KATHLEEN SHEEHAN

Discussions around improving access, coverage, and prior authorization for treatments and drugs under Medicare, Medicare Advantage, and private insurance. Seniors Timely Access to Care (S.4532 / H.R. 8702) - CONNECT for Health Act of 2023 (H.R.4189/S.2016) - provisions related to permanent telehealth services in Medicare and interstate telehealth services. Telehealth Modernization Act (H.R. 7623 / S. 3967) - All Provisions. Protecting Health Care for All Patients Act of 2023 (H.R. 485) - provisions to ban the usage of quality adjusted life years in public insurance programs. HELP Copays Act (H.R.830 / S.1375) -- Provisions related to health insurance plans requirement to apply payments made by or on behalf of plan enrollees toward a plan's cost-sharing requirements, i.e. a ban on copay-accumulator adjust programs. BENEFIT Act of 2023 (H.R.1092/S.526) - Provisions related to increases in patient and advocate role in FDA benefit-risk framework for drug approval through leveraging patient experience, PFDD, and related data. Connecting Caregivers to Medicare Act of 2024 (H.R. 7274/S. 3766) - All provisions. Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691) - All provisions HEALTHY BRAINS Act (H.R. 9233) - All Provisions relating to creating a research grant program to study environmental toxin exposure, its impact on the development of neurodegenerative diseases like ALS, and developing strategies to prevent, treat, and slow the progression of neurodegenerative diseases.

Further Consolidated Appropriations Act of 2024 (HR 2882) & Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations (S. 2624) --Requested that the House and Senate Appropriations LHHS Subcommittee provide at least $150 million for ALS research at NIH in fiscal year 2024 to attract the next generation of scientists, accelerate the discovery and development of new treatments and increase the number of ALS clinical trials. Requested at least $75 000,000 to implement the expanded access program established by the ACT for ALS Act (P.L. 117-79). Requested at least $15 million to continue CDCs National ALS Registry and Biorepository in fiscal year 2024 to help identify risk factors for ALS to reduce the number of new cases, connect patients with clinical trials, conduct surveillance of incidence and prevalence and biospecimens, and support research of ALS prevention in the military. Requested the House and Senate Appropriations Defense Subcommittee provide at least $80 million for the ALS Research Program in fiscal year 2024 to allow the program to build on a solid foundation of promising preclinical research to increase the number of ALS clinical trials by funding its own early phase trials. Consolidated Appropriations Act of 2024 (HR 4366) . Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations (H.R. 4368) --Requested the House and Senate Appropriations Agriculture Subcommittee provide at least $25 million specifically for ALS research to the FDA Orphan Products Grants Program in fiscal year 2024 to fund P.L. 117-79 the FDA Rare Neurodegenerative Disease Grant Program which is authorized to provide ALS research grants. Continuing Appropriations and Extensions Act, 2025 (H.R.9747) - Provisions related to continuing resolution funding for public health programs, veterans administration, and the Food and Drug Administration. Conversations surrounding Appropriations for Fiscal Year 2025

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

Discussion around improving the prior authorization process for treatments and drugs under Medicare, Medicare Advantage, and private insurance. CONNECT for Health Act of 2023(H.R.4189/S.2016) - provisions related to permanent telehealth services in Medicare and interstate telehealth services. Protecting Health Care for All Patients Act of 2023 (H.R. 485) - provisions to ban the usage of quality adjusted life years in public insurance programs. Elizabeth Dole Home Care Act of 2023 (H.R. 542 / S.141) - would raise the cap on the Veterans Administrations payments for home care from 65% to 100% and would expand VA home care programs. HELP Copays Act (H.R.830 / S.1375) -- Provisions related to health insurance plans requirement to apply payments made by or on behalf of plan enrollees toward a plan's cost-sharing requirements, i.e. a ban on copay-accumulator adjust programs. BENEFIT Act of 2023 (H.R.1092/S.526) - Provisions related to increases in patient and advocate role in FDA benefit-risk framework for drug approval through leveraging patient experience, PFDD, and related data. H.R. 7274/S. 3766 - Connecting Caregivers to Medicare Act of 2024 - All provisions. H.R. 1691, Ensuring Patient Access to Critical Breakthrough Products Act - All provisions

HR 2882, Further Consolidated Appropriations Act of 2024 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations (S. 2624) --Requested that the House and Senate Appropriations LHHS Subcommittee provide at least $150 million for ALS research at NIH in fiscal year 2024 to attract the next generation of scientists, accelerate the discovery and development of new treatments and increase the number of ALS clinical trials. Requested at least $75 000,000 to implement the expanded access program established by the ACT for ALS Act (P.L. 117-79). Requested at least $15 million to continue CDCs National ALS Registry and Biorepository in fiscal year 2024 to help identify risk factors for ALS to reduce the number of new cases, connect patients with clinical trials, conduct surveillance of incidence and prevalence and biospecimens, and support research of ALS prevention in the military. Requested the House and Senate Appropriations Defense Subcommittee provide at least $80 million for the ALS Research Program in fiscal year 2024 to allow the program to build on a solid foundation of promising preclinical research to increase the number of ALS clinical trials by funding its own early phase trials. HR 4366, the Consolidated Appropriations Act of 2024. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations (H.R. 4368) --Requested the House and Senate Appropriations Agriculture Subcommittee provide at least $25 million specifically for ALS research to the FDA Orphan Products Grants Program in fiscal year 2024 to fund P.L. 117-79 the FDA Rare Neurodegenerative Disease Grant Program which is authorized to provide ALS research grants. Conversations surrounding Appropriations for Fiscal Year 2025 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations (S. 2624) --Requested that the House and Senate Appropriations LHHS Subcommittee provide at least $150 million for ALS research at NIH in fiscal year 2025 to attract the next generation of scientists, accelerate the discovery and development of new treatments and increase the number of ALS clinical trials. Requested at least $75 000,000 to implement the expanded access program established by the ACT for ALS Act (P.L. 117-79). Requested at least $15 million to continue CDCs National ALS Registry and Biorepository in fiscal year 2024 to help identify risk factors for ALS to reduce the number of new cases, connect patients with clinical trials, conduct surveillance of incidence and prevalence and biospecimens, and support research of ALS prevention in the military. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations (H.R. 4368) --Requested the House and Senate Appropriations Agriculture Subcommittee provide at least $25 million specifically for ALS research to the FDA Orphan Products Grants Program in fiscal year 2024 to fund P.L. 117-79 the FDA Rare Neurodegenerative Disease Grant Program which is authorized to provide ALS research grants. Department of Defense Appropriations Act (H.R. 4365) -- Requested the House and Senate Appropriations Defense Subcommittee provide at least $80 million for the ALS Research Program in fiscal year 2024 to allow the program to build on a solid foundation of promising preclinical research to increase the number of ALS clinical trials by funding its own early phase trials.

Promising Pathways Act (H.R. 4408/S. 1906) - Discussion around a provisional approval path for drugs and biological interventions that meet unmet needs of rare diseases like ALS and coverage for these drugs. BENEFIT Act of 2023 (H.R.1092/S.526) - Provisions related to increases in patient and advocate role in FDA benefit-risk framework for drug approval through leveraging patient experience, PFDD, and related data.

THE ALS ASSOCIATION

THE ALS ASSOCIATION

THE ALS ASSOCIATION