SUPERSEDED Local Coverage Determination (LCD)

ProMark® Risk Score

L36675

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Proposed LCD
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Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L36675
Original ICD-9 LCD ID
Not Applicable
LCD Title
ProMark® Risk Score
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL36675
Original Effective Date
For services performed on or after 10/10/2016
Revision Effective Date
For services performed on or after 11/24/2022
Revision Ending Date
12/06/2023
Retirement Date
N/A
Notice Period Start Date
08/25/2016
Notice Period End Date
10/09/2016
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

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Issue

Issue Description

This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity.

Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

42 CFR 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80.0 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, §80.1.1 Certification Changes

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

This Contractor will provide limited coverage for the ProMark® (Metamark Genetics) to help determine which patients with early stage, needle biopsy proven prostate cancer can be conservatively managed rather than treated with definitive surgery or radiation therapy.

Summary of Evidence

In 2014, nearly 233,000 men in the US will be diagnosed with prostate cancer, which accounts for 14% of all new cancer diagnosis. More than 29,000 men will die from this disease representing 5% of all cancer deaths. Gratefully 98.9% of men are surviving at 5 years.3

Many individuals do not need treatment for their prostate cancer in as much as their prognosis is excellent even without treatment. However, physicians and patients struggle to know who can safely be observed versus the subgroup that needs more aggressive treatment to achieve cure, and recognize that definitive treatment for localized prostate cancer can have lifelong morbidities.5,8

Traditionally, clinicopathologic characteristics are utilized to determine risk and subsequent treatment. Several nomograms have been introduced to try to determine who is at risk of developing metastatic disease and who, if treated early, could avoid this outcome. A representative nomogram taken from the National Comprehensive Cancer Network (NCCN) and American Urological Association (AUA), divides early prostate cancer into several groups based initially on life expectancy, with a second stratification using clinical exam, reassessment of life expectancy, biopsy (Gleason score), prostate-specific antigen (PSA) and imaging after 5 years.

These groups are detailed below:

 

Risk Category

  Very Low Low Intermediate High
Clinicopathologic Findings
  • T1c AND
  • Gleason score ≤ 6 AND
  • PSA ≤ 10 ng/mL AND
  • < 3 prostate cores with tumor AND
  • ≤ 50% tumor in any core AND
  • PSA density of < 0.15 ng/mL/g
  • T1-T2a AND
  • Gleason score ≤ 6/Gleason grade group 1 AND
  • PSA ≤ 10 ng/mL
  • T2b-T2c OR
  • Gleason score 3+4=7/Gleason grade group 2 OR
  • Gleason score 4+3=7/Gleason grade group 3 OR
  • PSA 10-20 ng/mL
  • T3a OR
  • Gleason Score 8/Gleason grade group 4 OR
  • Gleason score 9-10/Gleason grade group 5 OR
  • PSA > 20 ng/mL
Treatment Options        
≥ 20 y life expectancy
  • Active Surveillance
  • RT or Brachy
  • RP (± LND)
     
≥ 10 y life expectancy
  • Active Surveillance
  • Active Surveillance
  • RT or Brachy
  • RP (± LND
  • RP (± LND)
  • RT or Brachy ± Adj Horm
  • RT + Adj Horm
  • RT + Brachy
  • RP + LND ± RT, ADT
< 10 y life expectancy
  • Observation
  • Observation
  • RT or Brachy ± Adj Horm
  • Observation
  • N/A

Table 1: NCCN 2017 V2 - Localized Prostate Cancer Risk Stratification and Treatment (PSA – Prostate Specific Antigen; RT – Radiation Therapy; RP – Radical Prostatectomy; LND – lymph node dissection; Adj Horm – Adjuvant Androgen Deprivation)

 

Use of these stratification and treatment approaches has led to high cure rates for early stage prostate cancer, yet it is widely accepted that many men are over-treated to achieve this cure rate. In the PIVOT trial9 men with early prostate cancer, initially randomized to radical prostatectomy or observation, showed that over 12 years there was no difference in absolute mortality between the groups. However, this study was hampered by several factors including:

  • Only 731 of 5023 eligible patients chose to participate in the study based on randomization criteria.
  • In the group randomized to RP: only 85% of the men received definitively therapy (79% surgery; 6% other).
  • In the observational group: 10% of the observation group received RP initially and additional 20% eventual received definitive treatment.
  • Despite broad inclusion criteria, > 50% of patients had a PSA of <10 (median PSA of 7) and had biopsy proven T1c disease. Although there were a significant number of patients with Gleason score ≥7 (25%), 40% of men were classified initially as being low risk; and 30% were intermediate.

Although subgroups were small, it appears that high-risk groups (including those with PSA > 10) benefitted from RP. Furthermore, there was a trend for the intermediate risk patients to benefit from RP as well. The small number of patients willing to enter the study, and the high rate of crossover (both initially and subsequently) demonstrates the difficulty of doing observation trials in the United States.

Although there is early data that may suggest that some patients with intermediate risk prostate cancer could potentially be considered for active surveillance (AS) (Gleason Score 3+4 = 7, PSA < 10), the NCCN and other mainstream groups still do not recommend this approach, with the NCCN stating, “Active surveillance of intermediate and high-risk clinically localized cancers is not recommended in patients with life expectancy ≥10 years as a category 1 recommendation. The shortcomings in the current system have driven the development of emerging biomarker-based tools for assessing risk.

ProMark® Test

Test Description

ProMark® is a biopsy-based prostate cancer prognostic test that utilizes an automated, quantitative protein-based multiplex immunofluorescent in situ imaging platform to evaluate standard formalin-fixed, paraffin-embedded (FFPE) prostate tissue to differentiate indolent from aggressive prostate cancer.1,6,7 The assay measures the signal intensity of 8 protein biomarkers (i.e., CUL2, DERL1, FUS, HSPA9, PDSS2, pS6, SMAD4 and YBX1) in tumor and benign prostate glands on FFPE biopsy tissue sections to generate an algorithmically derived risk score indicating the likelihood of having high-risk disease. Unlike deoxyribonucleic acid (DNA)/ribonucleic Acid (RNA)-based tests that require biopsy tissue to be homogenized prior to analysis, ProMark® technology allows for analysis of proteins directly from the cancerous regions of interest. The test has shown the ability to predict prostate cancer aggressiveness regardless from which region the prostate biopsy was taken, a key feature and benefit given the considerable heterogeneity that exists in biopsied tissue.6

Test Development and Performance

ProMark® was validated through a series of studies from initial proof of concept to final marker lock-down and validation trials involving more than 1200 patients in a 3-phase program.

The assay development study was a non-interventional and retrospective study devised to define the best marker subset from those candidate proteins previously shown to correlate with both prostate pathology aggressiveness and lethal outcome. The study goal was to define a model able to distinguish between prostate pathology usually recommended for active surveillance (“GS 6”; surgical Gleason 3+3 and ≤T3a) versus those more likely to require prostatectomy (“non-GS 6”; surgical Gleason ≥3+4 or non-localized >T3a or N or M). This GS 6 versus non-GS 6 definition was based on studies showing that tumors with surgical Gleason 3+3 at prostatectomy do not metastasize. A logistic regression model was trained on the training set, and risk scores were obtained for samples in both the training and testing sets. The final marker coefficients were used in a logistic regression model for calculation of the risk score, a continuous scale from 0 to 1, which estimated the likelihood of "non-GS6" pathology.

The validation study cohort (N=276) was separate and independent from the assay development cohort, and comprised biopsy samples with matched prostatectomy specimens. It was a non-interventional, blinded, prospectively designed, retrospectively collected clinical study to predict prostate pathology on its own and relative to current systems for patient risk categorization. A risk score was generated for each sample. Inclusion criteria were biopsies with a centralized Gleason score 3+3 or 3+4 (biopsies with discordant grading by two expert pathologists of 3+4 and 4+3 were included as well), and matched prostatectomy with pathologic TNM staging, PSA level, and resulting surgical Gleason score. Central review was performed on biopsies, whereas for prostatectomies the investigators relied on the original pathology annotation, due to practical challenges in accessing all the different locations where these had been conducted; however, all prostatectomy pathology annotation was done according to new International Society of Urological Pathology (ISUP) classification. Matched prostatectomy samples with annotated surgical Gleason scores ultimately classified the tumor as "favorable" or "non-favorable" for the purposes of evaluating assay results. Sample sizes were statistically designed, with power greater than 95% for both cohorts. Receiver operating characteristics (ROC) and corresponding area under the curves (AUC) determined for the 8-biomarker risk score quantitatively evaluated performance of the assay.

Favorable (Gleason ≤3+4 and organ-confined disease (≤T2)) versus non-favorable (Gleason ≥4+3 or non-organ-confined disease (T3a, T3b, N, or M)) pathology were co-primary endpoints in the validation study. The other co-primary endpoints were “GS6” pathology (Gleason 3+3 and localized disease (≤T3a)) versus “non-GS 6” pathology (Gleason ≥3+4 or non-localized disease (T3b, N, or M)). The analysis for “favorable” pathology yielded an AUC of 0.68 with 95% CI, 0.61-0.74. The associated P value was <0.0001, with an OR for risk score of 20.9 per unit change. “GS 6” pathology yielded an AUC of 0.65 with 95% CI, 0.58-0.72. The associated P value was <0.0001, with an OR for risk score of 12.6 per unit change.

The intended use of ProMark® is to categorize a patient to favorable versus non-favorable disease pathology based on his risk score on the specificity curve (not provided). The positive predictive value (PPV) for favorable pathology, at a risk score of ≤0.33, was 83.6% (specificity, 90%). Conversely, at a risk score of >0.80, 76.9% had non-favorable disease (i.e., only 23.1% of patients in the high-risk score category had favorable disease). This translates to 39% of patients in this study population having risk scores ≤0.33 or >0.8, of which 81% were correctly identified by ProMark®. Of patients with intermediate risk scores (0.33< risk score ≤0.8), 58.3% had favorable disease. The PPV of ProMark® was also compared with those of the NCCN and D’Amico risk categories. The PPV for favorable pathology, at a risk score of ≤0.33, was 75% for patients in the NCCN intermediate-risk category; 81.5% for NCCN low-risk patients, and 95% for NCCN very low-risk, with an overall PPV for favorable pathology of 85%. This contrasts favorably with the PPVs obtained for the NCCN risk categories alone, which were 40.9% for intermediate risk, 63.8% for low-risk, and 80.3% for very low-risk.

These findings suggest that the ProMark® risk score provides additional confidence that a patient categorized to the NCCN very low-risk group indeed has a favorable pathology based on his biopsy from 80.3% to 95%. Conversely, the predictive value for non-favorable pathology was 76.9% at a risk score >0.8, but reached 100% at a risk score cutoff point of >0.9. For all NCCN and D'Amico risk categories, a higher ProMark® risk score correlated with decreased frequency of favorable cases.

Analysis of Evidence (Rationale for Determination)

Level of Evidence

Quality – Limited to Moderate
Strength – Limited to Moderate
Weight - Limited

Criteria for Coverage

The ProMark® assay is covered only when the following clinical conditions are met:

  • Needle biopsy with localized adenocarcinoma of prostate (no clinical evidence of metastasis or lymph node involvement), and
  • Patient Stage as defined by the one of the following:
    • Very Low Risk Disease (T1c AND Gleason Score ≤ 6 AND PSA ≤ 10 ng/mL AND AND ≤ 50% cancer in any core AND PSA density of < 0.15 ng/mL/g) OR
    • Low Risk Disease (T1-T2a AND Gleason Score ≤ 6 AND PSA ≤ 10 ng/mL), and
  • Patient has an estimated life expectancy of greater than or equal to 10 years, and
  • Patient is a candidate for and is considering conservative therapy and yet and would be eligible for definitive therapy (radical prostectomy, radiation therapy or brachytherapy), and
  • Patient has not received pelvic radiation or androgen deprivation therapy prior to the biopsy, and
  • Patient has not received pelvic radiation or androgen deprivation therapy prior to the biopsy, and
  • Test is ordered by a physician certified in the Metamark Genetics Certification and Training Registry (CTR), and
  • Patient is monitored for disease progression according to active surveillance guidelines as recorded in NCCN guidelines, and
  • Physician must report the development of metastasis or prostate cancer deaths in patients not treated definitively who were deemed low risk by the assay.

Certification and Training Registry (CTR) Program

Because of the complicated nature of management decisions utilizing the ProMark® 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 Molecular Diagnostic Services Program (MolDX®) approved ProMark® 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 Metamark will provide to the Contractor reports every 6 months in a mutually agreed upon format.

The goals of the Metamark Genetics ProMark® CTR program are as follows:

  • To ensure that physicians understand the limitations of the test based on its validation, and
  • To inform prescribers and patients on the safe-use conditions for ProMark® assay, and
  • To make a good faith effort to identify any safety concerns from the use of the test, and
  • To facilitate understanding of the incremental clinical utility of the test versus adherence to current NCCN guidelines

This Contractor expects Metamark Genetics to:

  • Establish and maintain the ProMark® Certification and Training Registry (CTR);
  • Ensure that healthcare providers who order the ProMark® assay are registered and certified in the ProMark® CTR program and that the ProMark® assay is available only through these providers;
  • Maintain a secure registry database of Metamark's ProMark® 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., ProMark® Risk Score), and
      • Treatment recommendation based on test results, and
      • Final physician-patient treatment decision, and
      • Report utilization data by clinic-pathologic staging;
      • Any subsequent change in patient 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.

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
N/A
Contact for Comments on Proposed LCD

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

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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

Additional ICD-10 Information

General Information

Associated Information
N/A
Sources of Information

N/A

Bibliography
  1. Blume-Jensen P, Berman DM, Rimm DL, et al. Development and clinical validation of an in situ biopsy-based multimarker assay for risk stratification in prostate cancer. Clin Cancer Res. 2015;21(11):2591-2600. doi:10.1158/1078-0432.CCR-14-2603
  2. D'Amico AV, Whittington R, Malkowicz SB, et al. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998;280(11):969-974. doi:10.1001/jama.280.11.969
  3. National Cancer Institute. Cancer Stat facts. Surveillance, Epidemiology, and End Results Program. http://seer.cancer.gov/statfacts/html/ . Accessed November 8, 2021.
  4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Prostate Cancer. Version 1.2022. https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf . Accessed November 8, 2021.
  5. Resnick MJ, Koyama T, Fan KH, et al. Long-term functional outcomes after treatment for localized prostate cancer. N Engl J Med. 2013;368(5):436-445. doi:10.1056/NEJMoa1209978
  6. Shipitsin M, Small C, Giladi E, et al. Automated quantitative multiplex immunofluorescence in situ imaging identifies phospho-S6 and phospho-PRAS40 as predictive protein biomarkers for prostate cancer lethality. Proteome Sci. 2014;12:40. doi:10.1186/1477-5956-12-40
  7. Shipitsin M, Small C, Choudhury S, et al. Identification of proteomic biomarkers predicting prostate cancer aggressiveness and lethality despite biopsy-sampling error. Br J Cancer. 2014;111(6):1201-1212. doi:10.1038/bjc.2014.396
  8. Truong M, Slezak JA, Lin CP, et al. Development and multi-institutional validation of an upgrading risk tool for Gleason 6 prostate cancer. Cancer. 2013;119(22):3992-4002. doi:10.1002/cncr.28303
  9. Wilt TJ, Brawer MK, Jones KM, et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med. 2012;367(3):203-213. doi:10.1056/NEJMoa1113162

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
11/24/2022 R12

R12

Revision Effective: 11/24/2022

Revision Explanation: Annual review, no changes 

  • Other (Annual Review)
12/30/2021 R11

R11

Revision Effective: 12/30/2021

Revision Explanation: Under Analysis of Evidence (Rationale for Determination) added the Criteria for Coverage that was previously deleted in error.

Acronyms were inserted where appropriate throughout the LCD. ProMark® was inserted throughout the LCD were applicable.

01/19/2022 :At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
12/30/2021 R10

R10

Revision Effective: 12/30/2021

Revision Explanation: Under LCD Title added registered symbol to ProMark and revised to ProMark® Risk Score. Under CMS National Coverage Policy removed regulation CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80.2 Clinical Laboratory services and updated descriptions to regulations. Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were inserted where appropriate throughout the LCD. ProMark® was inserted throughout the LCD were applicable.

11/17/2021 :At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
11/28/2019 R9

R9

Revision Effective: N/A

Revision Explanation: Annual review, no changes were made.

10/21/2020 :At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual review)
11/28/2019 R8

R8

Revision Effective: 11/14/2019

Revision Explanation: Annual review conducted no changes made to the polcy.

11/21/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
11/14/2019 R7

R7

Revision Effective: 11/14/2019 Revision Explanation: This LCD is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: ProMark Risk Score A57034 article.

11-08-2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
09/19/2019 R6

R6

Revision Effective: 09/19/2019 Revision Explanation: Converted policy into new policy template that no longer includes coding section based on CR 10901. For Approval, no changes.

09/13/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To Code Removal
09/19/2019 R5

R5

Revision Effective: 09/19/2019 Revision Explanation: Converted policy into new policy template that no longer includes coding section based on CR 10901.

09/12/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To Code Removal
09/12/2019 R4

Revision#: R4

Revision Effective: 9-12-2019

Revision Explanation: All coding located in the Coding Information section has been moved into the related Billing and Coding: MolDX: ProMark Risk Score A57034 article and removed from the LCD. 

09/05/2019: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
10/17/2017 R3

Revision#: R3

Revision Effective: N/A

Revision Explanation: Annual review no changes made.

 

10/30/2018: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
10/17/2017 R2

Revision#: R2
Revision Effective: 09/28/2017
Revision Explanation: Corrected formatting from conversion to the new LCD format. Added additional information to Low, Intermediate, and High categories in Clinocopathologic Findings. Updated the NCCN Prostate Cancer Guidelines to 2017, V2.

 

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
10/17/2017 R1

Revision#: R1
Revision Effective: N/A
Revision Explanation: Annual review no changes made.

 

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 

  • Other (Annual Review)
N/A

Associated Documents

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Public Versions
Updated On Effective Dates Status
11/29/2023 12/07/2023 - N/A Currently in Effect View
11/16/2022 11/24/2022 - 12/06/2023 Superseded You are here
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