CMS signals plans to increasingly rely on coverage with evidence development (CED) in a final guidance that backs away from an earlier expectation that the agency would only use the policy infrequently as new technologies were presented for coverage early in the development process. The agency also reiterates that it will neither duplicate efforts by other agencies such as FDA nor duplicate existing medical evidence; and that national coverage determinations (NCD) can be expedited by building interim analysis into a study. CMS also says that Medicare Administrative Contractors (MACs) may be able to use CED as part of their local coverage determinations but does not include details, saying the agency will work to provide further guidance for the MACs.
CED was created as a way to get new products and procedures to Medicare beneficiaries earlier, when those technologies look promising but CMS wants more evidence before agreeing to pay for them indefinitely. CED allows CMS to conditionally pay for care while researching services and products to determine whether to continue that coverage, the Nov. 20 guidance states. The process is used as part of NCDs, which is the process by which CMS decides what products or services are covered nationally by Medicare instead of relying regional Medicare contractors to determine coverage.
The guidance has been long anticipated. Stakeholders began to raise questions and concerns about the CED policyas CMS started increasing its use of the policy in 2006. CMS’ Medical Evidence & Coverage Advisory Committee (MEDCAC) took up the issue in May 2012, and the agency released a draft version of the guidance in November of that year.
CMS says it issued the final guidance “to help the public understand CMS’ implementation of coverage with evidence development (CED) through the national coverage determination process.”
The agency in its initial guidance on CED in 2005 said one of the eight guiding principles for the policy was that it expected to use CED only infrequently. The agency says it dropped that principle in its newest guidance because the nature of NCD requests have changed since 2006.
“Technology is being presented to the agency for coverage earlier in the technology lifecycle, and requesters more frequently ask CMS to consider using CED for their particular technology. With these changes, it is no longer appropriate to include as a guiding principle our expectation that CED will be used only ‘infrequently,’” CMS says in response to comments from stakeholders on the draft guidance.
The agency reaffirms its stance that CED should not be used when other forms of coverage are “justified,” nor should it duplicate research efforts of other agencies or existing medical evidence.
Some commenters on the draft guidance said CED should not not be applied to long-covered technologies, medically accepted indications or technologies under FDA post approval studies.
But CMS disagreed, saying there are many items and services that are covered under NCDs for which evidence has never been established. “CMS may find it appropriate to reconsider an NCD and require CED to fully consider the effectiveness of some of these technologies,” CMS says.
Some stakeholders wanted the agency to set a time line for the CED process that gives predetermined endpoints allowing NCDs to be determined more quickly.
The agency says it is “impracticable” to set an across-the-board time line for CEDs because of the nature of research studies — noting that such studies tend to have specific start and endpoints built in as part of an individual study’s methodology. CMS does say that researchers can build interim analyses into their studies that can help speed up the NCD process.
“While CMS does not believe that beneficiaries should have broad access to these items or services when scientific results are unavailable, there are ways to avoid or minimize the gap between the end of clinical studies under a CED NCD and revised coverage based on the results of CED studies. As discussed in the guidance, sponsors should build interim analyses into their study design and communicate these results to CMS. If the results support consideration of a change in the coverage status of the item or service, a revised NCD could be expedited,” the agency says.
CMS says CEDs can be used for coverage of drugs and biologics, but it will not use the policy for drugs or biologics that have not been approved by FDA for at least one indication. The agency did not see this as happening very often as most drugs and biologics are self-administered by patients leaving them under the scope of Medicare Part D rather than Parts A and B — leaving them “outside the scope of CED.”
Although the statutory language for MACs’ local coverage determination process does not explicitly support CED, CMS says the LCD process is open and transparent enough for the policy’s use. The agency does not offer details on MACs using CED, but said it “will work toward providing guidance to the MACs.” — Todd Allen Wilson(firstname.lastname@example.org)