LCD Reference Article Response To Comments Article

Response to Comments: MolDX: Cystatin C Measurement

A56177

Expand All | Collapse All
Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

Document Note

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A56177
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: MolDX: Cystatin C Measurement
Article Type
Response to Comments
Original Effective Date
11/01/2018
Revision Effective Date
N/A
Revision Ending Date
N/A
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2024, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

N/A

Article Guidance

Article Text

The comment period for the MolDX: Cystatin C Measurement DL37581 began on 02/14/2018 and ended on 03/31/2018. Comments were received from the provider community. The notice period begins on 11/01/2018 and ends 12/16/2018. The LCD becomes final on 12/17/2018.

Response To Comments

Number Comment Response
1

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.

2

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, with potential kidney donation being one. Additional testing instead of or in addition to Cystatin C measurement may also be indicated, but such testing is outside of the scope of this LCD.

N/A

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Additional ICD-10 Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A N/A
N/A
Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation
N/A

Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L37598 - Cystatin C Measurement
Related National Coverage Documents
N/A
SAD Process URL 1
N/A
SAD Process URL 2
N/A
Statutory Requirements URLs
N/A
Rules and Regulations URLs
N/A
CMS Manual Explanations URLs
N/A
Other URLs
N/A
Public Versions
Updated On Effective Dates Status
10/24/2018 11/01/2018 - N/A Currently in Effect You are here

Keywords

N/A