Article - Billing and Coding: MolDX: Pharmacogenomics Testing (A57385)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1833(e), prohibits Medicare payment for any claim lacking the necessary documentation to process the claim.Article TextThe information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Pharmacogenomics Testing L38337Relevant 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 A58121Billing and Coding: MolDX: Repeat Germline Testing A57332Additional 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 of PLA codeEnter 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 837PItem 19 for paper claimEnter 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 claimBlock 80 for the UB04 claim formSelect the appropriate ICD-10-CM codeFor 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 informationTable 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.GeneCPT Code(s)Generic NameTrade Name(s)Intended use for Drug(s)GuidanceABCG281479rosuvastatinCrestorAntihyperlipidemicCPICBCHE81479mivacurium, succinylcholineMivacurium chloride, AnectineNeuromuscular blocking agentFDACYP2B681479efavirenzSustivaAntiretroviral; HIVCPIC/FDACYP2B681479sertralineZoloftAntidepressant-Selective Serotonin Reuptake Inhibitor (SSRI)CPIC/FDACYP2C1981225brivaracetam, clobazamBriviact, OnfiAnticonvulsantFDACYP2C1981225citalopram, escitalopram, sertralineCelexa, Lexapro, ZoloftAntidepressant - Selective Serotonin Reuptake Inhibitor (SSRI)CPIC/FDACYP2C1981225amitriptyline, clomipramine, doxepin, imipramine, trimipramineElavil, Anafranil, Silenor, Tofranil, SurmontilAntidepressant - TricyclicCPICCYP2C1981225voriconazoleVfendAntifungalCPIC/FDACYP2C1981225belzutifanWeliregAntineoplasticFDACYP2C1981225flibanserinAddyiMixed serotonin agonistFDACYP2C1981225clopidogrelPlavixPlatelet aggregation inhibitorCPIC/FDACYP2C1981225dexlansoprazole, lansoprazole, omeprazole, pantoprazoleDexilant, Prevacid, Prilosec, ProtonixProton Pump Inhibitor (PPI)CPIC/FDACYP2C1981225abrocitinibCibingoSelective ImmunosuppressantFDACYP2C981227warfarinJantoven, CoumadinAnticoagulantCPIC/FDACYP2C981227fosphenytoin, phenytoinCerebyx, DilantinAnticonvulsantCPIC/FDACYP2C981227dronabinolMarinol, SyndrosAntiemeticFDACYP2C981227nateglinideStarlixAntihyperglycemicFDACYP2C981227fluvastatinLescolAntihyperlipidemicCPICCYP2C981227erdafitinibBalversaFGFR kinase inhibitor, bladder cancerFDACYP2C981227siponimodMayzentMultiple sclerosisFDACYP2C981227celecoxib, flurbiprofen, lornoxicam, meloxicam, piroxicam, tenoxicamCelebrex, Ansaid, Ocufen, Chlortenoxicam, Xefo, Mobic, Vivlodex, Anjeso, Qmiiz ODT, Feldene, MobiflexNon-steroidal anti-inflammatory (NSAID)CPIC/FDACYP2D681226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076UcarvedilolCoregAlpha - Beta blockerFDACYP2D681226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076UpropafenoneRythmolAntiarrhythmicFDACYP2D681226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076Ufluvoxamine, paroxetine, venlafaxine, vortioxetineLuvox, Paxil, Effexor XR, Brintellix, TrintellixAntidepressant  Selective Serotonin Reuptake Inhibitor (SSRI)CPIC/FDACYP2D681226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076Uamitriptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, trimipramineElavil, Anafranil, Norpramin, Silenor, Tofranil, Aventyl, Pamelor, SurmontilAntidepressant - TricyclicCPICCYP2D681226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076Umeclizine, ondansetron, tropisetronAntivert, Zofran ODT, TropisetronAntiemeticCPIC/FDACYP2D681226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076Ugefitinib, tamoxifenIressa, Soltamox, NolvadexAntineoplasticCPIC/FDACYP2D681226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076Uaripiprazole, aripiprazole lauroxil, brexpiprazole, clozapine, iloperidone, perphenazine, pimozide, thioridazineAbilify, Aristada, Rexulti, Clozaril, FazaClo, Versacloz, Fanapt, Trilafon, Orap, MellarilAntipsychoticFDACYP2D681226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076Uamphetamine, atomoxetineAdzenys ER, Dyanavel XR, Adderall, StratteraAttention Deficit - Hyperactivity (ADHD) TherapyCPIC/FDACYP2D681226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076UmetoclopramideReglanGastrointestinal prokinetic agentFDACYP2D681226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076UeliglustatCerdelgaGaucher's diseaseFDACYP2D681226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076Udeutetrabenazine, tetrabenazineAustedo, XenazineMovement disorder therapyFDACYP2D681226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076UpitolisantWakixNarcolepsy therapy agentFDACYP2D681226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076Ucodeine, oliceridine, tramadolOlinvyk, UltramOpioidCPIC/FDACYP2D681226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076UlofexidineLucemyraOpioid withdrawalFDACYP2D681226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076UcevimelineEvoxacSaliva stimulantFDACYP2D681226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076UtolterodineDetrolUrinary antispasmodicFDACYP2D681226, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076UvalbenazineIngrezzaVMAT2 inhibitorFDACYP3A581231tacrolimusPrografAntirejectionCPIC/FDACYP4F281479warfarinJantoven, CoumadinAnticoagulantCPIC/FDADPYD81232