Lower Costs, More Cures Act of 2019

H.R. 3, (117th Cong.) Elijah E. Cummings Lower Drug Costs Now Act H.R. 19, (117th Cong.) Lower Costs, More Cures Act of 2021 H.R. 830, Help Ensure Lower Patient (HELP) Copays Act H.R. 1503/S. 2916, Prescription Information Modernization Act of 2023 H.R. 1550, (117th Cong.) PREVENT HPV Cancers Act of 2021 H.R. 2679, Pharmacy Benefits Manager Accountability Act H.R. 2691, Transparent Prices Required to Inform Consumer and Employers (Transparent PRICE) Act H.R. 2816, Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 2940/S. 1355, Pioneering Antimicrobial Subscriptions To End Upsurging Resistance Act (PASTEUR) Act of 2023 H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3285, Fairness for Patient Medications Act H.R. 4368/S. 2131, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 H.R. 4895, Lowering Drug Costs for American Families Act H.R. 5376/S. 2474, Share the Savings with Seniors Act H.R. 6283, Delinking Revenue from Unfair Gouging (DRUG) Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 1339, Pharmacy Benefit Manager Reform Act S. 1895 (116th Congress) Lower Health Care Costs Act S. 2333, Pandemic and All-Hazards Preparedness and Response Act S. 2543 (116th Congress) Prescription Drug Pricing Reduction Act of 2019 Issues relating to, 340B program integrity; 340B of the Public Health Services Act; 340B issues; 340B drug pricing program; Drug pricing; Drug pricing and reimbursement issues; Anti-microbial Resistance; Cost and value of medicines; Respiratory Syncytial Virus (RSV) immunization; Vaccines catch up; Vaccines issues; Package inserts, labeling issues, and E-Labeling authorization legislation; Pharmaceutical Supply Channel issues; Drug shortage issues; Inflation Reduction Act (P.L. 117-169), issues relating to drug pricing provisions; Issues related to the Patent and Trademark Law Amendments Act (PL 96-517); FY-2023 Budget and Appropriations Legislation; Intellectual property protection and trade issues; WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; WTO IP Waiver for COVID therapeutics Animal Health; Animal Health Technology Issues; Animal Health Policy Issues: ADUFA & Funding for Electronic Animal Traceability; One Health Issues; General pharmaceutical issues; Farm Bill 2023; Vaccine Injury Compensation Program (VICP); Diversity in clinical trials; Accelerated approval reform; Pharmacy Benefit Manager (PBM) policy issues; Pharmacy Benefit Manager reforms.

Client expense: $1,940,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3, (117th Cong.) Elijah E. Cummings Lower Drug Costs Now Act H.R. 19, (117th Cong.) Lower Costs, More Cures Act of 2021 H.R. 830, Help Ensure Lower Patient (HELP) Copays Act H.R. 1418/S. 1844, Animal Drug User Fee Amendments of 2023 H.R. 1503/S. 2916, Prescription Information Modernization Act of 2023 H.R. 1550, (117th Cong.) PREVENT HPV Cancers Act of 2021 H.R. 2679, Pharmacy Benefits Manager Accountability Act H.R. 2691, Transparent Prices Required to Inform Consumer and Employers (Transparent PRICE) Act H.R. 2816, Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 2940/S. 1355, Pioneering Antimicrobial Subscriptions To End Upsurging Resistance Act (PASTEUR) Act of 2023 H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3285, Fairness for Patient Medications Act H.R. 4368/S. 2131, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 H.R. 4895, Lowering Drug Costs for American Families Act H.R. 5376/S. 2474, Share the Savings with Seniors Act S. 150, Affordable Prescriptions for Patients Act of 2023 S. 2543 (116th Congress) Prescription Drug Pricing Reduction Act of 2019 S. 1895 (116th Congress) Lower Health Care Costs Act S. 2333, Pandemic and All-Hazards Preparedness and Response Act S. 4348, (117th Cong) Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 Issues relating to, 340B program integrity; 340B of the Public Health Services Act; 340B issues; 340B drug pricing program; Drug pricing; Anti-microbial Resistance; Vaccines; Cost and value of medicines; Respiratory Syncytial Virus (RSV) immunization; Vaccines catch up; Vaccines issues; Package inserts, labeling issues, and E-Labeling authorization legislation; Pharmaceutical Supply Channel issues; Drug shortage issues; Inflation Reduction Act (P.L. 117-169), issues relating to drug pricing provisions; FY-2023 Budget and Appropriations Legislation; Intellectual property protection and trade issues; WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; WTO IP Waiver for COVID therapeutics Animal Health; Animal Health Technology Issues; Animal Health Policy Issues: ADUFA & Funding for Electronic Animal Traceability; Animal Drug User Fee Reauthorization; One Health Issues; General pharmaceutical issues; Farm Bill 2023; Vaccine Injury Compensation Program (VICP); Step therapy requirements in commercial health plans; Diversity in clinical trials; Accelerated approval reform; Pharmacy Benefit Manager (PBM) policy issues Pharmacy Benefit Manager reforms.

Client expense: $2,130,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3, (117th Cong.) Elijah E. Cummings Lower Drug Costs Now Act H.R. 19, (117th Cong.) Lower Costs, More Cures Act of 2021 H.R. 830, Help Ensure Lower Patient (HELP) Copays Act H.R. 1418/S. 1844, Animal Drug User Fee Amendments of 2023 H.R. 1503/S. 1844, Prescription Information Modernization Act of 2023 H.R. 1550, (117th Cong.) PREVENT HPV Cancers Act of 2021 H.R. 2679, Pharmacy Benefits Manager Accountability Act H.R. 2691, Transparent Prices Required to Inform Consumer and Employers (Transparent PRICE) Act H.R. 2816, Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 2940/S. 1355, Pioneering Antimicrobial Subscriptions To End Upsurging Resistance Act (PASTEUR) Act of 2023 H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3285, Fairness for Patient Medications Act H.R. 4368/S. 2131, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 S. 150, Affordable Prescriptions for Patients Act of 2023 S. 2543 (116th Congress) Prescription Drug Pricing Reduction Act of 2019 S. 1895 (116th Congress) Lower Health Care Costs Act S. 4348, (117th Cong) Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 Issues relating to, 340B program integrity; 340B of the Public Health Services Act; 340B issues; 340B drug pricing program; Drug pricing; Anti-microbial Resistance; Vaccines; Cost and value of medicines; Respiratory Syncytial Virus (RSV) immunization; Vaccines catch up; Vaccines issues; Package inserts, labeling issues, and E-Labeling authorization legislation; Pharmaceutical Supply Channel issues; Drug shortage issues; Inflation Reduction Act (P.L. 117-169), issues relating to drug pricing provisions; FY-2023 Budget and Appropriations Legislation; Intellectual property protection; WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; WTO IP Waiver for COVID therapeutics Animal Health; Animal Health Technology Issues; Animal Health Policy Issues: ADUFA & Funding for Electronic Animal Traceability; Animal Drug User Fee Reauthorization; One Health Issues; General pharmaceutical issues; Farm Bill 2023; Vaccine Injury Compensation Program (VICP); Step therapy requirements in commercial health plans; Diversity in clinical trials; Accelerated approval reform; Pharmacy Benefit Manager (PBM) policy issues.

Client expense: $2,980,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 19 Lower Costs, More Cures Act of 2021 H.R. 1550, PREVENT HPV Cancers Act of 2021 H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 3173, Improving Seniors Timely Access to Care Act of 2021 H.R. 3655, Vaccine Injury Compensation Modernization Act of 2021 H.R. 3932/S. 2079, Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act of 2021 H.R. 4127, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2021 H.R. 5416, Give Kids a Chance Act H.R. 5801, Help Ensure Lower Patient (HELP) Copays Act H.R. 6584, Diverse and Equitable Participation in Clinical Trials (DEPICT) Act H.R. 6963, Accelerated Approval Integrity Act of 2022 H.R. 7559, Prescription Information Modernization Act of 2022 H.R. 7667, Food and Drug Amendments of 2022 S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019 S. 2774, Pride in Patent Ownership Act S. 2891, Restoring the America Invents Act S. 2543 (116th Congress) Prescription Drug Pricing Reduction Act of 2019 S. 1895 (116th Congress) Lower Health Care Costs Act S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 S. 4760, (116th Congress) The PASTEUR Act Issues relating to, 340B program integrity; 340B of the Public Health Services Act; 340B policy; 340B issues; 340B drug pricing program; Drug pricing; Drug Pricing reforms - international reference prices and government price setting; Anti-microbial Resistance; Vaccines; COVID-19 vaccines; COVID-19 therapeutics coverage issues; COVID-19 Pandemic response; Cost and value of medicines; Respiratory Syncytial Virus (RSV) immunization; Vaccines catch up; Vaccine provisions; Vaccine Issues, including return to care access, and pandemic-related policy; Package inserts, labeling issues, and E-Labeling authorization legislation; Pharmaceutical Supply Channel issues; Prescription Drug User Fees Act (P.L. 102-571); Inflation Reduction Act (P.L. 117-169), issues relating to drug pricing provisions; Animal Drug User Fee Act (P.L. 108-130); Prescription drug cost-sharing; Accelerated approval reform; Food and Drug Administration Safety and Landmark Advancements (FDASLA); Executive Order 13937, Access to Affordable Life-Saving Medications; FY-2023 Budget and Appropriations Legislation; Intellectual property protection; WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; Animal Health; Animal Health Technology Issues; One Health Issues; Rural Broadband Issues; General pharmaceutical issues; Farm Bill 2023; Animal Drug User Fee Act 2023 Vaccine Injury Compensation Program.

Client expense: $2,490,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, White House Office

CMS-9115-P Interoperability and Patient Access Final Rule HHS ONC RIN-0955-AA01 - 21st Century Cures Interoperability and Information Blocking Final Rule H.R. 3, Elijah E. Cummings Lower Drug Prices Now Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 (116th Congress) S. 2164, Lower Cost, More Cures Act of 2021 COVID-19 Response, including COVID-19 bills legislation implementation The Senate Amendment to H.R. 133, Consolidated Appropriations Act, 2021 (surprise billing legislation implementation) H.R. 19, Lower Cost, More Cures Act of 2021 Inflation Reduction Act of 2022 (HR 5376) Public Law No. 117-169 CMS-9908-IFC Surprise Billing, Part II; Interim Final Rule with Comment Period

Client expense: $1,220,000 · 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), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 19 Lower Costs, More Cures Act of 2021 H.R. 1550, PREVENT HPV Cancers Act of 2021 H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 3173, Improving Seniors Timely Access to Care Act of 2021 H.R. 3932/S. 2079, Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act of 2021 H.R. 4127, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act H.R. 5376, Inflation Reduction Act of 2022, including provisions relating to drug pricing H.R. 5416, Give Kids a Chance Act H.R. 5801, Help Ensure Lower Patient (HELP) Copays Act H.R. 6584, Diverse and Equitable Participation in Clinical Trials (DEPICT) Act H.R. 6963, Accelerated Approval Integrity Act of 2022 H.R. 7559, Prescription Information Modernization Act of 2022 H.R. 7667, Food and Drug Amendments of 2022 S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019 S. 2774, Pride in Patent Ownership Act S. 2891, Restoring the America Invents Act S. 2543 (116th Congress) Prescription Drug Pricing Reduction Act of 2019 S. 1895 (116th Congress) Lower Health Care Costs Act S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 Issues relating to, 340B program integrity; 340B of the Public Health Services Act; 340B policy; 340B issues; 340B drug pricing program; Drug pricing; Drug Pricing reforms - international reference prices and government price setting; Anti-microbial Resistance; Vaccines; COVID-19 vaccines; COVID-19 therapeutics coverage issues; COVID-19 Pandemic response; Cost and value of medicines; Respiratory Syncytial Virus (RSV) immunization; Vaccines catch up; Vaccine provisions; Vaccine Issues, including return to care access, and pandemic-related policy; Package inserts, labeling issues, and E-Labeling authorization legislation; Pharmaceutical Supply Channel Isssues; Prescription Drug User Fees Act (P.L. 102-571); Prescription drug cost-sharing; Accelerated approval reform; Food and Drug Administration Safety and Landmark Advancements (FDASLA); Executive Order 13937, Access to Affordable Life-Saving Medications; FY-2023 Budget and Appropriations Legislation; Intellectual property protection; WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; Animal Health; Animal Health Technology Issues; One Health Issues; Rural Broadband Issues; General pharmaceutical issues; Farm Bill 2023; Animal Drug User Fee Act 2023.

Client expense: $1,080,000 · Firm income: Not reported

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

CMS-9115-P Interoperability and Patient Access Final Rule HHS ONC RIN-0955-AA01 - 21st Century Cures Interoperability and Information Blocking Final Rule H.R. 3, Elijah E. Cummings Lower Drug Prices Now Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 (116th Congress) S. 2164, Lower Cost, More Cures Act of 2021 COVID-19 Response, including COVID-19 bills legislation implementation The Senate Amendment to H.R. 133, Consolidated Appropriations Act, 2021 (surprise billing legislation implementation) H.R. 19, Lower Cost, More Cures Act of 2021 Build Back Better Act (House and Senate) CMS-9908-IFC Surprise Billing, Part II; Interim Final Rule with Comment Period

Client expense: $1,240,000 · 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), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 19 Lower Costs, More Cures Act of 2021 H.R. 1550, PREVENT HPV Cancers Act of 2021 H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 3173, Improving Seniors Timely Access to Care Act of 2021 H.R. 3932/S. 2079, Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act of 2021 H.R. 4127, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act H.R. 5376, Build Back Better Act H.R. 5416, Give Kids a Chance Act H.R. 5801, Help Ensure Lower Patient (HELP) Copays Act H.R. 6584, Diverse and Equitable Participation in Clinical Trials (DEPICT) Act H.R. 6963, Accelerated Approval Integrity Act of 2022 H.R. 7559, Prescription Information Modernization Act of 2022 H.R. 7667, Food and Drug Amendments of 2022 S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019 S. 2774, Pride in Patent Ownership Act S. 2891, Restoring the America Invents Act S. 2543 (116th Congress) Prescription Drug Pricing Reduction Act of 2019 S. 1895 (116th Congress) Lower Health Care Costs Act S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 Issues relating to, 340B program integrity; 340B of the Public Health Services Act; 340B policy; 340B issues; 340B drug pricing program; Drug pricing; Drug Pricing reforms - international reference prices and government price setting; Anti-microbial Resistance; Vaccines; COVID-19 vaccines; COVID-19 therapeutics coverage issues; COVID-19 Pandemic response; Cost and value of medicines; Respiratory Syncytial Virus (RSV) immunization; Vaccines catch up; Vaccine provisions; Vaccine Issues, including return to care access, and pandemic-related policy; Package inserts, labeling issues, and E-Labeling authorization legislation; Pharmaceutical Supply Channel Isssues; Prescription Drug User Fees Act (P.L. 102-571); Prescription drug cost-sharing; Accelerated approval reform; Food and Drug Administration Safety and Landmark Advancements (FDASLA); Executive Order 13937, Access to Affordable Life-Saving Medications; FY-2023 Budget and Appropriations Legislation; Intellectual property protection; WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; Animal Health; Animal Health Technology Issues; One Health Issues; Rural Broadband Issues; General pharmaceutical issues; Farm Bill 2023; Animal Drug User Fee Act 2023.

Client expense: $2,610,000 · Firm income: Not reported

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

CMS-9115-P Interoperability and Patient Access Final Rule HHS ONC RIN-0955-AA01 - 21st Century Cures Interoperability and Information Blocking Final Rule H.R. 3, Elijah E. Cummings Lower Drug Prices Now Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 (116th Congress) S. 2164, Lower Cost, More Cures Act of 2021 COVID-19 Response, including COVID-19 bills legislation implementation The Senate Amendment to H.R. 133, Consolidated Appropriations Act, 2021 (surprise billing legislation implementation) H.R. 19, Lower Cost, More Cures Act of 2021 Build Back Better Act (House and Senate) CMS-9908-IFC Surprise Billing, Part II; Interim Final Rule with Comment Period

Client expense: $1,370,000 · 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), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 19 Lower Costs, More Cures Act of 2021 H.R. 1550, PREVENT HPV Cancers Act of 2021 H.R. 2061, Advancing Emergency Preparedness Through One Health Act of 2021 H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 3173, Improving Seniors Timely Access to Care Act of 2021 H.R. 3932/S. 2079, Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act of 2021 H.R. 4127, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2021 H.R. 5260, Reduced Costs and Continued Cures Act H.R. 5376, Build Back Better Act H.R. 5801, Help Ensure Lower Patient (HELP) Copays Act H.R. 6584, Diverse and Equitable Participation in Clinical Trials (DEPICT) Act H.R. 6963, Accelerated Approval Integrity Act of 2022 S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 2774, Pride in Patent Ownership Act S. 2891, Restoring the America Invents Act S. 2543 (116th Congress) Prescription Drug Pricing Reduction Act of 2019 S. 1895 (116th Congress) Lower Health Care Costs Act Issues relating to, 340B program integrity; 340B of the Public Health Services Act; 340B policy; 340B issues; 340B drug pricing program; Drug pricing; Drug Pricing reforms - international reference prices and government price setting; Anti-microbial Resistance; Vaccines; COVID-19 vaccines; COVID-19 therapeutics coverage issues; COVID-19 FDA Emergency Use Authorization issues; COVID-19 Pandemic response; Cost and value of medicines; Drug importation; Respiratory Syncytial Virus (RSV) immunization; Vaccines catch up; Vaccine provisions; Vaccine Issues, including return to care access, and pandemic-related policy; Package inserts, labeling issues, and E-Labeling authorization legislation; Prescription Drug User Fee Authorization (PDUFA VII); Prescription Drug User Fees Act (P.L. 102-571); Executive Order 13937, Access to Affordable Life-Saving Medications; FY-2023 Budget and Appropriations Legislation; Intellectual property protection; WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; Animal Health; One Health Issues; Rural Broadband Issues; General pharmaceutical issues; Farm Bill 2023; Animal Drug User Fee Act 2023.

Client expense: $2,120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare Advantage and Part D prescription drug programs; Issues related to Prescription Drug Rebates; Issues related to Dual Eligible and Medicare Advantage Special Needs Plans; Issues related to Social Determinants of Health (SDOH)/Health Equity; and Issues related to Telehealth. 117th Congress Budget Reconciliation/Biden Administration Build Back Better Plan COVID-19 American Rescue Plan American Jobs Plan Medicare Sequester COVID Moratorium Act (H.R. 315) Delay of the Prescription Drug Rebate Rule Ensuring Parity in MA for Audio-Only Telehealth Act of 2021 (S. 150) The Ensuring Parity in MA and PACE for Audio-Only Telehealth Act (HR 2166) Previous Congresses H.R. 3461, Community-Based Independence for Seniors Act H.R. 3877, Bipartisan Budget Act H.R. 19, Lower Costs, More Cures Act of 2019 S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 748, CARES Act H.R. 6800, HEROES Act H.R. 7659, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 S. 4318, American Workers, Families and Employers Assistance Act S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.4840, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 Bipartisan Coronavirus Relief and Omnibus Funding Bill H.R. 4074, Addressing Social Determinants in Medicare Advantage PL 115-123: H.R. 1892, The bipartisan Budget Act of 2018; H.R. 3168, To amend title XVIII of the Social Security Act to provide continued access to specialized Medicare Advantage plans for special needs individuals, and for other purposes; S. 870, CHRONIC Care Bill PL 115-271: H.R. 6, SUPPORT for Patients and Communities Act

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

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

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; P.L. 111-148, Patient Protection and Affordable Care Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Discussions related to CURES 2.0 potential legislation and provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R.1319, P.L. 117-2, American Rescue Plan Act of 2021 - provisions related to COVID-19 vaccinations, testing, treatment, Medicaid rebates, and prevention and mental health services; H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 464, Safe Step Act - provisions related to step therapy policy (House companion bill not yet introduced); S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act (116th Congress) - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 19, Lower Costs, More Cures Act of 2019 (116th Congress) - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening;

Client expense: $1,790,000 · Firm income: Not reported

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

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R.1319, P.L. 117-2, American Rescue Plan Act of 2021 - provisions related to COVID-19 vaccinations, testing, treatment, Medicaid rebates, and prevention and mental health services; H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 464, Safe Step Act - provisions related to step therapy policy (House companion bill not yet introduced); H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act (116th Congress) - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 19, Lower Costs, More Cures Act of 2019 (116th Congress) - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States;

Client expense: $690,000 · Firm income: Not reported

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare Advantage and Part D prescription drug programs; Issues related to Prescription Drug Rebates; Issues related to Dual Eligible and Medicare Advantage Special Needs Plans; Issues related to Social Determinants of Health (SDOH)/Health Equity; and Issues related to Telehealth. 117th Congress Budget Reconciliation/Biden Administration Build Back Better Plan COVID-19 American Rescue Plan American Jobs Plan Medicare Sequester COVID Moratorium Act (H.R. 315) Delay of the Prescription Drug Rebate Rule Ensuring Parity in MA for Audio-Only Telehealth Act of 2021 (S. 150) The Ensuring Parity in MA and PACE for Audio-Only Telehealth Act (HR 2166) Previous Congresses H.R. 3461, Community-Based Independence for Seniors Act H.R. 3877, Bipartisan Budget Act H.R. 19, Lower Costs, More Cures Act of 2019 S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 748, CARES Act H.R. 6800, HEROES Act H.R. 7659, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 S. 4318, American Workers, Families and Employers Assistance Act S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.4840, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 Bipartisan Coronavirus Relief and Omnibus Funding Bill H.R. 4074, Addressing Social Determinants in Medicare Advantage PL 115-123: H.R. 1892, The bipartisan Budget Act of 2018; H.R. 3168, To amend title XVIII of the Social Security Act to provide continued access to specialized Medicare Advantage plans for special needs individuals, and for other purposes; S. 870, CHRONIC Care Bill PL 115-271: H.R. 6, SUPPORT for Patients and Communities Act

Client expense: $140,000 · Firm income: Not reported

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

116th Congress S. 1895, The Lower Health Care Costs Act, Sec. 306 Health Plan Oversight of PBMs; 116th Congress H.R. 19-Lower Cost, More Cures Act, provisions on drug prices and Part D cost-sharing; 116th Congress H.R. 3-Elijah E. Cummings Lower Drug Costs Act Now,--provisions establishing drug pricing and Part D cost sharing; Value-based contracting for pharmaceuticals; 116th Congress H.R. 5304, PBM Transparency in Prescription Drug Costs Act,--provisions related to PBM contracting; education on the value of biosimilars; outreach on PBMs role in social determinants of health and education and outreach on drug patent thickets and other pharmaceutical anticompetitive behavior; S.Con.Res.14 - A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031 provisions related to drug pricing and a change to the safe harbor rules for drug rebates.

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

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

S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program S.4796, The Fair Care Act of 2020 - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value

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

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

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

H.R. 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

Issues related to Medicare Part D policies, including patient access, non-interference and rebate policy issues. Drug costs and pricing issues. Transparency policy issues. H.R.3 Lower Drug Costs Now Act of 2019, H.R.19 Lower Costs, More Cures Act of 2019, S.2543 Prescription Drug Pricing Reduction Act, and S.3129 Lower Costs, More Cures. General issue on the need for the Centers for Medicare & Medicaid Services to increase awareness around the need for screening and treatment for various cancers during the Covid-19 pandemic (no specific bills).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; P.L. 111-148, Patient Protection and Affordable Care Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Discussions related to CURES 2.0 potential legislation and provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R.1319, P.L. 117-2, American Rescue Plan Act of 2021 - provisions related to COVID-19 vaccinations, testing, treatment, Medicaid rebates, and prevention and mental health services; H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 464, Safe Step Act - provisions related to step therapy policy (House companion bill not yet introduced); S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act (116th Congress) - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 19, Lower Costs, More Cures Act of 2019 (116th Congress) - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening;

Client expense: $1,890,000 · Firm income: Not reported

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

116th Congress S. 1895, The Lower Health Care Costs Act, Sec. 306 Health Plan Oversight of PBMs ; 116th Congress HR 19-Lower Cost, More Cures Act, provisions on drug prices and Part D cost-sharing; 116th Congress HR 3-Elijah E. Cummings Lower Drug Costs Act Now, --Provisions establishing drug pricing and Part D cost sharing; S. 464/H.R. 2163, Safe Step Act,-Amending ERISA to specify exceptions for medication step therapy; Value-based contracting for pharmaceuticals; 116th Congress H.R. 5304, PBM Transparency in Prescription Drug Costs Act,-provisions related to PBM contracting; S. 164/P.S. 117-8 Advancing Education on Biosimilars Act of 2021-provisions related to an FDA campaign for prescriber education on biosimilars; S. 415/P.L. 117-9, A bill to clarify the meaning of a new chemical entity by the FDA; ; potential suspension of pharmacy audits during the public health emergency and reform of the orphan drug act; measures to combat pharma patent thickets

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

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

Issues related to Medicare Advantage and Part D prescription drug programs; Issues related to Prescription Drug Rebates; Issues related to Dual Eligible and Medicare Advantage Special Needs Plans; Issues related to Social Determinants of Health (SDOH)/Health Equity; and Issues related to Telehealth. 117th Congress COVID-19 American Rescue Plan American Jobs Plan Medicare Sequester COVID Moratorium Act (H.R. 315) Delay of the Prescription Drug Rebate Rule Ensuring Parity in MA for Audio-Only Telehealth Act of 2021 (S. 150) The Ensuring Parity in MA and PACE for Audio-Only Telehealth Act (HR 2166) Previous Congresses H.R. 3461, Community-Based Independence for Seniors Act H.R. 3877, Bipartisan Budget Act H.R. 19, Lower Costs, More Cures Act of 2019 S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 748, CARES Act H.R. 6800, HEROES Act H.R. 7659, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 S. 4318, American Workers, Families and Employers Assistance Act S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.4840, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 Bipartisan Coronavirus Relief and Omnibus Funding Bill H.R. 4074, Addressing Social Determinants in Medicare Advantage PL 115-123: H.R. 1892, The bipartisan Budget Act of 2018; H.R. 3168, To amend title XVIII of the Social Security Act to provide continued access to specialized Medicare Advantage plans for special needs individuals, and for other purposes; S. 870, CHRONIC Care Bill PL 115-271: H.R. 6, SUPPORT for Patients and Communities Act

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

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

H.R. 3: Lower Drug Costs Now Act of 2019 [116th Congress] H.R. 19: Lower Costs, More Cures Act of 2019 [116th Congress] H.R. 1167: Advancing Enrollment and Reducing Drug Costs Act of 2021 - Provisions related to Part D H.R. 1227: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference H.R. 1976: To establish an improved Medicare for All national health insurance program - Provisions related to Part D and non-interference H.R. 2010: To amend the Patient Protection and Affordable Care Act to establish a public health insurance option - Provisions related to Part D and non-interference H.R. 2071: To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - Provisions related to Part D and non-interference H.R. 2139: To amend title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes - Provisions related to Part D and non-interference H.R. 2170: To amend title XIX of the Social Security Act to improve access to adult vaccines under Medicaid - Provisions related to COVID-19 vaccines S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference S. 833: A bill to amend XVIII of the Social Security Act to allow the Secretary of Health and Human Services to negotiate fair prescription drug prices under part D of the Medicare program - Provisions related to Part D and non-interference S. 983: A bill to amend the Patient Protection and Affordable Care Act to establish a public health insurance option, and for other purposes - Provisions related to Part D and non-interference Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related policy issues Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans Calendar Year (CY) 2022 Request for Applications (RFA) for the Part D payment Modernization Model - Part D Formulary Flexibility Final Rule; Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements Final Rule; Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees

Client expense: $1,800,000 · Firm income: Not reported

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

Issues related to Medicare Part D policies, including patient access, non-interference and rebate policy issues. Drug costs and pricing issues. Transparency policy issues. H.R.3 Lower Drug Costs Now Act of 2019, H.R.19 Lower Costs, More Cures Act of 2019, S.2543 Prescription Drug Pricing Reduction Act, and S.3129 Lower Costs, More Cures. General issue on the need for the Centers for Medicare & Medicaid Services to increase awareness around the need for screening and treatment for various cancers during the Covid-19 pandemic (no specific bills).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

CMS-9115-P Interoperability and Patient Access Final Rule HHS ONC RIN-0955-AA01 - 21st Century Cures Interoperability and Information Blocking Final Rule H.R. 3, Lower Drug Costs Now Act of 2019 (116th Congress) S. 2543, Prescription Drug Pricing Reduction Act of 2019 (116th Congress) S. 3129, Lower Cost, More Cures Act of 2019 (116th Congress) H.R. 6800, Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act S. 4775, Delivering Immediate Relief to Americas Families, Schools and Small Business Act COVID-19 Response, including COVID-19 bills legislation implementation The Senate Amendment to H.R. 133, Consolidated Appropriations Act, 2021 (surprise billing legislation implementation) H.R. 1319, American Rescue Plan Act of 2021; P.L. 117-2 H.R. 19, Lower Cost, More Cures act of 2019 (116th Congress)

Client expense: $1,080,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

AMP Cap Anti-Kickback Statute policy issues ASP reporting policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Drug Pricing Drug wastage rebates policy issues Innovative Pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Medicaid Medicaid rebates and waiver policy issues Medicare Part A, B and D Outcomes based Contracting/value based arrangements Patient Cost-Sharing and Smoothing Reimbursement for cell therapy products Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals Transparency policy issues Tenncare III 1115 Medicaid Demonstration - Closed formulary issues S.2543: Prescription Drug Pricing Reduction Act of 2019 [116th Congress] H.R. 3: Lower Drug Costs Now Act of 2019 [116th Congress] H.R. 19: Lower Costs, More Cures Act of 2019 [116th Congress] S. 386/H.R. 1227: Medicare-X Choice Act of 2021

Client expense: $2,170,000 · 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

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

S.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program S.4796, The Fair Care Act of 2020 - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value

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

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

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

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

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

H.R. 3: Lower Drug Costs Now Act of 2019 [116th Congress] H.R. 19: Lower Costs, More Cures Act of 2019 [116th Congress] H.R. 1167: Advancing Enrollment and Reducing Drug Costs Act of 2021 - Provisions related to Part D H.R. 1227: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference H.R. 1976: To establish an improved Medicare for All national health insurance program - Provisions related to Part D and non-interference H.R. 2010: To amend the Patient Protection and Affordable Care Act to establish a public health insurance option - Provisions related to Part D and non-interference H.R. 2071: To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - Provisions related to Part D and non-interference H.R. 2139: To amend title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes - Provisions related to Part D and non-interference H.R. 2170: To amend title XIX of the Social Security Act to improve access to adult vaccines under Medicaid - Provisions related to COVID-19 vaccines S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference S. 833: A bill to amend XVIII of the Social Security Act to allow the Secretary of Health and Human Services to negotiate fair prescription drug prices under part D of the Medicare program - Provisions related to Part D and non-interference S. 983: A bill to amend the Patient Protection and Affordable Care Act to establish a public health insurance option, and for other purposes - Provisions related to Part D and non-interference Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related policy issues Tenncare III 1115 Medicaid Demonstration - Closed formulary policy issues Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations Calendar Year (CY) 2022 Request for Applications (RFA) for the Part D payment Modernization Model - Part D Formulary Flexibility Final Rule; Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements Final Rule; Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees

Client expense: $8,540,000 · Firm income: Not reported

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

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; Discussions related to amending P.L. 97-414, Orphan Drug Act; Issues related to global pharmaceutical supply chain operations and manufacturing locations; Bayh-Dole march-in rights policy issues; 42 USC 1320a-7b, Anti-Kickback Statute; 42 USC 1395nn, Stark Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; H.R.1319, P.L. 117-2, American Rescue Plan Act of 2021 - provisions related to COVID-19 vaccinations, testing, treatment, Medicaid rebates, and prevention and mental health services; H.R. 2017, S. 883, To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - provisions related to Part D and drug pricing negotiation; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 464, Safe Step Act - provisions related to step therapy policy (House companion bill not yet introduced); H.R. 1730, S. 670, The STAT Act - The Speeding Therapy Access Today Act of 2021 - provisions related to establishment of a Rare Disease Center of Excellence within FDA; S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act (116th Congress) - provisions related to prescription drug vial sizes and rebates; S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (116th Congress) - provisions related to lower prescription drug prices and transparency of pharmaceutical prices and transactions; H.R. 19, Lower Costs, More Cures Act of 2019 (116th Congress) - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States;

Client expense: $650,000 · Firm income: Not reported

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

Implementation of S.2003 of the SUPPORT Act of Patients and Communities Act, provisions related to the implementation of Every Prescription Conveyed Securely Act. Final Rule, Department of Health and Human Services: Office of Inspector General, issued November 20, 2020 entitled 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 Services Fees, outreach on pharmacy direct and indirect remuneration in Medicare Part D. 116th Congress HR 19, Lower Cost, More Cures Act, provisions on drug prices and Part D cost-sharing. 116th Congress HR 3, Elijah E. Cummings Lower Drug Costs Act Now, provisions establishing drug pricing and Part D cost sharing; value-based contracting for pharmaceuticals.

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

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

116th Congress S.1895, The Lower Health Care Costs Act. Sec.306 Health Plan Oversight of PBMs. 116th Congress HR 19, Lower Cost, More Cures Act, provisions on drug prices and Part D cost-sharing. 116th Congress HR 3, Elijah E. Cummings Lower Drug Costs Act Now, provisions establishing drug pricing and Part D cost sharing.

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

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

Issues related to Medicare Advantage and Part D prescription drug programs; Issues related to Prescription Drug Rebates; Issues related to Dual Eligible and Medicare Advantage Special Needs Plans; Issues related to Social Determinants of Health (SDOH)/Health Equity; and Issues related to Telehealth. 117th Congress COVID-19 American Rescue Plan American Jobs Plan Medicare Sequester COVID Moratorium Act (H.R. 315). Delay of the Prescription Drug Rebate Rule Ensuring Parity in MA for Audio-Only Telehealth Act of 2021 (S. 150) The Ensuring Parity in MA and PACE for Audio-Only Telehealth Act (HR 2166) Previous Congresses H.R. 3461, Community-Based Independence for Seniors Act H.R. 3877, Bipartisan Budget Act H.R. 19, Lower Costs, More Cures Act of 2019 S. 3013, Encouraging Innovative Benefit Design to Lower Costs for Seniors Act H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201, Families First Coronavirus Response Act H.R. 748, CARES Act H.R. 6800, HEROES Act H.R. 7659, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 S. 4318, American Workers, Families and Employers Assistance Act S. 4199, Prescription Drug Pricing Reduction Act of 2020 S.4840, Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 Bipartisan Coronavirus Relief and Omnibus Funding Bill PL 115-123: H.R. 1892, The bipartisan Budget Act of 2018; H.R. 3168, To amend title XVIII of the Social Security Act to provide continued access to specialized Medicare Advantage plans for special needs individuals, and for other purposes; S. 870, CHRONIC Care Bill PL 115-271: H.R. 6, SUPPORT for Patients and Communities Act

Client expense: $270,000 · Firm income: Not reported

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

H.R. 1570 / S. 668 - Removing Barriers to Colorectal Cancer Screening Act of 2019. Opposition to H.R. 2143 - Promoting Integrity in Medicare Act of 2019. Support for H.R. 2282 / S. 966 Medicare Care Coordination Improvement Act of 2019. Opposition to step therapy requirement in Medicare Advantage. Support of proposed rules, Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations (84 FR 55766) and Medicare and State Healthcare Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements (84 FR 55694). S. 2543, the Prescription Drug Pricing Reduction Act of 2019, sec. 102; and S. 3129/H.R. 19, the Lower Costs, More Cures Act of 2019. The Public Health and Social Services Emergency Fund in H.R. 748, the CARES Act.

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

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

H.R. 19- Lower Costs More Cures Act S. 2543- Prescription Drug Pricing Reduction Act Make changes to Medicare by adding an out-of-pocket maximum for beneficiaries and adjust the payment liability for stakeholders including insurers, beneficiaries, drug manufacturers, and the Medicare system

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Part B payment reform. S. 2543, the Prescription Drug Pricing Reduction Act of 2019 and S. 3129/H.R. 19, the Lower Costs, More Cures Act of 2019. H.R. 748, the CARES Act. Coronavirus relief waivers.

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

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

H.R. 1570 / S. 668 - Removing Barriers to Colorectal Cancer Screening Act of 2019. Opposition to H.R. 2143 - Promoting Integrity in Medicare Act of 2019. Support for H.R. 2282 / S. 966 Medicare Care Coordination Improvement Act of 2019. Opposition to step therapy requirement in Medicare Advantage. Support of proposed rules, Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations (84 FR 55766) and Medicare and State Healthcare Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements (84 FR 55694). S. 2543, the Prescription Drug Pricing Reduction Act of 2019, sec. 102; and S. 3129/H.R. 19, the Lower Costs, More Cures Act of 2019. Implementation of the Public Health and Social Services Emergency Fund in H.R. 748.

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

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

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; Communications with DFC regarding Project Warp Speed - provisions related to use of plasma to treat COVID-19; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; S.4160 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - provisions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; VA MISSION Act of 2018 (P.L. 115 - 182) - provisions related to healthcare coverage after dischange from active duty; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heroes Act - provisions related to tax issues and plasma treatments; Discussions related to Most Favored Nation/International Reference Pricing including the Executive Order; E.O. 13937, Access to Affordable Life-Saving Medications; E.O. 13938, Increasing Drug Importation to Lower Prices for American Patients; E.O. 13939, Lowering Drug Prices by Eliminating Kickbacks to Middlemen; E.O. 13947, 13948, Lowering Drug Prices by Putting America First; E.O. 13944, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States; E.O. 13951, An America-First Healthcare Plan; E.O 13950, Combating Race and Sex Stereotyping.

Client expense: $1,190,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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: $2,030,000 · 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.2543: Prescription Drug Pricing Reduction Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.19: Lower Costs, More Cures Act of 2019. S.551, REFUND Act of 2019 HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program - Drug pricing issues - Prescription Drug User Fee Act reauthorization - Issues related to prescription drug value

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