Give Kids a Chance Act of 2025

Issues related to access to rare disease therapies, diagnosis and testing. Issues related to FDA modernization and rare disease drug development. Issues related to the Accelerated Approval Program. Issues related to Public Law No. 117-169 - The Inflation Reduction Act of 2022. Issues related to alternative funding programs. Issues related to the Rare Pediatric Disease Priority Review Voucher program, including H.R.1262/S.932 - Give Kids a Chance Act of 2025.

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Pediatric Review Reauthorization. H.R.946/S.1862: ORPHAN Cures Act. H.R.1672: Maintaining Investments in New Innovation (MINI) Act. H.R.1262/S.932: Give Kids a Chance Act of 2025.

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

Government targets: HOUSE OF REPRESENTATIVES, 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

Issues related to the implementation of the Inflation Reduction Act. H.R.1672 - Maintaining Investments in New Innovation Act. H.R.1262/S.932 - Give Kids a Chance Act of 2025. Issues related to drug pricing policy.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Research into spinal muscular atrophy, timely access to care, treatments, medical devices, and home and community-based services, Medicaid home care (paid family caregiving & self-directed care), Give Kids a Chance Act (H.R.1261/ S.932- FDA Pediatric Priority Review Voucher Program), DOD Congressionally Directed Medical Research Program & Peer-Reviewed Medical Research Program, Local Coverage Determination related to seat elevation in Group 2 standard power wheelchairs, Labor-Health and Human Services, and Education Appropriations bill, Family Caregiver Awareness, Resources, and Education (CARE) Partnerships Act, Pediatric Palliative Care Homes, National Institute on Disability, Independent Living, and Rehabilitation Research funding, Seat Elevation in Group 2 Non-Complex Power Wheelchairs, Coverage of Standing Systems in Group 3 Power Wheelchair, Competitive Bidding for Tracheostomy, Ostomy and Urological Supplies; FDA Rare Disease Patient Listening Session, Coverage of Respiratory Assist Devices (RADs) and Home Mechanical Ventilators (HMVs), Accelerating Kids Access to Care Act (H.R. 1509/S. 752, National Institutes of Health grant management process & funding; Medicaid home and community-based services, Public Law 119-21 Medicaid Community Engagement Requirements - disability and medically frail definition; Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5343), Veterans STAND Act (H.R. 6835), Veterans SPORTS Act (S. 3138) Consolidated Appropriations Act of 2026 (P.L. 119-75); Timely Access to Coverage Decisions Act (H.R. 8500); HCBS Access Act ( H.R.8540/ S.5321); Supporting Our Direct Care Workforce and Family Caregivers Act (S. 4889); Safe Step Act (H.R. 5509/ S. 2903), Recognizing the Role of Direct Support Professionals Act to establish a Standard Occupational Classification (SOC) for Direct Support Professionals (S.3211)

Client expense: $75,000 · Firm income: Not reported

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

Pennsylvania is a global leader in researching and developing new therapies, devices and diagnostics that help patients live longer, healthier lives. This innovation is due in part to the policy and regulatory ecosystem we enjoy in the United States.The Rare Pediatric Disease Priority Review Voucher Program (PPRV) incentivizes the development of novel therapies to treat rare pediatric diseases. This program was not reauthorized by the end of 2024 and has therefore expired. The reauthorization of this vital program would be extended to September 30, 2029. The full US House of Representatives has not yet voted on this legislation. The Senate version of Give Kids a Chance Act of 2025 (S.932) was introduced in March and is awaiting any movement from the Senate HELP Committee.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor and engage on legislative and administrative action related to health care policy. Monitor and engage on legislative and administrative action related to womens health issues. Monitor and engage on legislative and administrative action related to over-the-counter consumer care products. Monitor and engage on legislative and administrative action related to dietary supplements, including purchasing through HSA funds. Monitor and engage on legislative and administrative action related to servicing of medical device equipment. Monitor and engage on legislative and administrative action related to FDA monograph reform and user fees. Monitor and engage on legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor and engage on legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor and engage on legislative and administrative action related to 340B drug discount program. Monitor and engage on legislative and administrative action related to drug supply chain issues, including pharmacy benefit manager (PBM) reform. Monitor and engage on legislative and administrative action related to copay assistance. Monitor and engage on legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP). Monitor and engage on legislative and administrative action related to long-acting reversable contraception usage. Monitor and engage on legislative and administrative action related to access to treatments for kidney patients. Monitor and engage on legislative and administrative action related to broader insurance coverage of supplemental imaging procedures for women with dense breast tissue. Monitor and engage on legislative and administrative action related to phenylephrine. Monitor and engage on legislative and administrative action related to e-labeling. Monitor and engage on legislative and administrative action related to DEA-determined pseudoephedrine quotas. Monitor and engage on legislative and administrative action related to Make America Healthy Again (MAHA). Monitor and engage on legislative and administrative action related to generally recognized as safe (GRAS) rules for food additives. H.R. 1262, Give Kids a Chance Act of 2025. H.R. 7366, Dietary Supplement Regulatory Uniformity Act. S. 932, Give Kids a Chance Act of 2025. S. 3677, Dietary Supplement Listing Act of 2026.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

