Medicare Negotiation and Competitive Licensing Act of 2019

Engagement with lawmakers about how China engages in unfair trade and investment practices, preventing U.S. equipment manufacturers from competing on a level playing field and hurting U.S. workers. H.R.3975 - Generalized System of Preferences and Miscellaneous Tariff Bill Modernization Act of 2021, Section 30002, Limitation on Duty Suspensions of Reductions for Finished Goods. Foreign market access issues impacting U.S. manufacturing. Executive Order on Critical Supply Chains. Tariffs levied on goods under Section 301 of the Trade Act of 1974 (P.L.93-618). Reintroduction of legislation from the 116th Congress entitled the Bicameral Congressional Trade Authority Act to restore. Section 232 of the Trade Expansion Act of 1962 (P.L.87-794). H.R.826 - Supply Chain Security and Resilience Act. S.153 - Fair Trade with China Enforcement Act. S.377 - Domestic Reinvestment Act of 2023. S.805 - Fighting Trade Cheats Act of 2023. Congressional authority over tariffs enacted under section 232 of the Trade Expansion Act of 1962 (P.L.87-794). Mechanism for capturing paid tariffs enacted under Section 232 of the Trade Expansion Act of 1962 (P.L.87-794) and redirecting them for the purpose of investments in domestic manufacturing capacity. H.R.5188 - Congressional Trade Authority Act of 2023. H.R.6571 - To establish a critical supply chain resiliency and crisis response program in the Department of Commerce, and to secure American leadership in deploying emerging technologies, and for other purposes. MAC Protocol international commercial treaty.

Client expense: $640,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Export-Import Bank of the United States (EXIM Bank), HOUSE OF REPRESENTATIVES, Intl Trade Administration (ITA), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

Engagement with lawmakers about how China engages in unfair trade and investment practices, preventing U.S. equipment manufacturers from competing on a level playing field and hurting U.S. workers. H.R.3975 - Generalized System of Preferences and Miscellaneous Tariff Bill Modernization Act of 2021, Section 30002, Limitation on Duty Suspensions of Reductions for Finished Goods. Foreign market access issues impacting U.S. manufacturing. Executive Order on Critical Supply Chains. Tariffs levied on goods under Section 301 of the Trade Act of 1974 (P.L.93-618). Reintroduction of legislation from the 116th Congress entitled the Bicameral Congressional Trade Authority Act to restore. MAC Protocol to the Cape Town Convention on Mobile Assets Section 232 of the Trade Expansion Act of 1962 (P.L.87-794). H.R.826 - Supply Chain Security and Resilience Act. S.153 - Fair Trade with China Enforcement Act. S.377 - Domestic Reinvestment Act of 2023. S.805 - Fighting Trade Cheats Act of 2023. Congressional authority over tariffs enacted under section 232 of the Trade Expansion Act of 1962 (P.L.87-794). Mechanism for capturing paid tariffs enacted under Section 232 of the Trade Expansion Act of 1962 (P.L.87-794) and redirecting them for the purpose of investments in domestic manufacturing capacity. H.R.5188 - Congressional Trade Authority Act of 2023. H.R.6571 - To establish a critical supply chain resiliency and crisis response program in the Department of Commerce, and to secure American leadership in deploying emerging technologies, and for other purposes.

Client expense: $810,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Export-Import Bank of the United States (EXIM Bank), HOUSE OF REPRESENTATIVES, Intl Trade Administration (ITA), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

Engagement with lawmakers about how China engages in unfair trade and investment practices, preventing U.S. equipment manufacturers from competing on a level playing field and hurting U.S. workers. H.R.3975 - Generalized System of Preferences and Miscellaneous Tariff Bill Modernization Act of 2021, Section 30002, Limitation on Duty Suspensions of Reductions for Finished Goods. Foreign market access issues impacting U.S. manufacturing. Executive Order on Critical Supply Chains. Tariffs levied on goods under Section 301 of the Trade Act of 1974 (P.L.93-618). Reintroduction of legislation from the 116th Congress entitled the Bicameral Congressional Trade Authority Act to restore. MAC Protocol to the Cape Town Convention on Mobile Assets Section 232 of the Trade Expansion Act of 1962 (P.L.87-794). H.R.826 - Supply Chain Security and Resilience Act. S.153 - Fair Trade with China Enforcement Act. S.377 - Domestic Reinvestment Act of 2023. S.805 - Fighting Trade Cheats Act of 2023. Congressional authority over tariffs enacted under section 232 of the Trade Expansion Act of 1962 (P.L.87-794). Mechanism for capturing paid tariffs enacted under Section 232 of the Trade Expansion Act of 1962 (P.L.87-794) and redirecting them for the purpose of investments in domestic manufacturing capacity. H.R.5188 - Congressional Trade Authority Act of 2023. H.R.6571 - To establish a critical supply chain resiliency and crisis response program in the Department of Commerce, and to secure American leadership in deploying emerging technologies, and for other purposes.

