Protecting Consumer Access to Generic Drugs Act of 2019

H.R. 3 - Lower Drug Costs Now Act of 2019 H.R.19, Lower Costs, More Cures 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.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act H.R. 1319, The American Rescue Plan of 2021 H.R./S. XX American Jobs Plan S. 920 - The Affordable and Safe Prescription Drug Importation Act S. 909 - The Prescription Drug Price Relief Act S. 908 - The Medicare Drug Price Negotiation Act S.4796, The Fair Care Act of 2020 - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B and general reference pricing - Issues related to CMMI

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. 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) S.1895, Lower Health Care Costs Act of 2019 S. 2543, Prescription Drug Pricing Reduction Act of 2019 S.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1499, the Protecting Consumer Access to Generic Drugs Act S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act H.R. 1319, The American Rescue Plan of 2021 H.R./S. XX American Jobs Plan S. 920 - The Affordable and Safe Prescription Drug Importation Act S. 909 - The Prescription Drug Price Relief Act S. 908 - The Medicare Drug Price Negotiation Act S.4796, The Fair Care Act of 2020 S.1773 - Prescription Drug Pricing Dashboard Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B and general reference pricing - Issues related to CMMI

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.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. 3 - Lower Drug Costs Now Act of 2019 H.R.19, Lower Costs, More Cures 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.977 - Transparent Drug Pricing Act of 2019 S.551, REFUND Act of 2019 H.R. 1520, the Purple Book Continuity Act H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 2296 - More Efficient Tools to Realize Information for Consumers Act H.R. 5741- Strengthening Innovation in Medicare and Medicaid Act H.R. 1319, The American Rescue Plan of 2021 H.R./S. XX American Jobs Plan S. 920 - The Affordable and Safe Prescription Drug Importation Act S. 909 - The Prescription Drug Price Relief Act S. 908 - The Medicare Drug Price Negotiation Act S.4796, The Fair Care Act of 2020 - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part B and general reference pricing - Issues related to CMMI

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.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

Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---Domestic Manufacturing Requirement ---March-In Rights Compulsory licensing ---S.2387: We Protect American Investment in Drugs Act of 2019 Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Restrictions on Intellectual Property Rights Drug Patenting ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 Patenting of Biological Inventions ---Section 101 Modernization The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions 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

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

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

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

Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)

Client expense: $540,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Bayh-Dole Act/Tech Transfer ---Bayh-Dole 40th Anniversary ---Domestic Manufacturing Requirement ---March-In Rights Compulsory licensing ---S.2387: We Protect American Investment in Drugs Act of 2019 Coronavirus (COVID-19) Pandemic ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Restrictions on Intellectual Property Rights Drug Patenting ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Intellectual Property International Enforcement ---China ---S.3952: A bill to require the imposition of sanctions with respect to foreign persons that have engaged in significant theft of trade secrets of United States persons, and for other purposes. Patent Reform ---H.R.7259/S.2814: Patents for Humanity Program Improvement Act of 2020 Patenting of Biological Inventions ---Section 101 Modernization The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions 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

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

S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.4100 - DISARM Act of 2019 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act (HCR) 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 Ac - 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 relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data

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

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

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

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

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

S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.4100 - DISARM Act of 2019 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 - 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

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

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

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

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

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

S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.4100 - DISARM Act of 2019 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R. 1503, the Orange Book Transparency Act;consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 H.R. 6443, Securing the National Supply Chain Act H.R. 6630, Securing Americas Critical Minerals Supply Chain Act H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act H.R. 6713, Furthering Our Recovery With American Research and Development H.R. 6863, COVID-19 Accountability Act H.R. 6903, Bring American Companies Home Act H.R. 6930, To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes. H.R. 7505, American Innovation Act H.R. 7527, To rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions. H.R. 7537, Infectious Disease Therapies Research and Innovation Act H.R. 7555, More Cures Act H.R. 7556, Start-ups for Cures Act S. 3593, Furthering Our Recovery With American Research and Development S. 3945, Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act S. 3827, Medical Supplies for Pandemics Act H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act H.R. 6731, Securing Americas Pharmaceutical Supply Chain Act S. 3432, Securing Americas Medicine Cabinet [SAM-C] Act S. 3478, Commission on Americas Medical Security Act S. 3538, Strengthening America's Supply Chain and National Security Act S. 3635, Protecting our Pharmaceutical Supply Chain from China Act (previously S. 3537) H.R. 6531, Medical Supplies for Pandemics Act H.R. 6876, To amend the Public Health Service Act to ensure that the contents of the Strategic National Stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile, and for other purposes. H.R. 6049, Medical Supply Chain Security Act H.R. 6062 - to amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes H.R. 6080, Preventing Drug Shortages Act H.R. 6393, Strengthening America's Supply Chain and National Security Act H.R. 6660, Limit Ongoing Shortages and Stabilize Supply Act H.R. 6670, Prescription for American Drug Independence Act H.R. 6708, Securing Americas Medicine Cabinet Act H.R. 6885, Safe and Secure Medicine Supply for Hardworking Americans Act S. 2723, Mitigating Emergency Drug Shortages Act S. 3343, Medical Supply Chain Security Act S. 3780, Help Onshore Manufacturing Efficiencies for Drugs and Devices Act (HOME) Act S. 3781, Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act S. 3942, Securing Americas Medical Supply Chain and Advancing the Production of Life Saving Medicines 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 Medical Supply Chain - Issues related to pharmaceutical supply chains - Issues related to reporting on location of origin of pharmaceutical products - Issues related to drug shortages - Issues related to pharmaceutical manufacturing

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

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

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

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

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

S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R. 1503, the Orange Book Transparency Act;consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 - 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

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

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

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

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

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

Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)

Client expense: $830,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions

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

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

H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions

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

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

H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions H.R. 133, the Consolidated Appropriations Act of 2021, regarding all bio-pharmaceutical related provisions

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

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

S. 3129, Crapo The Lower Costs, More Cures Act HR 19 Walden, the Lower Costs, More Cures Act HR 5444 Underwood, Lower Insulin Costs Now Act HR 5304 Schrader, PBM Transparency in Prescription Drug Costs Act HR 4906, DeGette, Regarding the costs of insulin HR 5442, Porter, regarding drug pricing S. 2543, Prescription Drug Pricing Reduction Act HR 2296, regarding prescription drug pricing HR 3, regarding prescription drug pricing (Pelosi) HR 4455, regarding Biologics in Medicare Part D S. 2543, Prescription Drug Pricing Reduction Act HR 1781, regarding access to data for MedPAC and MACPAC HR 2113, regarding drug price transparency HR 2374, regarding generic drugs and citizens petitions HR 2375, regarding pay for delay agreements and generic drugs HR 2376, regarding the Federal Trade Commissions role in assuring competition in the pharmaceutical supply chain HR 2064, regarding reporting of prescription drug samples given to physicians by manufacturers HR 478 and S. 61, regarding drug reimportation HR 965 and S 340, regarding abuse of Risk Evaluation and Mitigation Strategies (REMS) (CREATES Act) HR 1499, regarding pay for delay in pharmaceutical markets HR 1503, regarding the FDA Orange Book HR 1520, regarding the FDA Purple Book HR 938, regarding generic drug approvals HR 2113, regarding drug pricing transparency

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

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

Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543 - Prescription Drug Pricing Reduction Act S. 1416 - Affordable Prescriptions for Patients Act S. 1895 - Lower Health Care Costs Act of 2019 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act H.R. 6431 - Made in America Emergency Preparedness Act S. 4134 - Increasing Access to Biosimilars Act of 2020 Electronic Labeling of Prescription Drugs H.R. 133 - Consolidated Appropriations Act, 2021 H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 8644 - Secure Americas Medicine Act of 2020 H.R. 8588 - Improving the American Drug Supply Chain Act of 2020

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

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

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act

Client expense: $310,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act

Client expense: $310,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543 - Prescription Drug Pricing Reduction Act S. 1416 - Affordable Prescriptions for Patients Act S. 1895 - Lower Health Care Costs Act of 2019 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act H.R. 6431 - Made in America Emergency Preparedness Act S. 4134 - Increasing Access to Biosimilars Act of 2020 Electronic Labeling of Prescription Drugs H.R. 133 - Consolidated Appropriations Act, 2021 H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 8644 - Secure Americas Medicine Act of 2020 H.R. 8588 - Improving the American Drug Supply Chain Act of 2020

Client expense: $550,000 · Firm income: Not reported

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

Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support HR 1763/ S 348, Resident Physician Shortage Reduction Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions; Oppose HR 506,Hospital Competition Act of 2019, a bill to amend title XVIII of the Social Security Act to increase hospital competition; Statement submitted to the House Judiciary on the hearing "Diagnosing the Problem: Exploring the Effects of Consolidation and Anticompetitive Conduct in Health Care Markets"; Support HR 965/ S340, Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019, a bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products; Support HR 986/ S466 Protecting Americans with Preexisting Conditions Act of 2019, a bill provide that certain guidance related to waivers for State innovation under the Patient Protection and Affordable Care Act shall have no force or effect; Support HR 987 Strengthening Health Care and Lowering Prescription Drug Costs Act, a bill to amend the Patient Protection and Affordable Care Act to provide for Federal Exchange outreach and educational activities; Support HR 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019, a bill to amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes; Support HR 1010, a bill to provide that the rule entitled Short-Term, Limited Duration Insurance shall have no force or effect; Support HR 1499 Protecting Consumer Access to Generic Drugs Act of 2019, a bill to prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes; Support HR 1425 State Health Care Premium Reduction Act, a bill to amend the Patient Protection and Affordable Care Act to provide for a Improve Health Insurance Affordability Fund to provide for certain reinsurance payments to lower premiums in the individual health insurance market; Support HR 1386/ S 1905 Expand Navigators Resources for Outreach, Learning, and Longevity Act of 2019 or the ENROLL Act of 2019,a bill to amend the Patient Protection and Affordable Care Act to provide for additional requirements with respect to the navigator program, and for other purposes; Support HR 1520 Purple Book Continuity Act of 2019, a bill to amend the Public Health Service Act to provide for the publication of a list of licensed biological products, and for other purposes; Support HR 1503 Orange Book Transparency Act of 2019A bill that would increase transparency for the patent status of both approved biological products and approved drugs; Support HR 2439/ HR 3414 Opioid Workforce Act of 2019, a bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis; Submitted statement to the House Committee on Ways and Means Overcoming Racial Disparities and Social Determinants in the Maternal Mortality Crisis sharing information regarding hospitals and health systems efforts to address maternal morbidity and mortality, as we seek ways to improve outcomes and reduce health inequities for expectant and new mothers, and give their children the best possible start in life; Submitted oral and written testimony to the House Committee on Ways and Means Subcommittee on Health Hearing on Protecting Patients from Surprise Medical Bills. Protecting patients from surprise medical bills is a top priority and we have adopted a set of guiding principles to use as we evaluate legislative proposals: Define surprise bills, Protect the patient financially, Ensure patient access to emergency care, Preserve the role of private negotiation, Remove the patient from health plan/provider negotiations, Educate patients about their health care coverage, Ensure patients have access to comprehensive provider networks and accurate network information, and Support state laws that work; Letters submitted to the Energy & Commerce Committee in response to the request for comments on their surprise billing discussion draft. Concerned with the Committees draft legislations approach to determining reimbursement for out-of-network providers. Once the patient is protected from surprise bills, providers and insurers should then be permitted to negotiate payment rates for services provided. We strongly oppose approaches that would impose arbitrary rates on providers. We look forward to continuing to work with the Committee on solutions to stop surprise medical bills; Letter sent to the HELP Committee in response to the Lower Health Care Costs Act of 2019 discussion draft about our concerns about several of the proposals that would allow the government to intrude into private commercial contracts between providers and insurers. For example, several of the provisions could undermine value-based purchasing arrangements aimed directly at improving the quality of care while reducing costs. We strongly urge the Committee to remove these provisions; Submitted oral and written testimony to the House Committee on Energy and Commerce, Subcommittee on Health Hearing on No More Surprises: Protecting Patients from Surprise Medical Bills asking that the Committee preserve the ability of providers and insurers to negotiate private contracts and not establish a fixed payment amount for out-of-network services; Oppose HR 1309 Workplace Violence Prevention for Health Care and Social Service Workers Act, a bill to direct the Secretary of Labor to issue an occupational safety and health standard that requires covered employers within the health care and social service industries to develop and implement a comprehensive workplace violence prevention plan, and for other purposes; Concerns about S.1531, Stopping The Outrageous Practice of Surprise Medical Bills Act of 2019 or the STOP Surprise Medical Bills Act of 2019, to amend the Public Health Service Act to provide protections for health insurance consumers from surprise billing; Concerns about S. 1895 Lower Health Care Costs Act Letter addressed concerns about the legislative provision that sets a benchmark rate in statute for the out-of-network payments, as well as provisions that seek to change privately negotiated contracting arrangements between hospitals and insurance companies; Support HR 3425, Advancing Medical Resident Training in Community Hospitals Act of 2019, to amend title XVIII of the Social Security Act to establish rules for payment for graduate medical education (GME) costs for hospitals that establish a new medical residency training program after hosting resident rotators for short durations; Expressed concerns regarding the provisions that reduce reimbursements to providers and hospitals that administer drugs the Prescription Drug Pricing Reduction Act (PDPRA) of 2019: including about Section 107, Medicare Part B Rebate by Manufacturers for Drugs or Biologicals with Prices Increasing Faster than Inflation, Section 110, Establishment of Maximum Add-on Payment for Drugs, Biologicals, and Biosimilars, this provision would establish $1,000 as the maximum add-on amount that a provider can be paid for a separately payable drug, biological or biosimilar, Section 111, Treatment of Drug Administration Services Furnished by an Off-Campus Outpatient Department of a Provider, the site neutral payment reduction would cut aggregate hospital payments; Support S. 2091, Backlog Elimination, Legal Immigration, and Employment Visa Enhancement Act, this legislation would increase the total number of employment-based visas from 140,000 to 270,000 and ensure that critical health care workers needed in the U.S. have access to employment-based visas by carving out health care workers in designated shortage occupations from the limit; Support S 350, The Competitive Health Insurance Reform Act of 2019, a bill to restore the application of the Federal antitrust laws to the business of health insurance to protect competition and consumers; Submitted statement to Subcommittee on Health of the Committee on Energy and Commerce for the hearing on Improving Maternal Health: Legislation to Advance Prevention Efforts and Access to Care; Concerns with S. 386 and HR 1044, Fairness for High-Skilled Immigrants Act of 2019, this bill increases the per-country cap on family-based immigrant visas from 7% of the total number of such visas available that year to 15%, and eliminates the 7% cap for employment-based immigrant visas. It also removes an offset that reduced the number of visas for individuals from China; Support H.R. 4538, Closing Loopholes for Orphan Drugs Act, a bill to amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title; Discussions of provisions we support and those we recommend be changes in a draft bill called the Mitigating Existing Drug Shortages (MEDS) Act; Discussions in support of the allowing states to designate hospitals as necessary providers for purposes of waiving the critical access hospital mileage requirements; Provided comments to W&M on legislation to expand Health Profession Opportunity Grants; Support S. 2723, The Mitigating Emergency Drug Shortages (MEDS) Act, a bill to amend Sec. 506C of the Federal Food, Drug, and Cosmetic Act which strengthens requirements for drug manufacturers to disclose the root causes and expected duration of shortages, extends reporting requirements to active pharmaceutical ingredients manufacturers, requires manufacturers have contingency plans to ensure ongoing supply, develops recommendations to incentivize manufacturers to enter the market for drugs in shortage and examines the national security risks of shortages; Discuss DEA reductions in annual quotas for opioid products used by hospitals for sedation and pain management; Meeting with the Office of the Assistant Secretary of Preparedness and Response (ASPR) to discuss developments in the hospital preparedness program, the pilot projects for the Regional Disaster Healthcare System and other issues; Rural access to health care, including identifying core services needed in rural communities, outlining approaches and considerations for delivering those services, and examining access and quality in the rural context; ONCs proposed rule to implement the 21st Century Cures provision on information blocking; Supported members serving on the HHS Quality Summit panel, which was convened by the Deputy Secretary to gather input regarding how to improve and energize quality and safety improvement activities across health care system; Discussion with HHS on drug pricing, 340b, and price transparency policies, as well as the International Pricing Index ANPRM; Discussion with HHS about the work of Aligning for Health to address social determinants of health; Support S 2902, Strengthening Our Rural Health Workforce Act of 2019, a bill to enhance the rural health workforce; Meetings and correspondence with staff members of Senate Financing Committee on a proposal to support rural health care access (REH, re-opening necessary provider CAH, infrastructure funding); Letter to Ways & Means committee Rural and Underserved Communities Health Task Force in response to RFI on factors that contribute to health outcomes in these areas, examples of successful models and lessons from the field that address access and outcomes, and considerations for the unique circumstances of rural and underserved communities; Letter to Energy and Commerce Members regarding health information technology priorities; Letter of Support to Senate Appropriations on funding for the Centers for Disease Control and Prevention and the National Institutes of Health to study gun violence; Support S.2741 and H.R. 4932,Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019, a bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes; Support S 2603, Resolving Extended Limbo for Immigrant Employees and Families (RELIEF) Act, a bill to amend the Immigration and Nationality Act to end the immigrant visa backlog, and for other purposes; Support HR 4995, Maternal Health Quality Improvement Act of 2019, a bill to amend the Public Health Service Act to improve obstetric care and maternal health outcomes, and for other purposes; Concerns with HR 5800,Ban Surprise Billing Act, a bill to address surprise medical bills that relies on a median in-network rate to resolve out-of-network payments and allows for an independent dispute resolution process to determine the final payment. Concerned with the Committee's legislative approach to determining reimbursement for out-of-network providers. Oppose approaches that would impose arbitrary rates on providers, which could have significant consequences far beyond the scope of surprise medical bills. It is the insurers' responsibility to maintain comprehensive provider networks, and a default payment rate would remove incentives for health plans to contract with providers or to offer fair terms; Support HR 5826, Consumer Protections Against Surprise Medical Bills Act, a bill that prohibits providers from balance billing patients for emergency services or medical care the patient reasonably could have expected to be in-network, and from charging patients more than the in-network cost-sharing amount. Rather than rely on a benchmark payment rate to determine out-of-network reimbursement, the legislation provides a period for health plans and providers to negotiate out-of-network reimbursement, followed by a mediated dispute resolution process if necessary; Letter urging HHS to take regulatory actions to help hospitals and health systems prepare and respond to COVID-19; Letter requesting $100 billion to prepare and respond to COVID-19; Letter urging the Department of Labor to accurately define health care provider when promulgating regulations implementing key sections of the Families First Coronavirus Response Act; Letter sent to the President asking for the use of the Defense Production Act to increase the production of medical supplies and equipment; Letter to HHS regarding $100 billion emergency fund, asking HHS and CMS to directly and expediently distribute to rural and urban hospitals and health systems funds from the Public Health and Social Services Emergency Fund that were designated for providers in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The CARES Act increased funding by $100 billion in order to reimburse eligible health care providers for health care-related expenses or lost revenues that are attributable to COVID-19. In the letter, we urged HHS and CMS to immediately distribute funding to all hospital types in the US - with additional funding going to COVID-19 hotspots; Letter urging Congress to modernize the Stafford Act as part of its next COVID-19 legislative package to allow all hospitals to recoup financial losses from this pandemic and future disasters; Letter to the Federal Reserve System, the Federal Deposit Insurance Corporation and the Office of the Comptroller of the Currency requesting they, as primary federal regulators for insured depository institutions, take prompt action to assist health care providers on the front line of the COVID-19 pandemic should the need to do so arise; Letter to the Secretary of the Treasury and the Federal Reserve Chair of the Board of Governors urging a supplement to the New Main Street Loan Facility term sheet with prompt guidance to ensure that access to this critically-necessary loan facility will be attainable for hospitals without delay; Letter was sent to the SBA urging it to ensure that small- and mid-size public hospitals, including those that have both nonprofit and public designations, are allowed to apply for and receive loans under the newly-authorized SBA Paycheck Protection Program; Letter in response to FEMAs request for input on establishing a voluntary agreement, under the Defense Production Act, of key private sector stakeholders relevant to responding to COVID-19, urging that such an agreement account for the full breadth of COVID-19 medical supply and equipment needs; Support H.R. 6474/S.3838 Healthcare Broadband Expansion During COVID-19 Act, a bill that would provide an additional $2 billion in funding for the FCC Rural Health Care program and increase the subsidy for health care providers from 65 to 85 percent. This legislation also simplifies the program to allow for more efficient application processes and disbursement of much needed funding; Support HR 6654 Emergency COVID-19 Telehealth Response Act, a bill that would codify an expanded list of providers to deliver and bill for telehealth services during the PHE; Support HR 7233Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act of 2020, a bill that would require the Department of Health and Human Services and the Government Accountability Office (GAO) to conduct studies to provide information about the expanded use of telehealth during the COVID-19 pandemic; Letter to Senate HELP Committee in response to request for feedback on preparing for next pandemic; Discussion about telehealth waivers and flexibilities with HHS; Discussion about CARES provider relief fund distributions with HHS; Oppose HR 6559/ S 3677 COVID-19 Every Worker Protection Act of 2020, a bill to require the Occupational Safety and Health Administration to promulgate an emergency temporary standard to protect employees from occupational exposure to SARS-CoV-2, and for other purposes; Joint letter with ANA urging Congress to act quickly to get needed resources into the health care system, so that hospitals, nurses and physicians responding to COVID-19 are able to continue to provide treatments, front-line health care personnel are able to provide care and patients are able access health care services; Statement to Committee on Ways and Means for the hearing on The Disproportionate Impact of COVID-19 on Communities of Color urging Congress to employ the resources of the National Institute on Minority Health and Health Disparities - which is congressionally-mandated to coordinate the research of the other National Institutes of Healths centers and institutes related to minority health - to research and develop approaches to specifically address the COVID-19 needs of minority populations; Advocate with Congress for full forgiveness of COVID-19 related accelerated payments received by hospitals; Support S 3781Pharmaceutical Accountability, Responsibility, and Transparency (PART) Act, a bill to increase reporting of, help mitigate potential shortages related to, and promote, accountability and transparency for pharmaceuticals and medical devices; Support S 3780 Help Onshore Manufacturing Efficiencies (HOME) for Drugs and Devices Act, a bill to encourage domestic advanced manufacturing of critical drugs and devices in order to address economic, health, and security concerns, combat shortages of critical drugs and devices, and promote increased domestic diversification of, and independence from foreign reliance on, pharmaceutical and medical device supply chains; Support S.3763 Pandemic Responder Service Award Act, a bill to establish the Pandemic Responder Service Award program to express our gratitude to front-line health care workers; Support HR 6788/ S 3599 Healthcare Workforce Resilience Act, a bill to enhance our Nations nurse and physician workforce during the COVID-19 crisis by recapturing unused immigrant visas; Urged support for joint House and Senate letter to the Administration asking for flexibility for hospitals with respect to J-1 and H-1B visa programs; Letter to Senate Finance Committee to address the important issue of maternal health and the opportunity to provide suggestions regarding how to improve maternal health in this country; Support the Temporary Reciprocity to Ensure Access to Treatment Act, a bill that allows for the temporary reciprocity for treatment by medical professionals licensed in one state to patients in other states; Letter urging the Senate to include in the next COVID-19 relief bill provisions to strengthen the federal response for racial and ethnic minority and marginalized communities, which are disproportionately affected by the pandemic;Letter asking Congress to allocate as part of the next COVID-19 relief package at least an additional $100 billion to the emergency relief fund to provide direct funding to front line health care personnel and providers to continue to respond to this pandemic; Letter sent to HHS urging them to direct HRSA to take action to stop three drug manufacturers from limiting the distribution of 340B drugs to 340B covered entities. These drug manufacturers have taken separate actions to either limit the distribution of 340B drugs or require 340B covered entities provide claims level data for investigatory purposes if that 340B covered entity uses a contract pharmacy arrangement; Letter to the Congressional Leadership asking them to not to include in the next COVID-19 relief package any surprise medical billing legislation - such as a reimbursement rate set in statute - that would further destabilize hospitals finances during the pandemic; Support S 4507, Getting Early Treatment and Comprehensive Assessments Reduces Emergencies Act of 2020 or the GET CARE Act of 2020, a bill to amend the Public Health Service Act to provide for a national campaign to raise awareness of the importance of seeking preventive health services and the utilization of such services; Comment letter addressing concerns on the proposed rule from the Departments of the Treasury, Labor and Health and Human Services that would allow certain grandfathered health plans to increase patient cost-sharing beyond current limits, without losing their grandfathered status; Letter urging the Administration to work with the AHA and Congress to create a future for telehealth that allows not only clinicians, but also hospitals and health systems, to code and bill for virtual services. We further urge CMS and HHS to continue to provide hospitals with the flexibility for annual beneficiary consent to telehealth treatment to be obtained at the same time, and not necessarily before, services are furnished; Support HR 8061,Community Immunity During COVID-19 Act of 2020, a bill that would provide funding to state and local health departments to work with community providers and organizations to increase immunization rates for Advisory Committee on Immunization Practices (ACIP)-recommended vaccines during the COVID-19 public health emergency; Letter again expressing concern with recent actions taken by several major drug manufacturers to limit the distribution of certain 340B drugs to our hospital members. While we understand that the HRSA is further investigating these actions, we urge swift and decisive action to halt these pernicious tactics so as to prevent other manufacturers from following suit; Comment letter outlining our concerns about the ability of hospital systems to distribute provider relief funds among the parent and subsidiaries. HHS published certain FAQs that place problematic restrictions on the use of CARES Act provider relief fund dollars. Specifically, the FAQs restrict the ability of a hospital system to allocate the funds throughout its system where COVID-19 related expenses and lost revenues are occurring; Submitted comments in response to HRSAs RFI on Health Professional Shortage Area (HPSA) scoring. HPSA scores are important for rural hospitals and clinics ability to recruit physicians and other clinicians, namely from the National Health Service Corps (NHSC) program. Letter asking HHS to reinstate the COVID-19 Provider Relief Fund reporting requirements; Support S 4349, Dr. Lorna Breen Health Care Provider Protection Act, a bill to address behavioral health and well-being among health care professionals; Support S. 3595Ensuring Understanding of COVID-19 to Protect Public Health Act, a bill that directs the NIH to conduct a longitudinal study on mild, moderate, and severe cases of COVID-19 on a diverse patient population.

Client expense: $4,460,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

Issues related to prescription drug coverage and pharmacy benefits H.R.803/S.988: Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.1034/S.640: Phair Pricing Act of 2019 H.R.1035: Prescription Drug Price Transparency Act H.R.5800: Ban Surprise Billing Act S.2543: Prescription Drug Pricing Reduction Act S.2247: Phair Relief Act S.1895: Lower Health Care Costs Act Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market Prescription drug pricing transparency H.R.1264/S.801: Payment Commission Data Act H.R.2376/S.1227: Prescription Pricing for the People Act H.R.3223/S.1532 PBM Study Act H.R.1781: Payment Commission Data Act H.R.2113: Prescription Drug Sunshine, Transparency, Accountability and Reporting Act H.R.2115: Public Disclosure of Drug Discounts Act H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.133: Consolidated Appropriations Act, 2021 S.476: C-THRU Act S.2543: Prescription Drug Pricing Reduction Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits H.R.19/S.3129:Lower Costs More Cures Act H.R.2279/S.2546: Safe Step Act H.R.6557: MAIL Act H.R.3: Lower Drug Costs Now Act S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act S.3384: Lowering Prescription Drug Prices for America's Seniors and Families Act Executive Order on An America-First Healthcare Plan Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen 42 CFR Part 1001 RIN 0936-AA08: 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 Access to prescription drugs during the coronavirus pandemic H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R.6557 MAIL Act H.R.6800: HEROES Act Generic and biosimilar utilization H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes (McKinley) Issues related to prescription drug patents and approval process H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act H.R.985: Fair Access for Safe and Timely (FAST) Generics Act H.R.1499: Protecting Consumer Access to Generic Drugs Act H.R.1520: Purple Book Continuity Act H.R.1503: Orange Book Transparency Act S.64: Preserve Access to Affordable Generics and Biosimilars Act S.659: Biologic Patent Transparency Act Issues related to coverage of prescription drugs in the commercial market H.R.5304: PBM Transparency in Prescription Drug Costs Act H.R.5800: Ban Surprise Billing Act S.657: Drug Price Transparency Act S.977: Transparent Drug Pricing Act S.1895: Lower Health Care Costs Act

Client expense: $2,000,785 · 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), Office of Management & Budget (OMB), SENATE

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act

Client expense: $310,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act

Client expense: $310,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

S. 3548 - CARES Act (Coronavirus Stimulus 3) H.R.6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R.6201 - Families First Coronavirus Response Act H.R.4100 - DISARM Act of 2019 S.340- CREATES Act of 2019 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book H.R. 1499, the Protecting Cok Continuity Act; H.R.3: Lower Drug Costs Now Act of 2019 S.1895, Lower Health Care Costs Act of 2019 S.551, REFUND Act of 2019 S.4760, The Pioneering Antimicrobial Subscriptions To End Up Surging Resistance Act of 2020 H.R.133 - Consolidated Appropriations Act, 2021 H.R. 6800 - The Heroes Act (HCR) 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 Ac - 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 relating to privacy and securing the data of and personal information of consumers - Issues relating to medical research data

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

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

: Issues related to lung disease treatment, prevention and research; public health; Issues related asthma; COPD; influenza; lung cancer; pneumonia; tuberculosis and other lung diseases; Issues related to tobacco cessation; Issues related to the Affordable Care Act; Issues related to the Childrens Health Insurance Program; Issues related to the President's Budget; Issues related to telehealth; Issues related to changing federal poverty line calculation; Issues related to COVID-19 Response;; H.R.986 Protecting Americans with Preexisting Conditions Act of 2019 H.R.987 Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.1010 To provide that the rule entitled "Short-Term, Limited Duration Insurance" shall have no force or effect. H.R.1385 SAVE Act H.R.1386 ENROLL Act of 2019 H.R.1425 State Health Care Premium Reduction Act H.R.1499 Protecting Consumer Access to Generic Drugs Act of 2019 H.R.1884 Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019 H.R.2508 Better Respiration through Expanding Access to Tele-Health Act;H.R.2862 VACCINES Act of 2019; H.R.3630 No Surprises Act H.R.4622 Family Asthma Act S.466 Protecting Americans with Pre-existing Conditions Act of 2019 S.946 Henrietta Lacks Enhancing Cancer Research Act of 2019 S.1125 Protect Act S.1895 Lower Health Care Costs Act S.1944 Public Health Funding Restoration Act. HR 3 Elijah E. Cummings Lower Drug Costs Now Act; H.R.4716 I CAN Act; HR 5230 Elijah E. Cummings Family Asthma Act; HR 6201 - Families First Coronavirus Act; HR 6704 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020; HR 748 - CARES Act; S. 3548 - CARES Act; S. 1531 - Stopping the Outrageous Practice of Surprise Medical Bills Act of 2019; HR 6408 -- To extend the charitable deduction to all taxpayers regardless of whether a taxpayer itemizes deductions in order to encourage and increase charitable giving, and to provide for loans and loan guarantees to certain public charities; HR 7610 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2021; HR 7667 Commerce, Justice, Science, and Related Agencies Appropriations Act, 2021; HR 7617 Department of Defense Appropriations Act, 2021; HR 7612 Department of the Interior, Environment, and Related Agencies Appropriations Act, 2021; HR 2468 School-Based Allergies and Asthma Management Program Act; HR 7614 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021; HR 7609 Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2021; HR 7616 Transportation, Housing and Urban Development, and Related Agencies Appropriations Act, 2021; HR 7608 Department of State, Foreign Operations, and Related Programs Appropriations Act, 2021; H.R.5076 Protecting Seniors Through Immunization Act of 2019; H.R.6561 Improving Social Determinants of Health Act of 2020; HR 6800 HEROES Act; H.R.6935 Protecting the Health of America's Older Adults During COVID-19 and Beyond Act; HR 7286 Quit Because of COVID-19 Act; S. 4775 Delivering Immediate Relief to Americas Families, Schools and Small Businesses Act; S. 4321 The Continuing Small Business Recovery and Paycheck Protection Program Act; S. 4318 The American Workers, Families, and Employers Assistance Act; S. 4317 SAFE TO WORK Act; S. 4322 The Safely Back to School and Back to Work Act; S. 4320 Coronavirus Response Additional Supplemental Appropriations Act, 2020; ;H.R.8061 Community Immunity During COVID-19 Act of 2020;H.R.8406 The Heroes Act; H.R.925 The Heroes Act; S.4557 COVER Act; S.4740 A bill to support public health infrastructure; H.RES.957 Expressing support for the designation of May as "National Asthma and Allergy Awareness Month"; H.R.7011 Pandemic Risk Insurance Act of 2020; H.R.8261 Presumptive Benefits for War Fighters Exposed to Burn Pits and Other Toxins Act of 2020; S.4572 Presumptive Benefits for War Fighters Exposed to Burn Pits and Other Toxins Act of 2020; S.4355 Katherine's Lung Cancer Early Detection and Survival Act of 2020; H.RES.1192 Expressing support for the goals of November National Lung Cancer Awareness Month and for the early detection of lung cancer; H.R.8158 To amend title XVIII of the Social Security Act to waive budget neutrality for oxygen under the Medicare program, and for other purposes.;H.R.7481 RESTART Act; S.4737 A bill to amend the Public Health Service Act to direct the Secretary of Health and Human Services to make grants to covered health departments to increase the rate of recommended immunizations, and for other purposes; S.Res.780 A resolution designating November 2020 as "National Lung Cancer Awareness Month" and expressing support for the early detection of lung cancer; H.R.8623 SAVE for Seniors Act; S.4864 HAPI Act; H.R.8725 HAPI Act; H.R.8595 To nullify the effect of Executive Order 13950 relating to combating race and sex stereotyping; Senate Labor HHS Appropriations bill; Senate Defense Appropriations bill; Senate Transportation, Housing and Urban Development and Related Agencies Appropriations bill; Senate Agriculture, Rural Development, FDA, and Related Agencies Appropriations bill; Senate Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2021H.R.133 Consolidated Appropriations Act, 2021; H.J.Res.110 - Extension of Continuing Appropriations Act, 2021

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Federal Reserve System, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Postal Regulatory Commission, SENATE, Small Business Administration (SBA), Treasury, Dept of, White House Office

Proposed changes to Medicare hospital reimbursement policy Health care policy H.R. 986/S. 466 Protecting Americans with Preexisting Conditions Act of 2019, a bill provide that certain guidance related to waivers for State innovation under the ACA shall have no force or effect H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting (STAR) Act" - provisions related to studying rising hospital drug prices and reporting of drug costs H.R. 965/S. 340, "CREATES Act" H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019 - provisions related to eligibility for approval of a subsequent generic drug and to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval H.R. 1499 Protecting Consumer Access to Generic Drugs Act of 2019 - provisions related to prohibiting brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products S. 2543, the Prescription Drug Pricing Reduction Act H.R. 3, "Elijah E. Cummings Lower Drug Costs Now Act" Additional legislative proposals to address rising drug costs H.R. 1559, "340B Protection and Accountability Act" Additional legislative proposals modifying the 340B program S.1895, Lower Health Care Costs Act- provisions related to surprise billing and provider/payer agreements S. 1531, "STOP Surprise Medical Bills Act" H.R. 3630, "No Surprises Act" H.R.5826, "Consumer Protections Against Surprise Medical Bills Act of 2020" Other proposals to address surprise billing Proposals to strengthen the health care system and achieve ACA market stability Legislation aimed at combating COVID-19 - provisions related to healthcare and hospitals H.R. 925, "Health and Economic Recovery Omnibus Emergency Solutions Act (HEROS Act 2.0) H.R. 133, "Consolidated Appropriations Act, 2021" - provisions related to COVID-response and hospitals Legislative proposals aimed at combating coronavirus

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- Patent Trade Office reforms - H.R.1499 "Protecting Consumer Access to Generic Drugs Act of 2019", regarding all provisions - S. 1419, "Early Participation in Regulations Act of 2019", regarding all provisions

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

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

Legislation and proposals related to the COVID-19 crisis; HR 3199-Terminating the Extension of Rights Misappropriated Act of 2019; S.64-Preserve Access to Affordable Generic & Biosimilars Act; HR 1499-Protecting Consumer Access to Generic Drugs Act; HR 1344-Competitive Drugs Act of 2019; HR 938-Bringing Low Cost Options & Competition While Keeping Incentives for New Generics Act ("BLOCKING Act"); HR 1506-Fair & Immediate Release of Generic Drugs Act; HR 1520-Purple Book Continuity Act; HR 1503-Orange Book Transparency Act; S.344/HR 990-Hatch-Waxman Integrity Act; Stronger Patents Act; S.1895-Lower Health Care Costs Act; S. 2543-Prescription Drug Pricing Reduction Act; HR 3-Elijah E Cummings Lower Drug Costs Now Act; Administration review of drug pricing policies; Proposals to improve pharmaceutical supply-chain vlunterabilities; HR 4597-Acting to Cancel Copays & Ensure Substantial Savings for Biosimilars (ACCESS) Act; HR 4455-Bolstering Innovative Options to Save Immediately on Medicines (BIOSIMS) Act; HR 6179-Lowering Costs for Taxpayers & Medicare Seniors with Biosimilars; HR 4629-Star Ratings for Biosimilars Act.

Client expense: $610,000 · Firm income: Not reported

Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), SENATE, White House Office

S. 474, Stop the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act; H.R. 447 / S. 97, Affordable and Safe Prescription Drug Importation Act; S. 61 / H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 102 / H.R. 465, Prescription Drug Price Relief Act of 2019; H.R.1478, Affordable Insulin Act of 2019; S. 3, Keeping Health Insurance Affordable Act of 2019; H.R 965 / S. 340, CREATES Act of 2019; H.R. 1332, Fair Care Act of 2019; S. 637, CURE High Drug Prices Act; H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019; S. 657, A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits; S. 709, Prescription Drug Pricing Dashboard Act; S. 977, Transparent Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act; H.R. 2296, FAIR Drug Pricing Act of 2019; H.R. 3947, the Competition Prescription Act of 2019; H.R. 2279, the Safe Step Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; S. 2543, the Prescription Drug Pricing Reduction Act of 2019; H.R. 19 / S. 3129, the Lower Costs, More Cures Act of 2019; S. 4199, the Prescription Drug Pricing Reduction Act of 2020

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

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

S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1499: Protecting Consumer Access to Generic Drugs Act Cell, gene and radioligand therapies 340B Drug Discount Program Drug Importation Outcomes based Contracting/Value based arrangements Orphan Drugs Medicaid Payment Reform AMP Cap S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues PDUFA, BSUFA, GDUFA Drug vial size policy issues Pharmaceutical supply chain H.R. 4710 - Pharmaceutical Independence Long-Term Readiness Reform Act S. 3635 - Protecting our Pharmaceutical Supply Chain from China Act of 2020 S. 3538 - Strengthening Americas Supply Chain and Medical Security Act H.R. 6431 - Made in America Emergency Preparedness Act HR 6080 - Prevent Drug Shortages Act S. 3432 - Securing Americas Medicine Cabinet Act of 2020 H.R. 6670 - Prescription for American Drug Independence Act of 2020 H.R. 6930 - MADE in America Act HR 4439 - Creating Hope Reauthorization Act Pharmaceutical quality COVID 19 H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 S. 3370 - Coronavirus Vaccine Act CARES Act, Pub. L. 116-136 H.R. 6080 - Preventing Drug Shortages Act Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Diversity in Clinical Trials FY 2021 Labor-HHS Appropriations Cures 2.0 Energy and Commerce RFI Part B Home Infusion Notice of Benefit Payment Parameters (NBPP) Priority Review Voucher (PRV) H.R. 4400 - The Advancing Education on Biosimilars Act of 2019 Vaccines 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, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Medicaid Generics Penalty fix HR 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act H.R.2374 - Stop STALLING Act H.R. 5239 - Prescription Drug Price Reporting Act H.R. 6258 - Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 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 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 H.R. 6395/S. 4049 - National Defense Authorization Act for Fiscal Year 2021 HHS PREP Act declaration relating to COVID-19 Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues FDA modernization 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 COVID-19 policy issues Transparency Issues Policy Issue H.R. 2477 - Beneficiary Enrollment Notification and the Eligibility Simplification (BENES) Act of 2019 H.R. 6800 - Heroes Act

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

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

Medicare Part D coverage and reimbursement Value of Prescription Drugs Innovative Payment Model (VBAs) Price Transparency Medicaid and 340B issues & drug discount program H.R. 1499, Protecting Consumer Access to Generic Drugs Act S. 1416, Affordable prescriptions for Patients Act H.R. 107, To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs ANPRM: Importation of Prescription drugs and Most Favored Nations

Client expense: $680,000 · Firm income: Not reported

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

S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 1520, Purple Book Continuity Act of 2019 H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 S. 1224, The Stop STALLING Act S. 1416, The Affordable Prescriptions for Patients Act S.659 - the Biologics Patent Transparency Act H.R. 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics H.R. 5133 Affordable Prescriptions for Patients Through Promoting Competition H.R. 3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2374 Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act H.R. 2375 Preserve Access to Affordable Generics and Biosimilars Act Patent eligibility reform, no specific bill

Client expense: $2,560,000 · Firm income: Not reported

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

Biosimilars, no specific bill Prescription drug value issues, no specific bill FDA issues, no specific bill S. 657 Drug Price Transparency Act S. 658 Accelerated Drug Approval for Prescription Therapies Act S. 660 Efficiency and Transparency in Petitions Act S. 1895, Lower Health Care Costs Act, a comprehensive bill designed to improve healthcare transparency and reduce healthcare costs, including prescription drugs H.R. 1499, Protecting Consumer Access Generic Drugs Act H.R. 1344, Competitive Deals Resulting in Unleashed Generics and Savings (DRUGS) Act S. 1169, Ensuring Timely Access to Generics Act S. 1617, Second Look at Drug Patents Act H.R. 1520, Purple Book Continuity Act S. 977, Transparent Drug Pricing Act S. 102, Prescription Drug Price Relief Act S. 659, Biologic Patent Transparency Act H.R. 1503, Orange Book Transparency Act H.R. 2296, Fair Accountability and Innovative Research (FAIR) Drug Pricing Act S. 1664, Prescription Drug Price Reporting Act S.659 - the Biologics Patent Transparency Act Supply Chain Issues, no specific bill

Client expense: $2,560,000 · Firm income: Not reported

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

Legislation and regulations related to pharmaceuticals and medical products, and access to affordable medicines; Coronavirus impact and response; pharmaceutical supply chain; policies impacting Medicare coverage and reimbursement for prescription drugs; H.R.938, BLOCKING Act of 2019; H.R.1499, Protecting Consumer Access to Generic Drugs Act of 2019; H.R.5444, Lower Insulin Costs Now Act; Implementation of H.R.6201, Families First Coronavirus Response Act (P.L.116-127); Implementation of H.R.748, CARES Act (P.L.116-136); H.R.6800, The Heroes Act; Implementation of H.R.266, Paycheck Protection Program and Health Care Enhancement Act (P.L.116-139); H.R.8337, Continuing Appropriations Act, 2021 and Other Extensions Act; H.R.6482/S.3537/S.3635, Protecting Our Pharmaceutical Supply Chain from China Act of 2020; H.R.6431, Made in America Emergency Preparedness Act; H.R.133, Making consolidated appropriations for the fiscal year ending September 30, 2021, providing coronavirus emergency response and relief, and for other purposes (P.L.116-260).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE