FDA assists CMS with investigational medical device coverage decisions
The need to modify the FDA’s policy on the categorization of investigational medical devices to assist CMS with Medicare coverage (reimbursement) decisions was the impetus for a draft guidance document issued by the FDA. The draft guidance, entitled “FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions,” is designed to implement a December 2, 2015, memorandum of understanding (MOU No. 225-16-004) between CMS’ Coverage and Analysis Group and the FDA’s Center for Devices and Radiological Health (CDRH) to streamline and facilitate the efficient categorization of investigational medical devices (Notice, 81 FR 35032, June 1, 2016).
Background. On September 19, 1995, the Health Care Financing Administration (n/k/a CMS) published a Final rule (60 FR 48417) and entered into an Interagency Agreement (IA) with FDA regarding reimbursement categorization of investigational devices. The Final regulations (42 CFR part 405, subpart B) established that certain devices with an investigational devices exemption (IDE) approved by FDA (and certain services related to those devices) may be covered under Medicare, and set forth the process by which the FDA would assist CMS in identifying such devices.
Under the 1995 Final rule, the FDA would assign a device with an FDA approved IDE to one of two categories: (1) Experimental/Investigational (Category A) devices; or (2) Non-experimental/Investigational (Category B) devices based on the level of risk the device presented to patients.
The IA set forth criteria which the FDA would use to categorize the devices into one of eight subcategories. The categorization would then be used by CMS as part of its determination of whether or not devices met the requirements for Medicare coverage. At the time, both CMS and the FDA recognized that experience in categorizing devices might require changes to the IA.
FDA experience. In the last 20 years, the FDA has received a number of IDEs which do not easily fit into any of the eight subcategories identified in the IA. There also has been the development of the guidance document entitled “Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies;” and an increase in submission of early feasibility studies to the FDA, as well as modifications to CMS’ regulations regarding IDEs, which have prompted both the FDA and CMS to revise their shared understanding regarding the categorization of IDE devices. This led the parties to execute the December 2, 2015 MOU, which takes effect on June 2, 2016 (6 months from the date of execution of the parties).
New criteria. In addition to implementing the MOU, the draft guidance further describes the framework and criteria that the FDA intends to use to help determine the appropriate category for a device to be studied. The draft guidance also describes a pathway for changing the device category from Category A to Category B.
Comments on the draft guidance may be submitted to CDRH through August 1, 2016.
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