LCD Reference Article Response To Comments Article

Response to Comments: Biomarker Testing for Prostate Cancer Diagnosis

A59220

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Article ID
A59220
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Article Title
Response to Comments: Biomarker Testing for Prostate Cancer Diagnosis
Article Type
Response to Comments
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11/01/2022
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As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the Biomarker Testing for Prostate Cancer Diagnosis Local Coverage Determination. The official notice period for the final LCD begins on September 15, 2022, and the final determination will become effective on November 1, 2022.

Response To Comments

Number Comment Response
1

One practicing Urologist commented, “ Like my urology colleagues, I view the exclusion of PCPs from physicians who can order EPI in the current Draft LCD L37733 as regrettable and unjustifiable. The groups of physicians involved in the screening and diagnostic evaluation of prostate cancer are primary care physicians and urologists, not oncologists. Based on the above, I strongly urge National Government Services (NGS -LCD: L 37733) to allow primary care physicians to order the EPI biomarker Test. This will allow me to continue to see and treat the highest­ risk men for high-grade disease in a more timely and productive manner that could be lifesaving.”

NGS agrees and will revise the LCD to allow primary care physicians to order the EPI test as well as other biomarkers as discussed in the LCD.

2

The Chief Scientific Officer, Vice President of Exosome Diagnostics, a subsidiary of Bio-Techne, strongly supported the proposed LCD; however, recommended two modifications: 1. Removal of the exclusion for patients with an abnormal Digital Rectal Exam (DRE), and 2. Allowance of the test to be ordered by the treating physician other than urologist or oncologist.

NGS agrees and will revise the LCD to allow primary care physicians to order the EPI test. However, NGS disagrees with removing the exclusion for patients with an abnormal Digital Rectal Exam (DRE), based on NCCN and societal guidelines. The NCCN guidelines state, “An abnormal DRE in this setting of elevated PSA has a high predictive value (reference 62 in NCCN product) and the panel strongly recommends biopsy in these individuals.” Furthermore, “the NCCN guidelines note that the positive predictive value of DRE in those with low PSA is poor. (References 67, 175) However, a DRE that is very suspicious for cancer, independent of PSA, could be an indication of high-grade cancer in individuals with normal PSA values, and therefore biopsy can be considered. Clinical judgement should be used.”

3

One practicing Urologist/Oncologist also recommended that the exclusion of patients with an abnormal DRE be removed, and that the EPI test be allowed to be ordered by the PCP.

Please see response #2.

4

A practicing, Contractor Advisory Committee Pathologist representative commented, “ from the pathology standpoint, hopefully the test will be helpful for a lot of men and prevent them from getting over- treatment”.

NGS appreciates your participation and comment.

5

Beckman-Coulter commented, “Beckman Coulter supports NGS Medicare’s proposal to allow coverage for phi testing in men for whom initial or repeat prostate biopsy is being considered — subject to additional proposed DL37733 indications and limitations — with the following exceptions specific to phi testing:

  • We strongly oppose the proposed coverage limitation requiring phi testing to be ordered by a urologist or oncologist.
  • We respectfully disagree with the proposed change which appears to limit coverage to one biomarker test annually.
  • We urge NGS Medicare amend the title of proposed DL37733 to “Biomarker Testing Prior to Initial or Repeat Biopsy for Prostate Cancer Diagnosis.”
  • NGS agrees and will revise the LCD to allow primary care physicians to order phi testing.
  • NGS disagrees with allowing more than one biomarker test annually.
  • The current title reflects general coverage of biomarker testing which is inclusive of “prior to initial or prior to repeat” testing.
6

NCCN commented: “NCCN also respectfully notes the following discrepancies between the Proposed LCD and NCCN Guidelines and requests the following changes:

  • The coverage language includes the following tests: %fPSA, PHI, 4Kscore, EPI, SelectMDx, ConfirmMDx. Please note NCCN also recommends MyProstateScore (MPS) and IsoPSA and respectfully requests this be added to the coverage language.
  • NCCN also notes that the NCCN Guidelines for Prostate Cancer Early Detection® include separate recommendations for tests recommended prior to initial biopsy verses tests recommended prior to repeat biopsy. As the coverage language includes testing prior to both initial and repeat biopsy, please see the list of tests recommended prior to initial vs repeat biopsy below:
    • %fPSA: Initial, Repeat
    • PHI: Initial, Repeat
    • 4Kscore: Initial, Repeat
    • EPI (ExoDx Prostate Test): Initial
    • SelectMDx: Initial
    • ConfirmMDx: Repeat
    • PCA3: Repeat MPS: Initial, Repeat
    • IsoPSA: Initial, Repeat

 

  • The Rationale for Determination section includes an overview of the NCCN Guidelines for Prostate Cancer Early Detection® discussion section. NCCN notes that the discussion section is currently watermarked as an evolving draft and, as such, the recommendations within the algorithm are the most up to date and appropriate to NCCN requests that NGS update the NCCN references in the Rationale for Determination as follows: "NCCN recommends (Category 2A) "consideration" of a biomarker test (one that has been validated in peer-reviewed, multi-site studies using an independent cohort of patients) to better define the probability of HGPC in patients who meet PSA standards for consideration of prostate biopsy(]). For biopsy-nai've patients, the NCCN Guidelines cite %fPSA, PHI, SelectMDx, 4Kscore, EPI, MyProstateScore (MPS), and JsoPSA, while adding PCA3 and ConfirmMDx and removing EPI and SelectMDx in the setting of patients thought to be at higher risk despite a prior negative biopsy." This updated language reflects the most up to date NCCN Guideline recommendations.
  • The Rationale for Determination also notes that the coverage restrictions related to a patient having indications for or against biopsy is based on NCCN However, NCCN notes that the restrictions listed within the coverage language 1 and 2 are not derived from NCCN Guidelines.
  • NCCN also notes that we have recently taken on an initiative to move toward gender-neutral language within our Clinical Practice Guidelines. This language is intended to be inclusive of all individuals with cancer including individuals that have a prostate and do not identify as such, NCCN requests that NGS consider gender neutral language within the LCD to be inclusive of all patients that may be at risk for prostate cancer”.

 

NGS will revise the LCD to include the two additional biomarkers: the MyProstate Score and the isoPSA test.

NGS will clarify which tests are recommended for use prior to prostate biopsy and what tests are recommended for use after biopsy of the prostate.

NGS will update the language as requested in the LCD concerning biomarker testing and clarifying the information in the Rationale for Determination section.

NGS recommends that the NCCN approach CMS about using gender neutral pronouns in our LCD and Billing and Coding articles developed by the Medicare Administrative Contractors. This should be a change that is recommended by CMS and adopted by all the Medicare Administrative Contractors.

7

Multiple primary care physicians each commented,I strongly urge National Government Services (NGS - LCD: L 37733) to allow primary care physicians to order the EPI biomarker test. This will allow me to continue to offer the test to my patients as part of the risk-stratified approach to PSA screening and biopsy decision making”.

NGS agrees and will revise the LCD to allow primary care physicians to order the EPI test along with other biomarkers found in the LCD.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L37733 - Biomarker Testing for Prostate Cancer Diagnosis
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