evekhm/cms_iom_500 huggingface dataset:
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.
Article - Billing and Coding: Pharmacogenomics Testing (A58801)
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).
Article - Billing and Coding: Pharmacogenomics Testing (A58801)
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, voriconazole
Article - Billing and Coding: Pharmacogenomics Testing (A58801)
efavirenz, 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, CerebyxCYP4F281479warfarin
Article - Billing and Coding: Pharmacogenomics Testing (A58801)
Ziagen, 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, XelodaG6PD81247
Article - Billing and Coding: Pharmacogenomics Testing (A58801)
tacrolimusPrograf, 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, 0286U
Article - Billing and Coding: Pharmacogenomics Testing (A58801)
Zocor, 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, tobramycinArikayce, ZemdriABCG20193U, 0423UrosuvastatinCrestorTable 2.Table ofPHARMACOGENOMICassociationsfrom the FDA for which the data support therapeutic recommendations or a potential impact on safety or response (last updated October 26, 2022):GeneCPT CodeDrugBrand NameAffected Subgroups+BCHE81479mivacuriumMivacurium chlorideintermediate or poor metabolizersBCHE81479succinylcholineAnectineintermediate or poor metabolizersCYP2B681479, 0423UefavirenzSustivapoor metabolizersCYP2C1981225, 81418, 0423UbrivaracetamBriviactintermediate or poor metabolizersCYP2C1981225, 81418, 0423UcitalopramCelexapoor metabolizersCYP2C1981225, 81418, 0423UclobazamOnfiintermediate or poor metabolizersCYP2C1981225, 81418, 0423UclopidogrelPlavixintermediate or poor metabolizersCYP2C1981225, 81418, 0423UflibanserinAddyipoor metabolizersCYP2C1981225, 81418, 0423UpantoprazoleProtonixIntermediate or poor metabolizersCYP2C1981225, 81418, 0423U
Article - Billing and Coding: Pharmacogenomics Testing (A58801)
poor metabolizersCYP2C1981225, 81418, 0423UpantoprazoleProtonixIntermediate or poor metabolizersCYP2C1981225, 81418, 0423UvoriconazoleVfendintermediate or poor metabolizersCYP2C1981225, 81418, 0423UabrocitinibCibinqopoor metabolizersCYP2C1981225, 81418, 0423UmavacamtenCamzyosintermediate or poor metabolizersCYP2C19 and/or UGT2B1781225, 81418, 0423UbelzutifanCibinqopoor metabolizersCYP2C981227, 0423UcelecoxibCelebrexpoor metabolizers or *3 carriersCYP2C981227, 0423UdronabinolMarinolintermediate or poor metabolizersCYP2C981227, 0423UerdafitinibBalversa*3/*3 (poor metabolizers)CYP2C981227, 0423UflurbiprofenAnsaidpoor metabolizers or *3 carriersCYP2C981227, 0423UfosphenytoinCerebyxintermediate or poor metabolizersCYP2C981227, 0423UmeloxicamMobicpoor metabolizers or *3 carriersCYP2C981227, 0423Unateglinidepoor metabolizersCYP2C981227, 0423UphenytoinDilantinintermediate or poor metabolizersCYP2C981227, 0423UpiroxicamFeldeneintermediate or poor metabolizersCYP2C981227, 0423UsiponimodMayzentintermediate or poor metabolizersCYP2C981227, 0423UwarfarinCoumadinintermediate or poor metabolizersCYP2D681226, 81418, 0423UamphetamineAdderallpoor metabolizersCYP2D6
Article - Billing and Coding: Pharmacogenomics Testing (A58801)
warfarinCoumadinintermediate or poor metabolizersCYP2D681226, 81418, 0423UamphetamineAdderallpoor metabolizersCYP2D681226, 81418, 0423UaripiprazoleAbilifypoor metabolizersCYP2D681226, 81418, 0423Uaripiprazole lauroxilAristadapoor metabolizersCYP2D681226, 81418, 0423UatomoxetineStratterapoor metabolizersCYP2D681226, 81418, 0423UbrexpiprazoleRexultipoor metabolizersCYP2D681226, 81418, 0423UclozapineClozaril, FazaClo, Versaclozpoor metabolizersCYP2D681226, 81418, 0423Ucodeineultrarapid metabolizers, poor metabolizersCYP2D681226, 81418, 0423UdeutetrabenazineAustedopoor metabolizersCYP2D681226, 81418, 0423UeliglustatCerdelgaultrarapid, normal, intermediate, or poor metabolizersCYP2D681226, 81418, 0423UgefitinibIressapoor metabolizersCYP2D681226, 81418, 0423UIloperidoneFanaptpoor metabolizersCYP2D681226, 81418, 0423UlofexidineLucemyrapoor metabolizersCYP2D681226, 81418, 0423UmeclizineAntivertultrarapid, intermediate, or poor metabolizersCYP2D681226, 81418, 0423UmetoclopramideReglanpoor metabolizersCYP2D681226, 81418, 0423UpimozideOrappoor metabolizersCYP2D681226, 81418, 0423UpropafenoneRythmolpoor metabolizers
Article - Billing and Coding: Pharmacogenomics Testing (A58801)
pimozideOrappoor metabolizersCYP2D681226, 81418, 0423UpropafenoneRythmolpoor metabolizersCYP2D681226, 81418, 0423UtetrabenazineXenazinepoor metabolizersCYP2D681226, 81418, 0423UthioridazineMellarilpoor metabolizersCYP2D681226, 81418, 0423UtramadolUltramultrarapid metabolizers, or poor metabolizersCYP2D681226, 81418, 0423UvalbenazineIngrezzapoor metabolizersCYP2D681226, 81418, 0423UvenlafaxineEffexorpoor metabolizersCYP2D681226, 81418, 0423UvortioxetineTrintellixpoor metabolizersCYP2D681226, 81418, 0423UcarvedilolCoregpoor metabolizersCYP2D681226, 81418, 0423UcevimelineEvoxacpoor metabolizersCYP2D681226, 81418, 0423UperphenazineTrilafonpoor metabolizersCYP2D681226, 81418, 0423UtolterodineDetrolpoor metabolizersCYP2D681226, 81418, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U, 0423UoliceridineOlinvykpoor metabolizersCYP2D681226, 81418, 0070U, 0071U, 0072U, 0073U, 0074U, 0075U, 0076U, 0423UpitolisantWakixpoor metabolizersCYP3A581231, 0423UtacrolimusPrografintermediate or normal metabolizersCYP4F281479warfarinCoumadinV433M variant carriers
Article - Billing and Coding: Pharmacogenomics Testing (A58801)
CYP3A581231, 0423UtacrolimusPrografintermediate or normal metabolizersCYP4F281479warfarinCoumadinV433M variant carriersDPYD81232capecitabineXelodaintermediate or poor metabolizersDPYD81232fluorouracilFluoroplex, Tolak, Efudexintermediate or poor metabolizerHLA-A81381, 81374, 0423UcarbamazepineTegretol*31:01 allele positiveHLA-B81381, 81374, 0423UabacavirZiagen*57:01 allele positiveHLA-B81381, 81374, 0423UcarbamazepineTegretol*15:02 allele positiveHLA-B81381, 81374, 0423UfosphenytoinCerebyx*15:02 allele positiveHLA-B81381, 81374, 0423UallopurinolZyloprim, Aloprim*58:01 allele positiveHLA-B81381, 81374, 0423UoxcarbazepineTrileptal, Oxtellar*15:02 allele positiveHLA-B81381, 81374, 0423UpazopanibVotrient*57:01 allele positiveHLA-B81381, 81374, 0423UphenytoinDilantin*15:02 allele positiveHLA-DQA181383, 81377lapatinibTykerb*02:01 allele positiveHLA-DRB181383, 81377lapatinibTykerb*07:01 allele positiveNAT281479amifampridineFirdapse, Ruzurgipoor metabolizersNAT281479amifampridine phosphatepoor metabolizersNonspecific (NAT)81479isoniazidpoor metabolizersNonspecific (NAT)81479procainamidePronestyl, Procanpoor metabolizersNonspecific (NAT)81479sulfamethoxazole and trimethoprim
Article - Billing and Coding: Pharmacogenomics Testing (A58801)
Nonspecific (NAT)81479procainamidePronestyl, Procanpoor metabolizersNonspecific (NAT)81479sulfamethoxazole and trimethoprimSulfatrim, Bactrimpoor metabolizersNonspecific (NAT)81479sulfasalazineAzulfidinepoor metabolizersSLCO1B181328, 0423UsimvastatinFloLipid, Zocor521 TC or 521 CC (intermediate or poor function transporters)NUDT15 and/orTPMT81306, 81335, 0286UazathioprineImuran, Azasanintermediate or poor metabolizersNUDT15 and/orTPMT81306, 81335, 0286UmercaptopurinePurixan, Purinetholintermediate or poor metabolizersNUDT15 and/orTPMT81306, 81335, 0286UthioguanineTabloidintermediate or poor metabolizersUGT1A181350belinostatBeleodaq*28/*28 (poor metabolizers)UGT1A181350irinotecanCamptosar*1/*6, *1/*28 (intermediate metabolizers) or *6/*6, *6/*28, *28/*28 (poor metabolizers)UGT1A181350nilotinibTasigna*28/*28 (poor metabolizers)UGT1A181350pazopanibVotrient*28/*28 (poor metabolizers)UGT1A181350sacituzumabgovitecan-hziyTrodelvy*28/*28 (poor metabolizers)VKORC181355warfarinCoumadin-1639G>A variant carriersThe CPT codes relevant to the related LCD are listed in the coding section below. If no CPT code is available for the gene(s) being tested, the unlisted molecular pathology procedure code 81479 should be used as indicated below.Utilization ParametersGermline testing may be performed once in a lifetime per beneficiary.Documentation Requirements
