Code of Federal Regulations Title 42. Public Health § 42.405.607 Coverage period

(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.

(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.