CMS last week signaled plans to revisit an underused tool for gathering clinical evidence on medical technologies with the opening of a public comment period on coverage with evidence development.

Under coverage with evidence, or CED, CMS provides reimbursement for services on the condition that additional data is collected via patient participation in a registry or clinical trial. (See Also see "What Ails Coverage With Evidence Development? MedPAC Discusses Issues" - Medtech Insight, 16 November, 2009..)

“There is significant potential to realize benefits for the Medicare program, the medical community, including manufacturers, and the public if CED is considered more broadly” – CMS’ Louis Jacques

CMS may use the strategy for technologies or procedures that are not yet fully proven or in instances where the agency wants to ensure that the treatment or diagnostic is being used in the appropriate patient population. CED has been applied to several high-profile device coverage policies, including primary prevention for sudden cardiac death with implantable cardioverter defibrillators.

While device companies appear to have become more accepting of the approach since it first arose as a formal concept in 2005, some remain concerned that CMS may sometimes use the tool to overstep its authority. In addition, some are concerned that Medicare-mandated data could be used inappropriately.

But Louis Jacques, director of the coverage and analysis group within CMS, says there is untapped opportunity for the CED program.

“We believe that there is significant potential to realize benefits for the Medicare program, the medical community, including manufacturers, and the public if CED is considered more broadly,” Jacques told “The Gray Sheet.”

CMS is taking comments through Jan. 6 on implementation of CED policies as part of national coverage determinations, how CED impacts Medicare beneficiaries and how new approaches might maximize benefits.

In an email exchange, Jacques said the experience with the CED process over the years has led to lessons learned from internal and external stakeholders. “We value public input on the issue.”

Depending on the direction of the public comments it receives, CMS may simply publish clearer guidance on existing CED policy or decide to make substantial changes to the program, Jacques acknowledged.

“Stakeholder perspective on CED has evolved over time as CMS has done more CED-based decisions,” Jacques said. “Broader use of CED will entail significant effort to develop policy documents and to provide learning opportunities for parties interested in participating in CED.”

A timeline for implementing any CED program changes would also depend in part on the volume and direction of the public comments, Jacques noted.

CMS Senses Increasing Industry Willingness

Among the advantages of the greater use of CED, he explained, are “earlier access to promising but less mature medical technologies,” as well as “greater assurance that patient protections will be in place when technologies are used at the fringes of evidence that may support their more narrow use.”

Jacques is optimistic that industry appears more onboard with CED that it was in the past.

“I have heard more supportive comments from companies over the past year than I had in the previous years,” he said.

CED has received some pushback from industry, however, even recently. In public comments related to a national coverage analysis on the first magnetic resonance imaging-compatible pacemaker to receive FDA approval, for instance, device makers argued that questions of post-market safety should be left to FDA, not CMS. (See Also see "Industry Asks CMS Not To Tread On FDA's Medtech Safety Authority" - Medtech Insight, 11 April, 2011..)

“CMS may in many cases find that a company can satisfy FDA postmarket needs and address CMS needs under the CED paradigm,” Jacques said. “Thus there is a greater likelihood that broader application of CED would actually make it easier for companies.”

Funding for specific postmarket studies would depend on available resources among the parties involved, Jacques explained, adding that clinical costs under CED are generally submitted as Medicare claims.

A few months ago, several former CMS officials published a report calling for substantial changes to Medicare coverage policy, including offering more explicit legal authority to the agency for its CED policies. (See Also see "Former Medicare Officials Urge Reforms To Coverage Process" - Medtech Insight, 19 September, 2011..)

Jacques said that in the absence of any specific statutory amendments regarding CED from Congress, CMS will work within its current statutes. If Congress does make changes, “we will certainly look to that legislation for guidance,” he said.

Cost effectiveness research will play no role in CED policy going forward, at least not at this time, Jacques affirmed.

PET Registry Cited As Success

As part of CED, once sufficient evidence is available, the data-collection requirement associated with a coverage policy should be able to be dropped.

This has not been a common occurrence in the life of the CED program, but it has happened at least once, with the Medicare coverage policy for positron emission tomography scans for various cancers.

In 2009, CMS removed CED requirements for positron emission tomography scans in diagnosing or staging many types of tumors based on the results of the National Oncologic PET Registry. (See Also see "Oncology PET Scan Coverage Expands As CMS Lifts Some Data Mandates" - Medtech Insight, 13 April, 2009..)

Jacques pointed to that as a CED success story.

When asked if there are certain types of medical technologies specially suited to CED, Jacques said “it may be premature to exclude any specific technology at this time.”

The public is invited to weigh in on whether and how CMS could apply CED beyond the national coverage process.

“Though CED has historically been conducted in the context of the Medicare Part A and Part B benefit, I am not aware of any inherent reason why it could not be more broadly applied,” Jacques said, adding he would defer to CMS staffers who oversee the other programs.

“The local coverage determination process is also a publicly transparent process that includes public comment,” Jacques continued. “We anticipate that some stakeholders, especially those whose claims are processed by a single or limited number of contractors, for example certain laboratory-developed tests, may see an advantage in a more local process that might, for them, be more readily accomplished.”

In addition, Jacques noted that interest is growing among private payers to use CED-like paradigms in their own coverage analyses.

He also signaled a willingness to consider private-public partnerships on CED.

CMS Coverage-With-Evidence-Development Policy Could Face Revamp

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