Inside The Diagnostics Industry: Medicare Coverage of Molecular Tests Continues to Evolve
Advanced diagnostic tests are emerging faster than the clinicians can document their clinical utility. All of this creates an interesting dilemma for payors as far as coverage is concerned. Normally the most cautious of payors, Medicare has demonstrated an increasing willingness to cover newfangled tests—at least in certain circumstances—with the expectation that they do work and that the studies will eventually catch up. The recent local coverage determinations (LCDs) issued by Palmetto, GBA, one of Medicare’s most important contractors, is an excellent illustration of where things seem to be evolving with regard to Medicare coverage of new molecular diagnostic tests. What’s At Stake First, a quick refresher on LCDs. Medicare covers only services that are "reasonable and necessary." Each Medicare contractor has discretion to decide which services meet those criteria. LCDs set out the particular contractor’s coverage rules. So-called draft LCDs typically contain proposed revisions and updates to coverage rules and are open to comment for at least 45 days. Once the comment period ends, the contractor issues a final LCD. The lab test LCDs discussed in this article are draft LCDs that Palmetto issued on Dec. 23. The comment period runs between Feb. 6 and Mar. 23. So you […]
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