Renal pays for BRLI incompetence

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OPKO Plans to Address Draft Local Coverage Determination Published by Novitas Solutions for 4Kscore Test

MIAMI, May 18, 2018 (GLOBE NEWSWIRE) -- OPKO Health, Inc.(Nasdaq:OPK) today announced that Novitas Solutions, Inc. issued a draft local coverage determination (LCD) for the 4Kscore test®. The draft LCD is a proposed non-coverage policy for the 4Kscore test for Medicare and, prior to its effectiveness, is subject to a public comment period ending July 5, 2018. OPKO plans to submit comments during this time period.

The 4Kscore test has been included in the National Comprehensive Cancer Network Guidelines® (NCCN) since 2015, and European Association of Urology Prostate Cancer Guidelines since 2016. Recommendations are based upon expert panels’ assessment of peer reviewed literature to provide clinical standards for prostate cancer care. Both guidelines recommend the 4Kscore test can be used as an aid in decision making before a first or repeat prostate biopsy in men with elevated PSA or other clinical symptoms. 4Kscore test has 95% sensitivity and 93% Negative Predictive Value for the identification of aggressive prostate cancer in patient population recommended by NCCN.

The 4Kscore test has been ordered by more than 9,000 practicing physicians worldwide and extensively studied with results presented in 18 peer-reviewed scientific publications involving more than 25,000 patients. Results of five new studies covering the 4Kscore test will be presented at the American Urological Association's 2018 Annual Meeting this weekend in San Francisco, including the second study demonstrating the 4Kscore test’s ability to predict prostate cancer mortality in men with elevated PSA. A study will also be presented at the American Society Clinical Oncology meeting in June 2018 demonstrating the 4Kscore has clinical utility for management decisions of men diagnosed with low and intermediate risk prostate cancer due to its strong association with radical prostatectomy pathology outcome.

“The 4Kscore test has proven to be a significant benefit to my patients, by both identifying those men who are at higher risk of significant prostate cancer who would benefit from a prostate biopsy, while also helping me to avoid biopsies in men who are at low risk,” said Edward Schaeffer, MD, PhD, Chair of the Department of Urology at Feinberg School of Medicine and Program Director of the Genitourinary Oncology Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. “There are numerous cases where the PSA may not have led to a biopsy, but an elevated 4Kscore led to finding aggressive prostate cancer early enough to be beneficial. It would be a real loss if 4Kscore was not available to assist in making the best decision for my patients.”

Novitas Solutions is an administrative services processing company for government-sponsored health care programs on behalf of the federal government, including the Centers for Medicare and Medicaid Services. Novitas serves as the Medicare Administrative Contractor for a jurisdiction that includes the State of New Jersey, where OPKO’s BioReference Laboratories is located and where all 4Kscore test samples are processed.
 






Their non-coverage letter seamed to mimic Palmettos non-coverage letter. However, neither took into consideration the VA Hospital blind validation study that was conducted in multiple locations. The study validated the test accurately predicted aggressive firms of prostate cancer in both African American and non-African America veterans. I hope that they will independently assess all available studies instead of being pressured by Palmetto’s earlier decision which failed to take into account several current validation studies that clearly addressed their reported concerns (e.g. African American Results).
 






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