Billing and Coding: MolDX: Pharmacogenomics Testing

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX:
Pharmacogenomics Testing L38294.

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 A57503
  * Billing and Coding: MolDX: Repeat Germline Testing A58017

**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 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
    * 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. 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

|

Welireg

|

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

|

Cibinqo

|

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, atorvastatin, 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.

**Test Name** | **Company** | **Intended Use**  
---|---|---  
Genesight | Assurex Health | Major Depressive Disorder (MDD) or
Neuropsychiatric  
Genomind Professional PGx ExpressTM | Genomind, Inc. | Neuropsychiatric  
NeuroIDgenetix | AltheaDx | Major Depressive Disorder (MDD) or
Neuropsychiatric  
Neuropharmagen | Precision Molecular Solutions | Neuropsychiatric  
PGXPSYCH | PHD Laboratory LLC | Neuropsychiatric  
Psychotropic Pharmacogenomics 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