The 340B PATIENTS Act of 2024

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

Contract Pharmacy-HR 7635, The 340B PATIENTS Act of 2024 340B Transparency-No legislation yet Contract Pharmacy Protect 340B-340B Patients Act 340B Transparency-Opposition to H.R. 3290 (overly burdensome reporting legislation that distorts the 340B program) Letter to HHS Secretary Becerra

Client expense: $15,000 · Firm income: Not reported

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

Congressional outreach and monitoring regarding the following: -Healthcare and hospital workforce budget and appropriations, generally; -340B Drug Discount Program & HRSA/CMS policies; -CMS Wage Index; -National Provider Identification; -Telehealth, generally; -Site Neutral Payment Proposals; -Rural Medicare Programs; -Medicaid DSH Payments; -Medicare reimbursement rates, generally; -H.R. 10545, Further Continuing Appropriations Act, 2025; -H.R. 2584 / S. 2768, Safety From Violence for Healthcare Employees Act; -H.R. 7635 / S. 3922, The 340B PATIENTS Act of 2024; -H.R.8702 / S. 4532, Improving Seniors Timely Access to Care Act of 2024.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health care policy Funding for the National Emerging Special Pathogen Training and Education Center (NETEC) and Regional Emerging Special Pathogen Treatment Centers (RESPTC) Proposals to address rising drug costs Legislative proposals related to the 340B program H.R. 2534, PROTECT 340B Act H.R. 3290, legislation requiring 340B program covered entities report a wide range of data H.R. 7635/S.5021 340B PATIENTS Act H.R. 5378, Lower Costs, More Transparency Act -provisions related to 340B covered entity reporting, reimbursement of 340B covered drugs, price transparency, and funding for health programs Proposals related to telehealth H.R. 4189/S. 2016, CONNECT for Health Act SUPPORT Act reauthorization H.R. 10545, "American Relief Act"

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Proposals related to addressing drug pricing Proposals to modify 340B program H.R. 2534, The Protect 340B Act H.R. 7635/S.5021 340B PATIENTS Act H.R. 5378, Lower Costs, More Transparency Act - provisions related to 340B covered entity reporting, reimbursement of 340B covered drugs, price transparency, and funding for health programs H.R. 10545, the American Relief Act"

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Proposals related to telehealth H.R. 4189/S. 2016, CONNECT for Health Act Healthcare policy Proposals to reduce drug costs and improve access Proposals to modify the 340B program H.R. 2534, PROTECT 340B Act H.R. 7635/S.5021 340B PATIENTS Act H.R. 3290 and proposals implementing reporting requirements for 340B covered entities H.R. 5378, Lower Costs, More Transparency Act H.R. 7153/S. 3679, Dr. Lorna Breen Health Care Provider Protection Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 766: Dr. Michael C. Burgess Preventive Health Savings Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2024 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4818: Treat and Reduce Obesity Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7024 Tax Relief for American Families and Workers Act of 2024 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 9096: Pharmacists Fight Back Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2477: Equitable Community Access to Pharmacist Services Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 3430: Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023 S. 5021: 340B PATIENTS Act of 2024 S. 5040: Protecting Patients from Deceptive Drugs Online Act S. 5459: Biosimilars Access and Affordability Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Artificial intelligence policy issues Vaccine provisions of the Inflation Reduction Act Policy issues related to vaccines

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

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

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

340B Drug Discount Program, eligibility waiver H.R. 3290 H.R. 2389, S.1302 - Resident Physician Shortage Reduction Act H.R. 3561 - PATIENT Act H.R. 2665 - Supporting Safety-Net Hospitals Act HR 7635 - 340B PATIENTS Act SUSTAIN 340B Act ACCESS 340B Act Graduate Medical Education Disproportionate Share Hospital (DSH) payments Childrens Health Insurance Program Medicare Dependent Hospital Program (MDH) Medicaid Low Volume Payments (LV) Federal Medical Assistance Percentage Extension Inpatient Prospective Payment System Outpatient Prospective Payment System Bad debt/charity care Hospital Outpatient Department payments Site Neutral Payment Policies Acute Hospital Care at Home Program Telehealth coverage

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1770, The Equitable Community Access to Pharmacist Services Act H.R. 2389, The Resident Physician Shortage Reduction Act of 2023 H.R. 5378, The Lower Costs, More Transparency Act; hospital outpatient department funding H.R. 7635, The 340B PATIENTS Act of 2024 H.R. 9351, The Save Our Safety-Net Hospitals Act of 2024 H.R. 9669/S.5091, The Basic Assistance for Students In College (BASIC) Act S. 4667, The Risky Research Review Act S. 5397/H.R. 10225, Rebuild Americas Health Care Schools Act of 2024 Hospital Inpatient Prospective Payment System (IPPS); funding for Graduate Medical Education (GME) resident physician slots H.R. 9029/S. 4942, FY 2025 Labor, Health and Human Services, Education and Related Agencies Appropriations Act; funding for the Children's Hospital Graduate Medical Education (GME) Program Medicaid Disproportionate Share Hospital (DSH) funding cut repeal related issues; extension of Medicare telehealth program related issues; issues related to Medicare Physician Fee Schedule related payment issues; Hospital Outpatient Prospective Payment System related issues Medicaid related issues

Client expense: $440,000 · Firm income: Not reported

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

Educated congressional offices about the importance of the 340B program to Texas Children's Hospital. Requested support for HR 7635, the 340B Pharmaceutical Access To Invest in Essential, Needed Treatments & Support Act, or 340B PATIENTS Act, which would prohibit drug companies from imposing restrictions on covered entity access to 340B pricing through contract pharmacies. Educated congressional offices about how site neutral policies, which seek to reimburse for care provided in a hospital off campus outpatient department setting at the same rate as physician offices, would impact Texas Children's ability to continue expanding access to care in the communities we serve throughout Texas. Sought support for HR 4758/S 2372, the Accelerating Kids Access to Care Act, which would streamline Medicaid provider enrollment when a child needs to travel to another state for care.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support for the 340B PATIENTS Act (HR 7635) Issues related to the 340B Drug Pricing Program

Client expense: Not reported · Firm income: Not reported

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. 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

Issues related to FDA authority to manage drug shortages, regulation of pharmacy compounding, and implementation of the Drug Quality and Security Act. Issues related to pharmacy benefit manager (PBM) abuses and transparency, including support for the following bills: the Drug Price Transparency in Medicaid Act of 2023 (H.R. 1613), the PBM Accountability Act (H.R. 2679), the Modernizing and Ensuring PBM Accountability Act (S. 2973), and the Pharmacy Benefit Manager Reform Act (S. 1339). Issues related to 340B program nondiscrimination and contract pharmacy arrangements, including support for the following bills: The PROTECT 340B Act (H.R. 2534) and the 340B Pharmaceutical Access to Invest in Essential, Needed Treatments & Support Act of 2024 (H.R. 7635). Issues related to manufacturer attempts to undercut the 340B program (generally, no specific legislation). Issues related to pharmacy residency funding, including support for the Rebuild Americas Health Care Schools Act of 2024 (S. 5397/H.R. 10225). Issues related to drug price negotiations and patient out-of-pocket costs (generally, no specific legislation). The Biosimilar Red Tape Elimination Act (S. 2305) and the Affordable Prescriptions for Patients Act of 2023 (S. 150), issues related to accelerating biosimilar adoption.

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

Government targets: Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

Issues related to the 340B Drug Pricing Program - regarding all bio-pharmaceutical related provisions H.R.7635, the 340B PATIENTS Act H.R.2163, to amend the Employee Retirement Income Security Act to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for a medication step therapy protocol, and for other purposes

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

H.R. 1613, Drug Price Transparency in Medicaid Act of 2023 H.R. 2666, Medicaid VBPs for Patients (MVP) Act H.R. 7174, 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. 7635, The 340B PATIENTS Act of 2024 Issues relating to, Medicare; Medicare Part B and D drug pricing issues; 340B program integrity; 340B of the Public Health Services Act; 340B drug pricing program; Drug pricing; Drug pricing and reimbursement issues; FY-2024 Budget and Appropriations Legislation; Medicaid drug rebate program (MDRP); Medicare coverage of COVID antiviral medicines.

