4Kscore test

[pjoshea13]

-Patrick

360dx.com/reimbursement-new...

Opko 4Kscore Prostate Cancer Test Receives LCD

Nov 14, 2019 | staff reporter

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.

[User2008]

I saw a car on the road today with a "wrap" touting Opko's 4Kscore.com. I didn't know what it was, so I turned to this group and did a search. It seems that someone posts a comment on it every year or so for the last 4 years but there aren't many comments. Is this test in common use today? I guess since most everyone on our site has already been diagnosed, 4Kscore isn't all that relevant. I had never heard of it, so I just thought I'd throw it out there.

[pjoshea13 in reply to User2008]

I think that there has been more interest in Europe because of the potential impact on costs.

In the U.S., doctors who profit from biopsies may not be particularly interested in screening tools beyond PSA.

I don't think that insurance pays for the 4K in the U.S. at this time, but there is supposedly an alternative test that is covered.

I have a friend who had a Gleason 3+3 diagnosis over 5 years ago. He is on active surveillance & refuses to have the standard periodic biopsies. The 4K test allows him to avoid the annual fight with his doc.

-Patrick

[User2008 in reply to pjoshea13]

Thanks for the reply, pjoshea13!