H.R. 1262/S. 932 - Mikaela Naylon Give Kids a Chance Act General discussions about ultra-rare diseases General discussions about ultra-rare disease drug development General discussions about regulatory reform, including scientific-focused drug development meetings General discussions about mitochondrial diseases H.R. 1532/S. 822, the Scientific EXPERT Act of 2025FDA Rare Disease Innovation Hub Fiscal Year 2026 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (H.R. 4121 / S. 2256) H.R.6280/S.3607 - Access to Genetic Counselor Services Act of 2025/Access to Genetic Counselor Services Act of 2026 H.R.4709 - Newborn Screening Saves Lives Reauthorization Act of 2025 General discussions about genetic testing, diagnostics General discussions about accelerated approval pathway (AAP)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues regarding childrens health care coverage and access to care under Medicaid, CHIP, the Exchanges, TRICARE, and private insurance Issues regarding childrens mental health and the national emergency in childrens mental health, including mental health parity, the mental health workforce, suicide and injury prevention, and related access issues. Issue regarding Medicaid supplemental payments and directed payments. Issues regarding the importance of Medicaid to children, including military and veteran families.  Issues regarding Medicaid support for providers caring for children on Medicaid, including DSH payments. Issues regarding Children's Hospitals Graduate Medical Education (CHGME) program and funding. Issues related to 340B Drug Pricing Program, the Prescription Drug User Fee Act, prescription drug pricing, drug shortages, drug compounding, high-cost drugs/therapies and pharmaceutical supply chain. Issues related to pediatric workforce, Medicare GME and the Pediatric Specialty Loan Repayment Program. Issues related to hospital financing. Issues regarding site neutrality, facility fees, and price transparency in health care.  Issues regarding pediatric pandemic and disaster preparedness and response and emergency preparedness, including work with the Pediatric Pandemic Network (PPN) and related to the Pandemic and All-Hazards Preparedness Act (PAHPA). Issues related to Emergency Medical Services for Children (EMSC). Issues related to mental health services in schools Issues regarding Artificial Intelligence (AI). Issues regarding oversight and implementation of EPSDT. Issues involving pediatric medical research and funding, specifically including research at the National Institutes of Health. Issues involving gun violence prevention. Issues regarding health care innovation. Issues involving Making America Healthy Again. Issues involving Medical Device User Fee Authorization. Issues involving biomedical research policies. Issues involving the 988 Suicide Prevention Lifeline. Issues involving the Community Mental Health Services Block Grant. Issues involving the Pediatric Mental Health Care Access Program. Issues involving telehealth. Issues involving Appropriations for pediatric health care programs. Issues involving Hospital at Home. Issues involving the Lorna Breen Health Care Provider Protections program. Issues involving National Provider Identifier. H.R. 5582/S.2355 Patients Deserve Price Tags Act H.R. 6396 Kid Providing Resources for Optimal Outcomes Against Fatalities (Kid PROOF) Act H.R.169/S.357 Prevent Family Fire Act H.R.4768/S.2448 Health Care Fairness for Military Families Act of 2025 H.R. 1509/S. 752 Accelerating Kids Access to Care Act H.R. 1735 / S. 779, The Early Action and Responsiveness Lifts Youth (EARLY) Minds Act H.R. 2587/S. 1266, Youth Mental Health Research Act H.R. 2483, SUPPORT for Patients and Communities Reauthorization Act H.R.3255/S.1673, Mental Health Infrastructure Act Issues related Pub. L No. 119-21; specifically state direct payments. H.R. 3890, Resident Physician Shortage Reduction Act of 2025 H.R. 1262/S.932, Give Kids a Chance Act H.R. 3505, Barriers to Suicide Act H.R. 4262, To reauthorize programs related to health professions education, and for other purposes.