Client expense: $1,730,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare and Medicaid payment issues Health care workforce Drug Shortages Health Equity / Social determinants of health Maternal Health Behavioral and Mental Health MACRA reform Hospital consolidation Health care pricing transparency Tax Exempt Hospitals Primary Care and Health Workforce Expansion Act Lower Cost More Transparency Act Site Neutral 340B Drug Pricing MA prior authorization Medicare hospital wage index Telehealth and digital health Home health / Hospice Rural health Pediatric drug shortages and the Pediatric Cancer Drug Supply Act of 2024 (H.R. 6963) COMPLETE Care Act (H.R. 5819) Artificial intelligence Lorna Breen Health Care Worker Safety Reauthorization Act (S. 3679 / H.R. 7153) and appropriations to same SAVE Act (S. 2768 / H.R. 2584) Lab developed tests Mobile stroke unit funding Connected MOM (S. 712) 340B Patients Act (H.R. 7635 / S. 3922) Improving Seniors' Timely Access to Care Act (H.R. 9702 / S. 4532) Connect Act (H.R. 4189 /S. 2016) MAPS Act (H.R. 6992) H. Res. 389 - In support of Healthcare workers TEAM Model implementation Physician Fee Schedule Medical Graduate Investment Act Connected MOM Enforcement Act Legislation to address eCQM CMS issue No fees for EFTs Act (S. 3805/H.R. 6487)

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

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

Specific Lobbying Issues: Medicaid/Medicare: - Medicaid Disproportionate Share Hospital (DSH) Cuts: Advocated for elimination of cuts. Medicare Site-Neutral Payments: - Opposed proposed cuts to site-neutral payments. Extension of Public Health Emergency (PHE) Waivers: - Supported continuation of waivers for Hospital-at-Home (H@H) programs and telehealth services. Healthcare Workforce: - Graduate Medical Education (GME): Advocated for increased GME slots. Improving Medicaid and CHIP Provider Enrollment Processes: - Supported proposals to streamline enrollment. Healthcare Programs: - 340B Drug Pricing Program: Supported the program and opposed efforts to impose restrictive policies. - Community Health Center Funding: Advocated for extension of funding. Administrative Reforms: - Prior Authorization Improvements: Supported measures to improve access to timely care. - National Provider Identifier (NPI): Opposed proposals included in H.R. 5378 that would impact the NPI process. Legislation Monitored and Supported/Opposed: H.R. 7635 / S. 5021 - 340B PATIENTS Act of 2024 H.R. 8260 / S. 4350 - Hospital Inpatient Services Modernization Act H.R. 5378 - Lower Costs, More Transparency Act H.R. 2389 - Resident Physician Shortage Reduction Act of 2023 H.R. 9351 - Save Our Safety-Net Hospitals Act of 2024 H.R. 8702 / S. 4532 - Improving Seniors Timely Access to Care Act of 2024 H.R. 4758 - Accelerating Kids Access to Care Act H.R. 2407 - Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act Meetings/letters with Congressional offices to discuss the above issues and legislative priorities. Advocacy for specific funding levels, policy changes, and program extensions.

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

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

H.R. 2534 - the PROTECT 340B Act of 2023 - all provisions H.R. 7635 - The 340B Patietns Act of 2024 - all provisions H.R. 8702 & S. 4532 - Improving Seniors' Timely Access to Care Act of 2024 H.R. 5378, the Lower Costs, More Transparency Act: Sec.203.Parity in Medicare payments for hospital outpatient department services furnished off-campus; & Sec.204.Requiring a separate identification number and an attestation for each off-campus outpatient department of a provider. The Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act draft legislation - all provisions. Continuing the federal Medicare telehealth geographic and site restriction waivers. Extending waivers for the federal Acute Hospital Care at Home program. Continued funding for the Medicare-Dependent Hospital and Low-Volume Hospital Adjustment programs. General concerns about Medicare underpayments to hospitals. Draft continuing resolution to fund the federal government. Section 228. Requiring a separate identification number and an attestation for each off-campus outpatient department of a provider.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2534 - the PROTECT 340B Act of 2023 - all provisions H.R. 7635 - The 340B Patietns Act of 2024 - all provisions H.R. 8702 & S. 4532 - Improving Seniors' Timely Access to Care Act of 2024 H.R. 5378, the Lower Costs, More Transparency Act: Sec.203.Parity in Medicare payments for hospital outpatient department services furnished off-campus; & Sec.204.Requiring a separate identification number and an attestation for each off-campus outpatient department of a provider. The Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act draft legislation - all provisions. Continuing the federal Medicare telehealth geographic and site restriction waivers. Extending waivers for the federal Acute Hospital Care at Home program. Continued funding for the Medicare-Dependent Hospital and Low-Volume Hospital Adjustment programs. General concerns about Medicare underpayments to hospitals. Draft continuing resolution to fund the federal government. Section 228. Requiring a separate identification number and an attestation for each off-campus outpatient department of a provider. Declaring a shortage of IV solutions and taking other steps necessary to give health care providers maximum flexibility to deal with the IV fluid shortage caused by Hurricane Helenes closure of Baxters plant in Marion, N.C.

