DRAFT LCD Reference Article Billing and Coding Article

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

DA60155

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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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DA60155
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Draft Article Title
Billing and Coding: MolDX: Molecular Testing for Solid Organ Allograft Rejection
Article Type
Billing and Coding
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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 Manuals, 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 proposed LCD MolDX: Molecular Testing for Solid Organ Allograft Rejection DL40062.

Billing information

  • For a given patient encounter, only one molecular service (which may include more than one assay) for assessing allograft rejection status (within scope of this policy) may be billed for a given patient indication and encounter. Any additional molecular services billed after the first will be denied.
  • As noted in the LCD, a molecular test and biopsy cannot be billed on the same date of service (DOS) or within a timeframe that will not reasonably allow the results of one test to inform the other. However, for the rare case that fulfills the exemption outlined in the LCD, an automated denial will be issued for a molecular test performed on the same DOS as biopsy. This may be appealed to allow for manual review.
  • 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. Additional information is provided below.

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

NOTE: When entering the DEX Z-Code® on the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line.

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 DL40062

  • The tests below have completed a MolDX technical assessment and are deemed compliant with policy. However, the tests must be billed in compliance with the policy requirements.
  • The UOS = 1. Each service is represented by a bundle of testing timepoints. The price of each bundle reflects the number of timepoints demonstrated to be R&N according to the criteria in the accompanying LCD. If evidence develops to support a change in the number of tests comprising a given bundle, the price may be modified to reflect that evidence.
  • 3 separate Z-codes are required for the different intended uses per organ transplant type as follows:
    • Kidney: For-Cause; Surveillance Year 1 bundle; Subsequent Surveillance Bundle
    • Heart: For-Cause; Surveillance Year 1 bundle; Subsequent Surveillance Bundle
    • Lung: For-Cause; Surveillance Year 1 bundle; Subsequent Surveillance Bundle

“Bundle” refers to the multiple tests comprising the service

ADDITIONAL NOTES:

  • To-date, NO test has been approved for use in patients who have undergone multiple transplants.
  • Note: Unless otherwise specified, tests that are comprised only of dd-cfDNA must be performed at least 2 weeks post-transplantation.

Test (Manufacturer)

Methodology

Specimen Source

Analyte(s) and Principle of Test

Transplant Type(s)

Indication(s)

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

Surveillance

(Testing must be performed at least 2 months (≥55 days) post-transplantation)

 

 

AlloSure®

(Care Dx)

 

NGS

(targeting 266 SNPs)

Blood

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

 

Kidney

 

For-cause & Surveillance

Heart

For-cause & Surveillance

Lung

 

Surveillance in Bilateral Lung Transplants only

 

Prospera™ (Natera™)

 

mmPCR-NGS

(targeting 13,926 SNPs)

 

Blood

 

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

 

 

Kidney

 

 

For-cause & Surveillance

Heart

 

For-cause & Surveillance

Lung

Surveillance (must be at least 28 days post-transplant)

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

 

 

 

 

 

 

 

For-cause & Surveillance

 

Tutivia

(Verici DX)

 

NGS (RNA Seq) with algorithm

 

Blood

 

Analyzes the gene expression of 17 RNA biomarkers to produce a risk score for transplant rejection.

 

Kidney

 

For-cause & Surveillance

 

TruGraf® (Eurofins-Transplant Genomics)

 

GEP (RT-PCR)

 

Blood

 

GEP signatures identify patients that are adequately immunosuppressed

 

Kidney

 

 

Surveillance

 

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

 

Low-coverage WGS

querying

>100,000

SNPs

 

 

Blood

 

 

% dd-cfDNA is measured to identify AR

 

 

Kidney

 

 

For-cause & Surveillance

 

VitaGraft/GraftAssureCore (Insight Molecular Diagnostics Inc.)

 

droplet digital PCR (ddPCR)

 

Blood

 

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

 

Kidney

For-cause (must be at least 12 days post-transplant)

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

For more information regarding the MolDx Technical Assessment process, please visit MolDX - Technical Assessment (palmettogba.com).

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Coding Information

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ICD-10-CM Codes that Support Medical Necessity

Group 1

(13 Codes)
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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
T86.298 Other complications of heart transplant
T86.810 Lung transplant rejection
T86.818 Other complications of lung transplant
T86.819 Unspecified complication of lung transplant
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
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

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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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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
NCDs
260.9 - Heart Transplants
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