Strengthening Innovation in Medicare and Medicaid Act

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: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of the Vice President of the United States, SENATE, 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: Centers For Medicare and Medicaid Services (CMS), 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, SENATE, 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 ---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.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S. 3013, Encouraging Innovative Benefit Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B - Issues related to CMMI

Client expense: $2,030,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

H.R.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S. 3013, Encouraging Innovative Benefit Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act -Issues related to Medicare and Medicaid coverage and reimbursement -Issues related to the 340B Drug Discount Program -Issues related to drug pricing -Medicare reimbursement for biosimilars -MACRA treatment and reimbursement of Part B drugs -Medicare payments for inpatient antimicrobials -Issues related to drug importation -Issues related to the International Pricing Index for Medicare Part B -Issues related to CMMI

Client expense: $2,750,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

H.R.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S. 3013, Encouraging Innovative Benefit Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B - Issues related to CMMI

Client expense: $1,930,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

H.R.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S. 3013, Encouraging Innovative Benefit Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B - Issues related to CMMI

Client expense: $2,790,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

H.R 856 - Physicians Pro Bono Care Act - charitable deduction for pro-bono health services H.R. 3796 - Health Savings for Seniors Act - This bill permits a Medicare beneficiary to participate in and contribute to health savings accounts. S. 1227 - Prescription Pricing for the People Act of 2019 - Thisbill requiresthe Federal Trade Commission (FTC) to report about anticompetitive practicesand other trendswithin the pharmaceuticalsupply chain that may impact the cost of prescriptionsdrugs. H.R. 5198 - Patients' Right to Know Their Medication Act of 2019 - Creates FDA approved standard method of sharing consumer information. S. 2441 - Health Savings Account Expansion Act of 2019 - Thisbill permitsindividualswho are not enrolled in a high deductible health plan to participate in healthsavingsaccounts. S. 2440 - Qualified Health Savings Account Distribution Act of 2019 - This bill amends the Internal Revenue Code, with respect to the requirements for tax-preferred health accounts, to modify the rules for using a conversion or termination of a flexible spending account or a health reimbursement arrangement to establish a health savings account. H.R. 603 - Health Savings Account Expansion Act of 2019 - This bill modifies the requirements for health savings accounts (HSAs) to: increase the maximum contribution amounts, permit the use of HSAs to pay health insurance premiums and for direct primary care service arrangements, repeal the restriction on using HSAs for over-the-counter medications, eliminate the requirement that a participant in an HSA be enrolled in a high deductible health care plan, and decrease the additional tax for HSA distributions not used for qualified medical expenses. H.R. 5596, S. 3112 - Personalized Care Act of 2020 - This bill revises provisions relating to health savings accounts (HSAs) H.R. 5566 - Patient Fairness Act of 2020 - This bill revises requirements for health savings accounts (HSAs) H.R. 5076 - Protecting Seniors Through Immunization Act of 2019 - Seeks to eliminate out-of-pocket expenses for everyone covered by Medicare and spares seniors the decision to delay or not seek vaccines due to their share of the cost. S. 3537 - Protecting Our Pharmaceutical Supply Chain from China Act of 2020 - Requires Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States. S. 3432 - Securing America's Medicine Cabinet Act of 2020 - This bipartisan legislation would reduce American reliance on foreign manufacturing of active pharmaceutical ingredients (APIs). H.R. 6286 - Health Savings Act of 2020 - This bill revises requirements for health savings accounts (HSAs) H.R. 6336 - Increasing Hospital Capacity to Fight the Coronavirus Act of 2020 - This bill allows unapproved capital expenses that are made by health care facilities during the public health emergency declared on January 31, 2020, relating to COVID-19 (i.e., coronavirus disease 2019) to be included in federal payment determinations under Medicare and Medicaid. H.R. 3502 - Protecting People From Surprise Medical Bills Act - This bill makes a series of changes relating to health care costs and billing practices. S. 2543 - Prescription Drug Pricing Reduction Act of 2019 - Seeks to lower drug costs by establishing rebate programs for brandname drugs and biologics used for Part B and Part D with prices that increase faster than the rate of inflation. H.R.6663 - Truth in Healthcare Marketing - Strives to reduce confusion over professional licensure, education level, training, degrees obtained, and clinical expertise and makes it unlawful for providers to misrepresent these credentials. H.R. 6813, S. 3703 - Promoting Alzheimer's Awareness to Prevent Elder Abuse Act - Works toward providing this protection by requiring the development of training materials for anyone who responds, investigates, or prosecutes cases of elder abuse involving seniors afflicted with dementias H.R. 7233, S. 4216 - Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act - The expansion of telehealth would provide a convenient, cost-effective tool that complements traditional in-office medical visits. S. 4106 - Healthcare PRICE Transparency Act - Codifies two healthcare price transparency rules requiring hospitals and insurers to disclose their discounted cash rates and negotiated rates to consumers before they receive medical care. S. 3993 - Equal Access to Care Act - Expands access to telemedicine during the coronavirus emergency by allowing licensed health care providers to treat patients over the phone and online wherever the patient is located. H.R. 6930 - Manufacturing API, Drugs, and Excipients (MADE) in America Act - Addresses our drug supply chains dependence on foreign countries like China and works to mitigate drug shortages while incentivizing the domestic manufacturing of drugs, active pharmaceutical ingredients (API), personal protective equipment (PPE), and diagnostics. S. 4134 - Increasing Access to Biosimilars Act - TheIncreasing Access to Biosimilars Actwould direct the Department of Health and Human Services to create a shared savings demonstration program for biosimilar drugs in the Medicare program, which will help increase competition and expand access to biosimilars. H.R. 7008 - Family Savings Flexibility Act - This bill (1) increases to $2,750 the maximum amount of unused benefits or contributions remaining in a health flexible or dependent care spending arrangement that may be carried over from the 2020 to the 2021 plan year, (2) increases the maximum contribution amount for health savings accounts, and (3) increases the exclusion from employee gross income of employer-paid dependent care assistance. S. 3872 - Promising Pathway Act - Requires the US Food and Drug Administration to establish a rolling, real-time, priority review pathway to evaluate provisional approval applications for drugs intended to treat, prevent, or diagnose serious or life-threatening diseases or conditions, including those that pose a threat of epidemic or pandemic. S. 4185 - End Surprise Medical Bills for Air Ambulances Act of 2020 - A bill to establish an independent dispute resolution process for surprise air ambulance bills, and for other purposes. S. 4198 - Affordable Coronavirus Testing Act - This bill requires health insurance plans to cover through 2021 without cost sharing COVID-19 (i.e., coronavirus disease 2019) serology testing, which looks for the presence of antibodies made in response to an infection. S. 4158 - PPE Supply Chain Transparency Act of 2020 - This bill requires the Federal Emergency Management Agency (FEMA) to issue, within 90 days, a public report on the security and resilience of the supply chain for personal protective equipment during the COVID-19 (i.e., coronavirus disease 2019) pandemic. S. 4151 & H.R. 4838 - The Sustaining Outpatient Services (SOS) Act - Prevents certain off-campus hospital outpatient services from receiving significant Medicare reimbursement cuts. S. 4367 and H.R. 8032 - Health Savings Accounts for All Act - Qualified medical expenses would include expenses incurred during the prior or current tax year before establishing the HSA and fees paid for personal patient care. H.R.5741 - Strengthening Innovation in Medicare and Medicaid Act - Recognizes the important work done by CMMI and incorporates protections into the processes including, limiting the scope of models to only the size needed to realize a statistically valid sample; encouraging feedback from beneficiaries in developing CMMI models; and limiting the testing of new payment and delivery models to five years to shield beneficiaries from being subjected to potentially harmful models. H.R. 5741 also provides for key Congressional oversight for CMMI demonstrations that will improve transparency and patient safety. S. 4866 - updating standards for oversight of nursing homes S. 4796 & H.R. 7617 - proposing free market reforms to healthcare S. 4367 and H.R. 8032 - Expansion of health savings accounts.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues concerning the Medicare Hospice Benefit and children's hospice issues. Issues concerning hospice payment and alternative payment models. Issues related to advanced care illness management. Issues involving inpatient respite care, bereavement funding, palliative care and a community-based palliative care demonstration. Issues related to COVID-19 emergency funding, extension of the public health emergency, testing and COVID-19 related legislation. Issues related to telehealth flexibilities and regulatory flexibilities granted under the public health emergency. Issues involving hospice providers and tax treatment and reporting requirements of the CARES Act Public Health and Social Services Emergency Fund. Issues concerning hospice program integrity. Issues concerning Medicare Advantage Value-Based Insurance Design. Issues pertaining to the hospice election statement and election statement addendum. HOSPICE Act (H.R. 5821); Hospice Care Improvement Act of 2019 (S. 2807); Rural Access to Hospice Act (H.R.2594/S.1190); COVID-19 Hospice Respite Care Relief Act of 2020 (S. 4423/H.R. 8322); CONNECT Act (S. 2741/H.R. 4932); Palliative Care and Hospice Education and Training Act (H.R.647/S.2080); Provider Training in Palliative Care Act (S. 1921); CARES Act (H.R. 748); HEROES Act (H.R. 6200); Strengthening Innovation in Medicare and Medicaid Act (H.R.5741); Eliminating the Provider Relief Fund Tax Penalties Act of 2020 (H.R.7819); National Hospice and Palliative Care Month Proclamation Request and Senate Resolution

