0938-AT19 201710 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0938 Centers for Medicare & Medicaid Services CMS 0900 Department of Health and Human Services HHS Expedited Coverage of Innovative Technology (ExCITe) (CMS-3344-P)

This proposed rule would provide Medicare coverage of certain devices under investigation through a clinical research study and the associated routine care items and services in that research, to the extent permitted by law, under the proposed Expedited Coverage of Innovative Technology (ExCITe) coverage pathway. The ExCITe pathway would remove the barrier in evidence generation by allowing CMS to provide faster access to new technologies that would have the potential to improve patient health and quality of care.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No Fully or Partially Exempt 42 CFR 405 42 U.S.C. 405(a), 1302, 1320b-12, 1395x, 1395y(a)(1)(E), and 1395hh No NPRM 01/00/2018 No Businesses Federal No No No No Joseph Chin Dr. Deputy Director, Coverage and Analysis Group 0938 Centers for Medicare & Medicaid Services CMS 410 786-2281 joseph.chin@cms.hhs.gov Center for Clinical Standards and Quality, MS: S3-02-01, 7500 Security Boulevard, Baltimore MD 21244