LCD Reference Article Response To Comments Article

Response to Comments: MolDX- CDD: ProMark Risk Score

A55470

Expand All | Collapse All
Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

Document Note

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A55470
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: MolDX- CDD: ProMark Risk Score
Article Type
Response to Comments
Original Effective Date
06/01/2017
Revision Effective Date
N/A
Revision Ending Date
N/A
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

N/A

Article Guidance

Article Text
Noridian's response to provider recommendations for comment period ending 08/08/2016.

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.
N/A

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Additional ICD-10 Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A N/A
N/A
Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation
N/A

Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
N/A
SAD Process URL 1
N/A
SAD Process URL 2
N/A
Statutory Requirements URLs
N/A
Rules and Regulations URLs
N/A
CMS Manual Explanations URLs
N/A
Other URLs
N/A
Public Versions
Updated On Effective Dates Status
03/23/2017 06/01/2017 - N/A Currently in Effect You are here

Keywords

  • MolDX
  • Promark
  • L36704