CLASS Act

340B Drug Discount Program 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. 2534, PROTECT 340B Act of 2023 340B Contract Pharmacy Policy S. 1133, 340B Accountability Act Accelerated Approval Advanced Research Projects Agency for Health (ARPA-H) Alternative Funding Programs Biosimilar approval and reimbursement policy issues Buy American Executive Order Cancer Moonshot Cell, gene and radioligand therapies Co-pay accumulator programs Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Genetically Targeted Technologies H.R. 2534, Preserving Rules Ordered for the Entities Covered Through (PROTECT) 340B Act H.R. 2679, Pharmacy Benefits Manager Accountability Act H.R. 5376, Inflation Reduction Act H.R. 4822, Health Care Price Transparency Act of 2023 Inflation Reduction Act Implementation H.R. 5416, The Give Kids a Chance Act The Medicaid VBPs for Patients (MVP) Act H.R. 830/S. 1375, HELP Co-pays Act H.R. 1613, The Drug Price Transparency in Medicaid Act H.R. 198, Drug Pricing Transparency and Accountability Act H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan drug policy issues Outcomes based contracting/value based arrangements Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain Pharmacy benefit manager policy issues Priority Review Voucher (PRV) Reauthorization of PAHPA Regulatory efficiencies policy issues S. 652/H.R. 2630, Safe Step Act S. 79/H.R. 1717, Interagency Patent Coordination and Improvement Act of 2023 S. 2837, 340B Accountability Act 2021 S. 476/HR. 5567 The Maintaining Investments in New Innovations (MINI) Act H.R. 5539, ORPHAN Cures Act S. 1246, SMART Prices Act S. 127, The Pharmacy Benefit Manager Transparency Act of 2023 S. 1339, Pharmacy Benefit Manager Reform Act S. 1542, Delinking Reveue from Unfair Gouging (DRUG) Act S. 1967, Patients Before Middlemen Act S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act H.R. 5378, Lower Costs, More Transparency Act H.R. 2880, Protecting Patients Against PBM Abuses Act Step Therapy Transparency policy issues Utilization management issues Health industry vertical integration CBO modeling 340B Program Implementation & Oversight 340B Accountability Act S. 1182: The 340B Reporting and Accountability Act H.R.2534: PROTECT 340B Act of 2023 H.R.2408: Access to Innovative Treatments Act of 2023 H.R.1790: Biologics Competition Act of 2023 S.113: Prescription Pricing for the People Act of 2023 S.150: Affordable Prescriptions for Patients Act of 2023 Drug Benefit Design

Client expense: $1,360,000 · 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

Anti-Kickback Statute policy issues ASP reporting policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Drug Pricing H.R. 1613/S. 1038, Drug Price Transparency in Medicaid Act of 2023 H.R. 5376, Inflation Reduction Act H.R. 2666, Medicaid for VBPs for Patients (MVP) Act H.R. 2880, Protecting Patients Against PBM Abuses Act H.R. 3285, Fairness for Patient Medications Act S. 1967, Patients Before Middlemen Act S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency Innovative Pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Inflation Reduction Act Impact on Innovative Pharmaceuticals Medicaid Medicaid rebates and waiver policy issues Medicare Part A, B and D Medicare Part D Negotiations Medicare Part D Re-design and out of pocket cap Outcomes based Contracting/value based arrangements Patient Cost-Sharing and Smoothing Reimbursement for cell therapy products Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals Transparency policy issues Advanced Safe Testing at Residence Telehealth Act of 2023 S. 2052, Protect Patient Access to Pharmacies Act S. 476/HR. 5567, The Maintaining Investments in New Innovations (MINI) Act H.R. 5539, ORPHAN Cures Act Value-Based Purchasing (VBP) Rule CBO modeling H.R.2139/S.908: Medicare Drug Price Negotiation Act H.R.2148/S.909: Prescription Drug Price Relief Act H.R.5125: Strengthening Innovation in Medicare and Medicaid Act S.127: Pharmacy Benefit Manager Transparency Act of 2023 S.142: Preserve Access to Affordable Generics and Biosimilars Act S.150: Affordable Prescriptions for Patients Act of 2023 S.775: Increasing Transparency in Generic Drug Applications Act S.1067: Ensuring Timely Access to Generics of 2023 COVID-19 Pricing-Related Provisions National Coverage Determination Alternative Payment Arrangements for Gene Therapies Average Manufacturer Price Calculations Medicaid Drug Rebate Program Rule (MDRP) Medicare Part B Physician-Administered Products National Coverage Determination Patient Cost-Sharing and Smoothing Protected Classes Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications

HR 452 Education Savings Accounts for Military Families Act, all provisions. HR 631 A PLUS Act, all provisions. HR 5110 Protecting Hunting Heritage and Education Act, all provisions. HR 5567 Combating the Lies of Authoritarians in School Systems Act, all provisions. HR 5634 No Vaccine Mandates in Higher Education Act, all provisions. Issues pertaining to a literacy resolution.

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

Government targets: HOUSE OF REPRESENTATIVES