Palliative Care and Hospice Education and Training Act

Access to AEDs Act (H.R. 2370/S. 1024) Cardiac Arrest Survival Act (H.R. 1012) Easy Enrollment in Healthcare Act (H.R. 1113/S. 423) Palliative Care and Hospice Education and Training Act (S.2243) Self-Insurance Protection Act (H.R. 2813) Telehealth Benefit Expansion for Workers Act (H.R. 824) Association Health Plans Act (H.R. 2868) Improving Whole Health for Veterans with Chronic Conditions Act (S. 1954) FAMILY Act (S. 1714/H.R. 3481) Social Determinants of Health Act of 2023 (no bill number) Preventing Maternal Deaths Reauthorization Act of 2023 (H.R. 3838/S. 2415) PREEMIE Reauthorization Act of 2023 (H.R. 3226/S. 1573) Charles Rochester Blood Clot Prevention and Treatment Act (H.R. 5699) Cardiomyopathy Health Education, Awareness, Research, and Training in the Schools (HEARTS) Act (H.R. 6829) Stroke Act (no bill number) Harold B. Kohl Physical Activity for Americans Act (no bill number) Congenital Heart Futures Reauthorization Act of 2024 (H.R.7189) Living Donor Protection Act (H.R. 2923/S.1384) Health Care Affordability Act (H.R. 9774/S. 5194) Implementation of the No Surprises Act Credit for Caring Act (H.R. 7165/S. 3702) Legislation to allow Medicare to reimburse services provided by mobile stroke units (no bill number) HEARTS Act (H.R. 6829)

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

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

Access to AEDs Act (H.R. 2370/S. 1024) Cardiac Arrest Survival Act (H.R. 1012) Easy Enrollment in Healthcare Act (H.R. 1113/S. 423) Palliative Care and Hospice Education and Training Act (S.2243) Self-Insurance Protection Act (H.R. 2813) Telehealth Benefit Expansion for Workers Act (H.R. 824) Association Health Plans Act (H.R. 2868) Improving Whole Health for Veterans with Chronic Conditions Act (S. 1954) FAMILY Act (S. 1714/H.R. 3481) Social Determinants of Health Act of 2023 (no bill number) Preventing Maternal Deaths Reauthorization Act of 2023 (H.R. 3838/S. 2415) PREEMIE Reauthorization Act of 2023 (H.R. 3226/S. 1573) Charles Rochester Blood Clot Prevention and Treatment Act (H.R. 5699) Cardiomyopathy Health Education, Awareness, Research, and Training in the Schools (HEARTS) Act (H.R. 6829) Stroke Act (no bill number) Harold B. Kohl Physical Activity for Americans Act (no bill number) Congenital Heart Futures Reauthorization Act of 2024 (H.R.7189) A resolution designating September 2024 as "National Cholesterol Education Month" and September 30, 2024, as "LDL-C Awareness Day"(S.Res.566) Living Donor Protection Act (H.R. 2923/S.1384) Health Care Affordability Act (H.R. 9774/S. 5194) Opposed H.J. Res. 181 - Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Labor relating to "Definition of 'Employer'-Association Health Plans" Implementation of the No Surprises Act HHS finalization of proposed rule on Short-Term, Limited-Duration Insurance; Independent, Non- coordinated Excepted Benefits Coverage; Level-Funded Plan Arrangements; and Tax Treatment of Certain Accident and Health Insurance (CMS-9904-P)

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

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

Access to AEDs Act (H.R. 2370/S. 1024) Cardiac Arrest Survival Act (H.R. 1012) Easy Enrollment in Healthcare Act (H.R. 1113/S. 423) Palliative Care and Hospice Education and Training Act (S.2243) Self-Insurance Protection Act (H.R. 2813) Telehealth Benefit Expansion for Workers Act (H.R. 824) Association Health Plans Act (H.R. 2868) Improving Whole Health for Veterans with Chronic Conditions Act (S. 1954) FAMILY Act (S. 1714/H.R. 3481) Social Determinants of Health Act of 2023 (no bill number) Preventing Maternal Deaths Reauthorization Act of 2023 (H.R. 3838/S. 2415) PREEMIE Reauthorization Act of 2023 (H.R. 3226/S. 1573) Charles Rochester Blood Clot Prevention and Treatment Act (H.R. 5699) Cardiomyopathy Health Education, Awareness, Research, and Training in the Schools (HEARTS) Act (H.R. 6829) Stroke Act (no bill number) Harold B. Kohl Physical Activity for Americans Act (no bill number) Congenital Heart Futures Reauthorization Act of 2024 (H.R.7189) A resolution designating September 2024 as "National Cholesterol Education Month" and September 30, 2024, as "LDL-C Awareness Day"(S.Res.566) Living Donor Protection Act (H.R. 2923/S.1384) Health Care Affordability Act (H.R. 9774/S. 5194) Opposed H.J. Res. 181 - Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Labor relating to "Definition of 'Employer'-Association Health Plans" Implementation of the No Surprises Act HHS finalization of proposed rule on Short-Term, Limited-Duration Insurance; Independent, Non- coordinated Excepted Benefits Coverage; Level-Funded Plan Arrangements; and Tax Treatment of Certain Accident and Health Insurance (CMS-9904-P)

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

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

Access to AEDs Act (H.R. 2370/S. 1024) Cardiac Arrest Survival Act (H.R. 1012) Easy Enrollment in Healthcare Act (H.R. 1113/S. 423) Palliative Care and Hospice Education and Training Act (S.2243) Self-Insurance Protection Act (H.R. 2813) Telehealth Benefit Expansion for Workers Act (H.R. 824) Association Health Plans Act (H.R. 2868) Improving Whole Health for Veterans with Chronic Conditions Act (S. 1954) FAMILY Act (S. 1714/H.R. 3481) Social Determinants of Health Act of 2023 (no bill number) Preventing Maternal Deaths Reauthorization Act of 2023 (H.R. 3838/S. 2415) PREEMIE Reauthorization Act of 2023 (H.R. 3226/S. 1573) Charles Rochester Blood Clot Prevention and Treatment Act (H.R. 5699) Cardiomyopathy Health Education, Awareness, Research, and Training in the Schools (HEARTS) Act (H.R. 6829) Stroke Act (no bill number) Harold B. Kohl Physical Activity for Americans Act (no bill number) Congenital Heart Futures Reauthorization Act of 2024 (H.R.7189) Living Donor Protection Act (H.R. 2923/S.1384) Health Care Affordability Act (H.R. 9774/S. 5194) Implementation of the No Surprises Act Credit for Caring Act (H.R. 7165/S. 3702) Legislation to allow Medicare to reimburse services provided by mobile stroke units (no bill number) HEARTS Act (H.R. 6829)

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

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

Child passenger safety; Appropriations for the Indian Health Service - HIS; Appropriations for Environmental Programs (including EPA) - EPA; Maternal, Infant, and Early Childhood Home Visiting Program Reauthorization & Implementation - HRSA, CMS, HHS, ACF; Infant sleep product safety - CPSC; Lead exposure prevention - EPA, CDC, HUD, FDA; Food safety - FDA, EPA, CDC; Paid family and medical leave; Regulation of high-powered magnet sets - CPSC; Climate change, Inflation Reduction Act Implementation - EPA; Vehicle emissions standards - EPA, NHTSA; Button battery ingestions - CPSC; Early childhood education - HHS; Child product safety and injury prevention - CPSC; Furniture tip-overs - CPSC; Child Abuse Prevention and Treatment Act (CAPTA) Reauthorization; CAPTA Plans of safe care grants - HHS, ACF & ASPE; Family First Prevention Services Act implementation - HHS, ACF; CAPTA Fatalities Prevention and Response - HHHS, ACF; Title IV-B Reauthorization (including H.R. 9076: Protecting Americas Children by Strengthening Families Act) - HHS, ACF; Congregate care reform - HHS, ACF; Mental health supports for foster youth/former foster youth - HHS, ACF; Mercury and Air Toxics Standards, ozone and particulate matter NAAQS, EPA greenhouse gas regulation - EPA; QRTP/IMDs (including H.R. 4056 - Ensuring Medicaid Continuity for Children in Foster Care Act of 2023) - HHS, ACF; Firearm Violence Prevention (Including Research Funding; Background Checks) - WH Domestic Policy Council; WH Office of Gun Violence Prevention; CDC; NIH; DOJ; Pregnant Workers Fairness Act Implementation - EEOC; Childcare Funding & Resources - HHS, OCC; Native American Child Health - DOI; EPA, HHS, HIS; Water Beads (including H.R. 4648: Ban Water Beads Act; S. 4298: Esthers Law) - CPSC Continuous Eligibility for Children in Medicaid and CHIP (including H.R. 9688 - Keep Kids Covered Act) - HHS/CMS; Medicaid Payment Parity (including H.R. 952 - Kids Access to Primary Care Act) - HHS/CMS; Access to Care in Medicaid/CHIP - HHS/CMS; Medicaid/CHIP renewal policies - HHS/CMS; QRTP/IMDs (including H.R. 4056 - Ensuring Medicaid Continuity for Children in Foster Care Act of 2023, and S. 3196 - Ensuring Medicaid Continuity for Children in Foster Care Act of 2023); Accelerating Kids Access to Care Act (HR 4758, S 2372); Medicaid Early and Periodic Screening, Diagnostic, and Treatment requirement - HHS/CMS; Vaccines for Children program improvements - HHS/CMS, CDC; Medicaid prior authorization and medical necessity determinations; Telehealth - DEA tele-prescribing extension and Medicare telehealth extension - HHS, DEA; H.R. 10438 - Helping Families Access Pediatric Care Act; S. 2243 - Palliative Care and Hospice Education and Training Act (PCHETA); CY2025 Medicare Physician Fee Schedule - CMS Standards in ORR Custody - ORR, HHS; Licensure of ORR Shelters - ORR, HHS; Public Charge; Child Nutrition Reauthorization/WIC - USDA; SNAP/Farm Bill - USDA; Mental Health for Children HRSA; H.R. 6, DREAM Act; Medical Nutrition Equity Act; Lift the Bar Act (H.R. 4170/S. 2038); PAHPA Reauthorization; CARE for Families Act HR 3107; WIC Act (S. 1604/H.R. 3364); MODERN WIC Act (S. 984/H.R. 2424) Strengthening Efforts to End Violence Against Children Act (H.R. 4798); MINDS Act (H.R. 1570/S. 767); FY25 SFOPS Appropriations - report language on children with disabilities globally; International Protections for Children with Disabilities Act (S.847) - subsection S.4797; Implementation of the Global Child Thrive Act - USAID; Violence Against Children Ministerial Meeting - HHS, NSC, USAID; Violence Against Children Surveys - Department of State; Issue/Bill - Agency FY25 Labor, Health and Human Services, and Education Appropriations Bill: Pediatric Subspecialty Loan Repayment Program, Firearm Injury and Mortality Prevention Research, Pediatric Mental Health Care Access Program, Emergency Medical Services for Children, National Center for Birth Defects and Developmental Disabilities, Global Immunization, Sudden Unexpected Infant Death and Sudden Death in Childhood, Vaccine Injury Compensation Program, VACCINES Act, Antimicrobial Resistance, Maternal and Child Health, School Based Health Centers, Healthy Start, Section 317 Immunization Grants; FY25 Agriculture, Rural Development, Food and Drug Administration Appropriations Bill: Pediatric Device Consortia; Newborn Screening Saves Lives Reauthorization Act; FY25 National Defense Authorization Act - Department of Defense / Defense Health Agency; Defense Health Agency - Fluoride varnish; Improving the Health of Children Act; Strengthening the Vaccines for Children Program Act; Banning Electronic Stimulation Devices - FDA; SSI Savings Penalty Elimination Act (S.2767/H.R.5408); HCBS Access Act (S.762/H.R. 1493); Better Care Better Jobs Act (S.100/H.R. 547); Autism Family Caregivers Act; PREVENT HPV Cancers Act (H.R. 3633); Supplemental Security Income Equality Act (H.R. 256); IDEA Full Funding Act (S.2217/H.R.4519); Promoting Physical Activity for Americans Act (S.397); Pandemic and All Hazards Preparedness Act (PAHPA); PREEMIE Reauthorization Act (H.R. 3226/S. 1573); Autism CARES Act of 2024 (H.R. 7213/S.4762); Supplemental Security Income/Social Security - Social Security Administration; School Access to Naloxone Act (H.R. 3065); HEADs UP Act (H.R. 3380); Preventing Maternal Deaths Reauthorization Act of 2023 (S. 2415/H.R.3838); SHINE for Autumn Act (H.R.5012/S.2647); Artificial Intelligence; Congenital Heart Futures Reauthorization Act (S.3757/H.R.7189); HERO Act (H.R. 6251); SSI Restoration Act (H.R. 7138); NURSE Act (S. 3953/H.R. 3197); Vaccines for Children coverage of Nirsevimab and COVID-19 immunizations - CDC, HHS; WEAR IT Act (H.R. 6279); Probiotic use in the NICU - FDA, CDC, NIH; Maternal mental health/perinatal mental health Kids Online Safety Act (S. 1409/H.R. 7891); Children and Teens Online Privacy Protection Act (S. 1418/H.R. 7890); Legislation to Protect Young People Online; Pediatric Subspecialty Loan Repayment Program Funding and Program Implementation - Health Resources and Services Administration; Adolescent Health Issues, including mpox -Department of Health and Human Services Office of the Assistant Secretary for Health; Regulation of Tobacco Products -Food and Drug Administration; Innovation in Pediatric Drugs Act (H.R. 6664); Ethical Considerations when Studying Youth Online -White House Office of Science and Technology Policy

