LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: Molecular Testing for Solid Organ Allograft Rejection

A58170

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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
A58170
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: Molecular Testing for Solid Organ Allograft Rejection
Article Type
Billing and Coding
Original Effective Date
07/04/2021
Revision Effective Date
02/29/2024
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.

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Copyright © 2023, 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

Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80.1.2 - A/B MAC (B) Contacts With Independent Clinical Laboratories

CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory Claims, §60.1.1 Independent Laboratory Specimen Drawing, §60.2. Travel Allowance

CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, §10 Reporting ICD Diagnosis and Procedure Codes

Article Guidance

Article Text

The information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Molecular Testing for Solid Organ Allograft Rejection L38671.

Billing information

-Different Z-Code identifiers must be used for protocol vs for-cause testing. This will allow this contractor to better understand the intended use of the test.

To report a service, please submit the following claim information:

  • Select CPT® code
  • Enter 1 unit of service (UOS)
  • Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part B claim field/types:
    • Loop 2400 or SV101-7 for the 5010A1 837P
    • Item 19 for paper claim
  • Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
    • Line SV202-7 for 837I electronic claim
    • Block 80 for the UB04 claim form
  • Select the appropriate ICD-10-CM code

While all covered services can be identified on the DEX registry (dexzcodes.com), below is a list of tests covered under this policy. 

Solid Organ Allograft Rejection Tests that meet coverage criteria of policy L38671

The tests below have completed a MolDx technical assessment and are deemed compliant with policy. However, the tests must be billed in accordance with the specific required indications/coverage criteria outlined in the policy.

Test (Manufacturer)

Methodology

Specimen Source

Analyte(s) and Principle of Test

Transplant Type(s)

AlloMap®

(CareDx)

GEP

(qRT- PCR)

Blood

GEP is used to calculate a score associated with the level of immune quiescence and probability of AR

Heart

 

AlloSure®

(CareDx)

 

 

NGS

(targeting 266 SNPs)

 

Blood

% dd-cfDNA is measured to identify graft injury and AR

 

Kidney

Heart

Lung

HeartCare (CareDx)

AlloSure Heart + AlloMap Heart performed on the same patient sample

Blood

See AlloSure Heart and AlloMap Heart

Heart

Prospera™ (Natera™)

 

mmPCR-NGS

(targeting 13,926 SNPs)

Blood

% dd-cfDNA is measured to identify graft injury and AR

Kidney

Heart

Lung

QSant™ (NephroSant)

 

 

 

 

 

 

Multianalyte assay with algorithmic analysis

 

 

 

 

 

 

 

Urine

 

 

 

 

 

 

 

 

 

 

The concentrations of 6 urinary biomarkers (cell- free DNA (cfDNA), methylated cfDNA (m-cfDNA), CXCL10, clusterin, total protein and creatinine) are incorporated into an algorithm to calculate a composite score (Q-score), to demonstrate the probability of rejection risk.

 

 

 

Kidney

 

 

 

 

 

 

 

 

TruGraf® (Transplant Genomics)

GEP

(RT-PCR)

Blood

 

GEP signatures identify patients that are adequately immunosuppressed

 

 

Kidney

 

Viracor TRAC™ (Transplant Rejection Allograft Check) (Eurofins)

 

Low-coverage whole genome sequencing (WGS)

querying

>100,000

SNPs

Blood

 

% dd-cfDNA is measured to identify AR

Kidney

 

 

VitaGraft/ Allaro Kidney (Oncocyte)

 

 

droplet digital PCR (ddPCR)

 

 

Blood

 

% dd-cfDNA is measured to identify graft injury and AR

 

 

Kidney

AR: acute rejection; dd-cfDNA: donor-derived cell-free DNA; GEP: gene expression profile; NGS: next generation sequencing; PCR: polymerase chain reaction; WGS: whole genome sequencing

Response To Comments

Number Comment Response
1
N/A

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

(4 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
Code Description
81479 UNLISTED MOLECULAR PATHOLOGY PROCEDURE
81595 CARDIOLOGY (HEART TRANSPLANT), MRNA, GENE EXPRESSION PROFILING BY REAL-TIME QUANTITATIVE PCR OF 20 GENES (11 CONTENT AND 9 HOUSEKEEPING), UTILIZING SUBFRACTION OF PERIPHERAL BLOOD, ALGORITHM REPORTED AS A REJECTION RISK SCORE
81599 UNLISTED MULTIANALYTE ASSAY WITH ALGORITHMIC ANALYSIS
0118U TRANSPLANTATION MEDICINE, QUANTIFICATION OF DONOR-DERIVED CELL-FREE DNA USING WHOLE GENOME NEXT-GENERATION SEQUENCING, PLASMA, REPORTED AS PERCENTAGE OF DONORDERIVED CELL-FREE DNA IN THE TOTAL CELL-FREE DNA
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

(12 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
Code Description
T86.10 Unspecified complication of kidney transplant
T86.19 Other complication of kidney transplant
T86.20 Unspecified complication of heart transplant
T86.30 Unspecified complication of heart-lung transplant
T86.810 Lung transplant rejection
Z48.21 Encounter for aftercare following heart transplant
Z48.22 Encounter for aftercare following kidney transplant
Z48.24 Encounter for aftercare following lung transplant
Z94.0 Kidney transplant status
Z94.1 Heart transplant status
Z94.2 Lung transplant status
Z94.3 Heart and lungs transplant status
N/A

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

Group 1

(5 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
Code Description
N17.0 Acute kidney failure with tubular necrosis
N17.1 Acute kidney failure with acute cortical necrosis
N17.2 Acute kidney failure with medullary necrosis
N17.8 Other acute kidney failure
N17.9 Acute kidney failure, unspecified
N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Additional ICD-10 Information

N/A

Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

Code Description
N/A

Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

N/A


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
02/29/2024 R6

Removed previous version and replaced article with the following changes. Under CMS National Coverage Policy corrected the following citation: CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory Claims, §60.1.1 Independent Laboratory Specimen Drawing, §60.2 Travel Allowance. Under Article Text deleted subsections “INTERPRETATIVE AND EDUCATIONAL INFORMATION” and “Intended use requirements”. Revised subsection heading “Additional billing information” to read “Billing information” and deleted first paragraph. Revised last sentence to read “While all covered services can be identified on the DEX registry (dexzcodes.com), below is a list of tests covered under this policy” and added table.

03/31/2023 R5

Updated to indicate this article is an LCD Reference Article.

03/31/2023 R4

Under Article Text added four paragraphs and deleted table. Under CPT/HCPCS Codes Group 1: Paragraph deleted sentence.

Under Article Text added additional verbiage after the first paragraph. Deleted subsection “NOTES” and replaced with the heading “Additional billing information”. Revised the paragraph following the new subsection heading “Additional billing information”. Added the verbiage “This will allow this contractor to better understand the intended use of the test” after the sentence “Different Z-Code identifiers must be used for protocol vs for-cause testing”. The 3 paragraphs following this sentence were deleted. Added sentence “Covered services can be identified on the DEX registry (dexzcodes.com)” after sentence “Select the appropriate ICD-10-CM code”.

07/14/2022 R3

Under CMS National Coverage Policy updated section heading. Under Article Text revised the methodology for the third test on the table. Formatting, punctuation, and typographical errors were corrected throughout the article.

03/24/2022 R2

Under Article Text revised the table to add the last row. This revision is retroactive effective for dates of service on or after 7/4/2021.

11/25/2021 R1

11/25/2021: Under Article Text revised the title of the table to read, “Solid Organ Allograft Rejection Tests that meet coverage criteria of policy L38568” and revised the table to add the last row. Under CPT/HCPCS Codes Group 1: Codes added 0118U. This revision is retroactive effective for dates of service on or after 10/5/2021.

06/06/2021: Under Article Text added table; Under CPT/HCPCS Codes Group 1: Paragraph added the statement, “AlloSure® Heart is to be billed in conjunction with AlloMap®”. This revision is retroactive effective for dates of service on or after 6/6/2021.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
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SAD Process URL 1
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SAD Process URL 2
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Statutory Requirements URLs
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Rules and Regulations URLs
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CMS Manual Explanations URLs
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Other URLs
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Public Versions
Updated On Effective Dates Status
02/23/2024 02/29/2024 - N/A Currently in Effect You are here
11/22/2023 03/31/2023 - 02/28/2024 Superseded View
08/08/2023 03/31/2023 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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