[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: 42CFR405.211]



[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. 405.211  Procedures for Medicare contractors in making coverage 

decisions for a non-experimental/investigational (Category B) device.



    (a) General rule. In their review of claims for payment, Medicare 

contractors are bound by the statute, regulations, and all CMS 

administrative issuances, including all national coverage decisions.

    (b) Potentially covered non-experimental/investigational (Category 

B) devices. Medicare contractors may approve coverage for any device 

with an FDA-approved IDE categorized as a non-experimental/

investigational (Category B) device if all other coverage requirements 

are met.

    (c) Other considerations. Medicare contractors must consider whether 

any restrictions concerning site of service, indications for use, or any 

other list of conditions for coverage have been placed on the device's 

use.