Clinical Trial Modernization Act

HR 3521/ S 4440 Clinical Trial Modernization Act HR 946/S 1862 Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act Discuss Vaccine concerns Cell Therapy Broad discussion on drug pricing CMMI GENEROUS Demo FDA modernization policy 340B policy Demo for CMMI regarding copay caps Policies related to international reference pricing for pharmaceuticals Issues related to pharmacy benefit manager (PBM) reform Issues related to mitigation of 340B Issues and policies related to 340B Rebate Model Pilot Program for IRA compliance Issues related to most-favored nations drug pricing proposals Issues related to implementation and/or expansion of the Inflation Reduction Act (IRA) Issues related to the price and manufacture of inhaled medicines Issues related to next generation propellant and PFAS Issues related to vaccine access and vaccine R&D, including ACIP recommendations Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials clinical trial modernization act

Client expense: $810,000 · Firm income: Not reported

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

Issues related to lung disease treatment, prevention and research; Issues related to public health; Issues related asthma, COPD, influenza, lung cancer, pneumonia, pulmonary fibrosis, tuberculosis and other lung diseases; Issues related to tobacco cessation; Issues related to the Affordable Care Act; Issues related to agency restructuring; Issues related to the Childrens Health Insurance Program; Issues related to Medicaid; Issues related to ERISA; Issues related to COVID-19 Response; Issues related to vaccines; Issues related to infrastructure; Issues related to supplemental oxygen; Issues related to the implementation of the No Surprises Act; Issues related to Medicare sequestration; Issues related to Cancer Moonshot; Issues related to short-term limited duration plans; Issues related to Healthy Future Taskforce; Issues related to regulatory reform; Issues relating to FY26 appropriations; Issues relating to FY27 appropriations; S 1406 the Supplemental Oxygen Access Reform Act; HR 2902 the Supplemental Oxygen Access Reform Act; H.R. 783 Sustainable Cardiopulmonary Rehabilitation Services in the Home Act; S. 248 Sustainable Cardiopulmonary Rehabilitation Services in the Home Act; S 717Increasing Access to Quality Cardiac Rehabilitation Care Act of 2025; S 77 Early Participation in Regulations Act; S 81 Guidance Clarity Act; HR 77 Midnight Rules Relief Act; H.R. 3701 Family Vaccine Protection Act; H.R. 3521 Clinical Trial Modernization Act; HR 4417 Mobile Cancer Screening Act HR 3701 Family Vaccine Protection Act; HR 5304Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026; S 2587 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026; HR 5278/S 2756 Affordable Inhalers and Nebulizers Act of 2025; HR 6703 Lower Health Care Premiums for All Americans Act; S 2466 Senior Savings Protection Act; HR Senior Savings Protection Act; HR 6052 Elijah E. Cummings Family Asthma Act; HR 6319 Benay Taub Lung Cancer Research Act; HR 45448 Protecting Free Vaccines Act; Consolidated Appropriations Act, 2026; Breaking the Gridlock Act; HR 9260, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2027; S. 4440, Clinical Trial Modernization Act; S. 5428, Stop the Wait Act of 2026; H.R. 2319, Women and Lung Cancer Research and Preventive Services Act of 2025; S. 1157 Women and Lung Cancer Research and Preventive Services Act of 2025

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

Issues relating to FY25 appropriations; Issues relating to the Presidents FY26 budget; Issues related to asthma, COPD, influenza, lung cancer, pneumonia, pulmonary fibrosis, tuberculosis and other lung diseases; Issues related to NIH reorganization; Issues related to agency restructuring; Issues related to lung disease treatment, prevention and research; Issues related to COVID-19; Issues related to telehealth; Issues related to infrastructure; Issues related to supplemental oxygen; Issues related to health equity; Issues related to Cancer Moonshot; Issues related to CDC public health workforce and data modernization; Issues related to regulatory reform; Issues related to Medicaid; H.R. 1509/S. 752, the Accelerating Kids Access to Care Act; S 1406 the Supplemental Oxygen Access Reform Act; HR 2902 the Supplemental Oxygen Access Reform Act; H.R. 783 Sustainable Cardiopulmonary Rehabilitation Services in the Home Act; S. 248 Sustainable Cardiopulmonary Rehabilitation Services in the Home Act; S 717 Increasing Access to Quality Cardiac Rehabilitation Care Act of 2025; S 77 Early Participation in Regulations Act; S 81 Guidance Clarity Act; HR 77 Midnight Rules Relief Act; H.R. 3521 Clinical Trial Modernization Act; HR 4417 Mobile Cancer Screening Act; HR 5304 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026; S 2587 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026; HR 5278/S 2756 Affordable Inhalers and Nebulizers Act of 2025; HR 45448 Protecting Free Vaccines Act; HR 9260, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2027; S. 4440, Clinical Trial Modernization Act

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

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

HJRes 197 / SJRes 197, CRA related to the 2027 NBPP; HR 247 / S 46, Health Care Affordability Act; HR 6867 / S 3562, the NIH Clinical Trial Integrity Act; HR 3521 / S 4440, the Clinical Trial Modernization Act; HR 4710 / S 2420, No Surprises Act Enforcement Act; HR 5526 / S 1954, Biosimilar Red Tape Elimination Act; HR 5582 / S 2355, the Patients Deserve Price Tags Act; HR 6248 / S 4027, Healthy Competition for Better Care Act HR 6485 / S 43, Skinny Labels, Big Savings Act; HR 6867 / S 3562, NIH Clinical Trial Integrity Act; HR 7895, the PBM Kickback Prohibition Act; HR 8879 / S 4509, Patients Before Monopolies Act; HR 8908, the STOP GAMES Act; HR 9393, Lower Costs, More Transparency Act; HR 9396, the Prior Authorization Accountability Act; HR 9397, the Premium Transparency Act; HR 9645, the Health Care Price Certainty for All Americans Act; HR 9661 / S 1414, the Expedited Access to Biosimilars Act; HR 10370, the AIM to Cure Kids with Cancer Act; HR 10788, the Lower Premiums, Faster Payments Act; S 976, the Insurance Fraud Accountability Act; S 1041, Affordable Prescriptions for Patients Act; S 1095, Stop STALLING Act; S 1096, Preserve Access to Affordable Generics & Biosimilars Act S 1097, Interagency Patent Coordination & Improvements Act; S 2658, Medication Affordability & Patent Integrity Act; S 3014, Ensuring Timely Access to Generics Act; S 3822, the Break Up Big Medicine Act Policies to address the expiration of the enhanced Advanced Premium Tax Credits; Policies to improve transparency in hospital and insurer costs and finances; Policies to streamline pediatric patient access to subspecialist care via telemedicine; Policies to protect patients and consumers from junk insurance, including short-term limited duration insurance; Policies related to modernization of clinical trials; Policies related to the 2027 FDA user fee agreements; Implementation of the No Surprises Act; Policies related to oversight of insurance agents and brokers; Oversight and patient impact of the 340B program; Policies related to consolidation within the healthcare sector;

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

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE

Clinical trials, medication affordability, and medication access for people with Parkinson's. H.R. 3521 | S. 4440, Clinical Trial Modernization Act.

Client expense: $240,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

Parkinson's disease-related and general medical/disease research funding and clinical trials. OMB-2026-0034, Regulation for Federal Financial Assistance, the Office of Management and Budget's rule that revises guidance for federal funding, grants, cooperative agreements, and other forms of assistance. H.R. 3521 | S. 4440, Clinical Trial Modernization Act.

Client expense: $240,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE

H.R. 9770 - FY2027 Continuing Appropriations Act; H.R. 6500 - FY2027 Continuing Appropriations and Extensions Act; H.R. 9495 - Department of Defense Appropriations Act, 2027; H.R. 9260 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2027; S. 4632 - Lankford-Hassan Prevent Government Shutdowns Act of 2026; S. 4440 - Clinical Trial Modernization Act; H.R. 3521 - Clinical Trial Modernization Act; S. 4494 - America Cures Act; Issues related to funding for NIH; Issues related to funding for CDC; Issues related to funding for CMS; Issues related to funding for Alzheimer's

