CMS took steps to further refine its coverage-with-evidence-development (CED) policy with release of a new draft guidance Nov. 29.

The document replaces a 2006 guidance, making substantial changes based on public comments and six years of experience with the program, in which national coverage is provided on the condition that data be collected on use of the item or service in Medicare beneficiaries. (See Also see "New Coverage-With-Evidence-Development Guidance In The Works Following MedCAC Meeting" - Medtech Insight, 21 May, 2012..)

For one, unlike previous guidelines, the new document makes no claim that CED will be used only rarely. (See Also see "CMS Offers Two Paths To “Coverage With Evidence” In Revised Guidance" - Medtech Insight, 17 July, 2006..) Instead, it cites a recent White House report calling for more “frequent” use of the program. (See Also see "Reimbursement In Brief" - Medtech Insight, 7 May, 2012..)

CED requirements have been a component of several recent national coverage determinations, including for transcatheter aortic heart valve replacement, transcutaneous electrical nerve stimulation for treating chronic back pain and autologous platelet-rich plasma wound therapy.

The new draft also retreats from the concept of “coverage with appropriateness determination” (CAD) which CMS introduced in 2006 as one form of CED focused on ensuring that a covered item is used appropriately. “The CAD form of CED does not fundamentally encompass the concept of research. As such, we will no longer use the term CAD to describe CED,” the draft states.

The draft also reflects the closer working relationship of late between CMS and FDA, suggesting the possibility that FDA post-approval requirements could align with CED research requirements. But the Medicare agency stresses that “this is simply an example of a CED application rather than a new CED paradigm.”

The guidelines lay out for the first time precisely when CED requirements for an item or service will end: if no CED studies are approved within the timeframe required by the coverage decision; if approved CED studies are not completed within the timeframe required by the coverage decision; or when the CED studies are complete.

“Under CED, there is a potential period of noncoverage between the end of the study and the agency’s review of the scientific results,” CMS notes.

Further, the draft discusses specific factors that might cause CMS to apply CED and emphasizes the role of the Agency for Healthcare Research and Quality in facilitating studies to fulfill CED requirements.

Public comments are due on the draft Jan. 28.

[Editor’s note:Look for more coverage of CMS’s coverage-with-evidence-development guidance in upcoming issues of “The Gray Sheet.”]

CMS Redefines Coverage-With-Evidence-Development In Draft Guidance

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