By Jessica Jankowski, Senior Practice Manager Vachette Pathology
Since January 2014, there are more and more issues coming out of the woodwork with FSH billing and reimbursement. Earlier this year, we saw United Health Care (UHC) create their own application of an MUE to any CPT Code 88368 billed more than once per patient per day. While UHC is now in the process of recanting this, we are continuing to see Blue Cross Blue Shield of South Carolina (BCBS SC) deny 88368 as investigational.
According to BCBS SC, they are taking issue with an assay component used in some FSH testing that requires a more “clear association with clinical outcomes” (Blue Cross Blue Shield South Carolina , 2013). The policy goes on to further state that “the clinical utility of the HERmark® assay has not been demonstrated, and clinical trials are needed to determine the impact on the clinical outcome of patients stratified by the HERmark® assay” (Blue Cross Blue Shield South Carolina , 2013).
There are two problems that I see in this policy:
1) The policy is based on the use of the HERmark® assay for FSH testing and only this assay, and
2) The HERmark® assay test is not an FDA-approved test; it is considered a homebrew test (Blue Cross Blue Shield South Carolina , 2013).
My question to BCBS SC is, how can they assume every FSH test done by a pathologist uses only the HERmark® assay? And one that is not even FDA-approved? Can they truly believe this is the only method? In fact, there are other FDA-approved FSH assays being used, such as PathVysion™, Inform®HER2/neu and as well as Dako’s HER2 IFSH pharmDx™ assay technology (FDA, 2010).
In an effort to appeal the denials of BCBS SC, we recommend that billers provide data showing the type of FSH assay used, as well as information validating the FDA-approval of the assay.
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Blue Cross Blue Shield South Carolina . (2013, December). Medical Policies . Retrieved June 2014, from https://www.cam-policies.com
Dako. (2013, February ). Dako: an Agilent Technologies Company . Retrieved June 2014, from About Dako : https://www.dako.com
FDA. (2010, October ). Medical Devices . Retrieved June 2014, from U.S food and Drug Administration : https://www.fda.gov