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Access to Care One Big Beautiful Bill, P.L. 119-21. Advocate to protect cancer patients in implementation of changes to Medicaid under the law. Health Care Affordability Act, H.R.247, S.46. Bill would permanently extend the enhanced Affordable Care Act tax credits. Association Health Plans Act, H.R.2528, S.1847. This bill would amend the Employee Retirement Income Security Act of 1974 to treat association health plans as employers. Self-Insurance Protection Act, H.R. 2571. This bill would amend the Employee Retirement Income Security Act of 1974 to exclude from the definition of health insurance coverage certain medical stop-loss insurance. Access to Breast Cancer Diagnosis Act, H.R. 3037/S.1500. 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. Women and Lung Cancer Research and Preventative Services Act of 2025, H.R.2319, S.1157. This bill requires the Department of Health and Human Services working with the Department of Defense, to conduct an interagency review to evaluate the status of and identify opportunities for research on women and lunch cancer preventative services. Safe Step Act, H.R. 5509, S. 2903. Bill would require an exceptions process for any medication step therapy protocol in commercial insurance plans. Bipartisan Premium Tax Credit Extension Act, H.R. 5145. Bill would extend the enhanced ACA tax credits for one year. Breaking the Gridlock Act, H.R. 1834. Bill would extend the enhanced Affordable Care Act tax credits for three years. Common Ground for Affordable Health Care Act, H.R.6575. Bill would extend the enhanced Affordable Care Act tax credits for one year and make other adjustments. Bipartisan Health Insurance Affordability Act, H.R.6501. Bill would extend the enhanced Affordable Care Act tax credits for two years and make other adjustments. Medically Tailored Home-Delivered Meals Demonstration Pilot Act, H.R.5439, S.2834. The bill would create a pilot program in Medicare for beneficiaries with diet-related diseases to receive medically tailored meals to their own home. Womens Health and Cancer Rights Modernization Act of 2025, H.R.5813. This bill amends the Womens Health & Cancer Rights Act to require that commercial health plans provide coverage of breast or wall reconstruction provided as part of breast cancer treatment. HELP Copays Act, H.R. 6423, S. 864. Bill would apply financial assistance towards the cost-sharing requirements of health insurance plans. Lung Cancer Screening and Prevention Act, H.R.1406. To amend title XVIII of the Social Security Act to authorize the coverage of additional lung cancer screening tests under the Medicare program. Colorectal Cancer Early Detection Act, H.R. 5162, S. 5287. This bill will authorize the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, to make grants to States to increase awareness and education for colorectal cancer and improve early detection of colorectal cancer. Mobile Cancer Screening Act, H.R. 4417, S. 2927. The bill would award grants, contracts, or cooperative agreements for supporting new mobile cancer screening units to expand patient access to essential screening services in rural and underserved communities. Breast Cancer Research Stamp Reauthorization Act of 2026, H.R.8358, S.4318. This bill would allow the U.S. Postal Service to extend its authority to issue the Breast Cancer Research semipostal stamp for 10 more years to raise funding for breast cancer research. Recognizing April as Cancer Prevention and Early Detection Month, H.Res.1196. The resolution would uplift the national commitment to cancer prevention and early detection to reduce the cancer burden and improve health outcomes for all Americans. Womens Health and Cancer Rights Modernization Act of 2025, H.R.5813. This bill would require group health plans and health insurers offering group or individual health insurance coverage to cover specified breast or chest wall reconstruction services related to breast cancer treatment. Medical Records Access Fairness Act, H.R.7790. The bill would require health care providers to give patients free access to their medical records at least once a year. Expand Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act, S.2024/H.R.3907. This bill would extend funding for the Marketplace navigator program. Health Disparities Screening for Communities to Receive Early and Equitable Needed Services (SCREENS for Cancer Act, H.R. 2381, S.1866. Reauthorizes the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) through 2030 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. Education and Awareness Requires Learning Young (EARLY) Act, H.R. 4541, S. 2339. This bill would reauthorize the CDC program that supports young and high-risk women as well as their providers to better understand breast health. Prostate-Specific Antigen Screening for High-Risk Insured Men (PSA Screening for HIM) Act, H.R. 1300, S. 297. 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.1406. To amend title XVIII of the Social Security Act to authorize the coverage of additional lung cancer screening tests under the Medicare program. Data Equity. Legislative and regulatory funding to support the collection of detailed demographic data toward reducing disparities in cancer prevention, detection, and treatment. Prevent HPV Cancer Act of 2025, H.R. 6561. This bill would create a national public awareness campaign to promote education and awareness of HPV and HPV-associated cancers and would increase funding for the NBCCED program to boost breast and cervical cancer screening. Health Equity and Accountability Act, H.R.9877, S.5066. This bill advances policies to reduce health disparities and improve cancer prevention, research, and care for underserved communities. Childhood Cancer Childhood Cancer Survivorship, Treatment, Access, and Research Reauthorization Act (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. Accelerating Kids Access to Care Act, P.L. 119-75. 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. Give Kids and Chance Act of 2025, P.L. 119-75. Legislation that would accelerate pediatric cancer treatments and expand access to live-saving therapies for children battling rare diseases, spur drug development for pediatric rare diseases, improve outcomes for patients, and close gaps in pediatric drug research. One Big Beautiful Bill, P.L. 119-21, Advocate to protect pediatric cancer patients in implementation of changes to Medicaid under the law. Quality of Life Palliative Care Palliative Care and Hospice Education and Training Act (PCHETA), S. 22870, H.R. 4425. 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 include funding for palliative care research in the FY26 LHHS Appropriations bill. Lainie Jones Comprehensive Cancer Survivorship Act, H.R. 8839, S.5052. The bill would create pathways to address the financial challenges of cancer survivorship and maintain patients access to the health services needed to address the long-term effects of cancer. Federal Health Care Programs Department of Defense Cancer Research Funding. Ensure continued funding for cancer research within the DOD's Congressionally Directed Medical Research Program. Clinical Trials Clinical Trial Modernization Act, H.R. 3521, S. 4440. Increase access to clinical trials for all persons with cancer to participate by reducing barriers to enrollment including support for and remote access to trials. Harley Jacobson Clinical Trial Participant Income Exemption Act, H.R. 4184, S.5127. Legislation to amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants.

Client expense: $1,790,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

Clinical Trial Modernization Act, H.R. 3521, S. 4440. Increase access to clinical trials for all persons with cancer to participate by reducing barriers to enrollment, including support for ancillary (non-medical) costs. Harley Jacobsen Clinical Trial Participant Income Exemption Act, S.5127, H.R. 4184. Legislation to amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants. To amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants, and for other purposes, H.R. 4184. Legislation to amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants. Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act, H.R. 5269, S. 2761. Bill would address Medicare reimbursement of laboratory services. Asal Sayas National Strategy on Young Adult Cancers Act, S. 4717: Directs the NIH to develop a comprehensive national strategy to address the alarming rise of cancers in adults ages 18 to 49. American Cures Act, S. 4494. This bill would permanently fund several federal agencies and programs that perform biomedical research. Knock Out Cancer Act (H.R. 3873, or KO Cancer Act). The will would boost National Cancer Institute funding by 25% annually for FY2026-2030 to match cancers mortality toll and direct a report on drug shortages.

