LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: HBB Gene Tests

A54267

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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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Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A54267
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: HBB Gene Tests
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
11/16/2023
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.

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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

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Article Guidance

Article Text

Effective for dates of service on and after 05/03/2013

HBB gene testing may be performed during the diagnosis of Sickle cell disease (SCD). Since clinical symptoms and diagnosis usually occur prior to Medicare eligibility and carrier testing is not a covered benefit, the MolDX Team has determined HBB gene testing is a statutorily excluded service. MolDX will also deny panels of tests that include the HBB gene.

To receive a HBB gene sequencing service denial, please submit the following claim information:

  • Select the appropriate CPT® code based on gene test:
    • 81361 – HBB, common variants
    • 81362 - HBB, known familiar variants
    • 81363 - HBB, duplication/deletion
    • 81364 - HBB, full gene sequence
    • 81443 – Genetic testing for severe inherited conditions
  • 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 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

Code Description
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CPT/HCPCS Codes

Group 1

(4 Codes)
Group 1 Paragraph

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Group 1 Codes
Code Description
81361 HBB (HEMOGLOBIN, SUBUNIT BETA) (EG, SICKLE CELL ANEMIA, BETA THALASSEMIA, HEMOGLOBINOPATHY); COMMON VARIANT(S) (EG, HBS, HBC, HBE)
81362 HBB (HEMOGLOBIN, SUBUNIT BETA) (EG, SICKLE CELL ANEMIA, BETA THALASSEMIA, HEMOGLOBINOPATHY); KNOWN FAMILIAL VARIANT(S)
81363 HBB (HEMOGLOBIN, SUBUNIT BETA) (EG, SICKLE CELL ANEMIA, BETA THALASSEMIA, HEMOGLOBINOPATHY); DUPLICATION/DELETION VARIANT(S)
81364 HBB (HEMOGLOBIN, SUBUNIT BETA) (EG, SICKLE CELL ANEMIA, BETA THALASSEMIA, HEMOGLOBINOPATHY); FULL GENE SEQUENCE

Group 2

(1 Code)
Group 2 Paragraph

CPT® codes that are also referenced in other articles.

Group 2 Codes
Code Description
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)
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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

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Group 1 Codes

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

Group 1

Group 1 Paragraph

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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
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
11/16/2023 R15

Revision Effective: 11/16/2023

Revision Explanation: Updated LCD Reference Article section.

10/31/2019 R14

Revision Effective: 10/31/2019
Revision Explanation: Guidelines was left in title in error and has been removed as indicated in revision #12.

10/31/2019 R13

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

10/31/2019 R12

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, to remove all coding from LCDs and incorporate into related Billing and Coding Articles.

Under Article Title changed the title to “Billing and Coding: MolDX: HBB Gene Tests”. Under Article Text removed the bullet that reads “Select the appropriate diagnosis for the patient”, and removed the last paragraph. Under CPT/HCPCS Codes moved CPT® code 81443 from Group 1: Codes to Group 2: Codes. Under Group 2: Paragraph added the verbiage "CPT® codes that are also referenced in other articles." Under CPT/HCPCS Modifiers Group 1: Codes added modifiers GX and GY. CPT® was inserted throughout the article where applicable.

10/03/2019 R11

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

01/01/2019 R10

Revision Effective date: 01/01/2019
Revision Explanation: During annual HCPCS update new code81443 was added to this article. Also updated article with specific code for HBB tests 8131-81364.

10/01/2017 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

10/01/2017 R7

Revision Effective date: 10/01/2017
Revision Explanation: Replaced "identifier" verbiage with the appropriate DEX Z code identifier verbiage.

10/01/2015 R6 Revision Effective date: N/A
Revision Explanation: Annual review no changes made.
10/01/2015 R5 Revision Effective: N/A
Revision Explanation: Corrected numerical order of codes in text.
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 R1
Revison Effective: N/A
Revision Explanation: Clarified CPT codes and bullet # 4 had wording changes for clarification
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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
11/10/2023 11/16/2023 - N/A Currently in Effect You are here
12/26/2019 10/31/2019 - 11/15/2023 Superseded View
11/26/2019 10/31/2019 - N/A Superseded View
10/23/2019 10/31/2019 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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