HELP Copays Act

PBM Transparency and Reform: S1375/HH830 - Help Ensure Lower Patient (HELP) Copays Act S1542/HR6283 - Delinking Revenue from Unfair Gouging (DRUG) Act S2973 - Modernizing and Ensuring PBM Accountability Act S3430 - Better Mental Health Care, Lower Cost Drugs, and Extenders Act HR5378 - Lower Costs More Transparency Act Inflation Reduction Act /Medicare Price Setting 340B Reform Cell and Gene Therapy Access Model HR1458 - Access to Prescription Digital Therapeutics Act of 2023

Client expense: $3,740,000 · Firm income: Not reported

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

H.R. 6645, Medicare Audiology Access Improvement Act of 2023, all provisions S. 2377, Medicare Audiology Access Improvement Act of 2023, all provisions H.R. 1610, Chiropractic Medicare Coverage Modernization Act of 2023, all provisions S. 799, Chiropractic Medicare Coverage Modernization Act of 2023, all provisions H.R. 4189, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2023, all provisions S. 2016, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2023, all provisions H.R. 8532, Connected MOM Act, all provisions S. 712, Connected MOM Act, all provisions H.R. 1770, Equitable Community Access to Pharmacist Services Act, all provisions S. 2477, Equitable Community Access to Pharmacist Services Act, all provisions H.R. 751, Fair Access In Residency (FAIR) Act, all provisions H.R. 4968, Getting Over Lengthy Delays in Care As Required by Doctors (GOLD CARD) Act of 2023, all provisions H.R. 2713, Improving Care and Access to Nurses (I CAN) Act, all provisions S. 2418, Improving Care and Access to Nurses (I CAN) Act, all provisions H.R. 2583, Increasing Access to Quality Cardiac Rehabilitation Care Act of 2023, all provisions H.R. 6487, No Fees for EFTs Act, all provisions S. 3805, No Fees for EFTs Act, all provisions H.R. 977, Patient Access to Higher Quality Health Care Act of 2023, all provisions S. 470, Patient Access to Higher Quality Health Care Act of 2023, all provisions H.R. 2389, Resident Physician Shortage Reduction Act of 2023, all provisions S. 1302, Resident Physician Shortage Reduction Act of 2023, all provisions H.R. 7050, Substance Use Disorder Workforce Act, all provisions H.R. 7623, Telehealth Modernization Act of 2024, all provisions H.R. 2474, Strengthening Medicare for Patients and Providers Act, all provisions H.R. 830, Help Ensure Lower Patient (HELP) Copays Act, all provisions S. 1375, Help Ensure Lower Patient (HELP) Copays Act, all provisions H.R. 6371, Provider Reimbursement Stability Act of 2023, all provisions H.R. 6545, Physician Fee Schedule Update and Improvements Act, all provisions H.R. 5378, Lower Costs, More Transparency Act, all provisions H.R. 6683, Preserving Seniors Access to Physicians Act of 2023, all provisions H.R. 5013, Value in Health Care Act of 2023, all provisions S. 3503, Value in Health Care Act of 2023, all provisions H.R. 8702, Improving Seniors Timely Access to Care Act of 2024, all provisions S. 4532, Improving Seniors Timely Access to Care Act of 2024, all provisions S. 4518, Improving Seniors Timely Access to Care Act of 2024, all provisions S. 4935, Physician Fee Stabilization Act, all provisions H.R. 6366, To amend title XVIII of the Social Security Act with respect to the work geographic index for physician payments under the Medicare program, and to revise the phase-in of clinical laboratory test payment changes under such program, all provisions H.R. 7463, Extension of Continuing Appropriations and Other Matters Act, 2024, provisions relating to Medicare payments H.R. 7931, Preserving Emergency Access in Key Sites (PEAKS) Act, all provisions S. 4338, Pay PCPs Act of 2024, all provisions H.R. 8563, Preserving Access To Care in Hawaii (PATCH) Act, all provisions S. 4395, Protecting Access To Care in Hawaii (PATCH) Act, all provisions H.R. 6369, To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models, all provisions H.R. 7665, ACO Assignment Improvement Act of 2024, all provisions S. 3939, ACO Assignment Improvement Act of 2024, all provisions H.R. 8404, Radiation Oncology Case Rate (ROCR) Value Based Program Act of 2024, all provisions S. 4330, Radiation Oncology Case Rate (ROCR) Value Based Program Act of 2024, all provisions H.R. 4829, Physical Therapist Workforce and Patient Access Act of 2023, all provisions H.R. 8235, Rural Physician Workforce Preservation Act, all provisions H.R. 1745, Medicare Fraud Detection and Deterrence Act of 2023, all provisions H.R. 1746, Preventing Medicare Telefraud Act, all provisions H.R. 8261, Preserving Telehealth, Hospital, and Ambulance Access Act, all provisions S. 1491, Pharmacy and Medically Underserved Areas Enhancement Act, all provisions S. 669, Increasing Mental Health Options Act of 2023, all provisions H.R. 7618, Stopping Addiction and Falls for the Elderly (SAFE) Act, all provisions H.R. 3730, Rural Health Clinic Burden Reduction Act, all provisions H.R. 7279, Remove Duplicative Unnecessary Clerical Exchanges (REDUCE) Act, all provisions H.R. 7708, Requiring Enhanced & Accurate Lists of (REAL) Health Providers Act, all provisions S. 3508, Requiring Enhanced & Accurate Lists of (REAL) Health Providers Act, all provisions H.R. 9001, Physician Led and Rural Access to Quality Care Act, all provisions S. 5218, A bill to amend titles XI and XVIII of the Social Security Act to strengthen, increase oversight of, and compliance with, security standards for health information, and for other purposes, all provisions S. 4054, Health Care Cybersecurity Improvement Act of 2024, all provisions H.R. 8588, Linking Seniors to Needed Legal Services Act of 2024, all provisions H.R. 5526, Seniors Access to Critical Medications Act of 2024, all provisions H.R. 9129, Patient Debt Relief Act, all provisions Fewer Burdens for Better Care Act/draft MACRA/MIPS program reform legislation/draft FY 2025 Medicare physician payment increase/draft Medical Chaperones in Medicare/draft Medicare program: No Surprises Act implementation Medicare program: 21st Century Cures Act implementation Medicare program: FY 2025 Physician payment cut Medicare program: Information Blocking Disincentives Medicare program: Merit-based Incentive Payment System (MIPS) reform Medicare program: Medicare Economic Index (MEI) Medicare program: Medicare Access and CHIP Reauthorization Act (MACRA) reform Medicare program: Budget neutrality reforms/Inflationary update Medicare program: G2211 Inherent complexity code Medicare program: Protecting Access to Medicare Act (PAMA 2014) lab cut reform Medicare program: High-cost disposable services payment Medicare program: Medicare Administrative Contractor/local-coverage determinations Medicare program: Making Care Primary alternative payment models (APM) Medicare program: Rural physicians APM Medicare program: Site neutral payment Medicare program: Physician-owned hospitals Medicare program: Graduate Medical Education (GME) funding Medicare program: Audio-visual supervision of residents/permanent expansion Medicare program: Conditions of Participation (COP)/Obstetrical service Medicare program: MACRA/physician burdens Medicare program: Health Information Technology/physician burdens Medicare program: Prior authorization/Medicare Advantage plans Medicare program: Interoperability/data sharing/information blocking/provider disincentives Medicare program: Promoting interoperability reporting Medicare program: Trusted exchange framework/common agreement Medicare program: Data segmentation Medicare program: Quality payment program Medicare program: Medicare Shared Savings Program/Advanced APM Medicare program: Public health reporting and data exchange Medicare program: Accountable Care Organizations/APM flexibilities Medicare program: Certified Electronic Health Record (EHR) Technology Medicare program: Physician Practice Information (PPI) survey/practice expense Medicare program: MIPS Value Pathways (MVPs)/APMs Medicare program: Telehealth flexibilities Medicare and Medicaid programs: Data Privacy and Cybersecurity Medicare and Medicaid programs: Health Insurance Portability and Accountability Act (HIPAA)/electronic records

Client expense: $5,330,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Office of Science & Technology Policy (OSTP), SENATE, Veterans Affairs, Dept of (VA)

Issues related to prescription-to- over the counter switch; issues related to influenza vaccines; issues related to 340B; issues related to Respiratory Syncytial Virus (RSV) access; general issues related to vaccines; issues related to clinical trial diversity; general issues related to drug pricing; issues related to out of pocket (OOP); general issues to insulin pricing; issues related to Additional Condition for Prescription Use (ACNU); issues related to copay accumulators; issues related to HR3656 "Vaccine Access Improvement Act"; issues related to Vaccine Issues Compensation Program (VICP); issues related to HR 830 "HELP Copays Act"; issues related to Pandemic and All-Hazards Preparedness Act (PAHPA)reauthorization; issues related to HR 1503 "Prescription Information Modernization Act of 2023"; general issues related FDA; issues related to FDA Drug Development; issues related to Pharmacy Benefit Managers (PBMs); issues related to insurance design; issues related to S. 1542 "DRUG Act"; issues related to S. 1375 "HELP Copays Act"; issues related to tax credits; issues related to S. 1339 "PBM Reform Act"; issues related to delinking; issues related to HR 2880 "Protecting Patients Against PBM Abuse Act"; issues related to Type 1 Diabetes screening; issues related to intellectual property; issues related to Transplant; issues related HR 5339 and S. 3131 "Orphan Cures Act"; Rare Pediatric Priority Review Voucher Program related to HR 7834 "Creating Hope Reauthorization Act of 2024"; Orphan Drug Negotiation within HR5378 "Inflation Reduction Act"; issues related to drug price negotiations; issues related to COPD Research funding; Biologic/Small Molecule drug negotiation eligibility within HR7174 "EPIC Act"; CDC Type 1 Diabetes Awareness and Education with LHHS appropriations; issues related to S.4504 "SCREEN for Type 1 Diabetes"; issues related to HRSA - Type 1 Diabetes Screening in LHHS Appropriations; general issues related to Inflation Reduction Act; issues related to Routine Immunizations Rates; issues related to HR5376 "Inflation Reduction Act"; issues related to Rebate Pass Through; and issues related to S. 2916 "Prescription Information Modernization Act of 2023";

Client expense: $690,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pharmacy Benefit Managers. 340B. Tort Litigation reform. Health care supply chain. S.1375/HR 830 - HELP Copays Act. Inflation Reduction Act Implementation.

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

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

Patient Access to drug treatment therapies; and drug cost and drug pricing reform. Oversight of the pharmaceutical industry and drug pricing. H.R.830 - HELP Copays Act S. 1375 - HELP Copays Act Monitoring policies as they relate to PBMs

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 652 / H.R. 2630, Safe Step Act and issues related to medication step therapy. S.1375 / H.R. 830, HELP Copays Act, as it relates to out-of-pocket costs for prescription drugs. H.R. 10445, Furthering Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025, as it relates to pharmacy benefit management reforms. H.R. 10545, The American Relief Act of 2025.

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

Government targets: HOUSE OF REPRESENTATIVES, 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 - Electronic 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 H.R. 10545 - American Relief Act of 2025 H.R. 8774 - Department of Defense Appropriations Act, 2025 H.R. 9029 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025

Client expense: $70,000 · 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 - Electronic 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 H.R. 10545 - American Relief Act of 2025 H.R. 8774 - Department of Defense Appropriations Act, 2025 H.R. 9029 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025

Client expense: $70,000 · 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 - Electronic 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 H.R. 10545 - American Relief Act of 2025 H.R. 8774 - Department of Defense Appropriations Act, 2025 H.R. 9029 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2025

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

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

Support for H.R.5539 - Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Legislation regarding orphan drug pricing, value, and reimbursement, relative to the Inflation Reduction Act of 2022. H.R.2630/S.652, the SAFE Step Act; H.R.830/S.1375, the HELP Copays Act. Policies regarding copay accumulators and impact on rare disease patients. Support of reauthorization of priority review voucher program.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

H.R. 830: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS H.R. 2630: SAFE STEP ACT; ALL PROVISIONS H.R. 4758: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS H.R. 5378: LOWER COSTS, MORE TRANSPARENCY ACT; ALL PROVISIONS H.R. 7383: RETAINING ACCESS AND RESTORING EXCLUSIVITY (RARE) ACT; ALL PROVISIONS H.R. 7623: TELEHEALTH MODERNIZATION ACT OF 2024; ALL PROVISIONS H.R. 7829: SUPPLEMENTAL OXYGEN ACCESS REFORM (SOAR) ACT OF 2024; ALL PROVISIONS H.R. 8702: IMPROVING SENIORS' TIMELY ACCESS TO CARE ACT OF 2024; ALL PROVISIONS H.R. 9774: HEALTH CARE AFFORDABILITY ACT OF 2024; ALL PROVISIONS S. 652: SAFE STEP ACT; ALL PROVISIONS S. 1339: PHARMACY BENEFIT MANAGER REFORM ACT; ALL PROVISIONS S. 1375: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS S. 2372: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS S. 2973: MODERNIZING AND ENSURING PBM ACCOUNTABILITY ACT; ALL PROVISIONS S. 3821: SUPPLEMENTAL OXYGEN ACCESS REFORM (SOAR) ACT OF 2024; ALL PROVISIONS S. 4518: IMPROVING SENIORS' TIMELY ACCESS TO CARE ACT OF 2024; ALL PROVISIONS S. 5194: HEALTH CARE AFFORDABILITY ACT OF 2024; ALL PROVISIONS GENERAL DISCUSSIONS REGARDING PHARMACY BENEFIT MANAGER PRACTICES GENERAL DISCUSSIONS REGARDING THIRD-PARTY ENTITIES THAT CONTRACT WITH EMPLOYER-SPONSORED HEALTH PLANS TO IMPORT PRESCRIPTION DRUGS FROM OUTSIDE THE UNITED STATES, ALSO KNOWN AS ALTERNATIVE FUNDING PLANS GENERAL DISCUSSIONS REGARDING THE 2025 FISCAL YEAR APPROPRIATIONS; PROVISIONS RELATING TO FUNDING FOR DOMESTIC AND GLOBAL AMR PROGRAMS, PUBLIC HEALTH WORKFORCE REPAYMENT PROGRAM, BIO-PREPAREDNESS WORKFORCE PILOT PROGRAM AND PROTECTION OF MEDICARE, MEDICAID, AND SOCIAL SECURITY PROGRAMS, HEALTH AND HUMAN SERVICES AND RELATED AGENCIES, FOOD AND DRUG ADMINISTRATION AND RELATED AGENCIES, CENTER FOR DISEASE CONTROL AND PREVENTION AND RELATED AGENCIES, NATIONAL INSTITUTES OF HEALTH AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION; AND POLICY RIDERS IN DRAFT LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION RELATED AGENCIES FUNDING BILL

Client expense: $120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 830: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS H.R. 1305: SAVING US FROM PANDEMIC ERA RESISTANCE BY BUILDING A UNIFIED GLOBAL STRATEGY (SUPER BUGS) ACT OF 2023; ALL PROVISIONS H.R. 2630: SAFE STEP ACT; ALL PROVISIONS H.R. 2940: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS H.R.: 3433: GIVE KIDS A CHANCE ACT OF 2024; ALL PROVISIONS H.R. 4758: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS H.R. 5378: LOWER COSTS, MORE TRANSPARENCY ACT; ALL PROVISIONS H.R. 7383: RETAINING ACCESS AND RESTORING EXCLUSIVITY (RARE) ACT; ALL PROVISIONS H.R. 7384: CREATING HOPE REAUTHORIZATION ACT OF 2024; PROVISIONS REGARDING THE REAUTHORIZATION OF THE RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER PROGRAM H.R. 7623: TELEHEALTH MODERNIZATION ACT OF 2024; ALL PROVISIONS H.R. 7829: SUPPLEMENTAL OXYGEN ACCESS REFORM (SOAR) ACT OF 2024; ALL PROVISIONS H.R. 8702: IMPROVING SENIORS' TIMELY ACCESS TO CARE ACT OF 2024; ALL PROVISIONS H.R. 8964: MEDICAL RECORDS ACCESS FAIRNESS ACT OF 2024; ALL PROVISION H.R. 9774: HEALTH CARE AFFORDABILITY ACT OF 2024; ALL PROVISIONS S. 652: SAFE STEP ACT; ALL PROVISIONS S. 1339: PHARMACY BENEFIT MANAGER REFORM ACT; ALL PROVISIONS S. 1355: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS S. 1375: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS S. 2372: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS S. 2973: MODERNIZING AND ENSURING PBM ACCOUNTABILITY ACT; ALL PROVISIONS S. 3821: SUPPLEMENTAL OXYGEN ACCESS REFORM (SOAR) ACT OF 2024; ALL PROVISIONS S. 4426: PROMISING PATHWAY ACT 2.0; ALL PROVISIONS S. 4518: IMPROVING SENIORS' TIMELY ACCESS TO CARE ACT OF 2024; ALL PROVISIONS S. 4581: SAVING US FROM PANDEMIC ERA RESISTANCE BY BUILDING A UNIFIED GLOBAL STRATEGY (SUPER BUGS) ACT OF 2024; ALL PROVISIONS S. 5194: HEALTH CARE AFFORDABILITY ACT OF 2024; ALL PROVISIONS (DRAFT) CURES 2.0; ALL PROVISIONS GENERAL DISCUSSIONS REGARDING PHARMACY BENEFIT MANAGER PRACTICES GENERAL DISCUSSIONS REGARDING PROPOSED FRAMEWORK FOR REFORMING NATIONAL INSTITUTES OF HEALTH GENERAL DISCUSSIONS REGARDING THE 2025 FISCAL YEAR APPROPRIATIONS; PROVISIONS RELATING TO FUNDING FOR DOMESTIC AND GLOBAL AMR PROGRAMS, PUBLIC HEALTH WORKFORCE REPAYMENT PROGRAM, BIO-PREPAREDNESS WORKFORCE PILOT PROGRAM AND PROTECTION OF MEDICARE, MEDICAID, AND SOCIAL SECURITY PROGRAMS, HEALTH AND HUMAN SERVICES AND RELATED AGENCIES, FOOD AND DRUG ADMINISTRATION AND RELATED AGENCIES, CENTER FOR DISEASE CONTROL AND PREVENTION AND RELATED AGENCIES, NATIONAL INSTITUTES OF HEALTH AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION; AND POLICY RIDERS IN DRAFT LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION RELATED AGENCIES FUNDING BILL GENERAL DISCUSSIONS REGARDING THIRD-PARTY ENTITIES THAT CONTRACT WITH EMPLOYER-SPONSORED HEALTH PLANS TO IMPORT PRESCRIPTION DRUGS FROM OUTSIDE THE UNITED STATES, ALSO KNOWN AS ALTERNATIVE FUNDING PLANS

