Local Coverage Article Billing and Coding

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

A58170

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Article Information

General Information

Article ID
A58170
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
07/14/2022
Revision Ending Date
N/A
Retirement Date
N/A
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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

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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.

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

Additional Articles may be added to provide more specific billing and coding instruction for specific services.

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

Test (Manufacturer) Methodology Specimen Source Analyte(s) and Principle of Test Indication/Transplant Type Intended Use Comments
Prospera (Natera) mmPCR-NGS (targeting 13,926 SNPs) Blood % dd-cfDNA is measured to identify graft injury and AR Kidney

The Prospera test is intended to supplement clinical evaluation and management of AR in patients who have undergone renal transplantation. The test discriminates AR (vs no-AR) and may assist with ruling in or out this condition when assessing the need for or results of a diagnostic biopsy.

 

AlloSure® Kidney (Care Dx®)

NGS (targeting 266 SNPs) Blood % dd-cfDNA is measured to identify graft injury and AR Kidney AlloSure® Kidney assesses the probability of AR in kidney transplant recipients with clinical suspicion of rejection and informs clinical decision-making about the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment.  

TruGraf® (Transplant Genomics)

GEP (RT-PCR) Blood GEP signatures identify patients that are adequately immunosuppressed Kidney TruGraf® is intended for use in patients with stable renal function to assess immune status as an alternative to surveillance biopsy in kidney transplant patients who are more than 90 days post-transplant.  
AlloSure® Heart (Care Dx®) NGS (targeting 266 SNPs) Blood % dd-cfDNA is measured to identify graft injury and AR Heart AlloSure® Heart is only covered when used in conjunction with AlloMap® to assess the probability of allograft rejection in heart transplant recipients with clinical suspicion of rejection and to inform clinical decision-making about the necessity of a heart biopsy in such patients at least 55 days post-transplant in conjunction with standard clinical assessment. AlloMap® has been characterized as a “rule-out” test for AR that can be complemented by a cfDNA “rule-in” test (AlloSure® Heart).

AlloMap® (Care Dx®)

GEP (qRT-PCR) Blood GEP is used to calculate a score associated with the level of immune quiescence and probability of AR Heart

AlloMap® is intended to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe AR in conjunction with standard clinical assessment at least 2 months (≥55 days) since transplantation.

AlloMap® has been characterized as a “rule-out” test for AR that can be complemented by a cfDNA “rule-in” test (AlloSure Heart).

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

The Viracor TRAC® test is intended to assess the probability of allograft rejection in transplant recipients with clinical suspicion of rejection and to inform clinical decision-making about the necessity of biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment.

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

QSantis designed to supplement the evaluation and management of acute rejection in patients who have undergone renal transplantation by determining a Q-score to demonstrate the probability of rejection risk. QSantrules IN and rules OUT active risk of rejection.

 

AR = acute rejection ; dd-cfDNA = donor-derived cell-free DNA ; GEP = gene-expression profile; NGS = next generation sequencing ; mmPCR = massively multiplexed polymerase chain reaction ; qPCR = quantitative real-time polymerase chain reaction; SNPs = single nucleotide polymorphisms

Coding Information

CPT/HCPCS Codes

Group 1

(4 Codes)
Group 1 Paragraph

AlloSure® Heart is to be billed in conjunction with AlloMap®.

Group 1 Codes
CodeDescription
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

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(12 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
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

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

Group 1

(5 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
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

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

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.

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.

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Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
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.

Associated Documents

Related National Coverage Documents
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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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Public Versions
Updated On Effective Dates Status
07/06/2022 07/14/2022 - N/A Currently in Effect You are here
04/01/2022 03/24/2022 - 07/13/2022 Superseded View
11/23/2021 11/25/2021 - 03/23/2022 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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