Client expense: $1,370,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE

Issues regarding childrens health care coverage and access to care under Medicaid and CHIP, including oversight and implementation of Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) and guidance to states.   Issues related to implementation of aspects of childrens health coverage under Medicaid and CHIP. Issues regarding mental health parity and the mental health workforce. Issue regarding Medicaid supplemental payments, including Disproportionate Share Hospitals (DSH) and directed payments. Issues regarding out of state care for children enrolled in Medicaid. Issues related to Hospital at Home. H.R. 1262/S.932 Give Kids a Chance Act H.R. 1509/S. 752 Accelerating Kids Access to Care Act Issues related Pub. L No. 119-21; specifically state directed payments.

Client expense: $1,370,000 · Firm income: Not reported

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

Mental Health issues (incl. mental health parity, suicide prevention) General Health Care issues for people living with Tourette Syndrome or other Tic Disorders (preexisting coverage, Medicare/Medicaid) Medicare Part D Protected Class Drugs Coverage, Part D coverage Research, medical and scientific issues (including BRAIN initiative) Drug Pricing Broadly Telehealth (including HR 4206/ S 1261 - Connect for Health Act of 2025) H.R. 3514/S.1816- Improving Seniors Timely Access to Care Act of 2025 H.R. 5509/S. 2903- Safe Step Act of 2025 H.R. 1262/S. 932- Give Kids a Chance Act

Client expense: $60,000 · 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

Direct to Consumer Advertising 340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program H.R.9504: Tax Exempt Hospital Transparency Act 340B Program Implementation & Oversight H.R. 9599 - SECURE 340B Act Accelerated Approval Breast Cancer Research H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues S. 1682/H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products 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. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation 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 IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Utilization management policies Clinical trial data in China S.3788: CLEAR Labels Act S. 4784/H.R. 8800: National Defense Authorization Act for Fiscal Year 2027

Client expense: $1,410,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Implementation of the Inflation Reduction Act of 2022, ORPHAN Cures Act (HR 946, S 1862), Mikaela Naylon Give Kids A Chance Act (HR 1262), Give Kids A Chance Act (S 932), Cameron's Law (HR 1414), Kids Access to Care Act (Accelerating HR 1509, S 752), Small Biotech Innovations Act (HR 3731, S 1930), EPIC Act (HR 1492, S 832), One Big Beautiful Bill Act (HR 1), BINSA Act, H.R. 9102, Issues related to protecting patient access to medicines in Medicare and Medicaid, Issues related to access to medicines for Parkinson's disease patients, Issues related to Antipsychotic use in Medicare, Issues related to most-favored-nation policies.

Client expense: $700,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

HR 1262, S 932 Give Kids a Chance Act to renew PRV program; related provisions in H.R.1, One Big Beautiful Bill Act; HR 4709, the Newborn Screening Saves Lives Reauthorization Act; PDUFA/regulatory review process; H.R. 9102, Biotech Investment National Security Act (BINSA)

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

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

H.R.1262/S.932, Give Kids a Chance Act H.R.1509/S.752, Accelerating Kids Access to Care Act

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

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

Issues related to the implementation of the Inflation Reduction Act. H.R.1672 - Maintaining Investments in New Innovation Act. H.R.1262/S.932 - Give Kids a Chance Act of 2025. Issues related to drug pricing policy.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Give Kids a Chance Act (H.R.1262),(S.932) and other issues related to therapeutics

