340B ACCESS Act

Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act

Client expense: $390,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Inflation Reduction Act (IRA) HR 7174 - Ensuring Pathways to Innovative Cures (EPIC) Act Medicare Price Setting Drug Shortages Global Access to Medicines Trade-Related Aspects of Intellectual Property Rights (IPR) March-in Framework Guidance and Policies S 79/ HR 1717 - Interagency Patent Coordination and Improvement Act of 2023 S 142 - Preserve Access to Affordable Generics and Biosimilars Act HR 6986 - To address patent thickets S 150 - Affordable Prescriptions for Patients Act of 2023 S 2780/ HR 5429 - Medication Affordability and Patent Integrity Act Antimicrobial Resistance PBM Transparency and Reform S 1542 - Delinking Revenue from Unfair Gouging (DRUG) Act S 3430 - Better Mental Health Care, Lower-Cost Drugs and Extenders Act S 2973 - Modernizing and Ensuring PMB Accountability Act 340B Reform HR 8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

Inflation Reduction Act (IRA) HR 7174 - Ensuring Pathways to Innovative Cures (EPIC) Act Medicare Price Setting Drug Shortages Global Access to Medicines Trade-Related Aspects of Intellectual Property Rights (IPR) March-in Framework Guidance and Policies S 79/ HR 1717 - Interagency Patent Coordination and Improvement Act of 2023 S 142 - Preserve Access to Affordable Generics and Biosimilars Act HR 6986 - To address patent thickets S 150 - Affordable Prescriptions for Patients Act of 2023 S 2780/ HR 5429 - Medication Affordability and Patent Integrity Act Antimicrobial Resistance PBM Transparency and Reform S 1542 - Delinking Revenue from Unfair Gouging (DRUG) Act S 3430 - Better Mental Health Care, Lower-Cost Drugs and Extenders Act S 2973 - Modernizing and Ensuring PMB Accountability Act 340B Reform HR 8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act

Client expense: $2,390,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

The 340B Drug Pricing Program; H.R. 2534, The Protect 340B Act; FY24 and FY25 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations bills. HR 3290,to amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R.3561 - PATIENT Act of 2023, The Stop Drug Shortages Act (Draft legislation- House), H.R. 5378: Lower Costs, More Transparency Act, S. 1182: 340B Reporting and Accountability Act; S.1133: 340B Accountability Act of 2023,S.1038: Drug Price Transparency in Medicaid Act of 2023,H.R.1613: Drug Price Transparency in Medicaid Act of 2023,H.R.198: Drug Pricing Transparency and Accountability Act; S. 2973: Modernizing and Ensuring PBM Accountability Act, Draft Senate legislation the SUSTAIN 340B Act, HR 7635 and S. 5021, the 340B PATIENTS Act.H.R. 8574, 340B ACCESS Act: H.R.8144 - Rural 340B Access Act of 2024

Client expense: $260,046 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE

Inflation Reduction Act (IRA) HR 7174 - Ensuring Pathways to Innovative Cures (EPIC) Act Medicare Price Setting Drug Shortages Global Access to Medicines Trade-Related Aspects of Intellectual Property Rights (IPR) March-in Framework Guidance and Policies S 79/ HR 1717 - Interagency Patent Coordination and Improvement Act of 2023 S 142 - Preserve Access to Affordable Generics and Biosimilars Act HR 6986 - To address patent thickets S 150 - Affordable Prescriptions for Patients Act of 2023 S 2780/ HR 5429 - Medication Affordability and Patent Integrity Act Antimicrobial Resistance PBM Transparency and Reform S 1542 - Delinking Revenue from Unfair Gouging (DRUG) Act S 3430 - Better Mental Health Care, Lower-Cost Drugs and Extenders Act S 2973 - Modernizing and Ensuring PMB Accountability Act 340B Reform HR 8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act

Client expense: $2,830,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

H.R. 10545 American Relief Act, 2025 S.2840, Bipartisan Primary Care and Health Workforce Act H.R.7635, The 340B PATIENTS Act of 2024 H.R.5829, Health Care Practitioner Disaster Protection Act H.R.5378, Lower Costs, More Transparency Act H.R.1072, Health Center Community Transformation Hub Act H.R.9029, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 H.R.7623, Telehealth Modernization Act of 2024, including a joint letter with the National Association of Rural Health Clinics H.R.8574, 340B ACCESS Act Keeping Obstetrics Local Act SUSTAIN Act Issues related to Community health center funding and potential lame duck legislative packages prior to the final passage of HR 10545 Issues related to incoming Trump Administrations stance on community health center and primary care workforce funding as outlined in the Paragon Health Institutes policy brief Issues related to disaster relief funding package and carving out specific funds to HRSA for FQHC-related payments Issues related to health center electronic health records privacy and other health-related cyber security issues Issues related to the 340B program (including 340C) Issues related to the Developing the Community Health Workforce Act Issues related to the Emergency Preparedness for Underserved Populations Act Issues related to Food as medicine policy proposals Issues related to value-based care options for federally qualified health centers and safety net settings including the AHEAD model at CMMI and Making Care Primary model at CMS Issues related to the Transforming Maternal Health model at CMMI Issues related to community health center workforce data with the Health Resources and Services Administration Issues related to maternal health in community health centers Issues related to 340B provisions in the Inflation Reduction Act Issues related to the 340B rebate model

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, White House Office

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

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

Education about the 340(b) program. H.R.830 - HELP Copays Act. H.R.5378 - Lower Costs, More Transparency Act. S.2973 - Modernizing and Ensuring PBM Accountability Act. H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act. H.R.2880 - Protecting Patients Against PBM Abuses Act.

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

Government targets: HOUSE OF REPRESENTATIVES

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

Issues related to drug pricing reform Changes to Public law 117-1769 Inflation Reduction Act Awareness of implications to patients and research and development of Public law 117-1769 Inflation Reduction Act S. 113 Prescription Pricing for the People Act of 2023 S.127 Pharmacy Benefit Manager Transparency Act HR 830/ S 1375 HELP Copays Act HR 485 Protecting Health Care for All Patients Act HR 5378 Lower Costs, More Transparency Act R 2534 PROTECT 340B Act of 2023 HR 3561 the PATIENT Act S. 1542 DRUG Act S. 1967 PBM Act HR 3503 The NIH Clinical Trials Diversity Act Issues related to cardiovascular disease awareness and treatment Issues related to Federal Trade Commission FDA issues Issues related to patient affordability issues, including copay cards, copay accumulators, copay maximizers, National Benefit Payment Parameters Biosimilars reimbursement issues, no specific bill Supply Chain Issues, no specific bill Issues related to 340B Issues related to pharmacy benefit managers Proposed rule: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program HR 4818/ S. 2407 Treat and Reduce Obesity Act S. 2305 Biosimilar Red Tape Elimination Act S. 2129 Ensuring Access to Lower-Cost Medicines for Seniors Act Issues related to PAHPA reauthorization Modernizing and Ensuring PBM Accountability Act (Finance Committee) S. 652/ HR2630 SAFE Step Act S 2474/ HR 5376 Share the Savings with Seniors Act S 2456 Protecting Seniors from High Drug Costs Act HR4881 To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program HR 3281 Protecting Patients Against PBM Abuses Act HR 4822 Health Care Price Transparency Act of 2023 S 1339 Pharmacy Benefit Manager Reform Act HR 2679 Pharmacy Benefits Manager Accountability Act HR 4507 Transparency in Coverage Act of 2023 HR 1352 Increasing Access to Biosimilars Act of 2023 HR 2880 Protecting Patients Against PBM Abuses Act Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. HR 5539 Orphan Cures Act HR 5547 Maintaining Investments in New Innovation Act S 3558 BIOSECURE Act HR 7174 Ensuring Pathways to Innovative Cures (EPIC Act) S Res 566 Cholesterol Education Month 2024 HR 7635 340B PATIENTS Act of 2024 H.R. 5391 / S. 2764 The Protecting Patient Access to Cancer and Complex Therapies Act H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act. HR 5376 Share the Savings With Seniors Act S 3430 Mental Health, Lower Cost Drugs and Extenders Package. BIOCOMPETE (no bill number)- Issues related to prohibiting the export of biotechnology to certain foreign entities HR 8412 Clinical Trial Modernization Act S 5573 Skinny Labels, Big Savings Act HR 10515 American Relief Act

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

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

Issues related to drug pricing reform Changes to Public law 117-1769 Inflation Reduction Act Awareness of implications to patients and research and development of Public law 117-1769 Inflation Reduction Act S. 113 Prescription Pricing for the People Act of 2023 S.127 Pharmacy Benefit Manager Transparency Act HR 485 Protecting Health Care for All Patients Act HR 5378 Lower Costs, More Transparency Act HR 2534 PROTECT 340B act of 2023 HR 3561 the PATIENT act Issues related to cardiovascular disease awareness and treatment Issues related to ESRD Issues related to asthma and self-administered drug list Issues related to reimbursement for biologics/biosimilars Proposed rule: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program HR 4818/ S2407 Treat and Reduce Obesity Act S. 2129 Ensuring Access to Lower-Cost Medicines for Seniors Act Issues related to PAHPA reauthorization Modernizing and Ensuring PBM Accountability Act (Finance Committee) S. 1542/HR 6283 DRUG Act S652 SAFE Step Act HR 3281 Protecting Patients Against PBM Abuses Act HR 4822 Health Care Price Transparency Act of 2023 S 1339 Pharmacy Benefit Manager Reform Act HR 2679 Pharmacy Benefits Manager Accountability Act HR 4507 Transparency in Coverage Act of 2023 S 2474/HR 5376 Share the Savings with Seniors Act S 2456 Protecting Seniors from High Drug Costs Act HR4881 To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program HR 1352 Increasing Access to Biosimilars Act of 2023 HR 2880 Protecting Patients Against PBM Abuses Act HR 5547 Maintaining Investments in New Innovation Act HR 7174 Ensuring Pathways to Innovative Cures (EPIC Act) HR 7635 340B PATIENTS Act of 2024 H.R. 5391 / S. 2764 The Protecting Patient Access to Cancer and Complex Therapies Act H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act. HR 5376 Share the Savings With Seniors Act. S 3430 Mental Health, Lower Cost Drugs and Extenders Package HR 5539 Orphan Cures Act HR 10515 American Relief Act