Client expense: $1,790,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

One Big Beautiful Bill Act, P.L.119-21. Advocate to protect cancer patients in implementation of changes to Medicaid under the law. Issues regarding expanding the availability of the charitable deduction for non-itemizers. Issues respecting charitable giving and life income planning, issues regarding taxation of charitable organizations, and issues regarding economic relief for nonprofit organizations. Issues related to stimulus for nonprofit organizations and increasing charitable giving. Clinical Trial Modernization Act, H.R. 3521, S. 4440. Increase access to clinical trials for all persons with cancer to participate by reducing barriers to enrollment including support for ancillary (non-medical) costs and remote access to trials. Harley Jacobsen Clinical Trial Participant Income Exemption Act, S.5127, H.R. 4184. Legislation to amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants. To amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants, and for other purposes, H.R. 4184. Legislation to amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants. Health Care Affordability Act, H.R. 247, S. 46. Bill would permanently extend the enhanced Affordable Care Act tax credits. Bipartisan Premium Tax Credit Extension Act, H.R. 5145. Bill would extend the enhanced ACA tax credits for one year. Breaking the Gridlock Act, H.R. 1834. Bill would extend the enhanced Affordable Care Act tax credits for three years. CommonGround for Affordable Health Care Act, H.R.6575. Bill would extend the enhanced Affordable Care Act tax credits for one year and make other adjustments. Bipartisan Health Insurance Affordability Act, H.R.6501. Bill would extend the enhanced Affordable Care Act tax credits for two years and make other adjustments. A bill to amend the Internal Revenue Code of 1986 to extend the temporary enhanced premium credits, S.2824. Bill would extend the enhanced ACA tax credits for two years. Charity Parity Act, H.R. 8783, S. 4511. The bill would allow taxpayers to make direct qualified charitable distributions (QCDs) from their employer sponsored retirement plans.

Client expense: $1,790,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1, One Big Beautiful Bill Act, implementation and patient access issues. S. 1816/H.R. 3514, Improving Seniors' Timely Access to Care Act. S. 1717/H.R. 5343, Ensuring Patient Access to Critical Breakthrough Products Act. H.R. 3521/S. 4440, Clinical Trial Modernization Act. S. 2903/H.R. 5509, Safe Step Act. FY 2027 Labor, HHS, Education appropriations for programs affecting people with chronic diseases and disabilities. S. 494/ H.R.1189 National Plan for Epilepsy Act Senate Finance Committee RFI on Drug Pricing and Health Coverage H.R. 9599 SECURE 340B Act Discussion Draft - 340B Drug Pricing Integrity and Affordability for Patients Act S. 5244 SUSTAIN 340B Act H.R.7352/S. 4875 PASTEUR Act S.3267/H.R. 6130 ASAP Act

Client expense: $21,227 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

-Alzheimer's Screening & Prevention Act (ASAP) H.R. 6130/ S. 3267 -Lowering Costs for Caregivers Act (S. 1565/H.R. 138) -Federal vaccine messaging -Impacts of IRA on Older Americans -National Institutes of Health advance funding of multi-year research grants -Clinical Trials Modernization Act H.R.3251/S 4440 -Patient Access to Cancer and Complex Therapies Act H.R. 4299 -Diabetes Foot Health and Modernization Access Act H.R. 7905 -Oppose PBM Kickbacks H.R. 7895 -Oppose Codification of MFN Drug Pricing Proposals (no bill) -End Coverage with Evidence Development for Alzheimer's medications and Trans Catheter Aortic Valve Replacement -Update CMS Long stay antipsychotic Quality measure -Update FDA Antipsychotic black box warning -Funding for NIH (HR 9260) -PASTEUR Act (HR 7352/S 4975) -Biosimilar Access and Affordability Act (HR10628/S5571) -CMS Fixed Dose Combination Therapies proposed policy -OMB Proposed Uniform Guidance on Federal Grantmaking (HR 6500) -Alzheimer's Early Detection Act (HR 9823) -CMS reporting requirements for Medicare Prescription Payment Program (HR 9260) -CMS Trans Catheter Aortic Valve Replacement NCD proposal

Client expense: $65,000 · 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

General issues related to rare disease and orphan drugs. Policies related to international reference pricing for pharmaceuticals. Pharmaceutical supply chain manufacturing. Pharmaceutical pricing negotiations. H.R.3521/S.4440: Clinical Trials Modernization Act. H.R.5509/S.2903: Safe Step Act. H.R.946/S.1862: Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act.

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

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

Clinical trial modernization legislation to make clinical trials faster, cheaper, and more efficient, including redlines on and support for Rep. Auchinclosss clinical trial bill, a supporting coalition letter, and introduction of a Senate companion (Sen. Hickenlooper); S. 4440, the Clinical Trial Modernization Act (Sen. Scott), including participant compensation provisions. Inclusion of pregnant individuals in clinical trials, including H.R. 8651, the Advancing Safe Medications for Moms and Babies Act of 2026 (Rep. Castor, Sen. Hickenlooper). FDA Sentinel system and real-world evidence provisions for potential health data legislation (Sen. Young), including an expert discussion with the office. Suggested questions to Senate staff for a hearing with Heidi Overton.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Clinical trial modernization legislation to make clinical trials faster, cheaper, and more efficient, including redlines on and support for Rep. Auchinclosss clinical trial bill, a supporting coalition letter, and introduction of a Senate companion (Sen. Hickenlooper); S. 4440, the Clinical Trial Modernization Act (Sen. Scott), including participant compensation provisions. Inclusion of pregnant individuals in clinical trials, including H.R. 8651, the Advancing Safe Medications for Moms and Babies Act of 2026 (Rep. Castor, Sen. Hickenlooper). FDA Sentinel system and real-world evidence provisions for potential health data legislation (Sen. Young), including an expert discussion with the office. Suggested questions to Senate staff for a hearing with Heidi Overton.

