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12:00 AM
 | 
Apr 09, 2012
 |  BioCentury  |  Regulation

ExCEDing the NCD

Debate over expanding Medicare's Coverage with Evidence Development

Companies are concerned that expanded use of coverage with evidence development by the Centers for Medicare & Medicaid Services could restrict access to new drugs, but not all doctors and policy specialists agree.

Once drugs or devices are approved by FDA, CMS is required by law to cover those that are "reasonable and necessary," although the term itself does not have a precise legal definition.

The agency also must cover off-label uses of treatments included in drug compendia or supported in peer-reviewed journals.

Thus CMS uses coverage with evidence development (CED) to provide conditional coverage contingent on some form of clinical data collection in the Medicare population.

CMS has issued only one CED for a therapeutic, but biopharma companies think this could change based on a request for comments posted by CMS last November. In the request, the agency asked for ways to improve CED policy, including extending CED beyond the scope of its National Coverage Determinations (NCD) process (see BioCentury, Nov. 21, 2011).

CMS has not disclosed its exact intentions; however, insight into the agency's thinking could come next month at a meeting of its Medical Evidence Development & Coverage Advisory Committee (MEDCAC).

Meanwhile, a proposal issued by CMS on March 29 to use CED as part of an NCD for laparoscopic sleeve gastrectomy in obese patients suggests the agency may already be incorporating some of industry's comments.

Early seeds

The agency leaves most coverage decisions related to Medicare Part A and B - products or services delivered in a physician's office or hospital - up to regional contractors. The contractors can make decisions on a case-by-case basis, or they can publish local coverage determinations.

But CMS has the authority to make nationwide decisions through the NCD process. The agency then gathers data to determine whether the product or service is reasonable and necessary.

For products or services that might not be covered due to insufficient evidence of safety or efficacy in the Medicare population, CMS can provide CED, which confines coverage to patients enrolled in registries or clinical trials until a final NCD is announced.

There are two types of CEDs. One is "coverage with appropriateness," in which CMS will provide coverage if specific data are submitted to a registry.

Data collected under coverage with appropriateness are used "to ensure that the item or service was provided in accordance with the NCD."

The second type of CED is "coverage with participation." In this case, CMS will cover a drug, device or procedure only if the patient is enrolled in a clinical trial prespecified in the...

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