Article - Billing and Coding: Pharmacogenomics Testing (A58801)

CMS National Coverage PolicyInternet Only Manuals (IOMs):CMS IOM Publication 100-03,Medicare National Coverage Determinations (NCD) Manual,Chapter 1, Part 2, Section 90.1 Pharmacogenomic Testing to Predict Warfarin ResponsivenessCMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 1, Section 60 Provider Billing of Non-covered Charges on Institutional ClaimsChapter 16 Laboratory ServicesChapter 23, Section 20.9 National Correct Coding Initiative (NCCI), Section 20.9.1.1 Instructions for Codes With Modifiers (A/B MACs (B) Only) andSection 40 Clinical Diagnostic Laboratory Fee ScheduleNational Correct Coding Initiative (NCCI):NCCI Policy Manual for Medicare Services,Chapter 10 Pathology/Laboratory Services, (A) Introduction and (F) Molecular PathologySocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period.Title XVIII of the Social Security Act, Section 1834A(d) This section addresses payment for new advanced diagnostic laboratory tests.Code of Federal Register (CFR) References:CFR, Title 42, Volume 3, Chapter IV, Part 414.50 Physician or other supplier billing for diagnostic tests performed or interpreted by a physician who does not share a practice with the billing physician or other supplier.CFR, Title 42, Volume 3, Chapter IV, Part 414, Subpart G Payment for Clinical Diagnostic Laboratory Tests.Article TextThis Billing and Coding Article provides billing and coding guidance for Local Coverage Determination (LCD) L39063 Pharmacogenomics Testing. Please refer to the LCD for reasonable and necessary requirements.Laboratory tests that investigate the same germline genetic content, for the same genetic information, that has already been tested in the same Medicare beneficiary is duplicative and should not be reported.Examples of germline tests include (but are not limited to) single gene and specific gene panel tests for: hereditary cancer syndromes or cancer predisposition, inherited disorders, and pharmacogenomics/cytochrome P450 testing.Providers should take reasonable measures to be aware of what, if any, germline testing a beneficiary has had prior to billing for germline testing so as to avoid billing Medicare for services that are not medically reasonable and necessary. Clinicians who order germline testing may wish to be aware of whether the test that they are ordering is covered under Medicare and may wish to verify that they are not ordering repeat germline testing.Germline testing, including panels containing some genetic content already tested in the same Medicare beneficiary, may be considered medically reasonable and necessary if there is established clinical utility in the remaining, non-duplicative genetic components of the test.Coding GuidanceNotice:It is not appropriate to bill Medicare for services that are not covered (as described by the entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.CPT codes 81355 (VKORC1) and 81227 (CYP2C9) are not considered medically reasonable and necessary for warfarin testing. Please refer to the CMS IOM Publication 100-03,Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 2, Section 90.1 Pharmacogenomic Testing to Predict Warfarin Responsiveness.If a treating clinician orders a single gene test or a test for a particular allele(s), but as a matter of operational practicality, the laboratory tests that single gene or allele on a platform that looks for variants in other genes/alleles as well, that particular test done in that particular instance is considered a single gene/allele test for coverage purposes. In this scenario the provider may bill for the component of the test that was medically reasonable and necessary (in this example, the single gene test).Genes can be assayed serially or in parallel. Genes assayed on the same date of service are considered to be assayed in parallel if the result of one assay does not affect the decision to complete the assay on another gene, and the two genes are being tested for the same indication. Genes assayed on the same date of service are considered to be assayed serially when there is a reflexive decision component where the results of the analysis of one or more genes determines whether the results of additional analyses are medically reasonable and necessary. If two or more genes are tested, please refer to the Molecular Pathology and Genetic Testing Article A58917 for multi-gene testing.When billing 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.When billingCPT code 81418, the following information should be provided:List the names of the specific genes that are tested in addition to genes CYP2C19 and CYP2D6 in the comment/narrative field for the following claim field/types:Part A Claims:Loop SV202-7 for the 837I electronic claimBlock 80 for the UB04 claim formPart B Claims:Loop 2400 or SV101-7 for the 5010A1 837PBox 19 for the paper claimNOTE:TestingMUSTbe for at least 6 genesper the CPT code descriptor for 81418: Drug metabolism (e.g., pharmacogenomics) genomic sequence analysis panel, must include testing of at least 6 genes, including CYP2C19, CYP2D6, and CYP2D6 duplication/deletion analysisThe following 2 tables represent relevant gene/drug associations. Table 1 is from CPIC and Table 2 is from FDA sources.Table 1.Current CPIC guidelines as of October 26, 2022:Gene/TestCPT CodeIntended use for DrugBrand NameCFTR81220ivacaftorKalydecoCYP2B681479, 0392U, 0423Uefavirenz, sertralineSustiva, ZoloftCYP2C1981225, 81418, 0423Uclopidogrel, voriconazolePlavix, VfendCYP2C1981225, 81418, 0423UPPIs (class): omeprazole, lansoprazole, pantoprazole, dexlansoprazolePrilosec, Prevacid, Protonix, DexilantCYP2C1981225, 81418, 0423USSRIs (class): citalopram, escitalopram, fluvoxamine, paroxetine, sertralineCelexa, Lexapro, Luvox, Paxil, ZoloftCYP2C1981225, 81418, 0423UTricyclic antidepressants (class): amitriptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, trimipramineAnafranil, Norpramin, Silenor,Pamelor, SurmontilCYP2C981227, 0423Uphenytoin, fosphenytoinDilantin, CerebyxCYP2C981227, 0423UwarfarinJantoven, CoumadinCYP2C981227, 0423UNSAIDs (class): celecoxib, flurbiprofen, ibuprofen, lornoxicam, meloxicam, piroxicam, tenoxicamCelebrex, Ocufen, Chlortenoxicam, Mobic, Feldene, MobiflexCYP2C981227, 0423UfluvastatinLescolHLA-B81381, 81374, 0423Uabacavir, allopurinol, oxcarbazepine, phenytoin, carbamazepine, fosphenytoinZiagen, Zyloprim, Aloprim, Trileptal, Oxtellar, Dilantin, Tegretol, CerebyxCYP4F281479warfarinJantoven, CoumadinVKORC181355warfarinJantoven, CoumadinCYP2D681226, 81418, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U, 0423Uatomoxetine, codeine, ondansetron, tropisetron, tamoxifen, tramadol, hydrocodoneStrattera, Zofran, Soltamox, UltramCYP2D681226, 81418, 0392U, 0423UvenlafaxineEffexorCYP2D681226, 81418, 0392U, 0423UvortioxetineTrintellixCYP2D681226, 81418, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U, 0423USSRIs (class): citalopram, escitalopram, fluvoxamine, paroxetine, sertralineCelexa, Lexapro, Luvox, Paxil, ZoloftCYP2D681226, 81418, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U, 0423UTricyclic antidepressants (class): amitriptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, trimipramineAnafranil, Norpramin, Silenor,Pamelor, SurmontilCYP3A581231, 0423UtacrolimusPrograf, ProtopicDPYD81232Fluoropyrimidines (class): fluorouracil, capecitabineAdrucil, XelodaG6PD81247rasburicaseElitekG6PD81247dapsone, methylene blue, nitrofurantoin, pegloticase, primaquine, tafenoquineAczone, Provayblue, Furadantin, Macrobid, Macrodantin, Krystexxa, Primaquine, Arakoda, KrintafelHLA-A81381, 81374, 0423UcarbamazepineTegretolIFNL381283peginterferon alfa-2a, peginterferon alfa-2bPegasys, Pegintron, SylatronIFNL481479peginterferon alfa-2a, peginterferon alfa-2bPegasys, Pegintron, SylatronRYR181406Volatile anesthetics (class): desflurane, enflurane, halothane, isoflurane, methoxyflurane, sevoflurane, succinylcholineSuprane, Ethrane, Fluothane, Forane, Penthrox, Ultane, Anectine, QuelicinCACNA1S81479Volatile anesthetics (class): desflurane, enflurane, halothane, isoflurane, methoxyflurane, sevoflurane, succinylcholineSuprane, Ethrane, Fluothane, Forane, Penthrox, Ultane, Anectine, QuelicinSLCO1B181328, 0423UStatins (class): simvastatin, pravastatin, atorvastatin, lovastatin, rosuvastatin, fluvastatin, pitavastatinZocor, FloLipid, Pravachol, Lipitor, Altoprev, Crestor, Lescol, LivaloNUDT1581306, 0286UThiopurines (class): mercaptopurine, azathioprine, thioguaninePurixan, Azasan, TabloidTPMT81335Thiopurines (class): mercaptopurine, azathioprine, thioguaninePurixan, Azasan, TabloidUGT1A181350atazanavirReyatazMT-RNR181401Aminoglycosides (class): gentamicin, amikacin, paromomycin, streptomycin, plazomicin, tobramycin