Local Coverage Article Billing and Coding

Billing and Coding: MolDX: Know error®

A55274

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Contractor Information

Article Information

General Information

Article ID
A55274
Article Title
Billing and Coding: MolDX: Know error®
Article Type
Billing and Coding
Original Effective Date
12/01/2017
Revision Effective Date
01/01/2023
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 2022 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 © 2022 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, §1862(a)(1)(A) statutory exclusion covers diagnostic testing "except for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member".

Article Guidance

Article Text

The know error® DNA Specimen Provenance Assay is a forensic assay to confirm that a surgical specimen belongs to the patient evaluated for treatment. Although MolDX agrees the healthcare community should define and follow strict procedures regarding patient and patient specimen identification and handling, tests performed to measure the quality of a process do not provide information to diagnose or treat a patient illness or injury as defined in the Medicare benefit category. Therefore, the know error® DNA Specimen Provenance Assay is a statutorily excluded test. Although an Advance Beneficiary Notice (ABN) is not required for a statutory exclusion, providers supplying this test (directly or through a purchased service) should ensure patients understand the test is not a covered benefit.

To receive a DNA Specimen Provenance Assay service denial, please submit the following claim information:

  • CPT code 84999 – unlisted chemistry procedure
    • For a voluntary issued ABN, append with GX modifier
    • To indicate a statutorily excluded service, append with a GY modifier. An Advance Beneficiary Notice (ABN) is not required for statutorily excluded service
  • Select the appropriate diagnosis for the patient

If you believe your practice has submitted claims and received reimbursement in error, you may take the following corrective actions:

  • Complete a Self-Audit
    • identify incorrect submissions
    • contain further claim submission errors
  • Consider Self-Disclosure Protocol
    • self-disclosure guidelines available @ the following pathway: http://www.oig.hhs.gov/compliance/self-disclosure-info/index.asp

Coding Information

CPT/HCPCS Codes

Group 1

(1 Code)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
84999 UNLISTED CHEMISTRY PROCEDURE

CPT/HCPCS Modifiers

Group 1

(2 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
GX NOTICE OF LIABILITY ISSUED, VOLUNTARY UNDER PAYER POLICY
GY ITEM OR SERVICE STATUTORILY EXCLUDED, DOES NOT MEET THE DEFINITION OF ANY MEDICARE BENEFIT OR, FOR NON-MEDICARE INSURERS, IS NOT A CONTRACT BENEFIT

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

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.

CodeDescription
013x Hospital Outpatient

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.

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Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
01/01/2023 R3
Under CPT/HCPCS Codes Group 1: Codes the description was revised for 84999. This is due to the 2023 Annual/Q1 CPT/HCPCS Code Update and is  effective for dates of services on or after 1/1/2023.
Under Article Text removed verbiage regarding instructions on how to submit a DEX Z-code on claims. Formatting, punctuation, and typographical errors were corrected throughout the article for dates on or after 1/1/2023.
12/17/2021 R2

Noridian has modified certain language in this article to mirror the language used presently by the MolDX team at Palmetto GBA as part of an annual review. Revision history dates and language may not exactly match the MolDX PGBA revision history but is updated with the revisions made in an accurate timeline. However, these revisions do not change coverage or guidance.

10/24/2019: This article is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual. Under Article Title changed the title from “MolDX: know error® Billing and Coding Guidelines Update” to “Billing and Coding: MolDX: know error®”.

Under Article Text removed the last paragraph. Under CPT/HCPCS Codes Group 1: Codes added 84999. Under CPT/HCPCS Modifiers Group 1: Codes added modifiers GX and GY.

01/01/2020 R1

This article is converted to a formal Billing and Coding type article. Added CMS regulations. GX and GY modifiers were added to the proper code field. Title is updated.

Associated Documents

Related Local Coverage Documents
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Related National Coverage Documents
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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
01/26/2023 01/01/2023 - N/A Currently in Effect You are here
02/23/2022 12/17/2021 - 12/31/2022 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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