Pharmacy Benefits Manager Accountability Act

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

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

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

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

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

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

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

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

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

Issues related to Medicare Part D, Medicare Advantage, Medicaid, mental health, and telehealth. Issues related to COVID testing, vaccination, and treatment. Issues related to Accountable Care Organizations. Issues related to Medicare Shared Savings Program. S. 1339 - Pharmacy Benefit Manager Reform Act of 2023 S. 1967 - Patients Before Middlemen Act of 2023 S. 2973 - Modernizing and Ensuring PBM Accountability (MEPA) Act S. 3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act H.R. 2679 - Pharmacy Benefit Manager Accountability Act of 2023 H.R. 3285 - Fairness for Patient Medications Act H.R. 1613 - Drug Price Transparency in Medicaid Act of 2023 H.R. 3561 - Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 H.R. 5378 - Lower Costs, More Transparency Act H.R. 2880 - Protecting Patients Against PBM Abuses Act

Client expense: $2,040,000 · Firm income: Not reported

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

Issues related to S. 113, the Prescription Pricing for the People Act; S. 127, the Pharmacy Benefit Manager Transparency Act; S. 1339, Pharmacy Benefit Manager Reform Act; S.1542/H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (previously H.R. 2691, Transparent PRICE Act); H.R. 3281, To promote hospital and insurer price transparency; H.R. 2880, Protecting Patients Against PBM Abuses Act; H.R. 2679, The PBM Accountability Act; H.R.3285, the Fairness for Patient Medications Act, to establish patient protections with respect to highly rebated drugs; H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information; H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3284, the Providers and Payers COMPETE Act; S. 1967 the Patients Before Middlemen (PBM) Act; Protect Patients Access to Pharmacies Act; S. 2406, PBM Oversight Act of 2023; S. 2973, Modernizing and Ensuring PBM Accountability Act; S. 2436, the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act; S. 2405, the Strengthening Pharmacy Access for Seniors Act; S. 2254, the Medicare PBM Accountability Act; S. 2052, the Protect Patient Access to Pharmacies Act; H.R. 4822, the Health Care Price Transparency Act of 2023; H.R. 3284, the Providers and Payers COMPETE Act; H.R. 4508, the Hidden Fee Disclosure Act; H.R. 4507, the Transparency in Coverage Act of 2023; H.R. 4895, the Lowering Drug Costs for American Families Act; H.R. 5378 Lower Costs, More Transparency Act; H.R. 4527, Health Data Access, Transparency, and Affordability Act (DATA) Act; H.R. 3285, Fairness for Patient Medications Act; S. 2973 Modernizing and Ensuring PBM Accountability Act; S. 3548, Health Care Prices Revealed and Information to Consumers Explained Transparency Act (Health Care PRICE Transparency Act 2.0); H.R.3285 - Fairness for Patient Medications Act; H.R. 3008, the Drug Shortage Prevention Act of 2023; H.R. 3810, the Drug Origin Transparency Act of 2023; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 7535, Prescription Drug Supply Chain Pricing Transparency Act; S. 2305, Biosimilar Red Tape Elimination Act; H.R. 6986/S.3583, to address patent thickets; H.R. 8261, the Preserving Telehealth, Hospital, and Ambulance Access Act; Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act); S.150, the Affordable Prescription Drug for Patients Act; S. 142, the Preserve Access to Affordable Generics and Biosimilars Act; S. 5503, H.R. 10362, the Patients Before Monopolies (PBM) Act; P.L. No: 118-158 and draft FY2025 Continuing Resolution, issues related to PBMs.

Client expense: $1,420,000 · 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

