SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: Pharmacogenomics Testing

A57384

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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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Source Article ID
N/A
Article ID
A57384
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: Pharmacogenomics Testing
Article Type
Billing and Coding
Original Effective Date
08/17/2020
Revision Effective Date
10/01/2023
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 lacking the necessary documentation 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 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.

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.

 

Gene

CPT Code(s)

Generic Name

Trade Name(s)

Intended use for Drug(s)

Guidance

ABCG2

81479

rosuvastatin

Crestor

Antihyperlipidemic

CPIC

BCHE

81479

mivacurium, succinylcholine

Mivacurium chloride, Anectine

Neuromuscular blocking agent

FDA

CYP2B6

81479

efavirenz

Sustiva

Antiretroviral; HIV

CPIC/FDA

CYP2B6

81479

sertraline

Zoloft

Antidepressant-Selective Serotonin Reuptake Inhibitor (SSRI)

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

belzutifan

Wellireg

Antineoplastic

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

CYP2C19

81225

abrocitinib

Cibingo

Selective Immunosuppressant

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

nateglinide

Starlix

Antihyperglycemic

FDA

CYP2C9

81227

fluvastatin

Lescol

Antihyperlipidemic

CPIC

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, Dyanavel 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

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

SLCO1B1

81328

simvastatin, artorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin

FloLipid, Zocor, Lipitor, Lescol, Mevacor, Altoprev, Altocor, Livalo, Zypitamag, Pravachol, Crestor

Antihyperlipidemic

CPIC/FDA

TPMT

81335, 0034U, 0286U

azathioprine, mercaptopurine, thioguanine

Azasan, Purixan, Tabloid

Antineoplastic

CPIC/FDA

UGT1A1

81350

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

Beleodaq, Camptosar, Tasigna, Votrient, Trodelvy

Antineoplastic

FDA

UGT1A1

81350

atazanavir

Reyataz

Antiretroviral, HIV

CPIC

UGT2B17

81479

belzutifan

Welireg

Antineoplastic

FDA

VKORC1

81355

warfarin

Jantoven, Coumadin

Anticoagulant

CPIC/FDA

Table 2 represents other relevant gene/drug associations that are not related to metabolism from CPIC and FDA sources. 

Table 2. This table represents other relevant therapeutic gene/drug associations from CPIC and FDA sources. 
Gene CPT Code(s) Generic Name Trade Name(s) Intended use for Drug(s) Guidance

APOE

81401 lecanemab Leqembi Alzheimer’s Disease FDA
CACNA1S 81479 desflurane, enflurane, halothane, isoflurane, methoxyflurane, sevoflurane, succinylcholine Suprane, Ethrane, Fluothane, Forane, Penthrox, Ultane, Anectine, Quelicin Volatile anesthetic

CPIC

G6PD

81247

rasburicase, pegloticase

Elitek, Krystexxa

Hyperuricemia

CPIC

G6PD

81247

dapsone

Accone, Avlosulfon

Antibacterial

CPIC

G6PD

81247

primaquine, tafenoquine

Jasoprim, Arakoda

Antimalarial

CPIC

HLA - A

81381

tebentafusp

Kimmtrak

Antineoplastic

FDA

HLA - A

81381, 81374

carbamazepine

Tegretol

Anticonvulsant

CPIC/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

 

RYR1

81406

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

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

Volatile anesthetic

CPIC

Covered multigene panels with intended uses

Panels with a specific intended use such as major depressive disorder (MDD) or neuropsychiatric must include relevant ICD-10 codes.

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

 

Response To Comments

Number Comment Response
1
N/A

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

(34 Codes)
Group 1 Paragraph

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

Group 1 Codes
Code Description
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
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
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
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
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CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

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Group 1 Codes

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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
Code Description
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
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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
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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.

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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
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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
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):

  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: 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.

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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
L38335 - MolDX: Pharmacogenomics Testing
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
01/19/2024 01/25/2024 - N/A Currently in Effect View
11/22/2023 10/01/2023 - 01/24/2024 Superseded View
10/10/2023 10/01/2023 - N/A Superseded You are here
09/14/2023 09/21/2023 - 09/30/2023 Superseded View
04/12/2023 04/20/2023 - 09/20/2023 Superseded View
01/06/2023 01/01/2023 - 04/19/2023 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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