View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/CMS RIN: 0938-AT88 Publication ID: Fall 2019 
Title: Medicare Coverage of Innovative Technologies (CMS-3372-P) 

This proposed rule modifies the Medicare coverage process to streamline coverage of breakthrough technologies that have the potential to improve patient health outcomes and quality of care.

Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: 42 CFR 405   
Legal Authority: 42 U.S.C. 405(a)    42 U.S.C. 1302    42 U.S.C. 1302b-12    42 U.S.C. 1395x    ...   
Legal Deadline:  None

Statement of Need:

We are using regulatory action to address the increasing need for a swift coverage mechanism to allow beneficiary access to certain new technologies.  This proposed rule squarely addresses that need by establishing a program that will allow beneficiary access to new technology.

Summary of the Legal Basis:

This proposed rule makes Medicare coverage policy updates pursuant to the authority at section 1862(a)(1)(E) of the Act.



Anticipated Costs and Benefits:

The impact of implementing MCIT is difficult to determine without knowing what technologies would be covered.  However, at this point, the MCIT coverage pathway would probably be a cost to the Medicare program in the short-range period when beneficiaries utilize technologies covered through MCIT. Because of the past trend of new technology costing more than existing technology.  Nevertheless, new technology may also mitigate ongoing chronic health issues thereby reducing some costs for Medicare.

 As we move toward publication, estimates of costs and benefits will be included in the proposed rule. 


Given that, under the current coverage infrastructure, new technologies may be covered at the local level, MCIT would not create any new risks for beneficiaries that did not exist previously.

Action Date FR Cite
NPRM  12/00/2019 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Linda Gousis
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Clinical Standards and Quality, MS: C1-26-12, 7500 Security Boulevard,
Baltimore, MD 21244
Phone:410 786-8616