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

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

Clinical trial modernization legislation to make clinical trials faster, cheaper, and more efficient, including redlines on and support for Rep. Auchinclosss clinical trial bill, a supporting coalition letter, and introduction of a Senate companion (Sen. Hickenlooper); S. 4440, the Clinical Trial Modernization Act (Sen. Scott), including participant compensation provisions. Inclusion of pregnant individuals in clinical trials, including H.R. 8651, the Advancing Safe Medications for Moms and Babies Act of 2026 (Rep. Castor, Sen. Hickenlooper). FDA Sentinel system and real-world evidence provisions for potential health data legislation (Sen. Young), including an expert discussion with the office. Suggested questions to Senate staff for a hearing with Heidi Overton.

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

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

- Labor-HHS Appropriations - CAR-T Therapy clarification - S. 4440/H.R. 3521, the Clinical Trial Modernization Act - OMB Uniform Guidance Oversight

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

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

Labor-HHS Appropriations Billing and Coding classifications CAR-T Therapy Clarifications OMB Uniform Guidance Oversight H.R. 2491/S. 1227, Alleviating Barriers to Care Act H.R. 5160/S.4109, the Stem Cell Therapeutic and Research Reauthorization Act of 2025 H.R.1262/S.932, the Give Kids a Chance Act S. 4440/H.R. 3521 - The Clinical Trial Modernization Act

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

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), Natl Institutes of Health (NIH), SENATE

H.R. 2213/S. 988, Medical Supply Chain Resilience Act H.R. 2332/S. 1101, States Handling Access to Reciprocity for Employment Act H.R. 3521/S. 4440, Clinical Trial Modernization Act H.R. 4464/S. 3204, Preventive Health Savings Act S. 2120, Older Americans Act Reauthorization Act Regulatory Advocacy U.S Department of Health and Human Services, Centers for Medicare & Medicaid Services Medicaid Program; Community Engagement Requirement for Certain Individuals Interim Final Rule with Comment Period (CMS-2454-IFC) U.S Department of Health and Human Services, Centers for Medicare & Medicaid Services Medicare and Medicaid Programs; CY 2027 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program (CMS-1848-P) U.S. Department of Health and Human Services, Office of the Assistant Secretary for Health Comments on Proposed Healthy People 2030 Objective: Social Determinants of Health-NEW-03 U.S. Department of Labor, Employee Benefits Security Administration, Office of Health Plan Standards and Compliance Assistance Electronic Disclosure by Group Health Plans Under ERISA Proposed Rule (RIN 1210-AC35)

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

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

H.R. 6423/S. 864: HELP Copays Act - requires health insurers to count third-party financial assistance toward patients' cost-sharing obligations, including deductibles and copays, for prescription drugs, with changes effective for plan years beginning January 1, 2026. S. 526: PBM Transparency Act - prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs H.R. 4191/S. 1784: MAPS Act - requires federal agencies to regularly update a list of essential medicines, assess and report on supply chain risks, map pharmaceutical supply chains, and enhance coordination and cybersecurity to protect public health and national security. H.R. 3955/S.2062: RAPID Reserve Act - establishes a $500 million program to create and maintain domestic reserves of critical drugs and their ingredients, prioritizing domestic manufacturing and supply chain resilience to prevent shortages during public health emergencies. H.R. 8339: Drug Origin Transparency Act to amend the Federal Food, Drug, and Cosmetic Act to enhance drug manufacturing amount information reporting H.R. 5526/S. 1954: Biosimilar Red Tape Elimination Act - streamlines the approval process for biosimilar biological products by automatically deeming them interchangeable with reference products, subject to certain exclusivity protections, and requires updated regulatory guidance to reflect these changes. H.R. 4101: Cancer Drug Parity Act of 2025 - requires group health plans to provide cost-sharing for oral anticancer drugs that is at least as favorable as for provider-administered anticancer medications, with protections against increased patient costs and a mandated GAO study on the law's impact. H.R. 3521/S. 4440: Clinical Trials Modernization Act - Increase clinical trial participation among underrepresented populations by providing grants, permitting certain participant reimbursements, and offering tax exclusions, while ensuring compliance with existing legal protections. S. 705: Innovation in Pediatric Drugs Act of 2025 - amends existing laws to enhance pediatric cancer research, mandates compliance measures, allocates funding for pediatric studies, and sets guidelines for orphan drugs, with specific timelines for implementation and evaluation. H.R. 5509/S. 2903: Safe Step Act - to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol, and for other purposes. H.R. 4425/S. 2287: Palliative Care and Hospice Education and Training Act - expands federal support for workforce development, education, public awareness, and research in palliative and hospice care, with targeted funding and statutory changes to improve care for patients with serious or life-threatening illnesses. H.R. 8839/S. 5052: Lainie Jones Comprehensive Cancer Survivorship Act of 2026 to address the health of cancer survivors.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Health care priorities of ACCC: 1) Prior authorization (Including: Improving Seniors Timely Access to Care Act of 2025 (S.1816/ H.R. 3514); 2) Oncology drug and medical supply shortages; 4) Financial toxicity for cancer patients; 5) Drug Pricing: Inflation Reduction Act implementation, Senate Finance Minority Drug Pricing RFI, and the Protecting Patient Access to Cancer and Complex Therapies Act (H.R.4299); 6) Reducing Physician Payment Reimbursement Cuts; 7) Healthcare Workforce improvement; 8) H.R. 6718 the Professional Student Degree Act (to endorse, not yet communicated to sponsors office); 9) Preserve Medicaid coverage for caregivers and other beneficiaries (mitigate potential impact of One Big Beautiful Bill Act (OBBBA) implementation on their coverage); 10) Safe Step Act (H.R. 5509/S. 2903); 11) Radiation Oncology Case Rate (ROCR) Value Based Program Act(H.R. 2120/S.1031); 12) Maintain and promote access to coverage (including renewal of ACA subsidies and mitigating impact of Medicaid changes in OBBBA); 13) Access to Genetic Counselor Services Act (S. 3607/H.R. 6280); 15) Support appropriations for strong NIH funding; 16) Planning and coalition work for advocacy on supportive cancer care, including efforts to get language in Senate appropriations bill relating to benefits and costs of such care; 17) Clinical Trial Modernization Act (HR 3521/S. 4440); 18) Proposals to reform the 340B program (Senate); 19) Request that Congressional appropriating committees oppose the implementation of the Office of Management and Budget (OMB) Uniform Guidance.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support for the Clinical Trials Modernization Act (S. 4440/H.R. 3521)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support passage of the Clinical Trials Modernization Act (S. 4440/ H.R. 3521)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support passage of the Clinical Trials Modernization Act (S. 4440/H.R. 3521) Support passage of the Gerald E. Connolly Esophageal Cancer Awareness Act (HR3490; Public Law No. 119-96)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1, One Big Beautiful Bill Act, implementation and patient access issues. S. 1816/H.R. 3514, Improving Seniors' Timely Access to Care Act. S. 1717/H.R. 5343, Ensuring Patient Access to Critical Breakthrough Products Act. H.R. 3521/S. 4440, Clinical Trial Modernization Act. S. 2903/H.R. 5509, Safe Step Act. FY 2027 Labor, HHS, Education appropriations for programs affecting people with chronic diseases and disabilities.