Client expense: $240,000 · Firm income: Not reported

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

Issues concerning the Medicare Hospice Benefit and children's hospice issues. Issues concerning hospice payment and alternative payment models. Issues related to advanced care illness management. Issues involving inpatient respite care, bereavement funding, palliative care and a community-based palliative care demonstration. Issues related to COVID-19 emergency funding, extension of the public health emergency, testing and COVID-19 related legislation. Issues related to telehealth flexibilities and regulatory flexibilities granted under the public health emergency. Issues involving hospice providers and tax treatment and reporting requirements of the CARES Act Public Health and Social Services Emergency Fund. Issues concerning hospice program integrity. Issues concerning Medicare Advantage Value-Based Insurance Design. Issues pertaining to the hospice election statement and election statement addendum. HOSPICE Act (H.R. 5821); Hospice Care Improvement Act of 2019 (S. 2807); Rural Access to Hospice Act (H.R.2594/S.1190); COVID-19 Hospice Respite Care Relief Act of 2020 (S. 4423/H.R. 8322); CONNECT Act (S. 2741/H.R. 4932); Palliative Care and Hospice Education and Training Act (H.R.647/S.2080); Provider Training in Palliative Care Act (S. 1921); CARES Act (H.R. 748); HEROES Act (H.R. 6200); Strengthening Innovation in Medicare and Medicaid Act (H.R.5741); Eliminating the Provider Relief Fund Tax Penalties Act of 2020 (H.R.7819); National Hospice and Palliative Care Month Proclamation Request and Senate Resolution

Client expense: $240,000 · Firm income: Not reported

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

Issues concerning the Medicare Hospice Benefit. Issues concerning hospice payment and alternative payment models. Issues related to advanced care illness management. Issues involving inpatient respite care, bereavement funding, palliative care and a community-based palliative care demonstration. Issues related to COVID-19 emergency funding, COVID-19 related legislation, telehealth flexibilities, regulatory flexibilities granted under the public health emergency, and extension of the public health emergency. Issues involving hospice providers and tax treatment of the CARES Act Public Health and Social Services Emergency Fund. Issues concerning hospice program integrity. Issues related to palliative care for seriously ill children. Issues concerning Medicare Advantage Value Based Insurance Design. HOSPICE Act (H.R. 5821); Hospice Care Improvement Act of 2019 (S.2807); Rural Access to Hospice Act (H.R.2594/S.1190); Palliative Care and Hospice Education and Training Act (H.R.647/S.2080); Provider Training in Palliative Care Act (S.1921); CARES Act (H.R. 748); HEROES Act (H.R. 6200); Strengthening Innovation in Medicare and Medicaid Act (H.R.5741); National Hospice and Palliative Care Month Proclamation Request

Client expense: $210,000 · Firm income: Not reported

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

Issues concerning the Medicare Hospice Benefit. Issues concerning hospice payment and alternative payment models. Issues related to advanced care illness management. Issues involving inpatient respite care, bereavement funding, palliative care and a community-based palliative care demonstration. Issues related to COVID-19 emergency funding, COVID-19 related legislation, telehealth flexibilities, regulatory flexibilities granted under the public health emergency, and extension of the public health emergency. Issues involving hospice providers and tax treatment of the CARES Act Public Health and Social Services Emergency Fund. Issues concerning hospice program integrity. Issues related to palliative care for seriously ill children. Issues concerning Medicare Advantage Value Based Insurance Design. Issues related to reasonable liability protections. HOSPICE Act (H.R. 5821); Hospice Care Improvement Act of 2019 (S.2807); Rural Access to Hospice Act (H.R.2594/S.1190); Palliative Care and Hospice Education and Training Act (H.R.647/S.2080); Provider Training in Palliative Care Act (S.1921); CARES Act (H.R. 748); HEROES Act (H.R. 6200); Strengthening Innovation in Medicare and Medicaid Act (H.R.5741); National Hospice and Palliative Care Month Proclamation Request

Client expense: $210,000 · Firm income: Not reported

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

Hospice and Medicare Advantage; hospice payment reform; hospice alternative payment models;HOSPICE Act (H.R. 5821); Hospice Care Improvement Act of 2019 (S.2807); Rural Access to Hospice Act (H.R.2594/S.1190); Palliative Care and Hospice Education and Training Act (H.R.647/S.2080); Provider Training in Palliative Care Act (S.1921); Strengthening Innovation in Medicare and Medicaid Act (H.R.5741); Coronavirus Aid, Relief, and Economic Security Act (S.3548); COVID-19 emergency funding and COVID-19 related legislation; Appropriations issues for veterans in hospice

Client expense: $290,000 · Firm income: Not reported

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

Hospice and Medicare Advantage; hospice payment reform; hospice alternative payment models;HOSPICE Act (H.R. 5821); Hospice Care Improvement Act of 2019 (S.2807); Rural Access to Hospice Act (H.R.2594/S.1190); Palliative Care and Hospice Education and Training Act (H.R.647/S.2080); Provider Training in Palliative Care Act (S.1921); Strengthening Innovation in Medicare and Medicaid Act (H.R.5741); Coronavirus Aid, Relief, and Economic Security Act (S.3548); COVID-19 emergency funding and COVID-19 related legislation; Appropriations issues for veterans in hospice

Client expense: $290,000 · Firm income: Not reported

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

Legislation and policies related to: Physician/nurse practitioner reimbursement Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Implementation of the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 (P.L. 114-10) including policies related to the Quality Payment Program Adoption of recommendations of the Institute of Medicine report, The Future of Nursing: Leading Change, Advancing Health Medicare Shared Savings Program beneficiary assignment requirements Medicare-Medicaid hospital conditions of participation Evaluation of the Medicare Graduate Nurse Education demonstration Medicare-Medicaid Program Integrity policies Medicaid maintenance of effort requirements Medicaid eligibility expansion and state options Medicaid waiver application procedures Medicaid per capita cap policy options Promoting Access to Diabetic Shoes Act (H.R. 808/S. 237) ACO Assignment Improvement Act of 2019 (H.R. 900) Medicare for All Act of 2019 (H.R. 1384) Protecting Patients Transportation to Care Act (H.R. 3935/S. 2846) Strengthening Innovation in Medicare and Medicaid Act (H.R. 5741) Home Health Care Planning Improvement Act of 2019 (S. 296/H.R. 2150) Childrens Health Insurance Program Pandemic Enhancement and Relief (CHIPPER) Act (S. 3881/H.R. 6797)

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

Importation of Prescription Drugs Proposed Rule, Docket No. FDA-2019-N-5711 S. 3546/H.R. 6338, the Pandemic Healthcare Access Act H.R. 5741, the Strengthening Innovation in Medicare and Medicaid Act H.R. 748, the CARES Act H.R.3, the Elijah E. Cummings Lower Drug Costs Now Act Issues related to Buy American Pharmacetucial mandates Issues related to Medicare Part D Pandemic Healthcare Access Act, S. 3546, H.R. 6338 Proposed International Pricing Index (IPI) for drugs administered under Medicare Part B S. 1895, the Lower Healthcare Costs Act S. 2543, the Prescription Drug Pricing Reduction Act S. 3129, the Lower Costs, More Cures Act H.R. 2500, the National Defense Authorization Act S. 3769, the Right to Test Act H.R. 7242, Legislation to amend the Internal Revenue Code of 1986 to permit expenditures from health savings accounts for gym memberships and costs of home gym H.R. 6800, The Heroes 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.7537, the Infectious Disease Therapies Research and Innovation Act 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 Transparency in Coverage Proposed Rule (CMS- 9915 -P)

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

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Energy Regulatory Commission (FERC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare Reimbursement. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response to the outbreak. Monitoring and outreach on legislative activity related to the HEALS Act (S. 4317 - S. 4324). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). House Draft, Department of Defense Appropriations Act, FY 2021. Senate Draft, Department of Defense Appropriations Act, FY 2021. H.R. 3, Lower Drug Costs Now Act of 2019. H.R.748, CARES Act (P.L. 116-136) and other legislation related to the policies in reaction to the national health crisis. H.R.7010, Paycheck Protection Program Flexibility Act of 2020 (P.L. 116-142). H.R. 1158, FY2020 Consolidated Appropriations Act (Defense, CJS, FSGG, Homeland Security). H.R. 1554, REDI Act. H.R. 2087, To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes. H.R. 2279, Safe Step Act. H.R. 2693, To amend title XVIII of the Social Security Act to improve access to, and utilization of, bone mass measurement benefits under part B of the Medicare program by establishing a minimum payment amount under such part for bone mass measurement. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019. H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019. H.R. 4378, FY2020 Continuing Appropriations Resolution (P.L. 116-59). S. 64, Preserve Access to Affordable Generics and Biosimilars Act. S. 283, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019. S. 1391, Fair Accountability and Innovative Research Drug Pricing Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 2546, Safe Step Act. H.R. 1763, Resident Physician Shortage Reduction Act. S. 348, Resident Physician Shortage Reduction Act. H.R. 6788, Workforce Resilience Act. S. 3599, Workforce Resilience Act. H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act. H.R. 8505, To amend title XVIII of the Social Security Act to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule, and for other purposes H.R. 8702, Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 H.R. 6644/S. 3741, Health Care at Home Act H.R. 4932/S. 2741, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act H.R. 266, Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139). S. 4014, The Prioritized Paycheck Protection Program (P4) Act. S. 4116, A bill to extend the authority for commitments for the paycheck protection program and separate amounts authorized for other loans under section 7(a) of the Small Business Act, and for other purposes (P.L. 116-147). S.4775, Delivering Immediate Relief to America's Families, Schools and Small Businesses Act. H.R. 6800, The Heroes Act. H.R. 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act (P.L. 116-159). P.L. 116-260, FY2021 Omnibus and COVID Relief and Response Act. H.R. 133: Consolidated Appropriations Act, 2021.