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

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

Issues related to prescription drug value, including implementation of the Inflation Reduction Act (PL 117-169). Issues related to vaccine development, distribution and injury compensation. Issues related to insulin pricing. Issues related to FDA regulation of pharmaceuticals. Issues related to prescription drug pricing and pharmacy benefit manager business practices, including S. 127, Pharmacy Benefit Manager Transparency Act, S.1339 - Pharmacy Benefit Manager Reform Act, H.R. 2679, the PBM Accountability Act, H.R.4822 - Health Care Price Transparency Act, H.R. 5378 - Lower Costs, More Transparency Act. Issues related to the 340B program, including H.R. 3290, to ensure transparency and oversight of the 340B drug discount program. Pandemic All-Hazards Preparedness Act (PAHPA) reauthorization, including S.2333 - Pandemic and All-Hazards Preparedness and Response Act. Issues related to Type 1 diabetes screening. H.R.10545, FY25 Continuing Appropriations.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug value, including implementation of the Inflation Reduction Act (PL 117-169). Issues related to vaccine development and distribution. Issues related to insulin pricing. Issues related to FDA regulation of pharmaceuticals. Issues related to prescription drug pricing and pharmacy benefit manager business practices, including S. 127, Pharmacy Benefit Manager Transparency Act, S.1339 - Pharmacy Benefit Manager Reform Act, H.R. 2679, the PBM Accountability Act, H.R.4822 - Health Care Price Transparency Act, H.R. 5378 - Lower Costs, More Transparency Act. Issues related to the 340B program, including H.R. 3290, to ensure transparency and oversight of the 340B drug discount program. Pandemic All-Hazards Preparedness Act (PAHPA) reauthorization, including S.2333 - Pandemic and All-Hazards Preparedness and Response Act. S.3558 - Biosecure. H.R.10545, FY25 Continuing Appropriations.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug value, including implementation of the Inflation Reduction Act (PL 117-169). Issues related to vaccine development, distribution and injury compensation. Issues related to FDA regulation of pharmaceuticals. Issues related to prescription drug pricing and pharmacy benefit manager business practices, including S. 127, Pharmacy Benefit Manager Transparency Act, S.1339 - Pharmacy Benefit Manager Reform Act, H.R. 2679, the PBM Accountability Act, H.R.4822 - Health Care Price Transparency Act, H.R. 5378 - Lower Costs, More Transparency Act. Issues related to the 340B program, including H.R. 3290, to ensure transparency and oversight of the 340B drug discount program. Pandemic All-Hazards Preparedness Act (PAHPA) reauthorization, including S.2333 - Pandemic and All-Hazards Preparedness and Response Act. H.R.10545, FY25 Continuing Appropriations.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug value, including implementation of the Inflation Reduction Act (PL 117-169). Issues related to FDA regulation of pharmaceuticals. Issues related to prescription drug pricing and pharmacy benefit manager business practices, including S. 127, Pharmacy Benefit Manager Transparency Act, S.1339 - Pharmacy Benefit Manager Reform Act, H.R. 2679, the PBM Accountability Act, H.R.4822 - Health Care Price Transparency Act, H.R. 5378 - Lower Costs, More Transparency Act. Issues related to the 340B program, including H.R. 3290, to ensure transparency and oversight of the 340B drug discount program. Pandemic All-Hazards Preparedness Act (PAHPA) reauthorization, including S.2333 - Pandemic and All-Hazards Preparedness and Response Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug value, including implementation of the Inflation Reduction Act (PL 117-169). Issues related to FDA regulation of pharmaceuticals. Issues related to prescription drug pricing and pharmacy benefit manager business practices, including S. 127, Pharmacy Benefit Manager Transparency Act, S.1339 - Pharmacy Benefit Manager Reform Act, H.R. 2679, the PBM Accountability Act, H.R.4822 - Health Care Price Transparency Act, H.R. 5378 - Lower Costs, More Transparency Act. Issues related to the 340B program, including H.R. 3290, to ensure transparency and oversight of the 340B drug discount program. Pandemic All-Hazards Preparedness Act (PAHPA) reauthorization, including S.2333 - Pandemic and All-Hazards Preparedness and Response Act. H.R. 10545, FY25 Continuing Appropriations.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare reimbursement issues. FDA regulations of biosimilars. Issues related to Drug Pricing Reduction and increasing access to Biosimilars. H.R.2679 - Pharmacy Benefits Manager Accountability Act. S.2305 - Biosimilar Red Tape Elimination Act. Inflation Reduction Act implementation.

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

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

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

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

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

Issues: Drug Pricing, Pharmacy Benefit Manager (PBM) Reform, Generic Drug Manufacturing, GLP-1s Bills: Senate Finance Committee PBM Reform Framework H.R. 5378 - The Lower Costs, More Transparency Act - A bill to require health care providers and insurers to disclose certain information about health care costs. It also establishes requirements for certain payment methodologies under Medicare and Medicaid and extends several public health programs. S. 127. - The Pharmacy Benefit Manager Transparency Act - This bill generally prohibits pharmacy benefit managers (PBMs) from engaging in certain practices when managing the prescription drug benefits under a health insurance plan, including charging the plan a different amount than the PBM reimburses the pharmacy. S.1339 - The Pharmacy Benefit Manager Reform Act - A bill to provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. H.R.2679 - The Pharmacy Benefits Manager Accountability Act - A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act, and the Internal Revenue Code of 1984 to increase oversight of pharmacy benefits manager services, and for other purposes. H.R. 3561 - PATIENT Act of 2023 - This bill expands hospital price transparency requirements and establishes additional reporting requirements with respect to prescription drugs and pharmacy benefit managers (PBMs). H.R. 2880 - Protecting Patients Against PBM Abuses Act -- This bill establishes requirements for Medicare pharmacy benefit managers (PBMs) with respect to remuneration, payments, and fees. Specifically, the bill restricts PBMs that are under contract with plans under the Medicare prescription drug benefit or Medicare Advantage from (1) receiving income for their services other than flat dollar amount service fees; (2) basing any service fees on the prices of covered drugs or any associated discounts, rebates, or other remuneration; (3) charging plan sponsors for ingredient costs or dispensing fees in amounts that are different than what is reimbursed to the pharmacy; or (4) reimbursing network pharmacies for less than that what is reimbursed to PBM-affiliated pharmacies.

