NC Medicaid: Cochlear And Auditory Brainstem Implants, 1A-4.

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NC MedicaidCochlear and AuditoryBrainstem ImplantsMedicaid and Health ChoiceClinical Coverage Policy No: 1A-4Amended Date: December 04, 2019To all beneficiaries enrolled in a Prepaid Health Plan (PHP): for questions about benefits andservices available on or after implementation, please contact your PHP.Table of Contents1.0Description of the Procedure, Product, or Service . 11.1Definitions . 12.0Eligibility Requirements . 12.1Provisions. 12.1.1 General . 12.2Special Provisions . 22.2.1 EPSDT Special Provision: Exception to Policy Limitations for a MedicaidBeneficiary under 21 Years of Age . 22.2.2 EPSDT does not apply to NCHC beneficiaries . 32.2.3 Health Choice Special Provision for a Health Choice Beneficiary age 6 through18 years of age . 33.0When the Procedure, Product, or Service Is Covered . 33.1General Criteria Covered . 33.2Specific Criteria Covered. 33.2.1 Specific criteria covered by both Medicaid and NCHC . 33.2.2 Cochlear Implant. 33.2.3 Auditory Brainstem Implants. 43.2.4 Upgrades and Maintenance . 53.2.5 Contralateral Cochlear Implant . 53.2.6 Simultaneous Bilateral Cochlear Implants. 53.2.7 Diagnostic Analysis and Programming . 63.2.8 Medicaid Additional Criteria Covered. 63.2.9 NCHC Additional Criteria Covered . 64.0When the Procedure, Product, or Service Is Not Covered . 64.1General Criteria Not Covered . 64.2Specific Criteria Not Covered. 64.2.1 Specific Criteria Not Covered by both Medicaid and NCHC. 64.2.2 Medicaid Additional Criteria Not Covered. 74.2.3 NCHC Additional Criteria Not Covered. 75.0Requirements for and Limitations on Coverage . 75.1Prior Approval . 75.1.1 Cochlear Implant. 75.1.2 Auditory Brainstem Implant . 75.1.3 Upgrades and Maintenance . 75.1.4 Contralateral Cochlear Implant . 85.1.5 Simultaneous Bilateral Cochlear Implants. 85.1.6 Aural Rehabilitation. 85.1.7 Diagnostic Analysis and Programming . 819K26i

NC MedicaidCochlear and AuditoryBrainstem Implants5.2Medicaid and Health ChoiceClinical Coverage Policy No: 1A-4Amended Date: December 04, 20195.1.8 Replacement Parts and Repairs. 8Prior Approval Requirements . 85.2.1 General . 86.0Providers Eligible to Bill for the Procedure, Product, or Service . 86.1Provider Qualifications and Occupational Licensing Entity Regulations. 96.2Provider Certifications . 97.0Additional Requirements . 97.1Compliance . 98.0Policy Implementation/Revision Information. 10Attachment A: Claims-Related Information . 12A.Claim Type . 12B.International Classification of Diseases and Related Health Problems, Tenth Revisions,Clinical Modification (ICD-10-CM) and Procedural Coding System (PCS) . 12C.Code(s) . 12D.Modifiers. 13E.Billing Units. 13F.Place of Service . 13G.Co-payments . 13H.Reimbursement . 1319K26ii

NC MedicaidCochlear and AuditoryBrainstem ImplantsMedicaid and Health ChoiceClinical Coverage Policy No: 1A-4Amended Date: December 04, 2019Related Clinical Coverage PoliciesRefer to https://medicaid.ncdhhs.gov/ for the related coverage policies listed below:13A, Cochlear and Auditory Brainstem Implant External Parts Replacement and Repair10A, Outpatient Specialized Therapies1.0Description of the Procedure, Product, or ServiceA cochlear implant is an electronic medical device designed to restore some ability to perceivesounds and understand speech by individuals with moderate to profound hearing loss. A cochlearimplant bypasses damaged hair cells in the cochlea and stimulates the remaining nerve fibersdirectly through the application of electrical current. Cochlear implants have external parts andinternal (surgically implanted) parts that work together to allow the user to perceive sound.An auditory brainstem implant (ABI) is a modification of the cochlear implant in which thestimulating electrode is placed directly into the brain.After surgery, these two devices require activation, fitting of essential external components,programming, and rehabilitation for proper function and benefit.1.1 DefinitionsNone Apply.2.0Eligibility Requirements2.1Provisions2.1.1General(The term “General” found throughout this policy applies to all Medicaid andNCHC policies)a. An eligible beneficiary shall be enrolled in either:1. the NC Medicaid Program (Medicaid is NC Medicaid program, unlesscontext clearly indicates otherwise); or2. the NC Health Choice (NCHC is NC Health Choice program, unlesscontext clearly indicates otherwise) Program on the date of service andshall meet the criteria in Section 3.0 of this policy.b. Provider(s) shall verify each Medicaid or NCHC beneficiary’s eligibilityeach time a service is rendered.c. The Medicaid beneficiary may have service restrictions due to theireligibility category that would make them ineligible for this service.Following is only one of the eligibility and other requirements forparticipation in the NCHC Program under GS 108A-70.21(a): Children mustbe between the ages of 6 through 18 (The term “Specific” found throughoutthis policy only applies to this policy)a. MedicaidNone Apply.CPT codes, descriptors, and other data only are copyright 2018 American Medical Association.All rights reserved. Applicable FARS/DFARS apply.19K261

NC MedicaidCochlear and AuditoryBrainstem ImplantsMedicaid and Health ChoiceClinical Coverage Policy No: 1A-4Amended Date: December 04, 2019b. NCHCNone Apply.2.2Special Provisions2.2.1EPSDT Special Provision: Exception to Policy Limitations for aMedicaid Beneficiary under 21 Years of Agea. 42 U.S.C. § 1396d(r) [1905(r) of the Social Security Act]Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) is afederal Medicaid requirement that requires the state Medicaid agency tocover services, products, or procedures for Medicaid beneficiary under 21years of age if the service is medically necessary health care to correct orameliorate a defect, physical or mental illness, or a condition [healthproblem] identified through a screening examination (includes anyevaluation by a physician or other licensed practitioner).This means EPSDT covers most of the medical or remedial care a childneeds to improve or maintain his or her health in the best condition possible,compensate for a health problem, prevent it from worsening, or prevent thedevelopment of additional health problems.Medically necessary services will be provided in the most economic mode,as long as the treatment made available is similarly efficacious to the servicerequested by the beneficiary’s physician, therapist, or other licensedpractitioner; the determination process does not delay the delivery of theneeded service; and the determination does not limit the beneficiary’s right toa free choice of providers.EPSDT does not require the state Medicaid agency to provide any service,product or procedure:1. that is unsafe, ineffective, or experimental or investigational.2. that is not medical in nature or not generally recognized as an acceptedmethod of medical practice or treatment.Service limitations on scope, amount, duration, frequency, location ofservice, and other specific criteria described in clinical coverage policies maybe exceeded or may not apply as long as the provider’s documentation showsthat the requested service is medically necessary “to correct or ameliorate adefect, physical or mental illness, or a condition” [health problem]; that is,provider documentation shows how the service, product, or procedure meetsall EPSDT criteria, including to correct or improve or maintain thebeneficiary’s health in the best condition possible, compensate for a healthproblem, prevent it from worsening, or prevent the development of additionalhealth problems.b. EPSDT and Prior Approval Requirements19K262

NC MedicaidCochlear and AuditoryBrainstem ImplantsMedicaid and Health ChoiceClinical Coverage Policy No: 1A-4Amended Date: December 04, 20191. If the service, product, or procedure requires prior approval, the fact thatthe beneficiary is under 21 years of age does NOT eliminate therequirement for prior approval.2. IMPORTANT ADDITIONAL INFORMATION about EPSDT andprior approval is found in the NCTracks Provider Claims and BillingAssistance Guide, and on the EPSDT provider page. The Web addressesare specified below.NCTracks Provider Claims and Billing Assistance roviders/providermanuals.htmlEPSDT provider page: https://medicaid.ncdhhs.gov/2.2.2EPSDT does not apply to NCHC beneficiaries2.2.3Health Choice Special Provision for a Health Choice Beneficiary age 6through 18 years of ageNC Medicaid shall deny the claim for coverage for an NCHC beneficiary whodoes not meet the criteria within Section 3.0 of this policy. Only servicesincluded under the NCHC State Plan and the NC Medicaid clinical coveragepolicies, service definitions, or billing codes are covered for an NCHCbeneficiary.3.0When the Procedure, Product, or Service Is CoveredNote: Refer to Subsection 2.2.1 regarding EPSDT Exception to Policy Limitations forMedicaid Beneficiaries under 21 Years of Age.3.1General Criteria CoveredMedicaid and NCHC shall cover the procedure, product, or service related to this policywhen medically necessary, and:a.the procedure, product, or service is individualized, specific, and consistent withsymptoms or confirmed diagnosis of the illness or injury under treatment, and notin excess of the beneficiary’s needs;b.the procedure, product, or service can be safely furnished, and no equally effectiveand more conservative or less costly treatment is available statewide; andc.the procedure, product, or service is furnished in a manner not primarily intendedfor the convenience of the beneficiary, the beneficiary’s caretaker, or the provider.3.2Specific Criteria Covered3.2.1Specific criteria covered by both Medicaid and NCHC3.2.2Cochlear Implanta. Medicaid and NCHC shall cover cochlear implants and aural rehabilitationfor Medicaid beneficiaries ages 12 months of age and older and for NCHCbeneficiaries ages 6 years through 18 years when ALL of the followingrequirements are met and are documented in the health record:19K263