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

Government targets: Commerce, Dept of (DOC), Export-Import Bank of the United States (EXIM Bank), HOUSE OF REPRESENTATIVES, Intl Trade Administration (ITA), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

Engagement with lawmakers about how China engages in unfair trade and investment practices, preventing U.S. equipment manufacturers from competing on a level playing field and hurting U.S. workers. H.R.3975 - Generalized System of Preferences and Miscellaneous Tariff Bill Modernization Act of 2021, Section 30002, Limitation on Duty Suspensions of Reductions for Finished Goods. Foreign market access issues impacting U.S. manufacturing. Executive Order on Critical Supply Chains. Tariffs levied on goods under Section 301 of the Trade Act of 1974 (P.L.93-618). Reintroduction of legislation from the 116th Congress entitled the Bicameral Congressional Trade Authority Act to restore. MAC Protocol to the Cape Town Convention on Mobile Assets Section 232 of the Trade Expansion Act of 1962 (P.L.87-794). H.R.826 - Supply Chain Security and Resilience Act. S.153 - Fair Trade with China Enforcement Act. S.377 - Domestic Reinvestment Act of 2023. S.805 - Fighting Trade Cheats Act of 2023. Congressional authority over tariffs enacted under section 232 of the Trade Expansion Act of 1962 (P.L.87-794). Mechanism for capturing paid tariffs enacted under Section 232 of the Trade Expansion Act of 1962 (P.L.87-794) and redirecting them for the purpose of investments in domestic manufacturing capacity. H.R.5188 - Congressional Trade Authority Act of 2023. H.R.6571 - To establish a critical supply chain resiliency and crisis response program in the Department of Commerce, and to secure American leadership in deploying emerging technologies, and for other purposes.

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

Government targets: Commerce, Dept of (DOC), Export-Import Bank of the United States (EXIM Bank), HOUSE OF REPRESENTATIVES, Intl Trade Administration (ITA), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

H.R.3975 - Generalized System of Preferences and Miscellaneous Tariff Bill Modernization Act of 2021, Section 30002, Limitation on Duty Suspensions of Reductions for Finished Goods. Foreign market access issues impacting U.S. manufacturing. Executive Order on Critical Supply Chains. Tariffs levied on goods from China under Section 301 of the Trade Act of 1974 (P.L.93-618). Reintroduction of legislation from the 116th Congress entitled the Bicameral Congressional Trade Authority Act to restore. MAC Protocol to the Cape Town Convention on Mobile Assets Section 232 of the Trade Expansion Act of 1962 (P.L.87-794). H.R.826 - Supply Chain Security and Resilience Act. S.153 - Fair Trade with China Enforcement Act. S.377 - Domestic Reinvestment Act of 2023. S.805 - Fighting Trade Cheats Act of 2023. Congressional authority over tariffs enacted under section 232 of the Trade Expansion Act of 1962 (P.L.87-794). Mechanism for capturing paid tariffs enacted under Section 232 of the Trade Expansion Act of 1962 (P.L.87-794) and redirecting them for the purpose of investments in domestic manufacturing capacity. H.R.5188 - Congressional Trade Authority Act of 2023. H.R.6571 - To establish a critical supply chain resiliency and crisis response program in the Department of Commerce, and to secure American leadership in deploying emerging technologies, and for other purposes.

