SUPERSEDED LCD Reference Article Billing and Coding Article

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

A58019

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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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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
03/31/2023
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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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, §60.1.2 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.

NOTES:
-For a given patient encounter, only one molecular test for assessing allograft status may be billed. Any additional molecular tests billed after the first will be denied and subject to medical review.

-Different Z-Code identifiers must be used for protocol vs for-cause testing.
NOTE that use of the molecular test for surveillance (protocol) testing is only compliant with the policy if the patient is enrolled at a center that utilizes this practice and would otherwise receive a surveillance (protocol) biopsy. Providers must demonstrate that such a practice (for protocol biopsies) is in place to meet coverage criteria of this policy.

-Performing this test is not compliant with the language of the policy if used for cause when it will not be performed in lieu of a biopsy or to further inform on the need for or results of a biopsy. As such, the test and the biopsy cannot be performed simultaneously or within a short window of time such that the test cannot reasonably inform medical management. Tests performed within a week AFTER a biopsy are not compliant with policy.

-Per policy, one of the intended uses of the molecular test is "For further evaluation of allograft status for the probability of allograft rejection after a physician-assessed pretest."
A pre-test is defined here as "other physiologic/laboratory/clinical evidence consistent with rejection."
Therefore, performing the molecular test at the same time as the pre-test is NOT compliant with the policy. The results of the pre-test must be available to the treating clinician to inform the need for a molecular test or biopsy.

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

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

Response To Comments

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Coding Information

Bill Type Codes

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Revenue Codes

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CPT/HCPCS Codes

Group 1

(4 Codes)
Group 1 Paragraph

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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
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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

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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
T86.30 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
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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
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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Other Coding Information

Group 1

Group 1 Paragraph

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Group 1 Codes

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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
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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
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
04/28/2023 03/31/2023 - N/A Currently in Effect View
02/20/2023 03/31/2023 - N/A Superseded You are here
07/06/2022 07/14/2022 - 03/30/2023 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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