Client expense: $140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare Part D, Medicare Advantage, Medicaid, mental health, and telehealth. Issues related to COVID testing, vaccination, and treatment. Issues related to Accountable Care Organizations. Issues related to Medicare Shared Savings Program. S. 1339 - Pharmacy Benefit Manager Reform Act of 2023 S. 1967 - Patients Before Middlemen Act of 2023 S. 2973 - Modernizing and Ensuring PBM Accountability (MEPA) Act S. 3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act H.R. 2679 - Pharmacy Benefit Manager Accountability Act of 2023 H.R. 3285 - Fairness for Patient Medications Act H.R. 1613 - Drug Price Transparency in Medicaid Act of 2023 H.R. 3561 - Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 H.R. 5378 - Lower Costs, More Transparency Act H.R. 2880 - Protecting Patients Against PBM Abuses Act

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response. FY2024 Defense Appropriations Act Fiscal 2024 Labor-HHS-Education Appropriations P.L. 116-136, CARES Act P.L. 113-5 Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) S. 127 - Pharmacy Benefit Manager Transparency Act H.R. 830 - The HELP Copays Act S. 1375 - HELP Copays Act H.R. 1202 - Resident Education Deferred Interest Act, or REDI Act S. 704 - REDI Act S. 665, HR 4942 - Conrad State 30 and Physician Access Reauthorization Act H.R. 2389 - Resident Physician Shortage Reduction Act S. 1302 - Resident Physician Shortage Reduction Act H.R. 2474 - Strengthening Medicare for Patients and Providers Act S. 652, H.R. 2630 - Safe Step Act S. 1339 - Pharmacy Benefit Manager Reform Act H.R. 2670 - National Defense Authorization Act H.R. 2816 - Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2679 - Pharmacy Benefits Manager Accountability Act H.R. 2474 - The Strengthening Medicare for Patients and Providers Act H.R.6371 - Provider Reimbursement Stability Act of 2023 S. 2764 - Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5391 - Protecting Patient Access to Cancer and Complex Therapies Act Appropriation legislation related to Medicare Physician Payments cuts implemented in 2024 Appropriations legislation related to the Congressionally Directed Medical Research Program Appropriations legislation related to the National Institutes of Health S. 705 - Specialty Physicians Advancing Rural Care (SPARC) Act H.R. 2761 - Specialty Physicians Advancing Rural Care (SPARC) Act H.R. 8702 - Improving Seniors Timely Access to Care Act of 2024 S. 4532 - Improving Seniors Timely Access to Care Act of 2024 H.R. 6664 - The Innovation in Pediatric Drugs Act S. 4349 - Prior Authorization for Prescription Drugs Act HR. 6487 - No Fees for EFTs Act S. 3805 - No Fees for EFTs Act S. 4935 - Physician Fee Stabilization Act H.R. 7623 - Telehealth Modernization Act S. 3967 - Telehealth Modernization Act H.R. 7153 - Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act S. 3679 - Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act H.R. 6545 - Physician Fee Schedule Update and Improvements Act

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response. FY2024 Defense Appropriations Act Fiscal 2024 Labor-HHS-Education Appropriations P.L. 116-136, CARES Act P.L. 113-5 Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) S. 127 - Pharmacy Benefit Manager Transparency Act H.R. 830 - The HELP Copays Act S. 1375 - HELP Copays Act H.R. 1202 - Resident Education Deferred Interest Act, or REDI Act S. 704 - REDI Act S. 665, HR 4942 - Conrad State 30 and Physician Access Reauthorization Act H.R. 2389 - Resident Physician Shortage Reduction Act S. 1302 - Resident Physician Shortage Reduction Act H.R. 2474 - Strengthening Medicare for Patients and Providers Act S. 652, H.R. 2630 - Safe Step Act S. 1339 - Pharmacy Benefit Manager Reform Act H.R. 2670 - National Defense Authorization Act H.R. 2816 - Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2679 - Pharmacy Benefits Manager Accountability Act H.R. 2474 - The Strengthening Medicare for Patients and Providers Act H.R.6371 - Provider Reimbursement Stability Act of 2023 S. 2764 - Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5391 - Protecting Patient Access to Cancer and Complex Therapies Act Appropriation legislation related to Medicare Physician Payments cuts implemented in 2024 Appropriations legislation related to the Congressionally Directed Medical Research Program Appropriations legislation related to the National Institutes of Health S. 705 - Specialty Physicians Advancing Rural Care (SPARC) Act H.R. 2761 - Specialty Physicians Advancing Rural Care (SPARC) Act H.R. 8702 - Improving Seniors Timely Access to Care Act of 2024 S. 4532 - Improving Seniors Timely Access to Care Act of 2024 H.R. 6664 - The Innovation in Pediatric Drugs Act S. 4349 - Prior Authorization for Prescription Drugs Act HR. 6487 - No Fees for EFTs Act S. 3805 - No Fees for EFTs Act S. 4935 - Physician Fee Stabilization Act H.R. 7623 - Telehealth Modernization Act S. 3967 - Telehealth Modernization Act H.R. 7153 - Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act S. 3679 - Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act H.R. 6545 - Physician Fee Schedule Update and Improvements Act