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare Reimbursement. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response to the outbreak. Monitoring and outreach on legislative activity related to the HEALS Act (S. 4317 - S. 4324). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). House Draft, Department of Defense Appropriations Act, FY 2021. Senate Draft, Department of Defense Appropriations Act, FY 2021. H.R. 3, Lower Drug Costs Now Act of 2019. H.R.748, CARES Act (P.L. 116-136) and other legislation related to the policies in reaction to the national health crisis. H.R.7010, Paycheck Protection Program Flexibility Act of 2020 (P.L. 116-142). H.R. 1158, FY2020 Consolidated Appropriations Act (Defense, CJS, FSGG, Homeland Security). H.R. 1554, REDI Act. H.R. 2087, To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes. H.R. 2279, Safe Step Act. H.R. 2693, To amend title XVIII of the Social Security Act to improve access to, and utilization of, bone mass measurement benefits under part B of the Medicare program by establishing a minimum payment amount under such part for bone mass measurement. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019. H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019. H.R. 4378, FY2020 Continuing Appropriations Resolution (P.L. 116-59). S. 64, Preserve Access to Affordable Generics and Biosimilars Act. S. 283, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019. S. 1391, Fair Accountability and Innovative Research Drug Pricing Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 2546, Safe Step Act. H.R. 1763, Resident Physician Shortage Reduction Act. S. 348, Resident Physician Shortage Reduction Act. H.R. 6788, Workforce Resilience Act. S. 3599, Workforce Resilience Act. H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act. H.R. 8505, To amend title XVIII of the Social Security Act to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule, and for other purposes H.R. 8702, Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 H.R. 6644/S. 3741, Health Care at Home Act H.R. 4932/S. 2741, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act H.R. 266, Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139). S. 4014, The Prioritized Paycheck Protection Program (P4) Act. S. 4116, A bill to extend the authority for commitments for the paycheck protection program and separate amounts authorized for other loans under section 7(a) of the Small Business Act, and for other purposes (P.L. 116-147). S.4775, Delivering Immediate Relief to America's Families, Schools and Small Businesses Act. H.R. 6800, The Heroes Act. H.R. 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act (P.L. 116-159). P.L. 116-260, FY2021 Omnibus and COVID Relief and Response Act. H.R. 133: Consolidated Appropriations Act, 2021.

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare Reimbursement. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response to the outbreak. Monitoring and outreach on legislative activity related to the HEALS Act (S. 4317 - S. 4324). Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). House Draft, Department of Defense Appropriations Act, FY 2021. Senate Draft, Department of Defense Appropriations Act, FY 2021. H.R. 3, Lower Drug Costs Now Act of 2019. H.R.748, CARES Act (P.L. 116-136) and other legislation related to the policies in reaction to the national health crisis. H.R.7010, Paycheck Protection Program Flexibility Act of 2020 (P.L. 116-142). H.R. 1158, FY2020 Consolidated Appropriations Act (Defense, CJS, FSGG, Homeland Security). H.R. 1554, REDI Act. H.R. 2087, To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes. H.R. 2279, Safe Step Act. H.R. 2693, To amend title XVIII of the Social Security Act to improve access to, and utilization of, bone mass measurement benefits under part B of the Medicare program by establishing a minimum payment amount under such part for bone mass measurement. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019. H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019. H.R. 4378, FY2020 Continuing Appropriations Resolution (P.L. 116-59). S. 64, Preserve Access to Affordable Generics and Biosimilars Act. S. 283, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019. S. 1391, Fair Accountability and Innovative Research Drug Pricing Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 2546, Safe Step Act. H.R. 1763, Resident Physician Shortage Reduction Act. S. 348, Resident Physician Shortage Reduction Act. H.R. 6788, Workforce Resilience Act. S. 3599, Workforce Resilience Act. H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act. H.R. 8505, To amend title XVIII of the Social Security Act to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule, and for other purposes H.R. 8702, Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 H.R. 6644/S. 3741, Health Care at Home Act H.R. 4932/S. 2741, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act H.R. 266, Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139). S. 4014, The Prioritized Paycheck Protection Program (P4) Act. S. 4116, A bill to extend the authority for commitments for the paycheck protection program and separate amounts authorized for other loans under section 7(a) of the Small Business Act, and for other purposes (P.L. 116-147). S.4775, Delivering Immediate Relief to America's Families, Schools and Small Businesses Act. H.R. 6800, The Heroes Act. H.R. 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act (P.L. 116-159). P.L. 116-260, FY2021 Omnibus and COVID Relief and Response Act. H.R. 133: Consolidated Appropriations Act, 2021.

