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The Balkanized State Of Molecular Diagnostics Reimbursement

Recent moves by CMS have left up in the air an innovative program that gives labs a clearer opportunity to demonstrate clinical utility and test value. It’s therefore unclear whether companies and their backers should expect any greater certainty over the ability to command premium prices for high-value diagnostic tests.

At the end of 2012, the Centers for Medicare & Medicaid Services (CMS) is set to end the practice of laboratories’ code stacking, but with less than two months to go, has yet to articulate fully what system will replace it. CMS has also announced that the regional contract of Palmetto GBA covering California is not being renewed at the end of the year, leaving up in the air an innovative program Palmetto runs there, called MolDx, that gives labs their clearest opportunity yet to demonstrate clinical utility and test value. And in November, CMS announced that while molecular pathology tests generally will be billed under the Clinical Lab Fee Schedule, in cases requiring physician interpretation of a test result and report it is creating a new code that will reside under a separate schedule.

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