This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
4Kscore may be considered medically necessary when the following criteria are met:
- No previous 4Kscore testing performed after the most recent negative biopsy when a result was successfully obtained; and
- No previous ConfirmMDx testing on the most recent negative biopsy when a result was successfully obtained; and
- Member is not under active surveillance for low stage prostate cancer; and
- Negative prostate biopsy within the past 24 months; and
- Member is considered at higher risk for prostate cancer by one or more of the following:
- Family history of 1st degree relative with prostate cancer diagnosed younger than age 65 years; and/or
- African American race; and/or
- Known mutation in a gene associated with increased risk of prostate cancer (e.g. BRCA1/2, MLH1, MSH2, MSH6, PMS2, EPCAM).
4Kscore for prostate cancer risk assessment is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.