Creating Hope Reauthorization Act of 2024

Extension of Priority Review Vouchers in S 4583; HR 7384 the Creating Hope Reauthorization Act, FDA reforms to improve rare disease patient perspective input and flexibilities

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Encouraged action on telehealth legislation to the Energy and Commerce Committee Supported H.R. 7623, the Telehealth Modernization Act of 2024 Supported H.R. 7858, Telehealth Enhancement for Mental Health Act and the Telehealth Modernization Act: Supported H.R. 7383, Retaining Access and Restoring Exclusivity (RARE) Act Supported H.R. 7384, Creating Hope Reauthorization Act of 2024 Supported the amended Give Kids a Chance Act Supported the introduction of legislation that increases access to genetic testing and genetic counselors Advocated for provisions addressing problems within the pharmacy benefit manager industry Supported the introduction of legislation that amends the anti-kickback statute to allow companies to cover the costs of traveling to obtain therapies Prepared for the reauthorization of the ACT for ALS Joined an Amicus Brief in American Association of Ancillary Benefits v. Becerra (12.18.24) Joined Coalition Comments to Centers for Medicare and Medicaid Services on Long-Term Care (LTC) Pharmacies (12.17.24) Joined Coalition Comments to Centers for Medicare and Medicaid Services on Federal Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Program (12.16.24) Joined Coalition Comments to Congressional Leadership on Partnership to Protect Coverage Healthcare Priorities (12.10.24) Joined Coalition Comments to HHS on Notice of Benefit and Payment Parameters for 2026 (11.12.24) Supported efforts to reform the Inflation Reduction Acts provisions on Medicare negotiation for orphan drugs

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

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

Prepared efforts for reauthorization of the Newborn Screening Saves Lives Reauthorization Act Encouraged action on telehealth legislation to the Energy and Commerce Committee Supported H.R. 7623, the Telehealth Modernization Act of 2024 Supported H.R. 7858, Telehealth Enhancement for Mental Health Act and the Telehealth Modernization Act: Supported the ALS Better Care Act Advocated for the protection of the Medicaid program to the White House and Congress Supported H.R. 7383, Retaining Access and Restoring Exclusivity (RARE) Act Supported H.R. 7384, Creating Hope Reauthorization Act of 2024 Supported the amended Give Kids a Chance Act Supported the MINI Act Supported the NIH Clinical Trial Diversity Act Supported H.R. 4758, Accelerating Kids Access to Care Act Supported the Access to Genetic Counseling Services Act Advocated for provisions addressing problems within the pharmacy benefit manager industry Supported the introduction of legislation that amends the anti-kickback statute to allow companies to cover the costs of traveling to obtain therapies Supported robust funding for NCATS Supported robust funding for NIAMS Prepared for the reauthorization of the ACT for ALS Joined coalition Comments to Congressional Leadership on Potential Changes to Medicaid (12.19.24) Joined an Amicus Brief in American Association of Ancillary Benefits v. Becerra (12.18.24) Joined Coalition Comments to Centers for Medicare and Medicaid Services on Long-Term Care (LTC) Pharmacies (12.17.24) Joined Coalition Comments to Centers for Medicare and Medicaid Services on Federal Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Program (12.16.24) Joined Coalition Comments to Congressional Leadership on Partnership to Protect Coverage Healthcare Priorities (12.10.24) Joined Coalition Comments to House Budget Committee and Senate Budget Committee Leadership on Protection of and Potential Cuts to Medicaid (12.10.24) Joined Amicus Briefs Filed in Response to Challenges to Section 1557 of the Affordable Care Act (ACA) Final Rule from U.S. Department of Health and Human Services: Texas v. Becerra (12.4.24) and Tennessee v. Becerra (11.26.24) Joined Coalition Comments to Congressional Leadership on Diagnostic Medical Equipment (DME) Access (12.2.24) Joined Coalition Comments to HHS on Notice of Benefit and Payment Parameters for 2026 (11.12.24) Joined Coalition Comments in Response to Proposed Data Collection on Proprietary Guidelines and Medicare Advantage Plan Audit Protocol (11.12.24) Joined Coalition Comments to Support S.5070, the Ensuring Access to Medicaid Buy-In Programs Act (11.12.24) Joined Coalition Comments on Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2026; Basic Health Program (11.12.24) Joined Coalition Comments on Access to Assistive Technology, Auxiliary Aids, Services, and Accommodations (11.6.24) Joined Coalition Comments to UnitedHealthcare on Changes to Prior Authorization Policies for Outpatient Rehabilitation Therapy Services (10.22.24) Joined Coalition Comments to Centers for Medicare & Medicaid Services (CMS) on Service Level Data Collection for Medicare Advantage Plans (10.8.24) Supported efforts to reform the Inflation Reduction Acts provisions on Medicare negotiation for orphan drugs

