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Current as of October 02, 2022 | Updated by FindLaw Staff
(a) When payment is not made. Medicare payment is not made for medical and hospital services that are related to the use of a device that is not covered because CMS determines the device is not “reasonable” and “necessary” under section 1862(a)(1)(A) of the Act or because it is excluded from coverage for other reasons. These services include all services furnished in preparation for the use of a noncovered device, services furnished contemporaneously with and necessary to the use of a noncovered device, and services furnished as necessary after-care that are incident to recovery from the use of the device or from receiving related noncovered services.
(b) When payment is made. Medicare payment may be made for—
(1) Covered services to treat a condition or complication that arises due to the use of a noncovered device or a noncovered device-related service; or
(2) Routine care items and services related to Category A (Experimental) devices as defined in § 405.201(b), and furnished in conjunction with FDA–approved clinical studies that meet the coverage requirements in § 405.211.
(3) Routine care items and services related to Category B (Nonexperimental/investigational) devices as defined in § 405.201(b), and furnished in conjunction with FDA–approved clinical studies that meet the coverage requirements in § 405.211.
Cite this article: FindLaw.com - Code of Federal Regulations Title 42. Public Health § 42.405.207 Services related to a noncovered device - last updated October 02, 2022 | https://codes.findlaw.com/cfr/title-42-public-health/cfr-sect-42-405-207/
FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature or via Westlaw before relying on it for your legal needs.
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