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

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

Monitor federal issues and legislation associated with health care policy. Monitor federal and legislative activity related to Medicare reimbursement. Monitor federal and legislative activity related to drug pricing. Monitoring and outreach on legislative activity related to the COVID-19 pandemic and the federal governments response. FY2024 Defense Appropriations Act Fiscal 2024 Labor-HHS-Education Appropriations P.L. 116-136, CARES Act P.L. 113-5 Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) S. 127 - Pharmacy Benefit Manager Transparency Act H.R. 830 - The HELP Copays Act S. 1375 - HELP Copays Act H.R. 1202 - Resident Education Deferred Interest Act, or REDI Act S. 704 - REDI Act S. 665, HR 4942 - Conrad State 30 and Physician Access Reauthorization Act H.R. 2389 - Resident Physician Shortage Reduction Act S. 1302 - Resident Physician Shortage Reduction Act H.R. 2474 - Strengthening Medicare for Patients and Providers Act S. 652, H.R. 2630 - Safe Step Act S. 1339 - Pharmacy Benefit Manager Reform Act H.R. 2670 - National Defense Authorization Act H.R. 2816 - Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2679 - Pharmacy Benefits Manager Accountability Act H.R. 2474 - The Strengthening Medicare for Patients and Providers Act H.R.6371 - Provider Reimbursement Stability Act of 2023 S. 2764 - Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5391 - Protecting Patient Access to Cancer and Complex Therapies Act Appropriation legislation related to Medicare Physician Payments cuts implemented in 2024 Appropriations legislation related to the Congressionally Directed Medical Research Program Appropriations legislation related to the National Institutes of Health S. 705 - Specialty Physicians Advancing Rural Care (SPARC) Act H.R. 2761 - Specialty Physicians Advancing Rural Care (SPARC) Act H.R. 8702 - Improving Seniors Timely Access to Care Act of 2024 S. 4532 - Improving Seniors Timely Access to Care Act of 2024 H.R. 6664 - The Innovation in Pediatric Drugs Act S. 4349 - Prior Authorization for Prescription Drugs Act HR. 6487 - No Fees for EFTs Act S. 3805 - No Fees for EFTs Act S. 4935 - Physician Fee Stabilization Act H.R. 7623 - Telehealth Modernization Act S. 3967 - Telehealth Modernization Act H.R. 7153 - Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act S. 3679 - Dr. Lorna Breen Healthcare Provider Protection Reauthorization Act H.R. 6545 - Physician Fee Schedule Update and Improvements Act

