PROTECT 340B Act of 2023

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

H.R. 544: Veterans Infertility Treatment Act of 2023; all provisions of the bill H.R. 547: Better Care Better Jobs Act; all provisions of the bill H.R. 830: Help Ensure Lower Patient (HELP) Copays Act; all provisions of the bill H.R. 2534: Preserving Rules Ordered for The Entities Covered Through 340B Act of 2023(PROTECT 340B Act); all provisions of the bill H.R. 2880: Protecting Patients Against PBM Abuses Act; all provisions of the bill H.R. 5378: Lower Costs, More Transparency Act; all provisions of the bill H.R. 6283: Delinking Revenue from Unfair Gouging (DRUG) Act; all provisions of the bill S. 100: Better Care Better Jobs Act; all provisions of the bill S. 1339: Pharmacy Benefit Manager Reform Act; all provisions of the bill S. 1375: Help Ensure Lower Patient (HELP) Copays Act; all provisions of the bill S. 1542: Delinking Revenue from Unfair Gouging (DRUG) Act; all provisions of the bill S. 1967: Patients Before Middlemen (PBM) Act; all provisions of the bill S. 2973: Modernizing and Ensuring PBM Accountability Act; all provisions of the bill S. 3430: Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023; provisions related to drug costs P.L. 117-169: Inflation Reduction Act of 2022; implementation of Drug pricing provisions General discussions related to 340B Drug Pricing Program policy issues General discussions related to Pharmacy Benefit Manager policy issues General discussions related to Healthcare supply chain policy issues General discussions related to Drug cost and pricing policy issues General discussions related to caregiving support and awareness policy issues General discussions related to the Cancer Moonshot Initiative and the Advanced Research Projects Agency for Health (ARPA-H)

Client expense: $530,000 · Firm income: Not reported

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

S. 2840, Bipartisan Primary Care and Health Workforce Act H.R. 3305 - Black Maternal Health Momnibus Act H.R. 4420, the Preparedness and Response Reauthorization Act H.R. 4531, the Support for Patients and Communities Reauthorization Act H.R. 2534, PROTECT 340B Act of 2023 H.R. 5013, the Value in Health Care Act of 2023 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. 7050 - Substance Use Disorder Workforce Act S.4101/ H.R.7931 - the Preserving Emergency Access in Key Sites Act Keeping Obstetrics Local Act S.4088, Welcome Back to the Health Care Workforce Act Issues related to essential hospital designation Issues related to health equity Issues related to the 340B Drug Pricing program Issues related to contact pharmacies Issues related to the health care workforce Issues related to Community Paramedicine Issues related to Artificial Intelligence and Health Care Issues related to hospital digital infrastructure Issues related to cybersecurity H.R. 9351 Save our Safety-Net Hospitals Act of 2024 Issues related to Opioid overdose reduction

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 1133: 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight H.R 2534 - PROTECT 340B Act S. 5021/HR. 7635 - 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act H.R. 2408: Access to Innovative Treatments Act of 2023 HR. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 2408: Access to Innovative Treatments Act of 2023 Accelerated Approval Drug Shortages Supply Chain Integrity and Traceability Drug Patenting PBM Reform S. 2973: Modernizing and Ensuring PBM Accountability (MEPA) Act Alternative Payment Arrangements for Gene Therapies Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues H.R. 5539/S. 3131: ORPHAN Cures Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 1214: Retaining Access and Restoring Exclusivity (RARE) Act Implementation of the Inflation Reduction Act (IRA) of 2022 Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2630/S. 652: SAFE STEP Act H.R. 5378: Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3433: Give Kids a Chance Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 5376: Share the Savings with Seniors Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 4953: Protect Drug Innovation Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues Accelerated approval authority policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues S. 2305: Biosimilar Red Tape Elimination Act IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

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

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.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

H.R. 544: Veterans Infertility Treatment Act of 2023; all provisions of the bill H.R. 547: Better Care Better Jobs Act; all provisions of the bill H.R. 830: Help Ensure Lower Patient (HELP) Copays Act; all provisions of the bill H.R. 2534: Preserving Rules Ordered for The Entities Covered Through 340B Act of 2023(PROTECT 340B Act); all provisions of the bill H.R. 2880: Protecting Patients Against PBM Abuses Act; all provisions of the bill H.R. 5378: Lower Costs, More Transparency Act; all provisions of the bill H.R. 6283: Delinking Revenue from Unfair Gouging (DRUG) Act; all provisions of the bill S. 100: Better Care Better Jobs Act; all provisions of the bill S. 1339: Pharmacy Benefit Manager Reform Act; all provisions of the bill S. 1375: Help Ensure Lower Patient (HELP) Copays Act; all provisions of the bill S. 1542: Delinking Revenue from Unfair Gouging (DRUG) Act; all provisions of the bill S. 1967: Patients Before Middlemen (PBM) Act; all provisions of the bill S. 2973: Modernizing and Ensuring PBM Accountability Act; all provisions of the bill S. 3430: Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023; provisions related to drug costs P.L. 117-169: Inflation Reduction Act of 2022; implementation of Drug pricing provisions General discussions related to 340B Drug Pricing Program policy issues General discussions related to Pharmacy Benefit Manager policy issues General discussions related to Healthcare supply chain policy issues General discussions related to Drug cost and pricing policy issues General discussions related to caregiving support and awareness policy issues General discussions related to the Cancer Moonshot Initiative and the Advanced Research Projects Agency for Health (ARPA-H)

Client expense: $750,000 · Firm income: Not reported

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

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2024 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 9096: Pharmacists Fight Back Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 5021: The 340B PATIENTS Act of 2024 BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Health Equity Inflation Reduction Act of 2022 (P.L. 117-169), Implementation IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues

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

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

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

S. 1133: 340B Accountability Act 340B Drug Discount Program - Program Implementation & Oversight H.R 2534 - PROTECT 340B Act 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. 2408: Access to Innovative Treatments Act of 2023 Accelerated Approval Alternative Funding Programs Drug Shortages Supply Chain Integrity and Traceability Drug Patenting S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 S. 113: Prescription Pricing for the People Act of 2023 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 Value-Based Purchasing (VBP) Rule 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. 2139/S. 909: Prescription Drug Price Relief Act H.R. 2630/S. 652: SAFE STEP Act H.R. 2666: Medicaid for VBPs for Patients (MVP) Act H.R. 4895: Lowering Drug Costs for American Families Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products National Coverage Determination Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications Value-Based Purchasing (VBP) Rule 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. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications 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 COVID-19 policy issues Pandemic preparedness policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues

Client expense: $740,000 · 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

HR 2534 Protect 340B Act HR 7635 340B Patients Act Sustain 340B Act HR 8574 340B ACCESS Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2024 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4818: Treat and Reduce Obesity Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 9096: Pharmacists Fight Back Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 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. 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. 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: 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 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 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 Artificial intelligence policy issues Cybersecurity policy issues

Client expense: $6,880,000 · Firm income: Not reported

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

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 SubstanceUse 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)

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

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

H.R.3046/S.1403 - Medical Student Education Authorization Act of 2023 Issue: Support grants for primary care training in medically under-resourced communities. Draft Social Determinants Accelerator Act Issue: Support grants to address social determinants of health. H.R.9161/S.4773 - Health Equity and Accountability Act of 2024 Issue: Support programs to improve health equity and address social determinants of health. S.2333 - Pandemic and All-Hazards Preparedness and Response Act H.R.4420 - Preparedness and Response Reauthorization Act H.R.4421 - Preparing for All Hazards and Pathogens Reauthorization Act H.R.4697 - Protecting PAHPA Act of 2023 Issues: Support the reauthorization of the Pandemic and All-Hazards Preparedness Act with increased funding authorization levels. Issue: Support authorities to strengthen CDCs and ASPRs ability to prevent and respond to existing and emerging threats. S.1995 - Public Health Infrastructure Saves Lives Act Issue: Support investments in core public health infrastructure. Issue: Educate Congress on how the 340B Drug Pricing Program helps safety-net providers to fulfill their missions and care for patients and communities. Support measures to preserve and strengthen the 340B Drug Pricing Program. Oppose efforts to reduce the scope of the program, restrict the use of contract pharmacies, define patient in the context of the program, and impose additional reporting requirements on 340B hospitals. Oppose pharmaceutical industry efforts to 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. 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: 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 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: 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.

Client expense: $617,103 · 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

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, restrict the use of contract pharmacies, define patient in the context of the program, and impose additional reporting requirements on 340B hospitals. Oppose pharmaceutical industry efforts to 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. 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: 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 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: 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.

Client expense: $617,103 · 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

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 (generally, no specific legislation). 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: $220,000 · 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

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 S. 3393, SUPPORT Act reauthorization

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

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

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 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

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

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

Clarify or reform the 340B program Patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Most Favored Nation/International Reference Pricing Co-pay accumulators maximizers, alternate funding models Amending P.L. 97-414, Orphan Drug Act Promoting the Congressional Plasma Caucus Senate Finance Committee PBM Framework Paper Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act, Health Care Related Provisions H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2679, Pharmacy Benefits Manager Accountability Act - Issues related to tranparency and data disclusure for PBMs H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S.113, Prescription Pricing for the People Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act

Client expense: $970,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), 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: $345,454 · 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

Monitor and support legislation for expanded telehealth services (CONNECT Act; H.R. 4189/S. 2016). PROTECT 340B Act of 2023 (H.R. 2534) Supporting Safety Net Hospitals Act (H.R. 2665). Safety from Violence for Healthcare Employees (SAVE) Act (H.R. 2584). 340B Transparency Act (H.R. 3290). Medicare reimbursement payments. Lower Costs, More Transparency Act (H.R. 5378).

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

S. 2840, Bipartisan Primary Care and Health Workforce Act H.R. 3305 - Black Maternal Health Momnibus Act H.R. 4420, the Preparedness and Response Reauthorization Act H.R. 4531, the Support for Patients and Communities Reauthorization Act H.R. 2534, PROTECT 340B Act of 2023 H.R. 5013, the Value in Health Care Act of 2023 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. 7050 - Substance Use Disorder Workforce Act S.4101/ H.R.7931 - the Preserving Emergency Access in Key Sites Act Keeping Obstetrics Local Act S.4088, Welcome Back to the Health Care Workforce Act Issues related to essential hospital designation Issues related to health equity Issues related to the 340B Drug Pricing program Issues related to contact pharmacies Issues related to the health care workforce Issues related to Community Paramedicine Issues related to Artificial Intelligence and Health Care Issues related to hospital digital infrastructure Issues related to cybersecurity H.R. 9351 Save our Safety-Net Hospitals Act of 2024 Issues related to Opioid overdose reduction

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

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 CDC Injury Control Research Centers Funding NIH Pediatric Medical Research Prioritization FDA Proposed Rule Titles "Medical Device Laboratory Developed Tests"

Client expense: $45,000 · 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 CDC Injury Control Research Centers Funding NIH Pediatric Medical Research Prioritization FDA Proposed Rule Titles "Medical Device Laboratory Developed Tests"

Client expense: $45,000 · 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

340B Program; H.R.2534 Protect 340B Act; 340B Transparency and Oversight H.R.3290/S.1133; The PATIENT Act H.R.3561; Resident Physician Shortage Reduction Act H.R.2389; Preventive Health Savings Act S.114/H.R.766; Safety from Violence for Healthcare Employees "SAVE" Act H.R.2584; H.R.5378 Lower Costs, More Transparency Act; Stop Drug Shortages Act; H.R.5378 Lower Costs, More Transparency Act; Senate 340B RFI - responded; 340B Access Act;

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

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. 885: TRACK Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1770: Equitable Community Access to Pharmacist Services Act 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 Bayh-Done march in rights policy issues 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. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 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 2023 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. 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 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. 8333 BIOSECURE Act H.R.8818 American Privacy Rights Act of 2024; Provisions related to pharmaceutical industry 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. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications 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; Transparency provisions, Medicare Part D Delinking; Commerical Marketplace Delinking 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. 1476: Pharmaceutical Research Transparency 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. 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. 2897: Give Kids a Chance Act of 2023 S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization 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) Vaccine provisions of the inflation reduction Act 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 Mental health 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: $1,510,000 · Firm income: Not reported

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

H.R. 544: Veterans Infertility Treatment Act of 2023; all provisions of the bill H.R. 547: Better Care Better Jobs Act; all provisions of the bill H.R. 830: Help Ensure Lower Patient (HELP) Copays Act; all provisions of the bill H.R. 2534: Preserving Rules Ordered for The Entities Covered Through 340B Act of 2023(PROTECT 340B Act); all provisions of the bill H.R. 2880: Protecting Patients Against PBM Abuses Act; all provisions of the bill H.R. 5378: Lower Costs, More Transparency Act; all provisions of the bill H.R. 6283: Delinking Revenue from Unfair Gouging (DRUG) Act; all provisions of the bill S. 100: Better Care Better Jobs Act; all provisions of the bill S. 1339: Pharmacy Benefit Manager Reform Act; all provisions of the bill S. 1375: Help Ensure Lower Patient (HELP) Copays Act; all provisions of the bill S. 1542: Delinking Revenue from Unfair Gouging (DRUG) Act; all provisions of the bill S. 1967: Patients Before Middlemen (PBM) Act; all provisions of the bill S. 2973: Modernizing and Ensuring PBM Accountability Act; all provisions of the bill S. 3430: Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023; provisions related to drug costs P.L. 117-169: Inflation Reduction Act of 2022; implementation of Drug pricing provisions General discussions related to 340B Drug Pricing Program policy issues General discussions related to Pharmacy Benefit Manager policy issues General discussions related to Healthcare supply chain policy issues General discussions related to Drug cost and pricing policy issues General discussions related to caregiving support and awareness policy issues General discussions related to the Cancer Moonshot Initiative and the Advanced Research Projects Agency for Health (ARPA-H)

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

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

Clarify or reform the 340B program Issues related to patient access of plasma therapies Global pharmaceutical supply chain operations and manufacturing locations Co-pay accumulator's maximizers, alternate funding models Promoting the Congressional Plasma Caucus Issues related to rare disease diagnosis and access to care Senate Finance Committee PBM Framework Paper Issues related to Pharmacy Benefit Managers (PBMs) Drug pricing, including House and Senate draft bills Bayh-Dole march-in rights policy issues S. 652/H.R. 2630, Safe Step Act - provisions related to step therapy policy H.R. 2534, PROTECT 340B Act of 2023 H.R. 830, S.1375, HELP Co-Pays Act H.R. 2670, S. 2226, National Defense Authorization Act H.R. 5539, S. 3131, ORPHAN Cures Act H.R. 2816, The PBM Sunshine and Accountability Act H.R. 2880, Protecting Patients Against PBM Abuses Act S. 127, Pharmacy Benefit Manager Transparency Act S.1131, Drug Price Transparency Act of 2023 S.1339, Pharmacy Benefit Manager Reform Act S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 H.R. 5378, The Lower Costs, More Transparency Act S. 2973, Modernizing and Ensuring PBM Accountability Act Issues related to dengue vaccines H.R. 6283, S. 1542, Delinking Revenue from Unfair Gouging "DRUG Act" S.1264, Strengthening Medicare And Reducing Taxpayer (SMART) Prices Act H.R. 7174, Ensuring Pathways to Innovative Cures (EPIC) Act S.2305- Biosimilar Red Tape Elimination Act S. 1906 Promising Pathways Act SUSTAIN 340B Act - No bill number H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act

Client expense: $1,050,000 · 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. 885: TRACK Act of 2023 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. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 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 2023 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. 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 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 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. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications 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. 1476: Pharmaceutical Research Transparency Act of 2023 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. 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. 2897: Give Kids a Chance Act of 2023 S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization 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) 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 Mental health 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: $6,960,000 · Firm income: Not reported

Government targets: Congressional Budget Office (CBO), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE