LCD Reference Article Response To Comments Article

Response to Comments: MolDX: Prometheus IBD sgi Diagnostic Policy (L37539)

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Article ID
A55879
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Article Title
Response to Comments: MolDX: Prometheus IBD sgi Diagnostic Policy (L37539)
Article Type
Response to Comments
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03/19/2018
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This article summarizes the comments WPS received for Draft Local Coverage Determinations (LCD) MolDX: Prometheus IBD sgi Diagnostic Policy (DL37539). Thank you for the comments.

Response To Comments

Number Comment Response
1

A physician observed that the specificity and sensitivity of this test is not very good, and that may be the reason this was given a non-coverage determination.  There is a clinical need to differentiate between forms of IBD, but the accuracy of this particular test is questionable.

Thank you for your comments.

2

A Gastroenterologist, stated that he uses the Prometheus IBD sgi Diagnostic test frequently, and finds it useful, when administered under the correct circumstances.  He agreed that there are cases where the test can be misused, but felt that blanket non-coverage would not serve the patient community very well.  He also reminded the committee that there is a difference between cost-effective treatment and helpful treatment, although the two are not mutually exclusive. 

He orders this test when the presentation is not typical; such as a patient with few ulcerations.  To label a diagnosis on a patient prematurely can affect subsequent treatment.  It is not helpful, he said, to order the test in a primary setting based on a complaint of abdominal pain.  Once a diagnosis of IBD has been diagnosed, the test is useful to identify between CD or UC.  Again, in patients who present atypically, this test provides additional information to help establish a diagnosis.

Atypical presentations are frequent in his specialty; they occur enough to make this test helpful.  He advised that this should only be run when the patient is already diagnosed with IBD and has evidence of a problem, or if the disease needs to be differentiated between CD and UC.  The test does not have to be performed more than once on a single patient and it should not be used during the first line of inquiry in diagnosing bowel illness.  The test reveals a pattern that is more consistent with CD or a pattern that is more consistent with UC

Thank you for your comments.  There are difficult cases when additional testing may be needed as has been noted in the American College of Gastroenterology guidelines.  Testing for ASCA-IgA, ASCA-IgG and atypical perinuclear ANCA have been used by some.  There is no evidence in the peer reviewed literature that this 17-marker panel is superior.

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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
L37539 - MolDX: Prometheus® IBD sgi Diagnostic® Policy
Related National Coverage Documents
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