MolDx Program Updates LCD for Esophageal Molecular Testing: Non Coverage with Hurdles Listed

The MolDx program has finalized an LCD for Barrett's esophagus diagnosis, stating "non-coverage" but listing criteria for potential future coverage if a test meets the specified requirements. 

The LCD and accompanying documents, including a Q&A and redline-change version, provide insight into MolDx's current approach and criteria for coverage decisions.

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Several companies have developed various approaches, including molecular and IHC-based methods, to improve the diagnosis of Barrett's esophagus. The MolDx program has been actively involved in this area.  Besides PacificDx, see ESOPREDICT, from Capsulomics dba Previse, new PLA code 0398U.  This test rates oncogene methylation.   Another test is TISSUECYPHER, based on IHC (0108U).

They received an LCD update letter from PacificDx in May, 2020, 1 page, here.  They had a public advisory meeting on the topic, May, 2021.   A proposed LCD was posted in March 2022, about a year after the advisory meeting.

The draft LCD stated "non-coverage" but listed criteria that, if met, could allow coverage for a different, future test. The final LCD maintains this position, asserting that "there are currently no existing tests that have demonstrated Analytical Validity (AV), Clinical Validity (CV), and Clinical Utility (CU)."

Now, MolDx has finalized the LCD.   Find the final LCD here.   Find the billing coding article A59015 here.  Find the Q&A on comments, A59343,  here. 

Changes between draft and final were limited.  See redline text image down below (click to enlarge).  See redline PDF in cloud.  The redline changes, and the tone and approach of the non coverage argument, give insight into 'the MolDx Mind."  See also the Q&A noted above.

Noncoverage with Hurdles Listed

Limited changes were made between the draft and final LCDs. See the redline text image below (click to enlarge) and the redline PDF in the cloud. The redline changes and the non-coverage argument's tone and approach offer insight into the "MolDx Mind." The Q&A mentioned above is also relevant.

Non-coverage with Listed Hurdles: NCD DId It First

In 2021, CMS published an NCD for blood-based colorectal cancer screening tests. No available test (e.g., Epi pro Colon) met the statistical performance rule set by CMS, but the NCD was written to provide coverage for the first future test meeting the criteria.

This LCD follows a similar approach – no current test meets their requirements, yet the LCD is written with the potential to offer coverage (by administration decision) when a future test meets its criteria. Thus, the LCD and accompanying documents merit careful examination.

The "Whuh?" Moment

MolDx is a valuable program, but it occasionally produces a sentence that, although written sincerely, may puzzle many readers.

One such sentence can be found in A59343, the Q&A article: "Other tests may fall under this policy but are not within the scope of MolDx." The meaning of this sentence is unclear. It is doubtful that five average readers independently reviewing this sentence all agree on exactly what it means.

Q&A

The structure of the Q&A document is 40 pages long, featuring numerous and lengthy comments from various stakeholders. MolDx collectively responds to all the pages with five short remarks paired with Comment 1.  The subsequent comment letters receive a response stating, "See response 1."

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The LCD process takes a couple years as shown; see a new JAMA article that the "practice change' process takes 17 years, Rubin, here.

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I gave ChatGPT 4 the evidence review and analysis sections of the LCD.  I asked if it had any critiques. It had 3.

Bias and limitations: While the document presents a balanced view of the potential for molecular biomarker tests in EAC detection, it could benefit from a more explicit discussion of potential biases and limitations in the studies mentioned. This would provide readers with a better understanding of the challenges and obstacles in developing such tests.

Clarity of summary: The summary provided at the end of the review could be more concise and focused on the main points of the document. This would help readers quickly grasp the essential information and understand the implications of the findings.

Future perspectives: The document could benefit from a discussion of future directions in research and potential advancements in the field of molecular biomarker tests for EAC detection. This would provide readers with an understanding of the ongoing efforts and expectations for progress in this area.