RARE Act

Policy issues related to federal regulation of the healthcare industry and rare diseases, including the Retaining Access and Restoring Exclusivity (RARE) Act (118th, H.R. 7383 / S. 1214).

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

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

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

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

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

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

Promising Pathways Act (S.1906) - Discussion around a provisional approval path for drugs and biological interventions that meet unmet needs of rare diseases like ALS and coverage for these drugs. BENEFIT Act of 2023 (H.R.1092/S.526) - Provisions related to increases in patient and advocate role in FDA benefit-risk framework for drug approval through leveraging patient experience, PFDD, and related data. RARE Act (H.R.7383) - All provisions

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Newborn Screening Save Lives Reauthorization Act; Telehealth; Appropriations; S. 526, H.R. 1092 - Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT Act); Access to Genetic Counselor Services Act; Precision Medicine Answers for Kids Today Act (PMAKTA); MVP Act; H.R. 830 - HELP Copays Act; Safe Step Act; Accelerating Kids Access to Care Act; Technical corrections to the IRA; H.R. 6094 - PROTECT Rare Act; H.R. 7384, S. 4583 - Creating Hope Reauthorization Act; H.R. 7383, S. 1214 - RARE Act; H.R. 3433 - Give Kids a Chance Act of 2023; H.R. 6664 - Innovation in Pediatric Drugs Act of 2023; H.R. 9979 - Scientific External Process for Educated Review of Therapeutics (EXPERT) Act of 2024; H.R. 3433 - Give Kids a Chance Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Policy issues related to federal regulation of the healthcare industry and rare diseases, including the Retaining Access and Restoring Exclusivity (RARE) Act (H.R. 7383 / S. 1214, 118th Congress).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Testified in front of the ACHDNC on newborn screening 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 Filed comments to the FDA on the Platform Technology Designation Program for Drug Development Guidance for Industry Testified in front of an FDA CBER Patient Listening Session Filed comments to FDA in Response to Diversity Action Plan Guidance Prepared for the reauthorization of the ACT for ALS

Client expense: $70,000 · 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

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 Testified in front of an FDA CBER Patient Listening Session Prepared for the reauthorization of the ACT for ALS Filed comments to the FDA on the Platform Technology Designation Program for Drug Development Guidance for Industry

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

Testified in front of the ACHDNC on newborn screening 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 Provided comments to Energy and Commerce Committee on Medicaid access 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 Filed comments, and joined coalition comments, on the Consumer Financial Protection Bureau Proposed Medical Debt Rule Filed comments to the FDA on the Platform Technology Designation Program for Drug Development Guidance for Industry Joined Coalition Comments to the Contract Year 2025 Medicare Physician Fee Schedule Proposed Rule Joined Coalition Comments in Support of the Think Differently Database Act Testified in front of an FDA CBER Patient Listening Session Filed comments to FDA in Response to Diversity Action Plan Guidance Prepared for the reauthorization of the ACT for ALS

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

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. 1692: HEALTH CARE AFFORDABILITY 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. 4408: PROMISING PATHWAY ACT; ALL PROVISIONS H.R. 4758: ACCELERATING KIDS' ACCESS TO CARE 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. 8694: MEDICAL RECORDS ACCESS FAIRNESS ACT OF 2024; ALL PROVISION H.R. 9774: HEALTH CARE AFFORDABILITY ACT OF 2024; ALL PROVISIONS S. 8: IMPROVING HEALTH INSURANCE AFFORDABILITY ACT OF 2023; 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. 1906: PROMISING PATHWAY 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 (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 DRAFT BILL ON TAX CREDITS FOR AMR DEVELOPMENT GENERAL DISCUSSIONS REGARDING CLINICAL TRIAL DIVERSITY 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 THE CONSUMER FINANCIAL PROTECTION BUREAU'S PURPOSED RULE TO PROHIBIT THE USE OF MEDICAL INFORMATION BY CREDITORS FOR CREDIT DETERMINATIONS GENERAL DISCUSSIONS REGARDING THIRD-PARTY ENTITIES THAT CONTRACT WITH EMPLOYER-SPONSORED HEALTH PLANS TO IMPORT PRESCRIPTION DRUGS FROM OUTSIDE THE UNITED STATES, ALSO KNOWN AS ALTERNATIVE FUNDING PLANS GENERAL DISCUSSIONS RELATED TO ANTIMICROBIAL RESISTANCE AND THE PASTEUR ACT

H.R. 830: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS H.R. 1692: HEALTH CARE AFFORDABILITY ACT OF 2023: ALL PROVISIONS H.R. 4758: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS H.R. 7383: RETAINING ACCESS AND RESTORING EXCLUSIVITY (RARE) ACT; ALL PROVISIONS H.R. 7623: TELEHEALTH MODERNIZATION ACT OF 2024; ALL PROVISIONS H.R. 7829: SUPPLEMENTAL OXYGEN ACCESS REFORM (SOAR) ACT OF 2024; ALL PROVISIONS H.R. 8702: IMPROVING SENIORS' TIMELY ACCESS TO CARE ACT OF 2024; ALL PROVISIONS H.R. 9774: HEALTH CARE AFFORDABILITY ACT OF 2024; ALL PROVISIONS S. 8: IMPROVING HEALTH INSURANCE AFFORDABILITY ACT OF 2023; ALL PROVISIONS S. 1355: HELP COPAYS ACT; ALL PROVISIONS S. 2372: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS S. 2973: MODERNIZING AND ENSURING PBM ACCOUNTABILITY ACT; ALL PROVISIONS S. 3821: SUPPLEMENTAL OXYGEN ACCESS REFORM (SOAR) ACT OF 2024; ALL PROVISIONS S. 4518: IMPROVING SENIORS' TIMELY ACCESS TO CARE ACT OF 2024; ALL PROVISIONS GENERAL DISCUSSIONS REGARDING PHARMACY BENEFIT MANAGER PRACTICES 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

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

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

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 advanced premium tax credits. Retaining Access and Restoring Exclusivity (RARE) Act H.R.7383. This bill specifies that the seven-year market exclusivity period for drugs for rare diseases or conditions (i.e., orphan drug exclusivity period) prohibits the approval of the same drug for the same approved use or indication with respect to the disease or condition. 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. Equitable Community Access to Pharmacist Services Act, H.R.1770, S.2477. This bill expands Medicare coverage to permanently include services provided by a pharmacist, including incidental services and supplies, related to testing, vaccines, and treatment for COVID-19, influenza, and certain other illnesses. This bill also requires drug manufacturers to report on the suppliers of ingredients used in their products. 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 Senate Finance Committee Drug Shortage Proposal. This draft 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, for the first time, 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. 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.

Newborn Screening Save Lives Reauthorization Act; Telehealth; Appropriations; S. 526, H.R. 1092 - Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT Act); Access to Genetic Counselor Services Act; Precision Medicine Answers for Kids Today Act (PMAKTA); MVP Act; H.R. 830 - HELP Copays Act; Safe Step Act; Accelerating Kids Access to Care Act; Technical corrections to the IRA; H.R. 6094 - PROTECT Rare Act; H.R. 7384, S. 4583 - Creating Hope Reauthorization Act; H.R. 7383, S. 1214 - RARE Act; H.R. 3433 - Give Kids a Chance Act of 2023; H.R. 6664 - Innovation in Pediatric Drugs Act of 2023

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. H.R.7383/S.1214: RARE Act. Inflation Reduction Act Implementation. PRV Reauthorization. Lab-developed tests.

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), SENATE

Joined coalition letter supporting appropriations for newborn screening Testified in front of the ACHDNC on newborn screening 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 HHSs final rule on section 1557 of the ACA Joined Coalition Comments on 2026 Notice of Benefit and Payment Parameters (6.7.24) Joined coalition comments on Medicare Payment Plans Supported the ALS Better Care Act Joined Coalition Comments to CMS in Response to RFI on Medicare Advantage Data Joined Coalition Comments on Pending National Coverage Analysis for Standing Systems in Power Wheelchairs Provided comments to Energy and Commerce Committee on Medicaid access 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 Benefit Act Supported the MINI Act Supported the NIH Clinical Trial Diversity Act Supported H.R. 4758, Accelerating Kids Access to Care Act Supported the introduction of legislation that increases access to genetic testing and genetic counselors 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

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

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 HHSs final rule on section 1557 of the ACA Joined Coalition Comments on 2026 Notice of Benefit and Payment Parameters (6.7.24) Joined coalition comments on Medicare Payment Plans Joined Coalition Comments to CMS in Response to RFI on Medicare Advantage Data 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

Client expense: $80,000 · 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

Joined coalition letter supporting appropriations for newborn screening Testified in front of the ACHDNC on newborn screening 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 Benefit Act Supported the NIH Clinical Trial Diversity Act Supported robust funding for NCATS

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), Natl Institutes of Health (NIH), SENATE

H.R. 830: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS H.R. 4758: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS H.R. 7383: RETAINING ACCESS AND RESTORING EXCLUSIVITY (RARE) ACT; ALL PROVISIONS H.R. 7623: TELEHEALTH MODERNIZATION ACT OF 2024; ALL PROVISIONS H.R. 7829: SUPPLEMENTAL OXYGEN ACCESS REFORM (SOAR) ACT OF 2024; ALL PROVISIONS S. 1214: RARE ACT; ALL PROVISIONS S. 1355: 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 (DRAFT) IMPROVING SENIORS' TIMELY ACCESS TO CARE ACT; ALL PROVISIONS GENERAL DISCUSSIONS REGARDING THE ADVANCE PAYMENTS OF THE PREMIUM TAX CREDIT (APTC) UNDER THE AFFORDABLE CARE ACT AND RELATED ISSUES 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, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION

Client expense: $300,000 · Firm income: Not reported

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. 2940: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS H.R. 4408: PROMISING PATHWAY ACT; ALL PROVISIONS H.R. 4758: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS H.R. 7383: RETAINING ACCESS AND RESTORING EXCLUSIVITY (RARE) ACT; ALL PROVISIONS H.R. 7436: ANTIMICROBIAL RESISTANCE RESEARCH ASSESSMENT ACT OF 2024; ALL PROVISIONS H.R. 7623: TELEHEALTH MODERNIZATION ACT OF 2024; ALL PROVISIONS H.R. 7829: SUPPLEMENTAL OXYGEN ACCESS REFORM (SOAR) ACT OF 2024; ALL PROVISIONS H.R. 8467: FARM, FOOD, AND NATIONAL SECURITY ACT OF 2024; PROVISIONS RELATING TO SUPPLEMENTAL NUTRITION ASSISTANCE PROGRAM (SNAP) AND THE THRIFTY FOOD PLAN S. 1214: RETAINING ACCESS AND RESTORING EXCLUSIVITY (RARE) 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. 1906: PROMISING PATHWAY ACT; ALL PROVISIONS S. 2372: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS S. 2973: MODERNIZING AND ENSURING PBM ACCOUNTABILITY ACT; ALL PROVISIONS S. 4426: PROMISING PATHWAY ACT 2.0; ALL PROVISIONS (DRAFT) IMPROVING SENIORS' TIMELY ACCESS TO CARE ACT; ALL PROVISIONS (DRAFT) MEDICAL RECORDS ACCESS FAIRNESS ACT; ALL PROVISIONS GENERAL DISCUSSIONS REGARDING THE ADVANCE PAYMENTS OF THE PREMIUM TAX CREDIT (APTC) UNDER THE AFFORDABLE CARE ACT AND RELATED ISSUES GENERAL DISCUSSIONS REGARDING DRAFT BILL ON TAX CREDITS FOR AMR DEVELOPMENT 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, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION

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. 2940: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS H.R. 4408: PROMISING PATHWAY ACT; ALL PROVISIONS H.R. 4758: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS H.R. 7383: RETAINING ACCESS AND RESTORING EXCLUSIVITY (RARE) ACT; ALL PROVISIONS H.R. 7436: ANTIMICROBIAL RESISTANCE RESEARCH ASSESSMENT ACT OF 2024; ALL PROVISIONS H.R. 7623: TELEHEALTH MODERNIZATION ACT OF 2024; ALL PROVISIONS H.R. 7829: SUPPLEMENTAL OXYGEN ACCESS REFORM (SOAR) ACT OF 2024; ALL PROVISIONS H.R. 8467: FARM, FOOD, AND NATIONAL SECURITY ACT OF 2024; PROVISIONS RELATING TO SUPPLEMENTAL NUTRITION ASSISTANCE PROGRAM (SNAP) AND THE THRIFTY FOOD PLAN S. 1214: RETAINING ACCESS AND RESTORING EXCLUSIVITY (RARE) 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. 1906: PROMISING PATHWAY ACT; ALL PROVISIONS S. 2372: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS S. 2973: MODERNIZING AND ENSURING PBM ACCOUNTABILITY ACT; ALL PROVISIONS S. 4426: PROMISING PATHWAY ACT 2.0; ALL PROVISIONS (DRAFT) IMPROVING SENIORS' TIMELY ACCESS TO CARE ACT; ALL PROVISIONS (DRAFT) MEDICAL RECORDS ACCESS FAIRNESS ACT; ALL PROVISIONS GENERAL DISCUSSIONS REGARDING THE ADVANCE PAYMENTS OF THE PREMIUM TAX CREDIT (APTC) UNDER THE AFFORDABLE CARE ACT AND RELATED ISSUES GENERAL DISCUSSIONS REGARDING DRAFT BILL ON TAX CREDITS FOR AMR DEVELOPMENT 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, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION

H.R. 830: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS H.R. 4758: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS H.R. 7383: RETAINING ACCESS AND RESTORING EXCLUSIVITY (RARE) ACT; ALL PROVISIONS H.R. 7623: TELEHEALTH MODERNIZATION ACT OF 2024; ALL PROVISIONS H.R. 7829: SUPPLEMENTAL OXYGEN ACCESS REFORM (SOAR) ACT OF 2024; ALL PROVISIONS S. 1214: RARE ACT; ALL PROVISIONS S. 1355: 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 (DRAFT) IMPROVING SENIORS' TIMELY ACCESS TO CARE ACT; ALL PROVISIONS GENERAL DISCUSSIONS REGARDING THE ADVANCE PAYMENTS OF THE PREMIUM TAX CREDIT (APTC) UNDER THE AFFORDABLE CARE ACT AND RELATED ISSUES 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, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION

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

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 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; 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; 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; 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

Issues related to the development of therapies for rare diseases: drug pricing; Medicare and Medicaid; R&D tax expensing. 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

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

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. 1692, Improving Health Insurance Affordability Act of 2023, S.8. House and Senate bills would permanently extend the enhanced advanced premium tax credits. Retaining Access and Restoring Exclusivity (RARE) Act H.R.7383. This bill specifies that the seven-year market exclusivity period for drugs for rare diseases or conditions (i.e., orphan drug exclusivity period) prohibits the approval of the same drug for the same approved use or indication with respect to the disease or condition. 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. 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. Equitable Community Access to Pharmacist Services Act, H.R.1770, S.2477. This bill expands Medicare coverage to permanently include services provided by a pharmacist, including incidental services and supplies, related to testing, vaccines, and treatment for COVID-19, influenza, and certain other illnesses. This bill also requires drug manufacturers to report on the suppliers of ingredients used in their products. Drug Shortage Prevention Act, H.R. 3008, Protecting PAHPA Act of 2023 H.R.4697. 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, Protecting PAHPA Act of 2023, H.R.4697. 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, Protecting PAHPA Act of 2023, H.R.4697. 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, Protecting PAHPA Act of 2023 H.R.4697. This bill expands the scope of required notifications about medical device shortages beyond public health emergencies. 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 Senate Finance Committee Drug Shortage Proposal 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). 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, for the first time, 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. 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. 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.

Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. H.R.7383/S.1214: RARE Act. Inflation Reduction Act Implementation. H.R.4408/S.1906: Promising Pathway Act (PPA). Lab-developed tests (LDTs) and genetic testing access. PRV Reauthorization.

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

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

Newborn Screening Save Lives Reauthorization Act; Telehealth; Appropriations; S. 526, H.R. 1092 - Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT Act); Access to Genetic Counselor Services Act; Precision Medicine Answers for Kids Today Act (PMAKTA); MVP Act; H.R. 830 - HELP Copays Act; Safe Step Act; Accelerating Kids Access to Care Act; Technical corrections to the IRA; H.R. 6094 - PROTECT Rare Act; H.R. 7384, S. 4583 - Creating Hope Reauthorization Act; H.R. 7383, S. 1214 - RARE Act; H.R. 3433 - Give Kids a Chance Act of 2023; H.R. 6664 - Innovation in Pediatric Drugs Act of 2023

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 3991 / S 1624, the Gabriella Miller Kids First Act; HR 3503 / S 1701, The NIH Clinical Trial Diversity Act; HR 6301 / S. 2039, The Cancer Drug Parity Act; HR 824, the Telehealth Benefit Expansion for Workers Act; HR 2868, the Association Health Plans; HR 2813, Self-Insurance Protection Act; HR 3799, CHOICE Arrangement Act; HR 4363 / S 2213, Comprehensive Cancer Survivorship Act; HR 2630 / S 652, the Safe Step Act; HR 7383 / S 1214, the RARE Act; S 2243, the Palliative Care and Hospice Education and Training Act; S 3167, Multiple Employer Welfare Arrangement (MEWA) Act; HR 1692 / S 8, the Health Care Affordability Act; HR 3800, the Chronic Disease Flexible Coverage Act; HR 5688 the Bipartisan HSA Improvement Act; HR 5687, the HSA Modernization Act; HR 5609, the Advancing Health Savings Act; HR 1773, the Consumer Protection for Medical Debt Collections Act; S 2483, the Strengthening Consumer Protections and Medical Debt Transparency Act; HR 6003 / S 3103, the Medical Debt Relief Act; HR 7384, the Creating Hope Reauthorization Act; HR 6664, the Innovation in Pediatric Drugs Act; HR 6963, the Pediatric Cancer Drug Supply Chain Act; HR 3433 / S 2897, the Give Kids a Chance Act; S 127, the Pharmacy Benefit Manager Transparency Act; S 113, the Prescription Pricing for the People Act; HR 2880, the Protecting Patients Against PBM Abuses Act; S 1967 the Patients Before Middlemen Act; S 2973, the Modernizing and Ensuring PBM Accountability Act; S 1339, the Pharmacy Benefit Manager Reform Act; S 1542, the DRUG Act; Implementation of the FY23 omnibus, specifically provisions related to increasing access to clinical trials; Implementation of the No Surprises Act; Federal rulemaking related to Short-term Limited Duration Insurance (STLDI) plans; 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; Legislation to increase federal investment in Consumer Assistance Programs; FDA draft guidance related to dose optimization studies in clinical trials

Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. Prescription Drug User Fee Act (PDUFA) Reauthorization. H.R.7383/S.1214: RARE Act. Inflation Reduction Act Implementation. Rare Pediatric Disease Priority Review Vouchers (RDP-PRV). Pediatric Study Requirements. Promising Pathway Act (PPA). Lab-developed tests (LDTs) and genetic testing access.

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

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

Newborn Screening Save Lives Reauthorization Act; Telehealth; Appropriations; S. 526, H.R. 1092 - Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT Act); Access to Genetic Counselor Services Act; Precision Medicine Answers for Kids Today Act (PMAKTA); MVP Act; H.R. 830 - HELP Copays Act; Safe Step Act; Accelerating Kids Access to Care Act; Technical corrections to the IRA; H.R. 6094 - PROTECT Rare Act; H.R. 7384 - Creating Hope Reauthorization Act; H.R. 7383; S. 1214 - RARE Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE