LCD Reference Article Billing and Coding Article

Billing and Coding: Genetic Testing for Cardiovascular Disease

A58797

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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

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General Information

Source Article ID
N/A
Article ID
A58797
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Genetic Testing for Cardiovascular Disease
Article Type
Billing and Coding
Original Effective Date
01/30/2022
Revision Effective Date
07/01/2024
Revision Ending Date
N/A
Retirement Date
N/A

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CMS National Coverage Policy

Internet Only Manual (IOM) Citations:

  • CMS IOM Publication 100-04, Medicare Claims Processing Manual,
    • Chapter 1, Section 60 Provider Billing of Non-covered Charges on Institutional Claims
    • Chapter 16, Laboratory Services
    • Chapter 23, Section 20.9 National Correct Coding Initiative (NCCI), Section 20.9.1.1 Instructions for Codes with Modifiers (A/B MACs (B) Only), and Section 40 Clinical Diagnostic Laboratory Fee Schedule
  • CMS IOM Publication 100-08, Medicare Program Integrity Manual,
    • Chapter 3, Sections 3.4.1.3 Diagnosis Code Requirements and 3.6.2.3 Limitations of Liability Determinations

National Correct Coding Initiative (NCCI) Citation:

  • NCCI Policy Manual for Medicare Services,
    • Chapter 10, Pathology/Laboratory Services, (A) Introduction and (F) Molecular Pathology

Social Security Act (Title XVIII) Standard References:

  • Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period.
  • Title XVIII of the Social Security Act, Section 1834A(d) This section addresses payment for new advanced diagnostic laboratory tests.

Code of Federal Register (CFR) References:

  • CFR, Title 42, Volume 2, Chapter IV, Part 410.32(d)(3) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.
  • CFR, Title 42, Volume 3, Chapter IV, Part 414, Subpart G Payment for Clinical Diagnostic Laboratory Tests.
  • CFR, Title 42, Volume 3, Chapter IV, Part 414.50 Physician or other supplier billing for diagnostic tests performed or interpreted by a physician who does not share a practice with the billing physician or other supplier.

Article Guidance

Article Text

This Billing and Coding Article provides billing and coding guidance for Local Coverage Determination (LCD) L39084 Genetic Testing for Cardiovascular Disease. Please refer to the LCD for reasonable and necessary requirements.

Tier 2 CPT code 81406 is not appropriate to report for cardiovascular genetic testing because there are no genes associated with CPT code 81406 that meet the ClinGen evidence standards.

Coding Guidance

Notice: It is not appropriate to bill Medicare for services that are not covered (as described by the entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

All limitations of the LCD apply.

No genes currently meet criteria for coverage as outlined in the LCD.

Documentation Requirements

  1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
  2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
  3. The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
  4. The medical record must demonstrate the treating clinician who is responsible for the cardiovascular disease management is the ordering clinician.
  5. The medical record must clearly document the communication and discussion of pre-test and post-test counseling and the risk associated with genetic testing.
  6. The medical record must demonstrate disease appropriate phenotyping to establish clinical diagnosis or suspected diagnosis for which the test results would directly impact the management of the patient’s condition.
  7. The clinical actionability of the gene-disease relationship for the patient must be documented in the medical record.

Response To Comments

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Coding Information

Bill Type Codes

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Revenue Codes

Code Description

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CPT/HCPCS Codes

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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

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Due to non-coverage there are no ICD-10-CM Codes that support medical necessity at this time.

Group 1 Codes

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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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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
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
07/01/2024 R4

Article revised and published on 07/18/2024 effective for dates of service on and after 07/01/2024 in response to the July Quarterly HCPCS/CPT Code Updates. The following CPT code has been added to this article: 0466U added to Group 1 codes.

01/01/2024 R3

Article revised and published on 01/25/2024 effective for dates of service on and after 01/01/2024 to reflect the Annual HCPCS/CPT Code Updates. For the following CPT codes either the short description and/or the long description was changed. Depending on which description is used in this article, there may not be any change in how the code displays: 81403, 81404, 81405, and 81407 in Group 1 Codes.

07/01/2023 R2

Article revised and published on 07/20/2023 effective for dates of service on and after 07/01/2023 in response to the July Quarterly HCPCS/CPT Code Updates. The following CPT code has been added to this article: 0401U added to Group 1 codes. CPT code 81493 has been added as non-covered to prevent inappropriate reporting because the proprietary test is no longer available.

01/30/2022 R1

Article revised and published 12/30/2021 effective for dates of service 01/30/2022 to correct a typographical error. Under Article Text the word Proposed was removed as well as the "D" before the LCD #.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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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Public Versions
Updated On Effective Dates Status
07/12/2024 07/01/2024 - N/A Currently in Effect You are here
01/19/2024 01/01/2024 - 06/30/2024 Superseded View
07/14/2023 07/01/2023 - 12/31/2023 Superseded View
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