Article - Billing and Coding: Pharmacogenomics Testing (A58801)
Utilization ParametersGermline testing may be performed once in a lifetime per beneficiary.Documentation RequirementsAll documentation must be maintained in the patient's medical record and made available to the contractor upon request.Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.The provider performing the service must have a record of what drug(s) is/are being considered and for what indication to ensure the test performed is medically reasonable and necessary.The clinical record must clearly show the use of or intent to prescribe a drug that has known drug-gene interactions that require a PGx test to be ordered to define the safe use of that drug in that patient.Coding InformationWhen more than two codes from this list are submitted for the same beneficiary on the same date of service, the claims processing system will deny every code submitted after the first two services. However, if a lab runs more than two distinct procedural services from this list on a single date of service, then the lab must use the 59 modifier with each additional service billed as an attestation that it is a distinct procedural service. Billing the 59 modifier may result in a request for medical records.The molecular pathology codes include all analytical services performed during the test (e.g., cell lysis, nucleic acid stabilization, extraction, digestion, amplification, and detection).
Article - Billing and Coding: Platelet Rich Plasma (A58808)
CMS National Coverage PolicyIOM Citations:CMS Internet-Only Manual, Publication 100-03,Medicare National Coverage Determinations (NCD) Manual,Chapter 1, Part 4, Section 270.3 Blood-Derived Products for Chronic Non-healing WoundsSocial 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.Article TextThis Billing and Coding Article provides billing and coding guidance forLocal Coverage Determination (LCD) L39068, Platelet Rich Plasma. Please refer to the LCD for reasonable and necessary requirements.Note:For coverage information regarding G0465, please refer to NCD 270.3, Blood-Derived Products for Chronic Non-Healing Wounds.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.All PRP and related services provided outside of NCD 270.3 guidelines will be denied.Documentation RequirementsAll documentation must be maintained in the patient's medical record and made available to the contractor upon request.Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
Article - Billing and Coding: Platelet Rich Plasma (A58810)
CMS National Coverage PolicyIOM Citations:CMS Internet-Only Manual, Publication 100-03,Medicare National Coverage Determinations (NCD) Manual,Chapter 1, Part 4, Section 270.3 Blood-Derived Products for Chronic Non-healing WoundsSocial 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.Article TextThis Billing and Coding Article provides billing and coding guidance for Local Coverage Determination (LCD) L39071, Platelet Rich Plasma. Please refer to the LCD for reasonable and necessary requirements.Note:For coverage information regarding G0465, please refer to NCD 270.3, Blood-Derived Products for Chronic Non-Healing Wounds.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.All PRP and related services provided outside of NCD 270.3 guidelines will be denied.Documentation RequirementsAll documentation must be maintained in the patient's medical record and made available to the contractor upon request.Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.