Client expense: $120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

-S. 5353/H.R. 10210, National Plan for Epilepsy Act, support passage. -Support legislation to increase access to home and community-based services. -S. 652/H.R. 2630, Safe Step Act, support passage. -S. 1375/H.R. 830, HELP Copays Act, support passage. -S. 1339, PBM Reform Act, support patient-centric reforms including addition of the Safe Step Act and HELP Copays Act. -H.R. 2880, Protecting Patients Against PBM Abuses Act -Support preservation of Medicare Part Ds Six Protected Classes policy -Reauthorization of the Advance Premium Tax Credits -Support patient-centric implementation of Medicare Part D out-of-pocket cap and the Medicare Prescription Payment Plan -Urge patient priorities like standardized health plans and network adequacy in the 2026 Notice of Benefit and Payment Parameters rule. -Ensure any regulation of cannabis protects safe and legal access -Ensure continued access to needed healthcare via telehealth including prescribing of epilepsy medications that are controlled substances -Requests to join the Congressional Epilepsy Caucus. -H.R. 824, the Telehealth Benefit Expansion for Workers Act, oppose passage. -Support H.R. 670, S. 4174, Think Differently Database Act -Support S. 4325, the Lifespan Respite Care Program Reauthorization Act -Support the parity of coverage of mental health treatments -Support legislation and regulations that incentivize the development of rare disease treatments -Support the Clinical Trial Modernization Act -Support legislation and regulations that help to advance health equity for people with epilepsy -S. 5065/H.R. 9635, Seizure Awareness and Preparedness Act, support passage -Support legislation and regulations that would ban the use of electric shock devices that apply a shock to a persons skin to reduce or cease self-injurious or aggressive behaviors, including supporting the immediate release of a final rule -Supporting legislation and regulations that protect the current structure of the National Institutes of Health -Support legislation and regulations to keep insurance brokers accountable -Support H.R. 7573, Stop Medicaid Recovery Act -Support legislation and regulations on continuous eligibility in Medicaid -Support H.R. 4758/S.2372, Accelerating Kids Access to Care Act -Support legislation and regulations to streamline prior authorization processes -Support the creation of an Office of Caregiving at the Department of Health and Human Services -Comments on Medicare $2 Drug List Model -Support legislation and regulations to reduce the burden of medical debt -Support legislation and regulation on the responsible use of AI in healthcare -Support S.5070, the Ensuring Access to Medicaid Buy-In Programs Act -Support H.R. 7384/S. 4583, The Creating Hope Reauthorization Act -Support the Rare Pediatric Disease Priority Review Voucher Program -Oppose any cuts to Medicaid as part of reconciliation

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, Treasury, Dept of, Veterans Affairs, Dept of (VA)

HR 830/S 1375 - HELP Copays Act S 127 - Pharmacy Benefit Manager Transparency Act HR 2630/ S 652 - Safe Step Act HR 1770/S 2477 - Equitable Community Access to Pharmacist Services Act HR 2407/S 2085 - Medicare Multi-Cancer Early Detection Screening Coverage Act S 1246/HR 4895 - SMART Prices Act HR 4818/S 2407 - Treat and Reduce Obesity Act of 2023 Continuation of the Inflation Reduction Act Discussions regarding Health ACCESS Act (Health Accelerating Consumers Care by Expediting Self-Scheduling)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 830, HELP Copays Act S.1375, HELP Copays Act H.R. 5378, Lower Costs, More Transparency Act S. 1339, Pharmacy Benefit Manager Reform Act Drug cost and pricing policy issues Patient affordability issues Policy proposals relating to clinical trial diversity Issues related to the 340B program

Client expense: $1,080,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FY2025 Labor-HHS bill to include funding for Medicare low-income outreach and enrollment efforts Prohibiting copay accumulators in ACA Exchange plans: (H.R. 830 / S. 1375)- Help Ensure Lower Patient (HELP) Copays Act Prohibit use of Alternative Funding Programs in private insurance Transparency and streamline utilization management protocols including prior authorization and step therapy; Safe Step Act (H.R. 2630 / S. 652) and Improving Senior's Timely Access to Care Act (H.R. 8702/S. 4518) Medicare telehealth flexibilities Extend federal flexibilities for teleprescribing of controlled substances

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

H.R. 830: Help Ensure Lower Patient (HELP) Copays Act; all provisions of the bill H.R. 5378: Lower Costs, More Transparency Act; all provisions of the bill H.R. 6283: Delinking Revenue from Unfair Gouging (DRUG) Act; all provisions of the bill S. 1339: Pharmacy Benefit Manager Reform Act; all provisions of the bill S. 1375: Help Ensure Lower Patient (HELP) Copays Act; all provisions of the bill S. 1542: Delinking Revenue from Unfair Gouging (DRUG) Act; all provisions of the bill S. 2973: Modernizing and Ensuring PBM Accountability Act; all provisions of the bill S. 3430: Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023; provisions related to drug costs General discussions related to Drug cost and pricing policy issues General discussions related to Healthcare supply chain policy issues

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

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2024 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4818: Treat and Reduce Obesity Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act  H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 9096: Pharmacists Fight Back Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 3430: Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023 S. 5021: 340B PATIENTS Act of 2024 S. 5040: Protecting Patients from Deceptive Drugs Online Act S. 5459: Biosimilars Access and Affordability Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) IRA price negotiation expansion policy issues Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Compounding policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues  Pandemic preparedness policy issues Artificial intelligence policy issues

Client expense: $7,560,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 618, Improving Access to Workers Compensation for Injured Federal Workers Act, all provisions S. 131, Improving Access to Workers Compensation for Injured Federal Workers Act, all provisions H.R. 2923, Living Donor Protection Act, all provisions of 2023, all provisions S. 1384, Living Donor Protection Act, all provisions of 2023, all provisions H.R. 1359, Modernizing Opioid Treatment Access Act, all provisions S. 644, Modernizing Opioid Treatment Access Act, all provisions H.R. 2630, Safe Step Act, all provisions S. 652, Safe Step Act, all provisions H.R. 2761, Specialty Physicians Advancing Rural Care (SPARC) Act, all provisions S. 705, Specialty Physicians Advancing Rural Care (SPARC) Act, all provisions S. 2840, Bipartisan Primary Care and Health Workforce Act, all provisions S. 113, Prescription Pricing for the People Act of 2023, all provisions H.R. 7153, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, all provisions S. 3679, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act, all provisions H.R. 830, Help Ensure Lower Patient (HELP) Copays Act, all provisions S. 1375, Help Ensure Lower Patient (HELP) Copays Act, all provisions S. 127, Pharmacy Benefit Manager Transparency Act of 2023, all provisions H.R. 8325, Physician and Patient Safety Act, all provisions S. 4278, Physician and Patient Safety Act, all provisions H.R. 8383, Rural Obstetrics Readiness Act, all provisions S. 4079, Rural Obstetrics Readiness Act, all provisions S. 3447, Pregnant and Postpartum Women Treatment Reauthorization Act, all provisions H.R. 5012, SHINE for Autumn Act of 2023, all provisions S. 2647, SHINE for Autumn Act of 2023, all provisions S. 3370, Promoting Maternal and Child Health Through Substance Use Prevention Act, all provisions H.R. 1117, Advancing Safe Medications for Moms and Babies Act of 2023, all provisions H.R. 3417, Facilitating Accountability In Reimbursements (FAIR) Act, provisions relating to site neutral payments H.R. 6033, Supporting Patient Education And Knowledge (SPEAK) Act of 2024, provisions relating to telehealth/equity H.R. 2411, National Nursing Workforce Center Act of 2023, all provisions H.R. 6230, Doctor Knows Best Act of 2023, all provisions H.R. 9572, Enhanced Enforcement of Health Coverage Act, all provisions H.R. 6881, AI Foundation Model Transparency Act of 2023, all provisions H.R. 10282, Expanding Support for Living Donors Act of 2024, all provisions CURES 2.0/draft Dr. Paul Farmer Global Health Training Act/draft Artificial Intelligence for Care Utilization Research and Efficacy Act of 2024/draft Temporary Responders for Immediate Aid in Grave Emergencies (TRIAGE) Act/draft 21st Century Cures Act/implementation improvement No Surprises Act implementation Maternal Health Prior Authorization Public health/Infectious diseases/Chronic diseases Substance use disorder Cybersecurity Health IT and HIPAA/health data access privacy Augmented Intelligence Health Equity Reproductive health Health Information Technology/interoperability (HTI-2) Trusted Exchange Framework and Common Agreement (TEFCA) Health IT Certification Electronic Health Record (EHR) certification Physician burden reduction/Health IT Interoperability/data sharing/information blocking/provider disincentives Data segmentation Insights condition/maintenance of certification reporting CHANGE Healthcare Cyberattack Overdose epidemic Substance use disorder/barriers to care Rural and small hospitals/obstetrical services/conditions of participation Gender affirming care Nuclear power plants/decommissioning/health risks Nations drug supply/severe weather events