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

Government targets: HOUSE OF REPRESENTATIVES, President of the U.S., 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

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

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

Advocate for proposals to provide direct financial support to safety net hospitals with Congressional staff. Discuss opposition to Medicare site-neutral payment policies with Congressional staff. Educate Congressional staff on hospital price transparency federal rule (84 FR 65602). Oppose changes to NPIs for hospital outpatient departments (H.R. 7623, H.R. 4509, H.R. 7623 as amended, H.R. 4822). Meet with Congressional staff to discuss H.R. 5378, the Lower Costs, More Transparency Act of 2023, and comment on following proposals in bill: support for delay of Medicaid DSH cut, codification and expansion of Federal price transparency rule, oppose National Provider Identifier (NPI) requirements for hospital outpatient departments, oppose changes to 340B drug pricing program, support reauthorization of Community Health Centers, support reauthorization of National Health Service Corps, support reauthorization of Teaching Health Center Graduate Medical Education funding. Discuss hospital and health provisions in CAA, 2024 (H.R. 4366) with HHS staff and Congressional staff: support public health extenders and elimination of Medicaid DSH cut. Discuss support for the 340B Drug Pricing Program with Congressional staff and discuss certain changes: oppose 340B ACCESS Act (H.R. 7635), comment on SUSTAIN 340B Act discussion draft, support PATIENTS Act (H.R. 7635); oppose back-end rebate proposals. Discuss legislative proposals with Congressional staff to stabilize long-term care and post-acute care providers: establish a temporary per diem Medicare payment to ease capacity issues and address financial challenges from slow discharges (support); make permanent three-day hospital stay waiver (support) and other COVID-19 PHE regulatory flexibilities. Discuss Medicare Graduate Medical Education (GME) provisions in the Consolidated Appropriations Act (CAA), 2021 and CAA, 2023 with HHS staff. Discuss with Congressional staff support for Medicare GME expansion and changes to GME program: the Resident Physician Shortage Reduction Act, the Pathway to Practice Act of 2021, the Substance Use Disorder Workforce Act (H.R. 7050); additional GME slots in CAA, 2021 and CAA, 2023; Rural Residency Planning and Development Act (H.R. 7855); concerns on Rural Physician Workforce Preservation Act and opposition to modifications to ongoing slot distribution; Senate Finance Committee draft proposals to increase GME slots. Discuss with HHS staff and Congressional staff recommendations to address workforce shortages for nursing and ancillary health care workforce: faculty recruitment and retention, additional financial support for supervision and precepting students, Medicare payment for nursing and allied health, testing new workforce models, establishing incentives and early recruitment strategies, providing funding for clinical training site, and immigration reforms that expedite entry for foreign health care workers. Support passage of the Safety from Violence for Healthcare Employees (SAVE) Act (H.R. 2584/S.2768). Support revisions to Conrad 30 waiver program to increase the number of foreign physicians that may remain in the US after completing GME: S.665/H.R.4942, S.2719/H.R.6980, H.R. 4875. Discuss expiring COVID-19 Public Health Emergency Medicare flexibilities with Congressional staff and HHS staff and support legislative proposals to extend PHE telehealth flexibilities and Acute Hospital Care at Home Waiver: H.R. 7623. Oppose legislative proposals to impose financial penalties on hospitals relating to minimum cybersecurity standards (S.5218). Discuss legislative proposals to regulate the use of artificial intelligence in health care delivery with Congressional staff. Discuss FEMA COVID-19 Public Assistance payouts with Congressional staff. Support Improving Seniors Timely Access to Care Act (S. 4532/H.R. 8702). Discuss legislative proposals on consumer medical debt with Congressional staff. Outreach to HHS Assistant Secretary for Preparedness and Response urging certain regulatory flexibilities to alleviate IV fluid shortages.

