American Samoa
Guam
Hawaii
Northern Mariana Islands
01212 - A and B MAC
American Samoa
Guam
Hawaii
Northern Mariana Islands
01311 - A and B MAC
Nevada
01312 - A and B MAC
Nevada
01911 - A and B MAC
American Samoa
California - Entire State
Guam
Hawaii
Nevada
Northern Mariana Islands
Article Information
Article ID Number: A57384 Status: A-Approved
Article Title: Billing and Coding: MolDX: Pharmacogenomics Testing
Original Article Effective Date:
08/17/2020
Revision Effective Date:
01/01/2025
Article Text:
The information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Pharmacogenomics Testing L38335
Relevant National Coverage Determinations (NCDs):
NCD 90.1: Testing for CYP2C9 and VKORC1 for Warfarin dosage must adhere to the requirements set forth in this NCD.
Relevant Articles:
Billing and Coding: MolDX: Testing of Multiple Genes A58120
Billing and Coding: MolDX: Repeat Germline Testing A57331
Additional documentation requirements for coverage and billing:
Performing providers are required to acquire and retain records of the drugs under consideration for use or in use by the ordering physician that necessitate the use of ordered test.
MolDX may make available specific forms to assist with test Technical Assessments (TAs). Please follow the instructions on the MolDX website to assist with this process. If such forms are available that pertain to the test type in question, these forms are required for successful coverage determinations.
Billing instructions:
To report a pharmacogenomics testing service, please submit the following claim information:
Select the appropriate CPT® code or PLA code
Enter 1 unit of service (UOS)
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
Item 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
Select the appropriate ICD-10-CM code
For part B claims, the drug or drugs in consideration for use that require the use of the pharmacogenomics (PGx) test must be submitted in the applicable detail line 2400 loop. The character maximum for loop 2400 is 80. To prevent denials/rejects when indicating more than 80 characters, please indicate the required drug names first. If multiple drugs are being used/considered for the specified beneficiary on the claim, they should be added to the comment line separated by a "/" (example Drug 1/Drug 2). Do not list the same drug more than once. The use of the generic name is strongly preferred. For Part B paper claims, the drug or drugs in consideration for use that require the use of the pharmacogenomics (PGx) test must be submitted in Item 19 field.
Only one test may be performed per date of service; the test should be the most likely to identify the necessary alleles/variants for the drug/drugs in question. This applies to both single gene tests and multigene panels.
The medical necessity for the additional testing and the clinical decision making for the additional testing must be documented in the medical record. The CPT code set relevant to this policy is listed in the table below. If no CPT code is available for the gene being tested, the NOC code 81479 may be used. The identification of the proper recommended billing code is established as part of the test application process.
Gene/CPT coding/Drug information
Table 1 represents relevant gene/drug associations related to metabolizing enzymes from CPIC and FDA sources.
Table 1. This table represents metabolism gene/drug associations from CPIC and FDA sources.
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 policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
CPT/HCPCS Codes:
Group 1 Paragraph:
CPT® code 81479 is used to describe multi-gene panels and single genes not otherwise classified.
Group 1 CPT Codes:
0029U
DRUG METABOLISM (ADVERSE DRUG REACTIONS AND DRUG RESPONSE), TARGETED SEQUENCE ANALYSIS (IE, CYP1A2, CYP2C19, CYP2C9, CYP2D6, CYP3A4, CYP3A5, CYP4F2, SLCO1B1, VKORC1 AND RS12777823)
0030U
DRUG METABOLISM (WARFARIN DRUG RESPONSE), TARGETED SEQUENCE ANALYSIS (IE, CYP2C9, CYP4F2, VKORC1, RS12777823)
CYP2D6 (CYTOCHROME P450, FAMILY 2, SUBFAMILY D, POLYPEPTIDE 6) (EG, DRUG METABOLISM) GENE ANALYSIS, FULL GENE SEQUENCE (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0072U
CYP2D6 (CYTOCHROME P450, FAMILY 2, SUBFAMILY D, POLYPEPTIDE 6) (EG, DRUG METABOLISM) GENE ANALYSIS, TARGETED SEQUENCE ANALYSIS (IE, CYP2D6-2D7 HYBRID GENE) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0073U
CYP2D6 (CYTOCHROME P450, FAMILY 2, SUBFAMILY D, POLYPEPTIDE 6) (EG, DRUG METABOLISM) GENE ANALYSIS, TARGETED SEQUENCE ANALYSIS (IE, CYP2D7-2D6 HYBRID GENE) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0074U
CYP2D6 (CYTOCHROME P450, FAMILY 2, SUBFAMILY D, POLYPEPTIDE 6) (EG, DRUG METABOLISM) GENE ANALYSIS, TARGETED SEQUENCE ANALYSIS (IE, NON-DUPLICATED GENE WHEN DUPLICATION/MULTIPLICATION IS TRANS) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0075U
CYP2D6 (CYTOCHROME P450, FAMILY 2, SUBFAMILY D, POLYPEPTIDE 6) (EG, DRUG METABOLISM) GENE ANALYSIS, TARGETED SEQUENCE ANALYSIS (IE, 5' GENE DUPLICATION/MULTIPLICATION) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0076U
CYP2D6 (CYTOCHROME P450, FAMILY 2, SUBFAMILY D, POLYPEPTIDE 6) (EG, DRUG METABOLISM) GENE ANALYSIS, TARGETED SEQUENCE ANALYSIS (IE, 3' GENE DUPLICATION/ MULTIPLICATION) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0286U
CEP72 (CENTROSOMAL PROTEIN, 72-KDA), NUDT15 (NUDIX HYDROLASE 15) AND TPMT (THIOPURINE S-METHYLTRANSFERASE) (EG, DRUG METABOLISM) GENE ANALYSIS, COMMON VARIANTS
0345U
PSYCHIATRY (EG, DEPRESSION, ANXIETY, ATTENTION DEFICIT HYPERACTIVITY DISORDER [ADHD]), GENOMIC ANALYSIS PANEL, VARIANT ANALYSIS OF 15 GENES, INCLUDING DELETION/DUPLICATION ANALYSIS OF CYP2D6
0411U
PSYCHIATRY (EG, DEPRESSION, ANXIETY, ATTENTION DEFICIT HYPERACTIVITY DISORDER [ADHD]), GENOMIC ANALYSIS PANEL, VARIANT ANALYSIS OF 15 GENES, INCLUDING DELETION/DUPLICATION ANALYSIS OF CYP2D6
0419U
NEUROPSYCHIATRY (EG, DEPRESSION, ANXIETY), GENOMIC SEQUENCE ANALYSIS PANEL, VARIANT ANALYSIS OF 13 GENES, SALIVA OR BUCCAL SWAB, REPORT OF EACH GENE PHENOTYPE
81225
CYP2C19 (CYTOCHROME P450, FAMILY 2, SUBFAMILY C, POLYPEPTIDE 19) (EG, DRUG METABOLISM), GENE ANALYSIS, COMMON VARIANTS (EG, *2, *3, *4, *8, *17)
VKORC1 (VITAMIN K EPOXIDE REDUCTASE COMPLEX, SUBUNIT 1) (EG, WARFARIN METABOLISM), GENE ANALYSIS, COMMON VARIANT(S) (EG, -1639G>A, C.173+1000C>T)
81374
HLA CLASS I TYPING, LOW RESOLUTION (EG, ANTIGEN EQUIVALENTS); ONE ANTIGEN EQUIVALENT (EG, B*27), EACH
81377
HLA CLASS II TYPING, LOW RESOLUTION (EG, ANTIGEN EQUIVALENTS); ONE ANTIGEN EQUIVALENT, EACH
81381
HLA CLASS I TYPING, HIGH RESOLUTION (IE, ALLELES OR ALLELE GROUPS); ONE ALLELE OR ALLELE GROUP (EG, B*57:01P), EACH
81383
HLA CLASS II TYPING, HIGH RESOLUTION (IE, ALLELES OR ALLELE GROUPS); ONE ALLELE OR ALLELE GROUP (EG, HLA-DQB1*06:02P), EACH
81401
MOLECULAR PATHOLOGY PROCEDURE, LEVEL 2 (EG, 2-10 SNPS, 1 METHYLATED VARIANT, OR 1 SOMATIC VARIANT [TYPICALLY USING NONSEQUENCING TARGET VARIANT ANALYSIS], OR DETECTION OF A DYNAMIC MUTATION DISORDER/TRIPLET REPEAT)
81406
MOLECULAR PATHOLOGY PROCEDURE, LEVEL 7 (EG, ANALYSIS OF 11-25 EXONS BY DNA SEQUENCE ANALYSIS, MUTATION SCANNING OR DUPLICATION/DELETION VARIANTS OF 26-50 EXONS, CYTOGENOMIC ARRAY ANALYSIS FOR NEOPLASIA)
81418
DRUG METABOLISM (EG, PHARMACOGENOMICS) GENOMIC SEQUENCE ANALYSIS PANEL, MUST INCLUDE TESTING OF AT LEAST 6 GENES, INCLUDING CYP2C19, CYP2D6, AND CYP2D6 DUPLICATION/DELETION ANALYSIS
81479
UNLISTED MOLECULAR PATHOLOGY PROCEDURE
ICD-10 Codes That Are Covered
The following codes are for reference use only and are not to imply medical necessity or lack of medical necessity.
F20.0
Paranoid schizophrenia
F20.1
Disorganized schizophrenia
F20.2
Catatonic schizophrenia
F20.3
Undifferentiated schizophrenia
F20.5
Residual schizophrenia
F20.81
Schizophreniform disorder
F20.89
Other schizophrenia
F31.0
Bipolar disorder, current episode hypomanic
F31.11
Bipolar disorder, current episode manic without psychotic features, mild
F31.12
Bipolar disorder, current episode manic without psychotic features, moderate
F31.13
Bipolar disorder, current episode manic without psychotic features, severe
F31.2
Bipolar disorder, current episode manic severe with psychotic features
F31.31
Bipolar disorder, current episode depressed, mild
F31.32
Bipolar disorder, current episode depressed, moderate
F31.4
Bipolar disorder, current episode depressed, severe, without psychotic features
F31.5
Bipolar disorder, current episode depressed, severe, with psychotic features
F31.61
Bipolar disorder, current episode mixed, mild
F31.62
Bipolar disorder, current episode mixed, moderate
F31.63
Bipolar disorder, current episode mixed, severe, without psychotic features
F31.64
Bipolar disorder, current episode mixed, severe, with psychotic features
F31.71
Bipolar disorder, in partial remission, most recent episode hypomanic
F31.73
Bipolar disorder, in partial remission, most recent episode manic
F31.75
Bipolar disorder, in partial remission, most recent episode depressed
F31.77
Bipolar disorder, in partial remission, most recent episode mixed
F32.1
Major depressive disorder, single episode, moderate
F32.2
Major depressive disorder, single episode, severe without psychotic features
F32.3
Major depressive disorder, single episode, severe with psychotic features
F32.4
Major depressive disorder, single episode, in partial remission
F33.1
Major depressive disorder, recurrent, moderate
F33.2
Major depressive disorder, recurrent severe without psychotic features
F33.3
Major depressive disorder, recurrent, severe with psychotic symptoms
F33.41
Major depressive disorder, recurrent, in partial remission
F40.11
Social phobia, generalized
F41.0
Panic disorder [episodic paroxysmal anxiety]
F41.1
Generalized anxiety disorder
F41.3
Other mixed anxiety disorders
F41.8
Other specified anxiety disorders
F43.11
Post-traumatic stress disorder, acute
F43.12
Post-traumatic stress disorder, chronic
F60.5
Obsessive-compulsive personality disorder
F90.0
Attention-deficit hyperactivity disorder, predominantly inattentive type
F90.1
Attention-deficit hyperactivity disorder, predominantly hyperactive type
F90.2
Attention-deficit hyperactivity disorder, combined type
F90.8
Attention-deficit hyperactivity disorder, other type
ICD-10 Codes That Are Not Covered
N/A
Revision History Information
Revision History Date
Revision History Number
Revision History Explanation
01/01/2025
R15
Under CPT/HCPCS Codes Group 1: Codes deleted 0380U. This revision is due to the 2025 Annual/Q1 CPT/HCPCS Code Update and is effective 1/1/2025.
10/24/2024
R14
Under Article Text revised Table 2 to add HLA-A for afamitresgene autoleucel. This revision is due to FDA guidelines and is effective August 1, 2024.
01/25/2024
R13
Under Article Text subheading Billing Instructions revised 1st paragraph to add “For Part B paper claims, the drug or drugs in consideration for use that require the use of the pharmacogenomics (PGx) test must be submitted in Item 19 field.” This revision is effective 1/25/2024.
Under CPT/HCPCS Group 1: Codes added 0380U. This revision is due to new covered panel that has successfully completed a TA and is effective 5/11/2023.
10/01/2023
R12
Updated to indicate this article is an LCD Reference Article.
10/01/2023
R11
Under CPT/HCPCS Group 1: Codes added 0411U and 0419U. This revision is due to the 2023 Q4 CPT/HCPCS Code Update and is effective on October 1, 2023.
Under Article Text revised Table 2 to delete row for CFTR as this is not relevant to the general Medicare population. Under subheading Covered multigene panels with intended uses revised verbiage to read “Panels with a specific intended use such as major depressive disorder (MDD) or neuropsychiatric must include relevant ICD-10 codes.” and deleted Table 3. Under CPT/HCPCS Codes Group 1: Codes deleted 81220. This revision is effective on October 1, 2023
09/21/2023
R10
Under Article Text subheading Billing Instructions revised 1st bullet to read “Select the appropriate CPT® or PLA code”. Revised 3rd and 6th bullets to remove “DEX Z-Code™” and replaced with “DEX Z-Code®”. Under subheading Gene/CPT coding/Drug Information revised the first sentence to add “related to metabolizing enzymes”. Revised Table 1 to read, “This table represents metabolism gene/drug associations from CPIC and FDA sources” and deleted rows 3-4, 43-51, and 59. Added new Table 2 to clarify gene use. Under subheading Covered multigene panels with intended uses renamed “Table 2” to “Table 3”. Formatting was corrected throughout the article. This revision is due to updated published guidelines and recommendations and is effective on September 21, 2023.
Revised Table 1 to add new row for CYP2B6 for sertraline. Revised Table 2 to add new rows for G6PD for pegloticase, dapsone, primaquine, and tafenoquine. This revision is due to updated published guidelines and recommendations and is effective for 4/10/2023.
Revised Table 3 to add new row for PGXPSYCH. This revision is due to new covered multigene panel with specified uses that has successfully completed a TA and is effective for 4/17/2023.
Revised Table 2 to add new row for APOE for lecanemab. Under CPT/HCPCS Group 1: Codes added 81401 for APOE. This revision is due to FDA guidelines and is effective for July 6, 2023.
04/20/2023
R9
Under Article Text added the verbiage “The character maximum for loop 2400 is 80. To prevent denials/rejects when indicating more than 80 characters, please indicate the required drug names first.” under subsection heading, “Billing instructions” first paragraph. Revised Table 1 to update to the current CPIC and FDA dates. Added new rows for ABCG2 for rosuvastatin, CYP2C19 for belzutifan, CYP2C19 for abrocitinib, CYP2C9 for nateglinide, CYP2C9 for fluvastatin, and UTGT2B17 for belzutifan. Revised the row for SLCO1B1 to include additional generic and trade names.
01/01/2023
R8
Under CPT/HCPCS Codes Group 1:Codes added 81418. This revision is due to the 2023 Annual/Q1 CPT/HCPCS Code Update and is effective on January 1, 2023.
12/07/2022
R7
Under Article Text revised Table 1 to add new row for HLA-A for tebentafusp. This revision is effective for dates of service on or after 12/07/2022.
10/01/2022
R6
Under CPT/HCPCS Codes Group 1: Codes added 0345U. Typographical errors were corrected throughout the article.
This revision is due to Q4 CPT®/HCPCS Code Update and is effective for dates of service on or after 10/1/2022.
06/16/2022
R5
Under Article Text, revised table 2 to add the last row. Formatting, punctuation and typographical errors were corrected throughout the Article. This revision is retroactive effective for dates of service on or after 4/29/2022.
04/28/2022
R4
Under Article Text, revised Table 2 to add the verbiage, “or Neuropsychiatric.” This revision is effective on 4/28/2022
01/01/2022
R3
Under Article Text Table 1 Gene TPMT added 0034U and 0286U to the CPT Code column. Under CPT/HCPCS Codes Group 1: Codes added 0034U. This revision is retroactive effective for dates of service on or after 1/1/2022.
Under CPT/HCPCS Codes Group 1: Codes added 0286U. This revision is due to the 2022 Annual CPT®/HCPCS Code Update and is effective 1/1/2022.
08/23/2021
R2
08.23.2021: Under Article Text subheading Billing instructions added the verbiage, “The use of the generic name is strongly preferred.” to the end of the second paragraph. Under the third and fourth paragraph deleted the verbiage, “Multigene panels can be performed when (as defined in the policy):
More than one gene is reasonable and necessary for the safe use of the drug being considered or in use; or
More than one drug is in consideration or use that is associated with a gene-drug interaction
A multigene panel must include all relevant genes and variants for its intended use to be reasonable and necessary. If, after the initial test is completed and additional testing is warranted and is reasonable and necessary as stated in the associated policy and as defined in the Repeat Germline Testing policy, an additional test may be subsequently performed.” Under subheading Gene/CPT coding/Drug information revised the first sentence to read, “Table 1 represents relevant gene/drug associations from CPIC and FDA sources”. Table 1 and Table 2 were deleted and a new Table 1 was added. Under subheading Covered multigene panels the verbiage, “with intended uses” was added to the subheading. Table 3 was renamed Table 2 and added the verbiage, “Table 2 represents covered multigene panels with specified uses that have successfully completed a TA. These tests must fulfill all the criteria above and may be further limited to specific indications listed by ICD-10 codes, when applicable”. Rows 3 and 5 were added to the table. Under CPT/HCPCS Codes Group 1: Codes added 0029U.
This revision is retroactive effective for dates of service on or after 8/23/2021.
01.01.2021: Under Article Text subheading Billing instructions: added registered mark after CPT and added the verbiage, “If multiple drugs are being used/considered for the specified beneficiary on the claim, they should be added to the comment line separated by a "/" (example Drug 1/Drug 2). Do not list the same drug more than once”. Under subheading Gene/CPT coding/Drug information revised the two tables to include CPT® code 81479 where N/A was previously listed. Under subheading Covered multigene panels revised table to update the intended use of each test. Under subheading ICD-10 codes associated with intended uses revised table to update intended use, added additional ICD-10 codes, and deleted unspecified codes. Under CPT/HCPCS Codes Group 1: Paragraph added the verbiage, “CPT® code 81479 is used to describe multi-gene panels and single genes not otherwise classified”. Under CPT/HCPCS Codes Group 1: Codes added 81479. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added F20.0, F20.1, F20.2, F20.3, F20.5, F20.81, F20.89, F31.0, F31.11, F31.12, F31.13, F31.2, F31.31, F31.32, F31.4, F31.5, F31.61, F31.62, F31.63, F31.64, F31.71, F31.73, F31.75, F31.77, F40.11, F41.0, F41.1, F41.3, F41.8, F43.11, F43.12, F60.5, F90.0, F90.1, F90.2, F90.8 and deleted F32.9, F33.40, F33.9. This revision is retroactive effective for dates of service on or after 1/1/2021.
08/17/2020
R1
Under Article Text added the following verbiage that reads:
“Relevant National Coverage Determinations (NCDs):
NCD 90:1: Testing for CYP2C9 and VKORC1 for Warfarin dosage must adhere to the requirements set forth in this NCD.”
Discrepancies within the tables have been corrected and a column has been added listing brand name medications in tables 1 and 2. The link below table 2 has been revised.
Under CPT/HCPCS Codes – Group 1: Codes added codes 81247, 81328, 81374, 81377, 81381, 81383, and deleted codes 81371, 81373 and 81379.