(Medicare Benefit Policy Manual)

Any sponsor (i.e., manufacturer) that does not agree with the FDA decisio n that categorizes its device as Category A may submit a written request asking the FDA to reevaluate its categorization decision.  The sponsor (i.e., a manufacturer) may send a written request to the FDA at any time asking for a reevaluation of its original categorization decision, submitting any additional evidence and information which it believes supports a re -categorization.  The FDA notifies both CMS and the sponsor (i.e., manufacturer) of its reevaluation decision.  If the FDA reconfirms its original decision on the categorization of the device, the sponsor (e.g., a manufacturer) may seek a review by the CMS Central Office.  The device sponsor (e.g., a manufacturer) must submit its request in writing, and must include all materials submitted with its reevaluation request to the FDA.  Review  requests must be addressed to:   Centers f or Medicare & Medicaid Services  Attn:   IDE Categorization Review  Mail Stop:  S3- 02-01 Coverage and Analysis Group, Center for Clinical Standards and Quality, 7500 Security Blvd.  Baltimore, MD 21244- 1850  The CMS staff will review this information to determine whether to change the categorization of the device and will issue a written decision notifying both the device sponsor (e.g., a manufacturer) and the FDA of its decision.  In evaluating a manufacturers request for re -categorization, CMS will review only that information submitted to the FDA.  Information not submitted to the FDA for its considerati on will not be reviewed by CMS.   To the extent that CMS relies on confide ntial commercial or trade secret information in any judicial proceeding, CMS will maintain confidentiality of the information in accordance wi th Federal law.   No reviews of a categorization decision other than those described above are available to a spons or (e.g., a manufacturer).  Neither the FDA original categorization decision or reevaluation, nor CMS review constitutes an initial determination for purposes of the Medicare appeals processes under part 405, subpart G or subpart H or parts 417, 473, or 498 of title 42 of the Code of Federal Regulations.  30 - Hospital Institutional Review Board (IRB) Approved Non -significant Risk Devices  (Rev.  198, Issued: 11- 06-14, Effective: 01- 01-15, Implementation: 01- 05-15)  Clinical trials for non -significant risk d evices (devices which do not require a n FDA -approved IDE) are the responsibility of the hospitals IRB.  While these devices do not require an FDA -approved IDE, many of the FDA -approved IDE requirements apply to these non- significant risk devices (e.g., they may not be legally marketed).  Medicare contractors are responsible for making the coverage determinations on non- significant devices that are the responsibility of the hospitals IRB.  Contractors should apply the same coverage criteria, where appropri ate, to these devices as are applied to FDA -approved IDE Category A and B IDE devices.   30.1  Payment for Hospital IRB Approved Non -significant Risk Devices  (Rev.  198, Issued: 11- 06-14, Effective: 01- 01-15, Implementation: 01- 05-15)  Payment for an IRB approved device (provided to a non- hospital patient) and the related services may not exceed what Medicare would have paid for a comparable approved device and related services.   40 - Services Related to and Required as a Result of Services Which are Not C overed Under Medicare  (Rev.  198, Issued: 11- 06-14, Effective: 01- 01-15, Implementation: 01- 05-15)  Medicare payment is not made for medical and hospital services that are related to the use of a device that is not covered under Medicare.  These non- covered  services include all services furnished in preparation for the use of a non- covered device, services furnished contemporaneously with, and necessary to the use of, a non- covered device, and services furnished as necessary after -care that are incident to r ecovery from the use of the device or from receiving related non- covered services.   Refer to Pub. 100- 02, Medicare Benefit Policy Manual, Chapter 16, General Exclusions from Coverage, 180 -  Services Related to and Required as a Result of Services Which Are Not Covered Under Medicare.   Transmittals Issued for this Chapter  Rev #  Issue Date  Subject  Impl Date  CR#  R198BP  11/06/2014 Medicare Coverage of Items and Services in Category A and B Investigational Device Exemption (IDE) Studies  01/05/2015  8921 R1BP  10/01/2003 Initial Publication of Manual  NA NA Back to top of Chapter