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

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

- S 1375/HR 830, "HELP Copays Act", regarding all provisions. - PL 117-169, "The Inflation Reduction Act", regarding provisions impacting drug pricing and implementation. - PL 113-5 "Pandemic All Hazards Preparedness Reauthorization", regarding all provisions. - S 1355/HR 2940, "PASTEUR Act", regarding all provisions. - HR 3723, "Medical Device Electronic Labeling Act", regarding all provisions. - HR 2748, "Contact Lens Prescription Verification Modernization Act", regarding all provisions. - HR 4261, "Amputation Reduction and Compassion Act", regarding all provisions. - S 3131/HR 5539, "ORPHAN Cures Act", regarding all provisions. - HR 5372, "Expanding Access to Seniors Access to Lower Cost Medicines Act of 2023", regarding all provisions. - S 2305, "The Biosimilar Red Tape Elimination Act", regarding all provisions. - HR 1352, "Increasing Access to Biosimilars Act of 2023", regarding all provisions. - HR 7174, "Ensuring Pathways to Innovative Cures (EPIC) Act", regarding all provisions - HR 8574, the "340B Affording Care for Communities and Ensuring a Strong Safety-Net (ACCESS) Act", regarding all provisions - HR 7384, "Creating Hope Reauthorization Act", regarding all provisions - HR 7153/ S 3679 the "Dr. Lorna Breen Health Care Provider Protection Reauthorization Act", regarding all provisions Issues related to: - Obesity - Biosimilars - Health equity and diversity in clinical trials - Myopia - Ambulatory surgical services - Access to sterilization capacity for medical technologies - Peripheral artery disease - Cardiovascular health - Stroke care - FDA medical device shortage reporting requirements - Alternative funding programs - PBM practices - Health care workforce wellbeing - Medicaid Drug Rebate Program - the SUSTAIN 340B Act

Client expense: $1,520,000 · Firm income: Not reported

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

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.

Client expense: $6,570,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Occupational Safety & Health Administration (OSHA), SENATE, White House Office

Clarify or reform the 340B program Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Promoting the Congressional Plasma Caucus Pharmacy Benefit Managers (PBMs) H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 5378, The Lower Costs, More Transparency Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act

Client expense: $380,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Sustainability of safety net health systems; social determinants of health; promoting coordinated care; support of telehealth policies; 340B Protect Act, H.R. 4390; 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. 3281, the Transparent PRICE Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2665, the Supporting Safety Net Hospitals Act; and H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023; H.R. 5378, the Lower Costs, More Transparency Act; S.3548, the Health Care Prices Revealed and Information to Consumers Explained Transparency Act; H.R.6363, the Further Continuing Appropriations and Other Extensions Act, 2024; H.R. 2872, Further Additional Continuing Appropriations and Other Extensions Act, 2024; H.R. 7463, Extension of Continuing Appropriations and Other Matters Act, 2024; H.R. 8247, the Uterine Fibroid Intervention and Gynecological Health Treatment Act of 2024; H.R. 8574, the 340B Affording Care for Communities and Ensuring a Strong Safety-net Act; and H.R. 10337, Expanding the Health Care Workforce Act.

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

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

H.R. 8574, the 340B Affording Care for Communities and Ensuring a Strong Safety-net Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 830: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS OF THE BILL HR 2630: SAFE STEP ACT; ALL PROVISIONS OF THE BILL HR 2666: MEDICAID VBPS FOR PATIENTS ACT (MVP ACT); PROVISIONS RELATED TO OUTCOME BASED ARRANGEMENTS (OBA) AND VALUE BASED ARRANGEMENTS (VBA) HR 4758: ACCELERATING KIDS' ACCESS TO CARE ACT: ALL PROVISIONS OF THE BILL HR 7384: CREATING HOPE REAUTHORIZATION ACT OF 2024; ALL PROVISIONS OF THE BILL HR 8574: 340B AFFORDABLE CARE FOR COMMUNITIES AND ENSURING A STRONG SAFETY-NET (ACCESS) ACT; ALL PROVISIONS OF THE BILL HR 9184: PATIENT ACCESS ACT OF 2024; ALL PROVISIONS OF THE BILL S 2372: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS OF THE BILL S 4583: CREATING HOPE REAUTHORIZATION ACT OF 2024; ALL PROVISIONS OF THE BILL GENERAL DISCUSSIONS REGARDING GENETIC SCREENING, LONG TERM FOLLOW UP, CURES 3.0, AND ORPHAN DRUG ACT

Client expense: $490,000 · 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. 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

Support for elimination of Medicaid Disproportionate Share Hospital cuts Support for bolstering Medicare Graduate Medical Education program including the Resident Physician Shortage Reduction Act of 2023 (H.R.2389) Support for continuing key flexibilities beyond COVID-19 pandemic including telehealth policies and the hospitals at home program, and Substance Use Disorder Workforce Act (H.R. 7050) Support for Improving Seniors Timely Access to Care Act Support for bolstering healthcare workforce including the Healthcare Workforce Resilience Act Support for H.R. 9351 Opposition to proposals to cut providers including Medicare site-neutral payment reductions and policies to restrict the 340B drug pricing program Opposition to site-neutral cuts included in Lower Cost More Transparency Act and Bipartisan Primary Care and Health Workforce Act Opposition to Sec. 404 in Telehealth Modernization Act as marked up by Energy and Commerce Opposition to H.R. 2530, Nurse Staffing Standards for Hospital Patient Safety and Quality Care Act Support for H.R. 2534: Preserving Rules Ordered for the Entities Covered Through (PROTECT) 340B Act Support for: H.R. 7635: 340B Pharmaceutical Access to Invest in Essential, Needed Treatments and Support (PATIENTS) Act Opposition to H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B Access Act) Support for Healthcare in Your Language Bill Support for Nadler, Beatty, Williams Urge CMS to Issue Guidance on Informed Consent Requirements for Drug Testing of Pregnant Patients Opposition to proposals to implement National Provider Identifiers at Hospital Outpatient Departments

Client expense: $100,000 · Firm income: Not reported

Government targets: Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Inflation Reduction Act (IRA) HR 7174 - Ensuring Pathways to Innovative Cures (EPIC) Act Medicare Price Setting Drug Shortages Global Access to Medicines Trade-Related Aspects of Intellectual Property Rights (IPR) March-in Framework Guidance and Policies S 79/ HR 1717 - Interagency Patent Coordination and Improvement Act of 2023 S 142 - Preserve Access to Affordable Generics and Biosimilars Act HR 6986 - To address patent thickets S 150 - Affordable Prescriptions for Patients Act of 2023 S 2780/ HR 5429 - Medication Affordability and Patent Integrity Act Antimicrobial Resistance PBM Transparency and Reform S 1542 - Delinking Revenue from Unfair Gouging (DRUG) Act S 3430 - Better Mental Health Care, Lower-Cost Drugs and Extenders Act S 2973 - Modernizing and Ensuring PMB Accountability Act 340B Reform HR 8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act

Client expense: $2,760,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

Support 340B program. HR 2534 Protect 340B Act HR 7635 340B Patients Act Sustain 340B Act - comments on draft bill HR 8574 340B ACCESS Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Issues related to reforming and increasing transparency within the 340B Drug Pricing Program including in H.R. 3290 - To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program and H.R.8574 - To amend the Public Health Service Act to reform the 340B drug pricing program, and for other purposes. Issues related to PBM provisions included in H.R.10445 - Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1302 - Resident Physician Shortage Reduction Act of 2023: Provisions related to Graduate Medical Education. H.R. 7635 - The 340B PATIENTS Act of 2024, H.R. 8574 - 340B Access Act: Provisions related to Section 340B drug pricing. H.R. 5378 - Lower Costs, More Transparency Act: Provisions related to Section 340B drug pricing, site-neutral cuts, National Provider Identifier (NPI) cuts, and Disproportionate Share Hospitals. S. 2840 - Bipartisan Primary Care and Health Workforce Act: Provisions related to facility fees. Issues related to extensions of telehealth flexibilities in Sec. 319 of the Public Health Service Act. H.R. 2584, S. 2768 - Safety from Violence for Healthcare Employees (SAVE) Act: Provisions related to the healthcare workforce. Issues related to healthcare workforce, mental and behavioral health, artificial intelligence, cybersecurity, telehealth, community engagement, insurance, Laboratory Developed Tests, health equity, and National Provider Identifier (NPI) registry.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor the following: H.R.3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program, Indigent Care issues (340B Drug Discount program) Disproportionate Share Hospital programs Opioids related issues 340B Bipartisan Working Group/Draft Bill H.R.8574, 340B Affording Care for Communities and Ensuring a Strong Safety-net Act, Entirety Hospital Directed Payment Program related issues

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

Monitor the following: H.R.3290,To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program, Indigent Care issues (340B Drug Discount program) Veterans Medical Care/VA Mission Act, Implementation Disproportionate Share Hospital programs Prescription Drug Prices Nursing Education The Veterans Specific Education for Tomorrow's Health Professionals Act, Entirety 340B Bipartisan Working Group/Draft Bill H.R.8574, 340B Affording Care for Communities and Ensuring a Strong Safety-net Act, Entirety

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

Issues related to participation in the 340B Drug Discount Program HR 3290, 340B Transparency bill SUSTAIN 340B ACT - Draft Senate 340B reform legislation HR 8574 - 340B ACCESS Act Polices related to PBMs and drug cost transparency

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Discussions regarding H.R.5539, the ORPHAN Cures Act Discussions related to H.R.4534 - the Women and Lung Cancer Research and Preventive Services Act Discussions related to H.R.5391 - the Protecting Patient Access to Cancer and Complex Therapies Act 340B reform generally as well as H.R.8574 - the 340B ACCESS Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2665, The Supporting Safety Net Hospitals Act HR 2584, Safety from Violence for Healthcare Employees (Save) Act S 923, Better Mental Health Care for Americans Act HR 3046, Medical Student Education Authorization Act S 1133, the 340B Accountability Act of 2023 HR 3746, Fiscal Responsibility Act of 2023 HR 6833, Continuing Appropriations Act of 2023 HR 9747, Continuing Appropriations and Extensions Act, 2025 HR 3290, Transparency and Oversight of the 340B Drug Discount Program Act HR 3841, To reauthorize the program of payments to children's hospitals that operate graduate medical education programs HR 3887, The Children's Hospital GME Support Reauthorization Act of 2023 HR 4509 The Transparency in Billing Act HR 4507 The Transparency in Coverage Act of 2023 HR 4527 The Health DATA Act HR 4508 Hidden Fees Disclosure Act HR 4822 The Health Care Price Transparency Act of 2023 HR 1613 The Drug Transparency Act S 1038 The Drug Transparency Act HR 3561 The Patient Act HR 2534 Protect 340B Act of 2023 HR 3226 The PREEMIE Act of 2023 S 1573 The PREEMIE Act of 2023 HR 5378 The Lower Costs, More Transparency Act HR 6664 Innovation in Pediatric Drugs Act of 2023 HR 7635 The 340B Pharmaceutical Access to Invest in Essential, Needed Treatments & Support Act of 2024 HR 8574 340B Affording Care for Communities and Ensuring a Strong Safety-net Act HR 8260, Hospital Inpatient Services Modernization Act S 2768, Hospital Inpatient Services Modernization Act HR 10545 American Relief Act of 2025 S 2372 Accelerating Kids Access to Care Act HR 4758 Accelerating Kids Access to Care Act CDC Injury Control Research Centers Funding NIH Pediatric Medical Research Prioritization FDA Proposed Rule Titles "Medical Device Laboratory Developed Tests"

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

HR 2665, The Supporting Safety Net Hospitals Act HR 2584, Safety from Violence for Healthcare Employees (Save) Act S 923, Better Mental Health Care for Americans Act HR 3046, Medical Student Education Authorization Act S 1133, the 340B Accountability Act of 2023 HR 3746, Fiscal Responsibility Act of 2023 HR 6833, Continuing Appropriations Act of 2023 HR 9747, Continuing Appropriations and Extensions Act, 2025 HR 3290, Transparency and Oversight of the 340B Drug Discount Program Act HR 3841, To reauthorize the program of payments to children's hospitals that operate graduate medical education programs HR 3887, The Children's Hospital GME Support Reauthorization Act of 2023 HR 4509 The Transparency in Billing Act HR 4507 The Transparency in Coverage Act of 2023 HR 4527 The Health DATA Act HR 4508 Hidden Fees Disclosure Act HR 4822 The Health Care Price Transparency Act of 2023 HR 1613 The Drug Transparency Act S 1038 The Drug Transparency Act HR 3561 The Patient Act HR 2534 Protect 340B Act of 2023 HR 3226 The PREEMIE Act of 2023 S 1573 The PREEMIE Act of 2023 HR 5378 The Lower Costs, More Transparency Act HR 6664 Innovation in Pediatric Drugs Act of 2023 HR 7635 The 340B Pharmaceutical Access to Invest in Essential, Needed Treatments & Support Act of 2024 HR 8574 340B Affording Care for Communities and Ensuring a Strong Safety-net Act HR 8260, Hospital Inpatient Services Modernization Act S 2768, Hospital Inpatient Services Modernization Act HR 10545 American Relief Act of 2025 S 2372 Accelerating Kids Access to Care Act HR 4758 Accelerating Kids Access to Care Act CDC Injury Control Research Centers Funding NIH Pediatric Medical Research Prioritization FDA Proposed Rule Titles "Medical Device Laboratory Developed Tests"

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

Inflation Reduction Act (IRA) HR 7174 - Ensuring Pathways to Innovative Cures (EPIC) Act Medicare Price Setting Drug Shortages Global Access to Medicines Trade-Related Aspects of Intellectual Property Rights (IPR) March-in Framework Guidance and Policies S 79/ HR 1717 - Interagency Patent Coordination and Improvement Act of 2023 S 142 - Preserve Access to Affordable Generics and Biosimilars Act HR 6986 - To address patent thickets S 150 - Affordable Prescriptions for Patients Act of 2023 S 2780/ HR 5429 - Medication Affordability and Patent Integrity Act Antimicrobial Resistance PBM Transparency and Reform S 1542 - Delinking Revenue from Unfair Gouging (DRUG) Act S 3430 - Better Mental Health Care, Lower-Cost Drugs and Extenders Act S 2973 - Modernizing and Ensuring PMB Accountability Act 340B Reform HR 8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act

Client expense: $2,710,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

The 340B Drug Pricing Program; H.R. 2534, The Protect 340B Act; FY24 and FY25 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations bills. HR 3290,to amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. H.R.3561 - PATIENT Act of 2023, The Stop Drug Shortages Act (Draft legislation- House), H.R. 5378: Lower Costs, More Transparency Act, S. 1182: 340B Reporting and Accountability Act; S.1133: 340B Accountability Act of 2023,S.1038: Drug Price Transparency in Medicaid Act of 2023,H.R.1613: Drug Price Transparency in Medicaid Act of 2023,H.R.198: Drug Pricing Transparency and Accountability Act; S. 2973: Modernizing and Ensuring PBM Accountability Act, Draft Senate legislation the SUSTAIN 340B Act, HR 7635 and S. 5021, the 340B PATIENTS Act.H.R. 8574, 340B ACCESS Act: H.R.8144 - Rural 340B Access Act of 2024

Client expense: $260,046 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE

Issues pertaining to the 340B Drug Discount Program - H.R. 8574 340B ACCESS Act Issues pertaining to the implementation of the Inflation Reduction Act of 2022 Issues pertaining to Pharmacy Benefit Managers Issues pertaining to CMS Coverage of APS in LTC Alzheimers screening in Medicare - S. 2379 & H.R. 4752 - The Change Act of 2023 Issues pertaining to Medicares Six Protected Classes policy Medicare Part D Smoothing Benefit - FY 2025 Labor-HHS Appropriations; H.R. 8725 - Increasing Medication Access for Seniors Act of 2024 Orphan drug exclusion in the Inflation Reduction Act - H.R. 5539 & S. 3131 - The ORPHAN Cures Act of 2023 Small molecule discrepancy in the Inflation Reduction Act - H.R. 7174 - The EPIC Act

Client expense: $150,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Q4 Lobbying Report (Oct.1 -Dec. 31) HCR Transparency (surprise medical bills; public posting of hospital charges) 340B Drug Pricing Program Resident Physician Shortage Act of 2023 (H.R. 2389) No Surprises Act regulations Food and Drug Amendments No Surprise Bills for New Moms Act (H.R. 3387) Securing the U.S. Organ Procurement and Transplantation Network Act (H.R. 2544) Promoting Access to Treatments and Increasing Extremely Needed Transparency Act (H.R. 3561) Medicaid VBPs for Patients (MVP) Act (H.R. 2666) Providers and Payers COMPETE Act (H.R. 3284) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program (H.R. 3290) Transparent PRICE Act (H.R. 3281/H.R. 2691)) Resident Physician Shortage Reduction (S. 1302) Medical Student Education Authorization Act (H.R. 3046) Save Americas Rural Hospitals Act (H.R. 833) Chronic Care Management Improvement Act (H.R. 2829) Safety From Violence for Healthcare Employees Act (H.R. 2584) Supporting Safety Net Hospitals Act (H.R. 2665) Patient Access to Higher Quality Health Care Act (H.R. 977/S.470) FEMA re: COVID-19 related reimbursement Public Health Guidance Transparency and Accountability Act of 2023 (H.R. 4529) Public Health Emergency Congressional Review Act (H.R. 4381) CDC Leadership Accountability Act of 2023 (H.R. 3813) Preparing for All Hazards and Pathogens Reauthorization Act (H.R. 4421) Preparedness and Response Reauthorization Act (H.R. 4420) Childrens Hospital GME Support Reauthorization Act of 2023 (H.R. 3887) Health Care Price Transparency Act of 2023 (H.R. 4822) Providers and Payers COMPETE Act (H.R. 3284) Lower Costs, More Transparency Act (H.R. 5378 Transparency in Coverage Act (H.R. 4507) GOLD Card Act of 2023 (H.R. 4968) No Fees for EFTs Act (H.R.6487) Rural Health Care Facilities Revitalization Act (H.R. 5989) Dr. Lorna Breen Health Care Provider Protection Reauthorization Act (H.R. 7153) To amend title XVIII of the Social Security Act to establish a definition of essential health system in statute (H.R. 7397) Substance Use Disorder Workforce Act (H.R. 7050) 340B PATIENTS Act (H.R. 7635) The 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act (H.R. 8574) Improving Seniors Access to Timely Care Act (H.R. 8702/S.4532) The Preserving Emergency Access in Key Sites (PEAKS) Act (H.R. 7931) Rural Health Care Facilities Revitalization Act (H.R. 5989) MMM Accelerated and Advance Payment Program repayment flexibility Graduate Medical Education (GME) funding Telehealth flexibilities and payment Annual Prospective Payment System Rules Organ acquisition payment policies Californias Medicaid Hospital Quality Assurance Fee Program Medicare Advantage BUD FY 2025 Appropriations bills Nursing and allied health workforce funding FY 2025 budget request Further Continuing Appropriations and Other Extensions Act (H.R. 6363) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (H.R. 5894) Tax Relief for American Families and Workers Act of 2024 (H.R. 7024) Extension of Continuing Appropriations and Other Matters Act, 2024 (H.R. 7463) Submitted Comments Regulatory Comment Letters SUBJECT: CMS-10913, Medicare Part C Utilization Management Annual Data Submission and Audit Protocol Data Request; Notice, Agency Information Collection Activities: Proposed Collection; Comment Request; Federal Register (Vol 89, No 145), September 10, 2024

Client expense: $300,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE, Social Security Administration (SSA)

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.

Client expense: $620,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), SENATE, White House Office

H.R. 3226 & S.1573, The PREEMIE Reauthorization Act H.R. 3838 & S.2415, Preventing Maternal Deaths Reauthorization Act of 2023 H.R. 4714 & S. 2345, The Pediatricians Accelerate Childhood Therapies (PACT) Act    H.R.7087 & S.3641, MOMS Who Serve Act SUSTAIN 340B Act - Senate discussion draft H.R 7635, 340B PATIENTS Act H.R. 8574, 340B Access Act H.R. 2439 & S. 1135, Ally's Act   H.R. 7542 & S. 3864, Stop CMV Act  H.R. 3433, Give Kids a Chance Act   H.R. 6664 & S.4905, Innovation in Pediatric Drug Act of 2023 H.R. 7379, Patient Matching and Transparency in Certified Health IT (MATCH IT) Act CHGME Reauthorization H. Res. 1581, Expressing support for the designation of Prematurity Awareness Month" Analysis of sickle cell disease legislation in anticipation of future advocacy/endorsement of legislation Prep for military health care legislation support Continuing Resolution (CR)/Year End Package - H.R.10545 - American Relief Act, 2025 - Advocated for inclusion of: - H.R. 3226 & S.1573, The PREEMIE Reauthorization Act - H.R. 3838 & S.2415, Preventing Maternal Deaths Reauthorization Act of 2023 - Telehealth extension provisions

Client expense: $178,004 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to patient access and pricing. Issues related to policy changes to Medicare Part D. Issues related to PBM reform; H.R.2880, Protecting Patients Against PBM Abuses Act; H.R.5376, Share the Savings with Seniors Act; H.R.10445, Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025; H.R.10545, American Relief Act, 2025. Issues related to 340B reform; H.R.8574, To amend the Public Health Service Act to reform the 340B drug pricing program, and for other purposes. Issues related to the Ensuring Pathways to Innovative Cures (EPIC) Act, H.R.7174.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.3046/S.1403 - Medical Student Education Authorization Act of 2023 Issue: Support grants for primary care training in medically under-resourced communities. Draft Social Determinants Accelerator Act Issue: Support grants to address social determinants of health. H.R.9161/S.4773 - Health Equity and Accountability Act of 2024 Issue: Support programs to improve health equity and address social determinants of health. S.2333 - Pandemic and All-Hazards Preparedness and Response Act H.R.4420 - Preparedness and Response Reauthorization Act H.R.4421 - Preparing for All Hazards and Pathogens Reauthorization Act H.R.4697 - Protecting PAHPA Act of 2023 Issues: Support the reauthorization of the Pandemic and All-Hazards Preparedness Act with increased funding authorization levels. Issue: Support authorities to strengthen CDCs and ASPRs ability to prevent and respond to existing and emerging threats. S.1995 - Public Health Infrastructure Saves Lives Act Issue: Support investments in core public health infrastructure. Issue: Educate Congress on how the 340B Drug Pricing Program helps safety-net providers to fulfill their missions and care for patients and communities. Support measures to preserve and strengthen the 340B Drug Pricing Program. Oppose efforts to reduce the scope of the program and transition 340B into a rebate model. H.R.2534 - Preserving Rules Ordered for the Entities Covered Through 340B Act of 2023 (PROTECT 340B Act) Issue: Support measures to prevent pharmacy benefit managers and commercial insurers from imposing discriminatory reimbursement policies on 340B covered entities. H.R.7635 - 340B Pharmaceutical Access to Invest in Essential, Needed Treatments and Support (340B PATIENTS) Act Issue: Support amending the 340B statute to codify covered entities ability to use contract pharmacies. H.R.3290 - To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. Issue: Oppose efforts to impose additional reporting requirements on 340B hospitals. Draft Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B (SUSTAIN 340B) Act Issue: Support efforts to prohibit pharmaceutical and pharmacy benefit manager (PBM) discrimination against covered entities. Oppose efforts to define patient in the context of the program. Oppose efforts to impose additional administrative and reporting requirements on 340B hospitals. H.R.8574 - 340B ACCESS Act Issue: Oppose efforts to restrict hospital eligibility for the 340B program. Issue: Oppose insurance plans that do not meet Affordable Care Act requirements. Issue: Support policies to improve maternal health outcomes through expanded Medicaid coverage, enhanced data collection, and improved access to behavioral health care during the perinatal period. P.L. 118-159 - Servicemember Quality of Life Improvement and National Defense Authorization Act for Fiscal Year 2025 S.4638 National Defense Authorization Act for Fiscal Year 2025 Issue: Oppose prohibition on coverage for gender affirming care. H.R.2369 - Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2023 Issue: Educate Congress on development of laboratory developed tests (LDTs) at academic medical centers and oppose policies that would increase burdensome regulations and negatively impact patients access to care by allowing FDA regulation of the development of LDTs at academic medical centers. Issue: Educate Congress on the medical education and training continuum, the annual residency Match, and the role of the National Resident Matching Program (NRMP) in medical education and residency. Issue: Provide guidance on the implementation of the No Surprises Act (P.L.116-260). Issue: Educate Congress and the administration on the role of academic medicine in the provision of mental and behavioral health care, including initiatives to respond to the opioid epidemic. Support policies to strengthen the behavioral health workforce, promote the uptake of integrated behavioral health models, advance mental health research, and ensure access to coverage and care. Issue: Educate Congress about the financial challenges facing academic medical centers, including reimbursement challenges, workforce challenges, inflation, and others. Issue: Educate Congress and the administration about the impact of the unwinding of the COVID-19 public health emergency on the academic medicine community and the patients they serve. H.R.3887 - Childrens Hospital GME Support Reauthorization Act of 2023 H.R.3841 - To amend title III of the Public Health Service Act to reauthorize the program of payments to children's hospitals that operate graduate medical education programs. Issue: Support clean reauthorization of the Childrens Hospital GME program. Issue: Support reauthorization of the National Health Service Corps and Teaching Health Center Graduate Medical Education. Issue: Express concern regarding actions to inappropriately undermine FDA regulatory authority. Issue: Educate Congress and the administration about medical education on nutrition, hunger, and health; reproductive health; substance use disorders; medication assisted treatment for opioid use disorders; trans health; preventing fraud and abuse; diversity, equity, and inclusion; menopause management; health care for people with disabilities; and maternal health. Issue: Educate Congress and the administration about resident physician practice decision making post US SCOTUS decision in Dobbs. Issue: Educate Congress on resident expectations related to clinical practice and oppose so-called physician service mandates. H.R.7855 - Rural Residency Planning and Development Act of 2024 Issue: Support codification of HRSAs rural residency planning and development program. Issue: Support providing discretionary funds for rural teaching hospitals to expand their residency programs. Issue: Educate Congress on vaccine safety. Issue: Encourage changes to HRSA financial aid programs as a result of FAFSA updates. Issue: Educate Congress on the use of artificial intelligence (AI) in academic medicine. S.4031 - Providing Resources and Opportunities for Health Education and Learning (PRO-HEAL) Act Issue: Support HRSA grants to expand provider pipeline programs to create pathways to health care careers. H.R.7258/S.3968 - Community Training, Education, and Access for Medical Education, and Access for Medical Students (TEAMS) Act Issue: Support enhanced community-based training opportunities for medical students, particularly in rural and medically underserved areas, and fostering long-term sustainable physician practices in high-need communities. H.R.7153/S.3673 - Dr. Lorna Breen Health Care Provider Protection Reauthorization Act Issue: Support ability of HRSA to implement evidenced-based practices for preventing suicide and improving mental health and resiliency among health care professionals, and for training health care professionals in appropriate strategies to address substance use disorders. Issue: Provide input on Next Generation Cures initiative. Issue: Promote overdose prevention. H.R. 10047 The Closing the Substance Use Care Gap Act Issue: Support extension of SAMHSA harm reduction programs.

Client expense: $632,324 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Council on Disability, Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Vice President of the U.S., White House Office

S723/HR1458 - Access to Prescription Digital Therapeutics Act HR8816 - American Medical Innovation and Investment Act of 2024 PBM Transparency and Reform S1542/HR6283 - Delinking Revenue from Unfair Gouging (DRUG) Act HR2880 - Protecting Patients Against PBM Abuses Act HR5378 - Lower Costs More Transparency Act 340B Reform HR8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act

Client expense: $1,070,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.2840, Bipartisan Primary Care and Health Workforce Act H.R.7635, The 340B PATIENTS Act of 2024 H.R.5829, Health Care Practitioner Disaster Protection Act H.R.5378, Lower Costs, More Transparency Act H.R.1072, Health Center Community Transformation Hub Act H.R.9029, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025 H.R.7623, Telehealth Modernization Act of 2024 H.R.8574, 340B ACCESS Act Keeping Obstetrics Local Act SUSTAIN Act Issues related to the 340B program (including 340C) Issues related to the Developing the Community Health Workforce Act Issues related to the Emergency Preparedness for Underserved Populations Act Issues related to Community health center funding and potential lame duck legislative packages Issues related to the ending of the public health emergency, including redeterminations in the Medicaid program Issues related to Food as medicine policy proposals Issues related to value-based care options for federally qualified health centers and safety net settings including the AHEAD model at CMMI and Making Care Primary model at CMS Issues related to the transforming maternal health model at CMMI Issues related to community health center workforce data with the Health Resources and Services Administration Issues related to maternal health in community health centers, including a virtual congressional briefing Issues related to 340B provisions in the Inflation Reduction Act Issues related to the 340B rebate model ACH comments on the 2025 Physician Fee Schedule ACH comments on The Pay Primary Care Providers (PCP) Act of 2024 RFI

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, White House Office

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: $160,000 · Firm income: Not reported

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

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. 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. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues 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. 1906: Promising Pathway Act - Approval pathway policy issues 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 (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 5021: The 340B PATIENTS Act of 2024 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 Health Equity Inflation Reduction Act of 2022 (P.L. 117-169), Implementation 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 Real world evidence 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 Cybersecurity policy issues Artificial intelligence policy issues

Client expense: $1,540,000 · Firm income: Not reported

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