SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: MCOLN1 Genetic Testing Guidelines

A54277

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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.
Superseded
To see the currently-in-effect version of this document, go to the section.

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Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A54277
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: MCOLN1 Genetic Testing Guidelines
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
01/23/2020
Revision Ending Date
11/21/2023
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) allows coverage and payment for only those services that are considered to be 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

Effective for dates of service on and after February 6, 2013

Mutations found in mucolipin 1 (MCOLN1) are associated with Mucolipidosis, type IV, a disease characterized by psychomotor event delay in children evident before the first year of life. For infants and children, MCOLN1 genetic testing is used to confirm the clinical findings to diagnose Mucolipidosis. Genetic testing for adults is used to screen the population for potential carriers of the mutation. Therefore, the MolDX Team has determined that MCOLN1 genetic testing is not a Medicare benefit and is a statutorily excluded service. In addition to single gene testing, MolDX will also deny panels of tests that include a MCOLN1 gene test as a statutorily excluded service.

To receive a MCOLN1 test denial, please submit the following claim information:

  • CPT® code 81290, 81412, or 81443
  • An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services
    • For a voluntary issued ABN, append with GX modifier
    • To indicate a statutorily excluded service, append with a GY modifier
  • 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

 

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
81290 MCOLN1 (MUCOLIPIN 1) (EG, MUCOLIPIDOSIS, TYPE IV) GENE ANALYSIS, COMMON VARIANTS (EG, IVS3-2A>G, DEL6.4KB)

Group 2

(2 Codes)
Group 2 Paragraph

CPT® codes that are also referenced in other articles.

Group 2 Codes
Code Description
81412 ASHKENAZI JEWISH ASSOCIATED DISORDERS (EG, BLOOM SYNDROME, CANAVAN DISEASE, CYSTIC FIBROSIS, FAMILIAL DYSAUTONOMIA, FANCONI ANEMIA GROUP C, GAUCHER DISEASE, TAY-SACHS DISEASE), GENOMIC SEQUENCE ANALYSIS PANEL, MUST INCLUDE SEQUENCING OF AT LEAST 9 GENES, INCLUDING ASPA, BLM, CFTR, FANCC, GBA, HEXA, IKBKAP, MCOLN1, AND SMPD1
81443 GENETIC TESTING FOR SEVERE INHERITED CONDITIONS (EG, CYSTIC FIBROSIS, ASHKENAZI JEWISH-ASSOCIATED DISORDERS [EG, BLOOM SYNDROME, CANAVAN DISEASE, FANCONI ANEMIA TYPE C, MUCOLIPIDOSIS TYPE VI, GAUCHER DISEASE, TAY-SACHS DISEASE], BETA HEMOGLOBINOPATHIES, PHENYLKETONURIA, GALACTOSEMIA), GENOMIC SEQUENCE ANALYSIS PANEL, MUST INCLUDE SEQUENCING OF AT LEAST 15 GENES (EG, ACADM, ARSA, ASPA, ATP7B, BCKDHA, BCKDHB, BLM, CFTR, DHCR7, FANCC, G6PC, GAA, GALT, GBA, GBE1, HBB, HEXA, IKBKAP, MCOLN1, PAH)
N/A

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
N/A

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

N/A

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

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.

Code Description
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
N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

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
N/A
Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation
01/23/2020 R12

Revision Effective: 1/23/2020
Revision Explanation: Under CPT/HCPCS Codes created Group 2: Paragraph and added verbiage “CPT® codes that are also referenced in other articles”. Created Group 2: Codes and moved CPT® 81412 and 81443 from Group 1: Codes to Group 2: Codes.

12/12/2019 R11

Revision Effective: 12/12/2019
Revision Explanation: Added regulations to the CMS National policy section, removed the referenced section at end of the article text. Added modifiers to the modifier section.

10/03/2019 R10

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

10/03/2019 R9

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

01/01/2019 R8

Revision Effective date: 01/01/2019
Revision Explanation: During annual HCPCS update new codes 81412 and 81443 were added to this article.

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 date: N/A
Revision Explanation: Added Dex Z before identifier to show trade mark name.
10/01/2015 R4 Revision Effective date: N/A
Revision Explanation: Annual review no changes made.
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
11/15/2023 11/22/2023 - N/A Currently in Effect View
01/14/2020 01/23/2020 - 11/21/2023 Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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