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    Medicare to cover one PCa test, PPO covers another

    The ConfirmMDx for Prostate Cancer test qualifies for Medicare coverage effective Nov. 3, 2014, MDxHealth SA announced, while the maker of a second test, the Decipher Prostate Cancer Classifier, has added a new preferred provider organization to expand coverage of that test.

    Related - Epigenetic test may cut unneeded repeat PCa biopsies

    The Centers for Medicare & Medicaid Services released the final version of the coverage policy for ConfirmMDx issued by Palmetto GBA, the Medicare administrator responsible for the MolDX technology assessment program that evaluated the ConfirmMDx test. The MolDX title is “ConfirmMDx Epigenetic Molecular Assay,” and the LCD number is L35368.

    As part of an ongoing commitment to ensure that Medicare covers the appropriate use of the ConfirmMDx test, Palmetto GBA expects MDxHealth to continue accruing patients in the prospective, randomized PASCUAL clinical utility trial currently in process, and to enroll providers into its Certification and Training Registry, according to a press release from MDxHealth SA.

    “The LCD provides for coverage initially limited to patients of physicians enrolled in the ConfirmMDx Registry.  MDxHealth will conduct an interim analysis of the PASCUAL study to determine the repeat biopsy rate, and expects to complete the interim analysis in 2015. Provided the interim analysis yields positive results showing a substantially lower repeat biopsy rate, Palmetto will expand physician participation in the ConfirmMDx Registry, effectively increasing the number of Medicare patients covered,” the release stated.

    If the interim analysis demonstrates poor accrua, or fails to demonstrate a substantially decreased repeat biopsy rate, the LCD indicates that limited coverage will continue until either 1,200 patients have been tested or 3 years from the effective date of the LCD, which ever occurs first. MDxHealth said it expects to have tested 1,200 patients within the PASCUAL trial and the registry by second quarter of 2016. Unrestricted Medicare coverage, with the registry requirement removed, is expected with favorable PASCUAL trial findings.

    "The ConfirmMDx for Prostate Cancer test is an important tool validated to aid urologists with management of patients suspected to harbor undetected prostate cancer and the need for a repeat biopsy. The PASCUAL clinical trial is an opportunity to prospectively demonstrate how urologists utilize the test results in a patient population with a previous negative biopsy result," said principal study investigator Neal Shore, MD, of Carolina Urologic Research Center, Myrtle Beach, SC.

    “The ConfirmMDx test provides valuable genomic insights beyond standard pathology review, helping urologists make informed decisions about the need for repeat biopsy on high risk patients."


    Next: GenomeDx announces agreement with MultiPlan, Inc.


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