Client expense: $990,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Export-Import Bank of the United States (EXIM Bank), HOUSE OF REPRESENTATIVES, Intl Trade Administration (ITA), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

H.R.3975 - Generalized System of Preferences and Miscellaneous Tariff Bill Modernization Act of 2021, Section 30002, Limitation on Duty Suspensions of Reductions for Finished Goods. Foreign market access issues impacting U.S. manufacturing. Executive Order on Critical Supply Chains. Tariffs levied on goods from China under Section 301 of the Trade Act of 1974 (P.L.93-618). Reintroduction of legislation from the 116th Congress entitled the Bicameral Congressional Trade Authority Act to restore. MAC Protocol to the Cape Town Convention on Mobile Assets Section 232 of the Trade Expansion Act of 1962 (P.L.87-794). H.R.826 - Supply Chain Security and Resilience Act. S.153 - Fair Trade with China Enforcement Act. S.377 - Domestic Reinvestment Act of 2023. S.805 - Fighting Trade Cheats Act of 2023. Congressional authority over tariffs enacted under section 232 of the Trade Expansion Act of 1962 (P.L.87-794). Mechanism for capturing paid tariffs enacted under Section 232 of the Trade Expansion Act of 1962 (P.L.87-794) and redirecting them for the purpose of investments in domestic manufacturing capacity. H.R.5188 - Congressional Trade Authority Act of 2023. H.R.6571 - To establish a critical supply chain resiliency and crisis response program in the Department of Commerce, and to secure American leadership in deploying emerging technologies, and for other purposes.

Client expense: $990,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Export-Import Bank of the United States (EXIM Bank), HOUSE OF REPRESENTATIVES, Intl Trade Administration (ITA), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

H.R.3975 - Generalized System of Preferences and Miscellaneous Tariff Bill Modernization Act of 2021, Section 30002, Limitation on Duty Suspensions of Reductions for Finished Goods. Foreign market access issues impacting U.S. manufacturing. Executive Order on Critical Supply Chains. Tariffs levied on goods from China under Section 301 of the Trade Act of 1974 (P.L.93-618). Reintroduction of legislation from the 116th Congress entitled the Bicameral Congressional Trade Authority Act to restore. MAC Protocol to the Cape Town Convention on Mobile Assets Section 232 of the Trade Expansion Act of 1962 (P.L.87-794). H.R.826 - Supply Chain Security and Resilience Act. S.153 - Fair Trade with China Enforcement Act. S.377 - Domestic Reinvestment Act of 2023. S.805 - Fighting Trade Cheats Act of 2023. Congressional authority over tariffs enacted under section 232 of the Trade Expansion Act of 1962 (P.L.87-794). Mechanism for capturing paid tariffs enacted under Section 232 of the Trade Expansion Act of 1962 (P.L.87-794) and redirectring them for the pupose of investments in domestic manufacturing capacity. H.R.5188 - Congressional Trade Authority Act of 2023.

Client expense: $280,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

H.R.3975 - Generalized System of Preferences and Miscellaneous Tariff Bill Modernization Act of 2021, Section 30002, Limitation on Duty Suspensions of Reductions for Finished Goods. Foreign market access issues impacting U.S. manufacturing. Executive Order on Critical Supply Chains. Tariffs levied on goods from China under Section 301 of the Trade Act of 1974 (P.L.93-618). Reintroduction of legislation from the 116th Congress entitled the Bicameral Congressional Trade Authority Act to restore. MAC Protocol to the Cape Town Convention on Mobile Assets Section 232 of the Trade Expansion Act of 1962 (P.L.87-794). H.R.826 - Supply Chain Security and Resilience Act. S.153 - Fair Trade with China Enforcement Act. S.377 - Domestic Reinvestment Act of 2023. S.805 - Fighting Trade Cheats Act of 2023. Congressional authority over tariffs enacted under section 232 of the Trade Expansion Act of 1962 (P.L.87-794).