Client expense: $170,000 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Consumer Product Safety Commission (CPSC), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Highway Traffic Safety Administration (NHTSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), U.S. Agency for International Development (USAID), White House Office

Linking Seniors to Needed Legal Services Act (H.R. 8588) Accelerating Access to Dementia & Alzheimers Provider Training (AADAPT) Act (S. 4276/H.R. 7688) Amending the Rules of the House of Representatives to establish a Permanent Select Committee on Aging (H. Res. 1029) Improving Seniors' Access to Timely Care Act (S. 4532/H.R. 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 Harmonizing Environmental Analyses and Launching Therapeutic Hubs to Yield Bolstered Research And Innovation in Neurological Science (HEALTHY BRAINS) Act (H.R. 9233) Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT) Act (S. 526/H.R. 1092) Essential Caregivers Act of 2024 (S. 4280/H.R. 8331) Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691) PACE Part D Choice Act of 2023 (S. 1703/H.R. 3549) Credit for Caring Act of 2024 (S. 3702/H.R. 7165) Paid Family and Medical Leave Tax Credit Extension and Enhancement Act (S. 3680) CONNECT for Health Act of 2023 (S. 2016 / H.R. 4189) Lifespan Respite Care Reauthorization Act (H.R. 6160) to amend the Public Health Service Act to reauthorize a lifespan respite care program DeOndra Dixon Investigation of Co-occurring Conditions across the Lifespan to Understand Down Syndrome (INCLUDE) Project Act of 2024 (H.R. 7406) NAPA Reauthorization Act (S. 133/H.R. 619/P.L. 118-92) Alzheimers Accountability and Investment Act (S. 134/H.R. 620/P.L. 118-93) Comprehensive Care for Alzheimers Act (S. 626/H.R. 1637) Elizabeth Dole Home Care Act of 2023 (S. 141/H.R. 542) Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act (H.R. 8371) VA Clinician Appreciation, Recruitment, Education, Expansion, and Retention Support (CAREERS) Act of 2023 (S. 10) Mandating Exclusive Review of Individual Treatments (MERIT) Act (H.R. 133) Access to Innovative Treatments Act of 2023 (H.R. 2408) Elder Justice Reauthorization and Modernization Act of 2023 (H.R. 2718/S. 1198) Expanding Veterans Options for Long Term Care Act (H.R.1815/S. 495) Palliative Care and Hospice Education and Training Act (S.2243) Facilitating Innovative Nuclear Diagnostics Act of 2023 (H.R. 1199/S. 1544) Supporting Our Seniors Act (S. 2584) Alleviating Barriers for Caregiving Act (S. 3109) Reauthorization of the BOLD Infrastructure for Alzheimer's Act (P.L. 115-406) BOLD Reauthorization Act (P.L.118-142) Catching Up Family Caregivers Act (S. 5149 / H.R. 9764) Improving Retirement Security for Family Caregivers Act (S. 5148 / H.R. 9765) Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease Other matters related to care payment models, including the GUIDE model Other matters related to Medicare care planning code 99483 Other matters related to health care workforce shortages Other matters related to home- and community-based services Other matters related to disaster preparedness and older adults Other matters related to Social Security Other matters related to technology-enabled collaborative learning and capacity-building models (Project ECHO) Other matters related to beta amyloid PET scans Other matters related to selected diagnoses and services rendered under ICD-10 Other matters related to caregiving Other matters related to medical devices other matters related to rural health other matters related to veterans health other matters related to Tricare Other matters related to research Other matters related to biomarkers including blood based tests and cerebral spinal fluid (csf)

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE, Social Security Administration (SSA), Veterans Affairs, Dept of (VA)

H.R.8412 - Clinical Trial Modernization Act; a bill to modernize clinical trials and remove barriers for participation in clinical trials, and for other purposes. H.R. 2916/S. 1840 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act of 2023; bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2024 through 2028 H.R. 1092/S. 562 -Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act; requiring the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies and patient-reported outcome data, in the risk-benefit assessment framework used in the process for approving new drugs H.R. 3503/S. 1701 - NIH Clinical Trial Diversity Act; To direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 4363/S. 2213 - Comprehensive Cancer Survivorship Act; a bill to address the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment, in order to improve survivorship, treatment, transition to recovery and beyond, quality of life and palliative care, and long-term health outcomes, including by developing a minimum standard of care for cancer survivorship, irrespective of the type of cancer, a survivor's background, or forthcoming survivorship needs, and for other purposes. S. 2243 - Palliative Care and Hospice Education and Training Act; a bill amend the Public Health Service Act to increase the number of permanent faculty in palliative care at accredited allopathic and osteopathic medical schools, nursing schools and other programs, including social work, physician assistant, and chaplaincy education programs, to promote education and research in palliative care and hospice, and to support the development of faculty careers in academic palliative and hospice care. S. 2140 - Patient Eligibility Restoration Act; a bill to amend the law relating to patent subject matter eligibility to establish that only specified subject matter (e.g., a natural process wholly independent of human activity) is ineligible for patenting. Policies related to sterile injectable medications shortages Policies related to administrative actions necessary in breast imaging and breast cancer diagnosis Policies related to genetic counseling and testing Policies to increase clinical trial diversity and access for underrepresented populations Policies related to cancer survivorship Policies related to PBM and drug cost transparency Comments related to draft Womens Preventive Services Initiative recommendations to Health Resources and Services Administration regarding screening for Breast Cancer Screening for Women at Average Risk and Patient Navigation Services for Breast and Cervical Cancer Screening Comments in response to Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice (FDA-2024-D-2052)

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

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

Medicare home health payment policy. Medicare hospice payment policy. Medicaid HCBS payment and eligibility policy. Hospice Face to Face Telehealth recertification. H.R. 4189/S. 2016, CONNECT for Health Act. Health information technology funding and standards for long-term post-acute care providers. Hospice Special Focus Program (SFP). Access to Home and Community-Based Services and Long-Term Care Pharmacy services. Medicare Limited Income Newly Eligible Transition (LINET) program. S. 3109, Alleviating Barriers for Caregivers (ABC) Act. Medicare low-income outreach and enrollment funding. H.R. 7148, Medicare Home Health Accessibility Act. H.R. 7165/S. 3702, Credit for Caring Act of 2024. H.R. 7573, Stop Unfair Medicaid Recoveries Act. S. 2243, Palliative Care and Hospice Education and Training Act. H.R. 8114, to prohibit the Secretary of Health and Human Services from finalizing a rule proposed by the Centers for Medicare & Medicaid Services to place certain limitations on Medicaid payments for home or community-based services. H.R. 2941, Recognizing the Role of Direct Support Professionals Act. Draft legislation providing various reforms to the Medicare Hospice benefit. Hospice program integrity concerns. Controlled substances prescribing policy. Medicare hospice cost-savings research and draft legislation. H.R. 5159/S. 2137, Preserving Access to Home Health Act of 2023. CMS Proposed Medicaid Access Rule. S. 1845, Expanding Access to Palliative Care Act. H.R. 4104/S. 1976, Preserving Patient Access to Home Infusion Act.

Client expense: $180,000 · Firm income: Not reported

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

S. 2243, Palliative Care and Hospice Education and Training Act.

Client expense: $180,000 · Firm income: Not reported

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

Issues regarding healthcare workforce shortages. S. 2840, Bipartisan Primary Care and Health Workforce Act. S. 2243, The Palliative Care and Hospice Education and Training Act (PCHETA). Issues related to community based palliative care. Issues regarding bereavement care.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

(H.R.6033) - Supporting Patient Education and Knowledge (SPEAK) Act - Expressed support for the Supporting Patient Education and Knowledge. This legislation authorizes the Department of Health and Human Services to identify best practices and ways to improve telehealth access for patients with limited English proficiency and create new resources for telehealth providers. The bill outlines participation by health information technology providers, physicians, hospitals, insurance companies and language services providers in the process. Urged Congress to provide adequate resources including increased training and development programs to bolster the workforce, as well as to provide more flexibility in meeting staffing requirements and standards, including telehealth options. (H.R. 7623) Telehealth Modernization Act: Expressed support for the Telehealth Modernization Act - This legislation ensures that seniors and rural patients who may not have internet connectivity can receive the care they need through audio-only telehealth services, in addition to allowing health centers and rural health clinics to provide telehealth services. (H.R. 3305/S. 1606) Black Maternal Health Momnibus Act - Expressed support for the Black Maternal Health Momnibus Act. This legislation would make critical investments in the social determinants of health, address behavioral health needs, cultural competency, and gaps in the perinatal workforce, and bolster the collection of data to address every driver of maternal mortality, morbidity, and disparities in the United States. (H.R. 8245) Rural Hospital Stabilization Act: Expressed support for the Rural Hospital Stabilization Act. This legislation would ensure that healthcare providers in rural areas continue to provide services and meet their communities' needs. (H.R. 8244) Ensuring Seniors' Access to Care Act: Expressed support for the Ensuring Seniors' Access to Care Act. This legislation would allow nursing home providers, who have been prohibited from training staff to be certified nurse aids (CNA) because of compliance penalties, to begin training staff once they have demonstrated their return to compliance, rather than having to wait a full two years. Urged Congress to make essential telehealth flexibilities permanent well before the statutory deadline of Dec. 31, 2024. (S. 3410/H.R. 5796) The Protecting Rural Seniors' Access to Care Act - Expressed support for the Protecting Rural Seniors' Access to Care Act. This legislation would prohibit HHS from finalizing a proposed nursing home staffing requirement rule and establish an advisory panel on nursing home staffing. (H.R. 3226/S.1573) The PREMIE Reauthorization Act - Expressed support for the PREMIE Reauthorization Act. This legislation would reauthorize essential maternal and infant health programs and research at a time when maternal and infant death rates, especially in communities of color, have increased dramatically. (2584/S.2768) The Safety from Violence for Healthcare Employees Act - Expressed support for the Safety from Violence for Healthcare Employees Act. This legislation would address rising incidents of violence in healthcare settings by establishing stronger legal penalties for people who knowingly and intentionally assault or intimidate hospital employees. (H.R. 5568) The Care for Moms Act - Expressed support for the Care for Moms Act. This legislation supports the maternal health workforce, promotes access to prenatal and postpartum care, and provides essential resources to providers in rural areas. Urged Congress to support legislation on Proposed Nursing Home Staffing Requirements that prohibits the HHS Secretary from finalizing a proposed nursing home staffing rule. (H.R. 4771) - Children's Health Insurance Program Permanency (CHIPP) Act - Expressed support for the Children's Health Insurance Program Permanency (CHIPP) Act. This legislation would make the Children's Health Insurance Program (CHIP) permanent and place it on par with other federal public health insurance programs rather than needing periodic reauthorization. (S. 2415/H.R. 3838) - Preventing Maternal Deaths Reauthorization Act of 2023 - Expressed support for Preventing Maternal Deaths Reauthorization Act of 2023. This legislation continues crucial federal support for the state-based maternal mortality review committees (MMRCs) that review pregnancy-related deaths to identify causes and make recommendations for the prevention of future mortalities. Provided the Senate with information regarding the 340B program and expressed strong support for continuing to strengthen and protect this vital program. Urged Congress to provide a $1 billion increase for the Title V Maternal and Child Health (MCH) Services Block Grant in the FY2025 Labor, Health and Human Services, Education & Related Agencies Appropriations bill. Urged Congress to provide $100 million for the Surveillance for Emerging Threats to Mothers and Babies (SET-NET) at the Centers for Disease Control and Prevention (CDC). Urged Congress to bolster existing federal programs to build a strong health workforce and improve primary care to assist health providers in hiring and retaining workers. (H.R. 2389) - Resident Physician Shortage Reduction Act - Expressed support for the Resident Physician Shortage Reduction Act. (H.R. 3290) - To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program-Expressed opposition. (H.R. 3561) Section 302 - Expressed opposition to Section 302. This legislative provision would reduce payments for the drug administration services furnished in off-campus provider-based departments. Urged Congress to support access to quality palliative care and appropriate effective pain management by prioritizing a Palliative Care, Trans-Institute Strategy by the National Institute of Aging (NIA) in the Labor, Health and Human Services, Education, and Related Agencies appropriations bill. Urged Congress to increase funding for federally qualified health centers (FQHCs) as part of the Community Health Center Fund reauthorization. (S.2243) - Palliative Care and Hospice Education and Training Act (PCHETA). Urged Congress to support the Palliative Care and Hospice Education and Training Act. This legislation would address the palliative care workforce shortage and help respond to pressing issues including appropriate pain management and pandemic preparedness.

Client expense: $166,785 · 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 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 health care workforce shortages. Monitored S. 2243, The Palliative Care and Hospice Education and Training Act (PCHETA).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to health care workforce shortages. Monitored S. 2243, The Palliative Care and Hospice Education and Training Act (PCHETA).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation to improve care at the end of life, including S.10 - the VA CAREERS Act Palliative Care and Hospice Education and Training Act (S 2243) CONNECT for Health Act of 2023 (HR 4189 / S 2016) H.R.8137 - Patient Access to End of Life Care Act Compassionate Care Act, HR 9237 / S 4949 FY25 Financial Services and General Government Appropriations (H.R. 8773 / S. 4928)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation to improve care at the end of life, including S.10 - the VA CAREERS Act Palliative Care and Hospice Education and Training Act (S 2243) CONNECT for Health Act of 2023 (HR 4189 / S 2016) H.R.8137 - Patient Access to End of Life Care Act Compassionate Care Act, HR 9237 / S 4949 FY25 Financial Services and General Government Appropriations (H.R. 8773 / S. 4928)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Federal funding for National Institutes of Health, National Cancer Institute, National Institue of Nursing Research and Title VIII Nursing Workforce Development Program. S. 2243, the Palliative Care and Hospice Education and Training Act HR 6301/S. 2039 the Cancer Drug Parity Act HR 5212/S. 5025, Firefighter Investments to Recognize Exposure to Cancer Act

Client expense: $41,200 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, White House Office

Workforce development and clinical training site issues Issues surrounding opioid use disorders and medication-assisted treatment H.R. 3523/S. 1710 - Perinatal Workforce Act H.R. 3305/S. 1606 - Black Maternal Health Momnibus Act Physician Assistant Education Public Health Initiatives Act S. 2243 - Palliative Care and Hospice Education and Training Act H.R. 3080 - Health Center Service Expansion and Provider Shortage Reduction Act S.2840 - Bipartisan Primary Care and Health Workforce Act H.R. 4531/S.3393 - Support for Patients and Communities Reauthorization Act H.R. 4933/S.462 - Mental Health Professionals Workforce Shortage Loan Repayment Act S.4169 - PCTEC Act

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

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

Issues affecting hospice providers. Issues regarding healthcare work force shortages. S. 2243, the Palliative Care and Hospice Education and Training Act (PCHETA). S. 1845 Expanding Access to Palliative Care Act. S. 2840, Bipartisan Primary Care and Health Workforce Act. Issues related to advanced care illness management. Issues regarding bereavement care. Issues relating to opioid prescribing.

Client expense: $300,000 · 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

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: $160,000 · Firm income: Not reported

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

Access to AEDs Act (H.R. 2370/S. 1024) Cardiac Arrest Survival Act (H.R. 1012) Easy Enrollment in Healthcare Act (H.R. 1113/S. 423) Palliative Care and Hospice Education and Training Act (S.2243) Self-Insurance Protection Act (H.R. 2813) Telehealth Benefit Expansion for Workers Act (H.R. 824) Association Health Plans Act (H.R. 2868) Improving Whole Health for Veterans with Chronic Conditions Act (S. 1954) FAMILY Act (S. 1714/H.R. 3481) Social Determinants of Health Act of 2023 (no bill number) Preventing Maternal Deaths Reauthorization Act of 2023 (H.R. 3838/S. 2415) PREEMIE Reauthorization Act of 2023 (H.R. 3226/S. 1573) Charles Rochester Blood Clot Prevention and Treatment Act (H.R. 5699) Cardiomyopathy Health Education, Awareness, Research, and Training in the Schools (HEARTS) Act (H.R. 6829) Stroke Act (no bill number) Harold B. Kohl Physical Activity for Americans Act (no bill number) Congenital Heart Futures Reauthorization Act of 2024 (H.R.7189) A resolution designating September 2024 as "National Cholesterol Education Month" and September 30, 2024, as "LDL-C Awareness Day"(S.Res.566) Living Donor Protection Act (H.R. 2923/S.1384) Health Care Affordability Act (H.R. 9774/S. 5194) Opposed H.J. Res. 181 - Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Labor relating to "Definition of 'Employer'-Association Health Plans" Implementation of the No Surprises Act HHS finalization of proposed rule on Short-Term, Limited-Duration Insurance; Independent, Non- coordinated Excepted Benefits Coverage; Level-Funded Plan Arrangements; and Tax Treatment of Certain Accident and Health Insurance (CMS-9904-P)

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

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

Linking Seniors to Needed Legal Services Act (H.R. 8588) Accelerating Access to Dementia & Alzheimers Provider Training (AADAPT) Act (S. 4276/H.R. 7688) Amending the Rules of the House of Representatives to establish a Permanent Select Committee on Aging (H. Res. 1029) Improving Seniors' Access to Timely Care Act (S. 4532/H.R. 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 Harmonizing Environmental Analyses and Launching Therapeutic Hubs to Yield Bolstered Research And Innovation in Neurological Science (HEALTHY BRAINS) Act (H.R. 9233) Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT) Act (S. 526/H.R. 1092) Essential Caregivers Act of 2024 (S. 4280/H.R. 8331) Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691) PACE Part D Choice Act of 2023 (S. 1703/H.R. 3549) Credit for Caring Act of 2024 (S. 3702/H.R. 7165) Paid Family and Medical Leave Tax Credit Extension and Enhancement Act (S. 3680) CONNECT for Health Act of 2023 (S. 2016 / H.R. 4189) Lifespan Respite Care Reauthorization Act (H.R. 6160) to amend the Public Health Service Act to reauthorize a lifespan respite care program DeOndra Dixon Investigation of Co-occurring Conditions across the Lifespan to Understand Down Syndrome (INCLUDE) Project Act of 2024 (H.R. 7406) NAPA Reauthorization Act (S. 133/H.R. 619/P.L. 118-92) Alzheimers Accountability and Investment Act (S. 134/H.R. 620/P.L. 118-93) Comprehensive Care for Alzheimers Act (S. 626/H.R. 1637) Elizabeth Dole Home Care Act of 2023 (S. 141/H.R. 542) VA Clinician Appreciation, Recruitment, Education, Expansion, and Retention Support (CAREERS) Act of 2023 (S. 10) Mandating Exclusive Review of Individual Treatments (MERIT) Act (H.R. 133) Access to Innovative Treatments Act of 2023 (H.R. 2408) Elder Justice Reauthorization and Modernization Act of 2023 (H.R. 2718/S. 1198) Expanding Veterans Options for Long Term Care Act (H.R.1815/S. 495) Palliative Care and Hospice Education and Training Act (S.2243) Facilitating Innovative Nuclear Diagnostics Act of 2023 (H.R. 1199/S. 1544) Supporting Our Seniors Act (S. 2584) Alleviating Barriers for Caregiving Act (S. 3109) Reauthorization of the BOLD Infrastructure for Alzheimer's Act (P.L. 115-406) BOLD Reauthorization Act (S. 3775/ H.R. 7218) Other matters related to Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease Other matters related to care payment models, including the GUIDE model Other matters related to Medicare care planning code 99483 Other matters related to health care workforce shortages Other matters related to home- and community-based services Other matters related to disaster preparedness and older adults Other matters related to Social Security Other matters related to technology-enabled collaborative learning and capacity-building models (Project ECHO) Other matters related to beta amyloid PET scans Other matters related to selected diagnoses and services rendered under ICD-10 Other matters related to caregiving Other matters related to medical devices other matters related to rural health other matters related to veterans health other matters related to Tricare Other matters related to research Other matters related to biomarkers including blood based tests and cerebral spinal fluid (csf)

