LCD Reference Article Response To Comments Article

Response to Comments: MolDX-CDD: Genomic Health™ Oncotype DX® Prostate Cancer Assay

A55034

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A55034
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Article Title
Response to Comments: MolDX-CDD: Genomic Health™ Oncotype DX® Prostate Cancer Assay
Article Type
Response to Comments
Original Effective Date
07/05/2016
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Noridian’s Response to Provider Recommendations (for comment period ending 12/7/2015):

Response To Comments

Number Comment Response
1 Agree with the recommended draft policy as written. Thank you.
2 NCCN and Intermediate Risk Patients We believe that intermediate risk patients for whom AS is being considered should have access to the Oncotype DX Prostate Cancer Assay. Patients with Gleason sum 3+4 intermediate risk prostate cancer can have clinical outcomes indistinguishable from low risk disease (Raldow JAMA Oncol 2015) and recent studies indicate that between 8-16% of intermediate risk patients use AS as their primary management strategy(Shelton AUA 2015, Loeb AUA 2015). This commenter notes that accurate risk stratification remains a challenge and believes this GPS provides an independent measure of aggressiveness. The requestor notes footnote “n” in guidelines 1.2016 on page PROS-4 that states “Patients with favorable intermediate-risk prostate cancer (predominant Gleason grade 3)[i.e. Gleason score 3+4=7] and percentage of positive biopsy cores <50%, and no more than one NCCN intermediate risk factor) can be considered for active surveillance. Accurate prostate cancer risk stratification remains a challenge. The GPS assay validation studies showed that incorporation of GPS results with clinical assessment more accurately identified very low- and low risk biological potential, and thus, appropriate candidates for AS. Despite limited data from the validation studies that suggested some intermediate patients with a low GPS benefit from AS, the NCCN and other medical groups do not recommend this approach. Prospective clinical studies are ongoing by the test manufacturer aimed at addressing the clinical utility of GPS for intermediate risk patient. The results of these studies may permit Medicare coverage of intermediate risk patients in the future.
3 Life Expectancy 10-20 years In keeping with NCCN language, this should read “Patient has an estimated life expectancy of greater than or equal to 10 years (= 10 years). The language will be changed to reflect = 10 years.
4 Patient Registry Requirements The commenter notes that many of the requirement for a patient registry in the Draft LCD are met their ongoing, prospective observational trial of 1200 newly diagnosed prostate cancer patients. The commenter hopes that at the end of this trial, the data will allow continuing coverage and removal of all data collection and CTR requirements. This contractor hopes for the same outcomes.
5 CTR Requirements The commenter notes that the CTR training requirements and certification process can be achieved via an online training module. Physicians would have to have completed this training before GPS results will be released for patients, and provide instructions on how to report instances when patients present with advanced disease after having a low GPS result and following AS. Online training module is acceptable tool as long as physicians have a physician contact associated with the testing laboratory that can provide comprehensive responses to questions raised by a provider.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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Updated On Effective Dates Status
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Keywords

  • MolDX
  • Genomic Health™
  • Oncotype
  • Prostate