In an October 2022 blog, I noted that MolDx had issued a proposed revision to a melanoma gene expression test (GEP) LCD - here.
As of June 22, 2023, MolDx has issued a final version of the LCD. No changes are listed in the change management section. In the Q&A article, responses to comments, the main focus appears to be on maintaining that a GEP test on an uncertain melanoma lesion can only be ordered by a dermatopathologist.
Find the final LCD here, L39389, effective August 6, 2023. The "Changes" section suggests none, and I did a redline of the proposed and final, and found none. The billing article covers 0090U and 0314U. 0090U is Mypath Melanoma, which I think originated at Myriad, and 0314U is DecisionDx Melanoma.
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39389&ver=3
The 2022 proposal is still online, here:
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39388&ver=3
The responses to comments article, A59412, is online here:
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=59412&ver=4
Q&A
There are numerous lengthy comment letters, all of which are answers in the format of "Response #1."
Response #1 is 650 words.
The comments in total, tally about 14,000 words.
Here, for the blog, I offered my condensed version of Response #1. See the full article A59412 for the full MolDx text, and 4 citations.
Response Summarized:
The comment to which MolDx responds addresses the issue of allowing physicians other than dermatopathologists to order molecular assays for diagnosing cutaneous melanoma. The commenters argued for this change based on reasons such as improving access to care and simplifying practice workflows. However, the response notes that there is no supporting evidence from medical literature for this routine practice. The draft policy explicitly emphasizes the importance of subspecialty training and experience in dermatopathology for accurate diagnosis and clinical management of challenging melanocytic lesions.
The response cites studies that highlight the need for a second opinion from trained dermatopathologists in complex melanoma cases, as well as the benefits of diagnostic accuracy and reproducibility among board-certified or fellowship-trained dermatopathologists. Referring ambiguous cases for expert review and further diagnostic testing is considered standard practice, providing patients with the most accurate final diagnosis. This process does not require the patient to make an appointment or travel, as only the specimens/slides are sent to the expert dermatopathologist. [BQ - or possibly digital pathology.]
The response also clarifies that the current policy is not a departure from previous requirements but has slightly expanded the scope to include board-eligible dermatopathologists. The retention of the requirement for trained dermatopathologists to order molecular tests is justified based on the reasons stated, ensuring accurate diagnosis in challenging melanocytic neoplasms.
Billing Article
A59163, here:
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=59163&ver=4
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Note that this LCD is for "difficult case" diagnostics. MolDx has a separate LCD for "risk stratification" whichm aims to assist with decisions like invasive lymph node dissection. Here.
