RETIRED LCD Reference Article Billing and Coding Article

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

A53098

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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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Article Information

General Information

Source Article ID
N/A
Article ID
A53098
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
10/01/2015
Revision Effective Date
01/01/2021
Revision Ending Date
07/28/2024
Retirement Date
07/28/2024

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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
  • Select the appropriate ICD-10-CM diagnosis.
  • Enter 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 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

Response To Comments

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Coding Information

Bill Type Codes

Code Description

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Revenue Codes

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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

(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

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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
07/28/2024 R15

This article is being retired because the information in this article has been incorporated within the Billing and Coding: MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules A59470 article.

01/01/2021 R14

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 1/1/2021.

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 1/1/2021.

09/20/2018 R13

Added clarifying language to reimbursement conditions.

02/26/2018 R12 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this article begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
01/29/2018 R11 The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this article begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
11/16/2017 R10

Added Part A contract numbers and DEX Z-Code Identifier.

12/31/2015 R9 Added 2016 CPT code to the CPT/HCPC section
12/10/2015 R8 Reverted back to SV101-7 and removed MolDX ID field (MID), Corrected Z-Code ID to read Z-Code™ Identifier
11/19/2015 R7 Replace Palmetto reference with MolDX and replaced SV101-7 with MolDX ID (MID) field
11/19/2015 R6 added 81545 for Oncology CPT code.
11/13/2015 R5 Removed 2014 billing reference, added 2016 CPT code 81545, replaced SV101-7 with MID
10/01/2015 R4 Added the word "assigned" before Z-Code Identifier
10/01/2015 R3 Removed ICD-9 and ICD-10 codes from the article text. Added CPT code 81479 for claims after 10/1/2014. Removed Z-identifier.
10/01/2015 R2 Corrected article to make I-10s numeric and add I-10s to I-10 coding section.
10/01/2015 R1 Corrected Article to be consistent with ICD-9.
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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
L35025 - 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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Public Versions
Updated On Effective Dates Status
07/28/2024 01/01/2021 - 07/28/2024 Retired You are here
02/22/2021 01/01/2021 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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