This post outlines how Medicare covers IDE studies of Category A vs. Category B devices, and highlights how a sponsor may be able to change the device from Category A (no Medicare reimbursement for the device) to Category B (Medicare coverage of the device) during the lifecycle of a clinical trial.
Obtaining reimbursement coverage for a marketed medical device is challenging, and the earlier a manufacturer starts obtaining coverage, the sooner its device begins building up a reimbursement track record. If your company has ongoing IDE studies of Category A devices, the guidance and FDA webinar mentioned below will provide valuable information about categorization and potential pathways for changing those devices to Category B devices, which makes the devices themselves eligible for Medicare coverage (if other CMS requirements are met).
The guidance implements the December 2, 2015 memorandum of understanding between CMS and FDA by further explaining the framework that FDA intends to follow for categorizing IDE study devices as Category A or Category B. CMS uses FDA’s categorization as a factor in evaluating whether or not an IDE device receives Medicare coverage.
Category A vs. Category B Devices:
FDA designates each IDE study device as Category A or Category B in the IDE (original or supplemental) approval letter to the sponsor.
Category A devices are experimental. Initial questions of safety and effectiveness have not been resolved. If certain criteria are met, Medicare may cover only routine care items and services furnished in an FDA-approved Category A IDE study. Medicare will not cover the investigational device.
Category B devices are nonexperimental/investigational. Initial questions of safety and effectiveness have been resolved. If certain criteria are met, Medicare may cover both the investigational device and routine care items and services furnished in an FDA-approved Category B IDE study.
Changing a Device from Category A to Category B:
In the guidance, FDA differentiates between three types of studies: early feasibility studies, traditional feasibility studies and pivotal studies. FDA clarifies that a device can change categories during the series of studies and explains how this process occurs. The guidance explains that there are situations when sufficient data are provided to resolve initial questions of safety and effectiveness (e.g. data from a feasibility study becomes available), and, accordingly, a change of device category from Category A to Category B for subsequent studies of the same device may be merited.
The guidance lists the following as examples of data that may support a category change:
FDA Webinar for Industry:
On January 16, 2018, the FDA will host a webinar for industry to discuss and answer questions about this final guidance. Access the webinar. Registration is not required.
This contents of this alert should not be construed as legal advice or a legal opinion on any specific facts or circumstances. This content is not intended to and does not, by its receipt, create an attorney-client relationship. The contents are intended for general informational purposes only. We urge you to consult your attorney about the specific situation and any legal questions you may have. Attorney advertising in some jurisdictions. © 2023 Leibowitz Law. All rights reserved. “Leibowitz Law” is a trade name of Leibowitz LLC.
To be notified when we post new Insights, please sign up for our email list. As industry thought leaders, Leibowitz Law Insights address developing issues at the intersection of law, regulation, technology and life sciences…