Local Coverage Article Response to Comments

Response to Comments: Biomarker Testing (Prior to Initial Biopsy) for Prostate Cancer Diagnosis


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Response to Comments: Biomarker Testing (Prior to Initial Biopsy) for Prostate Cancer Diagnosis
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Response to Comments
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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 (Prior to Initial Biopsy) for Prostate Cancer Diagnosis LCD. The official notice period for the final LCD begins on June 10, 2021, and the final determination will become effective on August 1, 2021.

Response To Comments


We received a comment from the ExoDx Prostate Test (EPI) manufacturer requesting removal of the one-time test limitation. The comment notes that: 1/ prior EPI studies “included patients who had previously received biomarker testing, which did not impact test performance;” 2/ “NCCN guidelines call for ‘tailored’ repeat PSA testing at 1-4 year intervals depending on PSA age and DRE status to potentially maximize survival advantage; and 3/ “NCCN guidelines do not limit EPI testing to patients who have not previously been tested using a biomarker test nor do they limit patients to one EPI test per lifetime.” NCCN guidelines related to repeat testing after biopsy were also cited.

 Of note, the draft presented for comment does now cover limited repeat adjunctive biomarker testing, just not using the same biomarker (“each biomarker is covered once”). Nevertheless, we reject the premise that NCCN guidelines, specific to repeat PSA testing, necessarily apply to adjunctive biomarker repeat testing. Similarly, while NCCN guidelines do not “limit patients to one EPI test per lifetime,” unlike PSA, they also do not specifically recommend repeat EPI testing. While there is abundant literature related to repeat PSA testing, there are no specific studies addressing repeat EPI testing. EPI studies did apparently include some such patients, but the claim that this “did not impact test performance” cannot be evaluated as no formal subset analysis was published (e.g., the “EPI test utility in African-American patients” section of the Tutrone study) or provided. In summary, we stand by relatively circumscribed coverage since, as stated in the LCD: “none of these assays are recommended for routine use as they have not been prospectively tested or shown to improve long-term outcomes (e.g., quality of life, need for treatment, or survival).” We look forward to such data, due in 2023, according to the commenter. Finally, regarding repeat testing after initial biopsy, that is outside the scope of this LCD.


We received a comment from an academic urologist (and consultant to the manufacturer) also requesting removal of the one EPI test limitation. In the open meeting he stated: “I think there has to be some allowance for repeat testing if the scenario changes, if the PSA starts rising rapidly, if there's a new nodule, if there's symptoms. And there's a lot of scenarios where a repeat test could be quite valuable. But again, I would acknowledge there's no data yet.”

 See response to comment #1.


The EPI manufacturer and a practicing urologist each submitted comments requesting removal of the “suspicious DRE” limitation. The logic was similar to that of repeat testing, namely that: 1/ prior studies included patients with a prior DRE (some suspicious for cancer) without impacting EPI utility; and 2/ NCCN guidelines don’t specifically limit EPI testing to patients without a DRE suspicious for cancer.

This criterion was not changed, so was not open for comment. However, similar to the issue of repeat testing, we welcome formal published or provided subset analysis addressing this question. We would also emphasize the issue is not simply a prior DRE, but rather a prior DRE suspicious for cancer.


Associated Documents

Related Local Coverage Documents
L37733 - Biomarker Testing for Prostate Cancer Diagnosis
Related National Coverage Documents
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06/02/2021 08/01/2021 - N/A Currently in Effect You are here