Client expense: $540,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE, Social Security Administration (SSA), Veterans Affairs, Dept of (VA)

H.R.8412 - Clinical Trial Modernization Act; a bill to modernize clinical trials and remove barriers for participation in clinical trials, and for other purposes. H.R. 2916/S. 1840 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act of 2023; bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2024 through 2028 H.R. 1092/S. 562 -Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act; requiring the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies and patient-reported outcome data, in the risk-benefit assessment framework used in the process for approving new drugs H.R. 3503/S. 1701 - NIH Clinical Trial Diversity Act; To direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 4363/S. 2213 - Comprehensive Cancer Survivorship Act; a bill to address the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment, in order to improve survivorship, treatment, transition to recovery and beyond, quality of life and palliative care, and long-term health outcomes, including by developing a minimum standard of care for cancer survivorship, irrespective of the type of cancer, a survivor's background, or forthcoming survivorship needs, and for other purposes. S. 2243 - Palliative Care and Hospice Education and Training Act; a bill amend the Public Health Service Act to increase the number of permanent faculty in palliative care at accredited allopathic and osteopathic medical schools, nursing schools and other programs, including social work, physician assistant, and chaplaincy education programs, to promote education and research in palliative care and hospice, and to support the development of faculty careers in academic palliative and hospice care. S. 2140 - Patient Eligibility Restoration Act; a bill to amend the law relating to patent subject matter eligibility to establish that only specified subject matter (e.g., a natural process wholly independent of human activity) is ineligible for patenting. Comments in relation to the establishment of a Brain and Spine Metastasis Month Efforts related to breast screening recommendations by the United States Preventative Services Taskforce Policies related to ICD-10 codes for inflammatory breast cancer Policies related to sterile injectable medications shortages Policies related to administrative actions necessary in breast imaging and breast cancer diagnosis Policies related to genetic counseling and testing Policies to increase clinical trial diversity and access for underrepresented populations Policies related to cancer survivorship Policies related to PBM and drug cost transparency Policies related to reforms to the United States Preventative Services Taskforce Comments in response to Prohibition on Creditors and Consumer Reporting Agencies Concerning Medical Information (Regulation V) (CFPB-2024- 0023) Comments in response to the House Energy & Commerce Committee Framework for Discussion on Reforming the National Institutes of Health Comments in response to a Request for Information on 21st Century Cures Comments in response to Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (FDA-2021D-0789)

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Consumer Financial Protection Bureau (CFPB), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

Issues regarding healthcare workforce shortages. S. 2840, Bipartisan Primary Care and Health Workforce Act. S. 2243, The Palliative Care and Hospice Education and Training Act (PCHETA). Issues related to community based palliative care. Issues regarding bereavement care.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

(H.R.6033) - Supporting Patient Education and Knowledge (SPEAK) Act - Expressed support for the Supporting Patient Education and Knowledge. This legislation authorizes the Department of Health and Human Services to identify best practices and ways to improve telehealth access for patients with limited English proficiency and create new resources for telehealth providers. The bill outlines participation by health information technology providers, physicians, hospitals, insurance companies and language services providers in the process. Urged Congress to provide adequate resources including increased training and development programs to bolster the workforce, as well as to provide more flexibility in meeting staffing requirements and standards, including telehealth options. (H.R. 7623) Telehealth Modernization Act: Expressed support for the Telehealth Modernization Act - This legislation ensures that seniors and rural patients who may not have internet connectivity can receive the care they need through audio-only telehealth services, in addition to allowing health centers and rural health clinics to provide telehealth services. (H.R. 3305/S. 1606) Black Maternal Health Momnibus Act - Expressed support for the Black Maternal Health Momnibus Act. This legislation would make critical investments in the social determinants of health, address behavioral health needs, cultural competency, and gaps in the perinatal workforce, and bolster the collection of data to address every driver of maternal mortality, morbidity, and disparities in the United States. (H.R. 8245) Rural Hospital Stabilization Act: Expressed support for the Rural Hospital Stabilization Act. This legislation would ensure that healthcare providers in rural areas continue to provide services and meet their communities' needs. (H.R. 8244) Ensuring Seniors' Access to Care Act: Expressed support for the Ensuring Seniors' Access to Care Act. This legislation would allow nursing home providers, who have been prohibited from training staff to be certified nurse aids (CNA) because of compliance penalties, to begin training staff once they have demonstrated their return to compliance, rather than having to wait a full two years. Urged Congress to make essential telehealth flexibilities permanent well before the statutory deadline of Dec. 31, 2024. (S. 3410/H.R. 5796) The Protecting Rural Seniors' Access to Care Act - Expressed support for the Protecting Rural Seniors' Access to Care Act. This legislation would prohibit HHS from finalizing a proposed nursing home staffing requirement rule and establish an advisory panel on nursing home staffing. (H.R. 3226/S.1573) The PREMIE Reauthorization Act - Expressed support for the PREMIE Reauthorization Act. This legislation would reauthorize essential maternal and infant health programs and research at a time when maternal and infant death rates, especially in communities of color, have increased dramatically. (2584/S.2768) The Safety from Violence for Healthcare Employees Act - Expressed support for the Safety from Violence for Healthcare Employees Act. This legislation would address rising incidents of violence in healthcare settings by establishing stronger legal penalties for people who knowingly and intentionally assault or intimidate hospital employees. (H.R. 5568) The Care for Moms Act - Expressed support for the Care for Moms Act. This legislation supports the maternal health workforce, promotes access to prenatal and postpartum care, and provides essential resources to providers in rural areas. Urged Congress to support legislation on Proposed Nursing Home Staffing Requirements that prohibits the HHS Secretary from finalizing a proposed nursing home staffing rule. (H.R. 4771) - Children's Health Insurance Program Permanency (CHIPP) Act - Expressed support for the Children's Health Insurance Program Permanency (CHIPP) Act. This legislation would make the Children's Health Insurance Program (CHIP) permanent and place it on par with other federal public health insurance programs rather than needing periodic reauthorization. (S. 2415/H.R. 3838) - Preventing Maternal Deaths Reauthorization Act of 2023 - Expressed support for Preventing Maternal Deaths Reauthorization Act of 2023. This legislation continues crucial federal support for the state-based maternal mortality review committees (MMRCs) that review pregnancy-related deaths to identify causes and make recommendations for the prevention of future mortalities. Provided the Senate with information regarding the 340B program and expressed strong support for continuing to strengthen and protect this vital program. Urged Congress to provide a $1 billion increase for the Title V Maternal and Child Health (MCH) Services Block Grant in the FY2025 Labor, Health and Human Services, Education & Related Agencies Appropriations bill. Urged Congress to provide $100 million for the Surveillance for Emerging Threats to Mothers and Babies (SET-NET) at the Centers for Disease Control and Prevention (CDC). Urged Congress to bolster existing federal programs to build a strong health workforce and improve primary care to assist health providers in hiring and retaining workers. (H.R. 2389) - Resident Physician Shortage Reduction Act - Expressed support for the Resident Physician Shortage Reduction Act. (H.R. 3290) - To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program-Expressed opposition. (H.R. 3561) Section 302 - Expressed opposition to Section 302. This legislative provision would reduce payments for the drug administration services furnished in off-campus provider-based departments. Urged Congress to support access to quality palliative care and appropriate effective pain management by prioritizing a Palliative Care, Trans-Institute Strategy by the National Institute of Aging (NIA) in the Labor, Health and Human Services, Education, and Related Agencies appropriations bill. Urged Congress to increase funding for federally qualified health centers (FQHCs) as part of the Community Health Center Fund reauthorization. (S.2243) - Palliative Care and Hospice Education and Training Act (PCHETA). Urged Congress to support the Palliative Care and Hospice Education and Training Act. This legislation would address the palliative care workforce shortage and help respond to pressing issues including appropriate pain management and pandemic preparedness.

Client expense: $165,062 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues affecting hospice providers. Issues regarding healthcare work force shortages. S. 2243, the Palliative Care and Hospice Education and Training Act (PCHETA). S. 1845 Expanding Access to Palliative Care Act. S. 2840, Bipartisan Primary Care and Health Workforce Act. Issues related to advanced care illness management. Issues regarding bereavement care. Issues relating to opioid prescribing.

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

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

Issues related to health care workforce shortages. Monitored S. 2243, The Palliative Care and Hospice Education and Training Act (PCHETA).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to health care workforce shortages. Monitored S. 2243, The Palliative Care and Hospice Education and Training Act (PCHETA).

Client expense: $240,000 · 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.

Client expense: $1,650,000 · 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

S. 2243, Palliative Care and Hospice Education and Training Act.

Client expense: $180,000 · Firm income: Not reported

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

Medicare home health payment policy. Medicare hospice payment policy. Medicaid HCBS payment and eligibility policy. Hospice Face to Face Telehealth recertification. H.R. 4189/S. 2016, CONNECT for Health Act. Health information technology funding and standards for long-term post-acute care providers. Hospice Special Focus Program (SFP). Access to Home and Community-Based Services and Long-Term Care Pharmacy services. Medicare Limited Income Newly Eligible Transition (LINET) program. S. 3109, Alleviating Barriers for Caregivers (ABC) Act. Medicare low-income outreach and enrollment funding. H.R. 7148, Medicare Home Health Accessibility Act. H.R. 7165/S. 3702, Credit for Caring Act of 2024. H.R. 7573, Stop Unfair Medicaid Recoveries Act. S. 2243, Palliative Care and Hospice Education and Training Act. H.R. 8114, to prohibit the Secretary of Health and Human Services from finalizing a rule proposed by the Centers for Medicare & Medicaid Services to place certain limitations on Medicaid payments for home or community-based services. H.R. 2941, Recognizing the Role of Direct Support Professionals Act. Draft legislation providing various reforms to the Medicare Hospice benefit. Hospice program integrity concerns. Controlled substances prescribing policy. Medicare hospice cost-savings research. H.R. 5159/S. 2137, Preserving Access to Home Health Act of 2023. CMS Proposed Medicaid Access Rule. S. 1845, Expanding Access to Palliative Care Act.

Client expense: $180,000 · Firm income: Not reported

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

Federal funding for National Institutes of Health, National Cancer Institute, National Institue of Nursing Research and Title VIII Nursing Workforce Development Program. S. 2243, the Palliative Care and Hospice Education and Training Act HR 6301/S. 2039 the Cancer Drug Parity Act HR 5212/S. 5025, Firefighter Investments to Recognize Exposure to Cancer Act

Client expense: $47,500 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, White House Office

Workforce development and clinical training site issues Issues surrounding opioid use disorders and medication-assisted treatment H.R. 3523/S. 1710 - Perinatal Workforce Act H.R. 3305/S. 1606 - Black Maternal Health Momnibus Act Physician Assistant Education Public Health Initiatives Act S. 2243 - Palliative Care and Hospice Education and Training Act H.R. 3080 - Health Center Service Expansion and Provider Shortage Reduction Act S.2840 - Bipartisan Primary Care and Health Workforce Act H.R. 4531/S.3393 - Support for Patients and Communities Reauthorization Act H.R. 4933/S.462 - Mental Health Professionals Workforce Shortage Loan Repayment Act S.4169 - PCTEC Act Pathway to Practice Training program issues

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

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation to improve care at the end of life, including S.10 - the VA CAREERS Act Palliative Care and Hospice Education and Training Act (S 2243) CONNECT for Health Act of 2023 (HR 4189 / S 2016) H.R.8137 - Patient Access to End of Life Care Act Compassionate Care Act, HR 9237 / S 4949 FY25 Financial Services and General Government Appropriations (H.R. 8773 / S. 4928)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation to improve care at the end of life, including S.10 - the VA CAREERS Act Palliative Care and Hospice Education and Training Act (S 2243) CONNECT for Health Act of 2023 (HR 4189 / S 2016) H.R.8137 - Patient Access to End of Life Care Act Compassionate Care Act, HR 9237 / S 4949 FY25 Financial Services and General Government Appropriations (H.R. 8773 / S. 4928)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.8412 - Clinical Trial Modernization Act; a bill to modernize clinical trials and remove barriers for participation in clinical trials, and for other purposes. H.R. 2916/S. 1840 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act of 2023; bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2024 through 2028 H.R. 1092/S. 562 -Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act; requiring the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies and patient-reported outcome data, in the risk-benefit assessment framework used in the process for approving new drugs H.R. 3503/S. 1701 - NIH Clinical Trial Diversity Act; To direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 4363/S. 2213 - Comprehensive Cancer Survivorship Act; a bill to address the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment, in order to improve survivorship, treatment, transition to recovery and beyond, quality of life and palliative care, and long-term health outcomes, including by developing a minimum standard of care for cancer survivorship, irrespective of the type of cancer, a survivor's background, or forthcoming survivorship needs, and for other purposes. S. 2243 - Palliative Care and Hospice Education and Training Act; a bill amend the Public Health Service Act to increase the number of permanent faculty in palliative care at accredited allopathic and osteopathic medical schools, nursing schools and other programs, including social work, physician assistant, and chaplaincy education programs, to promote education and research in palliative care and hospice, and to support the development of faculty careers in academic palliative and hospice care. S. 2140 - Patient Eligibility Restoration Act; a bill to amend the law relating to patent subject matter eligibility to establish that only specified subject matter (e.g., a natural process wholly independent of human activity) is ineligible for patenting. Comments in response to draft legislation titled the Drug Shortages Prevention and Mitigation Act Comments in relation to the establishment of a Brain and Spine Metastasis Month Comments in response to a request for information on appropriate use of artificial intelligence in healthcare Efforts related to breast screening recommendations by the United States Preventative Services Taskforce Policies related to ICD-10 codes for inflammatory breast cancer Policies related to sterile injectable medications shortages Policies related to administrative actions necessary in breast imaging and breast cancer diagnosis Policies related to genetic counseling and testing Policies to increase clinical trial diversity and access for underrepresented populations Policies related to cancer survivorship Policies related to PBM and drug cost transparency Policies related to reforms to the United States Preventative Services Taskforce Comments in response to Draft Guidance for Industry: Cancer Clinical Trial Eligibility Criteria: Performance Status (FDA-2024-D-1377); Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications (FDA-2024-D1376); Cancer Clinical Trial Eligibility Criteria: Laboratory Values (FDA-2024-D-1402)

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

Access to AEDs Act (H.R. 2370/S. 1024) Cardiac Arrest Survival Act (H.R. 1012) Easy Enrollment in Healthcare Act (H.R. 1113/S. 423) Palliative Care and Hospice Education and Training Act (S.2243) Self-Insurance Protection Act (H.R. 2813) Telehealth Benefit Expansion for Workers Act (H.R. 824) Association Health Plans Act (H.R. 2868) Improving Whole Health for Veterans with Chronic Conditions Act (S. 1954) FAMILY Act (S. 1714/H.R. 3481) Social Determinants of Health Act of 2023 (no bill number) Preventing Maternal Deaths Reauthorization Act of 2023 (H.R. 3838/S. 2415) PREEMIE Reauthorization Act of 2023 (H.R. 3226/S. 1573) Charles Rochester Blood Clot Prevention and Treatment Act (H.R. 5699) Cardiomyopathy Health Education, Awareness, Research, and Training in the Schools (HEARTS) Act (HR 6829) Alleviating Barriers to Caregiving (ABC) Act (S. 3109) Legislation to enhance research, data collection, and education about stroke (no bill number) Harold B. Kohl Physical Activity for Americans Act (no bill number) Congenital Heart Futures Reauthorization Act of 2024 (H.R.7189) A resolution designating September 2023 as "National Cholesterol Education Month" and September 30, 2023, as LDL-C Awareness Day (S.Res.496) A resolution designating September 2024 as "National Cholesterol Education Month" and September 30, 2024, as "LDL-C Awareness Day" (S.Res.566) Expressing support for the goals and ideals of National Stroke Awareness Month (H. Res. 1216) A resolution designating May 2024 as American Stroke Month (S. Res. 711) Implementation of the No Surprises Act Department of Labor action to rescind Association Health Plan Final Rule (RIN 1210-AC16) HHS finalization of proposed rule on Section 1557; Nondiscrimination in Health Programs and Activities (RIN Number 0945AA17) HHS finalization of proposed rule on Clarifying Eligibility for a Qualified Health Plan (CMS-9894-P) HHS finalization of proposed rule on Short-Term, Limited-Duration Insurance; Independent, Non- coordinated Excepted Benefits Coverage; Level-Funded Plan Arrangements; and Tax Treatment of Certain Accident and Health Insurance (CMS-9904-P)

Client expense: $670,000 · Firm income: Not reported

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

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

Client expense: $540,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, 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 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

Client expense: $570,000 · 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), Natl Institutes of Health (NIH), SENATE, White House Office

Issues related to health care workforce shortages. S. 2243, The Palliative Care and Hospice Education and Training Act (PCHETA).

Client expense: $230,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues regarding healthcare workforce shortages. S. 2840, Bipartisan Primary Care and Health Workforce Act. S. 2243, The Palliative Care and Hospice Education and Training Act (PCHETA). Issues related to community based palliative care. Issues regarding bereavement care.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare home health payment policy. Medicare hospice payment policy. Medicaid HCBS payment and eligibility policy. CMMI VBID Medicare Advantage Carve-in proposal. Hospice Face to Face Telehealth recertification. H.R. 4189/S. 2016, CONNECT for Health Act. H.R. 547/S. 100, Better Care Better Jobs Act. Health information technology funding and standards for long-term post-acute care providers. Hospice Special Focus Program (SFP). Access to Home and Community-Based Services and Long-Term Care Pharmacy services. Medicare Limited Income Newly Eligible Transition (LINET) program. S. 3109, Alleviating Barriers for Caregivers (ABC) Act. Medicare low-income outreach and enrollment funding. H.R. 7148, Medicare Home Health Accessibility Act. H.R. 7165/S. 3702, Credit for Caring Act of 2024. H.R. 7573, Stop Unfair Medicaid Recoveries Act. S. 2243, Palliative Care and Hospice Education and Training Act. H.R. 8114, to prohibit the Secretary of Health and Human Services from finalizing a rule proposed by the Centers for Medicare & Medicaid Services to place certain limitations on Medicaid payments for home or community-based services. H.R. 2941, Recognizing the Role of Direct Support Professionals Act. Draft legislation providing various reforms to the Medicare Hospice benefit.

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

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