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Local Coverage Determinations Roundup: Opko Health, Bio-Techne, LynxDx, MDxHealth

NEW YORK – Medicare Administrative Contractor National Government Services released a draft local coverage determination (LCD) for biomarker testing for prostate cancer diagnosis.

The LCD would cover one biomarker test ordered by a urologist or oncologist per year in men older than 45 before a potential initial or repeat biopsy. The patient must have moderately elevated levels of prostate specific antigen (PSA) with no other relative indication or contraindication for prostate biopsy. Indications include a digital rectal exam found suspicious for cancer, a positive prior biopsy, a positive multiparametric MRI, or other major risk factors for prostate cancer.

Contraindications for a patient include a life expectancy of less than 10 years, invasive treatment for benign prostatic disease, medications within the past six months that influence PSA levels, or active prostatitis on antibiotics.

The proposed LCD mentions multiple tests that would be covered under the determination, including Opko Health's 4Kscore, Mi-Prostate Score (offered by LynxDx as MyProstateScore), and MDxHealth's SelectMDx and ConfirmMDx. It would also cover percent free PSA tests, PCA3 assays, and prostate health index tests.

Bio-Techne's ExoDx Prostate IntelliScore (EPI) test is also covered under the LCD, but with slightly different requirements. Patients must be older than 50 to have the test covered and certain risk factors that would rule out coverage, such as ethnicity and having a relative with prostate cancer, do not apply.

SVB Securities analyst Puneet Souda wrote in a note to investors that the decision "resolves the once in a lifetime limitation" for the EPI assay among the Medicare population. The previous guideline covered EPI once per lifetime after a negative biopsy result.

National Government Services noted in the LCD that it will provide "very circumscribed coverage" of these tests, "limited to patients with moderately elevated PSA levels, but with no other, even relative, indication for or against biopsy." It added that "these are men for whom the decision about whether to proceed with prostate biopsy is most ambiguous, and therefore for whom the information is most likely to impact clinical decision making."

None of the tests are recommended for routine use because "they have not been prospectively tested or shown to improve long-term outcomes," the MAC said.

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