Client expense: $430,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

H.R.3975 - Generalized System of Preferences and Miscellaneous Tariff Bill Modernization Act of 2021, Section 30002, Limitation on Duty Suspensions of Reductions for Finished Goods. Foreign market access issues impacting U.S. manufacturing. Executive Order on Critical Supply Chains. Tariffs levied on goods from China under Section 301 of the Trade Act of 1974 (P.L.93-618). Reintroduction of legislation from the 116th Congress entitled the Bicameral Congressional Trade Authority Act to restore. MAC Protocol to the Cape Town Convention on Mobile Assets Section 232 of the Trade Expansion Act of 1962 (P.L.87-794). H.R.826 - Supply Chain Security and Resilience Act. S.153 - Fair Trade with China Enforcement Act. S.377 - Domestic Reinvestment Act of 2023. S.805 - Fighting Trade Cheats Act of 2023. Congressional authority over tariffs enacted under section 232 of the Trade Expansion Act of 1962 (P.L.87-794).

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

340B drug pricing program, Resident Physician Shortage Reduction Act of 2019 (HR 1763, Living Donor Protection Act (H.R.1255/ S.377)

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

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

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. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies.

Client expense: $1,600,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies.

Client expense: $2,160,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies. Most Favored Nation (MFN) Model - (CMS-5528-IFC)

Client expense: $1,090,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

S. 3001 Toomey, regarding Medicare and Medicaid program extensions HR 4932, Thompson regarding telehealth in the Medicare program S. 2741 Schatz, regarding telehealth in the Medicare program HR 1839, the Medicaid Services Investment and Accountability Act HR 3253, The Empowering Beneficiaries, Ensuring Access and Strengthening Accountability Act (regarding Medicaid) HR 2131 and S. 1114, regarding the Medicare Advantage benchmark cap HR 3107, regarding the use of preauthorization in the Medicare Advantage program HR 3417 the Beneficiary Education Tools, Telehealth and Extenders Reauthorization Act (regarding Medicare) Legislation and regulation regarding the Medicare Advantage program HR 1839, regarding multiple Medicaid program changes, including the Medicaid Drug Rebate program. HR 1046 and S. 377, regarding Medicare Part D and requirements for HHS to negotiate drug prices HR 1781 Regarding MedPAC and MACPAC access to drug pricing and rebate data.

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

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

Lobbying is support of: H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 S.377 - Medicare Negotiation and Competitive Licensing Act of 2019

Client expense: Not reported · Firm income: $84,000

Government targets: AMTRAK - Natl Railroad Passenger Corporation, HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Mediation Board, Pension Benefit Guaranty Corporation (PBGC), SENATE, State, Dept of (DOS), Treasury, Dept of

Monitor legislative and administrative action related to Medicare and Medicaid policy. H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019. S. 377, Medicare Negotiation and Competitive Licensing Act of 2019.

Client expense: $1,370,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Bureau of Land Management (BLM), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

H.R. 803 / S. 988, Improving Transparency and Accuracy in Medicare Part D Drug Spending Act; H.R. 1034 / S. 640, Phair Pricing Act of 2019; H.R. 1035, Prescription Drug Price Transparency Act, S. 475, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act, S. 476, Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act; 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.448 / S. 99, Medicare Drug Price Negotiation Act; H.R. 275, Medicare Prescription Drug Price Negotiation Act of 2019; H.R. 1346, Medicare Buy-In and Health Care Stabilization Act of 2019; H.R. 366, Insulin Access for All Act of 2019; S. 62, Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019; S. 205 / H.R. 937, Right Rebate Act of 2019; H.R. 1046 / S. 377, Medicare Negotiation and Competitive Licensing Act of 2019; H.R. 1781 / S. 801, the Payment Commission Data Act of 2019; H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting (STAR) Act of 2019; H.R. 2115, To amend title XI of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers; Proposed rule, "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses, CMS-4180-P"; Proposed rule, "Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, OIG-0936-P"; Proposed rule, Medicaid Program; Medicaid and Childrens Health Insurance Plan (CHIP) Managed Care - CMS-2408-P; H.R. 1323, Rural Hospital Frontier Fairness Act; S. 551, REFUND Act of 2019; S. 691, Medicare Extra Rx HELP Act of 2019; S. 773, Telehealth Innovation and Improvement Act of 2019; S. 814, Expanding Access to Diabetes Self-Management Training Act of 2019; H.R. 1384 / S. 1129, Medicare for All Act of 2019; H.R. 3417, The Beneficiary Education Tools, Telehealth, and Extenders Reauthorization Act of 2019; H.R. 3408, Shop Rx Act of 2019; S. 1384, Prescription Drug Rebate Reform Act of 2019; H.R. 2113, Prescription Drug STAR Act; H.R. 2115, Public Disclosure of Drug Discounts Act S. 2447, the Phair Relief Act; S. 2771, the Protecting Home Oxygen and Medical Equipment Act of 2019; S. 1861 / H.R. 3924, the Streamlining Part D Appeals Process Act; H.R. 4946, the Ensuring Seniors Access to Local Pharmacies Act of 2019; H.R. 5281, the Drug Price Transparency in Medicaid Act of 2019; H.R. 5442, the Lowest Price for Patients Act; Report language for H.R.1865, the Further Consolidated Appropriations Act; Pharmacist Provider Status draft legislation

Client expense: $330,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

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

HR 7659 Re: ensuring parity for Audio Only Telehealth (Sewell) S. 3001 Toomey, regarding Medicare and Medicaid program extensions HR 4932, Thompson regarding telehealth in the Medicare program S. 2741 Schatz, regarding telehealth in the Medicare program HR 1839, the Medicaid Services Investment and Accountability Act HR 3253, The Empowering Beneficiaries, Ensuring Access and Strengthening Accountability Act (regarding Medicaid) HR 2131 and S. 1114, regarding the Medicare Advantage benchmark cap HR 3107, regarding the use of preauthorization in the Medicare Advantage program HR 3417 the Beneficiary Education Tools, Telehealth and Extenders Reauthorization Act (regarding Medicare) Legislation and regulation regarding the Medicare Advantage program HR 1839, regarding multiple Medicaid program changes, including the Medicaid Drug Rebate program. HR 1046 and S. 377, regarding Medicare Part D and requirements for HHS to negotiate drug prices HR 1781 Regarding MedPAC and MACPAC access to drug pricing and rebate data.

Client expense: $160,000 · Firm income: Not reported

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

CFIUS and Foreign Investment ---Implementation of Foreign Investment Risk Review Modernization Act (FIRRMA) of 2017 Digital Trade ---EU Digital Strategy Drug Importation ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---General Drug Pricing ---Executive Order on Lowering Drug Prices by Putting America First (Most Favored Nation, or MFN, EO) ---International Pricing Index Proposal ---Most Favored Nation (MFN) Model interim final rule (MFN Rule) Foreign Agricultural Biotechnology Laws and Regulations ---EU Ag-Biotech Policies and Regulations ---Korea Biotechnology Regulations ---Mexico Draft Decree Banning Genetically Modified Corn ---Mexico Import Approval Delays of Ag Biotech Genetically Engineered (GE) Animals ---International Consistency of Regulation for Gene Edited Products Genetically Engineered (GE) Plants ---International Consistency of Regulation for Gene Edited Products Intellectual Property International Enforcement ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. ---India The United States-Mexico-Canada Agreement (USMCA) ---Ag-Biotech Provisions ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---Ag-Biotech Provisions ---IP Provisions US-UK Trade Agreement ---Ag-Biotech Provisions ---IP Provisions ---Market Access World Health Organization (WHO) ---United States Withdrawal from the World Health Organization (WHO)

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

Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole ---State Attorney General Letter Compulsory licensing ---H.R.465/S.102: Prescription Drug Price Relief Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.2387: We Protect American Investment in Drugs Act of 2019 Diversity in Patenting ---S.4394: Inventor Diversity for Economic Advancement (IDEA) Act of 2020 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 Inter Partes Review Intellectual Property International Enforcement ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. ---India Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 ---Patent Litigation Reforms Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility 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

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

Drug Importation ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---General Genetically Engineered (GE) Animals ---FDA Proposed Guidance on Gene Editing ---GE Salmon language in Sec. 778 in H.R.133: Consolidated Appropriations Act for FY 2021 ---International Consistency of Regulation for Gene Edited Products ---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering Review and Labeling of Food Derived From Biotechnology ---Implementation of Disclosure Law

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

assist client with issues pertaining to medicare and medicaid. HR 6674 Medicare Crisis Program 2020; S3864 Medicare Mental Health Inpatient Equity Act of 2020; HR6811 WIC Act 2020; HR 4618 Medicare Hearing Act; S1114 Medicare Adv Quality Payment Relief Act; HR4665 Medicare Vision Act; HR913 Clinical Treatment Act 2019; HR1264 Payment Commission Data Act 2019; HR 1390 Mobile Health Record Act; HR1394 Medigap Consumer Protection 2019; HR1409 Transparency in all Healthcare Pricing Act 2019; HR1425 Patient Protection and Affordable Care Enhance Act; S.3 Keeping Insurance Affordable of 2019; S470 Medicaid at 50 Act; S773 Telelhealth Innovation and Improvement Act; S377 Medicare Negotiation and Competitive Licensing Act 2019; S618 Medicare Choices Empowerment and Protection Act;

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare; Medicaid; Health Coverage Tax Credit; Tax Cap on Health Care Plans; Protect Medicare and Medicaid benefits; Prescription drug reform; Medicare Negotiation and Competitive Licensing Act (H.R. 1046/S. 377); Priced Act (H.R. 3379); Surprise Billing; COVID-19 Health Care Worker Protection Act (H.R. 6139/S. 3475); HEALS Act; HEROES Act 2.0 (H.R.925); Worker Health Coverage Protection Act (S.4714); Alan Reinstein Ban Asbestos Now Act of 2019 (HR 1603); Asuncion Valdivia Heat Illness and Fatality Prevention Act of 2020 (S.4781); Consolidated Appropriations Act, 2021 (H.R. 133)

Client expense: $130,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Natl Highway Traffic Safety Administration (NHTSA), Natl Labor Relations Board (NLRB), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Customs & Border Protection, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), White House Office

assist client with issues pertaining to medicare and medicaid. HR6674 Medicare Crisis Program 2020; S3864 Medicare Mental Health Inpatient Equity Act of 2020; HR6811 WIC Act 2020; HR6445,S3563 Food Assistance for Kids and Families during COVID 2020.HR 6281, S3500 Medicare Wage Index Parity Act 2020; HR 4618 Medicare Hearing Act;HR913 Clinical Treatment Act 2019; HR1264 Payment Commission Data Act 2019; HR1390 Mobile Health Record Act; HR1394 Medigap Consumer Protection 2019; HR1409 Transparency in all Healthcare Pricing Act 2019; HR1425 Patient Protection & Affordable Care Act; S470 Medicaid at 50 Act; S773 Telehealth Innovation and Improvement Act; S377 Medicare Negotiation and Competitive Licensing Act 2019; S618 Medicare Choices Empowerment and Protection Act.; S1114 Medicare Adv Quality Payment Relief Act; H.R.2564 Medicare Enrollment Protection Act; H.R.275 Medicare Prescription Drug Price Negotiation Act of 2019;H.R.884 Medicare Mental Health Access Act; H.R.3127 Medicare Home Health Flexibility Act; H.R.1384 Medicare for All Act of 2019.

Client expense: Not reported · Firm income: $11,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies. Most Favored Nation (MFN) Model - (CMS-5528-IFC)

Client expense: $1,090,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

S.377/H.R.1046 Medicare Negotiation and Competitive Licensing Act (sections related to compulsory licensing) CARES ACT/Coronavirus Response and Relief Supplemental Appropriations Act, 2021/issues related to provider relief.

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

Government targets: HOUSE OF REPRESENTATIVES, Natl Institute of Standards & Technology (NIST), SENATE

Support of the National Institutes of Health in FY 21 appropriations bill, The Medicare Negotiation and Competitive Licensing Act (H.R. 1046 & S.377), issues related to rural health, regulatory burden relief, Medicare payment issues, graduate medical education, research policy issues, drug shortages, federal transplant policy, federal infrastructure and transportation and access to health care, issues related to the administrations policies on use of fetal tissue, issues related to non-human primate research, issues related to compulsory licenses/march in, H.R.3 - Elijah E. Cummings Lower Drug Costs Now Act, support of the Midwest Center of Excellence for Vector-Borne Diseases, support for increased access to maternal health care services, Medicaid coordination issues, issues related to the COVID-19 global pandemic, Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074), Families First Coronavirus Response Act (H.R. 6201), issues related to CARES Act implementation, issues related to HEROES Act (H.R. 6800), issues related to the impacts of COVID-19 on hospitals and need for financial relief U.S. supply chain issues, NIH funding regulatory relief, The TREAT Act (H.R. 8283 & S.4421), issues related to stem cell research, support for autism funding, issues related to Medicare telehealth