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

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

H.R. 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

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

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

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

Issues related to S. 113, the Prescription Pricing for the People Act; S. 127, the Pharmacy Benefit Manager Transparency Act; S. 1339, Pharmacy Benefit Manager Reform Act; S.1542/H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (previously H.R. 2691Transparent PRICE Act); H.R. 3281, To promote hospital and insurer price transparency; H.R.2880, Protecting Patients Against PBM Abuses Act; H.R. 2679, The PBM Accountability Act; H.R.3285, the Fairness for Patient Medications Act, to establish patient protections with respect to highly rebated drugs; H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information; H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3284, the Providers and Payers COMPETE Act; S. 1967 the Patients Before Middlemen (PBM) Act; Protect Patients Access to Pharmacies Act; S. 2406, PBM Oversight Act of 2023; S. 2973, Modernizing and Ensuring PBM Accountability Act; S. 2436, the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act; S. 2405, the Strengthening Pharmacy Access for Seniors Act; S.2254, the Medicare PBM Accountability Act; S. 2052, the Protect Patient Access to Pharmacies Act; H.R. 4822, the Health Care Price Transparency Act of 2023; H.R. 3284, the Providers and Payers COMPETE Act; H.R. 4508, the Hidden Fee Disclosure Act H.R. 4507, the Transparency in Coverage Act of 2023; H.R. 4895, the Lowering Drug Costs for American Families Act; H.R. 5378 Lower Costs, More Transparency Act; H.R. 4527, Health Data Access, Transparency, and Affordability Act (DATA) Act; H.R.3285, Fairness for Patient Medications Act; S.2973 Modernizing and Ensuring PBM Accountability Act; S. 3548, Health Care Prices Revealed and Information to Consumers Explained Transparency Act (Health Care PRICE Transparency Act 2.0); H.R.3285 - Fairness for Patient Medications Act; H.R. 3008, the Drug Shortage Prevention Act of 2023; H.R. 3810, the Drug Origin Transparency Act of 2023; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R.7535, Prescription Drug Supply Chain Pricing Transparency Act; S. 2780, Medication Affordability and Patent Integrity Act; S. 2305, Biosimilar Red Tape Elimination Act; H.R. 6986/S.3583, to address patent thickets; H.R. 8261, the Preserving Telehealth, Hospital, and Ambulance Access Act; Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act); H.R. 8574, 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act); S.150, the Affordable Prescription Drug for Patients Act; S. 142, the Preserve Access to Affordable Generics and Biosimilars Act.

Client expense: $1,720,000 · 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

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

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

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

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

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

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

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

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

Issues related to prescription drug value, including implementation of the Inflation Reduction Act (PL 117-169). Issues related to vaccine development, distribution and injury compensation. Issues related to insulin pricing. Issues related to FDA regulation of pharmaceuticals. Issues related to prescription drug pricing and pharmacy benefit manager business practices, including S. 127, Pharmacy Benefit Manager Transparency Act, S.1339 - Pharmacy Benefit Manager Reform Act, H.R. 2679, the PBM Accountability Act, H.R.4822 - Health Care Price Transparency Act, H.R. 5378 - Lower Costs, More Transparency Act. Issues related to the 340B program, including H.R. 3290, to ensure transparency and oversight of the 340B drug discount program. Pandemic All-Hazards Preparedness Act (PAHPA) reauthorization, including S.2333 - Pandemic and All-Hazards Preparedness and Response Act. Issues related to Type 1 diabetes screening.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug value, including implementation of the Inflation Reduction Act (PL 117-169). Issues related to vaccine development and distribution. Issues related to insulin pricing. Issues related to FDA regulation of pharmaceuticals. Issues related to prescription drug pricing and pharmacy benefit manager business practices, including S. 127, Pharmacy Benefit Manager Transparency Act, S.1339 - Pharmacy Benefit Manager Reform Act, H.R. 2679, the PBM Accountability Act, H.R.4822 - Health Care Price Transparency Act, H.R. 5378 - Lower Costs, More Transparency Act. Issues related to the 340B program, including H.R. 3290, to ensure transparency and oversight of the 340B drug discount program. Pandemic All-Hazards Preparedness Act (PAHPA) reauthorization, including S.2333 - Pandemic and All-Hazards Preparedness and Response Act. S.3558 - Biosecure.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug value, including implementation of the Inflation Reduction Act (PL 117-169). Issues related to vaccine development, distribution and injury compensation. Issues related to FDA regulation of pharmaceuticals. Issues related to prescription drug pricing and pharmacy benefit manager business practices, including S. 127, Pharmacy Benefit Manager Transparency Act, S.1339 - Pharmacy Benefit Manager Reform Act, H.R. 2679, the PBM Accountability Act, H.R.4822 - Health Care Price Transparency Act, H.R. 5378 - Lower Costs, More Transparency Act. Issues related to the 340B program, including H.R. 3290, to ensure transparency and oversight of the 340B drug discount program. Pandemic All-Hazards Preparedness Act (PAHPA) reauthorization, including S.2333 - Pandemic and All-Hazards Preparedness and Response Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug value, including implementation of the Inflation Reduction Act (PL 117-169). Issues related to FDA regulation of pharmaceuticals. Issues related to prescription drug pricing and pharmacy benefit manager business practices, including S. 127, Pharmacy Benefit Manager Transparency Act, S.1339 - Pharmacy Benefit Manager Reform Act, H.R. 2679, the PBM Accountability Act, H.R.4822 - Health Care Price Transparency Act, H.R. 5378 - Lower Costs, More Transparency Act. Issues related to the 340B program, including H.R. 3290, to ensure transparency and oversight of the 340B drug discount program. Pandemic All-Hazards Preparedness Act (PAHPA) reauthorization, including S.2333 - Pandemic and All-Hazards Preparedness and Response Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug value, including implementation of the Inflation Reduction Act (PL 117-169). Issues related to FDA regulation of pharmaceuticals. Issues related to prescription drug pricing and pharmacy benefit manager business practices, including S. 127, Pharmacy Benefit Manager Transparency Act, S.1339 - Pharmacy Benefit Manager Reform Act, H.R. 2679, the PBM Accountability Act, H.R.4822 - Health Care Price Transparency Act, H.R. 5378 - Lower Costs, More Transparency Act. Issues related to the 340B program, including H.R. 3290, to ensure transparency and oversight of the 340B drug discount program. Pandemic All-Hazards Preparedness Act (PAHPA) reauthorization, including S.2333 - Pandemic and All-Hazards Preparedness and Response Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

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

Medicare reimbursement issues. FDA regulations of biosimilars. Issues related to Drug Pricing Reduction and increasing access to Biosimilars. Ensuring Access to Lower-Cost Medicines for Seniors Act. S.4302 - Senator Marshall, the Biologics Market Transparency Act. H.R.2679 - Pharmacy Benefits Manager Accountability Act. H.R.1790 - Biologics Competition Act of 2023. S.2305 - Biosimilar Red Tape Elimination Act. Inflation Reduction Act implementation.

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

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

Issues: Insulin Copay Caps, Drug Pricing, Pharmacy Benefit Manager (PBM) Reform, Generic Drug Manufacturing, GLP-1s Bills: Senate Finance Committee PBM Reform Framework H.R. 5378 - The Lower Costs, More Transparency Act - A bill to require health care providers and insurers to disclose certain information about health care costs. It also establishes requirements for certain payment methodologies under Medicare and Medicaid and extends several public health programs. H.R. 1488/S. 954 - The Affordable Insulin Now Act -- A bill to provide for appropriate cost-sharing for insulin products covered under private health plans, and to establish a program to support health care providers and pharmacies in providing discounted insulin products to uninsured individuals. S. 127. - The Pharmacy Benefit Manager Transparency Act - This bill generally prohibits pharmacy benefit managers (PBMs) from engaging in certain practices when managing the prescription drug benefits under a health insurance plan, including charging the plan a different amount than the PBM reimburses the pharmacy. S.1339 - The Pharmacy Benefit Manager Reform Act - A bill to provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage. H.R.2679 - The Pharmacy Benefits Manager Accountability Act - A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act, and the Internal Revenue Code of 1984 to increase oversight of pharmacy benefits manager services, and for other purposes. H.R. 3561 - PATIENT Act of 2023 - This bill expands hospital price transparency requirements and establishes additional reporting requirements with respect to prescription drugs and pharmacy benefit managers (PBMs). H.R. 2630/S. 652 - The Safe Step Act -- This bill requires a group health plan to establish an exception to medication step-therapy protocol in specified cases. A medication step-therapy protocol establishes a specific sequence in which prescription drugs are covered by a group health plan or a health insurance issuer. H.R. 830/S. 1375 - The HELP Copays Act -- This bill requires health insurance plans to apply certain payments made by, or on behalf of, a plan enrollee toward a plan's cost-sharing requirements. Specifically, plans must apply third-party payments, financial assistance, discounts, product vouchers, and other reductions in out-of-pocket expenses toward the requirements. H.R. 2880 - Protecting Patients Against PBM Abuses Act -- This bill establishes requirements for Medicare pharmacy benefit managers (PBMs) with respect to remuneration, payments, and fees. Specifically, the bill restricts PBMs that are under contract with plans under the Medicare prescription drug benefit or Medicare Advantage from (1) receiving income for their services other than flat dollar amount service fees; (2) basing any service fees on the prices of covered drugs or any associated discounts, rebates, or other remuneration; (3) charging plan sponsors for ingredient costs or dispensing fees in amounts that are different than what is reimbursed to the pharmacy; or (4) reimbursing network pharmacies for less than that what is reimbursed to PBM-affiliated pharmacies.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare Part D, Medicare Advantage, Medicaid, mental health, and telehealth. Issues related to COVID testing, vaccination, and treatment. Issues related to Accountable Care Organizations. Issues related to Medicare Shared Savings Program. S. 1339 - Pharmacy Benefit Manager Reform Act of 2023 S. 1967 - Patients Before Middlemen Act of 2023 S. 2973 - Modernizing and Ensuring PBM Accountability (MEPA) Act S. 3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act H.R. 2679 - Pharmacy Benefit Manager Accountability Act of 2023 H.R. 3285 - Fairness for Patient Medications Act H.R. 1613 - Drug Price Transparency in Medicaid Act of 2023 H.R. 3561 - Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 H.R. 5378 - Lower Costs, More Transparency Act H.R. 2880 - Protecting Patients Against PBM Abuses Act

Client expense: $2,470,000 · Firm income: Not reported

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

Issues related to S. 113, the Prescription Pricing for the People Act; S. 127, the Pharmacy Benefit Manager Transparency Act; S. 1339, Pharmacy Benefit Manager Reform Act; S.1542/H.R. 6283, the Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 1613, the Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3561, the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023 (previously H.R. 2691Transparent PRICE Act); H.R. 3281, To promote hospital and insurer price transparency; H.R.2880, Protecting Patients Against PBM Abuses Act; H.R. 2679, The PBM Accountability Act; H.R.3285, the Fairness for Patient Medications Act, to establish patient protections with respect to highly rebated drugs; H.R. 3262, To amend title XI of the Social Security Act to increase transparency of certain health-related ownership information; H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; H.R. 2666, the Medicaid VBPs for Patients (MVP) Act; H.R. 3284, the Providers and Payers COMPETE Act; S. 1967 the Patients Before Middlemen (PBM) Act; Protect Patients Access to Pharmacies Act; S. 2406, PBM Oversight Act of 2023; S. 2973, Modernizing and Ensuring PBM Accountability Act; S. 2436, the Neighborhood Options for Patients Buying Medicines (NO PBMs) Act; S. 2405, the Strengthening Pharmacy Access for Seniors Act; S.2254, the Medicare PBM Accountability Act; S. 2052, the Protect Patient Access to Pharmacies Act; H.R. 4822, the Health Care Price Transparency Act of 2023; H.R. 3284, the Providers and Payers COMPETE Act; H.R. 4508, the Hidden Fee Disclosure Act; H.R. 4507, the Transparency in Coverage Act of 2023; H.R. 4895, the Lowering Drug Costs for American Families Act; H.R. 5378 Lower Costs, More Transparency Act; H.R. 4527, Health Data Access, Transparency, and Affordability Act (DATA) Act; H.R.3285, Fairness for Patient Medications Act; S.2973 Modernizing and Ensuring PBM Accountability Act; S. 3548, Health Care Prices Revealed and Information to Consumers Explained Transparency Act (Health Care PRICE Transparency Act 2.0); H.R.3285 - Fairness for Patient Medications Act; H.R. 3008, the Drug Shortage Prevention Act of 2023; H.R. 3810, the Drug Origin Transparency Act of 2023; H.R. 3793, the Ensuring Access to Lifesaving Drugs Act of 2023; H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R.7535, Prescription Drug Supply Chain Pricing Transparency Act; H.R. 6986/S.3583, to address patent thickets; S. 2220, Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act); H.R. 8261, the Preserving Telehealth, Hospital, and Ambulance Access Act; Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act (SUSTAIN 340B Act); H.R. 8574, 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act; S.150, the Affordable Prescription Drug for Patients Act; S. 148, the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Stop STALLING Act); S. 142, the Preserve Access to Affordable Generics and Biosimilars Act.

Client expense: $2,200,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Client expense: $680,000 · Firm income: Not reported

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

H.R. 167, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023; H.R. 2679, the Pharmacy Benefits Manager Accountability Act; H.R. 3008, the Drug Shortage Prevention Act; S. 1339, the Pharmacy Benefits Manager Reform Act; S. 1542 / H.R. 6283, the Delinking Revenue from Unfair Gouging Act; H.R. 1173, the Patients Right to Know Their Medication Act of 2023; Proposed rule for Medication Guides: Patient Medication Information (Docket No. FDA-2019-N-5959); Implementation of Public Law 113-54, the Drug Quality and Security Act; Draft Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, (Docket No. FDA-2015-D-3517); H.R. 5400 / S. 2436, the NO PBMs Act; S.3430,the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023; Request for Information for "Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act" (Docket No. FDA-2023-N-4806); Request for Information on Bipartisan 340B Senate Working Group SUSTAIN 340B Act Discussion Draft; H.R.4366, the Consolidated Appropriations Act, 2024; H.R.2882, the Further Consolidated Appropriations Act, 2024; Comments on implementation and enforcement of recent changes to USP Chapter <797>, regarding the Compounded Sterile Preparations (CSPs) in Category 3 to the FDA; Comments on "Agency Information Collection Activities; Proposed Collection; Comment Request; Proposed Small Dispensers Assessment Under the Drug Supply Chain Security Act" [Docket No.FDA-2024-N-0668]; Comments on " Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act"[Docket No. FDA-2023-N-0061];

Client expense: $340,000 · Firm income: Not reported

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

Issues related to drug pricing reform -Changes to Public law 117-1769 Inflation Reduction Act -Awareness of implications to patients and research and development of Public law 117-1769 Inflation Reduction Act S. 113 Prescription Pricing for the People Act of 2023 S.127 Pharmacy Benefit Manager Transparency Act HR 830/ S 1375 HELP Copays Act HR 485 Protecting Health Care for All Patients Act HR 5378 Lower Costs, More Transparency Act R 2534 PROTECT 340B Act of 2023 HR 3561 the PATIENT Act S. 1542/ hr 6283 DRUG Act S. 1967 PBM Act HR 3503 The NIH Clinical Trials Diversity Act Issues related to cardiovascular disease awareness and treatment Issues related to Federal Trade Commission FDA issues Issues related to patient affordability issues, including copay cards, copay accumulators, copay maximizers, National Benefit Payment Parameters Biosimilars reimbursement issues, no specific bill Supply Chain Issues, no specific bill Issues related to 340B Issues related to pharmacy benefit managers Proposed rule: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program HR 4818/ S. 2407 Treat and Reduce Obesity Act S. 2305 Biosimilar Red Tape Elimination Act S. 2129 Ensuring Access to Lower-Cost Medicines for Seniors Act Issues related to PAHPA reauthorization Modernizing and Ensuring PBM Accountability Act (Finance Committee) S. 652 SAFE Step Act S 2474/ HR 5376 Share the Savings with Seniors Act S 2456 Protecting Seniors from High Drug Costs Act HR4881 To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program HR 3281 Protecting Patients Against PBM Abuses Act HR 4822 Health Care Price Transparency Act of 2023 S 1339 Pharmacy Benefit Manager Reform Act HR 2679 Pharmacy Benefits Manager Accountability Act HR 4507 Transparency in Coverage Act of 2023 HR 1352 Increasing Access to Biosimilars Act of 2023 HR 2880 Protecting Patients Against PBM Abuses Act Issues pertaining to the implementation of PL 97-414 "Orphan Drug Act," all provisions. HR 5539 Orphan Cures Act HR 5547 Maintaining Investments in New Innovation Act S 3558 BIOSECURE Act HR 7174 Ensuring Pathways to Innovative Cures (EPIC Act) S Res 566 Cholesterol Education Month 2024 HR 7635 340B PATIENTS Act of 2024 H.R. 5391 / S. 2764 The Protecting Patient Access to Cancer and Complex Therapies Act . H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act . HR 5376 Share the Savings With Seniors Act . S 3430 Mental Health, Lower Cost Drugs and Extenders Package . BIOCOMPETE (no bill number)- Issues related to prohibiting the export of biotechnology to certain foreign entities

Client expense: $2,740,000 · Firm income: Not reported

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

Issues related to drug pricing reform -Changes to Public law 117-1769 Inflation Reduction Act -Awareness of implications to patients and research and development of Public law 117-1769 Inflation Reduction Act S. 113 Prescription Pricing for the People Act of 2023 S.127 Pharmacy Benefit Manager Transparency Act HR 485 Protecting Health Care for All Patients Act HR 5378 Lower Costs, More Transparency Act HR 2534 PROTECT 340B act of 2023 HR 3561 the PATIENT act Issues related to cardiovascular disease awareness and treatment Issues related to ESRD Issues related to asthma and self-administered drug list Issues related to reimbursement for biologics/biosimilars Proposed rule: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program HR 4818/ S2407 Treat and Reduce Obesity Act S2129 Ensuring Access to Lower-Cost Medicines for Seniors Act Issues related to PAHPA reauthorization Modernizing and Ensuring PBM Accountability Act (Finance Committee) S. 1542/ HR 6283 DRUG Act S652 SAFE Step Act HR 3281 Protecting Patients Against PBM Abuses Act HR 4822 Health Care Price Transparency Act of 2023 S 1339 Pharmacy Benefit Manager Reform Act HR 2679 Pharmacy Benefits Manager Accountability Act HR 4507 Transparency in Coverage Act of 2023 S 2474/HR 5376 Share the Savings with Seniors Act S 2456 Protecting Seniors from High Drug Costs Act HR4881 To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program HR 1352 Increasing Access to Biosimilars Act of 2023 HR 2880 Protecting Patients Against PBM Abuses Act HR 5547 Maintaining Investments in New Innovation Act HR 7174 Ensuring Pathways to Innovative Cures (EPIC Act) HR 7635 340B PATIENTS Act of 2024 H.R. 5391 / S. 2764 The Protecting Patient Access to Cancer and Complex Therapies Act . H.R.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act . HR 5376 Share the Savings With Seniors Act . S 3430 Mental Health, Lower Cost Drugs and Extenders Package . HR 5539 Orphan Cures Act

Client expense: $2,740,000 · Firm income: Not reported

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

H.R. 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