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Medical PolicyJoint Medical Policies are a source for BCBSM and BCN medical policy information only. These documentsare not to be used to determine benefits or reimbursement. Please reference the appropriate certificate orcontract for benefit information. This policy may be updated and is therefore subject to change.*Current Policy Effective Date: 4/19/22(See policy history boxes for previous effective dates)Title: CPT Category III Codes-Noncovered ServicesDescription/BackgroundCPT Category III codes are a set of temporary codes that allow data collection for emergingtechnology, services, and procedures. These codes are intended to be used for data collectionto substantiate widespread usage or to provide documentation for the Food and DrugAdministration (FDA) approval process. Category III codes are different from Category I CPTcodes in that they identify services that may not be performed by many health careprofessionals across the country, some may not have FDA approval, and someservices/procedure have no proven clinical efficacy.The inclusion of a service or procedure in this section neither implies nor endorses clinicalefficacy, safety, or the applicability to clinical practice.Regulatory StatusN/AMedical Policy StatementThe procedures, services and/or tests in this policy have been determined to beexperimental/investigational. They are not a covered benefit for all contracts that excludereimbursement for experimental/investigational services.1
Inclusionary and Exclusionary Guidelines (Clinically based guidelines that maysupport individual consideration and pre-authorization decisions)I.II.III.Governmental approval of a service will be considered in determining whether a serviceis experimental or investigational. The fact that a service has received governmentalapproval does not necessarily mean that it is of proven benefit or appropriate oreffective treatment for a particular diagnosis or for a particular condition.In determining whether there is rigorous scientific evidence to determine if a service isor is not experimental or investigational, we require that all of the following five criteriabe met:a. A service that is a medical device, drug, or biological product must have receivedfinal approval from the appropriate government regulatory bodies; such as theUnited States Food and Drug Administration (FDA). Any other approval grantedas an interim step in the FDA regulatory process (e.g., an Investigational DeviceExemption or an Investigational New Drug Exemption) is not sufficient.b. Published, peer-reviewed, medical literature must provide conclusive evidencethat the service has a definite, positive effect on health outcomes. The evidencemust include reports of well-designed investigations that have been reproducedby nonaffiliated, authoritative sources with measurable results, backed up by thepositive endorsements of national medical bodies or panels regarding scientificefficacy and rationale.c. Published, peer-reviewed, medical literature must provide demonstratedevidence that, over time, the service leads to improvement in health outcomes(e.g., the beneficial effects of the service outweigh any harmful effects).d. Published, peer-reviewed medical literature must provide proof that the service isat least as effective in improving health outcomes as established services ortechnologies or is usable in appropriate clinical contexts in which an establishedservice or technology is not employable.e. Published, peer-reviewed medical literature must provide proof that improvementin health outcomes is possible in standard conditions of medical practice, outsideof clinical investigatory settings.The Federal Employee Health Benefit Program (FEHBP/FEP) requires that procedures,devices or laboratory tests approved by the U.S. Food and Drug Administration (FDA)may not be considered investigational and thus these procedures, devices or laboratorytests may be assessed only based on their medical necessity.CPT/HCPCS Level II Codes (Note: The inclusion of a code in this list is not a guarantee ofcoverage. Please refer to the medical policy statement to determine the status of a given procedure.)Established codes:N/AOther codes (investigational, not medically necessary, etc.):Multiple2
Note: Code(s) may not be covered by all contracts or certificates. Please consult customer orprovider inquiry resources at BCBSM or BCN to verify coverage.RationaleThe use of a service, procedure or supply that is not recognized as standard medical care forthe condition, disease, illness or injury being treated is considered anexperimental/investigational service.A service is considered experimental/investigational if any of the following criteria aremet:1. The services, procedures or supplies requiring Federal or other Governmental bodyapproval, such as drugs and devices, do not have unrestricted market approval from theFood and Drug Administration (FDA) or final approval from any other governmentalregulatory body for use in treatment of a specified condition. Any approval that isgranted as an interim step in the regulatory process is not a substitute for final orunrestricted market approval.2. There is insufficient or inconclusive medical and scientific evidence that permits theevaluation of the therapeutic value of the service, procedure or supply. (Adequate evidenceis defined as at least two documents of medical and scientific evidence that indicate thatthe proposed treatment is likely to be beneficial to the member.)3. There is inconclusive medical and scientific evidence in peer-reviewed medical literaturethat the service, procedure or supply has a beneficial effect on health outcomes.4. The service, procedure or supply under consideration is not as beneficial as anyestablished alternatives.5. There is insufficient information or inconclusive scientific evidence that, when used in anon-investigational setting, the service, procedure or supply has a beneficial effect onhealth outcomes or is as beneficial as any established alternatives.The following CPT category III codes are excluded from coverage and consideredexperimental/investigational due to lack of literature establishing clinical efficacy, safety, or theapplicability to clinical practice.Table 1. CPT Category III Codes That are Noncovered Due toExperimental/Investigational StatusCodePolicy (If Applicable)0054TComputer Assisted Musculoskeletal Surgical Navigational Orthopedic procedure0055TComputer Assisted Musculoskeletal Surgical Navigational Orthopedic procedure0071T0072T0075T0076T0098TMagnetic Resonance-Guided Focused Ultrasound (MRgFUS)Magnetic Resonance-Guided Focused Ultrasound (MRgFUS)Endovascular Therapies for Extracranial Vertebral Artery DiseaseEndovascular Therapies for Extracranial Vertebral Artery DiseaseArtificial Intervertebral Disc-Cervical SpineExtracorporeal Shock Wave Therapy for Treatment of Plantar Fasciitis and other MusculoskeletalDisordersExtracorporeal Shock Wave Therapy for Treatment of Plantar Fasciitis and other Musculoskeletal0101T0102T3
0106T0107TDisordersQuantitative Sensory Testing (QST)Computer Assisted Musculoskeletal Surgical Navigational Orthopedic procedure0108TComputer Assisted Musculoskeletal Surgical Navigational Orthopedic procedure0109TComputer Assisted Musculoskeletal Surgical Navigational Orthopedic procedure0110TComputer Assisted Musculoskeletal Surgical Navigational Orthopedic 315T0316T0317T0329T0330T0331T0332T0333TArtificial Intervertebral Discs-Lumbar SpineArtificial Intervertebral Discs-Lumbar SpineArtificial Intervertebral Discs-Lumbar SpineScreening for Lung Cancer Using CT Scans-Chest-RaysScreening for Lung Cancer Using CT Scans-Chest-RaysPercutaneous Sacral AugmentationPercutaneous Sacral AugmentationEyelid Thermal Pulsation and Interferometric Color Assessment of the Tear Film for the Diagnosisand Treatment of Dry Eye SyndromeAutomated AudiometryAutomated AudiometryAutomated AudiometryAutomated AudiometryAutomated AudiometryPosterior Intrafacet ImplantPosterior Intrafacet ImplantPosterior Intrafacet ImplantPosterior Intrafacet ImplantAqueous Shunts and Stents for GlaucomaStem Cell Therapy in the Treatment of Peripheral Artery DiseaseStem Cell Therapy in the Treatment of Peripheral Artery DiseaseStem Cell Therapy in the Treatment of Peripheral Artery DiseaseBaroreflex Stimulation DevicesBaroreflex Stimulation DevicesBaroreflex Stimulation DevicesBaroreflex Stimulation DevicesBaroreflex Stimulation DevicesBaroreflex Stimulation DevicesBaroreflex Stimulation DevicesBaroreflex Stimulation DevicesTranscutaneous Electrical Modulation Pain Reprocessing (Scrambler Therapy)Vagus Nerve Blocking for the Treatment of Morbid ObesityVagus Nerve Blocking for the Treatment of Morbid ObesityVagus Nerve Blocking for the Treatment of Morbid ObesityVagus Nerve Blocking for the Treatment of Morbid ObesityVagus Nerve Blocking for the Treatment of Morbid ObesityVagus Nerve Blocking for the Treatment of Morbid ObesityContinuous Intraocular Pressure MonitoringEyelid Thermal Pulsation and Interferometric Color Assessment of the Tear Film for the Diagnosisand Treatment of Dry Eye SyndromeMyocardial Sympathetic Innervation ImagingMyocardial Sympathetic Innervation ImagingAutomated Visual Evoked Potentials for Routine Vision Screening in Pediatrics4
0442T0443T0444T0445T0465TSubtalar ArthroeresisRadiofrequency Ablation of the Renal Sympathetic Nerves as a treatment for ResistantHypertensionRadiofrequency Ablation of the Renal Sympathetic Nerves as a treatment for ResistantHypertensionRadiostereometric Analysis (RSA)Radiostereometric Analysis (RSA)Radiostereometric Analysis (RSA)Radiostereometric Analysis (RSA)Optical Coherence Tomography of the Breast and/or Axillary Lymph NodesOptical Coherence Tomography of the Breast and/or Axillary Lymph NodesOptical Coherence Tomography of the Breast and/or Axillary Lymph NodesOptical Coherence Tomography of the Breast and/or Axillary Lymph NodesHome Monitoring Device for Age-Related Macular DegenerationHome Monitoring Device for Age-Related Macular DegenerationElectronic BrachytherapyElectronic BrachytherapyConfocal Laser EndomicroscopyCardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient SettingCardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient SettingCardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient SettingCardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient SettingCardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient SettingCardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient SettingCardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient SettingCardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient SettingCardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient SettingCardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient SettingCardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient SettingAquablation of the ProstateTactile Breast Imaging by Computer-Aided Tactile SensorsLipoprotein-Associated Phospholipase A2 (Lp-PLA2) in the Assessment of Cardiovascular Risk,Measurement ofPhrenic Nerve Stimulation For Central Sleep ApneaPhrenic Nerve Stimulation For Central Sleep ApneaPhrenic Nerve Stimulation For Central Sleep ApneaPhrenic Nerve Stimulation For Central Sleep ApneaPhrenic Nerve Stimulation For Central Sleep ApneaPhrenic Nerve Stimulation For Central Sleep ApneaPhrenic Nerve Stimulation For Central Sleep ApneaPhrenic Nerve Stimulation For Central Sleep ApneaPhrenic Nerve Stimulation For Central Sleep ApneaPhrenic Nerve Stimulation For Central Sleep ApneaPhrenic Nerve Stimulation For Central Sleep ApneaPhrenic Nerve Stimulation For Central Sleep ApneaPhrenic Nerve Stimulation For Central Sleep ApneaCryoablation of Peripheral NervesCryoablation of Peripheral NervesCryoablation of Peripheral NervesSpectral Analysis of Prostate TissueSuprachoroidal Delivery of Pharmacologic Agent5
0529T0530T0531T0532T0533T0534T0535T0536TRetinal ProsthesisRetinal ProsthesisFetal Magnetocardiography (F-MCG)Fetal Magnetocardiography (F-MCG)Fetal Magnetocardiography (F-MCG)Fetal Magnetocardiography (F-MCG)Optical Coherence Tomography of the Middle Ear (e.g., PhotoniCare ClearView System)Optical Coherence Tomography of the Middle Ear (e.g., PhotoniCare ClearView System)Near-Infrared Spectroscopy for Wound ExaminationEx-Vivo Lung Perfusion (EVLP)Ex-Vivo Lung Perfusion (EVLP)Ex-Vivo Lung Perfusion (EVLP)Subtalar ArthroereisisSubtalar ArthroereisisExtracorporeal Shock Wave Treatment Of WoundsExtracorporeal Shock Wave Treatment Of Wounds6
0603T0604T0605T0606T0607T0608TTranscatheter Mitral Valve RepairTranscatheter Mitral Valve RepairHandheld Radiofrequency Spectroscopy for Intraoperative Assessment of Surgical Margins DuringBreast-Conserving Surgery (e.g., MarginProbe )Eyelid Theramal Pulsation and Interferometric Color Assessment of the Tear Film for Dry EyeChemosensitivity and Chemoresistance Assay, In VitroAutografts and allografts in the Treatment of Focal Articular Cartilage LesionsOrthopedic Applications of Stem-Cell TherapyImplantable Cardioverter Defibrillator (ICD), Including Subcutaneous ICDsImplantable Cardioverter Defibrillator (ICD), Including Subcutaneous ICDsImplantable Cardioverter Defibrillator (ICD), Including Subcutaneous ICDsImplantable Cardioverter Defibrillator (ICD), Including Subcutaneous ICDsImplantable Cardioverter Defibrillator (ICD), Including Subcutaneous ICDsImplantable Cardioverter Defibrillator (ICD), Including Subcutaneous ICDsImplantable Cardioverter Defibrillator (ICD), Including Subcutaneous ICDsImplantable Cardioverter Defibrillator (ICD), Including Subcutaneous ICDsImplantable Cardioverter Defibrillator (ICD), Including Subcutaneous ICDsImplantable Cardioverter Defibrillator (ICD), Including Subcutaneous ICDsCryosurgical Ablation of Miscellaneous Solid Tumors Other Than Liver, Prostate or DermologicTumorsFocal Treatments for Prostate CancerBalloon Dilation of the Eustachian Tube (BDET)Non-contact ultrasound for the treatment of woundsNon-contact ultrasound for the treatment of woundsOptical coherence tomography imaging, anterior eyeOptical coherence tomography imaging, anterior eyeOptical coherence tomography imaging, anterior eyeCardiac hemodynamic monitoring for the management of heart failure in the outpatient settingCardiac hemodynamic monitoring for the management of heart failure in the outpatient setting7
0663T0664T0665T0666T0667T0668T0669T0670TMagnetic resonance spectroscopyMagnetic resonance spectroscopyMagnetic resonance spectroscopyMagnetic resonance spectroscopyImplantable Cardioverter Defibrillator (ICD), Including Subcutaneous ICDsIntraocular lens implant for myopia (nearsightedness)Intraocular lens implant for myopia (nearsightedness)Intraocular lens implant for myopia (nearsightedness)Prostatic urethral lift procedure for the treatment of BPHNear Infrared Spectroscopic Examination of WoundsNear Infrared Spectroscopic Examination of WoundsNear Infrared Spectroscopic Examination of WoundsAmbulatory Event Monitor & Mobile Cardiac Outpatient TelemetryWireless Capsule EndoscopyFocal Treatments for ProstateVertebral Body Tethering and/or Stapling for ScoliosisVertebral Body Tethering and/or Stapling for Scoliosis8
0712T0713T9
Government RegulationsNational:No NCD ge-database/details/lcddetails.aspx?LCDId 35490&ver 40&CoverageSelection Local&ArticleType All&PolicyType Final&s Michigan&KeyWord category III&KeyWordLookUp Title&KeyWordSearchType And&bc gAAAACAAAAAA&(The above Medicare information is current as of the review date for this policy. However, the coverage issuesand policies maintained by the Centers for Medicare & Medicare Services [CMS, formerly HCFA] are updatedand/or revised periodically. Therefore, the most current CMS information may not be contained in thisdocument. For the most current information, the reader should contact an official Medicare source.)Related PoliciesN/AReferences1. Centers for Medicare and Medicaid Services. Local Coverage Determination (L35490):Category III Codes. For services performed on or after 06/01/2018.2. Excellus Blue Cross Blue Shield. Experimental or Investigational Services. Medical Policy.Published 09/16/99. Archived 02/26/09.3. Blue Cross Blue Shield of Rhode Island. CPT Category III Codes. Medical Policy.Published 04/05/11, last updated 04/05/11.4. American Medical Association. CPT Category III Codes. Last updated January 2018.The articles reviewed in this research include those obtained in an Internet based literature searchfor relevant medical references through March 2022, the date the research was completed.10
Joint BCBSM/BCN Medical Policy HistoryPolicyEffective DateBCBSMSignature DateBCNSignature Date11/1/188/21/188/21/1812/11/1812/11/18Removed questionable codes 0501T0504T and 0095T.2/19/192/19/19Codes 0387T-0391T, 0346T deleted1/1/19.4/16/194/16/19Codes 0479T and 0480T removedfrom policy as procedure is not E/I.Codes 0159T, 0188T-0196T, 0337T,0406T and 0407T are deleted codesand therefore removed from policy.The following codes were removedfrom the policy because they are nowpayable: 0215T-0218T, 0235T-0238Tand 0466T-0468T.6/18/196/18/19No new codes added/deleted.8/20/198/20/19Added E/I codes 0509T-0562T.10/15/1910/15/19Deleted codes 0537T, 0539T and0540T from policy.12/17/1912/17/19Added codes 0563T-0583T and0591T-0593T as E/I. Removed0398T as now it is established.2/18/202/18/20Removed the following codes:0205T, 0206T, 0254T, 0341T, 0357T,0375T, 0377T, 0380T, 0482T.4/14/204/14/20No new codes added/deleted.6/16/206/16/20No new codes added/deleted.8/18/208/18/20Added codes 0594T-0619T as E/I.10/1/2010/15/20Added codes 0620T-0639T as E/I.Removed code 0356T.12/15/2012/15/20No codes added or deleted.2/16/212/16/21Deleted codes as of 1/1/2021: 0058T,0085T, 0126T, 0228T-0231T, 0382T0386T, 0396T, 0400T-0401T, and0405T. Code 0601T nomenclaturerevised11CommentsJoint policy established
4/20/214/20/21Code 0552T removed from policy asthis code is now payable.6/15/216/15/21Code 0381T deleted, Code 0404Tnow established and removed fromthis policy.8/17/218/17/21Codes 0640T-0670T added, effective7/1/21. Code 0523T removed as it isa covered service.10/19/2110/19/21Codes 0446T-0448T removed asthey are now established.12/14/2112/14/21No additions or deletions.2/15/222/15/22Added codes 0671T-0713T effective1/1/22. Deleted codes 0290T, 0355T,0356T, 0376T, 0423T, 0451T-0463T,0466T-0468T, 0548T-0551T.4/19/224/19/22No additions or deletions, routinepolicy maintenance.Next Review Date:Every Qtr.Pre-Consolidation Medical Policy HistoryOriginal Policy DateCommentsBCN:Revised:BCBSM:Revised:12
BLUE CARE NETWORK BENEFIT COVERAGEPOLICY: CPT CATEGORY III CODES-NONCOVERED SERVICESI. Coverage Determination:Commercial HMO(includes Self-Fundedgroups unless otherwisespecified)BCNA (MedicareAdvantage)BCN65 (MedicareComplementary)Not coveredSee government sectionCoinsurance covered if primary Medicare covers theservice.II. Administrative Guidelines: The member's contract must be active at the time the service is rendered.Coverage is based on each member’s certificate and is not guaranteed. Pleaseconsult the individual member’s certificate for details. Additional information regardingcoverage or benefits may also be obtained through customer or provider inquiryservices at BCN.The service must be authorized by the member's PCP except for Self-Referral Option(SRO) members seeking Tier 2 coverage.Services must be performed by a BCN-contracted provider, if available, except forSelf-Referral Option (SRO) members seeking Tier 2 coverage.Payment is based on BCN payment rules, individual certificate and certificate riders.Appropriate copayments will apply. Refer to certificate and applicable riders fordetailed information.CPT - HCPCS codes are used for descriptive purposes only and are not a guaranteeof coverage.13
0418T Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting 0421T Aquablation of the Prostate 0422T Tactile Breast Imaging by Computer-Aided Tactile Sensors