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

Government targets: Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE

Proposed International Pricing Index (IPI) payment model for drugs administered under Medicare Part B S. 377/H.R. 1046 (Medicare Negotiation and Competitive Licensing Act) Reform of drug manufacturer rebates to third parties (e.g., pharmaceutical benefits managers, insurers) Proposed binding arbitration for enacting government price controls under Medicare Part D Inflationary penalty as government price controls in Medicare Part D/S. 2543 (Prescription Drug Pricing Reduction Act) S. 1129/H.R. 1384 (Medicare for All Act) Single-payer health care Government price controls on health care products, services, providers, payers H.R. 3 (Elijah E. Cummings Lower Drug Costs Now Act) drug price controls through international reference pricing, direct federal price dictation, confiscatory penalty on the most innovative medicines Importation of Prescription Drugs Proposed Rule (Docket No. FDA-2019-N-5711) H.R. 1425 (Patient Protection and Affordable Care Enhancement Act) H.R. 6674 (Medicare Crisis Program Act) Proposed most favored nation government price controls for pharmaceuticals 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 (Docket No. CMS-2482-P) Interim Final Rule, Most Favored Nation (MFN) Model (Docket No. CMS-5528-IFC)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

S. 2082/H.R. 3666 (STRONGER Patents Act) Trade-related intellectual property policy/practices/encroachment by foreign countries/companies against U.S. competitiveness interests - China, Committee on Foreign Investment in the United States review of Chinese acquisitions and joint ventures, United States-Mexico-Canada Agreement IP chapter, International Trade Commission exclusion of U.S. patent-infringing imports, ITC baseband chip set patent infringement remedy, intellectual property exclusivity and protections in trade agreements Piracy of online and streaming copyrighted content Compulsory licensing - S. 377/H.R. 1046 (Medicare Negotiation and Competitive Licensing Act), S. 102/H.R. 465 (Prescription Drug Price Relief Act), S. 977 (Transparent Drug Pricing Act) NIST Return on Investment Initiative for Unleashing American Innovation S. 344/H.R. 990 (Hatch-Waxman Integrity Act) FTC/patent licensing as exclusive property right Bayh-Dole Act/technology transfer, misuse of march-in rights Procedural and evidentiary standards used at Patent Trial and Appeal Board PTO patentable subject matter eligibility guidance Section 101 patentable subject matter reform Injunctive relief from willful infringement DOJ-DOC withdrawal of 2013 Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments S. 1273/H.R. 2426 (Copyright Alternative in Small-Claims Enforcement (CASE) Act) S. 1416 (Affordable Prescriptions for Patients Act) Obviousness/No Combination Drug Patents Act H.R. 4398/H.R. 5133 (Affordable Prescriptions for Patients Through Promoting Competition Act) H.R. 3991 (Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act) H.R. 5478 (Inventor Rights Act) Patent licensing/standards-essential patents/U.S. technological leadership in 5G and other technologies/economic and national security implications DOJ-PTO-NIST 2019 revised Joint Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments Efficient infringement Digital Millennium Copyright Act modernization Patent Trial & Appeal Board Covered Business Methods program PTAB Rules of Practice for Instituting on All Challenged Patent Claims and All Grounds and Eliminating the Presumption at Institution Favoring Petitioner as to Testimonial Evidence (Docket No. PTO-P-2019-0024) S. 3630 (Facilitating Innovation to Fight Coronavirus Act) Denial of rights of exclusivity for COVID-19-related innovations H.R. 7366 (Restoring Americas Leadership in Innovation Act) S. 3835 (SCRIPT Act) Proposed policy requiring privately produced, privately funded, copyrighted, peer-reviewed journal articles be given away free upon publication if they discuss any underlying research supported by a government grant Patent Trial and Appeal Board Covered Business Methods program statutory expiration Appointments Clause and the constitutionality of AdministrativePatent Judges invalidation of patents Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board (RIN:0651-AD47) Discretion to Institute Trials Before the Patent Trial and Appeal Board (Docket No. PTO-C-2020-0055) H.R. 133 (Consolidated Appropriations Act FY 2021 provisions related to Patent & Trademark Office, CASE Act, and copyright infringement via streaming loophole reform)

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

Lobbying is support of: H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 S.377 - Medicare Negotiation and Competitive Licensing Act of 2019

Client expense: Not reported · Firm income: $84,000

Government targets: AMTRAK - Natl Railroad Passenger Corporation, HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Mediation Board, Pension Benefit Guaranty Corporation (PBGC), SENATE, State, Dept of (DOS), 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

S.377/H.R.1046 Medicare Negotiation and Competitive Licensing Act (sections related to compulsory licensing) CARES ACT (116-136) issues related to provider relief.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Natl Institute of Standards & Technology (NIST), SENATE

Monitor legislative and administrative action related to Medicare and Medicaid policy. H.R. 1046, Medicare Negotiation and Competitive Licensing Act of 2019. S. 377, Medicare Negotiation and Competitive Licensing Act of 2019.

Client expense: $1,430,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Bureau of Land Management (BLM), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

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)

Client expense: $1,190,000 · 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), White House Office

Medicare; Medicaid; Health Coverage Tax Credit; Tax Cap on Health Care Plans; Protect Medicare and Medicaid benefits; Prescription drug reform; Medicare Negotiation and Competitive Licensing Act (H.R. 1046/S. 377); Priced Act (H.R. 3379); Surprise Billing; COVID-19 Health Care Worker Protection Act (H.R. 6139/S. 3475); HEALS Act; HEROES Act 2.0 (H.R.925); Worker Health Coverage Protection Act (S.4714); Alan Reinstein Ban Asbestos Now Act of 2019 (HR 1603); Asuncion Valdivia Heat Illness and Fatality Prevention Act of 2020 (S.4781)

Client expense: $230,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Natl Highway Traffic Safety Administration (NHTSA), Natl Labor Relations Board (NLRB), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Customs & Border Protection, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), White House Office

assist client with issues pertaining to medicare and medicaid. HR 6674 Medicare Crisis Program 2020; S3864 Medicare Mental Health Inpatient Equity Act of 2020; HR6811 WIC Act 2020; HR 4618 Medicare Hearing Act; S1114 Medicare Adv Quality Payment Relief Act; HR4665 Medicare Vision Act; HR913 Clinical Treatment Act 2019; HR1264 Payment Commission Data Act 2019; HR 1390 Mobile Health Record Act; HR1394 Medigap Consumer Protection 2019; HR1409 Transparency in all Healthcare Pricing Act 2019; HR1425 Patient Protection and Affordable Care Enhance Act; S.3 Keeping Insurance Affordable of 2019; S470 Medicaid at 50 Act; S773 Telelhealth Innovation and Improvement Act; S377 Medicare Negotiation and Competitive Licensing Act 2019; S618 Medicare Choices Empowerment and Protection Act;

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

assist client with issues pertaining to medicare and medicaid. HR6674 Medicare Crisis Program 2020; S3864 Medicare Mental Health Inpatient Equity Act of 2020; HR6811 WIC Act 2020; HR6445,S3563 Food Assistance for Kids and Families during COVID 2020.HR 6281, S3500 Medicare Wage Index Parity Act 2020; HR 4618 Medicare Hearing Act;HR913 Clinical Treatment Act 2019; HR1264 Payment Commission Data Act 2019; HR1390 Mobile Health Record Act; HR1394 Medigap Consumer Protection 2019; HR1409 Transparency in all Healthcare Pricing Act 2019; HR1425 Patient Protection & Affordable Care Act; S470 Medicaid at 50 Act; S773 Telehealth Innovation and Improvement Act; S377 Medicare Negotiation and Competitive Licensing Act 2019; S618 Medicare Choices Empowerment and Protection Act.; S1114 Medicare Adv Quality Payment Relief Act; H.R.2564 Medicare Enrollment Protection Act; H.R.275 Medicare Prescription Drug Price Negotiation Act of 2019;H.R.884 Medicare Mental Health Access Act; H.R.3127 Medicare Home Health Flexibility Act; H.R.1384 Medicare for All Act of 2019.

Client expense: Not reported · Firm income: $11,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE