THE ALS ASSOCIATION

Budget/Appropriations

-Requested that the House and Senate Appropriations LHHS Subcommittee provide at least $135 million for ALS research at NIH in fiscal year 2023 to attract the next generation of scientists, accelerate the discovery and development of new treatments and increase the number of ALS clinical trials. -Requested the House and Senate Appropriations LHHS Subcommittee provide at least $75 000,000 to implement the expanded access program established by the ACT for ALS Act (P.L. 117-79). -Requested the House and Senate Appropriations Defense Subcommittee provide at least $60 million for the ALS Research Program in fiscal year 2023 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. -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 2023 to to implement P.L. 117-79 to establish the FDA Rare Neurodegenerative Disease Grant Program which is authorized to provide grants for clinical trials for ALS and other neurodegenerative diseases. -Requested House and Senate Appropriations LHHS Subcommittee provide at least $10 million to continue the National ALS Registry and Biorepository in fiscal year 2023 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 collect biospecimens that will lead to a better understanding of who may develop ALS.

TargetedSENATE · HOUSE OF REPRESENTATIVES

Medicare/Medicaid

-The Telehealth Modernization Act (H.R. 1332/ S. 368) extends certain COVID telehealth flexibilities. Among other things, the bill allows (1) rural health clinics and federally qualified health centers to serve as the distant site (i.e., the location of the health care practitioner); (2) the home of a beneficiary to serve as the originating site (i.e., the location of the beneficiary) for all services (rather than for only certain services); and (3) all types of practitioners to furnish telehealth services, as determined by the Centers for Medicare & Medicaid Services. -The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act (H.R. 2903/ S. 1512) expands coverage of telehealth services under Medicare. Among other things, the bill allows the Centers for Medicare & Medicaid Services (CMS) to waive certain restrictions, such as geographic restrictions, for services provided in high-need health professional shortage areas; excludes mental health and emergency medical services, as well as services provided at rural health clinics, federally qualified health centers, and Indian Health Service facilities, from such geographic restrictions; and allows the CMS to generally waive coverage restrictions during national emergencies. Additionally, the Medicare Payment Advisory Commission must report on information relating to the access of Medicare beneficiaries to telehealth services at home. The Center for Medicare and Medicaid Innovation may also test alternative payment models relating to expanded telehealth services. CURES 2.0 Act (H.R. 6000) -- Provisions related to drug development, research, and access to emerging therapies for Americans with ALS and other rare diseases through the creation of ARPA-H and other mechanisms. Build Back Better Act (H.R. 5376) -- Provisions related to providing up to 12 weeks of paid family and medical leave; extending Medicare telehealth flexibilities beyond the COVID-19 public health emergency; and the establishment Advanced Research Projects Agency for Health (ARPA-H).