[Code of Federal Regulations]

[Title 42, Volume 2]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR405.207]



[Page 89]

 

                         TITLE 42--PUBLIC HEALTH

 

                    CHAPTER IV--CENTERS FOR MEDICARE

                          & MEDICAID SERVICES,

                        DEPARTMENT OF HEALTH AND

                             HUMAN SERVICES

 

PART 405_FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED--Table of 

Contents

 

Subpart B_Medical Services Coverage Decisions That Relate to Health Care 

                               Technology

 

Sec. 405.207  Services related to a noncovered device.



    (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 services related to experimental/investigational 

(Category A) devices as defined in Sec. 405.201(b); and furnished in 

conjunction with an FDA-approved clinical trial. The trial must meet 

criteria established through the national coverage determination 

process; and if the trial is initiated before January 1, 2010, the 

device must be determined as intended for use in the diagnosis, 

monitoring or treatment of an immediately life-threatening disease or 

condition.

    (3) Routine care services related to a non-experimental/

investigational (Category B) device defined in Sec. 405.201(b) that is 

furnished in conjunction with an FDA-approved clinical trial.



[60 FR 48423, Sept. 19, 1995, as amended at 69 FR 66420, Nov. 15, 2004]