Local Coverage Article Billing and Coding

Billing and Coding: MolDX: Pharmacogenomics Testing

A58395

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Article ID
A58395
Article Title
Billing and Coding: MolDX: Pharmacogenomics Testing
Article Type
Billing and Coding
Original Effective Date
07/26/2020
Revision Effective Date
01/01/2023
Revision Ending Date
N/A
Retirement Date
N/A
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CMS National Coverage Policy

Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Article Guidance

Article Text

The information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Pharmacogenomics Testing L38435.

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 A57880
Billing and Coding: MolDX: Repeat Germline Testing A57100

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
  • 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
    • 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
  • 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. 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 generic name is strongly preferred.

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 from CPIC and FDA sources.

Table 1. Current CPIC guidelines as of March 26, 2021 and Table of Pharmacogenomic Associations from the FDA for which the data support therapeutic recommendations or a potential impact on safety or responses as of November 08, 2021.

Gene

CPT Code(s)

Generic Name

Trade Name(s)

Intended use for Drug(s)

Guidance

BCHE

81479

mivacurium, succinylcholine

Mivacurium chloride, Anectine

Neuromuscular blocking agent

FDA

CACNA1S

81479

desflurane, enflurane, halothane, isoflurane, methoxyflurane, sevoflurane, succinylcholine

Suprane, Ethrane, Fluothane, Forane, Penthrox, Ultane, Anectine, Quelicin

Volatile anesthetic

CPIC

CFTR

81220

ivacaftor

Kalydeco

Cystic fibrosis

CPIC

CYP2B6

81479

efavirenz

Sustiva

Antiretroviral; HIV

CPIC/FDA

CYP2C19

81225

brivaracetam, clobazam

Briviact, Onfi

Anticonvulsant

FDA

CYP2C19

81225

citalopram, escitalopram, sertraline

Celexa, Lexapro, Zoloft

Antidepressant - Selective Serotonin Reuptake Inhibitor (SSRI)

CPIC/FDA

CYP2C19

81225

amitriptyline, clomipramine, doxepin, imipramine, trimipramine

Elavil, Anafranil, Silenor, Tofranil, Surmontil

Antidepressant - Tricyclic

CPIC

CYP2C19

81225

voriconazole

Vfend

Antifungal

CPIC/FDA

CYP2C19

81225

flibanserin

Addyi

Mixed serotonin agonist

FDA

CYP2C19

81225

clopidogrel

Plavix

Platelet aggregation inhibitor

CPIC/FDA

CYP2C19

81225

dexlansoprazole, lansoprazole, omeprazole, pantoprazole

Dexilant, Prevacid, Prilosec, Protonix

Proton Pump Inhibitor (PPI)

CPIC/FDA

CYP2C9

81227

warfarin

Jantoven, Coumadin

Anticoagulant

CPIC/FDA

CYP2C9

81227

fosphenytoin, phenytoin

Cerebyx, Dilantin

Anticonvulsant

CPIC/FDA

CYP2C9

81227

dronabinol

Marinol, Syndros

Antiemetic

FDA

CYP2C9

81227

erdafitinib

Balversa

FGFR kinase inhibitor, bladder cancer

FDA

CYP2C9

81227

siponimod

Mayzent

Multiple sclerosis

FDA

CYP2C9

81227

celecoxib, flurbiprofen, lornoxicam, meloxicam, piroxicam, tenoxicam

Celebrex, Ansaid, Ocufen, Chlortenoxicam, Xefo, Mobic, Vivlodex, Anjeso, Qmiiz ODT, Feldene, Mobiflex

Non-steroidal anti-inflammatory (NSAID)

CPIC/FDA

CYP2D6

81226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

carvedilol

Coreg

Alpha - Beta blocker

FDA

CYP2D6

81226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

propafenone

Rythmol

Antiarrhythmic

FDA

CYP2D6

81226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

fluvoxamine, paroxetine, venlafaxine, vortioxetine

Luvox, Paxil, Effexor XR, Brintellix, Trintellix

Antidepressant – Selective Serotonin Reuptake Inhibitor (SSRI)

CPIC/FDA

CYP2D6

81226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

amitriptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, trimipramine

Elavil, Anafranil, Norpramin, Silenor, Tofranil, Aventyl, Pamelor, Surmontil

Antidepressant - Tricyclic

CPIC

CYP2D6

81226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

meclizine, ondansetron, tropisetron

Antivert, Zofran ODT, Tropisetron

Antiemetic

CPIC/FDA

CYP2D6

81226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

gefitinib, tamoxifen

Iressa, Soltamox, Nolvadex

Antineoplastic

CPIC/FDA

CYP2D6

81226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

aripiprazole, aripiprazole lauroxil, brexpiprazole, clozapine, iloperidone, perphenazine, pimozide, thioridazine

Abilify, Aristada, Rexulti, Clozaril, FazaClo, Versacloz, Fanapt, Trilafon, Orap, Mellaril

Antipsychotic

FDA

CYP2D6

81226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

amphetamine, atomoxetine

Adzenys ER, Dyanvel XR, Adderall, Strattera

Attention Deficit - Hyperactivity (ADHD) Therapy

CPIC/FDA

CYP2D6

81226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

metoclopramide

Reglan

Gastrointestinal prokinetic agent

FDA

CYP2D6

81226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

eliglustat

Cerdelga

Gaucher's disease

FDA

CYP2D6

81226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

deutetrabenazine, tetrabenazine

Austedo, Xenazine

Movement disorder therapy

FDA

CYP2D6

81226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

pitolisant

Wakix

Narcolepsy therapy agent

FDA

CYP2D6

81226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

codeine, oliceridine, tramadol

Olinvyk, Ultram

Opioid

CPIC/FDA

CYP2D6

81226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

lofexidine

Lucemyra

Opioid withdrawal

FDA

CYP2D6

81226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

cevimeline

Evoxac

Saliva stimulant

FDA

CYP2D6

81226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

tolterodine

Detrol

Urinary antispasmodic

FDA

CYP2D6

81226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U

valbenazine

Ingrezza

VMAT2 inhibitor

FDA

CYP3A5

81231

tacrolimus

Prograf

Antirejection

CPIC/FDA

CYP4F2

81479

warfarin

Jantoven, Coumadin

Anticoagulant

CPIC/FDA

DPYD

81232

capecitabine, fluorouracil

Xeloda, Adrucil, Efudex, Fluoroplex, Tolak

Antineoplastic

CPIC/FDA

G6PD

81247

rasburicase

Elitek

Hyperuricemia

CPIC

HLA - A

81381, 81374

carbamazepine

Tegretol

Anticonvulsant

CPIC/FDA

HLA-A

81381

tebentafusp

Kimmtrak

antineoplastic

FDA

HLA - B

81381, 81374

carbamazepine, fosphenytoin, oxcarbazepine, phenytoin

Tegretol, Cerebyx, Trileptal, Dilantin

Anticonvulsant

CPIC/FDA

HLA - B

81381, 81374

pazopanib

Votrient

Antineoplastic

FDA

HLA - B

81381, 81374

abacavir

Ziagen

Antiretroviral; HIV

CPIC/FDA

HLA - B

81381, 81374

allopurinol

Aloprim, Zyloprim

Hyperuricemia

CPIC/FDA

HLA - DQA1

81377, 81383

lapatinib

Tykerb

Antineoplastic

FDA

HLA - DRB1

81377, 81383

lapatinib

Tykerb

Antineoplastic

FDA

IFNL3

81283

peginterferon alfa - 2a, peginterferon alfa - 2b

Pegasys, Pegasys ProClick, PegIntron, Sylatron

Antiviral, HCV

CPIC

NAT2

81479

procainamide

Procan, Pronestyl

Antiarrhythmic

FDA

NAT2

81479

sulfamethoxazole / trimethoprim

Bactrim

Antibacterial

FDA

NAT2

81479

isoniazid

Niazid

Antitubercular

FDA

NAT2

81479

sulfasalazine

Azulfidine

Disease-Modifying Antirheumatic Drug (DMARD): Other - inflammatory bowel agent

FDA

NAT2

81479

amifampridine, amifampridine phosphate

Ruzurgi, Firdapse

Multiple sclerosis

FDA

NUDT15

81306

azathioprine, mercaptopurine, thioguanine

Azasan, Purixan, Tabloid

Antineoplastic

CPIC/FDA

RYR1

81406

desflurane, enflurane, halothane, isoflurane, methoxyflurane, sevoflurane, succinylcholine

Suprane, Ethrane, Fluothane, Forane, Penthrox, Ultane, Anectine, Quelicin

Volatile anesthetic

CPIC

SLCO1B1

81328

simvastatin

FloLipid, Zocor

Antihyperlipidemic

CPIC/FDA

TPMT

81335, 0034U, 0286U

azathioprine, mercaptopurine, thioguanine

Azasan, Purixan, Tabloid

Antineoplastic

CPIC/FDA

UGT1A1

81350

belinostat, irinotecan, nilotinib, pazopanib, Sacituzumab Govitecan - ziy

Beleodaq, Camptosar, Tasigna, Votrient, Trodelvy

Antineoplastic

FDA

UGT1A1

81350

atazanavir

Reyataz

Antiretroviral, HIV

CPIC

VKORC1

81355

warfarin

Jantoven, Coumadin

Anticoagulant

CPIC/FDA

 

Covered multigene panels with intended uses
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.

Test name

Company

Intended Use

Genesight

Assurex health

Major Depressive Disorder (MDD) or Neuropsychiatric

Genomind Professional PGx Express™

Genomind, Inc.

Neuropsychiatric

NeuroIDgenetix

AltheaDx

Major Depressive Disorder (MDD) or Neuropsychiatric

Neuropharmagen

Precision Molecular Solutions

Neuropsychiatric

Psychotropic Pharmacogenomic Gene Panel

Mayo Clinic Laboratories

Neuropsychiatric

 

ICD-10 codes associated with intended uses

Intended Use

ICD-10 codes

Description

MDD

F32.1

Major depressive disorder, single episode, moderate

MDD

F32.2

Major depressive disorder, single episode, severe without psychotic features

MDD

F32.3

Major depressive disorder, single episode, severe with psychotic features

MDD

F32.4

Major depressive disorder, single episode, in partial remission

MDD

F33.1

Major depressive disorder, recurrent, moderate

MDD

F33.2

Major depressive disorder, recurrent severe without psychotic features

MDD

F33.3

Major depressive disorder, recurrent, severe with psychotic symptoms

MDD

F33.41

Major depressive disorder, recurrent, in partial remission

Neuropsychiatric

F20.0 Paranoid schizophrenia

Neuropsychiatric

F20.1 Disorganized schizophrenia

Neuropsychiatric

F20.2 Catatonic schizophrenia

Neuropsychiatric

F20.3 Undifferentiated schizophrenia

Neuropsychiatric

F20.5 Residual schizophrenia

Neuropsychiatric

F20.81 Schizophreniform disorder

Neuropsychiatric

F20.89 Other schizophrenia

Neuropsychiatric

F31.0 Bipolar disorder, current episode hypomanic

Neuropsychiatric

F31.11 Bipolar disorder, current episode manic without psychotic features, mild

Neuropsychiatric

F31.12 Bipolar disorder, current episode manic without psychotic features, moderate

Neuropsychiatric

F31.13 Bipolar disorder, current episode manic without psychotic features, severe

Neuropsychiatric

F31.2 Bipolar disorder, current episode manic severe with psychotic features

Neuropsychiatric

F31.31 Bipolar disorder, current episode depressed, mild

Neuropsychiatric

F31.32 Bipolar disorder, current episode depressed, moderate

Neuropsychiatric

F31.4 Bipolar disorder, current episode depressed, severe, without psychotic features

Neuropsychiatric

F31.5 Bipolar disorder, current episode depressed, severe, with psychotic features

Neuropsychiatric

F31.61 Bipolar disorder, current episode mixed, mild

Neuropsychiatric

F31.62 Bipolar disorder, current episode mixed, moderate

Neuropsychiatric

F31.63 Bipolar disorder, current episode mixed, severe, without psychotic features

Neuropsychiatric

F31.64 Bipolar disorder, current episode mixed, severe, with psychotic features

Neuropsychiatric

F31.71 Bipolar disorder, in partial remission, most recent episode hypomanic

Neuropsychiatric

F31.73 Bipolar disorder, in partial remission, most recent episode manic

Neuropsychiatric

F31.75 Bipolar disorder, in partial remission, most recent episode depressed

Neuropsychiatric

F31.77 Bipolar disorder, in partial remission, most recent episode mixed

Neuropsychiatric

F40.11 Social phobia, generalized

Neuropsychiatric

F41.0 Panic disorder [episodic paroxysmal anxiety]

Neuropsychiatric

F41.1 Generalized anxiety disorder

Neuropsychiatric

F41.3 Other mixed anxiety disorders

Neuropsychiatric

F41.8 Other specified anxiety disorders

Neuropsychiatric

F43.11 Post-traumatic stress disorder, acute

Neuropsychiatric

F43.12 Post-traumatic stress disorder, chronic

Neuropsychiatric

F60.5 Obsessive-compulsive personality disorder

Neuropsychiatric

F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type

Neuropsychiatric

F90.1 Attention-deficit hyperactivity disorder, predominantly hyperactive type

Neuropsychiatric

F90.2 Attention-deficit hyperactivity disorder, combined type

Neuropsychiatric

F90.8 Attention-deficit hyperactivity disorder, other type

Coding Information

CPT/HCPCS Codes

Group 1

(32 Codes)
Group 1 Paragraph

CPT® code 81479 is used to describe multi-gene panels and single genes not otherwise classified.

Group 1 Codes
CodeDescription
81220 CFTR (CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR) (EG, CYSTIC FIBROSIS) GENE ANALYSIS; COMMON VARIANTS (EG, ACMG/ACOG GUIDELINES)
81225 CYP2C19 (CYTOCHROME P450, FAMILY 2, SUBFAMILY C, POLYPEPTIDE 19) (EG, DRUG METABOLISM), GENE ANALYSIS, COMMON VARIANTS (EG, *2, *3, *4, *8, *17)
81226 CYP2D6 (CYTOCHROME P450, FAMILY 2, SUBFAMILY D, POLYPEPTIDE 6) (EG, DRUG METABOLISM), GENE ANALYSIS, COMMON VARIANTS (EG, *2, *3, *4, *5, *6, *9, *10, *17, *19, *29, *35, *41, *1XN, *2XN, *4XN)
81227 CYP2C9 (CYTOCHROME P450, FAMILY 2, SUBFAMILY C, POLYPEPTIDE 9) (EG, DRUG METABOLISM), GENE ANALYSIS, COMMON VARIANTS (EG, *2, *3, *5, *6)
81231 CYP3A5 (CYTOCHROME P450 FAMILY 3 SUBFAMILY A MEMBER 5) (EG, DRUG METABOLISM), GENE ANALYSIS, COMMON VARIANTS (EG, *2, *3, *4, *5, *6, *7)
81232 DPYD (DIHYDROPYRIMIDINE DEHYDROGENASE) (EG, 5-FLUOROURACIL/5-FU AND CAPECITABINE DRUG METABOLISM), GENE ANALYSIS, COMMON VARIANT(S) (EG, *2A, *4, *5, *6)
81247 G6PD (GLUCOSE-6-PHOSPHATE DEHYDROGENASE) (EG, HEMOLYTIC ANEMIA, JAUNDICE), GENE ANALYSIS; COMMON VARIANT(S) (EG, A, A-)
81283 IFNL3 (INTERFERON, LAMBDA 3) (EG, DRUG RESPONSE), GENE ANALYSIS, RS12979860 VARIANT
81306 NUDT15 (NUDIX HYDROLASE 15) (EG, DRUG METABOLISM) GENE ANALYSIS, COMMON VARIANT(S) (EG, *2, *3, *4, *5, *6)
81328 SLCO1B1 (SOLUTE CARRIER ORGANIC ANION TRANSPORTER FAMILY, MEMBER 1B1) (EG, ADVERSE DRUG REACTION), GENE ANALYSIS, COMMON VARIANT(S) (EG, *5)
81335 TPMT (THIOPURINE S-METHYLTRANSFERASE) (EG, DRUG METABOLISM), GENE ANALYSIS, COMMON VARIANTS (EG, *2, *3)
81350 UGT1A1 (UDP GLUCURONOSYLTRANSFERASE 1 FAMILY, POLYPEPTIDE A1) (EG, DRUG METABOLISM, HEREDITARY UNCONJUGATED HYPERBILIRUBINEMIA [GILBERT SYNDROME]) GENE ANALYSIS, COMMON VARIANTS (EG, *28, *36, *37)
81355 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
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
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)
0034U TPMT (THIOPURINE S-METHYLTRANSFERASE), NUDT15 (NUDIX HYDROXYLASE 15)(EG, THIOPURINE METABOLISM), GENE ANALYSIS, COMMON VARIANTS (IE, TPMT *2, *3A, *3B, *3C, *4, *5, *6, *8, *12; NUDT15 *3, *4, *5)
0070U CYP2D6 (CYTOCHROME P450, FAMILY 2, SUBFAMILY D, POLYPEPTIDE 6) (EG, DRUG METABOLISM) GENE ANALYSIS, COMMON AND SELECT RARE VARIANTS (IE, *2, *3, *4, *4N, *5, *6, *7, *8, *9, *10, *11, *12, *13, *14A, *14B, *15, *17, *29, *35, *36, *41, *57, *61, *63, *68, *83, *XN)
0071U 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

CPT/HCPCS Modifiers

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(44 Codes)
Group 1 Paragraph

The following codes are for reference use only and are not to imply medical necessity or lack of medical necessity.

Group 1 Codes
CodeDescription
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-CM Codes that DO NOT Support Medical Necessity

N/A

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.

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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.

N/A

Other Coding Information

N/A

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
01/01/2023 R11

Posted 01/26/2023 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 01/01/2023.

12/29/2022 R10

Posts 12/29/2022 Under Article Text revised Table 1 to add new row for HLA-A for tebentafusp. This revision is retroactive effective for dates of service on or after 08/03/2022.

10/01/2022 R9

Posted 10/27/2022: Under CPT/HCPCS Codes Group 1: Codes, added 0345U. Typographical errors were corrected throughout the article. This revision is due to Q4 2022 CPT®/HCPCS Code Update and is effective for dates of service on or after 10/01/2022.

06/30/2022 R8

Posted 06/30/2022- Under Article Text, revised Table 2 to add the verbiage, "or Neuropsychiatric" to NeuroIDgenetix intended use. 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.Review completed 05/27/2022.

01/01/2022 R7

Posted 01/27/2022-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 01/01/2022. Under CPT/HCPCS Codes Group 1: Codes added 0286U. This revision is due to the 2022 Annual CPT®/HCPCS Code Update and is effective 01/01/2022.

08/23/2021 R6

08/23/2021 - Added Generic Name tacrolimus for Gene CYP3A5 that was omitted in error, in Table 1 of Article Text.

08/23/2021 R5

08/23/2021 Corrected and removed text/typo in Article Text section that allowed table coding to appear as text in Article.

08/23/2021 R4

12/30/2021-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):

  1. More than one gene is reasonable and necessary for the safe use of the drug being considered or in use; or
  2. 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 R3

04/01/2021 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 unspecified dx codes F32.9, F33.40, F33.9. This revision is retroactive effective for dates of service on or after 1/1/2021. Reviewed on 03/03/2021.

07/26/2020 R2

10/02/2020 - Corrected codes in "Table 1. Current CPIC guidelines as of July 15, 2020." for HLA-B pazopanib Votrient

07/26/2020 R1

10/01/2020-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.

Associated Documents

Related National Coverage Documents
NCDs
90.1 - Pharmacogenomic Testing for Warfarin Response
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
01/20/2023 01/01/2023 - N/A Currently in Effect You are here
12/22/2022 12/29/2022 - 12/31/2022 Superseded View
10/18/2022 10/01/2022 - 12/28/2022 Superseded View
06/23/2022 06/30/2022 - 09/30/2022 Superseded View
01/21/2022 01/01/2022 - 06/29/2022 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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