NCD190.7

 

HUMAN TUMOR STEM CELL DRUG SENSITIVITY ASSAYS

 

Effective Date of this Version

• 7/1/1996

 

Benefit Category

• Diagnostic Laboratory Tests.

• Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

 

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.

o 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.

 

Indications and Limitations of Coverage

• 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.

 

National Coverage Analyses (NCAs)

• This NCD has been or is currently being reviewed under the National Coverage Determination process.

• The following are existing associations with NCAs, from the National Coverage Analyses database.

• Original consideration for Human Tumor Assay Systems (CAG-00044N)

 

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