Client expense: $6,590,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Nuclear Regulatory Commission (NRC), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), SENATE

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

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

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

H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Negotiation Act S. 476/H.R. 5547: Maintaining Investments in New Innovation Act H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act S. 79/H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023 PBM Reform Medicaid H.R. 2666: The Medicaid VBPs for Patients (MVP) Act Coverage of Accelerated Approval Products Drug Benefit Design Medicaid Drug Rebate Program Rule Pricing and Rebates Value-Based Purchasing (VBP) Rule Reimbursement and Coverage of Innovative Products H.R. 830/S. 1375: HELP Copays Act H.R. 2139/S. 908: Medicare Drug Price Negotiation Act H.R. 2148/S. 909: Prescription Drug Price Relief Act H.R. 2630/S. 652: SAFE STEP Act H.R. 4895: Lowering Drug Costs, More Transparency Act CMMI Authority Implementation of the Inflation Reduction Act (IRA) Lower Costs, More Cures Act Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Inflation Reduction Act of 2022 (P.L. 117-169) Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Rebate policy issues Value-based purchasing arrangements policy issues Center for Medicare and Medicaid Innovation (CMMI) and model policy issues CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum CMS Medicare Drug Price Negotiation Revised Guidance S.1544/H.R. 1199: Facilitating Innovative Nuclear Diagnostics Act of 2023

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

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

340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S.1133: 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biodefense Research, Development and Procurement Issues (Non-Funding) ---H.R.3577: Medical and Health Stockpile Accountability Act of 2023 ---H.R.3631: State Strategic Stockpile Act of 2023 ---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023 ---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies. ---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act ---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes. ---H.R.3832: Disease X Act of 2023 ---H.R.7085: BIOSECURE Act ---S.4667: Risky Research Review Act ---Bio COMPETES (Draft) ---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft) ---House GOP RFI on Supply Chain ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---American Pandemic Preparedness Plan (AP3) ---Gain of function (Viral Gain of Function Research Moratorium Act, Risky Research Act) ---MCM PRV Program ---NDAA ---Reasonable Pricing Clauses in BARDA Contracts ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) ---Tropical Disease Priority Review Voucher (PRV) Program ---VICP Loopholes ---White House National Biodefense Strategy ---WHO Pandemic Preparedness Accord Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Bio COMPETES (Draft) ---Biosimilar Copay ---House GOP RFI on Supply Chain ---Interchangeability and Pharmacy Substitution Cell & Gene Therapy Climate Change Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---H.R.8818: American Privacy Rights Act of 2025 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diagnostics and Personalized Medicine Regulation and Oversight Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---S.1906: Promising Pathway Act Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2780: Medication Affordability & Patient Integrity Act ---S.3583/H.R.6986: A bill to address patent thickets ---S.5573: A bill to amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products. ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547/S.476: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.775: Increasing Transparency in Generic Drug Application ---S.1067: Ensuring Timely Access to Generics ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.2305: Biosimilar Red Tape Elimination Act ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---H.R.2408: Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---Patients Before Monopolies (PBM) Act ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Efforts to expand the Bio Economy & Bio Manufacturing Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes. ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---MCM PRV ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2025 Appropriations ---VICP Funding for FDA ---FY 2025 Appropriations ---Creating Hope Reauthorization Act ---Prescription Drug User Fee Act (PDUFA) VII Implementation Funding for Health Resources and Services Administration (HRSA) ---FY 2025 Appropriations Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2025 Appropriations Funding for National Institutes of Health ---FY 2025 Appropriations ---Advanced Research Projects Agency for Health (ARPA-H) ---Funding for Womens Health Research Generic Drug Entry ---H.R.6973: Generic Drug Application Review Reforms ---S.148: Stop STALLING Act ---S.4351: Enhanced Access to Affordable Medicines Act Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4758: Accelerating Kids Access to Care Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Medicaid Drug Rebate Program Rule ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: Support for Patients and Communities Reauthorization Act ---Non-Opioid Analgesics ---Coverage and Reimbursement Orphan Drug Issues ---H.R.3433: Give Kids a Chance Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---Implementation of the Prepare for and Respond to Existing Viruses ---Emerging New Threats and (PREVENT) Pandemics Act ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART)Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---H.R.5796/S424: Protect our Seniors Act ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---In-Home Administration of Part B Drugs ---Lower Costs, More Cures Act ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---H.R.5260: Reduced Costs and Continued Cures Act ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---FY 2025 Appropriations ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $1,460,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), SENATE, State, Dept of (DOS), White House Office

340B Drug Discount Program ---H.R.8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net Act ---S.1133: 340B Accountability Act ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight ---PROTECT 340B Act ---SUSTAIN 340B Act Accelerated Approval Access to non-human Primates (NHPs) Artificial Intelligence (AI) Alternative Funding Programs Biosimilars ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.2305: Biosimilar Red Tape Elimination Act ---Biosimilar Copay ---BSUFA Negotiations ---Implementation of BSUFA Agreement ---Interchangeability and Pharmacy Substitution ---Reimbursement Cell & Gene Therapy Climate Change Clinical Trial Data in China Data Privacy ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---H.R.8818: American Privacy Rights Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Diversity & Inclusion ---Decentralized Clinical Trials ---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act Drug Evaluation and Review ---COVID-19 Lessons Learned ---FDA Hiring Flexibility Drug Importation Drug Manufacturing, Quality & Distribution ---Advanced Manufacturing ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1128: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents. ---S.3583/H.R.6986: A bill to address patent thickets ---Affordable Prescriptions for Patients Act ---Interagency Patent Coordination and Improvement Act ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.1790: Biologics Competition Act of 2023 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.5547: Maintaining Investments and New Innovation (MINI) Act ---H.R.6283: DRUG Act ---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) Act ---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023 ---S.113: Prescription Pricing for the People Act of 2023 ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.142: Preserve Access to Affordable Generics and Biosimilars Act ---S.148: Stop STALLING Act ---S.150: Affordable Prescriptions for Patients Act of 2023 ---S.1067: Ensuring Timely Access to Generics ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Access to Innovative Treatments Act ---CMMI Authority ---COVID-19 Pricing Related Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Negotiation and Competitive Licensing Act ---National Coverage Determination ---Patients Before Monopolies (PBM) Act ---PBM Reform ---Patient Cost-Sharing and Implementation ---Strengthening Innovation in Medicare and Medicaid Act Foreign Drug Data Protection Laws ---H.R.7085: BIOSECURE Act ---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024 ---Bio COMPETES (Draft) ---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern ---House GOP RFI on Supply Chain Funding for Antimicrobial Resistance (AMR) Programs ---FY 2025 Appropriations ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2025 Appropriations ---Funding for Strategic National Stockpile ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Generic Drug Entry ---S.148: Stop STALLING Act ---S.775: Increasing Transparency in Generic Drug Applications Act ---Enhanced Access to Affordable Medicines Act ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Issues Relating to Medical Research and Animal Testing Models ---H.R.7248: FDA Modernization Act 3.0 Medicaid ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---S.127: Pharmacy Benefit Manager Transparency Act of 2023 ---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act ---Medicaid Drug Rebate Program ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule National Defense ---National Defense Authorization Act of 2025 Opioid Crisis ---H.R.4531/S.2933: Support for Patients and Communities Reauthorization Act ---Non-Opioid Analgesics ---Transparency ---Coverage and Reimbursement Orphan Drug Issues ---H.R.5539/S.3131: ORPHAN Cures Act ---H.R.6664: Innovation in Pediatric Drugs Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Pandemic Preparedness ---Drug Supply Chain Management ---House GOP RFI on Supply Chain ---Implementation of the Prepare for and Respond to Existing Viruses ---Monoclonal Antibody Coverage and Utilization ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver ---WHO Pandemic Preparedness Accord Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.7384/S.4583: Creating Hope Reauthorization Act of 2024 ---Helping Experts Accelerate Rare Treatments (HEART) Act ---Rare Disease Pilot Program ---Speeding Therapy Access Today (STAT) Act Reimbursement and Coverage of Innovative Products ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.830/S.1375: HELP Copays Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2666: The Medicaid VBPs for Patients (MVP) Act ---H.R.4895: Lowering Drug Costs for American Families Act ---H.R.5378: Lower Costs, More Transparency Act ---Administration Rebate Rule ---CMMI Authority ---In-Home Administration of Part B Drugs ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2025 Appropriations ---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.2408: Access to Innovative Treatments Act of 2023 ---H.R.2630/S.652: SAFE STEP Act ---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---Adult Immunization ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine Safety Net and Vaccine Infrastructure ---Value of Vaccines and Vaccine Confidence Vaccine Injury Compensation Program ---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023 ---H.R.5143: Vaccine Access Improvement Act of 2023 ---VICP CICP (Discussion Draft)

