FDA Draft Guidance to Assist CMS With IDE Coverage Decisions

Posted 31 May 2016 By Michael Mezher

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The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to clarify difficulties in categorizing investigational medical devices for Medicare coverage, just two days before a memorandum of understanding is set to take effect between FDA and the Centers for Medicare and Medicaid Services (CMS).

While an agreement has been in place between the two agencies for more than two decades, FDA says it has run into issues with some devices not easily fitting in the categories specified by the agreement. The agency also says that the initial agreement wasn't clear on how to handle situations in which additional data justified coverage for a device that had previously been in a category that would not be covered.

As a result, the two agencies signed a memorandum of understanding (MOU) late last year, "to streamline and facilitate the efficient categorization of investigational medical devices in order to support CMS's ability to make Medicare coverage (reimbursement) determinations for … investigational devices under 42 CFR 405 Subpart B."

1995 Interagency Agreement

Two decades ago, the Health Care Financing Administration (which later became CMS) entered into an agreement with FDA to provide reimbursement for certain devices being studied under an investigational device exemption (IDE).

Under the agreement, FDA was charged with assisting CMS with identifying devices that would be covered by Medicare by categorizing the devices based on two risk classes: Category A (experimental/investigational) and the less-risky Category B (non-experimental/investigational) devices.

While devices in Category B qualify for Medicare reimbursement, only services related to Category A devices are covered, not the devices themselves.

According to the agreement, "Category A devices were devices believed to be in class III for with 'absolute risk' of the device type had not yet been established. That is, initial questions of safety and effectiveness had not been resolved and FDA was unsure whether the device type could be safe and effective."

Other devices, such as Class I or Class II, and Class III devices that did not meet the criteria for Category A, are considered Category B.

Draft Guidance & 2015 MOU

FDA says it developed its new draft guidance to facilitate the MOU by clarifying the criteria it uses for categorization decisions, and to detail the circumstances in which a device might be switched from Category A to Category B.

"The previous FDA policy did not adequately articulate categorization criteria that are relevant to certain feasibility studies, particularly those for devices similar to approved devices but with modifications which raise significant new safety questions," FDA writes.

In some cases, FDA says that Category A device can be moved into Category B when data from early feasibility studies "resolve initial questions of safety and effectiveness." In other cases, FDA says it may approve an IDE with conditions that once met may provide enough data to justify moving a device from Category A to Category B.

FDA Criteria for Device Categorization
Category A (If one or more criteria are met)Category B (If one or more criteria are 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.

No PMA approval, 510(k) clearance or de novo request has been granted for the proposed device or similar devices; however, available clinical data (e.g., feasibility study data) and/or non-clinical data for the proposed device or a similar device resolve the initial questions of safety and effectiveness.

The proposed device has different characteristics compared to a legally marketed device; and information related to the marketed device does not resolve initial questions of safety and effectiveness for the proposed device. Available non-clinical and/or clinical data on the proposed device also do not resolve these questions.

The proposed device has similar characteristics compared to a legally marketed device, and information related to the marketed device resolves the initial questions of safety and effectiveness for the proposed device. Additional non-clinical and/or clinical data on the proposed device may have been used in conjunction with the leveraged information to resolve these questions.

The proposed device is being studied for a new indication or new intended use for which information from the proposed or similar device related to the previous indication does not resolve initial questions of safety and effectiveness. Available non-clinical and/or clinical data on the proposed device relative to the new indication or intended use also do not resolve these questions.

The proposed device is being studied for a new indication or new intended use; however, information from the proposed or similar device related to the previous indication resolves the initial questions of safety and effectiveness. Additional non-clinical and/or clinical data on the proposed device may have been used in conjunction with the leveraged information to resolve these questions.

FDA

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Categories: Medical Devices, Clinical, Reimbursement, News, US, FDA

Tags: CMS, Reimbursement, Investigational Device Exemption, IDE, Early feasibility studies, EFS, Category A, Category B, Medicare

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