Client expense: $25,779 · Firm income: Not reported

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

H.R.2381/S.1866 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; a bill to reauthorize the National Breast and Cervical Cancer Early Detection Program H.R.4541/S.2339 - The EARLY Act Reauthorization of 2025; a bill to reauthorize the Young Womens Breast Health Education and Awareness Requires Learning Young Act of 2009. H.R.8358/S.4318 - Breast Cancer Research Stamp Reauthorization Act; efforts to introduce a bill to amend title 39, United States Code, to extend the authority of the United States Postal Service to issue a semipostal to raise funds for breast cancer research. H.R.8839 - Lainie Jones Comprehensive Cancer Survivorship Act of 2026; a bill to address the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment, in order to improve survivorship, treatment, transition to recovery and beyond, quality of life and palliative care, and long-term health outcomes, including by developing a minimum standard of care for cancer survivorship, irrespective of the type of cancer, a survivors background, or forthcoming survivorship needs, and for other purposes. H.R.3521/S.4440 - Clinical Trial Modernization Act; a bill to modernize clinical trials and remove barriers for participation in clinical trials, and for other purposes. H.Res.1196 - Recognizing April as Cancer Prevention and Early Detection Month; a House resolution to recognize April as Cancer Prevention and Early Detection month Efforts to introduce legislation related to the establishment of an interagency task force on breast cancer risk assessment tools Efforts related to the Office of Management and Budget Proposed Rule to revise the Guidance for Federal Financial Assistance Comments related the CMS Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model and Medicares six protected classes

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

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

Prohibiting copay accumulators in ACA Exchange plans: Help Ensure Lower Patient (HELP) Copays Act (H.R. 6423 / S. 864); Transparency and streamline utilization management protocols including prior authorization and step therapy, Safe Step Act, and Improving Senior's Timely Access to Care Act; Increase CMS outreach and education on the Medicare Prescription Payment Program, Increasing Medication Access for Seniors Act (H.R. 6401); Increase participation in clinical trials; Clinical Trials Modernization Act (H.R. 3521 / S. 4440).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General cancer care access, innovation and screening, including childhood cancer; NIH funding for Cancer Research. Clinical Trial Modernization Act (HR 3521/S.4440).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

-P.L. 119-21, Support policies and processes that reduce the impact of the cuts and changes to Medicaid on people with serious and chronic conditions, people with disabilities, and caregivers -Budget Reconciliation Packages, oppose additional cuts to Medicaid -S. 494/H.R. 1189, National Plan for Epilepsy Act, support passage -Requests to join the Congressional Epilepsy Caucus -S. 2903/H.R. 5509, Safe Step Act, support passage -S. 864/H.R. 6423, HELP Copays Act, support passage -WISeR Model, express concern with how it could impede access to some epilepsy treatments -PBM Reform, support legislative and regulatory policies on PBM reform and the inclusion of patient-centric policies -Medicare Part Ds Six Protected Classes policy, support coverage of and access to all epilepsy treatments and express concerns with the impact of the GUARD Model on the Six Protected Classes policy. -ACA marketplace rule, express concerns that changes will decrease enrollment and increase costs -Telehealth, support extensions of telehealth flexibilities including the prescribing of epilepsy medications that are controlled substances -S. 1024/H.R. 2151, Seizure Awareness and Preparedness Act, support passage -U.S. Department of Health and Human Services (HHS), support protecting the current structure of HHS and express concerns with HHS staffing changes and cuts -NIH, support the current structure, current facilities and administrative cost structure, and grantmaking process of the NIH; express concerns with leadership and staffing changes and an expansion of multiyear funding -Support programs that assist caregivers -Oppose legislative or regulatory policies that rely on metrics like Quality-Adjusted Life Years -Support rescheduling and safe and legal access to medical cannabis -S. 1816/ H.R. 3514, Improving Seniors Timely Access to Care Act, support passage -Express concerns with legislative and regulatory policies that would restrict the use of animals in research -Support legislation and policy preserving charitable giving including the Combined Federal Campaign -H.R. 6280, Access to Genetic Counselor Services Act, support passage -S. 4440, Clinical Trial Modernization Act, support passage -Support legislation and regulations that protect Medicaid Home- and Community-Based Services (HCBS) and increase access to these services -Prescription Drug User Fee Act Reauthorization, support priorities for the rare disease community -Fiscal Year 2027 Hospital Inpatient Prospective Payment Systems Proposed Rule, oppose proposals to repeal the alternative pathway for new technology add-on payments for breakthrough devices and eliminate the hospital outpatient prospective payment system device pass-through payments

Client expense: $150,000 · 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), Natl Institutes of Health (NIH), SENATE, Veterans Affairs, Dept of (VA)

Health care priorities of ACCC: 1) Prior authorization (Including: Improving Seniors Timely Access to Care Act of 2025 (S.1816/ H.R. 3514); 2) Oncology drug and medical supply shortages; 3) Financial toxicity for cancer patients; 4) Drug Pricing: Inflation Reduction Act implementation, Senate Finance Minority Drug Pricing RFI, and especially Protecting Patient Access to Cancer and Complex Therapies Act (H.R.4299); 5) Reducing Physician Payment Reimbursement Cuts; 6) Healthcare Workforce improvement, including re: streamlining visa processing and administration for international medical professionals, graduates, and students; 7) H.R. 6718 the Professional Student Degree Act; 8) Preserve Medicaid coverage for caregivers and other beneficiaries (mitigate potential impact of One Big Beautiful Bill Act (OBBBA) implementation on their coverage); 9) Safe Step Act (H.R. 5509/S. 2903); 10) Radiation Oncology Case Rate (ROCR) Value Based Program Act(H.R. 2120/S.1031); 11) Issues related to coverage (including renewal of ACA subsidies and mitigating impact of Medicaid changes in OBBBA); 12) Ensuring Access to Essential Providers Act of 2025 (S. 2793); 13) Access to Genetic Counselor Services Act (S. 3607/H.R. 6280); 14) Request to Designate April as Cancer Prevention and Early Detection month; 15) Modernize incentives for Advanced Alternative Payment Models (APMs); 16) Stabilize physician payment system and prepare for APMs; 17) Leverage the CMS Innovation Center; 18) Fiscal Year 2027 appropriations for these family caregiver support programs: National Family Caregiver Support Program, Lifespan Respite Care Program, Native American Caregiver Support Services, National Strategy Demonstration Grants; 19) FY 2027 appropriations funding recommendations in support of the Department of Veterans Affairs (VA) Medical and Prosthetic Research Program, funding to address VA research infrastructure deficiencies, and dedicated funding for VA research information technology modernization; 20) Appropriations for NIH funding; 21) Supportive cancer care, including discussion of federal legislation, such as the Lainie Jones Comprehensive Cancer Survivorship Act of 2026 (HR 8839)(not yet ACCC endorsed); 22) Clinical Trial Modernization Act (HR 3521/S. 4440); 23) 340B program.

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

Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE, State, Dept of (DOS), White House Office

S 1637 MVP Act and Medicaid VBPs for Patients S 2903 / HR 5509 Safe Step Act HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 3521 / S 4440 Clinical Trial Modernization Act HR 7118 Genomic Answers for Childrens Health Act Clinical Trials Modernization Act CMMI GENEROUS Demo FDA modernization policy Implementation of the Inflation Reduction Act (IRA) -- with specific focus on drug negotiation (orphan drug exemption language) BIOSECURE Act implementation Issues related to the Medicare title in the One Big Beautiful Bill Act Issues related to the IRA definition of a drug for purposes of price negotiation selection Duplicate discounts as required by IRA Issues related to expanding/amending the orphan drug exclusion in IRA Issues related to pharmacy benefit manager (PBM) reform Issues related to mitigation of 340B Issues related to 340B Rebate Model Pilot Program for IRA compliance Issues related to the US manufacturing of pharmaceuticals Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to the recruitment of patients for clinical trials Issues related to most-favored nations drug pricing proposals General issues related to rare disease and orphan drugs Policies related to international reference pricing for pharmaceuticals

Client expense: $1,680,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

One Big Beautiful Bill Act, P.L.119-21. Advocate to protect cancer patients in implementation of changes to Medicaid under the law. Issues regarding expanding the availability of the charitable deduction for non-itemizers. Issues respecting charitable giving and life income planning, issues regarding taxation of charitable organizations, and issues regarding economic relief for nonprofit organizations. Issues related to stimulus for nonprofit organizations and increasing charitable giving. Clinical Trial Modernization Act, H.R. 3521, S. 4440. Increase access to clinical trials for all persons with cancer to participate by reducing barriers to enrollment including support for ancillary (non-medical) costs and remote access to trials. To amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants, and for other purposes, H.R. 4184. Legislation to amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants. Health Care Affordability Act, H.R. 247, S. 46. Bill would permanently extend the enhanced Affordable Care Act tax credits. Bipartisan Premium Tax Credit Extension Act, H.R. 5145. Bill would extend the enhanced ACA tax credits for one year. Breaking the Gridlock Act, H.R. 1834. Bill would extend the enhanced Affordable Care Act tax credits for three years. CommonGround for Affordable Health Care Act, H.R.6575. Bill would extend the enhanced Affordable Care Act tax credits for one year and make other adjustments. Bipartisan Health Insurance Affordability Act, H.R.6501. Bill would extend the enhanced Affordable Care Act tax credits for two years and make other adjustments. A bill to amend the Internal Revenue Code of 1986 to extend the temporary enhanced premium credits, S.2824. Bill would extend the enhanced ACA tax credits for two years. Charity Parity Act, H.R. 8783, S. 4511. The bill would allow taxpayers to make direct qualified charitable distributions (QCDs) from their employer sponsored retirement plans.

Client expense: $1,240,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Clinical Trial Modernization Act, H.R. 3521, S. 4440. Increase access to clinical trials for all persons with cancer to participate by reducing barriers to enrollment, including support for ancillary (non-medical) costs. To amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants, and for other purposes, H.R. 4184. Legislation to amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants. Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act, H.R. 5269, S. 2761. Bill would address Medicare reimbursement of laboratory services. Asal Sayas National Strategy on Young Adult Cancers Act, S. 4717: Directs the NIH to develop a comprehensive national strategy to address the alarming rise of cancers in adults ages 18 to 49. American Cures Act, S. 4494. This bill would permanently fund several federal agencies and programs that perform biomedical research.

Client expense: $1,240,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Labor-HHS Appropriations Billing and Coding classifications CAR-T Therapy Clarifications H.R. 2491/S. 1227, Alleviating Barriers to Care Act H.R. 5160/S.4109, the Stem Cell Therapeutic and Research Reauthorization Act of 2025 H.R.1262/S.932, the Give Kids a Chance Act S. 4440/H.R. 3521 - The Clinical Trial Modernization Act

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

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), Natl Institutes of Health (NIH), SENATE

- Labor-HHS Appropriations - CAR-T Therapy clarification - S. 4440/H.R. 3521, the Clinical Trial Modernization Act

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

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

H.R. 6423/S. 864: HELP Copays Act - requires health insurers to count third-party financial assistance toward patients' cost-sharing obligations, including deductibles and copays, for prescription drugs, with changes effective for plan years beginning January 1, 2026. S. 526: PBM Transparency Act - prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs H.R. 4191/S. 1784: MAPS Act - requires federal agencies to regularly update a list of essential medicines, assess and report on supply chain risks, map pharmaceutical supply chains, and enhance coordination and cybersecurity to protect public health and national security. H.R. 3955/S.2062: RAPID Reserve Act - establishes a $500 million program to create and maintain domestic reserves of critical drugs and their ingredients, prioritizing domestic manufacturing and supply chain resilience to prevent shortages during public health emergencies. H.R. 8339: Drug Origin Transparency Act to amend the Federal Food, Drug, and Cosmetic Act to enhance drug manufacturing amount information reporting H.R. 5526/S. 1954: Biosimilar Red Tape Elimination Act - streamlines the approval process for biosimilar biological products by automatically deeming them interchangeable with reference products, subject to certain exclusivity protections, and requires updated regulatory guidance to reflect these changes. H.R. 4101: Cancer Drug Parity Act of 2025 - requires group health plans to provide cost-sharing for oral anticancer drugs that is at least as favorable as for provider-administered anticancer medications, with protections against increased patient costs and a mandated GAO study on the law's impact. H.R. 3521/S. 4440: Clinical Trials Modernization Act - Increase clinical trial participation among underrepresented populations by providing grants, permitting certain participant reimbursements, and offering tax exclusions, while ensuring compliance with existing legal protections. S. 705: Innovation in Pediatric Drugs Act of 2025 - amends existing laws to enhance pediatric cancer research, mandates compliance measures, allocates funding for pediatric studies, and sets guidelines for orphan drugs, with specific timelines for implementation and evaluation. H.R. 5509/S. 2903: Safe Step Act - to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol, and for other purposes. H.R. 4425/S. 2287: Palliative Care and Hospice Education and Training Act - expands federal support for workforce development, education, public awareness, and research in palliative and hospice care, with targeted funding and statutory changes to improve care for patients with serious or life-threatening illnesses. H.R. 8839: Lainie Jones Comprehensive Cancer Survivorship Act of 2026 to address the health of cancer survivors.

Client expense: $480,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE