Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2019

H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) H.R. 2113 - The Prescription Drug STAR Act H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.551 - REFUND Act of 2019 S.1712/H.R.4100 - DISARM Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act H.R. 1319, American Rescue Plan Act of 2021 H.R. 2163/S. 464 - Safe Step Act S.4796, The Fair Care Act of 2020 S.2076/H.R. 3932 PASTEUR Act S.1773 - Prescription Drug Pricing Dashboard Act S. 773/H.R. 3203 - [No official title] Related to The 340B Drug Discount Program S. 658- ADAPT Act- Accelerated Drug Approval for Prescription Therapies H.R.5260 - Reduced Costs and Continued Cures Act H.R. 5376 - Build Back Better Act H.R. 3684- Infrastructure Investment and Jobs Act H.R. 5030/S. 2706 - DIVERSE Trials Act H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. -Issues related to healthcare legislation -Patient access to Part B medicines during the COVID-19 public health emergency -Issues related to health equity, diversity, and inclusion in clinical trials -Issues related to advanced development and procurement of medical countermeasures (MCMs) -Issues related to patient assistance and access -Issues relating to privacy and securing the data of and personal information of consumers -Issues relating to medical research data -Issues relating to screening and diagnostics

Client expense: $1,580,000 · Firm income: Not reported

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

H.R. 1550, PREVENT HPV Cancers Act of 2021 H.R. 1978, Protecting Seniors Through Immunization Act of 2021 H.R. 2061, Advancing Emergency Preparedness Through One Health Act of 2021 H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 3173, Improving Seniors Timely Access to Care Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act H.R. 5376, Build Back Better Act H.R. 5801, Help Ensure Lower Patient (HELP) Copays Act S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 2774, Pride in Patent Ownership Act S. 2891, Restoring the America Invents Act H.R. 3, (116th Congress) Lower Drug Costs Now Act of 2019 H.R. 19 (116th Congress) Lower Costs, More Cures Act of 2019 S. 2543 (116th Congress) Prescription Drug Pricing Reduction Act of 2019 H.R. 4100/S. 1712 (116th Congress) Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019. H.R. 8920/S. 4760, (116th Congress) The Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act of 2020 S. 1895 (116th Congress) Lower Health Care Costs Act Issues relating to, 340B program integrity; 340B of the Public Health Services Act; 340B policy; 340B issues; 340B drug pricing program; Drug pricing; Drug Pricing reforms - international reference prices and government price setting; Anti-microbial Resistance; Vaccines; HIV, PrEP provisions; COVID-19 vaccines; COVID-19 therapeutics coverage issues; COVID-19 FDA Emergency Use Authorization issues; Vaccines catch up; Vaccine provisions; Vaccine Issues, including access and pandemic-related policy; Package inserts and labeling issues; Executive Order 13937, Access to Affordable Life-Saving Medications; FY-2022 Budget and Appropriations Legislation; Intellectual property protection; WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; Animal Health; One Health Issues; Rural Broadband Issues; General pharmaceutical issues; Farm Bill 2023; Animal Drug User Fee Act 2023.

Client expense: $1,500,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) H.R. 2113 - The Prescription Drug STAR Act H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.551 - REFUND Act of 2019 S.1712/H.R.4100 - DISARM Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act H.R. 1319, American Rescue Plan Act of 2021 H.R. 2163/S. 464 - Safe Step Act S.4796, The Fair Care Act of 2020 S.2076/H.R. 3932 PASTEUR Act S.1773 - Prescription Drug Pricing Dashboard Act S. 773/H.R. 3203 - [No official title] Related to The 340B Drug Discount Program S. 658- ADAPT Act- Accelerated Drug Approval for Prescription Therapies H.R.5260 - Reduced Costs and Continued Cures Act H.R. 5376 - Build Back Better Act - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues related to health equity, diversity, and inclusion in clinical trials - Issues related to advanced development and procurement of medical countermeasures (MCMs) - Issues related to patient assistance and access - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data - Issues relating to screening and diagnostics

Client expense: $2,670,000 · Firm income: Not reported

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

H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs H.R. 550: Immunization Infrastructure Modernization Act H.R.3684 - Infrastructure Investment and Jobs Act - provisions related to vial size wastage policy H.R.5260 - Reduced Costs and Continued Cures Act H.R. 7614: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021 H.R. 7616: Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and Human Services, Education, Transportation, Housing, and Urban Development Appropriations Act, 2021 H.R. 4100/S. 1712: DISARM Act of 2019 a Provisions related to antimicrobial drug development H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 Provisions related to prescription drug pricing and access H.R. 1227: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference H.R. 2010: Public Option Deficit Reduction Act - Provisions related to Part D and non-interference H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference H.R. 5260: Reduced Costs and Continued Cures Act - Provisions related to prescription drug pricing and access H.R. 5463: Drug Pricing Transparency and Accountability Act - To increase reporting requirements and transparency requirements in the 340B Drug Pricing Program, and for other purposes S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference S. 833: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Provisions related to Part D and non-interference S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference S. 983: CHOICE Act - Provisions related to Part D and non-interference S. 1619/H.R. 2862: VACCINES Act S. 1872/H.R. 5075: Protecting Seniors Through Immunization Act S. 2304: Strategies To Address Antibiotic Resistance Act a Provisions related to antimicrobial resistance (AMR) and other issues S. 4320: Coronavirus Response Additional Supplemental Appropriations Act, 2020 S. 4760/H.R. 8920: PASTEUR Act (AMR) S. 4864/H.R. 8725: HAP Act; Medicaid financial barriers S. 1123: PING Act - Provisions related to Part D and non-interference S. 1287: REFUND Act of 2021 - Provisions related to Part B and vial sizes S. 1773: Prescription Drug Pricing Dashboard Act - Provisions related to Medicare, Medicaid and prescription drug pricing transparency S. 1898: Affordable Medications Act - Provisions related to prescription drug pricing, Part D, non-interference, Part B, and intellectual property S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues VA drug pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues 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 policy issues ___ Tenncare III 1115 Medicaid Demonstration - regarding closed formulary Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations Final 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

Client expense: $1,200,000 · Firm income: Not reported

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

H.R. 1319, American Rescue Plan Act of 2021, medical provisions H.R. 1550, PREVENT HPV Cancers Act of 2021 H.R. 1978, Protecting Seniors Through Immunization Act of 2021 H.R. 2061, Advancing Emergency Preparedness Through One Health Act of 2021 H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 3173, Improving Seniors Timely Access to Care Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act H.R. 5376, Build Back Better Act S. 1435, Affordable Prescriptions for Patients Act of 2021 H.R. 3, (116th Congress) Lower Drug Costs Now Act of 2019 H.R. 19 (116th Congress) Lower Costs, More Cures Act of 2019 S. 2543 (116th Congress) Prescription Drug Pricing Reduction Act of 2019 H.R. 4100/S. 1712 (116th Congress) Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019. H.R. 8920/S. 4760, (116th Congress) The Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act of 2020 S. 1895 (116th Congress) Lower Health Care Costs Act Issues relating to, 340B program integrity; 340B of the Public Health Services Act; 340B policy; 340B issues; 340B drug pricing program; Drug pricing; Drug Pricing reforms - international reference prices and government price setting; Anti-microbial Resistance; Vaccines; HIV, PrEP provisions; COVID-19 vaccines; COVID-19 therapeutics coverage issues; Vaccines catch up; Vaccine provisions; Vaccine Issues, including access and pandemic-related policy; Package inserts and labeling issues; Executive Order 13937, Access to Affordable Life-Saving Medications; FY-2022 Budget and Appropriations Legislation; Intellectual property protection; WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; Animal Health; One Health Issues; Rural Broadband Issues.

Client expense: $1,700,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R.19, Lower Costs, More Cures Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S.3129 - Lower Costs, More Cures Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019 S.551 - REFUND Act of 2019 S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 S.1712/H.R.4100 - DISARM Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act H.R. 1319 , American Rescue Plan Act of 2021 H.R. xx - Safe Step Act (no bill number yet) S.4796, The Fair Care Act of 2020 H.R.1966/S.946 - Henrietta Lacks Enhancing Cancer Research Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021, 116th Congress (2019-2020) S. 4626, SAFE DATA Act S. 3456, Consumer Data Privacy and Security Act H.R. 2013, Information Transparency & Personal Data Control Act S. 2968, Consumer Online Privacy Rights Act - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues related to diversity in clinical trials - Issues related to advanced development and procurement of medical countermeasures (MCMs) - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data

Client expense: $3,175,000 · Firm income: Not reported

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

H.R. 708: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS H.R. 1319: AMERICAN RESCUE PLAN ACT OF 2021; PROVISIONS RELATED PAID FAMILY AND MEDICAL LEAVE, PERSONAL PROTECTIVE EQUIPMENT, AND ACCESS TO MEDICINE, NUTRITION ASSISTANCE PROGRAMS, AND ANTIMICROBIAL RESEARCH H.R. 4100 (116TH CONGRESS): DEVELOPING AN INNOVATIVE STRATEGY FOR ANTIMICROBIAL RESISTANT MICROORGANISMS (DISARM) ACT OF 2019; ALL PROVISIONS S. 168: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS S. 368: TELEHEALTH MODERNIZATION ACT; ALL PROVISIONS S. 1002: A BILL TO PROHIBIT FALSE OR MISLEADING ADVERTISING FOR HEALTH INSURANCE COVERAGE, REQUIRE WARNINGS AND REPORTING WITH RESPECT TO NONCOMPREHENSIVE HEALTH PLANS, ENCOURAGE ENROLLMENT IN HEALTH PLANS, AND FOR OTHER PURPOSES; ALL PROVISIONS S. 1556 (116TH CONGRESS): NO JUNK PLANS ACT; ALL PROVISIONS S. 1712 (116TH CONGRESS): DEVELOPING AN INNOVATIVE STRATEGY FOR ANTIMICROBIAL RESISTANT MICROORGANISMS (DISARM) ACT OF 2019; ALL PROVISIONS

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1319: AMERICAN RESCUE PLAN ACT OF 2021; PROVISIONS RELATED PAID FAMILY AND MEDICAL LEAVE, PERSONAL PROTECTIVE EQUIPMENT, AND ACCESS TO MEDICINE, NUTRITION ASSISTANCE PROGRAMS, AND ANTIMICROBIAL RESEARCH H.R. 4100 (116TH CONGRESS): DEVELOPING AN INNOVATIVE STRATEGY FOR ANTIMICROBIAL RESISTANT MICROORGANISMS (DISARM) ACT OF 2019; ALL PROVISIONS S. 1712 (116TH CONGRESS): DEVELOPING AN INNOVATIVE STRATEGY FOR ANTIMICROBIAL RESISTANT MICROORGANISMS (DISARM) ACT OF 2019; ALL PROVISIONS

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS H.R. 708: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS H.R. 1319: AMERICAN RESCUE PLAN ACT OF 2021; PROVISIONS RELATED PAID FAMILY AND MEDICAL LEAVE, PERSONAL PROTECTIVE EQUIPMENT, AND ACCESS TO MEDICINE, NUTRITION ASSISTANCE PROGRAMS, AND ANTIMICROBIAL RESEARCH H.R. 4100 (116TH CONGRESS): DEVELOPING AN INNOVATIVE STRATEGY FOR ANTIMICROBIAL RESISTANT MICROORGANISMS (DISARM) ACT OF 2019; ALL PROVISIONS H.R. 8920 (116TH CONGRESS): THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2020; ALL PROVISIONS S. 168: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS S. 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS S. 368: TELEHEALTH MODERNIZATION ACT; ALL PROVISIONS S. 1002: A BILL TO PROHIBIT FALSE OR MISLEADING ADVERTISING FOR HEALTH INSURANCE COVERAGE, REQUIRE WARNINGS AND REPORTING WITH RESPECT TO NONCOMPREHENSIVE HEALTH PLANS, ENCOURAGE ENROLLMENT IN HEALTH PLANS, AND FOR OTHER PURPOSES; ALL PROVISIONS S. 1556 (116TH CONGRESS): NO JUNK PLANS ACT; ALL PROVISIONS S. 1712 (116TH CONGRESS): DEVELOPING AN INNOVATIVE STRATEGY FOR ANTIMICROBIAL RESISTANT MICROORGANISMS (DISARM) ACT OF 2019; ALL PROVISIONS

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act H.R.19, Lower Costs, More Cures Act of 2021 S.2164 - Lower Costs, More Cures Act (LCMCA) H.R. 2113 - The Prescription Drug STAR Act H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.551 - REFUND Act of 2019 S.1712/H.R.4100 - DISARM Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act H.R. 1319, American Rescue Plan Act of 2021 H.R. 2163/S. 464 - Safe Step Act S.4796, The Fair Care Act of 2020 S.2076/H.R. 3932 PASTEUR Act S.1773 - Prescription Drug Pricing Dashboard Act S. 773/H.R. 3203 - [No official title] Related to The 340B Drug Discount Program S. 4626, SAFE DATA Act S. 3456, Consumer Data Privacy and Security Act H.R. 2013, Information Transparency & Personal Data Control Act S. 2968, Consumer Online Privacy Rights Act S. 3300, Data Protection Act of 2021 H.R.3801, Data Localization Compendium Legislation - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues related to diversity in clinical trials - Issues related to advanced development and procurement of medical countermeasures (MCMs) - Issues related to patient assistance and acces - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data

Client expense: $1,670,000 · Firm income: Not reported

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

H.R. 597, Pandemic Treatment Access and Affordability Act of 2021 H.R. 1319, American Rescue Plan Act of 2021, medical provisions H.R. 1550, PREVENT HPV Cancers Act of 2021 H.R. 1978, Protecting Seniors Through Immunization Act of 2021 H.R. 2061, Advancing Emergency Preparedness Through One Health Act of 2021 H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 3173, Improving Seniors Timely Access to Care Act of 2021 S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 2076, Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act of 2021 H.R. 3, (116th Congress) Lower Drug Costs Now Act of 2019 H.R. 19 (116th Congress) Lower Costs, More Cures Act of 2019 S. 2543 (116th Congress) Prescription Drug Pricing Reduction Act of 2019 H.R. 4100/S. 1712 (116th Congress) Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019. H.R. 8920/S. 4760, (116th Congress) The Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act of 2020 S. 1895 (116th Congress) Lower Health Care Costs Act Issues relating to, 340B program integrity; 340B of the Public Health Services Act; 340B policy; 340B issues; 340 drug pricing program; Drug pricing; Drug Pricing reforms - international reference prices and government price setting; Anti-microbial Resistance; Vaccines; HIV, PrEP provisions; COVID-19 vaccines; COVID-19 therapeutics coverage issues; Vaccines catch up; Vaccine provisions; Vaccine Issues, including access and pandemic-related policy; Package inserts and labeling issues; Executive Order 13937, Access to Affordable Life-Saving Medications; FY-2022 Budget and Appropriations Legislation; Intellectual property protection; WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; Animal Health; One Health Issues; Rural Broadband Issues.

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

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

H.R. 708: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS H.R. 1319: AMERICAN RESCUE PLAN ACT OF 2021; PROVISIONS RELATED PAID FAMILY AND MEDICAL LEAVE, PERSONAL PROTECTIVE EQUIPMENT, AND ACCESS TO MEDICINE, NUTRITION ASSISTANCE PROGRAMS, AND ANTIMICROBIAL RESEARCH H.R. 4100 (116TH CONGRESS): DEVELOPING AN INNOVATIVE STRATEGY FOR ANTIMICROBIAL RESISTANT MICROORGANISMS (DISARM) ACT OF 2019; ALL PROVISIONS S. 168: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS S. 368: TELEHEALTH MODERNIZATION ACT; ALL PROVISIONS S. 1002: A BILL TO PROHIBIT FALSE OR MISLEADING ADVERTISING FOR HEALTH INSURANCE COVERAGE, REQUIRE WARNINGS AND REPORTING WITH RESPECT TO NONCOMPREHENSIVE HEALTH PLANS, ENCOURAGE ENROLLMENT IN HEALTH PLANS, AND FOR OTHER PURPOSES; ALL PROVISIONS S. 1556 (116TH CONGRESS): NO JUNK PLANS ACT; ALL PROVISIONS S. 1712 (116TH CONGRESS): DEVELOPING AN INNOVATIVE STRATEGY FOR ANTIMICROBIAL RESISTANT MICROORGANISMS (DISARM) ACT OF 2019; ALL PROVISIONS

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 482: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS H.R. 708: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS H.R. 1319: AMERICAN RESCUE PLAN ACT OF 2021; PROVISIONS RELATED PAID FAMILY AND MEDICAL LEAVE, PERSONAL PROTECTIVE EQUIPMENT, AND ACCESS TO MEDICINE, NUTRITION ASSISTANCE PROGRAMS, AND ANTIMICROBIAL RESEARCH H.R. 4100 (116TH CONGRESS): DEVELOPING AN INNOVATIVE STRATEGY FOR ANTIMICROBIAL RESISTANT MICROORGANISMS (DISARM) ACT OF 2019; ALL PROVISIONS H.R. 8920 (116TH CONGRESS): THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2020; ALL PROVISIONS S. 168: TEMPORARY RECIPROCITY TO ENSURE ACCESS TO TREATMENT (TREAT) ACT; ALL PROVISIONS S. 350: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021; ALL PROVISIONS S. 368: TELEHEALTH MODERNIZATION ACT; ALL PROVISIONS S. 1002: A BILL TO PROHIBIT FALSE OR MISLEADING ADVERTISING FOR HEALTH INSURANCE COVERAGE, REQUIRE WARNINGS AND REPORTING WITH RESPECT TO NONCOMPREHENSIVE HEALTH PLANS, ENCOURAGE ENROLLMENT IN HEALTH PLANS, AND FOR OTHER PURPOSES; ALL PROVISIONS S. 1556 (116TH CONGRESS): NO JUNK PLANS ACT; ALL PROVISIONS S. 1712 (116TH CONGRESS): DEVELOPING AN INNOVATIVE STRATEGY FOR ANTIMICROBIAL RESISTANT MICROORGANISMS (DISARM) ACT OF 2019; ALL PROVISIONS

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1319: AMERICAN RESCUE PLAN ACT OF 2021; PROVISIONS RELATED PAID FAMILY AND MEDICAL LEAVE, PERSONAL PROTECTIVE EQUIPMENT, AND ACCESS TO MEDICINE, NUTRITION ASSISTANCE PROGRAMS, AND ANTIMICROBIAL RESEARCH H.R. 4100 (116TH CONGRESS): DEVELOPING AN INNOVATIVE STRATEGY FOR ANTIMICROBIAL RESISTANT MICROORGANISMS (DISARM) ACT OF 2019; ALL PROVISIONS S. 1712 (116TH CONGRESS): DEVELOPING AN INNOVATIVE STRATEGY FOR ANTIMICROBIAL RESISTANT MICROORGANISMS (DISARM) ACT OF 2019; ALL PROVISIONS

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act, 2020 S. 3548 - CARES Act (Coronavirus Stimulus 3), 2020 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R.19, Lower Costs, More Cures Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019 S.3129 - Lower Costs, More Cures Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019 S.551 - REFUND Act of 2019 S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 S.1712/H.R.4100 - DISARM Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act H.R. 1319 , American Rescue Plan Act of 2021 H.R. xx - Safe Step Act (no bill number yet) S.4796, The Fair Care Act of 2020 H.R.1966/S.946 - Henrietta Lacks Enhancing Cancer Research Act of 2019 H.R.133 - Consolidated Appropriations Act, 2021, 116th Congress (2019-2020) S. 4626, SAFE DATA Act S. 3456, Consumer Data Privacy and Security Act H.R. 2013, Information Transparency & Personal Data Control Act S. 2968, Consumer Online Privacy Rights Act - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation - Patient access to Part B medicines during the COVID-19 public health emergency - Issues related to diversity in clinical trials - Issues related to advanced development and procurement of medical countermeasures (MCMs) - Issues relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data

Client expense: $3,130,000 · Firm income: Not reported

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

H.R. 597, Pandemic Treatment Access and Affordability Act of 2021 H.R. 959, Black Maternal Health Momnibus Act of 2021 H.R. 1319, American Rescue Plan Act of 2021, medical provisions H.R. 1550, PREVENT HPV Cancers Act of 2021 H.R. 2061, To establish an interagency One Health Program, and for other purposes H.R. 3, (116th Congress) Lower Drug Costs Now Act of 2019 H.R. 19 (116th Congress) Lower Costs, More Cures Act of 2019 H.R. 133 (116th Congress) Consolidated Appropriations Act of 2021 AMP cap provision H.R. 4100/S. 1712 (116th Congress) Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019. S. 1895 (116th Congress) Lower Health Care Costs Act Issues relating to, 340B program integrity; 340B of the Public Health Services Act; 340B policy; 340B issues; 340 drug pricing program; Drug pricing; Drug Pricing reforms - international reference prices and government price setting; Anti-microbial Resistance; Maternal Health; Cost and value of medicines; Vaccines; HIV, PrEP provisions; COVID-19 vaccines; COVID-19 vaccine funding; COVID-19 therapeutics coverage issues; Vaccines catch up; Vaccine provisions; Vaccine Issues, including access and pandemic-related policy; General pharmaceutical issues; Package inserts and labeling issues; Average Manufacture Price (AMP) cap; Executive Order 13937, Access to Affordable Life-Saving Medications; FY-2022 Budget and Appropriations Legislation; Intellectual property; WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; Animal Health; One Health Issues; Rural Broadband Issues.

Client expense: $3,590,000 · Firm income: Not reported

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

Intellectual property; 340B Program; PPACA; Medicare & Medicaid prescription drug reimbursement, coverage and value; Prescription Drug Pricing Reduction Act (PDPRA - S.4199); Developing an Innovative Strategy for Antimicrobial Resistant Microorganism Act of 2019 (DISARM Act - S.1712); Consolidated Appropriations Act, 2021 (HR.133)

Client expense: $1,840,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---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

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

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

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

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

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

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

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

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

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

H.R. 133: Consolidated Appropriations Act, 2021; Discussions surrounding additional coronavirus relief measures; provisions related to paid family and medical leave, personal protective equipment, and access to medicine, nutrition assistance programs, and antimicrobial research H.R. 2507: Newborn Screening Saves Lives Reauthorization Act of 2019; all provisions H.R. 4100: Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019; all provisions H.R. 4386: Stop the Wait Act; all provisions H.R. 4932: Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019; all provisions H.R. 6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act; provisions related to paid family and medical leave, personal protective equipment, and access to medicine, nutrition assistance programs, and antimicrobial research H.R. 8920: The Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020; all provisions S. 1712: Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019; all provisions S. 2158: Newborn Screening Saves Lives Reauthorization Act of 2019; all provisions S. 2496: Stop the Wait Act; all provisions S. 2741: Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019; all provisions S. 4421: Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act; all provisions S. 4557: COVID Enrollment Response (COVER) Act; all provisions S. 4760: The Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020; all provisions

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4100: Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019; all provisions H.R. 4386: Stop the Wait Act; all provisions S. 1712: Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019; all provisions S. 2496: Stop the Wait Act; all provisions S. 4421: Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act; all provisions S. 4557: COVID Enrollment Response (COVER) Act; all provisions

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4100: Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019; all provisions H.R. 4386: Stop the Wait Act; all provisions S. 1712: Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019; all provisions S. 2496: Stop the Wait Act; all provisions

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Client expense: $5,130,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE

Antibiotics/stewardship; Value of prescription drugs; S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019; H.R. 4100, DISARM Act of 2019; S. 2543, Prescription Drug Pricing Reduction Act of 2019; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act; H.R. 6800, The HEROES Act; H.R. 925, The HEROES Act; H.R. 8337, Continuing Appropriations Act, 2021 and Other Extensions Act; Public Law 116-159; Issues related to vaccines; H.R. 133/P.L. 116-260, Consolidated Appropriations Act, 2021

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to the further development of antibiotics and antimicrobials for serious and unmet medical needs; Antibiotics/stewardship; S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019; Value of prescription drugs; Issues related to Medicare Parts B and D; Biosimilars policies; Medicaid AMP (Average Manufacturer Price) cap; S. 2543, Prescription Drug Pricing Reduction Act of 2019

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3, Lower Drug Costs Now Act of 2019, including provisions relating to international reference pricing H.R. 19, Lower Costs, More Cures Act of 2019 H.R. 133, Consolidated Appropriations Act of 2021, including provision relating to vaccine funding and vaccinations H.R. 4100/S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019. including provisions relating to Anti-microbial Resistance H.R. 4455, Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 H.R. 4629, Star Rating for Biosimilars Act H.R. 6197, Increasing Access to Biosimilars Act of 2020 H.R. 8061, Community Immunity During COVID-19 Act of 2020 H.R. 8920, The Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act of 2020 S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 S. 4760, The Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act 2020 Issues relating to, 340B Reforms; 340B program integrity; 340B of the Public Health Services Act; 340B policy; 340 drug pricing program; Drug pricing; Anti-microbial Resistance; Biosimilars; Maternal Health; Cost and value of medicines; Vaccines; Supply chain; COVID-19 vaccines; COVID-19 issues; Vaccines catch up; General pharmaceutical issues; Average Manufacture Price (AMP) cap; Executive Order 13937, Access to Affordable Life-Saving Medications; Department of Agriculture Center for Veterinary Biologics (CVB) funding.

Client expense: $1,210,000 · Firm income: Not reported

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

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

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

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

Drug Pricing. S.1712/H.R.4100: DISARM Act of 2019. 340B.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B drug discount program; drug pricing; importation of biopharmaceuticals; transparency; direct-to-consumer (DTC) advertising; international pharmaceutical supply chain; DoD TRICARE Pharmacy Benefits Program; education around COVID-19 therapies; COVID-19 liability protection legislative proposals. Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). Implementation of SUPPORT for Patients and Communities Act (P.L.115-271). S.1712/H.R.4100, DISARM Act of 2019. Executive Order on Access to Affordable Life-saving Medications (E.O. 13937). Executive Order on Increasing Drug Importation to Lower Prices for American Patients (E.O. 13938). Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen (E.O. 13939). Executive Orders on Lowering Drug Prices by Putting America First (E.O. 13947, E.O. 13948). Executive Order on Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (E.O. 13944). Executive Order on An America-First Healthcare Plan (E.O. 13951).

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

Issues related to health care, the Food and Drug Administration (FDA), 340B Program, drug pricing, importation of biopharmaceuticals, international pharmaceutical supply chain, TRICARE Pharmacy Program, education around COVID-19 therapies, and COVID-19 liability protection legislative proposals. Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1712/H.R.4100, DISARM Act of 2019. H.R.6395/S.4049, National Defense Authorization Act for Fiscal Year 2021. Executive Order on Access to Affordable Life-saving Medications (E.O. 13937). Executive Order on Increasing Drug Importation to Lower Prices for American Patients (E.O. 13938). Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen (E.O. 13939). Executive Orders on Lowering Drug Prices by Putting America First (E.O. 13947, E.O. 13948). Executive Order on Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (E.O. 13944). Executive Order on An America-First Healthcare Plan (E.O. 13951).

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

Government targets: Executive Office of the President (EOP), 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

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

Issues related to drug pricing, reimbursement for prescription drugs, and the pharmaceutical supply chain; Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act; HR 4100/S 1712 DISARM Act; Executive Order on Lowering Drug Prices by Putting America First; H.R. 133 / PL 116-260 - FY2021 Omnibus and COVID Relief and Response Act; Issues related to the Medicaid Drug Rebate Program

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug pricing, vaccines, animal health, and maternal health; Issues related to DISARM Act (S. 1712/H.R. 4100); Issues related to Section 340B of the Public Health Service Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to drug pricing, reimbursement for prescription drugs, and the pharmaceutical supply chain. Issues related to the illegal importation of prescription drugs. Issues related to capping out of pocket costs. S. 2543 - The Prescription Drug Price Reduction Act. H.R.3 - Lower Drug Costs Now Act of 2019. Issues related to pharmaceutical copayments within the CMS Proposed Notice of Benefit and Payment Parameters Rule for 2021. HR 4100/S 1712, DISARM Act. Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act; Executive Order on Lowering Drug Prices by Putting America First. H.R. 133 / PL 116-260 - FY2021 Omnibus and COVID Relief and Response Act; Issues related to the Medicaid Drug Rebate Program

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to drug pricing, reimbursement for prescription drugs, and the pharmaceutical supply chain. S. 2543 - The Prescription Drug Price Reduction Act. H.R. 3 - Lower Drug Costs Now Act of 2019. HR 4100/S 1712, DISARM Act; Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act; Executive Order on Lowering Drug Prices by Putting America First; H.R. 133 / PL 116-260 - FY2021 Omnibus and COVID Relief and Response Act; Issues related to the Medicaid Drug Rebate Program

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to pharmaceutical pricing and transparency. Provisions relating to Part D Pricing Reform. Proposal to eliminate Medicaid inflationary cap. Issues relating to biosimilars coverage & pricing. S. 2543 - The Prescription Drug Price Reduction Act. H.R. 3 - Lower Drug Costs Now Act of 2019. H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act; HR 4100/S 1712, DISARM Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4100, S. 1712.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Intellectual property; 340B Program; PPACA; Medicare & Medicaid prescription drug reimbursement, coverage, and value; Prescription Drug Pricing Reduction Act (PDPRA)(S.4199); Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2019 (DISARM Act)(S.1712); Consolidated Appropriations Act, 2021 (H.R.133)

Client expense: $950,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Allergy policies (H.R 2009, S.2246) Diagnostic test reimbursement and policies DISARM Act (H.R. 4100, S.1712) Precision Medicine (H.R. 4393, S. 3116) COVID-19 preparedness products and services PASTEUR Act (S.4760)

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE