Local Coverage Article Response to Comments

Response to Comments: MolDX: Cystatin C Measurement


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Response to Comments: MolDX: Cystatin C Measurement
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Response to Comments
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Noridian's response to provider recommendations for comment period ending 04/13/2018.


Response To Comments


A contract advisory committee member indicated that this test did not seem useful. There are other accurate tests for renal function and other methods for predicting cardiovascular risk

We agree that this test has limited use, and as such we are limiting coverage of this test to the confirmation of glomerular filtration rate estimates in stage 3A chronic kidney disease.


Thank you for the opportunity to review and comment on WPS' proposed coverage policy “MolDX - Cystatin C Measurement (DL37768)”. As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide.

The CAP appreciates WPS' willingness to provide limited coverage for Cystatin C. The CAP agrees in part with the coverage that is outlined in the proposed policy. However, we offer the following recommendations for your consideration.

The most important indication for measurement of cystatin C is confirmation of early renal insufficiency detected by creatinine-based calculation of estimated glomerular filtration rate (eGFR) in adults with no other markers of kidney damage. The proposed policy limits this indication to chronic kidney disease (CKD) stage 3A (defined as an eGFR between 45-59 ml/min/1.73 m2). Because there is variability in both the measurement of creatinine and the calculation of eGFR based on creatinine (including different calculations currently in use), we recommend that WPS broadened this indication to include CKD stage 3B.

We agree that measurement of cystatin C is reasonable when eGFR using creatinine is thought to be inaccurate or when needing to adjust the dosage of toxic drugs which are excreted by the kidneys. However, we do not think that it should be used to determine eligibility for kidney donation. For this indication, actual GFR measurement using exogenous filtration markers or creatinine clearance determination using a 24-hour urine collection should be required.

We also agree that the use of cystatin C-based eGFR determinations as predictors of cardiovascular risk is not yet well established and should not be covered.

Thank you again for the opportunity to review and comment on this proposed policy. We are happy to be of assistance in providing additional clinical or other information to assist you with this draft LCD.

Thank you for the comment. At this point our coverage policy limiting the use of Cystatin C to measuring renal function in patients with CKD stage 3A is consistent with major society guidelines, though we will continue to re-evaluate this decision as new information is brought forward. As regards the use of cystatin C in determining kidney donation eligibility, the draft LCD describes examples of scenarios where a more accurate knowledge of glomerular filtration rate could have a bearing on clinical management. We agree that once a patient is considered a potential kidney donor additional testing beyond the scope of this LCD will likely be appropriate.


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  • MolDX
  • Cystatin
  • C Measurement