Pharmacy Benefit Manager Transparency Act of 2023

1)Oppose S. 127 Pharmacy Benefit Manager (PBM) Transparency Act and its empowerment of the FTC.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

1)Oppose S. 127 Pharmacy Benefit Manager (PBM) Transparency Act and its empowerment of the FTC.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1613, S. 1038 - Drug Price Transparency in Medicaid Act, including issues related to PBM Spread Pricing; S. 260, H.R. 704 - Promoting Access to Diabetic Shoes Act; H.R. 1770 - Equitable Community Access to Pharmacist Services Act; S. 127 - Pharmacy Benefit Manager Transparency Act; Issues related to Food as Medicine initiatives and pharmacy scope of practice; S. 1339 - Pharmacy Benefit Manager Reform Act; S. 2052 - Protect Patient Access to Pharmacies Act; H.R. 5378 - The Lower Costs, More Transparency Act; H.R. 2484 - Seniors Access to Critical Medications Act; S. 575 / H.R. 1317 - Improving Care and Access to Nurses Act

Client expense: $410,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Policy Development, SENATE

H.R.830, HELP Copays Act of 2023 S.127, Pharmacy Benefit Manager Transparency Act of 2023 H.R.3283, Fairness for Patient Medications Act S.1339, Pharmacy Benefit Manager Reform Act H.R.5378, Lower Costs, More Transparency Act S.2973, Modernizing and Ensuring Equity Act H.R.8412, Clinical Trials Modernization Act

Client expense: $870,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 618, Improving Access to Workers Compensation for Injured Federal Workers Act, all provisions S. 131, Improving Access to Workers Compensation for Injured Federal Workers Act of 2023, all provisions H.R. 2923, Living Donor Protection Act of 2023, all provisions S. 1384, Living Donor Protection Act of 2023, all provisions H.R. 1359, Modernizing Opioid Treatment Access Act, all provisions S. 644, Modernizing Opioid Treatment Access Act, all provisions H.R. 766, Dr. Michael C. Burgess Preventive Health Savings Act, all provisions S. 114, Dr. Michael C. Burgess Preventive Health Savings Act, all provisions H.R. 2630, Safe Step Act, all provisions S. 652, Safe Step Act, all provisions S. 113, Prescription Pricing for the People Act of 2023, all provisions H.R. 7153, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, all provisions S. 3679, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, all provisions S. 2840, Bipartisan Primary Care and Health Workforce Act, all provisions S. 127, Pharmacy Benefit Manager Transparency Act of 2023, all provisions H.R. 8325, Physician and Patient Safety Act, all provisions S. 4278, Physician and Patient Safety Act, all provisions H.R. 3417, Facilitating Accountability In Reimbursements (FAIR) Act, provisions relating to site neutral payments H.R. 6033, Supporting Patient Education And Knowledge (SPEAK) Act of 2024, all provisions H.R. 2411, National Nursing Workforce Center Act of 2023, all provisions H.R. 6230, Doctor Knows Best Act of 2023, all provisions S. 4349, A bill to require private health plans to provide for secure electronic transmission of prior authorization requests for prescription drugs, all provisions H.R. 6881, AI Foundation Model Transparency Act of 2023, all provisions S. 5271, A bill to require the Administrator of the Drug Enforcement Administration to temporarily exempt buprenorphine from the Suspicious Orders Report System for the remainder of the opioid public health emergency, all provisions H.R. 206, Healthy Technology Act of 2023, all provisions Supporting Healthy Moms and Babies Act/draft Dr. Paul Farmer Global Health Training Act/draft Telehealth/Licensure portability Telehealth/Reserve Health Readiness Program South Asians in United States/Cardiovascular disease/high mortality rates OBGYN data/Georgia Health information technology/interoperability (HTI-2) Laboratory developed tests Telehealth/data needs Data Privacy and Cybersecurity Health Insurance Portability and Accountability Act (HIPAA)/electronic records Mental health parity/addiction equity CHANGE Healthcare cyberattack Cybersecurity incident reporting Nutrition/sodium reduction Maternal mortality Reproductive health Health equity Digital Health/AI Misinformation regulation Medical debt

Client expense: $5,330,000 · Firm income: Not reported

Government targets: Consumer Financial Protection Bureau (CFPB), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), SENATE, Treasury, Dept of

S. 127, the PBM Transparency Act; S. 113, the Prescription Pricing for the People Act; Request for Information on "Consolidation in Health Care Markets [Docket No. ATR 102]";

Client expense: $340,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE

Pharmacy Benefit Manager Transparency Act S.127; PBM reform bills; H.R.3561 The PATIENT Act; S.2973 MEPA;

