CMS GUIDANCE ON EVIDENCE-BASED COVERAGE HAS INDUSTRY WORRIED ABOUT IMPACT ON REIMBURSEMENT

A recent guidance issued by the Centers for Medicare & Medicaid (CMS) has industry groups worrying whether reimbursements for their products could be cut -- or even eliminated.

The guidance on national coverage determinations (NCDs) attempts to clarify how the agency will decide which "items and services" to cover and to what extent it will cover them.

The guidance focuses on the purpose of coverage with evidence development (CED), which is to:Evaluate whether a product or procedure is appropriate for Medicare beneficiaries; Evaluate whether future changes in coverage may be needed; and Generate clinical results that help physicians make more informed recommendations to beneficiaries about products or procedures.

Specifically, the CMS introduces two approaches to CED -- coverage with appropriateness determination and coverage with study participation -- that could change how it decides to cover devices.

But the guidance has left some devicemakers with more questions than answers, and industry groups say they are still evaluating it. (http://www.fdanews.com/ddl/33_28/)