FDA Updates IDE Categories for CMS Coverage Decisions

The FDA is changing the way it categorizes investigational devices in an effort to help the Centers for Medicare & Medicaid Services make coverage determinations.

The FDA lays out the framework CDRH and CBER intend to follow when categorizing investigational products based on risk in June 1 draft guidance.

The document follows a memorandum of understanding executed last December by CDRH and CMS’s Coverage and Analysis Group intended to aid reimbursement decisions for investigational devices. The MOU took effect June 2.

Two-Decade Facelift

The draft document updates policies that have been in place for two decades. In 1995, CMS, then known as the Health Care Financing Administration, and the FDA unveiled an agreement through which devices with an FDA-approved IDE could be covered by Medicare.

At the time, the FDA agreed to assign investigational devices to one of two categories, based on potential risks: Experimental/investigational (Category A) or non-experimental/investigational (Category B). There were a combined total eight subcategories in both groups.

Category A products were generally Class III, or device types whose safety and effectiveness had not been determined.

Those in Category B typically were Class I or II or Class III device types whose safety and effectiveness profiles were established.

Under Category A, coverage is allowed for routine care items and services furnished in the study, but not of the device itself. In a Category B IDE study, coverage is allowed for the device and the routine care items and services in the trial.

Although this system has worked for two decades, the FDA acknowledges it has received more IDEs that do not fit in these subcategories.

As a result, the FDA plans to assign investigational devices to Category A if at least one of the following criteria is met:

• No PMA approval, 510(k) clearance or de novo request has been granted for the proposed device or similar devices, and non-clinical and/or clinical data on the proposed device do not resolve initial questions of safety and effectiveness;
• The product has different characteristics than a legally marketed device; and information related to the marketed device does not resolve initial questions of safety; or
• The device is being studied for a new indication or intended use.

Products assigned to Category B will meet one or more of the following criteria:

• No PMA approval, 510(k) clearance or de novo request has been granted; however, available clinical data and/or non-clinical data for the proposed device or a similar device resolve the initial 308 questions of safety and effectiveness;
• The proposed device has similar characteristics compared to a legally marketed device, resolving the initial questions of safety and effectiveness; or
• The proposed device is being studied for a new indication or new intended use, and information from the proposed or similar device resolves the initial questions of safety and effectiveness.

The document provides examples of when Category A or B determinations may be appropriate, as well as instances when a device could change from Category A to B.

There are situations in which further data could resolve initial questions of safety and effectiveness and justify a change in device category. For example, when a completed study results in data that resolve initial questions of safety and effectiveness, the device could be reclassified as Category B.

Interested parties may comment through Aug. 1. Read the guidance document here: www.fdanews.com/06-06-16-guidance.pdf.