Laboratory Question for the Week of October 26, 2020

Question:

What criteria must be met for NGS for germline cancer coverage to be considered reasonable and necessary?

Answer:

In order for these services to be reasonable and necessary, in addition to being done in a CLIA certified laboratory and ordered by a treating physician, the following requirements must also be met:

• The patient must be diagnosed with ovarian or breast cancer; and,
• Possess a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer; and,
• Be proven to have a risk factor for germline (inherited) breast or ovarian cancer; and,
• The patient cannot have been tested before with the same germline test using NGS for the same germline genetic content.

This question was answered in an edition of our Laboratory Compliance Manager. For more hot topics relating to laboratory services, please visit our store or call us at 1.800.252.1578, ext. 2.