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

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

Recovery audit contractor reform; Medicare regulatory reform, including physician payment reforms; network adequacy oversight; prior authorization reform; Medicare accountable care organizations; electronic health record interoperability and vendor accountability; physician-owned hospital barriers, including related provisions in H.R. 3062 and S. 2860, the Patient Access to High Quality Health Care Act, to repeal changes made by health care reform laws to the Medicare exception to the prohibition on certain physician referrals for hospitals; private contracting, mandatory participation in demonstrations; telehealth services; and use of step therapy in Medicare and health insurance coverage. Coronavirus response efforts, including support for health care providers, patients and small business, including related provisions in H.R. 6800, the HEROES Act; H.R. 8406, the Heroes Act; S. 4318, the American Workers, Families, and Employers Assistance Act; S. 4320, the Coronavirus Response Additional Supplemental Appropriations Act, 2020; S. 4322, the Safely Back to School and Back to Work Act; and H.R. 133, the Consolidated Appropriations Act, 2021 - P.L. 116-260; related provisions in Sec. 2501 of H.R. 8337, the Continuing Appropriations Act, 2021 and Other Extensions Act re: modifications to the Accelerated and Advance Payment Programs. Enhance Center for Medicare & Medicaid Innovation quality initiatives and patient access to Medicare Part B covered drugs, including related provisions in H.R. 5741, the Strengthening Innovation in Medicare and Medicaid Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare quality standards for hospitals and transplant programs. Coronavirus response efforts, including support for health care providers and patients, and related provisions in H.R. 6800, the HEROES Act; H.R. 8406, the Heroes Act; S. 4318, the American Workers, Families, and Employers Assistance Act; S. 4320, the Coronavirus Response Additional Supplemental Appropriations Act, 2020; S. 4322, the Safely Back to School and Back to Work Act; and H.R. 133, the Consolidated Appropriations Act, 2021 - P.L. 116-260. Enhance Center for Medicare & Medicaid Innovation quality initiatives, including related provisions in H.R. 5741, the Strengthening Innovation in Medicare and Medicaid Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Enhance Center for Medicare & Medicaid Innovation quality initiatives, including related provisions in H.R. 5741, the Strengthening Innovation in Medicare and Medicaid Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation issues affecting patient access to Medicare covered pharmaceuticals and reimbursement adequacy, including related provisions modifying Medicare Parts B and D benefit parameters, coverage, and reimbursement requirements in H.R. 3, the Lower Drug Costs Now Act and S. 2543, the Prescription Drug Pricing Reduction Act; use of step therapy in Medicare and health insurance coverage. Coronavirus response efforts, including related provisions in H.R. 6800, the HEROES Act; H.R. 8406, the Heroes Act; S. 4318, the American Workers, Families, and Employers Assistance Act; S. 4320, the Coronavirus Response Additional Supplemental Appropriations Act, 2020; S. 4322, the Safely Back to School and Back to Work Act; and H.R. 133, the Consolidated Appropriations Act, 2021 - P.L. 116-260. Enhance Center for Medicare & Medicaid Innovation quality initiatives and patient access to Medicare Part B covered drugs, including related provisions in H.R. 5741, the Strengthening Innovation in Medicare and Medicaid Act. Legislative issues associated with patient access to treatment and the Presidents Executive Orders on: (1) Lowering Drug Prices by Putting America First; (2) Lowering Prices for Patients by Eliminating Kickbacks to Middlemen; (3) Increasing Drug Importation to Lower Prices for American Patients; and (4) Access to Life Saving Medications.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Update and reforms to Medicare payments for physicians and implementation of related provisions of the Medicare Access and CHIP Reauthorization Act, and Medicare Part B reimbursement for prescription drugs; and use of step therapy in Medicare and health insurance coverage; maintain patient access to In Office Ancillary Services; implementation of Electronic Health Records meaningful use requirements CMS implementation of misvalued codes in physician fee schedule final rule; and physician reimbursement issues related to the CMS Medicare Part B Drugs Payment Model. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans, including related provisions in H.R. 3107, the Improving Seniors Timely Access to Care Act, which establishes requirements with respect to the use of prior authorization under Medicare Advantage plans. Coronavirus response efforts, including support for health care providers, patients and small business, and related provisions in H.R. 6800, the HEROES Act; H.R. 8406, the Heroes Act; S. 4318, the American Workers, Families, and Employers Assistance Act; S. 4320, the Coronavirus Response Additional Supplemental Appropriations Act, 2020; S. 4322, the Safely Back to School and Back to Work Act; and H.R. 133, the Consolidated Appropriations Act, 2021 - P.L. 116-260. Enhance Center for Medicare & Medicaid Innovation quality initiatives and patient access to Medicare Part B covered drugs, including related provisions in H.R. 5741, the Strengthening Innovation in Medicare and Medicaid Act. Legislative Issues related to payment for Evaluation and Management (E/M) Codes.

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

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

Update and reforms to Medicare payments for physicians and implementation of related provisions of the Medicare Access and CHIP Reauthorization Act (MACRA), including regulatory relief for physicians in the MACRA Quality Payment Program, evaluation and management codes, and qualified clinical data registries; maintain patient access to In-Office Ancillary Services; issues related to adequate network coverage for dermatologic care within Medicare Advantage plans; legislative issues regarding implementation of Meaningful Use of Electronic Health Records; Medicare reimbursement for telemedicine; Medicare RAC reform; and use of step therapy in Medicare and health insurance coverage; advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans, including related provisions in H.R. 3107, the Improving Seniors Timely Access to Care Act, which establishes requirements with respect to the use of prior authorization under Medicare Advantage plans. Coronavirus response efforts, including support for health care providers, patients and small business, and related provisions in H.R. 6800, the HEROES Act; H.R. 8406, the Heroes Act; S. 4318, the American Workers, Families, and Employers Assistance Act; S. 4320, the Coronavirus Response Additional Supplemental Appropriations Act, 2020; S. 4322, the Safely Back to School and Back to Work Act; and H.R. 133, the Consolidated Appropriations Act, 2021 - P.L. 116-260. Enhance Center for Medicare & Medicaid Innovation quality initiatives and patient access to Medicare Part B covered drugs, including related provisions in H.R. 5741, the Strengthening Innovation in Medicare and Medicaid Act. Legislative Issues related to payment for Evaluation and Management (E/M) Codes.

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

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

H.R.3 - Lower Drug Costs Now Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R.19, Lower Costs, More Cures Act of 2019. S. 3013, Encouraging Innovative Benefit Design to Lowes Costs for Seniors Act S. 3129, Lower Cost, More Cures Act of 2019 H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B - Issues related to CMMI

Client expense: $2,020,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

H.R. 3--Elijah E. Cummings Lower Drug Costs Now Act H.R. 5741--The Strengthening Medicare and Medicaid Innovation Act S. 3548--Coronavirus Aid, Relief, and. Economic Security Act FY 2021 Hospital Inpatient PPS (IPPS) Proposed Rule CMS Proposed Rule, Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements; Most Favored Nation (MFN) model interim final rule with comment period (IFC) Executive Order 13948, on Lowering Drug Prices by Putting America First; General issues related to patient access to rare disease therapies, Part B and Part D drugs; issues related to home infusion for Part B patients; Center for Medicare and Medicaid Innovation (CMMI) policy issues; value-based payment arrangements; efforts to improve coding and coverage for rare disease therapies; rare disease patient and provider impacts from MFN

Client expense: $400,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Part A, B and D AMP Cap H.R 3 S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 1046/S.377 - Medicare Negotiation and Competitive Licensing Act of 2019 Innovative pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Drug Pricing Outcomes Based Contracts/value based arrangements Medicaid H.R.275 - Medicare Prescription Drug Price Negotiation Act of 2019 H.R.448 - Medicare Drug Price Negotiation Act H.R.19 - Lower Costs, More Cures Act of 2019 H.R.107 - To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R.4455 - BIOSIM Act H.R.4619 - Pharmaceutical Rebates for Excessive Pricing Above Inflation Act HR. 3772 - The Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 HR. 4597 - Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 S.3466 - ACCESS for Biosimilars Act of 2020 HR. 6179 - Increasing Access to Biosimilars Act of 2020 HR. 4629 - Star Rating for Biosimilars Act S. 3129 - Lower Costs, More Cures Act of 2019 S. 3384 - Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 S. 3457 - Preserving Patient Access to Home Infusion Act H.R.5741 - Strengthening Innovation in Medicare and Medicaid Act Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Transparency policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Proposed Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-P) Reimbursement for cell therapy products S. 3353/H.R. 5534 - Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act Patient Cost-Sharing and Smoothing S. 4134 - Increasing Access to Biosimilars Act of 2020 S. 102 - Prescription Drug Price Relief Act of 2019 CMS Proposed Rule: Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) or Drugs Covered in Medicaid, Revising Medicaid Rebate and Third Party Liability (TPL) Requirements (CMS-2482-P) H.R. 8624 - Protecting Access to Innovation During COVID-19 Act H.R. 8702 - Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 S. 1895 - Lower Health Care Costs Act S. 4199 - Prescription Drug Pricing Reduction Act of 2020 S. 4274 - Legalizing Drug Discounts for Seniors Act of 2020 Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related issues ASP reporting policy issues Non-covered drugs policy issues Drug wastage rebates policy issues

