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Prostate Cancer

Discussion in 'Oncology' started by Valery1957, Feb 9, 2019.

  1. Valery1957

    Valery1957 Famous Member

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    News > Medscape Medical News > Oncology News
    Medicare Won't Pay for Prostate Cancer Risk Test
    Flaws in Clinical Studies Are Cited
    Nick Mulcahy

    February 07, 2019

    • 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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  2. Valery1957

    Valery1957 Famous Member

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    Biological markers that could guide treatment for prostate cancer
    Date:
    January 3, 2019
    Source:
    Mayo Clinic
    Summary:
    Genetic alterations in low-risk prostate cancer diagnosed by needle biopsy can identify men that harbor higher-risk cancer in their prostate glands, researchers have discovered. The research found for the first time that genetic alterations associated with intermediate- and high-risk prostate cancer also may be present in some cases of low-risk prostate cancers.
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    Materials provided by Mayo Clinic. Note: Content may be edited for style and length.

    Cite This Page:

    Mayo Clinic. "Biological markers that could guide treatment for prostate cancer." ScienceDaily. ScienceDaily, 3 January 2019. <www.sciencedaily.com/releases/2019/01/190103110624.htm>.
     

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