FUTURE LCD Reference Article Response To Comments Article

Response to Comments: KidneyIntelX and KidneyIntelX.dkd Testing

A59758

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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.
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General Information

Source Article ID
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Article ID
A59758
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: KidneyIntelX and KidneyIntelX.dkd Testing
Article Type
Response to Comments
Original Effective Date
08/01/2024
Revision Effective Date
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Revision Ending Date
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Retirement Date
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CMS National Coverage Policy

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Article Guidance

Article Text

As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the KidneyIntelX and KidneyIntelx.dkd. testing. The official notice period for the final LCD begins on June 13, 2024, and the final determination will become effective on August 1, 2024.

Response To Comments

Number Comment Response
1

“Renalytix appreciates NGS’ work in developing DL39726 and strongly supports finalizing the LCD”

National Government Services appreciates your supportive comment. Thank you.

2

Renalytix commented: "Based on evidence, allow coverage of repeat testing in certain clinical cases to reassess risk for accelerated progression of CKD and Cardiovascular, Kidney, Metabolic Syndrome. Biomarkers are highly sensitive to and specific for changes in kidney function, independent of eGFR and UACR, which can fluctuate for multiple clinical reasons."

NGS does not agree at this time that more than a once in a lifetime KidneyIntelX or KidneyIntelX.dkd test is considered reasonable and necessary.

3

Renalytix recommended that NGS “Expand ICD-10 codes based on paid claims history and correct the CPT code effective dates.”

NGS does agree and will add additional ICD-10-CM diagnosis codes to the Billing and Coding Article. NGS also agrees to correct the effective dates of CPT codes in the Billing and Coding LCD Reference Article.

4

Renalytix further commented “The information included in the kidneyintelX.dkd Test requisition Form (TRF) should be considered in applying the coverage requirement that the “specific reason for the test must be documented by the treating practitioner in the medical documentation and demonstrate that the test is medically necessary” The TRF authorized by the ordering clinician documents compliance with intended use criteria in the coverage policy with both ICD-10 codes and reported clinical features.”

Based on CMS National Coverage Policy, described in the Local Coverage Determination, only the provision of limited information on a laboratory requisition form is not a substitute for the required patient medical record documentation by the the treating provider.

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Coding Information

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Revision History Information

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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
L39726 - KidneyIntelX and KidneyIntelX.dkd Testing
Related National Coverage Documents
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SAD Process URL 1
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SAD Process URL 2
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Public Versions
Updated On Effective Dates Status
06/03/2024 08/01/2024 - N/A Future Effective You are here

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