Palmetto GBA, a national contractor that administers Medicare benefits, has issued a positive coverage policy through the MolDX Program for the Decipher prostate cancer classifier, developer GenomeDx Biosciences reported.
Decipher is intended for men who have undergone radical prostatectomy and are considered by guidelines to be at high risk for recurrence. These are men who have specific risk factors for cancer recurrence, including positive surgical margins, pathologic stage T3 disease, or rising PSA after initial PSA nadir. The Medicare coverage policy covers men with prostate cancer who have these features and are weighing treatment options after a radical prostatectomy, GenomeDx said in a press release.
“We are pleased to have had the opportunity to work closely with Palmetto GBA to establish coverage for Decipher. This is an important milestone for GenomeDx and the thousands of men who may benefit from the valuable genomic information provided by Decipher,” GenomeDx CEO Doug Dolginow, MD, said in the release.
Decipher was recently found to predict rapid metastatic disease in node-negative, high-risk men managed by radical prostatectomy without adjuvant therapy, according to findings published online in European Urology.
The announcement also follows GenomeDx’s fall 2014 announcement that it had entered into a contractual agreement with MultiPlan, Inc. for diagnostic laboratory testing, providing access to the Decipher classifier to health plan members who access 500,000-plus providers who participate in the MultiPlan Network.
Since their U.S. rollout, newer prostate cancer tests have received positive coverage decisions from Medicare and private insurers:
- Palmetto GBA issued a draft local coverage determination (LCD) for the Prolaris prostate cancer test (Myriad Genetics, Inc.) in October 2014. Language in the draft LCD provides reimbursement coverage for the approximately 50% of prostate cancer patients defined as low and very low risk.
- Also in fall 2014, the Centers for Medicare & Medicaid Services released the final version of the coverage policy for ConfirmMDx for Prostate Cancer test (MDxHealth) issued by Palmetto GBA.
- Early in 2014, both GenomeDx and MDxHealth announced agreements aimed at expanding insurance coverage for the Decipher and ConfirmMDx tests, respectively. GenomeDx entered into a contractual agreement to provide the Decipher test to FEDMED payers, while MDxHealth signed an agreement with Prime Health Services, Inc., a preferred provider organization network, covering all 50 states.
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