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Opko 4Kscore Prostate Cancer Test Receives LCD

NEW YORK – The Centers for Medicare & Medicaid Services said last week that Medicare administrative contractor Novitas has issued a positive local coverage determination for Opko Health's 4Kscore test for prostate cancer.

According to the decision posted on CMS' website, Novitas will cover the test for patients 45 years or older with a confirmed moderately elevated level of prostate-specific antigen (PSA), between 3 ng/mL and 10 ng/mL, and no other indication or contraindication for prostate biopsies. If the patient has major risk factors for prostate cancer or less than a 10-year life expectancy, the test will not be covered. The test will also not be covered if there's a persistent and significant increase in the patient's PSA or if a digital rectal examination (DRE) is performed and there's a suspicion of cancer.

CMS noted that there must be evidence of shared decision-making between the physician and the patient to receive coverage.

Novitas serves as the MAC for a jurisdiction that includes New Jersey, where Opko's BioReference Laboratories is located and where all 4Kscore test samples are processed. The final LCD will be effective Dec. 30, 2019.

"This final determination is expected to significantly improve men's access to the 4Kscore test," said Jon Cohen, executive chairman of BioReference Laboratories. 

The final decision comes after three years of flip-flopping by Novitas on an LCD for the test. It originally issued a draft LCD in 2016, but withdrew the decision after another contractor, Palmetto, proposed a non-coverage determination. This past June, Novitas issued a proposed limited LCD for the 4Kscore test.

The 4Kscore test measures blood levels of four kallikrein protein markers, including total PSA, free PSA, intact PSA, and hK2, and combines the data with patient age, DRE, and prior biopsy history to reduce unnecessary biopsies.