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CMS Issues Preliminary Medicare Coverage Determination for GenomeDx's Prostate Cancer MDx

NEW YORK (GenomeWeb) – The Centers for Medicare and Medicaid Services on Thursday published a draft local coverage determination (LCD) for GenomeDx's Decipher genomic test for men who have undergone a radical prostatectomy.

The determination relates to Medicare coverage for the test. A 45-day comment period will begin on Nov. 10 and the final LCD will be posted within 45 days after comments are received and any revisions to the proposal are made. Medicare administrator Palmetto GBA issued the draft LCD for Decipher through the MolDX Program.

The Decipher test is for use by men who have had a radical prostatectomy and are considered to be at high risk for the return of their cancer. Such patients include men who have specific risk factors for the recurrence of prostate cancer, including positive surgical margins, stage T3 disease, or rising prostate-specific antigen levels after initial PSA nadir when PSA is undetectable, GenomeDx said.

The 22-biomarker assay uses oligonucleotide microarray technology to interrogate 1.4 million RNAs from formalin-fixed, paraffin-embedded tissue blocks of radical prostatectomy specimen, according to the CMS draft proposal.

In a statement, GenomeDx CEO Doug Dolginow called the draft LCD "a major step toward providing access to Decipher for the thousands of prostate cancer patients weighing treatment options after radical prostatectomy."

In its draft proposal, CMS said that each year about 40,000 men in the US who have undergone surgery for prostate cancer will subsequently experience adverse pathology or increased PSA levels, putting them at risk for prostate cancer recurrence and ultimately metastatic disease. The standard of care for these men is post-operative radiation therapy. A significant percentage of such patients may not need the procedure, though.

"The identification of the subgroup of men who do not need [post-operative radiation therapy] is important," CMS said. "However prospective studies of outcomes of early prostate cancer (especially where there is a non-intervention arm) will take decades to complete."

Patients would need to meet several criteria for Medicare coverage of Decipher, including having undergone a radical prostatectomy during the previous 60 months and being considered for post-operative secondary therapy due to one or more cancer recurrence risk factors. They would also need to have achieved initial PSA nadir within 30 days of radical prostatectomy and would need to have no evidence of distant metastasis. Other requirements would need to be met.

CMS also proposes that Decipher be provided only by physicians who are enrolled in a MolDx-approved certification and training registry program, due to the complexity around treatment decisions based on the test's results.

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