Client expense: $1,460,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Security Council (NSC), SENATE, State, Dept of (DOS), White House Office

Access to Care Inflation Reduction Act (IRA). ACS CAN actively monitors implementation of the Inflation Reduction Acts Medicare Drug Price negotiation provisions to ensure cancer patients have access to costly prescription drugs. ACS CAN also supports the Medicare Prescription Payment Plan, which allows Part D enrollees to spread their out-of-pocket costs over the plan year. Enhanced Advanced Premium Tax Credits, H.R. 9774, Improving Health Insurance Affordability Act of 2023, S.5194. House and Senate bills would permanently extend the enhanced Affordable Care Act tax credits. Help CoPays Act S.1375; Help Ensure Lower Patient Copays Act, H.R.830. 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. Safe Step Act, S.652, H.R. 2630. 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. Creating Opportunities Now for Necessary and Effective Technologies (CONNECT) for Health Act of 2023 H.R.4189, S.2016. This bill expands coverage of telehealth services under Medicare. Telehealth Modernization Act of 2924, H.R. 7623. Modifies requirements relating to coverage of telehealth services under Medicare. Permanently expands telehealth flexibilities first authorized during the public health emergency. The Preserving Telehealth, Hospital, and Ambulance Access Act, H.R. 8261. This bill allows employers to offer stand-alone telehealth benefits to all employees. This includes employees who are eligible for enrollment in their employer's group health plan. Drug Shortage Prevention Act, H.R. 3008. This bill requires drug manufacturers to notify the Food and Drug Administration (FDA) if there is an increased demand for certain critical essential medicines that may result in a shortage. Protecting Americans from Unsafe Drugs Act of 2023, H.R. 2500. This bill expands the authority of the Secretary of the Department of Health and Human Services (HHS) to order the recall of controlled substances to cover all drugs. Ensuring Access to Lifesaving Drugs Act of 2023, H.R. 3793. This bill allows the Food and Drug Administration (FDA) to obtain additional information from manufacturers of life-saving drugs in order to assess and potentially modify the drug's expiration date. (The bill defines life-saving drug as a medical countermeasure or a drug that is in short supply and that is life-supporting, life-sustaining, or intended to be used to prevent or treat a debilitating disease or condition in humans or animals.) Specifically, the FDA may order a manufacturer of a life-saving drug to submit data and other information from any stage of the drug's development in order to assess the drug's stability and the longest supported expiration date. If such information is not readily available, the FDA may order the manufacturer to conduct additional studies. The FDA may require changes to the drug's label accordingly. Manufacturers that fail to comply are subject to civil penalties. Medical Device Shortage Reduction Act of 2023, H.R. 3807. This bill expands the scope of required notifications about medical device shortages beyond public health emergencies. Protecting PAHPA Action of 2023, H.R. 4697. ACS CAN is lobbying on all provisions related to drug shortages. This bill extends through FY2028 and modifies various programs and activities that support public health preparedness and response. The bill also addresses matters concerning shortages of drugs and medical devices and recalls of drugs. Essential Medicines Strategic Stockpile Act of 2023, H.R. 405. This bill requires the Department of Health and Human Services (HHS) to create a pilot program to test the effectiveness of acquiring, maintaining, managing, and distributing a stockpile of generic drugs at risk of shortage. Alan Reinstein Ban Asbestos Now Act of 2023, H.R. 2402, S. 1069. This bill prohibits the manufacture, process, use, and distribution in commerce of commercial asbestos or any mixture or article containing commercial asbestos. RAPID Reserve Act, S. 2510. This bill improves supply chain resiliency for critical drug products with vulnerable supply chains and ensure that reserves of critical drugs and active pharmaceutical ingredients are maintained to prevent supply disruptions in the event of drug shortages or public health emergencies. Rolling Active Pharmaceutical Ingredient and Drug Reserve Act, H.R.6802. A bill to improve supply chain resiliency for critical drug products with vulnerable supply chains and ensure that reserves of critical drugs and active pharmaceutical ingredients are maintained to prevent supply disruptions in the event of drug shortages or public health emergencies Drug Shortage Prevention and Mitigation Act, S.2586. This legislation would address the ongoing drug shortage crisis. Access to Breast Cancer Diagnosis Act of 2023, H.R.3851, S.2464. To amend title XXVII of the Public Health Service Act to prohibit group health plans and health insurance issuers offering group or individual health insurance coverage from imposing cost-sharing requirements with respect to diagnostic and supplemental breast examinations. Health Disparities Nancy Gardner Sewell Multi-Cancer Early Detection Act, H.R. 2407. This bill allows for Medicare coverage and payment for multi-cancer early detection screening tests that are approved by the Food and Drug Administration and that are used to screen for cancer across many cancer types, if the Centers for Medicare & Medicaid Services determines such coverage is appropriate. Medicare Multi-Cancer Early Detection Screening Coverage (MCED) Act, S.2085. Legislation to improve access to new and innovative cancer screenings for Medicare beneficiaries by creating a pathway to allow Medicare to initiate coverage of multi-cancer tests following FDA approval if a clinical benefit is shown. Screening for Communities to Receive Early and Equitable Needed Services (SCREENS for Cancer) Act, S.1840, H.R.3916. Reauthorization of the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) for fiscal years 2024 through 2028 to provide the program greater flexibility in providing access to lifesaving screening, diagnostic, and treatment services and continue its innovative work aimed to reduce disparities and advance health equity in breast and cervical cancer. Prostate-Specific Antigen Screening for High-Risk Insured Men (PSA Screening for HIM) Act, S.2821, H.R.1826. Legislation to remove cost sharing of PSA testing for those at the highest risk of being diagnosed with prostate cancer. Lung Cancer Screening and Prevention Act, H.R.6693. To amend title XVIII of the Social Security Act to authorize the coverage of additional lung cancer screening tests under the Medicare program. Health Equity and Accountability Act (HEAA), H.R. 9161, S. 4773. Legislation to eliminate racial and ethnic health disparities. We actively advocate for provisions (HEAA), which focuses on health inequalities, societal injustices, and their intersection with immigration status, age, disability, sex, gender, sexual orientation, and socioeconomic status. Increased Funding for the National Institute for Minority Health and Health Disparities. Reducing disparities in the use of recommended preventive services targeting three leading causes of death in the United States - cancer, heart disease, and diabetes. Cancer Drug Parity Act of 2023, S.2039, H.R.6301. Level the playing field for cancer patients by ensuring that the cost-sharing for oral anticancer drugs is on par with intravenous chemotherapy, thereby removing a significant financial obstacle to effective treatment. Henrietta Lacks Enhancing Cancer Research Act of 2019 Report. Request for Congress to urge the Government Accountability Office (GAO) to revisit the Henrietta Lacks Enhancing Cancer Research Act of 2019 report, with respect to promoting diverse participation in cancer clinical trials and addressing fully the request for insight into either implementation challenges for current federal activities or recommendations for additional activities and policy changes related to clinical trial diversity. Data Equity. Legislative and regulatory funding to support the collection of detailed demographic data toward reducing disparities in cancer prevention, detection, and treatment. Childhood Cancer Childhood Cancer Survivorship, Treatment, Access, and Research Reauthorization Act of 2022 (STAR) Act. Continued implementation and funding of the Childhood Cancer STAR Act to promote the development of new, safer therapies for children with cancer. Our appropriations request includes $30 million for the Childhood Cancer STAR Act and $50 million for the Childhood Cancer Data Initiative. Gabriella Miller Kids First Research Act 2.0, H.R. 623, S. 1523. This bill reauthorizes through FY2028 a pediatric disease research initiative within the National Institutes of Health (NIH) and requires the NIH to coordinate pediatric research activities to avoid duplicative efforts. Additionally, the Department of Health and Human Services must report to Congress about research funded through the initiative. Promoting Resources to Expand Vaccination, Education and New Treatments for HPV Cancers (PREVENT) Act, H.R.3633. Legislation that would help prevent cancer and save lives by raising awareness about HPV and HPV-related cancers through a national campaign to educate providers, parents, and the public about the life-saving HPV vaccine. It would also boost resources for a federal initiative to provide access to timely cervical cancer screening and diagnostic services for uninsured and underserved individuals. Accelerating Kids Access to Care Act, S.2372, H.R.4758. Legislation that alleviates these burdens for families and providers by facilitating coordination across state lines and clarifying the process by which state Medicaid programs can cover specialized treatment regardless of where the child lives and where their care is received. Creating Hope Reauthorization Act of 2024, H.R. 7384. This bill extends until FY2029 a Food and Drug Administration program that awards priority review vouchers to manufacturers of drugs that treat rare pediatric diseases. (A priority review voucher entitles the voucher holder to priority review of a single human drug application.) Quality of Life Palliative Care Palliative Care and Hospice Education and Training Act (PCHETA), S.2243. Legislation to facilitate access to palliative care and coordinated care management. Palliative Care Research Funding. Funding to focus and expand national research programs in palliative care at the National Institutes of Health. Specifically, ACS CAN is working to ensure the U.S. Congress appropriates specific money for palliative care research, upon enactment of the FY2024 LHHS Appropriations bill. Patient Navigation for People with Cancer. Legislation and policies to increase access to patient navigation for people with cancer, prioritizing policies that create sustainable funding to ensure access to patient navigation services across the cancer continuum. Patient Navigation Assistance Act, H.R. 9446. This bill would require state Medicaid programs to provide patient navigation services for enrollees. Cancer Survivorship Comprehensive Cancer Survivorship Act (CCSA), S.2213, H.R.4363. ACS CAN supports legislation that sets new standards for survivorship from diagnosis to end of life, ensuring the best and most seamless experience for survivors, and their families and caregivers throughout the journey. CCSA will address gaps in survivorship care and develop needed standards to improve the overall patient-centered quality of care and navigation needs that cancer survivors and their families experience. Federal Health Care Programs Increased Funding Levels for Cancer Research and Prevention. Ensure continued progress in the fight against cancer at the National Institutes of Health (NIH), the National Cancer Institute (NCI), the Advanced Research Projects Agency for Health (ARPA-H), and the Centers for Disease Control and Preventions (CDC) cancer programs. CDC Cancer Programs, the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) Regulatory issues related to healthy food and dietary guidelines PC CARE Act, H.R.1315. This bill establishes a committee to develop, implement, and periodically revise a plan to coordinate federal activities and programs concerning prostate cancer, including those related to research, screening, diagnosis, and treatment. Women and Lung Cancer Research and Preventive Services Act of 2023, H.R.4534, S.2245. This bill requires the Department of Health and Human Services to conduct an interagency review of the status of women and lung cancer. Department of Defense Appropriations Act, 2024 H.R.4365, S.2587. DOD Congressionally Directed Medical Research Program. Cancer Alan Reinstein Ban Asbestos Act, H.R.2402, S.1069. This bill generally prohibits the manufacture, process, use, and distribution in commerce of commercial asbestos or any mixture or article containing commercial asbestos. The President may, on application, grant exemptions from the prohibition in situations where it is necessary to protect national security interests. Nutrition Medical Nutrition Act H.R.6407, S.3297. A bill to amend title XVIII of the Social Security Act to expand the availability of medical nutrition therapy services under the Medicare program Farm, Food, and National Security Act of 2024, H.R.8467. To provide for the reform and continuation of agricultural and other programs of the Department of Agriculture through fiscal year 2029, and for other purposes. Rural Prosperity and Food Security Act, S.5335. To provide for the reform and continuation of agricultural and other programs of the Department of Agriculture through fiscal year 2029, and for other purposes. Clinical Trials Clinical Trial Modernization Act, H.R. 8412. Increase diversity in clinical trials and make it easier for all persons with cancer to participate by reducing barriers to enrollment. Barriers may include ancillary (non-medical) costs, such as transportation and lodging, and remote access to trials, particularly for people who are underrepresented, including certain racial and ethnic groups, older adults, rural residents, and those with limited incomes. NIH Clinical Trial Diversity Act, S.1701, H.R.3503. Legislation to increase the diversity of participants in all National Institutes of Health (NIH)-funded trials. Harley Jacobsen Clinical Trial Participant Income Exemption Act, H.R.7090, H.R. 7418. Legislation to amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants.

