The draft LCD is on line here or here; Genomic Health's press release is here and coverage at Genomeweb (subscription), here.
Coverage conditions are similar to those proposed and finalized for the Myriad Genetics Prolaris test.
Similar to the Prolaris test, coverage is for men with "very low risk disease" or "low risk disease" based on tumor stage (size), Gleason grade, and other factors. As MolDX required in other recent LCDs, a training program for physicians is required. The draft LCD states as follows:
Certification and Training Registry (CTR) ProgramBecause of the complicated nature of management decisions utilizing the Oncotype DX® Prostate Cancer Assay and the potential for adverse harm to patients if the test is not used appropriately, testing must be furnished only by physicians who are enrolled in a MolDX approved Genomic Health™ Oncotype DX® Prostate Cancer Assay CTR program. This serves to assure the appropriate selection of patients, compliance with management decisions and stringent follow up to ensure the benefits of the test outweigh its risks. As part of this requirement Genomic Health™ will provide to Palmetto GBA reports every 6 months in a mutually agreed upon format.
The goals of the Genomic Health™ Oncotype DX® Prostate Cancer Assay CTR program are as follows:
• To ensure that physicians understand the limitations of the test based on its validation through retrospective and non-U.S. standards of care studies, and • To inform prescribers and patients on the safe-use conditions for Oncotype DX® Prostate Cancer Assay™, and • Make a good faith effort to identify any safety concerns from the use of the test, and • Facilitate understanding of the incremental clinical utility of the test versus adherence to current NCCN guidelines.
Palmetto GBA expects Genomic Health™ to:
• Establish and maintain the Oncotype DX® Prostate Cancer Assay Certification and Training Registry (CTR); • Ensure that healthcare providers who order the Oncotype DX® Prostate Cancer Assay score are registered and certified in the Oncotype DX® Prostate Cancer Assay CTR program and that the Oncotype DX Prostate Cancer Assay is available only through these providers; • Maintain a secure registry database of Genomic Health™ Oncotype DX® Prostate Cancer Assay CTR providers and obtain from referring physicians; ◦ NCCN risk group and treatment recommendation based on current NCCN guidelines prior to receipt of test result; ◦ Test result (i.e., GPS + NCCN risk group), and ▪ Treatment recommendation based on test results, and ▪ Physician-patient treatment decision, and ▪ Report utilization data by clinico-pathologic staging; ▪ Any subsequent change in patient or physician treatment decision, even if the patient has not progressed, and ▪ Immediately report (for patients not treated definitively who were deemed very low or low risk by the assay: ▪ Progression as defined by current NCCN guidelines for patients on AS, or ▪ Development of metastases, or ▪ Prostate cancer deaths.▪ Share all required data and reports in a HIPAA complaint fashion.
When I began working as a Medicare medical director in 2004, a senior former CMS medical director commonly remarked that "You grant coverage, or you don't, and if you grant coverage, they horse is out of the barn and that's the end of seeing any data." Clearly, this type of LCD puts the payer (and provider) in a very different relationship that was familiar from the 1990s or early 2000s.