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Response to Comments: MolDX: Prometheus IBD sgi Diagnostic Policy


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Response to Comments: MolDX: Prometheus IBD sgi Diagnostic Policy
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Response to Comments
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The comment period for the MolDX: Prometheus IBD sgi Diagnostic Policy LCD L37313 began on 06/01/2017 and ended on 08/14/2017. Comments were received from the provider community. The notice period begins on 12/14/2017 and ends 01/29/2018. The LCD becomes final on 01/30/2018.


Response To Comments


Although manufacturer data supports clinical validity of the test for diagnosing IBD, this evidence is insufficient to support an indirect chain of evidence for clinical utility due to lack of details about study methodology and lack of replication of the findings. For distinguishing UC from CD, clinical validity has not been established. No studies examining the clinical utility of IBD sgi Diagnostic™ have been identified.

While many of my colleagues and I agree that the value of this testing is not for every known or suspected IBD patient and often results will not influence patient care, there are well established clinical situations supported by published literature which should allow for coverage of this testing, or counterparts by Quest, LabCorp and others, for particular patient scenarios.


New diagnosis of Crohns in pediatric population   There is good evidence that high titers of pathogen antibodies with/without genetic marker positivity correlates strongly with poor prognosis re need for surgery, development of fistulae etc.  This can be quite helpful in guiding patient care to early intervention with biologic agents for the best chance of mucosal healing and stability, with higher probability of avoiding adverse outcomes.

In adults/Medicare beneficiary populations, the most helpful use of these tests are:

  1. A severe but indeterminate colitis of brief duration after negative pathogen testing (preferably by the MolDX methods described in DL37350 Proposed LCD Title MolDX: Foodborne Gastrointestinal Panels Identified by Multiplex Nucleic Acid Amplification Tests (NAATs)) where positive IBD markers may lead to appropriate intervention as IBD with higher predictivity of accurate diagnosis and warranting biologic agents.
  2. A patient with a pancolitis phenotype who appears to need surgery, but where strong Crohns predictive markers may lead to choice of conventional ileostomy rather than colectomy with ileal pouch anastomosis, which would have high risk of postop pouchitis, or IBD recurrence or peri anal disease.
  3. A patient who has such a pouch who has inflammatory disease and negative pathogen workup and poor response to conservative management.  Distinguishing local pouch vascular problems from IBD can be difficult and abnormal markers may again have diagnostic, prognostic value.

At the least, a strong statement within this LCD and others where individual case consideration is possible should make clear that post-hoc coverage is feasible will at least prevent physicians from depriving Medicare beneficiaries of testing that in certain cases can be quite valuable.  Patients will often refuse to have such testing when they believe the test will be noncovered.

Medicare policies are not directed towards the pediatric population.  However, if high titer pathogen antibodies predicts poor prognosis, then testing should be limited to the specific pathogens indicated.  Use of a large panel of serologic, immunologic and genetic markers is clearly not indicated.

Regarding adult and/or Medicare beneficiary populations, the use of this test in the patient groups suggested by the commenter are not supported in the literature.   Post-hoc or individual consideration of coverage is not feasible because there is no supporting scientific data.  When/if evidence based scientific medical data published in the peer reviewed core medical literature becomes available to support the use of this test a LCD reconsideration may be submitted.


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12/01/2017 01/30/2018 - N/A Currently in Effect You are here


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  • Prometheus IBD sgi
  • MolDX
  • inflammatory
  • bowel
  • Crohn's