LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: Pharmacogenomics Testing

A58324

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
CGS Administrators, LLC	MAC - Part A	15101 - MAC A	J - 15	Kentucky
CGS Administrators, LLC	MAC - Part B	15102 - MAC B	J - 15	Kentucky
CGS Administrators, LLC	MAC - Part A	15201 - MAC A	J - 15	Ohio
CGS Administrators, LLC	MAC - Part B	15202 - MAC B	J - 15	Ohio

Article Information

General Information

Article ID
A58324

Article Title
Billing and Coding: MolDX: Pharmacogenomics Testing

Article Type
Billing and Coding

Original Effective Date
08/03/2020

Revision Effective Date
01/25/2024

Revision Ending Date
N/A

Retirement Date
N/A

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

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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 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. 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.

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 Express™	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

Response To Comments

Number	Comment	Response
1

Coding Information

Bill Type Codes

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Revenue Codes

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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

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Group 1

Group 1 Paragraph

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

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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

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

N/A

ICD-10-PCS Codes

N/A

Additional ICD-10 Information

N/A

Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

Code	Description
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Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

Code	Description
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Other Coding Information

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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
			N/A	N/A

Non-Excluded CPT/HCPCS Ended Codes - Table Format

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

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation
01/25/2024	R16	R16 Revision Effective: 01/25/2024 Revision Explanation: 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.
11/16/2023	R15	R15 Revision Effective: 11/16/2023 Revision Explanation: Updated LCD Reference Article section.
10/01/2023	R14	R14 Revision Effective: 10/01/2023 Revision Explanation: 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	R13	R13 Revision Effective: NA Revision Explanation: Corrected paragraph for billing instructions on how to space drug names to show to use _ instead of /. This was updated in revsion 12 in error to show to use the /.
09/21/2023	R12	R12 Revision Effective: 09/21/2023 Revision Explanation: Under *Article Text* subheading Billing Instructions revised 1^st bullet to read “Select the appropriate CPT^®or PLA code”. Revised 3^rd and 6^th 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	R11	R11 Revision Effective: 04/20/2023 Revision Explanation: 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	R10	R10 Revision Effective: 01/01/2023 Revision Explanation: 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	R9	R9 Revision Effective: 12/07/2022 Revision Explanation: 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 8/3/2022.
10/01/2022	R8	R8 Revision Effective: 10/01/2022 Revision Explanation: 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	R7	R7 Revision Effective: 04/29/2022 Revision Explanation: Updated to us underscore instead of forward slash to separate drug names.
06/16/2022	R6	R6 Revision Effective: 04/29/2022 Revision Explanation: 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	R5	R5 Revision Effective: 04/28/2022 Revision Explanation: Under *Article Text,* revised Table 2 to add the verbiage, "or Neuropsychiatric."
01/01/2022	R4	R4 Revision Effective 01/01/2022 Revison Explanation: 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	R3	R3 Revision Effective 08/23/2021 Revison Explanation: 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	R2	R2 Revision Effective Date: 01/01/2021 Revision Explanation: 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.
08/03/2020	R1	Revision Effective Date: 07/26/2020 Revision Explanation: Under *Article Text* added the statement "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.", corrected discrepancies within the tables and added the following 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. Under *ICD-10 Codes that Support Medical Necessity – Group 1: Paragraph* added the statement “The following codes are for reference use only and are not to imply medical necessity or lack of medical necessity.” 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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L38394 - MolDX: Pharmacogenomics Testing

Updated On	Effective Dates	Status
01/19/2024	01/25/2024 - N/A	Currently in Effect	You are here
11/10/2023	11/16/2023 - 01/24/2024	Superseded	View
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Billing and Coding: MolDX: Pharmacogenomics Testing

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