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office

Issues related to drug pricing, generally; 340B Drug Pricing Program; pharmacy benefit managers; drug patents and patent reporting requirements; H.R. 1262/S. 932, Give Kids a Chance Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 7148 Consolidated Appropriations Act, 2026 HCR14-Establishing the congressional budget for the United States Government for fiscal year 2025 and setting forth the appropriate budgetary levels for fiscal years 2026 through 2034. H.R.1 One Big Beautiful Bill Act H.R. 3302 Healthy Start Reauthorization Act of 2025 H.R.5371 Continuing Appropriations and Extensions Act of 2026 S. 3389 Lowering Health care Cost for Americans Act H.R. 1262 Mikaela Naylon Give Kids a Chance Act H.R. 5582 Patients Deserve Price Tags Act H.R. 5304 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Act, 2026 H.R. 3277 Ensuring Lasting Smiles Act H.R. 9504 Tax Exempt Hospital Transparency Act H.R. 9599 SECURE 340B Act H.R. 5256 340B ACCESS ACT S. 2587 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Act, 2026 S. 2355 Patients Deserve Price Tags Act S. 891 Bipartisan Health Care Act S. 932 Give Kids a Chance Act of 2025 S. 1677 Ensuring Lasting Smiles Act S. 2372 340B PATIENTS Act

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

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

HR 7148 Consolidated Appropriations Act, 2026 HCR14-Establishing the congressional budget for the United States Government for fiscal year 2025 and setting forth the appropriate budgetary levels for fiscal years 2026 through 2034. H.R.1 One Big Beautiful Bill Act H.R. 3302 Healthy Start Reauthorization Act of 2025 H.R.5371 Continuing Appropriations and Extensions Act of 2026 S. 3389 Lowering Health care Cost for Americans Act H.R. 1262 Mikaela Naylon Give Kids a Chance Act H.R. 5582 Patients Deserve Price Tags Act H.R. 5304 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Act, 2026 H.R. 3277 Ensuring Lasting Smiles Act H.R. 9504 Tax Exempt Hospital Transparency Act H.R. 9599 SECURE 340B Act H.R. 5256 340B ACCESS ACT S. 2587 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Act, 2026 S. 2355 Patients Deserve Price Tags Act S. 891 Bipartisan Health Care Act S. 932 Give Kids a Chance Act of 2025 S. 1677 Ensuring Lasting Smiles Act S. 2372 340B PATIENTS Act

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

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

Research into spinal muscular atrophy, timely access to care, treatments, medical devices, and home and community-based services, Medicaid home care (paid family caregiving & self-directed care), Give Kids a Chance Act (H.R.1261/ S.932- FDA Pediatric Priority Review Voucher Program), DOD Congressionally Directed Medical Research Program & Peer-Reviewed Medical Research Program, Local Coverage Determination related to seat elevation in Group 2 standard power wheelchairs, Labor-Health and Human Services, and Education Appropriations bill, Family Caregiver Awareness, Resources, and Education (CARE) Partnerships Act, Pediatric Palliative Care Homes, National Institute on Disability, Independent Living, and Rehabilitation Research funding, Seat Elevation in Group 2 Non-Complex Power Wheelchairs, Coverage of Standing Systems in Group 3 Power Wheelchair, Competitive Bidding for Tracheostomy, Ostomy and Urological Supplies; FDA Rare Disease Patient Listening Session, Coverage of Respiratory Assist Devices (RADs) and Home Mechanical Ventilators (HMVs), Accelerating Kids Access to Care Act (H.R. 1509/S. 752, National Institutes of Health grant management process & funding; Medicaid home and community-based services, Public Law 119-21 Medicaid Community Engagement Requirements - disability and medically frail definition; Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5343), Veterans STAND Act (H.R. 6835), Veterans SPORTS Act (S. 3138) Consolidated Appropriations Act of 2026 (P.L. 119-75)

Client expense: $75,000 · Firm income: Not reported

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

Pennsylvania is a global leader in researching and developing new therapies, devices and diagnostics that help patients live longer, healthier lives. This innovation is due in part to the policy and regulatory ecosystem we enjoy in the United States.The Rare Pediatric Disease Priority Review Voucher Program (PPRV) incentivizes the development of novel therapies to treat rare pediatric diseases. This program was not reauthorized by the end of 2024 and has therefore expired. The reauthorization of this vital program would be extended to September 30, 2029. The full US House of Representatives has not yet voted on this legislation. The Senate version of Give Kids a Chance Act of 2025 (S.932) was introduced in March and is awaiting any movement from the Senate HELP Committee.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to access to rare disease therapies, diagnosis and testing. Issues related to FDA modernization and rare disease drug development. Issues related to the Accelerated Approval Program. Issues related to Public Law No. 117-169 - The Inflation Reduction Act of 2022. Issues related to alternative funding programs. Issues related to the Rare Pediatric Disease Priority Review Voucher program, including H.R.1262/S.932 - Give Kids a Chance Act of 2025.

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Pediatric Review Reauthorization. H.R.946/S.1862: ORPHAN Cures Act. H.R.1672: Maintaining Investments in New Innovation (MINI) Act. H.R.1262/S.932: Give Kids a Chance Act of 2025.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues regarding childrens health care coverage and access to care under Medicaid and CHIP, including oversight and implementation of Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) and guidance to states.   Issues related to implementation of aspects of childrens health coverage under Medicaid and CHIP. Issues regarding mental health parity and the mental health workforce. Issue regarding Medicaid supplemental payments, including Disproportionate Share Hospitals (DSH) and directed payments. Issues regarding out of state care for children enrolled in Medicaid. Issues related to Hospital at Home. Issues related to Make America Healthy Again. H.R. 1262/S.932 Give Kids a Chance Act H.R. 1509/S. 752 Accelerating Kids Access to Care Act Issues related Pub. L No. 119-21

Client expense: $1,440,000 · Firm income: Not reported

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

Issues regarding childrens health care coverage and access to care under Medicaid, CHIP, the Exchanges, TRICARE, and private insurance Issues regarding childrens mental health and the national emergency in childrens mental health, including mental health parity, the mental health workforce, suicide and injury prevention, and related access issues. Issue regarding Medicaid supplemental payments and directed payments. Issues regarding the importance of Medicaid to children, including military and veteran families.  Issues regarding Medicaid support for providers caring for children on Medicaid, including DSH payments. Issues regarding Children's Hospitals Graduate Medical Education (CHGME) program and funding. Issues related to 340B Drug Pricing Program, the Prescription Drug User Fee Act, prescription drug pricing, drug shortages, drug compounding, high-cost drugs/therapies and pharmaceutical supply chain. Issues related to pediatric workforce, Medicare GME and the Pediatric Specialty Loan Repayment Program. Issues related to hospital financing. Issues regarding site neutrality, facility fees, and price transparency in health care.  Issues regarding pediatric pandemic and disaster preparedness and response and emergency preparedness, including work with the Pediatric Pandemic Network (PPN) and related to the Pandemic and All-Hazards Preparedness Act (PAHPA). Issues related to Emergency Medical Services for Children (EMSC). Issues related to mental health services in schools Issues regarding Artificial Intelligence (AI). Issues regarding oversight and implementation of EPSDT. Issues involving pediatric medical research and funding, specifically including research at the National Institutes of Health. Issues involving gun violence prevention. Issues regarding health care innovation. Issues involving Making America Healthy Again. Issues involving Medical Device User Fee Authorization. Issues involving biomedical research policies. Issues involving the 988 Suicide Prevention Lifeline. Issues involving the Community Mental Health Services Block Grant. Issues involving the Pediatric Mental Health Care Access Program. Issues involving telehealth. Issues involving Appropriations for pediatric health care programs. H.R.169/S.357 Prevent Family Fire Act H.R.4768/S.2448 Health Care Fairness for Military Families Act of 2025 H.R. 1509/S. 752 Accelerating Kids Access to Care Act H.R. 1735 / S. 779, The Early Action and Responsiveness Lifts Youth (EARLY) Minds Act H.R. 2587/S. 1266, Youth Mental Health Research Act H.R. 2483, SUPPORT for Patients and Communities Reauthorization Act H.R.3255/S.1673, Mental Health Infrastructure Act Issues related Pub. L No. 119-21 H.R. 3890, Resident Physician Shortage Reduction Act of 2025 H.R. 1262/S.932, Give Kids a Chance Act H.R. 3505, Barriers to Suicide Act H.R. 4262, To reauthorize programs related to health professions education, and for other purposes.

Client expense: $1,440,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE, White House Office

Issues related to drug pricing, generally; 340B Drug Pricing Program; pharmacy benefit managers; drug patents and patent reporting requirements; H.R. 1262/S. 932, Give Kids a Chance Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1262/S. 932, Give Kids A Chance Act of 2025 H.R. 955, HOPE Act of 2025 H.R. 1, One Big Beautiful Bill Act - healthcare provisions

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues regarding childrens health care coverage and access to care under Medicaid, CHIP, the Exchanges, TRICARE, and private insurance Issues regarding childrens mental health and the national emergency in childrens mental health, including mental health parity, the mental health workforce, suicide and injury prevention, and related access issues. Issue regarding Medicaid supplemental payments and directed payments. Issues regarding the importance of Medicaid to children, including military and veteran families.  Issues regarding Medicaid support for providers caring for children on Medicaid, including DSH payments. Issues regarding Children's Hospitals Graduate Medical Education (CHGME) program and funding. Issues related to 340B Drug Pricing Program, the Prescription Drug User Fee Act, prescription drug pricing, drug shortages, drug compounding, high-cost drugs/therapies and pharmaceutical supply chain. Issues related to pediatric workforce, Medicare GME and the Pediatric Specialty Loan Repayment Program. Issues related to hospital financing. Issues regarding site neutrality, facility fees, and price transparency in health care.  Issues regarding pediatric pandemic and disaster preparedness and response and emergency preparedness, including work with the Pediatric Pandemic Network (PPN) and related to the Pandemic and All-Hazards Preparedness Act (PAHPA). Issues related to Emergency Medical Services for Children (EMSC). Issues related to mental health services in schools Issues regarding Artificial Intelligence (AI). Issues regarding oversight and implementation of EPSDT. Issues involving pediatric medical research and funding, specifically including research at the National Institutes of Health. Issues involving gun violence prevention. Issues regarding health care innovation. Issues involving Making America Healthy Again. Issues involving Medical Device User Fee Authorization. Issues involving biomedical research policies. Issues involving the 988 Suicide Prevention Lifeline. Issues involving the Community Mental Health Services Block Grant. Issues involving the Pediatric Mental Health Care Access Program. Issues involving telehealth. Issues involving Appropriations for pediatric health care programs. H.R.169/S.357 Prevent Family Fire Act H.R.4768/S.2448 Health Care Fairness for Military Families Act of 2025 H.R. 1509/S. 752 Accelerating Kids Access to Care Act H.R. 1735 / S. 779, The Early Action and Responsiveness Lifts Youth (EARLY) Minds Act H.R. 2587/S. 1266, Youth Mental Health Research Act H.R. 2483, SUPPORT for Patients and Communities Reauthorization Act H.R.3255/S.1673, Mental Health Infrastructure Act Issues related Pub. L No. 119-21 H.R. 3890, Resident Physician Shortage Reduction Act of 2025 H.R. 1262/S.932, Give Kids a Chance Act H.R. 3505, Barriers to Suicide Act H.R. 4262, To reauthorize programs related to health professions education, and for other purposes.

Client expense: $1,440,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), SENATE, White House Office

Issues regarding childrens health care coverage and access to care under Medicaid and CHIP, including oversight and implementation of Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) and guidance to states.   Issues related to implementation of aspects of childrens health coverage under Medicaid and CHIP. Issues regarding mental health parity and the mental health workforce. Issue regarding Medicaid supplemental payments, including Disproportionate Share Hospitals (DSH) and directed payments. Issues regarding out of state care for children enrolled in Medicaid. Issues related to Hospital at Home. Issues related to Make America Healthy Again. H.R. 1262/S.932 Give Kids a Chance Act H.R. 1509/S. 752 Accelerating Kids Access to Care Act Issues related Pub. L No. 119-21

Client expense: $1,440,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), 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 -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 -S. 932/ H.R. 1262, Give Kids A Chance Act, support reauthorization of the Rare Pediatric Disease Review Voucher -WISeR Model, express concern with how it could impede access to some epilepsy treatments -PBM Reform, support passage 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. -Enhanced Advance Premium Tax Credits, support reauthorization. -Medicare Part D out-of-pocket cap and the Medicare Prescription Payment Plan, support patient-centric implementation -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 -S. 752/H.R. 1509, Accelerating Kids Access to Care 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 -S. 455/H.R. 1061, Protecting Sensitive Locations Act, support passage -Oppose legislation that would weaken the Affordable Care Act protections, including H.R. 2528, Association Health Plans Act and H.R. 2571, Self-Insurance Protection Act -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 -Support legislation and regulations that protect Medicaid Home- and Community-Based Services (HCBS) and increase access to these services

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

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

Legislation regarding clinical research for rare diseases and orphan drug development, and the Accelerated Approval pathway. H.R.1262/S.932, Give Kids a Chance Act to renew PRV program. Related provisions in Pub. L. No. 119-21, One Big Beautiful Bill Act. The Newborn Screening Reauthorization Act. Importance of patient voice in rare kidney disease.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 932/HR 1262 Mikaela Naylon Give Kids a Chance Act of 2025; Preserving US competitiveness and patient access to lifesaving medicines; HR 7148 the Consolidated Appropriations Act of 2026

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

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

Monitor and engage on legislative and administrative action related to health care policy. Monitor and engage on legislative and administrative action related to womens health issues. Monitor and engage on legislative and administrative action related to over-the-counter consumer care products. Monitor and engage on legislative and administrative action related to dietary supplements, including purchasing through HSA funds. Monitor and engage on legislative and administrative action related to servicing of medical device equipment. Monitor and engage on legislative and administrative action related to FDA monograph reform and user fees. Monitor and engage on legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor and engage on legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor and engage on legislative and administrative action related to 340B drug discount program. Monitor and engage on legislative and administrative action related to drug supply chain issues, including pharmacy benefit manager (PBM) reform. Monitor and engage on legislative and administrative action related to copay assistance. Monitor and engage on legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP). Monitor and engage on legislative and administrative action related to long-acting reversable contraception usage. Monitor and engage on legislative and administrative action related to access to treatments for kidney patients. Monitor and engage on legislative and administrative action related to broader insurance coverage of supplemental imaging procedures for women with dense breast tissue. Monitor and engage on legislative and administrative action related to phenylephrine. Monitor and engage on legislative and administrative action related to e-labeling. Monitor and engage on legislative and administrative action related to DEA-determined pseudoephedrine quotas. Monitor and engage on legislative and administrative action related to Make America Healthy Again (MAHA). Monitor and engage on legislative and administrative action related to generally recognized as safe (GRAS) rules for food additives. H.R. 1262, Give Kids a Chance Act of 2025. H.R. 7366, Dietary Supplement Regulatory Uniformity Act. S. 932, Give Kids a Chance Act of 2025. S. 3677, Dietary Supplement Listing Act of 2026.

Client expense: $2,030,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

H.R. 1262/S. 932 - Mikaela Naylon Give Kids a Chance Act General discussions about ultra-rare diseases General discussions about ultra-rare disease drug development General discussions about regulatory reform, including scientific-focused drug development meetings General discussions about mitochondrial diseases H.R. 1532/S. 822, the Scientific EXPERT Act of 2025FDA Rare Disease Innovation Hub Fiscal Year 2026 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (H.R. 4121 / S. 2256) H.R.6280/S.3607 - Access to Genetic Counselor Services Act of 2025/Access to Genetic Counselor Services Act of 2026 H.R.4709 - Newborn Screening Saves Lives Reauthorization Act of 2025 General discussions about genetic testing, diagnostics General discussions about accelerated approval pathway (AAP)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.752, Accelerating Kids Access to Care Act. H.R.1262/S.932, Give Kids a Chance Act. Issues related to military-civilian medical training partnerships Issues related to the Rural Health Transformation Program. Issues related to expanding access in rural areas. Issues related to behavioral health.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

CMMI GENEROUS Demo Medicare Part B ASP compliance 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 direct-to-consumer drug delivery policy options 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 next generation propellant and PFAS Issues related to the US manufacturing of pharmaceuticals Issues related to the price and manufacture of inhaled medicines Issues related to environmental sustainability Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs) Issues related to vaccine access and vaccine R&D Issues related to FDA Orange Book patent listings 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 General issues related to health equity in rare disease and clinical trials General issues related to vaccine safety, efficacy, and access General issues related to ACIP recommendations Policies related to international reference pricing for pharmaceuticals Pediatric rare disease priority review voucher Reauthorization of the pediatric priority review voucher program HR 946/S 1862, Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act HR 1262/ S 932, Give Kids A Chance Act HR 4132/S 2027, Prescription Information Modernization Act HR 6166, the Lowering Drug Costs for American Families Act

Client expense: $2,280,000 · Firm income: Not reported

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

Education and advocacy regarding sickle cell disease, including H.R. 1796/S. 735- Sickle Cell Disease and Other Heritable Blood Disorders, Research, Surveillance, Prevention, and Treatment Act of 2025. Priority review vouchers: Give Kids a Chance Act of 2025 (H.R. 1262/S.932) Issues related to FDA Accelerated Approval Pathways

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1262 - Give Kids a Chance Act of 2025 S 3302/S 932 - Give Kids a Chance Act of 2025 HR 1762 - Lower Costs for Every Day Americans Act 42 CFR Part 513/514 - Global Benchmark for Efficient Drug Pricing (GLOBE) and Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Models EO 14297 - Exemption for Orphan Drugs from MFN Proposals

Client expense: $110,000 · Firm income: Not reported

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

Labor-HHS Appropriations Billing and Coding classifications CAR-T Therapy Clarifications Revaccination of Immunosuppressed Patients H.R. 1509/S. 752, The Accelerating Kids Access to Care Act 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

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

HR 7148 Consolidated Appropriations Act, 2026 HCR14-Establishing the congressional budget for the United States Government for fiscal year 2025 and setting forth the appropriate budgetary levels for fiscal years 2026 through 2034. H.R.1 One Big Beautiful Bill Act H.R. 3302 Healthy Start Reauthorization Act of 2025 H.R.5371 Continuing Appropriations and Extensions Act of 2026 S. 3389 Lowering Health care Cost for Americans Act H.R. 1262 Mikaela Naylon Give Kids a Chance Act H.R. 5582 Patients Deserve Price Tags Act H.R. 5304 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Act, 2026 S. 2587 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Act, 2026 S. 2355 Patients Deserve Price Tags Act S. 891 Bipartisan Health Care Act S. 932 Give Kids a Chance Act of 2025

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

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

HR 7148 Consolidated Appropriations Act, 2026 HCR14-Establishing the congressional budget for the United States Government for fiscal year 2025 and setting forth the appropriate budgetary levels for fiscal years 2026 through 2034. H.R.1 One Big Beautiful Bill Act H.R. 3302 Healthy Start Reauthorization Act of 2025 H.R.5371 Continuing Appropriations and Extensions Act of 2026 S. 3389 Lowering Health care Cost for Americans Act H.R. 1262 Mikaela Naylon Give Kids a Chance Act H.R. 5582 Patients Deserve Price Tags Act H.R. 5304 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Act, 2026 S. 2587 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Act, 2026 S. 2355 Patients Deserve Price Tags Act S. 891 Bipartisan Health Care Act S. 932 Give Kids a Chance Act of 2025

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

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

Pennsylvania is a global leader in researching and developing new therapies, devices and diagnostics that help patients live longer, healthier lives. This innovation is due in part to the policy and regulatory ecosystem we enjoy in the United States.The Rare Pediatric Disease Priority Review Voucher Program (PPRV) incentivizes the development of novel therapies to treat rare pediatric diseases. This program was not reauthorized by the end of 2024 and has therefore expired. The reauthorization of this vital program would be extended to September 30, 2029. The full US House of Representatives has not yet voted on this legislation. The Senate version of Give Kids a Chance Act of 2025 (S.932) was introduced in March and is awaiting any movement from the Senate HELP Committee.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE