LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: know error®

A54273

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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.

Document Note

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A54273
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: know error®
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
11/22/2023
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 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, §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

 

Response To Comments

Number Comment Response
1
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Coding Information

Bill Type Codes

Code Description
013x Hospital Outpatient
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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
84999 UNLISTED CHEMISTRY PROCEDURE
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CPT/HCPCS Modifiers

Group 1

(2 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
Code Description
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
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ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

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

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

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ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

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
013x Hospital Outpatient
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
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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
N/A N/A
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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
11/22/2023 R14

Revision Effective: 11/22/2023

Revision Explanation: Updated LCD Reference Article section.

01/01/2023 R13

Revision Effective: 01/01/2023
Revision Explanation: 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 retroactive 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. This revision is retroactive effective date for dates of services on or after 1/1/2023.

10/31/2019 R12

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

10/31/2019 R11

Revision Effective date: 10/31/2019
Revision Explanation: 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. Under Bill Type Codes: 013x.

10/03/2019 R10

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

07/20/2017 R9

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

10/01/2015 R8

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

07/20/2017 R7

Revision Effective date: 07/20/2017
Revision Explanation: Added DEX in front of Z-Code.

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 to Z code identifier instead of actual number.
10/01/2015 R4 Revision Effective: N/A
Revision Explanation: Annual review no changes made.
10/01/2015 R3 R1
Revision Effective:10/01/2015
Revision Explanation: Changed MoPath to MolDX .
10/01/2015 R2 Revision Effective: N/A
Revision Explanation: Added Part A loop information.
10/01/2015 R1 Revision Effective:10/01/2015
Revision Explanation: Corrected typo in the title.
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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
11/14/2023 11/22/2023 - N/A Currently in Effect You are here
01/24/2023 01/01/2023 - 11/21/2023 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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