LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: Afirma™ Assay by Veracyte Update

A55139

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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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Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A55139
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: Afirma™ Assay by Veracyte Update
Article Type
Billing and Coding
Original Effective Date
02/16/2017
Revision Effective Date
04/28/2022
Revision Ending Date
N/A
Retirement Date
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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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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

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Article Guidance

Article Text

The MolDX Team has completed the Afirma assessment and determined that the test meets criteria for analytical and clinical validity, and clinical utility as a reasonable and necessary Medicare benefit. Effective 10/01/2015, MolDX will reimburse Afirma services for patients with the following conditions (patient must have 1 and 2):

  1. Patients with one or more thyroid nodules with a history or characteristics suggesting malignancy such as:
    • Nodule growth over time
    • Family history of thyroid cancer
    • Hoarseness, difficulty swallowing or breathing
    • History of exposure to ionizing radiation
    • Hard nodule compared with rest of gland consistency
    • Presence of cervical adenopathy
  2. Have an indeterminate follicular pathology on fine needle aspiration

MolDX expects this test will be performed once per patient lifetime. Should the unlikely situation of a second, unrelated thyroid nodule with indeterminate pathology occur, coverage may be considered upon appeal with support documentation.

To report an Afirma service, please submit the following claim information:

  • Select the appropriate CPT® Code
  • Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information. 
  • 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 diagnosis. 

Response To Comments

Number Comment Response
1
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Coding Information

Bill Type Codes

Code Description
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Revenue Codes

Code Description
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CPT/HCPCS Codes

Group 1

(1 Code)
Group 1 Paragraph

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Group 1 Codes
Code Description
81546 ONCOLOGY (THYROID), MRNA, GENE EXPRESSION ANALYSIS OF 10,196 GENES, UTILIZING FINE NEEDLE ASPIRATE, ALGORITHM REPORTED AS A CATEGORICAL RESULT (EG, BENIGN OR SUSPICIOUS)
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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

(11 Codes)
Group 1 Paragraph

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Group 1 Codes
Code Description
D34 Benign neoplasm of thyroid gland
D44.0 Neoplasm of uncertain behavior of thyroid gland
D44.9 Neoplasm of uncertain behavior of unspecified endocrine gland
E01.0 Iodine-deficiency related diffuse (endemic) goiter
E01.1 Iodine-deficiency related multinodular (endemic) goiter
E01.2 Iodine-deficiency related (endemic) goiter, unspecified
E04.0 Nontoxic diffuse goiter
E04.1 Nontoxic single thyroid nodule
E04.2 Nontoxic multinodular goiter
E04.8 Other specified nontoxic goiter
E04.9 Nontoxic goiter, unspecified
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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

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Group 1 Codes

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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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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
04/28/2022 R7

Posted 06/27/2024-Review completed 05/22/2024 with no changes made to the document.

04/28/2022 R6

Posted 04/28/2022-Review completed 03/30/2022, no changes were made to the document.

01/01/2021 R5

02/25/2021-Under Article Text deleted first bullet verbiage “Claims received prior to 01/01/2016: CPT code 81479 - unlisted molecular pathology procedure” and second bullet verbiage “2016 CPT code 81545: Oncology (thyroid), gene expression analysis of 142 genes”. Added bullet to read “Select the appropriate CPT® code”. This revision is retroactive effective for dates of service on or after 01/01/2021.

Under CPT/HCPCS Codes Group 1: Codes deleted 81545 and added 81546. This revision is due to the Q1 2021 CPT/HCPCS Code Update and is retroactive effective for dates of service on or after 01/01/2021.

04/30/2020 R4

04/30/2020 Review completed 03/30/2020. Added “Billing and Coding:” to the title.

11/01/2018 R3

11/01/2018-Policy clarification: added numbering and (patient must have 1 and 2) to clarify coverage & changed coverage date from 01/01/12 to 10/01/2015.

06/01/2018 R2

 

06/01/2018-Annual review completed 05/01/2018.

07/01/2017 R1

07/01/2017- Annual review completed 06/08/2017; Updated billing instructions, added Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information & added Part A billing instructions and updated Part B instructions.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L36807 - MolDX: Molecular Diagnostic Tests (MDT)
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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Other URLs
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Public Versions
Updated On Effective Dates Status
06/18/2024 04/28/2022 - N/A Currently in Effect You are here
04/20/2022 04/28/2022 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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