About this policy
CMS National Coverage Determination | ncd_id=253 | manual_section=190.7 | coverage_level_code=3 | national_coverage_type=True | under_review=True | lab_ncd=False
Coverage indications
Human tumor drug sensitivity assays are considered experimental, and therefore, not covered under Medicare at this time. The clinical application of the assay, based on testing in tumor microorgans rather than in clones derived from single cells, is considered experimental, and therefore, not covered under Medicare at this time.
Documentation requirements
Item/Service Description: Human tumor stem cell drug sensitivity assays involve exposure of human tumor stem cell colonies grown in tissue culture to anticancer drugs and observing for cytotoxic effects. Their purpose is to screen potential anticancer drugs and predict the effects of these drugs on tumors of individual patients, to allow the selection of the most effective drug or drugs for that patient. The Fluorescent Cytoprint Assay, a miniaturized organ culture system for cancer chemosensitivity testing, allows for qualitative visual estimation of cell kill using low power microscopy and a noncytotoxic fluoresence probe for cell viability. Revision History: 07/1996 - Clarified that the clinical application of fluorescent cytoprint assay is experimental and not covered. Effective date NA. (TN 88) Benefit Categories: 18 - Diagnostic Laboratory Tests Transmittal: transmittal_number=88 | transmittal_issue_date=1996-07-01
Codes in this policy
Code numbers and each code’s status as the policy records it. CPT code descriptions are left out of this page, as are the passages that cite CPT codes; the official document has them.
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