OPKO Health Receives Proposed/Draft Medicare Local Coverage Determination for 4Kscore® Test
OPKO Health, Inc.
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (OPK) (“OPKO” or the “Company”) announces that Novitas Solutions has issued a draft local coverage determination for the 4Kscore® Test, the only blood test that accurately identifies an individual patient's risk for high-grade, aggressive prostate cancer. Novitas Solutions is a Medicare Administrative Contractor (MAC) for Medicare jurisdictions L and H, with responsibility for nearly 10 million Medicare beneficiaries in New Jersey, Pennsylvania, Maryland, the District of Columbia and Texas, among other geographies.
The draft local coverage determination is posted to the Medicare Coverage Database on the Centers for Medicare & Medicaid Services (CMS) website, and proposes to establish reimbursement coverage for patients with PSA levels >3 ng/mL who have not yet had a biopsy, or patients with a PSA level of >3 ng/mL who have had at least one prior negative biopsy and are considered to be at higher risk.
"This first MAC determination is a major milestone for the 4Kscore Test as it expands access to a potentially life-saving tool," said Phillip Frost, M.D., OPKO's Chairman and Chief Executive Officer. "We believe this decision by Novitas will help accelerate further coverage decisions by other payers, and will encourage adoption of the 4Kscore Test by physicians and patients. More importantly, it will allow broader access to this important test, which can assist patients and physicians in further defining a patient’s risk of having a high-grade prostate cancer that requires immediate or aggressive treatment.”
The draft local coverage determination follows the 4Kscore’s inclusion as a standard-of-care in the 2015 National Comprehensive Cancer Network Guidelines and in the 2016 European Association of Urology Prostate Cancer Guidelines for Prostate Cancer.