NC MedicaidCochlear and AuditoryBrainstem ImplantsMedicaid and Health ChoiceClinical Coverage Policy No: 1A-4Amended Date: December 04, 20191. The device must be used according to the U.S. Food and DrugAdministration (FDA) labeled indications.2. There are no contraindications for the surgery.3. The personal physician or otolaryngologist documents that thebeneficiary has realistic expectations of the performance of thedevice and is able to participate in a program of aural rehabilitation.4. The beneficiary has a confirmed diagnosis of severe to profound(greater than or equal to 70 dB HL) sensorineural hearing loss in theear to be implanted;Note: An exception to the degree of hearing loss provision of severeto profound sensorineural hearing loss (greater than or equal to 70dB HL) is the confirmed and documented case of auditoryneuropathy spectrum disorder wherein hearing thresholds may bebetter than this level but word recognition is poor.5. The beneficiary is free of middle ear infection, has an accessiblecochlear lumen that is structurally sound for implantation, and is freeof lesions in the auditory nerve and acoustic areas of the centralnervous system.b. the beneficiary age 12 months to 20 years has limited benefit from at least athree-consecutive month trial of appropriately fitted hearing aids. Whenradiological evidence of cochlear ossification on computerized tomography(CT) scan or obstruction exists, the trial requirement may be waived;Note: Limited benefit from amplification is defined by test scores of lessthan or equal to 40% correct in the ear to be implanted using an ageappropriate test of speech recognition.c. The beneficiary age 21 years of age and older has an appropriate hearing aidevaluation completed with an appropriate hearing aid fitting trialed by alicensed audiologist.3.2.3Auditory Brainstem ImplantsMedicaid and NCHC shall cover Auditory Brainstem Implants (ABIs) forMedicaid beneficiaries 12 years through 20 years of age and for NCHCbeneficiaries 12 years through 18 years of age when ALL the following criteriaare met:a. The beneficiary has been diagnosed with neurofibromatosis type 2;b. The beneficiary:1. is undergoing bilateral removal of tumors of the auditory nerves, and thebeneficiary is expected to become completely deaf as a result of thesurgery; or2. has had bilateral auditory nerve tumors removed and is now bilaterallydeaf;c. the FDA approved device must comply with the FDA indications for use.d. there are no contraindications for the surgery.19K264

NC MedicaidCochlear and AuditoryBrainstem Implants3.2.4Medicaid and Health ChoiceClinical Coverage Policy No: 1A-4Amended Date: December 04, 2019Upgrades and MaintenanceMedicaid and NCHC shall cover the replacement of an existing traditionalcochlear implant as medically necessary when ANY of the following criteria ismet:a. The currently used component is no longer functional and cannot be repairedand there is no evidence to suggest that the device has been abused orneglected;b. The currently used component renders the implanted beneficiary unable toadequately or safely perform age-appropriate activities of daily living; orc. The current technology has been made obsolete by the manufacturer.For information on requirements and limitations for external components, refer toClinical Coverage Policy 13A, Cochlear and Auditory Brainstem ImplantExternal Parts Replacement and Repair on Medicaid’s website athttps://medicaid.ncdhhs.gov/3.2.5Contralateral Cochlear ImplantMedicaid and NCHC shall consider coverage of contralateral cochlear implantafter the successful placement of the original implant on a case-by-case basis forMedicaid beneficiaries ages 12 months of age and older and for NCHCbeneficiaries 6 years through 18 years of age with documentation of medicalnecessity.Medicaid and NCHC shall cover contralateral cochlear implants, after theimplantation of the first side device, when ALL the following are met:a. demonstrated successful usage of the device;b. active participation in an appropriate auditory-based intervention program;c. active participation in an appropriate educational program;d. radiographic evidence that contralateral cochlea and nerves are present;e. demonstration by the beneficiary or family of the ability to care for theequipment needs of two devices;f. no evidence of severe physical, psychomotor, or cognitive delays; ANDg. when at least ONE of the following applies:1. continued usage of a hearing aid has been unsuccessful, if residual hearingis present;2. the first side device is non-functional for medical or surgical reasons andreplacement surgery is not an option;3. the first side is suspected of having a device failure but still provides somebeneficial auditory input; or4. the beneficiary develops significant delayed-onset visual impairment.3.2.6Simultaneous Bilateral Cochlear ImplantsMedicaid and NCHC shall cover simultaneous bilateral cochlear implants ONLYwhen there is:a. clear evidence of ongoing bilateral cochlear ossification or fibrosis fromprevious meningitis or cochlear inflammation orb. significant bilateral visual impairment present or expected to develop, suchas in Usher’s syndrome.19K265

NC MedicaidCochlear and AuditoryBrainstem Implants3.2.7Medicaid and Health ChoiceClinical Coverage Policy No: 1A-4Amended Date: December 04,

Cochlear implants have external parts and internal (surgically implanted) parts that work together to allow the user to perceive sound. An auditory brainstem implant (ABI) is a modification of the cochlear implant in which the

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