LCD Reference Article Billing and Coding Article

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

A58019

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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.

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Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A58019
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
06/06/2021
Revision Effective Date
02/29/2024
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

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 L38568.

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
    • Box 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 L38568

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

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Revenue Codes

Code Description

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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

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Group 1 Codes

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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

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Group 1 Codes

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Additional ICD-10 Information

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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

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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.

Code Description

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N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

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

Revision History Date Revision History Number Revision History Explanation
02/29/2024 R8

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 R7

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”.

03/31/2023 R6

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

07/14/2022 R5

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 R4

Under Article Text revised the table to add the last row. This revision is retroactive effective for dates of service on or after 6/6/2021.

11/25/2021 R3

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 R2

Under Article Text added table.

06/06/2021 R1

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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Public Versions
Updated On Effective Dates Status
02/23/2024 02/29/2024 - N/A Currently in Effect You are here
04/28/2023 03/31/2023 - 02/28/2024 Superseded View
02/20/2023 03/31/2023 - N/A Superseded View
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