Client expense: $660,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

Issues concerning the Medicare Hospice Benefit and children's hospice issues. Issues concerning hospice payment and alternative payment models. Issues related to advanced care illness management. Issues involving inpatient respite care, bereavement funding, palliative care and a community-based palliative care demonstration. Issues related to COVID-19 emergency funding, extension of the public health emergency, testing, vaccines, and COVID-19 related legislation. Issues concerning hospice sequestration relief. Issues related to telehealth flexibilities and regulatory flexibilities granted under the public health emergency. Issues involving hospice providers and tax treatment and reporting requirements of the CARES Act Public Health and Social Services Emergency Fund. Issues concerning hospice program integrity. Issues concerning Medicare Advantage Value-Based Insurance Design. Issues pertaining to the hospice election statement and election statement addendum. Consolidated Appropriations Act, 2021 (H.R.133); ChiPACC Act of 2020 (H.R.9002); Medicare Sequester COVID Moratorium Act (H.R.8840); Compassionate Care Act (S.4945); HOSPICE Act (H.R. 5821); Hospice Care Improvement Act of 2019 (S.2807); Rural Access to Hospice Act (H.R.2594/S.1190); COVID-19 Hospice Respite Care Relief Act of 2020 (S.4423/H.R.8322); CONNECT Act (S. 2741/H.R. 4932); Palliative Care and Hospice Education and Training Act (H.R.647/S.2080); Provider Training in Palliative Care Act (S. 1921); Strengthening Innovation in Medicare and Medicaid Act (H.R.5741); Eliminating the Provider Relief Fund Tax Penalties Act of 2020 (H.R.7819); National Hospice and Palliative Care Month Proclamation Request and Senate Resolution

Client expense: $240,000 · Firm income: Not reported

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

Issues concerning the Medicare Hospice Benefit and children's hospice issues. Issues concerning hospice payment and alternative payment models. Issues related to advanced care illness management. Issues involving inpatient respite care, bereavement funding, palliative care and a community-based palliative care demonstration. Issues related to COVID-19 emergency funding, extension of the public health emergency, testing, vaccines, and COVID-19 related legislation. Issues concerning hospice sequestration relief. Issues related to telehealth flexibilities and regulatory flexibilities granted under the public health emergency. Issues involving hospice providers and tax treatment and reporting requirements of the CARES Act Public Health and Social Services Emergency Fund. Issues concerning hospice program integrity. Issues concerning Medicare Advantage Value-Based Insurance Design. Issues pertaining to the hospice election statement and election statement addendum. Consolidated Appropriations Act, 2021 (H.R.133); ChiPACC Act of 2020 (H.R.9002); Medicare Sequester COVID Moratorium Act (H.R.8840); Compassionate Care Act (S.4945); HOSPICE Act (H.R. 5821); Hospice Care Improvement Act of 2019 (S.2807); Rural Access to Hospice Act (H.R.2594/S.1190); COVID-19 Hospice Respite Care Relief Act of 2020 (S.4423/H.R.8322); CONNECT Act (S. 2741/H.R. 4932); Palliative Care and Hospice Education and Training Act (H.R.647/S.2080); Provider Training in Palliative Care Act (S. 1921); Strengthening Innovation in Medicare and Medicaid Act (H.R.5741); Eliminating the Provider Relief Fund Tax Penalties Act of 2020 (H.R.7819); National Hospice and Palliative Care Month Proclamation Request and Senate Resolution

Client expense: $240,000 · Firm income: Not reported

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

Issues related to the Center for Medicare and Medicaid Innovation; H.R. 5741.

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

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 ---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

H.R. 133 - Consolidated Appropriations Act, 2021 H.R. 4100, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act H.R. 6 - SUPPORT for Patients and Communities Act H.R. 6788, Healthcare Workforce Resilience Act S.3599, Healthcare Workforce Resilience Act H.R. 6810, Health Care Protection Act H.R. 9035, the Permanency for Audio-Only Telehealth Act S.1712, DISARM Act S.3384, Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 S. 4421, Temporary Reciprocity to Ensure Access to Treatment Act S. 4456, the Patient Matching Improvement Act of 2020

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 133 - Consolidated Appropriations Act, 2021 H.R. 4100, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act H.R. 6 - SUPPORT for Patients and Communities Act H.R. 6788, Healthcare Workforce Resilience Act S.3599, Healthcare Workforce Resilience Act H.R. 6810, Health Care Protection Act H.R. 9035, the Permanency for Audio-Only Telehealth Act S.1712, DISARM Act S.3384, Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 S. 4421, Temporary Reciprocity to Ensure Access to Treatment Act S. 4456, the Patient Matching Improvement Act of 2020

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Promoting awareness of the biopharmaceutical and medical technology sectors. Opposing the imposition of price controls in the Medicare Part D program. Generally supporting intellectual property rights. Supporting changes to Medicare Part D's coverage gap liability assignment and out-of-pocket cliff. Supporting changes to the America Invents Act to prevent double jeopardy of patent challenges under the inter partes review process. Supporting the Hatch Waxman Integrity Act (HR 990, S344). Opposing the Medicare Negotiations and Competitive Pricing Act (HR 1046). Generally supporting the proposed CMS Safe Harbor rule. Opposing H.R. 3 legislation regarding health care costs Opposing the FDA's Proposed Rule regarding the importation of prescription drugs (Docket No. FDA-2019-N-5711) Supporting H.R. 5741, the "Strengthening Innovation in Medicare and Medicaid Act Supporting the CMS Notice of Benefit and Payment Parameters (NBPP) Proposed Rule (CMS-9944-P) Opposing a proposed White House Executive Order concerning the Buy America Act Opposing various legislative efforts to relocate supply and logistics chains Opposing various legislative and executive efforts to impose an international price index Supporting the SMART Act (S. 3752 and H.R. 6954) Supporting the DISARM Act (S. 1712 and H.R. 4100)

Client expense: $40,847 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R 856 - Physicians Pro Bono Care Act - charitable deduction for pro-bono health services H.R. 3796 - Health Savings for Seniors Act - This bill permits a Medicare beneficiary to participate in and contribute to health savings accounts. S. 1227 - Prescription Pricing for the People Act of 2019 - Thisbill requiresthe Federal Trade Commission (FTC) to report about anticompetitive practicesand other trendswithin the pharmaceuticalsupply chain that may impact the cost of prescriptionsdrugs. H.R. 5198 - Patients' Right to Know Their Medication Act of 2019 - Creates FDA approved standard method of sharing consumer information. S. 2441 - Health Savings Account Expansion Act of 2019 - Thisbill permitsindividualswho are not enrolled in a high deductible health plan to participate in healthsavingsaccounts. S. 2440 - Qualified Health Savings Account Distribution Act of 2019 - This bill amends the Internal Revenue Code, with respect to the requirements for tax-preferred health accounts, to modify the rules for using a conversion or termination of a flexible spending account or a health reimbursement arrangement to establish a health savings account. H.R. 603 - Health Savings Account Expansion Act of 2019 - This bill modifies the requirements for health savings accounts (HSAs) to: increase the maximum contribution amounts, permit the use of HSAs to pay health insurance premiums and for direct primary care service arrangements, repeal the restriction on using HSAs for over-the-counter medications, eliminate the requirement that a participant in an HSA be enrolled in a high deductible health care plan, and decrease the additional tax for HSA distributions not used for qualified medical expenses. H.R. 5596, S. 3112 - Personalized Care Act of 2020 - This bill revises provisions relating to health savings accounts (HSAs) H.R. 5566 - Patient Fairness Act of 2020 - This bill revises requirements for health savings accounts (HSAs) H.R. 5076 - Protecting Seniors Through Immunization Act of 2019 - Seeks to eliminate out-of-pocket expenses for everyone covered by Medicare and spares seniors the decision to delay or not seek vaccines due to their share of the cost. S. 3537 - Protecting Our Pharmaceutical Supply Chain from China Act of 2020 - Requires Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States. S. 3432 - Securing America's Medicine Cabinet Act of 2020 - This bipartisan legislation would reduce American reliance on foreign manufacturing of active pharmaceutical ingredients (APIs). H.R. 6286 - Health Savings Act of 2020 - This bill revises requirements for health savings accounts (HSAs) H.R. 6336 - Increasing Hospital Capacity to Fight the Coronavirus Act of 2020 - This bill allows unapproved capital expenses that are made by health care facilities during the public health emergency declared on January 31, 2020, relating to COVID-19 (i.e., coronavirus disease 2019) to be included in federal payment determinations under Medicare and Medicaid. H.R. 3502 - Protecting People From Surprise Medical Bills Act - This bill makes a series of changes relating to health care costs and billing practices. S. 2543 - Prescription Drug Pricing Reduction Act of 2019 - Seeks to lower drug costs by establishing rebate programs for brandname drugs and biologics used for Part B and Part D with prices that increase faster than the rate of inflation. H.R.6663 - Truth in Healthcare Marketing - Strives to reduce confusion over professional licensure, education level, training, degrees obtained, and clinical expertise and makes it unlawful for providers to misrepresent these credentials. H.R. 6813, S. 3703 - Promoting Alzheimer's Awareness to Prevent Elder Abuse Act - Works toward providing this protection by requiring the development of training materials for anyone who responds, investigates, or prosecutes cases of elder abuse involving seniors afflicted with dementias H.R. 7233, S. 4216 - Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act - The expansion of telehealth would provide a convenient, cost-effective tool that complements traditional in-office medical visits. S. 4106 - Healthcare PRICE Transparency Act - Codifies two healthcare price transparency rules requiring hospitals and insurers to disclose their discounted cash rates and negotiated rates to consumers before they receive medical care. S. 3993 - Equal Access to Care Act - Expands access to telemedicine during the coronavirus emergency by allowing licensed health care providers to treat patients over the phone and online wherever the patient is located. H.R. 6930 - Manufacturing API, Drugs, and Excipients (MADE) in America Act - Addresses our drug supply chains dependence on foreign countries like China and works to mitigate drug shortages while incentivizing the domestic manufacturing of drugs, active pharmaceutical ingredients (API), personal protective equipment (PPE), and diagnostics. S. 4134 - Increasing Access to Biosimilars Act - TheIncreasing Access to Biosimilars Actwould direct the Department of Health and Human Services to create a shared savings demonstration program for biosimilar drugs in the Medicare program, which will help increase competition and expand access to biosimilars. H.R. 7008 - Family Savings Flexibility Act - This bill (1) increases to $2,750 the maximum amount of unused benefits or contributions remaining in a health flexible or dependent care spending arrangement that may be carried over from the 2020 to the 2021 plan year, (2) increases the maximum contribution amount for health savings accounts, and (3) increases the exclusion from employee gross income of employer-paid dependent care assistance. S. 3872 - Promising Pathway Act - Requires the US Food and Drug Administration to establish a rolling, real-time, priority review pathway to evaluate provisional approval applications for drugs intended to treat, prevent, or diagnose serious or life-threatening diseases or conditions, including those that pose a threat of epidemic or pandemic. S. 4185 - End Surprise Medical Bills for Air Ambulances Act of 2020 - A bill to establish an independent dispute resolution process for surprise air ambulance bills, and for other purposes. S. 4198 - Affordable Coronavirus Testing Act - This bill requires health insurance plans to cover through 2021 without cost sharing COVID-19 (i.e., coronavirus disease 2019) serology testing, which looks for the presence of antibodies made in response to an infection. S. 4158 - PPE Supply Chain Transparency Act of 2020 - This bill requires the Federal Emergency Management Agency (FEMA) to issue, within 90 days, a public report on the security and resilience of the supply chain for personal protective equipment during the COVID-19 (i.e., coronavirus disease 2019) pandemic. S. 4151 & H.R. 4838 - The Sustaining Outpatient Services (SOS) Act - Prevents certain off-campus hospital outpatient services from receiving significant Medicare reimbursement cuts. S. 4367 and H.R. 8032 - Health Savings Accounts for All Act - Qualified medical expenses would include expenses incurred during the prior or current tax year before establishing the HSA and fees paid for personal patient care. H.R.5741 - Strengthening Innovation in Medicare and Medicaid Act - Recognizes the important work done by CMMI and incorporates protections into the processes including, limiting the scope of models to only the size needed to realize a statistically valid sample; encouraging feedback from beneficiaries in developing CMMI models; and limiting the testing of new payment and delivery models to five years to shield beneficiaries from being subjected to potentially harmful models. H.R. 5741 also provides for key Congressional oversight for CMMI demonstrations that will improve transparency and patient safety.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Bundled Payments for Care Improvement (BPCI) Initiative. H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act. Labor/HHS/Education Appropriations, FY2021, provisions on Bundled Payments for Care Improvement initiative. Medicare Advantage Health Risk Evaluation. COVID-19 relief.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and policies related to: Physician/nurse practitioner reimbursement Provisions of the Patient Protection & Affordable Care Act (P.L. 111-148) Implementation of the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 (P.L. 114-10) including policies related to the Quality Payment Program Adoption of recommendations of the Institute of Medicine report, The Future of Nursing: Leading Change, Advancing Health Medicare Shared Savings Program beneficiary assignment requirements Medicare-Medicaid hospital conditions of participation Evaluation of the Medicare Graduate Nurse Education demonstration Medicare-Medicaid Program Integrity policies Medicaid maintenance of effort requirements Medicaid eligibility expansion and state options Medicaid waiver application procedures Medicaid per capita cap policy options Promoting Access to Diabetic Shoes Act (H.R. 808/S. 237) ACO Assignment Improvement Act of 2019 (H.R. 900) Medicare for All Act of 2019 (H.R. 1384) Protecting Patients Transportation to Care Act (H.R. 3935/S. 2846) Strengthening Innovation in Medicare and Medicaid Act (H.R. 5741) Home Health Care Planning Improvement Act of 2019 (S. 296/H.R. 2150) Childrens Health Insurance Program Pandemic Enhancement and Relief (CHIPPER) Act (S. 3881/H.R. 6797)

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

Importation of Prescription Drugs Proposed Rule, Docket No. FDA-2019-N-5711 S. 3546/H.R. 6338, the Pandemic Healthcare Access Act H.R. 5741, the Strengthening Innovation in Medicare and Medicaid Act H.R. 748, the CARES Act H.R.3, the Elijah E. Cummings Lower Drug Costs Now Act Issues related to Buy American Pharmacetucial mandates Issues related to Medicare Part D Pandemic Healthcare Access Act, S. 3546, H.R. 6338 Proposed International Pricing Index (IPI) for drugs administered under Medicare Part B S. 1895, the Lower Healthcare Costs Act S. 2543, the Prescription Drug Pricing Reduction Act S. 3129, the Lower Costs, More Cures Act H.R. 2500, the National Defense Authorization Act S. 3769, the Right to Test Act H.R. 7242, Legislation to amend the Internal Revenue Code of 1986 to permit expenditures from health savings accounts for gym memberships and costs of home gym H.R. 6800, The Heroes 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.7537, the Infectious Disease Therapies Research and Innovation Act 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 Transparency in Coverage Proposed Rule (CMS- 9915 -P)

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

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Energy Regulatory Commission (FERC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare Reimbursement. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response to the outbreak. CARES Act and other legislation related to the policies in reaction to the national health crisis. H.R. 7010, The Paycheck Protection Program Flexibility Act. House Draft, Department of Defense Appropriations Act, FY 2021. Senate Draft, Department of Defense Appropriations Act, FY 2021. H.R. 3, Lower Drug Costs Now Act of 2019. Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.R. 1158, FY2020 Consolidated Appropriations Act (Defense, CJS, FSGG, Homeland Security). H.R. 1554, REDI Act. H.R. 2087, To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes. H.R. 2279, Safe Step Act. H.R. 2693, To amend title XVIII of the Social Security Act to improve access to, and utilization of, bone mass measurement benefits under part B of the Medicare program by establishing a minimum payment amount under such part for bone mass measurement. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019. H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019. H.R. 4378, FY2020 Continuing Appropriations Resolution (P.L. 116-59). S. 64, Preserve Access to Affordable Generics and Biosimilars Act. S. 283, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019. S. 1391, Fair Accountability and Innovative Research Drug Pricing Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 2546, Safe Step Act. H.R. 1763, Resident Physician Shortage Reduction Act. S. 348, Resident Physician Shortage Reduction Act. H.R. 6788, Workforce Resilience Act. S. 3599, Workforce Resilience Act. H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act. H.R.8505, To amend title XVIII of the Social Security Act to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule, and for other purposes H.R. 6644/S. 3741, Health Care at Home Act H.R. 4932/S. 2741, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare Reimbursement. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response to the outbreak. CARES Act and other legislation related to the policies in reaction to the national health crisis. H.R. 7010, The Paycheck Protection Program Flexibility Act. House Draft, Department of Defense Appropriations Act, FY 2021. Senate Draft, Department of Defense Appropriations Act, FY 2021. H.R. 3, Lower Drug Costs Now Act of 2019. Monitor implementation of the Patient Protection and Affordable Care Act (P.L. 111-148). Monitor implementation of Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10). Monitor implementation of 21st Century Cures Act (P.L. 114-255). H.R. 1158, FY2020 Consolidated Appropriations Act (Defense, CJS, FSGG, Homeland Security). H.R. 1554, REDI Act. H.R. 2087, To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under the Medicare program, and for other purposes. H.R. 2279, Safe Step Act. H.R. 2693, To amend title XVIII of the Social Security Act to improve access to, and utilization of, bone mass measurement benefits under part B of the Medicare program by establishing a minimum payment amount under such part for bone mass measurement. H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019. H.R. 3107, Improving Seniors' Timely Access to Care Act of 2019. H.R. 4378, FY2020 Continuing Appropriations Resolution (P.L. 116-59). S. 64, Preserve Access to Affordable Generics and Biosimilars Act. S. 283, Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2019. S. 1391, Fair Accountability and Innovative Research Drug Pricing Act of 2019. S. 2543, Prescription Drug Pricing Reduction Act of 2019. S. 2546, Safe Step Act. H.R. 1763, Resident Physician Shortage Reduction Act. S. 348, Resident Physician Shortage Reduction Act. H.R. 6788, Workforce Resilience Act. S. 3599, Workforce Resilience Act. H.R. 5741, Strengthening Innovation in Medicare and Medicaid Act. H.R.8505, To amend title XVIII of the Social Security Act to provide for a one-year waiver of budget neutrality adjustments under the Medicare physician fee schedule, and for other purposes H.R. 6644/S. 3741, Health Care at Home Act H.R. 4932/S. 2741, The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act

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

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