Final LCD for the 4Kscore Test

Have you heard the news that the final Local Coverage Determination (LCD) from the Medicare MAC for the 4Kscore® Test, Novitas, is now effective. The LCD includes defined coverage criteria from Medicare, including required documentation of Shared Decision Making prior to ordering the 4Kscore Test. Full text of the final LCD can be found here.

If you are a current client ordering the 4Kscore, please note that the test requisition form was modified to support the updated coverage criteria and is now the only requisition form that can be used to place an order for the 4Kscore Test. If documentation is INCOMPLETE, results may be delayed. In cases where complete documentation is not received by the lab following communication with your office, the test may be cancelled after a holding period.

Summary of Changes:

  • BOTH provider and patient signatures, legible names, and dates attesting to Shared Decision Making are required when ordering the 4Kscore Test, and must be sent to the laboratory.
  • ALL questions in the Prostate Cancer Risk Evaluation section of the requisition form MUST BE COMPLETED.
  • A COPY of the completed test requisition with Shared Decision Making should be retained in the patient’s medical record.

What is the 4Kscore Test?

The 4Kscore® test is used in men after an abnormal prostate-specific antigen (PSA) or digital rectal exam (DRE) result.  It provides the risk of finding high-grade prostate cancer if biopsy were to be performed and has the potential to minimize avoidable biopsy procedures. Data from two prospective clinical studies involving approximately 1,500 patients in urology centers in the U.S. demonstrated that the 4Kscore® test had 94% sensitivity and 95% Negative Predictive Value for detecting aggressive prostate cancer. 

If you have any questions, please contact our 4Kscore Customer Service team at 833-4KSCORE (833-457-2673) or visit the 4Kscore website here.

If you are a urologist and not currently ordering the 4Kscore test for patients, click here to be contacted by an account executive to set up your client account and begin ordering.