LCD Reference Article Response To Comments Article

Response to Comments: Lab: Special Histochemical and Immunohistochemical Stains

A60320

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Article ID
A60320
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Article Title
Response to Comments: Lab: Special Histochemical and Immunohistochemical Stains
Article Type
Response to Comments
Original Effective Date
11/02/2025
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The comment period for the Lab: Special Histochemical and Immunohistochemical Stains Local Coverage Determination (LCD) began on 05/15/2025 and ended on 06/28/2025. The Notice Period will begin on 09/18/2025 and end on 11/01/2025 becoming effective 11/02/2025.

The comments below were received from the provider community.

Response To Comments

Number Comment Response
1

The proposed changes better align with current evidence and guidelines and will help ensure appropriate coverage for IHC and special stains. We also appreciate the changes to the policy language that was out of step with current standards of practice and where the use of non-standard, unconventional language obscured the policy’s coverage intent. The language clarification is helpful to providers who seek to rely on the policy for clear guidance on whether IHC stains and special stains for a particular item or service are covered.

Thank you for your comment. 

2

"While there are a number of promising additional biomarkers, such as Ki-67, P13K and gene expression assays, the College of American Pathologists (CAP), the American Society of Clinical Oncologists® (ASCO®) and the National Comprehensive Caner Network® (NCCN®) have not recognized these markers in patient treatment pathways." 

NCCN respectfully notes that this statement is not consistent with the current NCCN Clinical Practice Guidelines in Oncology for Breast Cancer.11 PCR-based PIK3CA-mutation testing and gene expression assays are not the subject of this LCD, but determination of such biomarkers in breast cancer are noted in the NCCN Guidelines to identify candidates for alpelisib-containing regimen or to aid in prediction of response to adjuvant cytotoxic chemotherapy. Thus, NCCN recommends that Noridian refers to the latest NCCN Guidelines and revision the statement.

Thank you for addressing this. This statement is limited to addressing special stains. A clarification is made to address this. 

3

Within the proposed LCD, Noridian States that:

"Claims data indicate combinations of gram stain, PAS, Ki-67 and ProExC stains on all cervical biopsies from select pathology practices, and combinations of p53, Ki-67, CD20 and CD44 on bladder biopsies from select pathology practices."

As the statement references version 1.2024 of the NCCN Guidelines for Ovarian Cancer, NCCN respectfully notes that this content is not found in either version 1.2024 or the current version 2.2025 of the NCCN Guidelines for Ovarian Cancer®. Additionally, this information is not found in the NCCN Guidelines for cervical cancers or bladder cancers. As such, NCCN requests this reference be removed.

Thank you for noting the error, the reference has been removed.

4

I support the proposed changes

Thank you for your comment.

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