. 726 - Personal Care Products Safety Act, regarding all provisions - Issues related to the regulation of over-the-counter drugs - Issues related to cosmetic regulatory reform - Issues related to cosmetic animal testing - Issues related to biosimilars - Issues related to maternal mortality - Issues related to contact lens safety - Issues related to medical product communications - Issues related to medical product review - Issues related to ingredient safety - Issues related to diversity in clinical trials - Issues related to health care pricing transparency - Issues related to peripheral artery disease - H.R. 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - Issues related to drug importation - S. 2543, "Prescription Drug Pricing Reduction Act of 2019", regarding all provisions - H.R. 19, "Lower Costs, More Cures Act of 2019", regarding all provisions - H.R. 748/ S. 3458, "'Coronavirus Aid, Relief, and. Economic Security Act'', regarding all provisions - H.R. 6074, "Coronavirus Preparedness and Response Supplemental Appropriations Act", regarding all provisions - H.R. 6201, "Families First Coronavirus Response Act", regarding all provisions - H.R. 3975, the Contact Lens Prescription Verification Modernization Act, regarding all provisions - H.R. 5663, the Safeguarding Therapeutics Act, regarding all provisions - Issues related to counterfeit health care goods - S. 3468, Preventing Essential Medical Device Shortages Act of 2020 - Issues related to counterfeit medical devices and combination products and authority to destroy counterfeit medical products - Issues related to reporting medical device shortages - Issues related to pandemic response - S. 2740, "Over the Counter Monograph Safety, Innovation, and Reform Act of 2019", regarding all provisions - H.R. 5279, "Cosmetic Safety Enhancement Act", regarding all provisions - H.R. 4296, "Safe Cosmetics and Personal Care Products Act of 2019", regarding all provisions - Issues related to social determinants of health - H.R. 5076/S. 1872, "Protecting Seniors Through Immunization", regarding all provisions - H.R.6062, "To amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes", regarding all provisions. - H.R.6952, "To direct the President to appoint a Medical Supplies Response Coordinator to coordinate the efforts of the Federal Government regarding the supply and distribution of certain supplies and equipment relating to COVID-19", regarding all provisions - S.3942, "Securing America's Medical Supply Chain and Advancing the Production of Life Saving Medicines Act", regarding all provisions - S.3945, "Bring Entrepreneurial Advancements To Consumers Here In North America Act", regarding all provisions - S.3780, "HOME Act", regarding all provisions - S.3781, "PART Act", regarding all provisions - Issues related to diversity in clinical trials

Client expense: $1,760,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Access to immunizations; Maternal immunizations; Health information technology/IIS; Quality measures; HHS Healthy People 2030 Process; H.R. 2862, VACCINES Act; S. 1872/H.R. 5076, Protecting Seniors Through Immunization Act; CARES Act - Public Law No: 116-136; Families First Coronavirus Response Act - Public Law No: 116-127; Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - Public Law No: 116-123; HR 6800, Health and Economic Recovery Omnibus Emergency Solutions Act or the HEROES Act.

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

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

Part D cost sharing and quality measures for vaccines; S. 1872/H.R. 5076, Protecting Seniors Through Immunization Act; Medicare reimbursement for vaccine education, counseling and administration.

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

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

Medicare payment issues including the Independent Payment Advisory Board (IPAB) and Medicaid issues. Medicare Part D. 101 drug pricing. S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019. Vaccine legislation; H.R. 5076, S. 1872. Policies impacting U.S. address to the Covid-19 pandemic, including H.R. 604 Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No: 116-123.; H. R . 6201 Families First Coronavirus Response Act, Public Law No: 116-127; and H. R. 748 CARES Act, Public Law No: 116-136.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Medicare Part D Program; S.1872/H.R.5076, Protecting Seniors Through Immunization Act of 2019.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and policies relating to: Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Reauthorization of funding for the Childrens Health Insurance Program Reauthorization of the Child Nutrition Act Section 2706 of the ACA regarding provider non-discrimination Policies related to health insurance market stabilization Policies affecting nurse practitioner education and workforce Definition, evaluation and enforcement of essential health benefits and provider network adequacy Health information technology and electronic health records Mental health services and violence prevention Human and child trafficking Draft 21st Century Cures 2.0 legislation Palliative Care and Hospice Education and Training Act (H.R. 647/S. 2080) Title VIII Nursing Workforce Reauthorization Act of 2019 (H.R. 728/S. 1399) Coronavirus Aid, Relief, and Economic Security (CARES) Act (H.R. 748/S.3548) Emergency Medical Services for Children Program Reauthorization Act of 2019 (H.R. 776/S. 1173) End Surprise Billing Act of 2019 (H.R. 861) Fairness for Breastfeeding Mothers Act (H.R. 866/S. 528) Workplace Violence Prevention for Health Care and Social Service Workers Act (H.R. 1309) Healthy Families Act (H.R. 1784/S. 840) Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act (H.R. 1897) Community Health Investment, Modernization, and Excellence Act of 2019 (H.R. 2328) Newborn Screening Saves Lives Reauthorization Act of 2019 (H.R. 2507) Pregnant Workers Fairness Act (H.R. 2694) Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) for Health Act of 2019 (H.R. 2781) VACCINES Act of 2019 (H.R. 2862) Physical Activities Recommendations for Americans Act of 2019 (H.R. 2891) Safe Cribs Act of 2019 (H.R. 3170) Safe Sleep for Babies Act of 2019 (H.R. 3172) Pathways to Health Careers Act (H.R. 3398) Chronic Care Management Improvement Act (H.R. 3436) No Surprises Act (H.R. 3630) Midwives for Maximizing Optimal Maternity Services (Midwives for MOMS) Act of 2019 (H.R. 3849) Social Determinants Accelerator Act of 2019 (H.R. 4004/S. 2986) Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019 (H.R. 3328/H.R. 4100/S. 1712) Effective Suicide Screening and Assessment in the Emergency Department Act of 2019 (H.R. 4861/S. 3006) United States Public Health Service Modernization Act of 2019 (H.R. 4870/S. 2629) Medication Access and Training Expansion (MATE) Act (H.R. 4974) Maternal Health Quality Improvement Act of 2019 (H.R. 4995) Helping Medicaid Offer Maternity Services (MOMS) Act of 2019 (H.R. 4996) Protecting Seniors Through Immunization Act of 2019 (H.R. 5076/S. 1872) Pursuing Equity in Mental Health Act of 2019 (H.R. 5469) Primary and Behavioral Health Care Access Act (H.R. 5575) Ban Surprise Billing Act (H.R. 5800) Consumer Protections Against Surprise Medical Bills Act of 2020 (H.R. 5826) Black Maternal Health Momnibus Act of 2020 (H.R. 6142/S. 3424) Families First Coronavirus Response Act (H.R. 6201) Take Responsibility for Workers and Families Act (H.R. 6379) Community and Public Health Programs Extension Act (S. 192) National Nurse Act of 2019 (S. 696/H.R. 1597) Excellence in Mental Health and Addiction Treatment Expansion Act (S. 824/H.R. 1767) Nursing Where It's Needed Act (S. 1045) Promoting Physical Activity for Americans Act (S. 1608) Lower Health Care Costs Act (S. 1895) Child Care Improvement Act of 2019 (S. 2683) CAPTA Reauthorization Act of 2019 (S. 2971) Suicide Prevention Act (S. 3198/H.R. 5619)

Client expense: Not reported · Firm income: $24,000

Government targets: Bureau of Alcohol Tobacco Firearms & Explosives, Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)

H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1323: Rural Hospital Frontier Fairness Act - Provisions related to the 340B drug discount program H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 4812: Ensuring Compliance Against Drug Diversion Act of 2019 - Provisions related to registrations under the Controlled Substances Act H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6019: Cure the Coronavirus Act - Provisions related to FDA prescription drug approvals H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6173: Covering Coronavirus Test Act of 2020 - Provisions related to medical device pricing and coverage H.R. 6213: No Cost for COVID-19 Testing Act - Provisions related to medical device pricing and coverage H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6253: To expand certain securities exemptions to respond to COVID-19, to establish an X-prize for creating an effective COVID-19 vaccine, and for other purposes - Provisions related to prescription drug research and development H.R. 6261: To provide for coverage of testing for COVID-19 at no cost sharing for Indians receiving health services through the Indian Health Service, and for other purposes - Provisions related to medical device pricing and coverage H.R. 6264: To prohibit price gouging during a state of emergency declaration, and for other purposes - Provisions related to prescription drug and medical device pricing H.R. 6351: To authorize the Secretary of Health and Human Services to administer vaccinations for COVID-19, once available, at no cost to the inoculated, in response to the COVID-19 outbreak, and for other purposes - Provisions related to prescription drug patient access and cost sharing H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 801: Payment Commission Data Act of 2019 - Provisions related to prescription drug pricing transparency S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and foreign reference pricing S. 1089: Restoring Access to Medication Act of 2019 - Provisions related to prescription drug access S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and negotiated rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1567: Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2019 - Provisions related to rare disease research and funding S1872/HR5076 Protecting Seniors Through Immunization Act S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 2004: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug pricing S. 2103: Affordable Insulin Approvals Now Act - Provisions related to FDA prescription drug approvals S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 2897: Patient-Centered Outcomes Research Institute Reauthorization Act - Provisions related to PCORI reauthorization S. 3162: Affordable Drug Manufacturing Act of 2019 - Provisions related to prescription drug manufacturing S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing S. 3180: Responsibility in Drug Advertising Act of 2020 - Provisions related to prescription drug direct-to-consumer advertising S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3439: Lower Health Insurance Deductibles Act - Provisions related to prescription drug pricing and insurance plan design S. 3432: Securing America's Medicine Cabinet Act of 2020 - Provisions related to advanced manufacturing and prescription drugs S. 3442: Care for COVID-19 Act - Provisions related to prescription drug pricing and access S. 3499: A bill to amend coverage requirements to ensure that no person incurs cost sharing when receiving a test to confirm a COVID-19 infection - Provisions related to medical device pricing and access S. 3505: A bill to require private health insurance to rapidly cover preventive services and vaccines related to the coronavirus - Provisions related to prescription drug pricing and access S. 3545: A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes - Provisions related to FDA prescription drug marketing approvals S. 3564: A bill to amend title XIX of the Social Security Act to require States to provide medical assistance for COVID-19 treatment services for individuals who are diagnosed with COVID-19, and for other purposes - Provisions related to prescription drug pricing and access S. 3570: A bill to provide for the expedited procurement of equipment needed to combat COVID-19 under the Defense Production Act of 1950 - Provisions related to the Defense Production Act Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Expanded access policy issues Antimicrobial resistance policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues Monograph Reform CDC Programmatic Funding Restoration of HSA/FSAs 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Cancer drug vial size policy issues Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

Client expense: $940,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Coronavirus (COVID-19) Pandemic ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.6201: Families First Coronavirus Response Act of 2020 ---Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Patient Cost-Sharing and Smoothing ---Reasonable Pricing Provisions Drug Pricing ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous (FLAT) Prices Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.2387: STOP GAMES Act of 2019 ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Reasonable Pricing Provisions Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---Alternative payment arrangements for gene therapies ---Pricing and Rebates Reimbursement and Coverage of Innovative Products ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications Vaccines and Infectious Diseases ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019

Client expense: $2,890,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Biodefense Research, Development and Procurement Issues (Non-funding) ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.6201: Families First Coronavirus Response Act of 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 Coronavirus (COVID-19) Pandemic ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.6201: Families First Coronavirus Response Act of 2020 ---Drug Supply Chain Management ---Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Patient Cost-Sharing and Smoothing ---R&D Funding for Medical Countermeasures ---Reasonable Pricing Provisions Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.6102/S3404: VALID Act of 2020 Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---Patient-Focused Drug Development ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---General Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous prices (FLAT) prices Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 Drug Pricing ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.2387: STOP GAMES Act of 2019 ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Reasonable Pricing Provisions Funding for Antimicrobial Resistance Programs ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Pricing and Rebates Opioid Crisis ---General ---Implementation of the SUPPORT for Patients and Communities Act of 2018 Orphan Drug Issues ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439: Creating Hope Reathorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement ---IP Provisions US-China Trade Negotiations ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccine Injury Compensation Program Tax ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 202 ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.6201: Families First Coronavirus Response Act of 2020 Vaccines and Infectious Diseases ---H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.6201: Families First Coronavirus Response Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives

Client expense: $2,890,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Medicare payment issues including the Independent Payment Advisory Board (IPAB) and Medicaid issues. Medicare Part D. 101 drug pricing. S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019. Vaccine legislation; H.R. 5076, S. 1872. Policies impacting U.S. address to the Covid-19 pandemic, including H.R. 604 Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No: 116-123.; H. R . 6201 Families First Coronavirus Response Act, Public Law No: 116-127; and H. R. 748 CARES Act, Public Law No: 116-136.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

Access to immunizations; Health information technology/IIS; Quality measures; HHS Healthy People 2030 Process; H.R. 2862, VACCINES Act; S. 1872/H.R. 5076, Protecting Seniors Through Immunization Act; CARES Act - Public Law No: 116-136; Families First Coronavirus Response Act - Public Law No: 116-127.

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

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

Part D cost sharing and quality measures for vaccines; S. 1872/H.R. 5076, Protecting Seniors Through Immunization Act.

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

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

Lobbying Issues Description: Budget and appropriations for disease and injury prevention, including obesity and related diseases; pandemic influenza and emerging infectious diseases; physical activity; public health bioterrorism preparedness; food safety, environmental health; paid sick days; womens and childrens health; community-based public health interventions, and substance misuse/behavioral health issues. Specific Legislation: 1. Implementation of the Patient Protection and Affordable Care Act (Public Law 111-148) 2. Implementation of the FDA Food Safety Modernization Act (Public Law 111353) 3. Implementation of Pandemic and All-Hazards Preparedness Reauthorization Act and Pandemic and All-Hazards Preparedness and Advancing Innovation Act (Public Law 113-5, 116-22) 4. Implementation of Healthy, Hunger-Free Kids Act of 2010 (Public Law 111296) 5. Implementation of Child Care and Development Block Grant Act of 2014 (Public Law 113-186) 6. Implementation of Every Student Succeeds Act (Public Law 114-95) 7. Implementation of the Comprehensive Addition and Recovery Act (Public Law 114-98) 8. FY 2020 Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations (H.R. 2740/Not Yet Introduced)) 9. FY 2020 Departments of Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations (H.R. 3164/Not yet introduced) 10. FY2020 Departments of Transportation, HUD and related agencies Appropriations (H.R. 3163/Not Yet Introduced) 11. FY2020 Further Consolidated Appropriations Act (H.R. 1865/P.L. 116-94) 12. Midnight Rules Relief Act (S.34/H.R. 21) 13. Regulations from the Executive in Need of Scrutiny Act (S. 21/H.R. 26) 14. Regulatory Accountability Act (S.951/H.R. 5/H.R. 45/H.Res.33) 15. Searching for and Cutting Regulations that are Unnecessarily Burdensome (SCRUB) Act (H.R. 998) 16. Regulatory Integrity Act (H.R. 1004) 17. OIRA Insight, Reform, and Accountability Act (S. 676/H.R. 1009) 18. A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026 (S.Con.Res. 3) 19. American Health Care Act (H.R. 1628/H.Res. 228) 20. Ozone Standards Implementation Act (S. 263/H.R. 806) 21. Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the final rule of the Bureau of Land Management relating to "Waste Prevention, Production Subject to Royalties, and Resource Conservation" (S.J. Res. 11/H.J.Res.36) 22. Common Sense Nutrition Disclosure Act (S. 261/H.R. 772) 23. Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act (H.R. 1840) 24. Preservation of Antibiotics for Medical Treatment Act (H.R. 1587) 25. Preventing Antibiotic Resistance Act (S. 629) 26. Better Care Reconciliation Act (H.R. 1628) and related amendments 27. Public Health Emergency Response Act (S. 196) 28. Recognizing the importance of vaccinations and immunizations in the United States (H.Res.327) 29. Consolidated Appropriations Act, 2017 (Public Law 115-31) 30. Treat and Reduce Obesity Act (S. 830/H.R. 1953) 31. Community Health and Medical Professionals Improve Our Nation (CHAMPION) Act (H.R. 3922) 32. Community Health Investment, Modernization, and Excellence Act of 2017 (S. 1899) 33. Tobacco Tax Equity Act (S. 1837) 34. Healthy Kids Act (S. 1821/H.R. 3921) 35. Implementation of the Drug Quality and Security Act (P.S. 113-54) 36. Continuing Appropriations Act, 2018 and Supplemental Appropriations for Disaster Relief Requirements Act, 2017 (Public Law 115-56) 37. Friendly Airports for Mothers Act (S. 1110/H.R. 2375) 38. Lead-Safe Housing for Kids Act (S. 1845) 39. Supporting Working Moms Act (S. 2122/H.R. 3255) 40. Championing Healthy Kids Act (H.R. 3922) 41. Making further continuing appropriations for fiscal year 2018, and for other purposes (Public Law 115-90) 42. An Act to amend the Homeland Security Act of 2002 to require the Secretary of Homeland Security to issue Department of Homeland Security-wide guidance and develop training programs as part of the Department of Homeland Security Blue Campaign, and for other purposes (Public Law 11596) 43. Tax Cuts and Jobs Act (Public Law 115-97) 44. Pandemic and All-Hazards Preparedness Advancing Innovation Act (S. 2852/H.R. 6378/H.R. 7328/S. 1379/H.R. 269) 45. Vaccine Access Improvement Act (H.R. 4993) 46. Relief from New Source Performance Standards Act (H.R. 453) 47. Strategies to Address Antimicrobial Resistance (S. 2469) 48. Opioid Quota Reform Act (S. 2535) 49. Hospital Preparedness Program Reauthorization Act (H.R. 4776) 50. Blocking Regulatory Interference from Closing Kilns Act (H.R. 1917) 51. Opioid Crisis Response Act of 2018 (S. 2680) 52. Agriculture and Nutrition Act (H.R. 2) 53. Agriculture Improvement Act (S. 3042) 54. SECURE Act (H.R. 5998) 55. Trauma-Informed Care for Children and Families Act (S. 774) 56. SUPPORT for Patients and Communities Act (H.R. 6) 57. Centers for Disease Control Emergency Response Act (S. 3161) 58. LABEL Opioids Act (S. 3428) 59. Relief from New Source Performance Standards Act (S. 1857) 60. Outdoors for All Act (S. 3499) 61. The MOMMA Act (H.R. 5977) 62. Preventing Maternal Deaths Act (H.R. 1318) 63. Medicare Access to Vaccines Equity Act (note yet introduced) 64. The Support Act (H.R. 6) 65. Climate Change Health Protection and Promotion Act (S. 529) 66. FY 2020 Departments of the Interior, Environment, and Related Agencies Appropriations Act (H.R. 3052/Not Yet Introduced) 67. NURSE Act (H.R. 1597) 68. Investing for the People Act (H.R. 2021) 69. Child Care for Working Families Act (H.R. 365/S. 568) 70. FAMILY Act (H.R. 1185/S. 463) 71. Transportation Alternatives Enhancement Act (S. 1098) 72. Lower Health Care Costs Act (S. 1895) 73. LIFT America Act (H.R 2479) 74. Public Health Funding Restoration Act (H.R. 3447/S. 1944) 75. Older Americans Act reauthorization (not yet introduced) 76. Campus Prevention and Recovery Services for Students Act (H.R. 3591) 77. Healthier Students for Stronger Campuses Act (S. 1281) 78. Saving Lives Through Better Data Act (S. 1793) 79. VACCINES Act (H.R. 2862) 80. DISARM Act (H.R. 4100/S. 1712) 81. Community Access, Resources, and Education for Families Act (H.R. 3117) 82. Protecting Seniors Through Immunization Act (S. 1872) 83. Tobacco-Free Youth Act (S. 1541) 84. Tobacco to 21 Act (H.R. 2411/S. 1258) 85. Investing for People Act (H.R. 2021) 86. School Based Health Centers Reauthorization Act (H.R.2075/S.1013) 87. Reversing the Youth Tobacco Epidemic Act of 2019 (H.R. 2339) 88. Social Determinants Accelerator Act (H.R. 4004) 89. Mental Health Professionals Workforce Shortage Loan Repayment Act (H.R. 2431) 90. The UNDERSTAND Act (S. 1323) 91. Americas Transportation Infrastructure Act (S. 2302) 92. Health Equity and Accountability Act (Not yet introduced) 93. Barriers to Suicide Act of 2019 (H.R. 4309) 94. Promoting Physical Activity for Americans Act (S. 1608/H.R. 2891) 95. Public Health Infrastructure Modernization Act of 2019 (H.R. 5321) 96. Supporting Healthy Mothers and Infants Act (H.R. 5249) 97. Lead-Free Future Act (H.R. 4416) 98. Home Visiting to Reduce Maternal Mortality and Morbidity Act (H.R. 4768) 99. Recognizing the anniversary of the eradication of smallpox and the importance of vaccination in the United States and worldwide (H. Res. 592) 100. Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) 101. Families First Coronavirus Response Act (H.R. 6201) 102. Coronavirus Aid, Relief, and Economic Security (CARES) Act (H.R. 748) 103. Connecting Americas Transportation Infrastructure Act (S. 2302) 104. Improving Access to Remote Behavioral Health Treatment Act (S. 2244/H.R. 4131) 105. National Suicide Hotline Designation Act (S. 2661/H.R. 4194) 106. Suicide Prevention Lifeline Improvement Act (H.R. 4564) 107. Campaign to Prevent Suicide Act (H.R. 4585) 108. Medicaid Reentry Act (H.R. 1329) 109. Excellence in Mental Health and Addiction Treatment Expansion Act (S. 824/H.R. 1767) 110. Mental Health Services for Students Act (S. 1122/H.R. 1109) 111. Suicide Training and Awareness Nationally Delivered for Universal Prevention (STANDUP) Act (S. 2492/H.R. 2599) 112. Mental Health Parity Compliance Act (S. 1737/H.R. 3165) 113. Behavioral Health Transparency Act (S. 1576/H.R. 2874) 114. Medicare Mental Health Access Act (S. 2772/H.R. 884) 115. Public Health Emergency Response and Accountability Act (S. 3309) 116. Family Violence Prevention and Services Improvement Act (H.R. 5041) House(s) of Congress and Federal Agencies lobbied during the quarter: House, Senate, Exec Office of Pres, HHS, CDC, FDA, CMS, OMB, DOT, HUD, EPA, NIMH, Education, USDA, DHS, FEMA, and SAMHSA

Client expense: $35,610 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Office of Management & Budget (OMB), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Transportation, Dept of (DOT)

Medicare Part D Program; S.1872/H.R.5076, Protecting Seniors Through Immunization Act of 2019.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Part D Out of Pocket Costs; Drug pricing - Independent patient assistance programs; S.2911 Seniors Prescription Drug Relief Act of 2019 - H.R. 5076/S.1872 Protecting Seniors Through Immunization Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE