A big issue in prostate cancer is differentiating patients with an aggressive tumor that needs immediate treatment from patients with lower-risk disease that may never spread and can be managed with active surveillance.
One test that addresses this problem is the 4Kscore (Opko Health), a blood test that predicts the likelihood of having a high-grade prostate cancer after an elevated prostate-specific antigen (PSA) test result.
However, this test has received a "noncoverage" determination from a Medicare administrative contractor, according to a report in the South Florida Business Journal.
The Medicare contractor, Novitas Solutions, said they found flaws with clinical studies of the test.
Opko will appeal the decision with the US Centers for Medicare & Medicaid Services, the report added.
More than 12,000 practicing physicians have ordered the 4Kscore test, according to the company.
4Kscore is an assay panel that combines three PSA measures (total, free, and intact) with another prostate-specific measure, human kallikrein 2, in an algorithm that takes into account a patient's age, digital rectal examination result, and previous biopsy status.
The test reportedly helps distinguish men who are at higher risk for aggressive disease from those at lower risk, possibly aiding in personal decisions to undergo biopsy.
Novitas, which acts as stand-in for Medicare and makes coverage decisions in 10 states and Washington, DC, issued a proposed ruling that Medicare should not reimburse for the 4Kscore in May 2018.
Last week, the test manufacturer said that Novitas set March 20 as the date that the noncoverage determination goes into effect, according to the South Florida Business Journal.
"We remain committed to our goal of widespread and affordable access to 4Kscore," said Phillip Frost, CEO of Opko.
In an apparently unrelated matter, Frost recently agreed to a settlement with the Securities and Exchange Commission in a civil case related to "lucrative market manipulation schemes" worth $27 million, per CNBC.
Clinician Support for the 4Kscore Test
The new Medicare ruling may come as a surprise to clinicians who have followed the story of the blood test.
In 2014, 4Kscore investigator Daniel Lin, MD, from the University of Washington in Seattle, told Medscape Medical News that "this is a test that can personalize the risk of having a clinically relevant prostate cancer that deserves diagnosis."
In 2015, Medscape urology expert commentator Gerald Chodak, MD, highlighted the fact that the American Medical Association has issued a CPT (current procedural technology) code rating of level I for the test, "which means that it is likely that insurance companies and Medicare will find the test more acceptable for reimbursement in the future."
Chodak said the 4Kscore test "clearly is better" than traditional PSA testing in identifying men at risk for high-grade disease before biopsy.
However, he also said that one of the test's shortcomings is that "it misses in the range of 10% to 18% of potentially high-risk cancers."
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Cite this: Medicare Won't Pay for Prostate Cancer Risk Test - Medscape - Feb 07, 2019.