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October 22, 2015

Specimen Validity Testing (CM00060)

According to the CMS Internet-Only Manual (IOM) 100-04, Chapter 16, Section10External PDF, a diagnostic laboratory test must be ordered by the treating physician and the test results must be used in the management of the beneficiary’s specific medical problem. Although some laboratory requisitions allow the ordering physician to designate specimen validity testing (e.g.: creatinine, oxidant, pH, specific gravity) to ensure that a patient specimen has not been adulterated, the results of this testing are not used in the management of the beneficiary’s medical problem. Therefore, MolDX has determined that specimen validity testing is a statutorily excluded service.

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