LCD Reference Article Response To Comments Article

Response to Comments: MolDX- CDD: ProMark Risk

A55305

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A55305
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Response to Comments: MolDX- CDD: ProMark Risk
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Response to Comments
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10/10/2016
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The comment period began on 06/13/16 and ended on 08/08/2016 for the MolDX team. Comments were received from the provider community. The notice period begins on 08/25/2016 and ends 10/09/2016. The LCD becomes final on 10/10/2016.

Response To Comments

Number Comment Response
1 Criteria for Coverage We understand the rationale for consistency in the coverage criteria of the prognostic assays that have received LCDs under MolDx. We would, however, ask Palmetto to evaluate whether the‘Patient Stage’ criteria should be modified to include certain men with intermediate risk prostate cancer. The most recent NCCN Prostate Cancer Guidelines1 (NCCN Prostate Cancer Guidelines Version 2.2016) now include a statement about the use of AS in certain intermediate risk men. On PROS-4 of these guidelines it is noted that, “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) may be considered for active surveillance.” Given that men fitting these criteria may now be making choices about active surveillance, we believe it is important to allow access to advanced prognostic assays that can inform these decisions. We recommend that the LCD reference the NCCN Version2.2016 guidelines. NCCN version 3.2016 specifies “Patients with favorable intermediate-risk prostate cancer (predominate Gleason grade 3 [i.e., Gleason score 3+4=7], and percentage of positive biopsy cores <50percent, and no more than one NCC intermediate risk factor) may be considered for active surveillance.” Published data does not include the group of patients and no nationally recognized professional organization includes this group of patients in their AS recommendation. When published data supports inclusion of intermediate risk patients and their national guidelines recommend AS, the policy can be amended.
2 Certification and Training Registry (CTR) We agree with the goals of the proposed CTR and will work with MolDx on the implementation of the training and data collection requirements under the CTR. We are hopeful that the accumulation of additional data on the impact of ProMark and other advanced prognostic assays via the MolDx CTRs for prostate cancer will enable a transition from the CDD structures in the future. Your comment is appreciated.
3 Correction Please change the format of the company name from MetaMark to Metamark in the LCD (the second ‘m’ should be lowercase). Correction made in LCD.
4 On the other draft Urologic LCD, Promark Risk Score for prostate cancer (DL 36704), I would ask that you consider adding Gleason 3+4, small volume cancer, PSA <10 as "low risk disease" and therefore a covered indication. The policy as written, divides risk as Gleason 6 or Gleason 7 (low or intermediate risk). Unfortunately, not all Gleason 7 tumors are the same: the "7" is the sum or two components and Gleason 3+4 acts as a Gleason 3+3 (6) while Gleason 4+3 acts more aggressively. Thus, the LCD is too simplified and should recognize that a different approach may be reasonable for the lower risk of these two. Thus, an elderly man with PSA<10, T1c-T2 disease, small volume Gleason 3+4 cancer on biopsy should be covered for Promark testing. In fact, this is the most efficient use of this test (moderately older man with more than 10 year life expectancy, small volume cancer, Gleason 3+4, PSA <10 who is considering Active Surveillance or more aggressive treatment). With that minor change, the LCD is fine. Extending this argument, Gleason 3+4, small volume, PSA<10 should also be covered for Prolaris testing (another assay performed on biopsy tissue to further inform the decision to actively treat or watch with Active Surveillance) considering this as low risk disease. This LCD which is already approved should be Reconsidered and Amended. The following response to comment address comment received by Noridian Administrative Services on draft policy DL36704. NCCN version 3.2016 specifies “Patients with favorable intermediate-risk prostate cancer (predominate Gleason grade 3 [i.e., Gleason score 3+4=7], and percentage of positive biopsy cores <50percent, and no more than one NCC intermediate risk factor) may be considered for active surveillance.” [Emphasis added by author.] Published data does not include this group of patients and no nationally recognized professional organization includes this group of patients in their AS recommendation. When published data supports inclusion of intermediate risk patients and their national guidelines recommend AS, the policy can be amended for ProMark, Prolaris or other comparable assays.
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LCDs
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