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

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

Prepared efforts for reauthorization of the Newborn Screening Saves Lives Reauthorization Act Supported H.R. 7383, Retaining Access and Restoring Exclusivity (RARE) Act Supported H.R. 7384, Creating Hope Reauthorization Act of 2024 Supported the amended Give Kids a Chance Act Supported the NIH Clinical Trial Diversity Act Supported robust funding for NCATS Prepared for the reauthorization of the ACT for ALS Supported efforts to reform the Inflation Reduction Acts provisions on Medicare negotiation for orphan drugs

Client expense: $60,000 · 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), Natl Institutes of Health (NIH), SENATE

Issues related to access to rare disease therapies 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 rare disease diagnosis and testing Issues related to alternative funding programs Issues related to the Rare Pediatric Disease Priority Review Voucher program, including H.R. 7384 - Creating Hope Reauthorization Act of 2024

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to access to rare disease therapies 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 rare disease diagnosis and testing Issues related to alternative funding programs Issues related to the Rare Pediatric Disease Priority Review Voucher program, including H.R. 7384 - Creating Hope Reauthorization Act of 2024

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to access to rare disease therapies 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 rare disease diagnosis and testing Issues related to alternative funding programs Issues related to the Rare Pediatric Disease Priority Review Voucher program, including H.R. 7384 - Creating Hope Reauthorization Act of 2024

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to access to rare disease therapies 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 rare disease diagnosis and testing Issues related to alternative funding programs Issues related to the Rare Pediatric Disease Priority Review Voucher program, including H.R. 7384 - Creating Hope Reauthorization Act of 2024

Client expense: $500,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation regarding FDA and clinical research, particularly with respect to rare disease and orphan drug development and the accelerated approval pathway, and related legislation regarding FY 2024 Appropriations. FY 2025 appropriations for CDC newborn screening programs. HR 7384/S. 4583, Creating Hope Reauthorization Act to renew PRV program. HR 10445, the Continuing Resolution and provisions related to the PRV program.

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

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

HR 1692 / S 8, the Health Care Affordability Act; HR 2630 / S 652, the Safe Step Act; HR 3433 / S 2897, the Give Kids a Chance Act; HR 3503 / S 1701, The NIH Clinical Trial Diversity Act; HR 3991 / S 1624, the Gabriella Miller Kids First Act; HR 4363 / S 2213, Comprehensive Cancer Survivorship Act; HR 6003 / S 3103, the Medical Debt Relief Act; HR 6301 / S. 2039, The Cancer Drug Parity Act; HR 7383 / S 1214, the RARE Act; HR 8311 / S 4289, Medical Debt Cancellation Act; HR 824, the Telehealth Benefit Expansion for Workers Act; HR 1773, the Consumer Protection for Medical Debt Collections Act; HR 2813, Self-Insurance Protection Act; HR 2868, the Association Health Plans; HR 2880, the Protecting Patients Against PBM Abuses Act; HR 3799, CHOICE Arrangement Act; HR 3800, the Chronic Disease Flexible Coverage Act; HR 5609, the Advancing Health Savings Act; HR 5688, the Bipartisan HSA Improvement Act; HR 5687, the HSA Modernization Act; HR 6664, the Innovation in Pediatric Drugs Act; HR 6963, the Pediatric Cancer Drug Supply Chain Act; HR 7384, the Creating Hope Reauthorization Act; HR 8261, Preserving Telehealth, Hospital, and Ambulance Access Act; HR 8412, the Clinical Trial Modernization Act; HR 8574, the 340B ACCESS Act; HR 9129, Patient Debt Relief Act; S 113, the Prescription Pricing for the People Act; S 127, the Pharmacy Benefit Manager Transparency Act; S 1339, the Pharmacy Benefit Manager Reform Act; S 1542, the DRUG Act; S 1967 the Patients Before Middlemen Act; S 2243, the Palliative Care and Hospice Education and Training Act; S 2483, the Strengthening Consumer Protections and Medical Debt Transparency Act; S 2973, the Modernizing and Ensuring PBM Accountability Act; S 3167, Multiple Employer Welfare Arrangement (MEWA) Act; HR 9774 / S 5194, the Health Care Affordability Act; Legislation to protect insurance purchasers interacting with insurance brokers; Implementation of the No Surprises Act; Federal rulemaking related to Short-term Limited Duration Insurance (STLDI) plans; Efforts to extend and make permanent the current enhanced Advance Premium Tax Credits; Insurance appeals and denials; Federal rulemaking related to Association Health Plans; Consumer protections related to consumers who will lose insurance due to the end of certain federal Medicaid maintenance-of-effort requirements; FDA draft guidance related to dose optimization studies in clinical trials

Client expense: $180,000 · 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

H.R.7384/S.4583, Creating Hope Reauthorization Act H.R.2666/S.4204, Medicaid VBPs for Patients (MVP) Act H.R.9184, Patient Access Act of 2024

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Advocate on issues related to regulation of, access to, and reimbursement for regenerative medicine companies and products. Value Based Payment legislation. CMS policies regarding Value Based legislation. FDA appropriations. FDA staffing. Prescription Drug User Fee Act (PDUFA). Medicaid reimbursement. Provider credentialing. Medicare reimbursement. NTAP. Medicaid VBPs for Patients (MVP) Act (H.R.2666/S.4204). Accelerating Kids Access to Care Act (S.2372/H.R.4758). MDRP. CMMI. Creating Hope Reauthorization Act of 2024 (H.R.7384/S.4583). Rare Pediatric Disease Designation and Priority Review Voucher (PRV) Programs. Preventive Health Savings Act (H.R.766/S.114). Patient Access Act of 2024 (H.R.9184).

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

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1305: SAVING US FROM PANDEMIC ERA RESISTANCE BY BUILDING A UNIFIED GLOBAL STRATEGY (SUPER BUGS) ACT OF 2023; ALL PROVISIONS H.R. 2940: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS H.R.: 3433: GIVE KIDS A CHANCE ACT OF 2024; ALL PROVISIONS H.R. 7384: CREATING HOPE REAUTHORIZATION ACT OF 2024; PROVISIONS REGARDING THE REAUTHORIZATION OF THE RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER PROGRAM S. 1355: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS S. 4426: PROMISING PATHWAY ACT 2.0; ALL PROVISIONS S. 4581: SAVING US FROM PANDEMIC ERA RESISTANCE BY BUILDING A UNIFIED GLOBAL STRATEGY (SUPER BUGS) ACT OF 2024; ALL PROVISIONS (DRAFT) CURES 2.0; ALL PROVISIONS GENERAL DISCUSSIONS REGARDING PROPOSED FRAMEWORK FOR REFORMING NATIONAL INSTITUTES OF HEALTH GENERAL DISCUSSIONS REGARDING THE 2025 FISCAL YEAR APPROPRIATIONS; PROVISIONS RELATING TO FUNDING FOR DOMESTIC AND GLOBAL AMR PROGRAMS, PUBLIC HEALTH WORKFORCE REPAYMENT PROGRAM, BIO-PREPAREDNESS WORKFORCE PILOT PROGRAM AND PROTECTION OF MEDICARE, MEDICAID, AND SOCIAL SECURITY PROGRAMS, HEALTH AND HUMAN SERVICES AND RELATED AGENCIES, FOOD AND DRUG ADMINISTRATION AND RELATED AGENCIES, CENTER FOR DISEASE CONTROL AND PREVENTION AND RELATED AGENCIES, NATIONAL INSTITUTES OF HEALTH AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION; AND POLICY RIDERS IN DRAFT LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION RELATED AGENCIES FUNDING BILL

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 7384/S. 4583, the Creating Hope Reauthorization Act of 2024 H.R. 4758/S. 2372, the Accelerating Kids Access to Care Act H.R. 3433, the Give Kids A Chance Act General discussions about ultra-rare disease drug development General discussions about regulatory reform, including scientific-focused drug development meetings H.R. 1092/S. 526, the BENEFIT Act General discussions about mitochondrial diseases H.R. 9979, the Scientific EXPERT Act of 2024 General discussions about ultra-rare diseases FDA Rare Disease Innovation Hub

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.7384/S.4583, Creating Hope Reauthorization Act H.R.2666/S.4204, Medicaid VBPs for Patients (MVP) Act H.R.9184, Patient Access Act of 2024

Client expense: Not reported · Firm income: Not reported

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

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

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

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

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

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

Extension of Priority Review Vouchers in S 4583; HR 7384 the Creating Hope Reauthorization Act, FDA reforms to improve rare disease patient perspective input and flexibilities; HR 10545 American Relief Act of 2025

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2666/S. 4204, the Medicaid VBPs for Patients (MVP) Act; Center for Medicare and Medicaid Innovations (CMMI) Cell and Gene Therapy Access Model; H.R. 4758/S. 2372, Accelerating Kids Access to Care Act; H.R. 7384, Creating Hope Reauthorization Act of 2024; H.R. 10545, American Relief Act, 2025

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

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 the annual Notice of Benefit and Payment Parameters for the Exchanges and private insurance Issues regarding childrens mental health and the national emergency in childrens mental health, including mental health parity, the mental health workforce and related access issues. Issue regarding Medicaid supplemental payments and directed payments Issues related to Health Information Technology, interoperability, information blocking, and cybersecurity 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, prescription drug pricing, drug shortages, high-cost drugs/therapies and pharmaceutical supply chain, including H.R. 3290 Issues related to pediatric workforce, Medicare GME, the Pediatric Specialty Loan Repayment Program, and Title VII and VIII Issues regarding Organ Procurement and Transplantation Network Issues regarding site neutrality, facility fees, and price transparency in health care  Issues regarding pediatric pandemic and disaster preparedness and response and emergency preparedness Issues regarding food security and nutrition Issues regarding drugs and medical device shortages and high costs, including IV fluid shortages and infant formula Issues related to the regulation of laboratory-developed tests Issues regarding prescribing of drugs via telehealth Issues related to mental health services in schools Issues related to pediatric cancer and the Moonshot Issues regarding Artificial Intelligence (AI) Issues regarding oversight and implementation of EPSDT H.R. 2412 The Helping Kids Cope Act S.2372/HR. 4758 - Accelerating Kids Access to Care Act  H.R. 1397, Telehealth Improvement for Kids Essential Services (TIKES) Act H.R. 7623/ S. 3967, Telehealth Modernization Act Issues involving Site Neutral payment legislation, including H.R. 3281 and H.R. 3561 S. 3029/H.R. 6085 PREEMIE Reauthorization Act H.R. 2584/S.2768, Safety form Violence for Healthcare employees (Save) Act S. 1409, Kids Online Safety Act H.R. 6663/S. 3364, Kid PROOF Act of 2023 H.R. 6664 Innovation for Pediatric Drugs Act of 2023 H.R. 7808, the Early Action and Responsiveness Lifts Youth (EARLY) Minds Act H.R. 7153/S. 3679 Dr. Lorna Breen Health Care Provider Protection Reauthorization Act S. 3757 Congenital Heart Futures Reauthorization Act of 2024 H.R. 6960 Emergency Medical Services for Children Reauthorization Act of 2024 H.R. 3391 Gabriella Miller Kids First Research Act 2.0 H.R. 6963 Pediatric Cancer Drug Supply Act H.R. 3433/ S. 2897, Give Kids A Chance Act H.R. 7384, Creating Hope Reauthorization Act. H.R. 6664/S. 4905, Innovation in Pediatric Drugs Act

Client expense: $1,600,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE

HR 830: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS OF THE BILL HR 2630: SAFE STEP ACT; ALL PROVISIONS OF THE BILL HR 2666: MEDICAID VBPS FOR PATIENTS ACT (MVP ACT); PROVISIONS RELATED TO OUTCOME BASED ARRANGEMENTS (OBA) AND VALUE BASED ARRANGEMENTS (VBA) HR 4758: ACCELERATING KIDS' ACCESS TO CARE ACT: ALL PROVISIONS OF THE BILL HR 7384: CREATING HOPE REAUTHORIZATION ACT OF 2024; ALL PROVISIONS OF THE BILL HR 8574: 340B AFFORDABLE CARE FOR COMMUNITIES AND ENSURING A STRONG SAFETY-NET (ACCESS) ACT; ALL PROVISIONS OF THE BILL HR 9184: PATIENT ACCESS ACT OF 2024; ALL PROVISIONS OF THE BILL S 2372: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS OF THE BILL S 4583: CREATING HOPE REAUTHORIZATION ACT OF 2024; ALL PROVISIONS OF THE BILL GENERAL DISCUSSIONS REGARDING GENETIC SCREENING, LONG TERM FOLLOW UP, CURES 3.0, AND ORPHAN DRUG ACT

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 7384/S.4583, Creating Hope Reauthorization Act H.R.4758/S.2372, Accelerating Kids Access to Care Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.7384, Creating Hope Reauthorization Act H.R.5539/S.3131, the ORPHAN Cures Act H.R.3433/S.2897, the Give Kids a Chance Act

Client expense: Not reported · Firm income: $160,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.4426, Promising Pathway Act 2.0 H.R.7384/S.4583, the Creating Hope Reauthorization Act of 2024 H.R.4758/S.2372, Accelerating Kids Access to Care Act H.R.3433, the Give Kids a Chance Act H.R. 10545, American Relief Act

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

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. 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 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. H.R. 3086, Find It Early Act. H.R. 3433, Give Kids a Chance Act of 2023. H.R. 7384, A bill to amend the Federal Food, Drug, and Cosmetic Act to extend the authority of the Secretary of HHS to issue priority review vouchers to encourage treatments for rare pediatric diseases. H.R. 10545, American Relief Act, 2025, including pharmacy benefit manager reform. S. 4583, Creating Hope Reauthorization Act of 2024.

Client expense: $2,010,000 · 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)

Issues related to access to rare disease therapies 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 rare disease diagnosis and testing Issues related to alternative funding programs Issues related to the Rare Pediatric Disease Priority Review Voucher program, including H.R. 7384 - Creating Hope Reauthorization Act of 2024

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to access to rare disease therapies 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 rare disease diagnosis and testing Issues related to alternative funding programs Issues related to the Rare Pediatric Disease Priority Review Voucher program, including H.R. 7384 - Creating Hope Reauthorization Act of 2024

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to access to rare disease therapies 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 rare disease diagnosis and testing Issues related to alternative funding programs Issues related to the Rare Pediatric Disease Priority Review Voucher program, including H.R. 7384 - Creating Hope Reauthorization Act of 2024

Client expense: $500,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support funding increases for the National Institutes of Health, National Science Foundation, and Food and Drug Administration Life Sciences Pennsylvania supports Federal incentivize investment in the R&D of therapies and cures for rare disorders as well as policies to improve public health and pandemic preparedness including anti-microbial resistance, PAHPA reauthorization, and substance use disorder crisis. H.R. 7384, the Creating Hope Reauthorization Act of 2024 would reauthorize the Rare Pediatric Disease Priority Review Voucher Program (PPRV). The program incentivizes the development of novel therapies to treat pediatric rare diseases. By September of 2024, the Pediatric Priority Review Voucher will expire, and Life Sciences Pennsylvania supports the reauthorization of this crucial legislation.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

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

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

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

PAHPA reauthorization (S. 2333 - Pandemic and All-Hazards Preparedness and Response Act; H.R. 4421 - the Preparing for All Hazards and Pathogens Reauthorization Act); Drug pricing issues; PBM reform (S. 2973 -Modernizing and Ensuring PBM Accountability Act and S. 3430 - Better Mental Health Care, Lower-Cost Drugs, and Extenders Act of 2023); Rare Pediatric Disease Priority Review Voucher Program reauthorization (H.R. 7384/ S. 4583 - Creating Hope Reauthorization Act); National Vaccine Injury Compensation Program.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

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

Issues related to drug pricing and value, generally Issues related to pharmacy benefit managers and drug rebate reform Issues related to drug patents and patent reporting requirements Issues related to march-in rights under the Bayh-Dole Act (Pub. L. 96-517) Creating Hope Reauthorization Act (H.R. 7384/S. 4583) Promising Pathway Act 2.0 (S.4426)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Creating Hope Reauthorization Act of 2024 - H.R. 7384 Give Kids a Chance Act of 2024 - H.R. 3433 Creating Hope Reauthorization Act of 2024 - S. 4583 March-in/Bayh-Dole Act Orphan drug policies Scientific EXPERT Act of 2024 - H.R.9979 H.R.9979 - Scientific EXPERT Act of 2024 H.R.10545 - American Relief Act, 2025

Client expense: $320,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Blood and plasma safety and awareness Bleeding disorders awareness Securing Equal Access to Research, Care, and Health (SEARCH) Act Creating Hope Reauthorization Act of 2024 (HR 7384)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to rare disease H. R. 7384/S. 4583 - Creating Hope Reauthorization Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues impacting rare disease treatments, including rare disease research incentives; H.R. 7384/S. 4583 - Creating Hope Reauthorization Act of 2024; H.R. 3433 - Give Kids a Chance Act of 2024; American Relief Act of 2025 (PL 118-158).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues and legislation related to access to gene therapies and treatment of rare diseases; the Medicaid VBPs for Patients (MVP) Act (H.R. 2666); Creating Hope Reauthorization Act (H.R. 7384 / S. 4583); Patient Access Act (H.R. 9184)

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

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

Issues and legislation related to access to gene therapies and treatment of rare diseases; the Medicaid VBPs for Patients (MVP) Act (H.R. 2666); Creating Hope Reauthorization Act (H.R. 7384 / S. 4583); Patient Access Act (H.R. 9184)

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

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

H.R. 5547, Maintaining Investments in New Innovation (MINI) Act H.R.7174, Ensuring Pathways to Innovative Cures (EPIC) Act H.R. 6094, Providing Realistic Opportunity To Equal and Comparable Treatment for (PROTECT) Rare Act H.R. 6664, Innovation in Pediatric Drugs Act H.R. 7384, Creating Hope Reauthorization Act H.R. 7383, Retaining Access and Restoring Exclusivity (RARE) Act H.R.7024, Tax Relief for American Families and Workers Act of 2024 H.R.3433 / S.2897, Give Kids a Chance Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S 765/HR 1526: Reducing Hereditary Cancer Act of 2023- provide hereditary cancer genetic testing Increasing access to telehealth S 2016/HR 4189: CONNECT for Health Act- expands access to telehealth services Medicare physician payment reforms HR 2474: Strengthening Medicare for Patients and Providers Act- physician reimbursement HR 5013: Value in Health Care Act of 2023 - provides a multi-year commitment to reforming care delivery by extending MACRA's 5 percent advanced APM incentives for an additional two years. S 3503: Value in Health Care Act of 2023 - A bill to direct the Secretary of Health and Human Services to revise certain regulations in relation to the Medicare shared savings program and other alternative payment arrangements to encourage participation in such program, and for other purposes HR 6371: Provider Reimbursement Stability Act of 2023 - To provide for certain adjustments to the physician fee schedule under the Medicare program. H.R. 6369: To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models - Extend incentive payments for participation in alternative payment models HR 3674: Providing Relief and Stability for Medicare Patients Act of 2023 - increase the nonfacility practice expense relative value units for specified services furnished under the Medicare program Reducing burdens caused by prior authorization requirements HR 4968: GOLD CARD Act of 2023 - exempt qualifying providers from prior authorization requirements under Medicare Advantage plans S 2372/HR 4758: Accelerating Kids' Access to Care Act - improve childrens access to needed out-of-state health care by streamlining Medicaid provider screening and enrollment processes. HR 6364: Medicare Telehealth Privacy Act of 2023 - To amend title XVIII of the Social Security Act to maintain certain telehealth flexibilities relating to provider privacy under the Medicare program S 2764/HR 5391: Protecting Patient Access to Cancer and Complex Therapies Act of 2023 - ensures patients will be able to access critical medications and providers will be reimbursed fairly, unaffected by drug pricing negotiations between Medicare and drug manufacturers. S 2345/HR 4714: Pediatricians Accelerate Childhood Therapies Act of 2023 - requires the National Institutes of Health (NIH) to make awards to support early-career pediatric researchers. It also provides statutory authority for the NIH Pediatric Research Consortium to coordinate pediatric research across national health research institutions. S 3967/HR 7623: Telehealth Modernization Act of 2024 - permanently extends telehealth flexibilities for Medicare beneficiaries. S 4518/HR 8702: To Amend title XVIII of the Social Security Act to establish requirements with respect to the use of prior authorization under Medicare Advantage plans - prior authorization HR 7384: Creating Hope Reauthorization Act of 2024 - This bill extends until FY2029 a Food and Drug Administration program that awards priority review vouchers to manufacturers of drugs that treat rare pediatric diseases. HR 8412: Clinical Trial Modernization Act - To modernize clinical trials and remove barriers for participation in clinical trials, and for other purposes. S 2407/HR 4818: Treat and Reduce Obesity Act of 2023 - Expands Medicare coverage of intensive behavioral therapy for obesity. HR 6545: Physician Fee Schedule Update and Improvements Act - To amend title XVIII of the Social Security Act to make improvements to the physician fee schedule under the Medicare program. HR 6683: Preserving Seniors' Access to Physicians Act of 2023 - This bill increases payments under the Medicare physician fee schedule for 2024. S 4935: Physician Fee Stabilization Act - A bill to amend title XVIII of the Social Security Act to update the budget neutrality threshold under the Medicare physician fee schedule. S. 4905: Innovation in Pediatric Drugs Act of 2024 - Ensure that children with rare diseases can benefit from new and innovative treatments. H.R. 6664: Innovation in Pediatric Drugs Act of 2023 - To encourage innovation in the development of pediatric drugs, and for other purposes. S. 4349: Electronic Prior Authorization for Prescription Drugs Act - A bill to require private health plans to provide for secure electronic transmission of prior authorization requests for prescription drugs.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE