SUPERSEDED LCD Reference Article Billing and Coding Article

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

A54185

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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
A54185
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
09/23/2021
Revision Ending Date
11/15/2023
Retirement Date
N/A

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

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Article Guidance

Article Text

The MolDX Program contractor 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, CGS Administrators and the MolDX Program contractor 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

Number Comment Response
1
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Coding Information

Bill Type Codes

Code Description
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Revenue Codes

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CPT/HCPCS Codes

Group 1

(1 Code)
Group 1 Paragraph

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Group 1 Codes
Code Description
81546 Onc thyr mrna 10,196 gen alg
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CPT/HCPCS Modifiers

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

(11 Codes)
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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

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ICD-10-PCS Codes

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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

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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
09/23/2021 R13

Revision Effective: 09/23/2021

Revision Explanation: Annual review no changes.

01/01/2021 R12

Revision Effective: 01/01/2021

Revision Explanation: 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 81479 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.

10/03/2019 R11

Revision Effective date: N/A
Revision Explanation: Annual review no changes made.

10/03/2019 R10

Revision Effective date: 10/03/2019
Revision Explanation: Converted article into new billing and coding article format.

05/01/2019 R9

Revision Effective:05/01/2019

Revision Explanation: Added clarifying language to reimbursement conditions

10/01/2015 R8

Revision Effective date: N/A
Revision Explanation: Annual review no changes made.

10/01/2015 R7

Revision Effective date: N/A
Revision Explanation: Annual review no changes made

10/01/2015 R6 Revision Effective date: N/A
Revision Explanation: Annual review no changes made.
10/01/2015 R5 Revision Effective: 10/01/2015
Revision explanation: Changed MolDX ID field to SV101-7 and Z-code to ZCode™ Identifier.
10/01/2015 R4 Revision Effective: 10/01/2015
Revision Explanation: Added the information for Part B concerning the new MolDX identifier field and new 2016 CPT code 81545.
10/01/2015 R3 Revision Effective: N/A
Revision Explanation: Annual review no changes made.
10/01/2015 R2 R1
Revision Effective:10/01/2015
Revision Explanation: Changed MoPath to MolDX.
10/01/2015 R1 Revision Effective: N/A
Revision Explanation: Added Part A loop information.
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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
L36021 - 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
11/08/2023 11/16/2023 - N/A Currently in Effect View
09/16/2021 09/23/2021 - 11/15/2023 Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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