Client expense: $2,570,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Indian Health Service, Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office

Discussions around improving access, coverage, and prior authorization for treatments and drugs under Medicare, Medicare Advantage, and private insurance. Seniors Timely Access to Care (S.4532 / H.R. 8702) - CONNECT for Health Act of 2023 (H.R.4189/S.2016) - provisions related to permanent telehealth services in Medicare and interstate telehealth services. Telehealth Modernization Act (H.R. 7623 / S. 3967) - All Provisions. Protecting Health Care for All Patients Act of 2023 (H.R. 485) - provisions to ban the usage of quality adjusted life years in public insurance programs. HELP Copays Act (H.R.830 / S.1375) -- Provisions related to health insurance plans requirement to apply payments made by or on behalf of plan enrollees toward a plan's cost-sharing requirements, i.e. a ban on copay-accumulator adjust programs. BENEFIT Act of 2023 (H.R.1092/S.526) - Provisions related to increases in patient and advocate role in FDA benefit-risk framework for drug approval through leveraging patient experience, PFDD, and related data. Connecting Caregivers to Medicare Act of 2024 (H.R. 7274/S. 3766) - All provisions. Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691) - All provisions HEALTHY BRAINS Act (H.R. 9233) - All Provisions relating to creating a research grant program to study environmental toxin exposure, its impact on the development of neurodegenerative diseases like ALS, and developing strategies to prevent, treat, and slow the progression of neurodegenerative diseases. Seniors Timely Access to Care (S.4532 / H.R. 8702) - All provisions

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

ALS Better Care Act (H.R 5663/S.3258) - Discussion around supplemental payment to designated ALS clinics that provide multidisciplinary services to people living with ALS. HELP Copays Act (H.R.830 / S.1375) -- Provisions related to health insurance plans requirement to apply payments made by or on behalf of plan enrollees toward a plan's cost-sharing requirements, i.e. a ban on copay-accumulator adjust programs. Access to Genetic Counselor Services Act of 2023 (H.R.3876) - Provisions related to modernization of Medicare to keep pace with generic and genomic medicine innovation. Improves the ability for practitioners to refer patients to genetic counselors, Provides 85% reimbursement of physicians fee schedule amount for service. Discussion around Telehealth permanence (no bill number) - provisions related to permanent telehealth services in Medicare and interstate telehealth services. Close the Medigap Act (HR 35) -Discussion around Medigap guarantee issue provisions for people living with ALS aged under 65. Alleviating Barriers for Caregivers (ABC) Act (S.3109/H.R.8018) - All provisions. Connecting Caregivers to Medicare Act of 2024 (H.R. 7274/S. 3766) - All provisions

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the Change Healthcare cyber-attack. Support for site neutrality policies including in H.R. 3561 - the Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or the PATIENT Act of 2023. Advocating for access to biosimilars. S. 652/HR 2630, Safe Step Act. S. 1375/HR 830, HELP Copays Act.

Client expense: $27,000 · Firm income: Not reported

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

Access to Breast Cancer Diagnosis (ABCD) Act (H.R.3851/S. 2464) Safe Step Act (H.R.2630/S. 652) Implementation of the Affordable Care Act HELP Copays Act (H.R.830/S.1375) Cancer survivorship issues Issues related to prescription drug affordability for patients Administrative actions necessary to reduce out-of-pocket costs for medical-necessary diagnostic breast imaging Congressional action to reduce out-of-pocket costs for medically necessary diagnostic breast imaging Find It Early Act (H.R.3086/S.5141) Policies related to coverage of preventive services with no cost-sharing Polices regarding White House Cancer Moonshot implementation Policies related to copay accumulator and maximizer adjustors Policies related to the extension of enhanced advanced premium tax credits Healthcare Affordability Act of 2024 (H.R. 9774 / S. 5194) H.R. 1692 - Health Care Affordability Act of 2023; S. 8 - Improving Health Insurance Affordability Act of 2023 Letter to tri-agencies (Department of Health and Human Services, Treasury, Labor) re Enhancing Coverage of Preventive Services Under the Affordable Care Act Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2026; and Basic Health Program (CMS-9888-P) House Ways and Means Committee Request for Information - Tax Priorities Protect patients from substandard and junk insurance products

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Personnel Management (OPM), Office of Science & Technology Policy (OSTP), SENATE, Treasury, Dept of, White House Office

Affordable Care Act implementation Coverage of hemophilia treatments and services in private insurance plans Policies related to co-pay accumulators, including The HELP Copays Act (HR 830/S.1375) Private insurance policies that discriminate coverage for high cost drugs and use of patient assistance programs, also known as the (Alternative Payment Model) Congressional sign-on letter to HHS/Treasury/Labor asking them to release promised rule closing the EHB loophole for ERISA plans Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2026; and Basic Health Program (CMS-9888-P)

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

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

Implementation of the Inflation Reduction Act of 2022; Issues Related to the Orphan Drug Tax Credit; Help Copays Act (HR 830 / S 1375); Orphan Cures Act (HR 5539 / S 3131); National Plan to End Parkinson's Act (HR 2365 / S 1064); Protect Rare Act (HR 6094); The Creating Hope Reauthorization Act (HR 7384 / S 4583) / HR 3433); BIOSECURE Act (HR 7085); The American Recovery Act (HR 10545).

Client expense: $510,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Federal policies impacting pharmaceutical development, approval, and reimbursement; Copay accumulators and maximizers, HELP Copays Act (H.R. 830/S. 1375); Alternative Funding Programs; Unmet medical need in acute pain; Barriers to patient access of non-opioid pain medicines; General education about kidney disease, including APOL-1; Cystic Fibrosis; Sickle cell disease; Innovations in Type 1 diabetes treatments.

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

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, SENATE

Increasing access to care by limiting step therapy. Safe Step Act HR 2630, S 652. Lowering out-of-pocket costs for patients. HELP Copays Act HR830, S1375 HHS response to HIV+Hep vs Baccerra law suit. FY 2026 HHS Notice of Benefit Payments and Parameters, copay assistance. Pharmacy Benefit Manager Reform. PBM Transparency Act S 127; Prescription Pricing for the People Act S 113; PBM Reform Act, S. 1339; Hidden Fee Disclosure Act HR 4508. Funding for medical research and education at the NIH and CDC. Biosimliar interchageability. HHS rule on Section 1557 of the Affordable Care Act (ACA) that will strengthen non-discrimination protections in health care. Fifth Circuits decision in Alliance for Hippocratic Medicine et al. v FDA et al. Committee on Education and Workforce ERISA RFI: step therapy reform, copay accumulators and maximizers. FDA - proposed guidance on Diversity Action Plans for medical clinical trials; proposed guidance on development of medications for pediatric inflamatory bowel disease patients.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), SENATE

P.L. 111-148 Affordable Care Act, modifications Prior authorization utilization policies Medicare Access and CHIP Reauthorization Act (P.L. 114-10) Improvement Issues Medicare Physician Payment Issues Drug Pricing and Shortages Issues Medicare Part B Drug Price Issues Expansion of Telehealth Services Vision Research Funding Implementation of No Surprises Act S. 652/H.R. 2630, the Safe Step Act The Ensuring Lasting Smiles Act Medicare Coverage for Low Vision Devices S. 1573/H.R. 3226 - Preemie Reauthorization Act of 2023 H.R.2474 - Strengthening Medicare for Patients and Providers Act Healthcare Workforce Issues H.R. 6545, the Physician Fee Schedule Update and Improvements Act H.R. 6683, the Preserving Seniors Access to Physicians Act of 2023 H.R. 6487/S. 3805, the No Fees for EFTs Act H.R. 4968, the GOLD CARD Act H.R. 830/S. 1375, the Help Ensure Lower Patient Copays Act (HELP Copays Act) H.R. 2748, the Contact Lens Prescription Verification Modernization Act H.R. 1503, the Prescription Information Modernization Act of 2023 H.R. 7745, the Embracing Anti-Discrimination, Unbiased Curriculum, and Advancing Truth in Education (EDUCATE) Act Funding for the Pediatric Specialty Loan Repayment Program H.R. 8400, the Early Detection of Vision Impairments for Children Act of 2024 (EDVI Act) H.R. 8702/S. 4532, the Improving Seniors Timely Access to Care Act H.R.9747 - Continuing Appropriations and Extensions Act, 2025

Client expense: $258,819 · Firm income: Not reported

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

Lobbying to Improve Prescription Drug Affordability and Accessibility: Advocacy for people living with Parkinson's via Medicare Part D redesign and benefits, including expanding the low-income subsidy (LIS) program, capping out-of-pocket costs, implementing a smoothing mechanism, and streamlining utilization management processes. Medicare Part D Six Protected Classes Policy: Requires Part D plans to cover all drugs in six classes: immunosuppressants, antidepressants, antipsychotics, anticonvulsants, antiretrovirals, and antineoplastics. Access to a wide range of treatment options for antidepressants and antipsychotics is essential for Parkinson's patients due to non-motor symptoms such as depression and psychosis. Advocacy includes coalition meetings and letters to CMS in response to Medicare Prescription Payment Plan Part One Guidance to support continued protection for the six protected classes. H.R.2360/S.652/S.1339 - Safe Step Act: A bill requiring group health plans to provide an exception process for any medication step therapy protocol to ensure that Parkinson's patients can access treatments safely and efficiently. Led a digital campaign to allow constituents to write to members of Congress in support of the legislation. H.R.830/S.1375 - Help Ensure Lower Patient Copays Act: This bill requires health insurance plans to apply third-party payments, financial assistance, discounts, and other reductions in out-of-pocket expenses toward a plan's cost-sharing requirements. Many Parkinson's patients rely on such payments to afford medications, and this legislation ensures they count toward out-of-pocket costs. S.1544/H.R.1199 - Facilitating Innovative Nuclear Diagnostics Act of 2023: A bill to establish separate payment requirements for diagnostic radiopharmaceuticals, including DaTscans, under the Medicare prospective payment system for hospital outpatient department services. This will help confirm Parkinson's diagnoses more efficiently. CMS-1809-P (2025 Medicare Outpatient Prospective Payment System Proposed Rule): Supported CMS's proposal to separate payment for certain diagnostic radiopharmaceuticals, including those used to diagnose Parkinson's disease and atypical parkinsonisms, from the procedure payment and reimburse them separately. H.R.8702/S.4532 - Improving Seniors Timely Access to Care Act: A bill to establish requirements regarding the use of prior authorization under Medicare Advantage plans. Lobbying CMS: Advocacy efforts to direct Durable Medical Equipment Medicare Administrative Contractors to provide clarification on the use of claim modifiers for DME therapies administered via an external infusion pump to expedite patient access to new Parkinson's therapies once they are approved by the FDA.

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

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

H.R.2365/S.1064 - National Plan to End Parkinson's Act: A bill to create an advisory council comprising members of federal agencies that support research, care, and services for Parkinson's disease, as well as patients, care partners, researchers, clinicians, and other non-federal experts, to ensure efficient and effective coordination among all federal entities responsible for managing, treating, and curing Parkinson's disease. General Parkinson's Disease Information: Covers symptoms, triggers, health coverage, health costs, social determinants of health, data collection, research, environmental risks, and health access for underserved communities, particularly through the CDC's National Neurological Conditions Surveillance System (NNCSS). H.R.2630/S.652/S.1339 - Safe Step Act: Requires group health plans to provide an exception process for any medication step therapy protocol to ensure that individuals living with Parkinson's disease can access treatments safely and efficiently. Establishing Parkinson's Disease ICD-10-CM Codes: Aims to assist in the coordination of care for Parkinson's patients who experience OFF episodes and to allow researchers to gather data to study disease progression. S.1544/H.R.1199 - Facilitating Innovative Nuclear Diagnostics Act of 2023: A bill to establish separate payment requirements for diagnostic radiopharmaceuticals, including DaTscans, which aid in confirming a Parkinson's diagnosis under the Medicare prospective payment system for hospital outpatient services. H.R.3432 - Telemental Health Care Access Act of 2023: Permanently removes Medicare's originating site requirements for mental health services furnished via telehealth. Parkinson's non-motor symptoms include mental health conditions, and many people with Parkinson's are Medicare beneficiaries who may face barriers due to in-person requirements. H.R.830/S.1375 - Help Ensure Lower Patient Copays Act: A bill requiring health insurance plans to apply certain payments, including third-party payments, financial assistance, and product vouchers, toward a plan's cost-sharing requirements. This helps Parkinson's patients afford medications for managing symptoms. The Medicare Part D Six Protected Classes Policy: Requires Part D plans to cover all drugs in six protected classes, including antidepressants and antipsychotics. For individuals with Parkinson's disease, these medications are crucial for managing non-motor symptoms such as depression and psychosis. H.R.4752/S.2379 - CHANGE Act of 2023: A bill to improve early screening, detection, and diagnosis of Alzheimer's and related dementias, including Parkinson's disease dementia, during Medicare wellness visits. H.R.4942/S.655 - Conrad State 30 and Physician Access Reauthorization Act: Reauthorizes the Conrad State 30 program and improves policies to address health care provider shortages, supporting neurological care for Parkinson's patients. H.R.8702/S.4532 - Improving Seniors Timely Access to Care Act: Establishes requirements regarding the use of prior authorization under Medicare Advantage plans. H.R.9233/S.- The HEALTHY Brains Act: Draft legislation to create a Centers of Excellence grant program within the National Institutes of Health to focus on the intersection between environmental risk factors and neurodegenerative diseases. H.R.8331/S. 4280 - Essential Caregivers Act of 2024: To amend titles XVIII and XIX of the Social Security Act to require skilled nursing facilities, nursing facilities, intermediate care facilities for the intellectually disabled, and inpatient rehabilitation facilities to permit essential caregivers access during any period in which regular visitation is restricted. General Outreach for Establishing an ""Office of Caregiver Health"": Supports the creation of an Office of Caregiver Health within the Department of Health and Human Services to address the needs of caregivers, particularly in relation to Parkinson's disease care.

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), President of the U.S., SENATE, White House Office

Lobby members of Congress regarding issues related to telemedicine. Advocate for a stable supply of medications and for mitigation of drug shortages, including lidocaine. Advocate for increased transparency regarding drug pricing. Advocate for reducing barriers to entry of generic drugs into the marketplace. Advocate for transparency on the part of pharmaceutical benefit managers. Advocate for patient access to compounded medications. Advocate for reducing the burdens of utilization management tools, including step therapy and prior authorization for pharmaceuticals and services. Advocate for a stable supply of medications and mitigate drug shortages. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 2630/S. 652, Safe Step Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Advocate for the continued and increased funding of Community Health Centers. Advocate for implementation of surprise medical billing legislation (enacted as part of P.L. 116-260, Consolidated Appropriations Act, 2021, H.R. 133) as intended by Congress. Support H.R. 5894/S. 2624. Support H.R. 1202/S. 704, Resident Education Deferred Interest Act or the REDI Act Support H.R. 2389/S1032, the Resident Physician Shortage Reduction Act Lobbied Congress on physician workforce, administrative burden, and workforce diversity issues Advocate for the FDA to implement the 2015 rule, General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products; and the Sunlamp Products Proposed; Amendment to Performance Standard, which would ban minors under the age of 18 from using tanning beds. Advocate for implementation of language to direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes (enacted as part of P.L. 117-328, Consolidated Appropriations Act, 2023, H.R. 2617). Advocate to replace scheduled and anticipated cuts in Medicare payments with positive, inflationary-based updates, eliminate the anticipated conversion factor cut in the CMS proposed rule for the 2024 Medicare Physician Fee Schedule (MPFS) associated with budget neutrality adjustments tied to Evaluation & Management (E/M) Code MPFS policy changes Advocate against H.R 618, Improving Access to Workers Compensation for Injured Federal Workers Act, which expands the role of nurse practitioners and physician assistants in providing services to injured federal workers under the federal workers' compensation program. Lobbied Congress on impact of the burden of small business issues impacting small physician practices, including Medicare reimbursement cuts. Advocate for H. Res. 365, in support of efforts to curb the incidences of skin cancer beginning with childhood skin protection. Support H.R.2474, Strengthening Medicare for Patients and Providers Act. Support H.R. 2761, S. 705, Specialty Physicians Advancing Rural Care Act (SPARC Act). Support H.R. 4402, Protecting and Continuing Physician Education and Patient Care Act Support H.R. 830/S. 1375, the Help Ensure Lower Patient (HELP) Copays Act. Support H.R. 3674, the Providing Relief and Stability for Medicare Patients Act of 2023. Support S. 935, the Fair Accountability & Innovative Research (FAIR) Drug Pricing Act. Support H.R. 4968, Getting Over Lengthy Delays in Care as Required by Doctors (GOLD CARD) Act. Support H.R.2389/S.1302, the Resident Physicians Shortage Reduction Act. Advocate regarding matters related to Merit-based Incentive Payment System (MIPS), MIPS Value Pathways (MVPs), and Qualified Clinical Data Registries. Advocate regarding AADA efforts in skin cancer prevention and AADA skin cancer prevention programs and initiatives. H.R.7153/S.3679, the Dr. Lorna Breen Health Care Provider Protection Reauthorization Act. S.Res.567/H.Res.1089, a resolution recognizing the seriousness of widespread health care worker burnout in the United States and the need to strengthen health workforce well-being, and expressing support for the designation of March 18, 2024, as the inaugural "Health Workforce Well-Being Day of Awareness".; H.R. 2819, Good Samaritan Health Professionals Act; S. 4349, Electronic Prior Authorization for Prescription Drugs Act

Client expense: $490,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office

Lobby members of Congress to implement oversight of the FDA regarding the importance of sunscreen use during the proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. Advocate for a stable supply of medications and mitigate drug shortages. Advocate for increased transparency regarding drug pricing. Advocate for reducing barriers to entry of generic drugs into the marketplace. Advocate for transparency on the part of pharmaceutical benefit managers. Advocate for patient access to compounded medications. Advocate for reducing the burdens of utilization management tools, including step therapy and prior authorization for pharmaceuticals. Advocate for implementation of language to direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes (enacted as part of P.L. 117-328, Consolidated Appropriations Act, 2023, H.R. 2617). Support S. 127, Pharmacy Benefit Manager Transparency Act Support H.R. 830/ S. 1375, the Help Ensure Lower Patient (HELP) Copays Act. Support S. 935, the Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2630/S. 652, Safe Step Act. Support H.R. 167, Patient Access to Urgent-Use Pharmacy Compounding Act

Client expense: $490,000 · Firm income: Not reported

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

S 652/HR 2630: Safe Step Act- implementing safe guards around step therapy (fail first) programs in ERISA regulated plan S 1375/HR 830: HELP Copays Act- copay accumulator programs Addressing Pharmacy Benefit Managers S 127: Pharmacy Benefit Manager Transparency Act of 2023- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 79: Interagency Patent Coordination and Improvement Act of 2023- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 2243: Palliative Care and Hospice Education and Training Act (PCHETA)- promote education and research in palliative care and hospice Palliative care S 2213: Comprehensive Cancer Survivorship Act- cancer survivorship S 2039: Cancer Drug Parity Act of 2023- oral parity for cancer drugs HR 3633: PREVENT HPV Cancers Act of 2023 S 1624/HR 3391: Gabriella Miller Kids First Research Act 2.0- pediatric cancer research Addressing healthcare workforce shortages Increasing diversity in clinical trials Mitigating drug shortages and increasing supply chain resiliency and future pandemic preparedness, including bolstering the strategic national stockpile S 1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023- require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks HR 3810: Drug Origin Transparency Act of 2023 - Require drug manufacturers to report to the Food and Drug Administration (FDA) quarterly the supplier's location and drug ingredients HR 3793: Ensuring Access to Lifesaving Drugs Act of 2023 - require manufacturers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes. S 2364: MAPS ACT - A bill to map the United States pharmaceutical supply chain S 2510: RAPID Reserve Act - establish reserves of both Active Pharmaceutical Ingredients (APIs) and finished drug products to be held as vendor-managed inventory and used when needed to prevent supply disruptions HR 5526: Seniors' Access to Critical Medications Act of 2023 - make permanent a waiver issued by the Centers for Medicare and Medicaid Services (CMS) that allowed for Medicare patients to receive critical medications by mail or allow for caregivers and family members to obtain medications for them. HR 6301: Cancer Drug Parity Act of 2023 - To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider. HR 6963: To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, and for other purposes - establish reserve supplies of covered pediatric cancer drugs, and for other purposes. HR 6992: Mapping America's Pharmaceutical Supply Act- require the Department of Health and Human Services to update its essential medicines list and create a database to help predict vulnerabilities in the U.S. pharmaceutical supply chain. S 3458: Seniors' Access to Critical Medications Act of 2023 - clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for drugs furnished under the Medicare program. HR 8404/S 4330: ROCR Value Based Program Act of 2024 - To amend title XVIII of the Social Security Act to create a Radiation Oncology Case Rate Value Based Payment Program exempt from budget neutrality adjustment requirements, and to amend section 1128A of title XI of the Social Security Act to create a new statutory exception for the provision of free or discounted transportation for radiation oncology patients to receive radiation therapy services. HR 3633: Prevent HPV Cancers ACt of 2023 - To amend the Public Health Service Act to provide for a public awareness campaign with respect to human papillomavirus, and for other purposes. HR 3008: Drug Shortage Prevention Act of 2023 - To amend the Federal Food, Drug, and Cosmetic Act to provide for notification by manufacturers of critical essential medicines of increased demand of such drugs, and for other purposes. S 5368/HR 10239: End Drug Shortages Act - To amend the Federal Food, Drug, and Cosmetic Act to expand drug shortage notification practices to include surges in demand for a drug, and for other purposes.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues pertaining to Pharmacy Benefit Managers Drug Affordability - H.R. 830, S. 1375 - the HELP Copays Act Step therapy reform - S. 6452 & H.R. 2630 - the Safe Step Act Neuroscience Drug Program - FY 2025 AgFDA Approps BRAIN Initiative - FY 2025 Labor-HHS Appropriations Migraine care - FY 2025 MilCon Approps BOLD Infrastructure for Alzheimers Reauthorization Act - H.R. 7218, S. 3775

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pharmacy Benefit Managers. 340B. Tort Litigation reform. Health care supply chain. S.1375/HR 830 - HELP Copays Act. Inflation Reduction Act Implementation.

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

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

HELP Copays Act, HR 830 and S 1375 (protect patients who rely on copay assistance to afford their therapies) PBM regulation Protect Medicaid coverage against funding cuts, coverage losses due to unwinding Support funding for federal health programs Strengthen ACA essential health benefits standards Strengthen disability discrimination regulations.

Client expense: Not reported · Firm income: Not reported

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