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HHS/CMS RIN: 0938-AT19 Publication ID: Fall 2017 
Title: Expedited Coverage of Innovative Technology (ExCITe) (CMS-3344-P) 
Abstract:

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.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: 42 CFR 405   
Legal Authority: 42 U.S.C. 405(a), 1302, 1320b-12, 1395x, 1395y(a)(1)(E), and 1395hh   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  01/00/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Dr. Joseph Chin
Deputy Director, Coverage and Analysis Group
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Clinical Standards and Quality, MS: S3-02-01, 7500 Security Boulevard,
Baltimore, MD 21244
Phone:410 786-2281
Email: joseph.chin@cms.hhs.gov