Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published MDDI October 2005

NEWSTRENDS

New devices that apply for Medicare coverage through local coverage decisions will not be subject to the new “Coverage with Evidence Development” principles, according to a memo from the Centers for Medicare and Medicaid Services (CMS).

The Coverage with Evidence Development program is intended to allow payment for services that are expansions of existing covered services.

Precise guidelines have not yet been written, and industry has been concerned about what kind of a burden they might impose. But the memo, dated July 12, 2005, clarifies that the program will only be considered for devices that apply for national coverage decisions. About 90% of Medicare coverage decisions are made at the local level, and those won't be affected.

The memo also states that CMS plans to issue another draft guidance that will specify when the program will apply, how its principles will be implemented, and how the data will be collected.

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