LCD Reference Article Billing and Coding Article

Billing and Coding: Molecular Pathology Procedures

A57451

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
First Coast Service Options, Inc.	A and B MAC	09101 - MAC A	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09102 - MAC B	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09201 - MAC A	J - N	Puerto Rico Virgin Islands
First Coast Service Options, Inc.	A and B MAC	09202 - MAC B	J - N	Puerto Rico
First Coast Service Options, Inc.	A and B MAC	09302 - MAC B	J - N	Virgin Islands

Article Information

General Information

Article ID
A57451

Article Title
Billing and Coding: Molecular Pathology Procedures

Article Type
Billing and Coding

Original Effective Date
10/03/2018

Revision Effective Date
01/01/2024

Revision Ending Date
N/A

Retirement Date
N/A

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CMS National Coverage Policy

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.

Article Guidance

Article Text

This Billing and Coding Article provides billing and coding guidance for Local Coverage Determination (LCD) L34519 Molecular Pathology Procedures. Please refer to the LCD for reasonable and necessary requirements.

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.

The American Medical Association (AMA) Current Procedural Terminology (CPT) manual states molecular pathology procedures are medical laboratory procedures involving the analyses of nucleic acid to detect variants in genes that may be indicative of germline (e.g., constitutional disorders) or somatic (e.g., neoplasia) conditions, or to test for histocompatibility antigens (e.g., HLA). Given the elimination of the stacking procedure codes and the array-based evaluation codes molecular pathology codes now include all analytical services performed in the test (e.g., cell lysis, nucleic acid stabilization, extraction, digestion, amplification, and detection). (Note: molecular pathology procedure techniques, such as microbial identification using molecular pathology techniques and in situ hybridization analyses, may be described in other sections of the Pathology and Laboratory section of CPT.

Code selection is typically based on the specific gene(s) that is being analyzed. Codes that describe tests to assess for the presence of gene variants use common gene variant names. Typically, all of the listed variants would be tested. However, these lists are not exclusive. If other variants are also tested in the analysis, they would be included in the procedure and not reported separately. Full gene sequencing should not be reported using codes that assess for the presence of gene variants unless the CPT code specifically states full gene sequence in the code descriptor. In other words, you may only assign the CPT code that is described as “full gene sequence” if the test assay performed was a full gene sequence.

Tier 2 molecular pathology procedures represent medically useful procedures that are generally performed in lower volumes than Tier 1 molecular pathology procedures (e.g., the incidence of the disease being tested is rare). They are arranged by level of technical resources and interpretive work by the physician or other qualified healthcare professional. If the analyte tested is not listed under one of the Tier 2 codes or is not represented by a Tier 1 code in CPT, use of the unlisted CPT code 81479 is required.

HCPCS code G0452 with modifier 26 should be used by pathologists when an interpretation of a molecular pathology test is performed. Non physician practitioners (e.g., PhD, scientists etc.) are not eligible to report this code, only physicians may use/bill this code. This code should not be billed without modifier 26 since it is an interpretation code only.

Documentation Requirements

All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
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.
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.
Documentation must be adequate to verify that coverage guidelines have been met. Thus, the medical record must contain documentation that the testing is expected to influence treatment of the condition toward which the testing is directed. The laboratory or billing provider must have on file the physician requisition which sets forth the diagnosis or condition that warrants the test(s).
Providers are required to code to specificity however, if CPT 81479 (unlisted molecular pathology procedure) is used the documentation must clearly identify the unique molecular pathology procedure performed. When multiple procedure codes are submitted on a claim (unique and/or unlisted) the documentation supporting each code should be easily identifiable.
For molecular pathology tests, the ordering provider must provide to the laboratory copies of the signed informed consent documentation.
An Advance Beneficiary Notice of Noncoverage (ABN) is required before furnishing a beneficiary a test which the physician or laboratory believes to be noncovered as not reasonable or necessary. The physician or laboratory must obtain a signed ABN from the beneficiary (or representative) that the physician or laboratory has informed him/her on the non-coverage of the test and that there will be a charge for the test.

Response To Comments

Number	Comment	Response
1

Coding Information

Bill Type Codes

Code	Description
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Revenue Codes

Code	Description
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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

N/A

ICD-10-CM Codes that Support Medical Necessity

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Group 1

(1 Code)

Group 1 Paragraph

N/A

Group 1 Codes

Code	Description
XX000	Not Applicable

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

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Group 1

(1 Code)

Group 1 Paragraph

N/A

Group 1 Codes

Code	Description
XX000	Not Applicable

ICD-10-PCS 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.

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

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

Non-Excluded CPT/HCPCS Ended Codes - Table Format

Code	Descriptor Generic Name	Descriptor Brand Name	Exclusion Effective Date	Exclusion End Date	Reason for Exclusion

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation
01/01/2024	R10	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 Group 1 CPT codes the long description was changed: 81171, 81172, 81243, 81244, 81403, 81404. Depending on which description is used in this article, there may not be any change in how the code displays.
01/01/2023	R9	Article revised and published on 01/26/2023 effective for dates of service on and after 01/01/2023 to reflect the Annual HCPCS/CPT Code Updates. For the following CPT code 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: 81330 in Group 1 Codes.
01/01/2022	R8	Article revised and published on 01/20/22 effective for dates of service on and after 01/01/2022 to reflect the Annual HCPCS/CPT Code Updates. The following CPT codes have been added to the ‘CPT/HCPCS Codes’ section for ‘Group 1 Codes’: 81349 and 81523. 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: 81228, 81229, 81405, 0154U, and 0155U in the ‘CPT/HCPCS Codes’ section for ‘Group 1 Codes’.
12/12/2021	R7	Article revised and published on 12/09/2021 effective for dates of service on and after 12/12/2021. Removed the following CPT codes from the “CPT/HCPCS Codes/Group 1 Codes:” section of the billing and coding article: 81220, 81225, 81226, 81227, 81230, 81231, 81232, 81247, 81283, 81306, 81328, 81335, 81346, 81350, 81355, 81406, 81407, and 81408. For Pharmacogenomics testing services, please see the new LCD L39073 and related billing and Coding Article A58812 for Pharmacogenomics Testing effective for dates of service on and after 12/12/2021. Minor formatting changes have been made throughout the article.
01/01/2021	R6	Article revised and published on 02/11/2021 effective for dates of service on and after 01/01/2021 to reflect the annual CPT code updates. The following CPT codes have descriptor changes: 81206, 81207, 81266, 81267, 81268, 81288, 81401, 81402, 81403, 81404, 81405, 0154U, and 0155U. Minor formatting changes have been made throughout the article.
10/01/2020	R5	Article revised and published on 10/29/2020 effective for dates of service on and after 10/01/2020 to that the following CPT code has undergone a long descriptor change: Group 1 Codes: 0154U. In addition, formatting changes were made throughout the article. (PITL # 2020PITLAB007).
04/01/2020	R4	Explanation of revision: Removed CPT codes 0154U and 0155U from the “CPT/HCPCS Codes/Group 1 Paragraph:” section of the billing and coding article, as the revised descriptor for CPT codes 0154U and 0155U is available in the “CPT/HCPCS Codes/Group 1 Codes:” section of the billing and coding article.
04/01/2020	R3	Revision Number: 3 Publication: April 2020 Connection LCR A/B2020-027 Explanation of Revision: Based on CR 11550, 11680, 11681, and 11691 (April 2020 Quarterly Updates), the “CPT/HCPCS Codes/Group 1 Codes:” section of the Billing and Coding article was updated to revise the descriptors for CPT codes 0154U and 0155U. The effective date of this revision is based on date of service.
01/01/2020	R2	Revision Number: 2 Publication: December 2019 Connection LCR A/B2020-001 Explanation of Revision: Annual 2020 HCPCS Update. Descriptor revised for CPT codes 81350, 81404, 81406, and 81407. In addition, added CPT codes 0153U, 0154U, 0155U, 0156U, 0157U, 0158U, 0159U, 0160U, 0161U, 0162U, 81277, 81307, 81308, and 81309. The effective date of this revision is based on date of service.
10/01/2019	R1	Moved HCPCS codes 0111U, 0129U, and 0130U from the “CPT/HCPCS Codes/Group 1 Paragraph:” section of the Billing and Coding article to the “CPT/HCPCS Codes/Group 1 Codes:” section of the Billing and Coding article.

Associated Documents

Related Local Coverage Documents
LCDs
L34519 - Molecular Pathology Procedures

Updated On	Effective Dates	Status
01/19/2024	01/01/2024 - N/A	Currently in Effect	You are here
01/20/2023	01/01/2023 - 12/31/2023	Superseded	View
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Billing and Coding: Molecular Pathology Procedures

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Response To Comments

Coding Information

Bill Type Codes

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CPT/HCPCS Modifiers

Group 1

ICD-10-CM Codes that Support Medical Necessity

Group 1

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

Group 1

ICD-10-PCS Codes

Group 1

Additional ICD-10 Information

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Other Coding Information

Group 1

Coding Table Information

Revision History Information

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