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Oppose S. 127 Pharmacy Benefit Manager Transparency Act's empowerment of the FTC. Support limits on HHS to use funds to set maximum nicotine levels or prohibit menthol cigarettes.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1692 / S 8, the Health Care Affordability Act; HR 2630 / S 652, the Safe Step Act; HR 3433 / S 2897, the Give Kids a Chance Act; HR 3503 / S 1701, The NIH Clinical Trial Diversity Act; HR 3991 / S 1624, the Gabriella Miller Kids First Act; HR 4363 / S 2213, Comprehensive Cancer Survivorship Act; HR 6003 / S 3103, the Medical Debt Relief Act; HR 6301 / S. 2039, The Cancer Drug Parity Act; HR 7383 / S 1214, the RARE Act; HR 8311 / S 4289, Medical Debt Cancellation Act; HR 824, the Telehealth Benefit Expansion for Workers Act; HR 1773, the Consumer Protection for Medical Debt Collections Act; HR 2813, Self-Insurance Protection Act; HR 2868, the Association Health Plans; HR 2880, the Protecting Patients Against PBM Abuses Act; HR 3799, CHOICE Arrangement Act; HR 3800, the Chronic Disease Flexible Coverage Act; HR 5609, the Advancing Health Savings Act; HR 5688, the Bipartisan HSA Improvement Act; HR 5687, the HSA Modernization Act; HR 6664, the Innovation in Pediatric Drugs Act; HR 6963, the Pediatric Cancer Drug Supply Chain Act; HR 7384, the Creating Hope Reauthorization Act; HR 8261, Preserving Telehealth, Hospital, and Ambulance Access Act; HR 8412, the Clinical Trial Modernization Act; HR 8574, the 340B ACCESS Act; HR 9129, Patient Debt Relief Act; S 113, the Prescription Pricing for the People Act; S 127, the Pharmacy Benefit Manager Transparency Act; S 1339, the Pharmacy Benefit Manager Reform Act; S 1542, the DRUG Act; S 1967 the Patients Before Middlemen Act; S 2243, the Palliative Care and Hospice Education and Training Act; S 2483, the Strengthening Consumer Protections and Medical Debt Transparency Act; S 2973, the Modernizing and Ensuring PBM Accountability Act; S 3167, Multiple Employer Welfare Arrangement (MEWA) Act; HR 9774 / S 5194, the Health Care Affordability Act; Legislation to protect insurance purchasers interacting with insurance brokers; Implementation of the No Surprises Act; Federal rulemaking related to Short-term Limited Duration Insurance (STLDI) plans; Efforts to extend and make permanent the current enhanced Advance Premium Tax Credits; Insurance appeals and denials; Federal rulemaking related to Association Health Plans; Consumer protections related to consumers who will lose insurance due to the end of certain federal Medicaid maintenance-of-effort requirements; FDA draft guidance related to dose optimization studies in clinical trials

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

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

Biosimilar Red Tape Elimination Act (S. 2305) Drug Patent Reform Pharmacy Benefit Manager (PBM) operations and practices, Spread Pricing, Rebates, Delinking Protecting Patients Against PBM Abuses Act (H.R. 2880) Drug Act (H.R. 6283) Robinson-Patman Act Reform Modernizing and Ensuring PBM Accountability (MEPA) Act (S.2973) Pharmacy Benefit Manager Transparency Act (S. 127) Pharmacy Benefit Manager Reform Act (S. 1339) Patients Before Middlemen Act (S.1967) Prescription Pricing for the People Act (S.113) Drug-Price Transparency for Consumers Act (S. 1250) Lower Cost, More Transparency Act (H.R. 5378) Continuing Resolution (H.R. 10545)

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

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

Supported H.R. 8574, 340B Affording Care for Committees and Ensuring a Strong Safety-net Act, which would establish oversight and transparency of the 340B program - while providing clear, practical, and achievable solutions to ensure the 340B program can be a force for good in the nations health care safety net. Supported H.R. 3799, The CHOICE Arrangement Act, which would allow employees to use money from their employer to buy a healthcare plan that works best for them. Supported H.R. 5378, the "Lower Costs, More Transparency Act," which will help small businesses lower health plan costs by increasing price transparency to facilitate direct primary care. Supported S. 127, Pharmacy Benefit Manager Transparency Act of 2023, which would prohibit pharmacy benefit managers (PBMs) from engaging in certain practices when managing the prescription drug benefits under a health insurance plan; including charging the plan a different amount than the PBM reimburses the pharmacy.

Client expense: Not reported · Firm income: $7,500

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 127 - Pharmacy Benefit Manager Transparency Act of 2023; S. 1339 - Pharmacy Benefit Reform Act; S. 1542 - DRUG Act; H.R. 1613 - Drug Price Transparency in Medicaid Act of 2023; H.R. 10362 - PBM Act of 2024.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1613, S. 1038 - Drug Price Transparency in Medicaid Act, including issues related to PBM Spread Pricing; S. 260, H.R. 704 - Promoting Access to Diabetic Shoes Act; H.R. 1770 - Equitable Community Access to Pharmacist Services Act; S. 127 - Pharmacy Benefit Manager Transparency Act; Issues related to Food as Medicine initiatives and pharmacy scope of practice; S. 1339 - Pharmacy Benefit Manager Reform Act; S. 2052 - Protect Patient Access to Pharmacies Act; H.R. 5378 - The Lower Costs, More Transparency Act

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

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Policy Development, SENATE

H.R. 1613 - Drug Price Transparency in Medicaid Act of 2023 - Rep. Carter, Earl - spread-pricing by PBMs for Medicaid H.R. 2880 - Protecting Patients Against PBM Abuses Act - Rep. Carter, Earl - PBM transparency H.R. 4818 - Treat and Reduce Obesity Act - Rep. Wenstrup, Brad - weight loss coverage H.R. 5372 - Expanding Seniors Access to Lower Cost Medicines Act of 2023 - Rep. Joyce, John - generic drugs, biosimilars cost H.R. 5378 - Lower Costs, More Transparency Act - Rep. McMorris Rodgers, Cathy - PBM transparency H.R. 5385 - Medicare PBM Accountability Act - Rep. Landsman, Greg McMorris - PBM transparency H.R. 6283 - DRUG Act - Rep. Miller-Meeks, Mariannette - PBM contracts H.R. 10445 - Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025 - Rep. Cole, Tom - PBM regulation S. 79 - Interagency Patent Coordination and Improvement Act of 2023 - Sen. Durbin, Richard - prescription drug patenting S. 113 - Prescription Pricing for the People Act of 2023 - Sen. Grassley, Chuck - PBM transparency S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 - Sen. Cantwell, Maria - PBM transparency S. 142 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - pharmacy and biosimilar prescription drugs S. 148 - Stop STALLING Act - Sen. Klobuchar, Amy - pharmacy market approval processes S. 150 - Affordable Prescriptions for Patients Act of 2023 - Sen. Cornyn, John - pharmacy and prescription drug prices, prevent patent thickets S. 574 - Increasing Prescription Drug Competition Act - Sen. Hassan, Maggie - closure of pharmaceutical patent loophole S. 652 - Safe Step Act - Sen. Murkowski, Lisa - medication step therapy protocol S. 954 - Affordable Insulin Now Act of 2023 - Sen. Warnock, Raphael - insulin pricing and cost sharing S. 1269 - INSULIN Act of 2023 - Sen. Shaheen, Jeanne - insulin pricing S. 1339 - Pharmacy Benefit Manager Reform Act - Sen. Sanders, Bernie - PBM transparency S. 1542 - DRUG Act - Sen. Marshall, Roger - PBM regulation S. 2973 - Modernizing and Ensuring PBM Accountability Act - Sen. Wyden, Ron - Plan implementation S. 3934 - Increasing Access to Biosimilars Act of 2023- Sen. Cornyn, John - Medicare drug access Issues related to the implementation of Inflation Reduction Act - Medicare negotiation; coverage of weight loss drugs; high priced drugs; patent reforms; Pharmacy Benefit Managers; and copay coupons.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response. FY2024 Defense Appropriations Act Fiscal 2024 Labor-HHS-Education Appropriations P.L. 116-136, CARES Act P.L. 113-5 Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) S. 127 - Pharmacy Benefit Manager Transparency Act H.R. 830 - The HELP Copays Act S. 1375 - HELP Copays Act H.R. 1202 - Resident Education Deferred Interest Act, or REDI Act S. 704 - REDI Act S. 665, HR 4942 - Conrad State 30 and Physician Access Reauthorization Act H.R. 2389 - Resident Physician Shortage Reduction Act S. 1302 - Resident Physician Shortage Reduction Act H.R. 2474 - Strengthening Medicare for Patients and Providers Act S. 652, H.R. 2630 - Safe Step Act S. 1339 - Pharmacy Benefit Manager Reform Act H.R. 2670 - National Defense Authorization Act H.R. 2816 - Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2679 - Pharmacy Benefits Manager Accountability Act H.R. 2474 - The Strengthening Medicare for Patients and Providers Act H.R.6371 - Provider Reimbursement Stability Act of 2023 S. 2764 - Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5391 - Protecting Patient Access to Cancer and Complex Therapies Act Appropriation legislation related to Medicare Physician Payments cuts implemented in 2024 Appropriations legislation related to the Congressionally Directed Medical Research Program Appropriations legislation related to the National Institutes of Health S. 705 - Specialty Physicians Advancing Rural Care (SPARC) Act H.R. 2761 - Specialty Physicians Advancing Rural Care (SPARC) Act H.R. 8702 - Improving Seniors Timely Access to Care Act of 2024 S. 4532 - Improving Seniors Timely Access to Care Act of 2024 H.R. 6664 - The Innovation in Pediatric Drugs Act S. 4349 - Electronic Prior Authorization for Prescription Drugs Act HR. 6487 - No Fees for EFTs Act S. 3805 - No Fees for EFTs Act S. 4935 - Physician Fee Stabilization Act H.R. 7623 - Telehealth Modernization Act S. 3967 - Telehealth Modernization Act H.R. 7153 - Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act S. 3679 - Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act H.R. 6545 - Physician Fee Schedule Update and Improvements Act H.R. 10545 - American Relief Act of 2025 H.R. 8774 - Department of Defense Appropriations Act, 2025 H.R. 9029 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response. FY2024 Defense Appropriations Act Fiscal 2024 Labor-HHS-Education Appropriations P.L. 116-136, CARES Act P.L. 113-5 Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) S. 127 - Pharmacy Benefit Manager Transparency Act H.R. 830 - The HELP Copays Act S. 1375 - HELP Copays Act H.R. 1202 - Resident Education Deferred Interest Act, or REDI Act S. 704 - REDI Act S. 665, HR 4942 - Conrad State 30 and Physician Access Reauthorization Act H.R. 2389 - Resident Physician Shortage Reduction Act S. 1302 - Resident Physician Shortage Reduction Act H.R. 2474 - Strengthening Medicare for Patients and Providers Act S. 652, H.R. 2630 - Safe Step Act S. 1339 - Pharmacy Benefit Manager Reform Act H.R. 2670 - National Defense Authorization Act H.R. 2816 - Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2679 - Pharmacy Benefits Manager Accountability Act H.R. 2474 - The Strengthening Medicare for Patients and Providers Act H.R.6371 - Provider Reimbursement Stability Act of 2023 S. 2764 - Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5391 - Protecting Patient Access to Cancer and Complex Therapies Act Appropriation legislation related to Medicare Physician Payments cuts implemented in 2024 Appropriations legislation related to the Congressionally Directed Medical Research Program Appropriations legislation related to the National Institutes of Health S. 705 - Specialty Physicians Advancing Rural Care (SPARC) Act H.R. 2761 - Specialty Physicians Advancing Rural Care (SPARC) Act H.R. 8702 - Improving Seniors Timely Access to Care Act of 2024 S. 4532 - Improving Seniors Timely Access to Care Act of 2024 H.R. 6664 - The Innovation in Pediatric Drugs Act S. 4349 - Electronic Prior Authorization for Prescription Drugs Act HR. 6487 - No Fees for EFTs Act S. 3805 - No Fees for EFTs Act S. 4935 - Physician Fee Stabilization Act H.R. 7623 - Telehealth Modernization Act S. 3967 - Telehealth Modernization Act H.R. 7153 - Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act S. 3679 - Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act H.R. 6545 - Physician Fee Schedule Update and Improvements Act H.R. 10545 - American Relief Act of 2025 H.R. 8774 - Department of Defense Appropriations Act, 2025 H.R. 9029 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response. FY2024 Defense Appropriations Act Fiscal 2024 Labor-HHS-Education Appropriations P.L. 116-136, CARES Act P.L. 113-5 Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) S. 127 - Pharmacy Benefit Manager Transparency Act H.R. 830 - The HELP Copays Act S. 1375 - HELP Copays Act H.R. 1202 - Resident Education Deferred Interest Act, or REDI Act S. 704 - REDI Act S. 665, HR 4942 - Conrad State 30 and Physician Access Reauthorization Act H.R. 2389 - Resident Physician Shortage Reduction Act S. 1302 - Resident Physician Shortage Reduction Act H.R. 2474 - Strengthening Medicare for Patients and Providers Act S. 652, H.R. 2630 - Safe Step Act S. 1339 - Pharmacy Benefit Manager Reform Act H.R. 2670 - National Defense Authorization Act H.R. 2816 - Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2679 - Pharmacy Benefits Manager Accountability Act H.R. 2474 - The Strengthening Medicare for Patients and Providers Act H.R.6371 - Provider Reimbursement Stability Act of 2023 S. 2764 - Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5391 - Protecting Patient Access to Cancer and Complex Therapies Act Appropriation legislation related to Medicare Physician Payments cuts implemented in 2024 Appropriations legislation related to the Congressionally Directed Medical Research Program Appropriations legislation related to the National Institutes of Health S. 705 - Specialty Physicians Advancing Rural Care (SPARC) Act H.R. 2761 - Specialty Physicians Advancing Rural Care (SPARC) Act H.R. 8702 - Improving Seniors Timely Access to Care Act of 2024 S. 4532 - Improving Seniors Timely Access to Care Act of 2024 H.R. 6664 - The Innovation in Pediatric Drugs Act S. 4349 - Electronic Prior Authorization for Prescription Drugs Act HR. 6487 - No Fees for EFTs Act S. 3805 - No Fees for EFTs Act S. 4935 - Physician Fee Stabilization Act H.R. 7623 - Telehealth Modernization Act S. 3967 - Telehealth Modernization Act H.R. 7153 - Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act S. 3679 - Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act H.R. 6545 - Physician Fee Schedule Update and Improvements Act H.R. 10545 - American Relief Act of 2025 H.R. 8774 - Department of Defense Appropriations Act, 2025 H.R. 9029 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025

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

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

Pharmacy Benefit Manager Bills- Pharmacy Benefit Manager Transparency Act (S. 127), PATIENT Act of 2023 (H.R.3561); Bills related to PBM transparency with implications for health plans like those managed by Mutual of Omaha

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 766: Dr. Michael C. Burgess Preventive Health Savings Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act 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. 3433: Give Kids a Chance Act of 2024 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4818: Treat and Reduce Obesity Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7024 Tax Relief for American Families and Workers Act of 2024 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 9096: Pharmacists Fight Back Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2477: Equitable Community Access to Pharmacist Services Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 3430: Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023 S. 5021: 340B PATIENTS Act of 2024 S. 5040: Protecting Patients from Deceptive Drugs Online Act S. 5459: Biosimilars Access and Affordability Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Artificial intelligence policy issues Vaccine provisions of the Inflation Reduction Act Policy issues related to vaccines

Client expense: $920,000 · Firm income: Not reported

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

S. 79/HR 1717 Interagency Patent Coordination and Improvement Act of 2023 S. 113 Prescription Pricing for the People Act of 2023 . S. 1250 Drug-price Transparency for Consumers Act S.127 Pharmacy Benefit Transparency Act S. 150 Affordable Prescriptions for Patients Act of 2023 S. 148 Stop STALLING Act S. 142 Preserve Access to Affordable Generics and Biosimilars Federal Trade Commission related issues, no specific bill Issues related to the Patent Act, no specific bill Issues related to March-In/Bayh Dole, WTO/TRIPS waiver, no specific bill Issues related to patent thickets/product hopping Issues related to obviousness/ double patenting S.2140 Patent Eligibility Restoration Act of 2023 S.2220/HR 4370 Promoting and Respecting Economically Vital American Innovation Leadership Act S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents H.R. 3858/S.1834: A bill to prohibit the President from negotiating or concluding any withdrawal, suspension, waiver, or modification to the Agreement on Trade-Related Aspects of Intellectual Property Rights without explicit authorization from Congress. H.R. 3535 Advancing Americas Interests Act H.R. 5475 Prohibiting Adversarial Patents Act of 2023 S.3385/HR 8333-- BIOSECURE Act BIOCOMPETE (no bill number)- Issues related to prohibiting the export of biotechnology to certain foreign entities Issues related to FDA/PTO coordination S.2780 Medication Affordability and Patent Integrity Act Issues related to skinny labeling S. 3583/HR 6986 To Address Patent Thickets S. 1956 Invent It Here, Make It Here Act S 5573 Skinny Labels, Big Savings Act

Client expense: $2,780,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable Care Act (ACA), ACA subsidies and tax credits; Telehealth/ telehealth flexibilities; Mental Health Care; Youth Mental Health; Site neutral payment reform; hospital billing; Transparency in coverage; Surprise Billing; Prior Authorization; Hospital Consolidation; Health Equity Index reward factor; Employer-provided health coverage; Cyber-attack & Cybersecurity; Provider Directories; Artificial Intelligence; Health Equity; Maternal Health; ACA fraud; 2025 Proposed NBPP/Individual Market/ACA exchanges; Rural healthcare; CMS Transforming Maternal Health (TMaH) model; Data Equity; No surprises enforcement S. 1451 Healthy Competition for Better Care Act To ban anticompetitive terms in facility and insurance contracts that limit access to higher quality, lower cost care. H.R.3120 - Healthy Competition for Better Care Act To ban anticompetitive terms in facility and insurance contracts that limit access to higher quality, lower cost care. S. 3548 Health Care PRICE Transparency Act To amend the Public Health Service Act to provide for hospital and insurer price transparency. H.R. 3305, Black Maternal Health Momnibus Act To end preventable maternal mortality, severe maternal morbidity, and maternal health disparities in the United States, and for other purposes. H.R.3838 - Preventing Maternal Deaths Reauthorization Act of 2023 To amend title III of the Public Health Service Act to reauthorize Federal support of States in their work to save and sustain the health of mothers during pregnancy, childbirth, and the postpartum period, to eliminate disparities in maternal health outcomes for pregnancy-related and pregnancy-associated deaths, to identify solutions to improve health care quality and health outcomes for mothers, and for other purposes. S.2415 - Preventing Maternal Deaths Reauthorization Act of 2023 To amend title III of the Public Health Service Act to reauthorize Federal support of States in their work to save and sustain the health of mothers during pregnancy, childbirth, and the postpartum period, to eliminate disparities in maternal health outcomes for pregnancy-related and pregnancy-associated deaths, to identify solutions to improve health care quality and health outcomes for mothers, and for other purposes. S.1869 - SITE Act To amend title XVIII of the Social Security Act and title XXVII of the Public Health Service Act to ensure fair billing practice for items and services furnished by off-campus hospital locations, to amend such title XVIII to provide for payments for graduate nursing education costs, and for other purposes. H.R.3417 - FAIR Act To ensure fair billing practices for items and services furnished by off-campus outpatient departments of a provider. H.R. 5378 Lower Costs, More Transparency Act To promote price transparency in the health care sector, and for other purposes. H.R.3630 - No Surprises Act To amend title XXVII of the Public Health Service Act to protect health care consumers from surprise billing practices, and for other purposes. H.R. 10545, American Relief Act, 2025 Making further continuing appropriations for the fiscal year ending September 30, 2025, and for other purposes. S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. S.1339 - Pharmacy Benefit Manager Reform Act

Client expense: $730,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE

Same-day billing restrictions in Medicaid; Medicare Advantage & MA Rate Notice H.R. 6860, Restore Protections for Dialysis Patients Act To amend title XVIII of the Social Security Act to clarify and preserve the breadth of the protections under the Medicare Secondary Payer Act. H.R. 5380 - To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage. To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage. S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. S.1339 - Pharmacy Benefit Manager Reform Act

Client expense: $730,000 · Firm income: Not reported

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

S. 127, the PBM Transparency Act; S. 113, the Prescription Pricing for the People Act; Request for Information on "Consolidation in Health Care Markets [Docket No. ATR 102]"; H.R.10362, the PBM Act of 2024;

Client expense: $412,000 · Firm income: Not reported

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE

HR 830/S 1375 - HELP Copays Act S 127 - Pharmacy Benefit Manager Transparency Act HR 2630/ S 652 - Safe Step Act HR 1770/S 2477 - Equitable Community Access to Pharmacist Services Act HR 2407/S 2085 - Medicare Multi-Cancer Early Detection Screening Coverage Act S 1246/HR 4895 - SMART Prices Act HR 4818/S 2407 - Treat and Reduce Obesity Act of 2023 Continuation of the Inflation Reduction Act Discussions regarding Health ACCESS Act (Health Accelerating Consumers Care by Expediting Self-Scheduling)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Biosimilar Red Tape Elimination Act (S. 2305) Drug Patent Reform Pharmacy Benefit Manager (PBM) operations and practices, Spread Pricing, Rebates, Delinking Protecting Patients Against PBM Abuses Act (H.R. 2880) Drug Act (H.R. 6283) Robinson-Patman Act Reform Modernizing and Ensuring PBM Accountability (MEPA) Act (S.2973) Pharmacy Benefit Manager Transparency Act (S. 127) Pharmacy Benefit Manager Reform Act (S. 1339) Patients Before Middlemen Act (S.1967) Prescription Pricing for the People Act (S.113) Drug-Price Transparency for Consumers Act (S. 1250) Lower Cost, More Transparency Act (H.R. 5378) Continuing Resolution (H.R. 10545)

Client expense: $1,110,000 · Firm income: Not reported

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

Issues related to S. 113, the Prescription Pricing for the People Act; S. 127, the Pharmacy Benefit Manager Transparency Act; S. 1339, Pharmacy Benefit Manager Reform Act; S.1542/H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (previously H.R. 2691, Transparent PRICE Act); H.R. 3281, To promote hospital and insurer price transparency; H.R. 2880, Protecting Patients Against PBM Abuses Act; H.R. 2679, The PBM Accountability Act; H.R.3285, the Fairness for Patient Medications Act, to establish patient protections with respect to highly rebated drugs; H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information; 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. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3284, the Providers and Payers COMPETE Act; S. 1967 the Patients Before Middlemen (PBM) Act; Protect Patients Access to Pharmacies Act; S. 2406, PBM Oversight Act of 2023; S. 2973, Modernizing and Ensuring PBM Accountability Act; S. 2436, the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act; S. 2405, the Strengthening Pharmacy Access for Seniors Act; S. 2254, the Medicare PBM Accountability Act; S. 2052, the Protect Patient Access to Pharmacies Act; H.R. 4822, the Health Care Price Transparency Act of 2023; H.R. 3284, the Providers and Payers COMPETE Act; H.R. 4508, the Hidden Fee Disclosure Act; H.R. 4507, the Transparency in Coverage Act of 2023; H.R. 4895, the Lowering Drug Costs for American Families Act; H.R. 5378 Lower Costs, More Transparency Act; H.R. 4527, Health Data Access, Transparency, and Affordability Act (DATA) Act; H.R. 3285, Fairness for Patient Medications Act; S. 2973 Modernizing and Ensuring PBM Accountability Act; S. 3548, Health Care Prices Revealed and Information to Consumers Explained Transparency Act (Health Care PRICE Transparency Act 2.0); H.R.3285 - Fairness for Patient Medications Act; H.R. 3008, the Drug Shortage Prevention Act of 2023; H.R. 3810, the Drug Origin Transparency Act of 2023; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 7535, Prescription Drug Supply Chain Pricing Transparency Act; S. 2305, Biosimilar Red Tape Elimination Act; H.R. 6986/S.3583, to address patent thickets; H.R. 8261, the Preserving Telehealth, Hospital, and Ambulance Access Act; Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act); S.150, the Affordable Prescription Drug for Patients Act; S. 142, the Preserve Access to Affordable Generics and Biosimilars Act; S. 5503, H.R. 10362, the Patients Before Monopolies (PBM) Act; P.L. No: 118-158 and draft FY2025 Continuing Resolution, issues related to PBMs.

Client expense: $1,420,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to health care, the Food and Drug Administration (FDA), oncology coverage, 340B Program, drug pricing, importation of biopharmaceuticals, international pharmaceutical supply chain, TRICARE Pharmacy Program, antimicrobial resistance legislation, and VICP Program; H.R.5376, Inflation Reduction Act of 2022 (P.L.117-169) implementation; Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization; H.R.830, HELP Copays Act; S.127, Pharmacy Benefit Manager Transparency Act of 2023; H.R.3285, Fairness for Patient Medications Act; S.1339, Pharmacy Benefit Manager Reform Act; S.1355, PASTEUR Act of 2023; H.R.5378, Lower Costs, More Transparency Act; S.3430, Better Mental Health Care Lower-Cost Drugs and Health Extenders Act; S.2973, Modernizing and Ensuring PBM Accountability Act; H.R.6283, DRUG Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 7024 - Tax Relief for American Families and Workers Act of 2024 including issues related to providing tax incentives to promote economic growth, specifically the provision related to the immediate deduction of the cost of U.S. based research and investment investments; S 866 - American Innovation and Jobs Act including issues related to revising and expanding the deductibility of research and development expenditures to allow for the immediate expensing of such expenditures; HR 2673 - American Innovation and R&D Competitiveness Act of 2023 including issues related to eliminating the five-year amortization requirement for research and experimental expenditures, thus allowing continued expensing of such expenditures in the taxable years in which they are incurred; HR 5688 - Bipartisan HSA Improvement Act of 2023 including issues related to Health Savings Account modernization; HR 5687 - HSA Modernization Act of 2023 including issues related to Health Savings Account modernization; S 127/HR 3561 - Pharmacy Benefit Manager Transparency Act of 2023 including issues related to reform and prescription drug pricing

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to pharmacy benefit managers; S.127 Pharmacy Benefit Manager Transparency Act of 2023; S.1339 Pharmacy Benefit Manager Reform Act; S.1542 DRUG Act; S.1979 Protecting Older Americans Act of 2023; H.R.5378 Lower Costs, More Transparency Act; H.R.7623 Telehealth Modernization Act of 2024; H.R.10545 American Relief Act, 2025.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Changes to Hatch-Waxman's 180-day exclusivity incentive. Changes to FDA approval process for pharmaceuticals. Implementation of the Inflation Reduction Act. Drug pricing proposals. Oversight and reform efforts affecting pharmacy benefit managers, including Pharmacy Benefit Manager Transparency Act (S. 127), Prescription Pricing for the People Act (S. 113), and Drug Price Transparency in Medicaid Act of 2023 (H.R. 1613), and Lower Costs, More Transparency Act (H.R. 5378); Patent reform, including the Preserve Access to Affordable Generics and Biosimilars Act (S. 142), Affordable Prescriptions for Patients Act (S. 150); Block, Report, and Suspend Suspicious Shipments Act (H.R. 501); Proposal related to drug shortages.

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

Government targets: HOUSE OF REPRESENTATIVES

Changes to Hatch-Waxman's 180-day exclusivity incentive. Changes to FDA approval process for pharmaceuticals. Implementation of the Inflation Reduction Act. Drug pricing proposals. Oversight and reform efforts affecting pharmacy benefit managers, including Pharmacy Benefit Manager Transparency Act (S. 127), Prescription Pricing for the People Act (S. 113), and Drug Price Transparency in Medicaid Act of 2023 (H.R. 1613), and Lower Costs, More Transparency Act (H.R. 5378); Patent reform, including the Preserve Access to Affordable Generics and Biosimilars Act (S. 142), Affordable Prescriptions for Patients Act (S. 150); Block, Report, and Suspend Suspicious Shipments Act (H.R. 501); Proposal related to drug shortages.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1835: Saving Access to Laboratory Services Act; H.R. 1770, S.2477: Equitable Community Access to Pharmacist Services Act; H.R. 4011 Timely Access to Cancer Treatment; Medically integrated physician dispensing regulations; S.127, PBM Transparency Act; Drug price transparency and cost savings opportunities.

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

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

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act 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. 3433: Give Kids a Chance Act of 2024 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4818: Treat and Reduce Obesity Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 9096: Pharmacists Fight Back Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 3430: Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023 S. 5021: 340B PATIENTS Act of 2024 S. 5040: Protecting Patients from Deceptive Drugs Online Act S. 5459: Biosimilars Access and Affordability Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Artificial intelligence policy issues

Client expense: $7,560,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Program/Transparency; generics access; Clinical Trial Diversity S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R. 9070, Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.2666 - EPCS 2.0 Act To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] S. 1067, Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] H.R.1359 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Rep. Norcross, Donald [D-NJ-1] S.644 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Sen. Markey, Edward J. [D-MA]

Client expense: $269,075 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.830, HELP Copays Act of 2023 S.127, Pharmacy Benefit Manager Transparency Act of 2023 H.R.3283, Fairness for Patient Medications Act S.1339, Pharmacy Benefit Manager Reform Act H.R.5378, Lower Costs, More Transparency Act S.2973, Modernizing and Ensuring Equity Act H.R.8412, Clinical Trials Modernization Act H.R.9747, Continuing Appropriations and Extensions Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Advantage Reimbursement. 2024 Medicare Advantage and Part D Rate Notice. Mental Health Coverage in Medicare. H.R. 830 - the HELP Copays Act. S. 127 - The Pharmacy Benefit Manager Transparency Act of 2023. S. 1339 - Pharmacy Benefit Manager Reform Act. H.R. 5378 - Lower Costs, More Transparency Act. H.R. 10545 - American Relief Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 618, Improving Access to Workers Compensation for Injured Federal Workers Act, all provisions S. 131, Improving Access to Workers Compensation for Injured Federal Workers Act, all provisions H.R. 2923, Living Donor Protection Act, all provisions of 2023, all provisions S. 1384, Living Donor Protection Act, all provisions of 2023, all provisions H.R. 1359, Modernizing Opioid Treatment Access Act, all provisions S. 644, Modernizing Opioid Treatment Access Act, all provisions H.R. 2630, Safe Step Act, all provisions S. 652, Safe Step Act, all provisions H.R. 2761, Specialty Physicians Advancing Rural Care (SPARC) Act, all provisions S. 705, Specialty Physicians Advancing Rural Care (SPARC) Act, all provisions S. 2840, Bipartisan Primary Care and Health Workforce Act, all provisions S. 113, Prescription Pricing for the People Act of 2023, all provisions H.R. 7153, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, all provisions S. 3679, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, all provisions H.R. 830, Help Ensure Lower Patient (HELP) Copays Act, all provisions S. 1375, Help Ensure Lower Patient (HELP) Copays Act, all provisions S. 127, Pharmacy Benefit Manager Transparency Act of 2023, all provisions H.R. 8325, Physician and Patient Safety Act, all provisions S. 4278, Physician and Patient Safety Act, all provisions H.R. 8383, Rural Obstetrics Readiness Act, all provisions S. 4079, Rural Obstetrics Readiness Act, all provisions S. 3447, Pregnant and Postpartum Women Treatment Reauthorization Act, all provisions H.R. 5012, SHINE for Autumn Act of 2023, all provisions S. 2647, SHINE for Autumn Act of 2023, all provisions S. 3370, Promoting Maternal and Child Health Through Substance Use Prevention Act, all provisions H.R. 1117, Advancing Safe Medications for Moms and Babies Act of 2023, all provisions H.R. 3417, Facilitating Accountability In Reimbursements (FAIR) Act, provisions relating to site neutral payments H.R. 6033, Supporting Patient Education And Knowledge (SPEAK) Act of 2024, provisions relating to telehealth/equity H.R. 2411, National Nursing Workforce Center Act of 2023, all provisions H.R. 6230, Doctor Knows Best Act of 2023, all provisions H.R. 9572, Enhanced Enforcement of Health Coverage Act, all provisions H.R. 6881, AI Foundation Model Transparency Act of 2023, all provisions H.R. 10282, Expanding Support for Living Donors Act of 2024, all provisions CURES 2.0/draft Dr. Paul Farmer Global Health Training Act/draft Artificial Intelligence for Care Utilization Research and Efficacy Act of 2024/draft Temporary Responders for Immediate Aid in Grave Emergencies (TRIAGE) Act/draft 21st Century Cures Act/implementation improvement No Surprises Act implementation Maternal Health Prior Authorization Public health/Infectious diseases/Chronic diseases Substance use disorder Cybersecurity Health IT and HIPAA/health data access privacy Augmented Intelligence Health Equity Reproductive health Health Information Technology/interoperability (HTI-2) Trusted Exchange Framework and Common Agreement (TEFCA) Health IT Certification Electronic Health Record (EHR) certification Physician burden reduction/Health IT Interoperability/data sharing/information blocking/provider disincentives Data segmentation Insights condition/maintenance of certification reporting CHANGE Healthcare Cyberattack Overdose epidemic Substance use disorder/barriers to care Rural and small hospitals/obstetrical services/conditions of participation Gender affirming care Nuclear power plants/decommissioning/health risks Nations drug supply/severe weather events

Client expense: $6,590,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Nuclear Regulatory Commission (NRC), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), SENATE

S.652 - Safe Step Act (Murkowski/Hassan), support passage H.R. 830 - HELP Copays Act, support passage S.935- Fair Accountability and Innovative Research Drug Pricing Act of 2023, support passage H.R. 485, Protecting Health Care For All Patients Act, oppose passage as currently written S.127, the Pharmacy Benefit Manager Transparency Act, support passage Urged HELP and House Energy and Commerce Committee to hold roundtables and advance proposals that address workforce issues within the healthcare community. S. 2333 - Pandemic and All-Hazards Preparedness and Response Act, support passage H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023, oppose passage H.R. 4421, Preparing for All Hazards and Pathogens Reauthorization Act, monitor legislation H.R. 4420, Preparedness and Response Reauthorization Act, monitor legislation Committee Draft -The Primary Care and Health Workforce Expansion Act, support passage S. 1339, the Pharmacy Benefit Manager Reform Act, support passage S.127, the PBM Transparency Act of 2023, support passage S.113, The Prescription Pricing for the People Act of 2023, support passage S.2052, Protect Patient Access to Pharmacies Act H.R. 1692, Health Care Affordability Act of 2023 H.R. 3561, the PATIENT Act of 2023, support passage H.R. 3284, Providers and Payers Compete Act, support passage H.R. 4507, Transparency in Coverage Act, support passage H.R. 4508, Hidden Fee Disclosure Act, support passage H.R. 2816, PBM Sunshine and Accountability Act, support passage S.79- Interagency Patent Coordination and Improvement Act of 2023, support passage S. 142- Preserve Access to Affordable Generics and Biosimilars Act, support passage S.148- Stop STALLING Act, support passage S.150- Affordable Prescriptions for Patients Act of 2023, support passage S.775-Increasing Transparency in Generic Drug Applications Act, monitoring S.1067-Ensuring Timely Access to Generics Act of 2023, support passage S. 2780 Medication Affordability and Patent Integrity Ac H.R. 4189, the CONNECT for Health Act, support passage H.R. 1843, the Telehealth Expansion Act, support passage H.R. 8018, the Alleviating Barriers for Caregivers Act, support passage S. 3109, the Alleviating Barriers for Caregivers Act, support passage H.R.6302, the Health Share Transparency Act of 2023 H.R.7623, the Telehealth Modernization Act of 2024

Client expense: $51,247 · 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, Health & Human Services, Dept of (HHS), SENATE

340B Program/Transparency; generics access; Clinical Trial Diversity S. 1114, Expanding Access to Low-Cost Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. Sponsor: Sen. Smith, Tina [D-MN] S. 2305 - Biosimilar Red Tape Elimination Act To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Sen. Lee, Mike [R-UT] S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 To prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes. Sponsor: Sen. Cantwell, Maria [D-WA] S. 148 - Stop STALLING Act A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. Sponsor: Sen. Amy Klobuchar (D-MN) S.1339 - Pharmacy Benefit Manager Reform Act To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. Sponsor: Sen. Sanders, Bernard [I-VT] S. 775, Increasing Transparency in Generic Drug Applications To provide for increased transparency in generic drug applications. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.3839 - To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. Sponsor: Rep. Dunn, Neal P. [R-FL-2] H.R. 9070, Affordable Prescriptions for Patients Act of 2024 To amend title 35, United States Code, to prohibit product hopping, and for other purposes. Sponsor: Rep. Issa, Darrell [R-CA-48] S. 150 - Affordable Prescriptions for Patients Act of 2023 To amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Sponsor: Sen. Cornyn, John [R-TX] S.1542, DRUG Act To improve services provided by pharmacy benefit managers. Sponsor: Sen. Marshall, Roger [R-KS] H.R.6094 - Providing Realistic Opportunity To Equal and Comparable Treatment (PROTECT) for Rare Act To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes. Sponsor: Rep. Matsui, Doris O. [D-CA-7] S. 142 - Preserve Access to Affordable Generics and Biosimilars Act To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Sponsor: Sen. Klobuchar, Amy [D-MN] S.2666 - EPCS 2.0 Act To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Sen. Hassan, Margaret Wood [D-NH] H.R.7312 - EPCS 2.0 Act To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Rep. Kuster, Ann M. [D-NH-2] S.4741 - PLASMA Act To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. Sponsor: Sen. Tillis, Thomas [R-NC] HR 6465 PLASMA Act To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program. Sponsor: Rep. Hudson, Richard [R-NC-9] S. 1067, Ensuring Timely Access to Generics Act To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions. Sponsor: Sen. Shaheen, Jeanne [D-NH] H.R.1359 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Rep. Norcross, Donald [D-NJ-1] S.644 - Modernizing Opioid Treatment Access Act To expand the take-home prescribing of methadone through pharmacies. Sponsor: Sen. Markey, Edward J. [D-MA]

Client expense: $1,760,000 · 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), SENATE, White House Office

S. 1133: 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight H.R 2534 - PROTECT 340B Act S. 5021/HR. 7635 - 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act H.R. 2408: Access to Innovative Treatments Act of 2023 HR. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) 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. 2408: Access to Innovative Treatments Act of 2023 Accelerated Approval Drug Shortages Supply Chain Integrity and Traceability Drug Patenting PBM Reform S. 2973: Modernizing and Ensuring PBM Accountability (MEPA) Act Alternative Payment Arrangements for Gene Therapies Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues H.R. 5539/S. 3131: ORPHAN Cures Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 1214: Retaining Access and Restoring Exclusivity (RARE) Act Implementation of the Inflation Reduction Act (IRA) of 2022 Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2630/S. 652: SAFE STEP Act H.R. 5378: Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3433: Give Kids a Chance Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 5376: Share the Savings with Seniors Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 4953: Protect Drug Innovation Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval authority policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues S. 2305: Biosimilar Red Tape Elimination Act IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies

Client expense: $720,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), 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, White House Office

340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S.1133: 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---S.4667: Risky Research Review Act ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Bio COMPETES (Draft) ---Biosimilar Copay ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Climate Change Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R.8818: American Privacy Rights Act of 2025 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2780: Medication Affordability & Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547/S.476: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2305: Biosimilar Red Tape Elimination Act ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---Patients Before Monopolies (PBM) Act ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---VICP Funding for FDA ---FY 2025 Appropriations ---Creating Hope Reauthorization Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Funding for Womens Health Research Generic Drug Entry ---H.R.6973: Generic Drug Application Review Reforms ---S.148: Stop STALLING Act ---S.4351: Enhanced Access to Affordable Medicines Act Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4758: Accelerating Kids Access to Care Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: Support for Patients and Communities Reauthorization Act ---Non-Opioid Analgesics ---Coverage and Reimbursement Orphan Drug Issues ---H.R.3433: Give Kids a Chance Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Emerging New Threats and (PREVENT) Pandemics Act ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.5260: Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,460,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), SENATE, State, Dept of (DOS), White House Office

340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S.1133: 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---H.R.8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1067: Ensuring Timely Access to Generics ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---Patients Before Monopolies (PBM) Act ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: Support for Patients and Communities Reauthorization Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---House GOP RFI on Supply Chain ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S.4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART) Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---VICP CICP (Discussion Draft)

Client expense: $1,460,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), SENATE, State, Dept of (DOS), White House Office

Affordable Care Act--extending enhanced APTCs (H.R. 9774, S. 5194) and unauthorized enrollments in Marketplace plans (S. 4767), Affordability (H.R. 3589), Behavioral Health, Employer-Provided Health Coverage, Health Equity, Maternal Health, Surprise Billing, Health IT, Cybersecurity, Interoperability, Health Care Innovation, Telehealth-extending flexibilities, Transparency & PBMs (S. 127, S. 1339, S. 3430, H.R. 3651, H.R. 4507, H.R. 4508, H.R. 4509, H.R. 4527, H.R. 4822, H.R. 5378), Provider Directories (S. 3430), Prescription Drugs (S. 150, S. 1067, S. 1114, S. 2305), Preventative Services

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

-HR 830 / S 1357, HELP Copays Act -HR 2630 / S 652, Safe Step Act -S 1339, Pharmacy Benefit Manager Reform Act -H.R. 1770, the Equitable Community Access to Pharmacist Services Act -HR 824, the Telehealth Benefit Expansion for Workers Act -Accelerating Kids Access to Care Act - S. 127 Pharmacy Benefit Manager Transparency Act of 2023 - S. 1339 Pharmacy Benefit Manager Reform Act - H.R. 4507 Transparency in Coverage Act of 2023 - H.R. 4822 Health Care Price Transparency Act of 2023 - H.R. 3561 PATIENT Act of 2023 -H.R. 5378 - The Lower Costs, More Transparency Act - H.R. 2761 SPARC Act, Specialty Physicians Advancing Rural Care (SPARC) Act - S.1701/H.R.3503 NIH Clinical Trial Diversity Act of 2023 - H.R. 1114 Long COVID RECOVERY NOW Act - S.2840 the Bipartisan Primary Care and Health Workforce Act - Reducing Drug Prices for Seniors Act - Improving Seniors Timely Access to Care Act - Health Care Affordability Act

Client expense: $75,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE