CMS Restores Medicare Coverage of Certain Genetic Thyroid Cancer Tests

The first two months of 2022 have been quite eventful for Interpace Biosciences. On Jan. 13, the personalized medicine firm announced it had initiated a $30 million subscription rights offering. But on Jan. 28, Interpace said it was pulling out of the deal in response to a new Centers for Medicare & Medicaid Services’ (CMS) decision limiting reimbursement for the firm’s thyroid cancer tests. The surprise and—at least for Interpace shareholders—happy ending came on Feb. 22 when the firm announced that CMS has reversed its earlier coverage decision.

The Medicare Coverage Roller Coaster

At issue was a Medicare reimbursement of a pair of Interpace tests for diagnosis of thyroid cancer from thyroid nodules:

• ThyGeNEXT, a next generation sequencing-based assay for the diagnosis of thyroid cancer from thyroid nodules; and
• ThyraMIR, a gene expression assay.

Having previously covered both tests under a local coverage determination (LCD) originally made by Medicare Administrative Contractor Novitas, CMS issued a new reimbursement policy stating that it would no longer cover ThyGeNEXT and ThyraMir when the tests are billed together by the same provider for the same beneficiary on the same date of service. In a recent statement, Interpace president and CEO Tom Burnell expressed disappointment and said the firm had decided to terminate the rights offering “due to the likely adverse impact of the change in CMS' policy.” The firm also said it was going to appeal the decision. And that’s just what it did, which turned out to be a good move. On Feb. 22, the New Jersey-based firm said that it had received a response from the National Correct Coding Initiative on behalf of CMS stating that the billing policy has been changed retroactive to Jan. 1. As a result, Interpace will continue to bill for both tests in accordance with the original Novitas LCD. Although the updated policy hasn’t yet been published, Interpace says that CMS will post it on its website and include it in its July 1 edit file.