SUPERSEDED LCD Reference Article Billing and Coding Article

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

A58061

Expand All | Collapse All
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.
Superseded
To see the currently-in-effect version of this document, go to the section.

Document Note

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A58061
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
11/16/2023
Revision Ending Date
02/28/2024
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.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

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, §60.1.2 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 L38582.

INTERPRETATIVE AND EDUCATIONAL INFORMATION

The below section provides additional interpretative and educational content to help providers and other stakeholders better understand the intent of the existing coverage criteria language of the policy. Reasonable and necessary thresholds for coverage are defined in the policy Coverage Criteria section and are not altered by the article language.

Intended use requirements

Tests within scope of the policy must comply with the stated requirements of the coverage criteria of the policy. The policy lists intended uses, that when met, can allow for coverage of services within scope of the policy, provided all other listed requirements are also met. Of note, the analysis of the evidence in the policy reflects the underlying value proposition of the test as one that can preclude an unnecessary tissue biopsy. This is therefore reflected in the intended use section of the coverage criteria.

The four intended uses that are established in the policy all require that the physician is concerned about at least one of the following: rejection (and would otherwise obtain a biopsy to evaluate the allograft), the adequacy of immunosuppression (and would otherwise obtain a biopsy to evaluate the allograft or is considering doing so), the probability of rejection with concerning clinical information (clinical pre-tests/information that inform whether a subsequent biopsy would likely be avoided), and/or the results of an inconclusive biopsy (wherein the test may subsequently preclude another biopsy).

In all scenarios presented the patients must be in consideration for a tissue biopsy or additional biopsy (such that the test prevents this when the biopsy won't likely be of benefit) OR require allograft evaluation because of a priori concern for rejection or rejection risk due to clinical or biological factors (pre-test). No other intended uses are allowed by the policy.

This leads to the following conclusions:

-If a biopsy is performed, 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 regarding the biopsy. Performance of the test simultaneously with biopsy or within a very narrow window of time from biopsy such that the results would not be available prior to the biopsy being performed would infer that the biopsy is performed regardless of test result and therefore the test has no impact on patient management. This is not consistent with the policy language.

-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 or risk of rejection” wherein additional evaluation is subsequently warranted. Therefore, the information that leads to the use of the test must pre-exist the performance of the test. The results of the pre-test must be available to the treating clinician to inform the need for a molecular test or biopsy. Performing the test before such conditions exist, or to establish such a condition cannot be interpreted to be in compliance with the policy.

-Although most coverage criteria are relevant to for cause tests, if a patient population exists such that they are at particularly high risk for rejection, and the pre-test clinical information would otherwise indicate a biopsy to evaluate the allograft health based on the risk of that population, the use of these services may fit within the intent of the policy coverage criteria language and analysis rationale.

An example of this may be in heart allografts within the first year of transplant that would otherwise get a tissue biopsy due to evaluated pre-test risk. As such, the use of a molecular test for surveillance (protocol) testing can only be reasonably seen as compliant with the policy if the patient would otherwise receive a surveillance (protocol) biopsy. Providers must demonstrate that such a practice (for protocol biopsies) would otherwise be performed to meet policy requirements. Other uses of surveillance testing are not compliant with the policy language and would require policy reconsideration for inclusion.

Additional billing information
-For a given patient encounter, only one molecular test for assessing allograft rejection status (within scope of this policy) may be billed. Any additional molecular tests billed after the first will be denied as this is expected to be a rare and unlikely occurrence. Appeals should be used for reimbursement for additional tests that meet coverage criteria. Of note, services that include multiple components are considered a single service by MolDX and should be registered as such, in alignment with established MolDX practice.

-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

Covered services can be identified on the DEX registry (dexzcodes.com).

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.

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
11/16/2023 R10

R9

Revision Effective: 11/16/2023

Revision Explanation: Updated LCD Reference Article section.

03/31/2023 R9

R8

Revision Effective: 03/31/2023

Revision Explanation: 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 R8

R7

Revision Effective: 03/31/2023

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

07/14/2022 R7

R6

Revision Effective: 07/14/2022

Revision Explanation: 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.

06/23/2022 R6

R5

Revision Effective: 06/23/2022

Revision Explanation: Annaul review, no changes made.

03/24/2022 R5

R4

Revision Effective: 03/24/2022

Revision Explanation: 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 R4

R3

Revision Effective: 10/05/2021

Revision Explanation: Under Article Text revised the title of the table to read, “Solid Organ Allograft Rejection Tests that meet coverage criteria of policy L38582” 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 R3

R2

Revision Effective: 06/06/2021

Revision Explanation: Added table in article text section.

06/06/2021 R2

R1

Revision Effective: 06/06/2021

Revision Explanation: 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.

06/06/2021 R1

R1

Revision Effective: 06/06/2021

Revision Explanation: 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.

N/A

Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
N/A
SAD Process URL 1
N/A
SAD Process URL 2
N/A
Statutory Requirements URLs
N/A
Rules and Regulations URLs
N/A
CMS Manual Explanations URLs
N/A
Other URLs
N/A
Public Versions
Updated On Effective Dates Status
02/23/2024 02/29/2024 - N/A Currently in Effect View
11/07/2023 11/16/2023 - 02/28/2024 Superseded You are here
04/28/2023 03/31/2023 - 11/15/2023 Superseded View
02/20/2023 03/31/2023 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

N/A