PBM Act of 2024

H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 2679, the Pharmacy Benefits Manager Accountability Act; H.R. 3008, the Drug Shortage Prevention Act; S. 1339, the Pharmacy Benefits Manager Reform Act; S. 1542 / H.R. 6283, the Delinking Revenue from Unfair Gouging Act; H.R. 1173, the Patients Right to Know Their Medication Act of 2023; Proposed rule for Medication Guides: Patient Medication Information (Docket No. FDA-2019-N-5959); Implementation of Public Law 113-54, the Drug Quality and Security Act; Draft Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, (Docket No. FDA-2015-D-3517); H.R. 5400 / S. 2436, the NO PBMs Act; S.3430,the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023; Request for Information for "Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act" (Docket No. FDA-2023-N-4806); Request for Information on Bipartisan 340B Senate Working Group SUSTAIN 340B Act Discussion Draft; H.R.4366, the Consolidated Appropriations Act, 2024; H.R.2882, the Further Consolidated Appropriations Act, 2024; Comments on implementation and enforcement of recent changes to USP Chapter <797>, regarding the Compounded Sterile Preparations (CSPs) in Category 3 to the FDA; Comments to FDA on "Agency Information Collection Activities; Proposed Collection; Comment Request; Proposed Small Dispensers Assessment Under the Drug Supply Chain Security Act" [Docket No.FDA-2024-N-0668]; Comments to FDA on " Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act"[Docket No. FDA-2023-N-0061]; H.R.9096, the Pharmacists Fight Back Act; Comments to FDA on Docket No. FDA-2023-N-4806 - Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket; Request for Information and Comment. Comments to FDA on "Pharmacy Compounding Advisory Committee's Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List Revisions to the Withdrawn or Removed List [Docket No. FDA-2024-N-4188]"; Comment to FDA on "Pharmaceutical Distribution Supply Chain; Drug Supply Chain Security" [Docket No. FDA-2024-N-3675]; Comment to FDA on "Opposition to Novo Nordisk and Eli Lillys Requests to Place GLP-1 Medications on the Demonstrably Difficult to Compound List" [Docket No. FDA-2015-N-0030]; H.R.10239/S.5368,the Ending Drug Shortages Act; H.R.10362, the PBM Act of 2024; H.R.10545, the American Relief Act, 2025;

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

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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.

H.R. 2584/ S. 2768, the Safety from Violence for Healthcare Employees (SAVE) Act, all provisions; S. 3211/ H.R. 6205, Healthcare Workforce Resilience Act, all provisions; S.665 / H.R. 4942, Conrad State 30 and Physician Access Reauthorization Act, all provisions; S 3679 / H.R. 7153, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, all provisions, S. 3770/ H.R. 7266, "The Future Advancement of Academic Nursing (FAAN Act)", all provisions; S. 1176 / H.R. 2663, Workplace Violence Prevention for Health Care and Social Service Workers Act, all provisions, Draft Bill , 340B SUSTAIN Act, all provisions, H.R. 7635, The 340B PATIENTS Act, all provisions; H.R.8574, the 340B Affording Care for Communities and Ensuring a Strong Safety-net (340B ACCESS) Act, all provisions; DRAFT Senate / H.R. 5804, Mental Health Infrastructure Improvement Act, all provisions; S. 5368, End Drug Shortages Act, all provisions, H.R. 10362 / S. 5493, To prohibit pharmacy benefit managers and pharmacies from being under common ownership, and for other purposes, all provisions, H.R. 7379, Patient Matching And Transparency in Certified Health IT Act of 2024, all provisions; Health & Human Services (HHS), Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2), Interoperability, improve transparency and electronic access and exchange of electronic health records; Health & Human Services (HHS) & Drug Enforcement Agency (DEA) Telemedicine Waivers for Controlled Substances, Waiver flexibilities for prescribing controlled substances through telemedicine ; Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA), IV Fluid Shortage Impact on Sepsis and Infection Care IV Fluid Shortage Impact on Sepsis and Infection Care; Medical Debt, Issues specific to medical debt incurred by patients and hospital billing and collection practices; Price Transparency, Issues related to hospital price transparency; Rural Health Care Access, Issues to protect access to rural health care; Tax-exempt status, Issues pertaining to not-for-profit hospitals' tax exempt status; Maternal Health and Child Health, Access to maternal and child health care and addressing related workforce shortages, conditions of participation (COP) and impact of recent payment rules; Behavioral Health, Issues related to expanding access to care and reducing regulatory barriers; Health Plan Accountability, Issues specific to prior authorization, patient access to care, adequate provider networks, inappropriate denials, reducing account receivables, prompt pay; Workforce, nurse staffing mandate, workforce development programs; Health Professions Diversity, National health service corps; centers of excellence; health careers opportunity programs; Hospital mergers and acquisitions, Issues pertaining to hospital consolidation, mergers an acquisition, physician practice acquisition; Physician Owned Hospitals Physician-owned hospitals; Supply Chain Issues, Baxter Plant / Hurricane Recovery, Issues pertaining to supply chain issues, IV Fluid Shortages, Baxter Plant, Hurricane Recovery, defense production act, national emergency declaration, Advanced Premium Tax Credits, Extension of Advanced Premium Tax Credits, Cyber Security & Resiliency, Issues pertaining to ongoing cyber risks to the health care field.

Legislation and regulation regarding pharmaceutical pricing, coverage and care; retail and inpatient pharmacy operations and the role of pharmacy benefit managers. S.2140 - Patent Eligibility Restoration Act of 2023 H.R. 2679, the PBM Accountability Act H.R.3285 - To establish patient protections with respect to highly rebated drugs S. 1067, the Ensuring Timely Access to Generics Act of 2023 S. 1114, the Expanding Access to Low-Cost Generics Act of 2023 S.1269 - INSULIN Act of 2023 S. 1909 Pharmacy DIR Reform to Reduce Senior Drug Costs Act S. 1967 The Patients Before Middlemen Act (the PBM Act) S. 1339 The Pharmacy Benefit Managers Reform Act S. 127, the Pharmacy Benefit Manager Transparency Act of 2023 H.R. 485, the Protecting Health Care for All Patients Act of 2023 S. 2780 & H.R. 5429 - Medication Affordability and Patent Integrity Act S. 2305 - Biosimilar Red Tape Elimination Act S.150 & H.R. 9070 - Affordable Prescriptions for Patients Act of 2023 S. 5503 and H.R. 10362 - The Patients Before Monopolies Act

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

Lower healthcare costs and bring transparency to pharmacy benefit managers (PBMs) through meaningful PBM reforms. H.R. 1613 Drug Price Transparency in Medicaid Act H.R. 1770 Equitable Community Access to Pharmacist Services Act H.R. 2534 Protect 340B Act of 2023 H.R. 2816 The PBM Sunshine and Accountability Act H.R. 2880 Protecting Patients Against PBM Abuses Act H.R. 2882 Fiscal 2024 Further Consolidated Appropriations Act (3-22 package) H.R. 3561 The Patient Act H.R. 4366 Consolidated Appropriations Act, 2024 (3-8 package) H.R. 5378 Lower Costs, More Transparency Act H.R. 5385 The Medicare PBM Accountability H.R. 5393 To amend title XVIII of the Social Security Act to ensure fair assessment of pharmacy performance and quality under Medicare part D, and for other purposes. H.R. 5400 TheNeighborhood Options for Patients Buying Medicines (NO PBMs) Act H.R. 5526 Seniors Access to Critical Medications Act of 2024 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 Act H.R. 9096 Pharmacists Fight Back Act H.R. 10362 - A bill to prohibit pharmacy benefit managers and pharmacies from being under common ownership, and for other purposes. H.R. 10545 CR - The American Relief Act, 2025 S. 1038Drug Price Transparency in Medicaid Act S. 113Prescription Pricing for the People Act S. 127Pharmacy Benefit Manager Transparency Act S. 1339Pharmacy Benefit Manager Reform Act S. 1491Pharmacy and Medically Underserved Areas Enhancement Act S. 2052Protect Patient Access to Pharmacies Act S. 2436TheNeighborhood Options for Patients Buying Medicines (NO PBMs) Act S. 2477Equitable Community Access to Pharmacist Services Act S. 2666ECAPS 2.0 Act S. 2973Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393The SUPPORT Act S. 3430Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023 (Better Act) S. 3458Seniors Access to Critical Medications Act of 2024 S. 5021The 340B Patients Act of 2024 S. 5503 A bill to prohibit pharmacy benefit managers and pharmacies from being under common ownership, and for other purposes.