Client expense: $350,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, White House Office

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

340B Drug Pricing Program, Drug Pricing Legislation, PBM Reform Legislation, Healthcare Transparency Legislation -- Bill H.R. 7635 340B PATIENTS Act, SUSTAIN 340B Act, 340B ACCESS Act

Client expense: Not reported · Firm income: Not reported

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

Educated congressional offices about the importance of the 340B program to Texas Children's Hospital. Requested support for HR 7635, the 340B Pharmaceutical Access To Invest in Essential, Needed Treatments & Support Act, or 340B PATIENTS Act, which would prohibit drug companies from imposing restrictions on covered entity access to 340B pricing through contract pharmacies. Educated congressional offices about how site neutral policies, which seek to reimburse for care provided in a hospital off campus outpatient department setting at the same rate as physician offices, would impact Texas Children's ability to continue expanding access to care in the communities we serve throughout Texas. Sought support for HR 4758/S 2372, the Accelerating Kids Access to Care Act, which would streamline Medicaid provider enrollment when a child needs to travel to another state for care.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1613 - Drug Price Transparency in Medicaid Act of 2023 - Rep. Carter, Earl - spread-pricing by PBMs for Medicaid H.R. 2880 - Protecting Patients Against PBM Abuses Act - Rep. Carter, Earl - PBM transparency H.R. 4818 - Treat and Reduce Obesity Act - Rep. Wenstrup, Brad - weight loss coverage H.R. 5372 - Expanding Seniors Access to Lower Cost Medicines Act of 2023 - Rep. Joyce, John - generic drugs, biosimilars cost H.R. 5378 - Lower Costs, More Transparency Act - Rep. McMorris Rodgers, Cathy - PBM transparency H.R. 5385 - Medicare PBM Accountability Act - Rep. Landsman, Greg McMorris - PBM transparency H.R. 6283 - DRUG Act - Rep. Miller-Meeks, Mariannette - PBM contracts H.R. 6963 - Pediatric Cancer Drug Supply Act of 2024 - Rep. Eshoo, Anna - establishes agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs H.R. 7635 - The 340B PATIENTS Act of 2024- Rep. Matsui, Doris - ensures accessibility of drugs under 340B drug discount program S. 79 - Interagency Patent Coordination and Improvement Act of 2023 - Sen. Durbin, Richard - prescription drug patenting S. 113 - Prescription Pricing for the People Act of 2023 - Sen. Grassley, Chuck - PBM transparency S. 127 - Pharmacy Benefit Manager Transparency Act of 2023 - Sen. Cantwell, Maria - PBM transparency S. 142 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy - pharmacy and biosimilar prescription drugs S. 148 - Stop STALLING Act - Sen. Klobuchar, Amy - pharmacy market approval processes S. 150 - Affordable Prescriptions for Patients Act of 2023 - Sen. Cornyn, John - pharmacy and prescription drug prices, prevent patent thickets S. 574 - Increasing Prescription Drug Competition Act - Sen. Hassan, Maggie - closure of pharmaceutical patent loophole S. 652 - Safe Step Act - Sen. Murkowski, Lisa - medication step therapy protocol S. 954 - Affordable Insulin Now Act of 2023 - Sen. Warnock, Raphael - insulin pricing and cost sharing S. 1038 - Drug Price Transparency in Medicaid Act of 2023 - Sen. Welch, Peter - drug pricing transparency S. 1269 - INSULIN Act of 2023 - Sen. Shaheen, Jeanne - insulin pricing S. 1339 - Pharmacy Benefit Manager Reform Act - Sen. Sanders, Bernie - PBM transparency S. 1542 - DRUG Act - Sen. Marshall, Roger - PBM regulation S. 2973 - Modernizing and Ensuring PBM Accountability Act - Sen. Wyden, Ron - Plan implementation S. 3934 - Increasing Access to Biosimilars Act of 2023- Sen. Cornyn, John - Medicare drug access Issues related to the implementation of Inflation Reduction Act - Medicare negotiation; coverage of weight loss drugs; high priced drugs; patent reforms; Pharmacy Benefit Managers; and copay coupons.

Client expense: $2,560,000 · Firm income: Not reported

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

Congressional outreach and monitoring regarding the following: -Healthcare and hospital workforce budget and appropriations, generally; -340B Drug Discount Program & HRSA/CMS policies; -CMS Wage Index; -Medicare reimbursement rates, generally; -H.R. 2584 / S. 2768, Safety From Violence for Healthcare Employees Act; -H.R.4895, Lowering Drug Costs for American Families Act; -H.R. 7635 / S. 3922, The 340B PATIENTS Act of 2024.

Client expense: $10,000 · 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. 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

H.R. 2534 - the PROTECT 340B Act of 2023 - all provisions H.R. 7635 - The 340B Patietns Act of 2024 - all provisions H.R. 8702 & S. 4532 - Improving Seniors' Timely Access to Care Act of 2024 H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program - all provisions. H.R. 5378, the Lower Costs, More Transparency Act: Sec.203.Parity in Medicare payments for hospital outpatient department services furnished off-campus; & Sec.204.Requiring a separate identification number and an attestation for each off-campus outpatient department of a provider. The Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act draft legislation - all provisions. Continuing the federal Medicare telehealth geographic and site restriction waivers. Extending waivers for the federal Acute Hospital Care at Home program. Continued funding for the Medicare-Dependent Hospital and Low-Volume Hospital Adjustment programs. General concerns about Medicare underpayments to hospitals. Medicare payments and cost report expenses for psychiatric distinct part units.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2534 - the PROTECT 340B Act of 2023 - all provisions H.R. 7635 - The 340B Patietns Act of 2024 - all provisions H.R. 8702 & S. 4532 - Improving Seniors' Timely Access to Care Act of 2024 H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program - all provisions. H.R. 5378, the Lower Costs, More Transparency Act: Sec.203.Parity in Medicare payments for hospital outpatient department services furnished off-campus; & Sec.204.Requiring a separate identification number and an attestation for each off-campus outpatient department of a provider. The Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act draft legislation - all provisions. Continuing the federal Medicare telehealth geographic and site restriction waivers. Extending waivers for the federal Acute Hospital Care at Home program. Continued funding for the Medicare-Dependent Hospital and Low-Volume Hospital Adjustment programs. General concerns about Medicare underpayments to hospitals. Medicare payments and cost report expenses for psychiatric distinct part units.

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

Government targets: HOUSE OF REPRESENTATIVES, 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

Client expense: $2,770,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), 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 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

Client expense: $2,770,000 · Firm income: Not reported

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

Draft Bill , 340B SUSTAIN Act, Issues pertaining to 340B Program access; H.R.9412 , Healthcare Cybersecurity Act of 2024, Issues pertaining to cyber security for health care field; Draft Bill , Strengthening Pathways to Healthcare Professions Act of 2024, Strengthening HRSA health workforce programs; H.R.8574, the 340B Affording Care for Communities and Ensuring a Strong Safety-net (340B ACCESS) Act, Issues pertaining to 340B Program access; 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; H.R. 7635, The 340B PATIENTS Act, all provisions; S. 4289, Medical Debt Cancellation Act , all provisions; H.R. 3120, Healthy Competition for Better Care Act, all provisions; H.R. 9457, Transparent Telehealth Bills Act of 2024, 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; S. 5025 , the SEPSIS Act , all provisions; Draft Bill , Rural 340B Access Act, Issues pertaining 340B Program access; Draft Bill , Draft Bill , Freestanding Emergency Departments; Cybersecurity and Infrastructure Security Agency (CISA) - Dept. Homeland Sec., Cyber Incident Reporting for Critical Infrastructure Act (CIRCIA) Reporting Requirements, Feedback on reporting requirements for cybersecurity incidents under CIRCIA; Occupational Safety and Health Administration (OSHA)Occupational Safety and Health Administrations (OSHA) proposed emergency response standard, Feedback to strengthen OSHA's emergency response standard for hospitals and health systems and their workforce; Health Resources Services Administration (HRSA), J&J Rebate Model for 340B Program, Feedback on Johnson & Johnson rebate model for 340B Program; Medical Debt, Issues specific to medical debt incurred by patients and hospital billing and collection practices; Price Transparency, STMT to Committee on Aging, Issues related to hospital price transparency; Cyber Security, Issues pertaining to ongoing cyber risks to the health care field. Change Health Care cyber-attack, breach notifications CrowdStrike, OneBlood, health records; 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; Drug Prices, Included in Cost of Healthcare Hearing , Issues related to prescription drug prices; Physician Owned Hospitals, Hill meetings, Physician-owned hospitals; 340B Program, Hill Letter, Johnson and Johnson 340B Proposal; DEA Telehealth Waivers, Telemedicine prescribing of controlled substances; 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 acquisitions, physician practice acquisition; Supply Chain Issues, HHS Calls, Issues pertaining to supply chain issues for medical devices and blood shortages; Rural 340B Access Act , Hill visit, Hill discussion about the Rural 340B Access Act (House and Senate); Outstanding COVID reimbursement for hospitals, Check in with FEMA, FEMA outreach about outstanding COVID reimbursement for hospitals.

Client expense: $5,450,000 · Firm income: Not reported

Government targets: Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Occupational Safety & Health Administration (OSHA), SENATE, White House Office