e-CFR Navigation Aids


Simple Search

Advanced Search

 — Boolean

 — Proximity


Search History

Search Tips


Latest Updates

User Info


Agency List

Incorporation By Reference

eCFR logo

Related Resources

Electronic Code of Federal Regulations

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We have made big changes to make the eCFR easier to use. Be sure to leave feedback using the Feedback button on the bottom right of each page!

e-CFR data is current as of March 3, 2021


42 CFR--PART 405

View Printed Federal Register page 86 FR 3009 in PDF format.

Amendment(s) published January 14, 2021, in 86 FR 3009

Effective Dates: Mar. 15, 2021

3. Subpart F, consisting of §§405.601-405.607, is added to read as follows:

Subpart F—Medicare Coverage of Innovative Technology


405.601   Medicare coverage of innovative technology.

405.603   Medical device eligibility.

405.605   Coverage of items and services.

405.607   Coverage period.

Subpart F—Medicare Coverage of Innovative Technology

§405.601   Medicare coverage of innovative technology.

(a) Basis and scope. Medicare coverage of innovative technology (MCIT) is a program that provides national, time-limited coverage under section 1862(a)(1)(A) of the Act for certain breakthrough medical devices. Manufacturer participation in the pathway for breakthrough device coverage is voluntary.

(b) Definitions. For the purposes of this subpart, the following definitions are applicable:

Breakthrough device means a device that receives such designation by the Food and Drug Administration (FDA) (section 515B(d)(1) of the FD&C Act (21 U.S.C. 360e-3(d)(1)).

MCIT stands for Medicare coverage of innovative technology.

§405.603   Medical device eligibility.

The MCIT pathway is available only to medical devices that meet all of the following:

(a) That are FDA-designated breakthrough devices.

(b) That were FDA market authorized on [Enter date 2 years prior to effective date of final rule] and thereafter.

(c) That are used according to their FDA approved or cleared indication for use.

(d) That are within a Medicare benefit category.

(e) That are not the subject of a Medicare national coverage determination.

(f) That are not otherwise excluded from coverage through law or regulation.

§405.605   Coverage of items and services.

Covered items and services furnished within the MCIT pathway may include any of the following, if not otherwise excluded from coverage and according to existing coverage and/or payment policies as applicable:

(a) The breakthrough device.

(b) Any reasonable and necessary procedures to implant and/or use the breakthrough device.

(c) Reasonable and necessary items and services to maintain the breakthrough device.

(d) Related care and services for the breakthrough device.

(e) Reasonable and necessary services to treat complications arising from use of the breakthrough device.

§405.607   Coverage period.

(a) Start of the period. The MCIT pathway begins on the date requested by the manufacturer in an email to CMS at any time opting in to the MCIT pathway provided the requested start date is no earlier than—

(1) The date the breakthrough device receives FDA market authorization; or

(2) The date requested by the manufacturer, provided that such a date is not later than 2 years after the date described in paragraph (a)(1) of this section.

(b) End of the period. The MCIT pathway for a breakthrough device ends as follows:

(1) No later than 4 years from the date the breakthrough device received FDA market authorization.

(2) Prior to 4 years if a manufacturer withdraws the breakthrough device from the MCIT pathway.

(3) Prior to 4 years if the breakthrough device becomes the subject of a national coverage determination or otherwise becomes noncovered through law, regulation, or at the discretion of the Secretary subsequent to an FDA medical device safety communication or Warning Letter.

(4) Prior to 4 years if the FDA removes authorization of a device, the breakthrough device is removed from the MCIT pathway.

Need assistance?