Medicare Nationally Covered Indications
For services performed on or after September 26, 2022, Medicare may cover cochlear implantation for bilateral pre- or post-linguistic, sensorineural, moderate-to-profound hearing loss when the member demonstrates limited benefit from amplification. All of the following criteria must be met.
ALL of the following
Diagnosis of bilateral moderate-to-profound sensorineural hearing impairment with limited benefit from appropriate hearing or vibrotactile aids. Limited benefit from amplification is defined as a score of less than or equal to 60% correct in the best-aided listening condition on recorded tests of open-set sentence recognition.<= 60% correct
Cognitive ability to use auditory clues and willingness to undergo an extended program of rehabilitation.
Freedom from middle-ear infection; an accessible cochlear lumen that is structurally suited to implantation; and freedom from lesions in the auditory nerve and acoustic areas of the central nervous system.
No contraindications to surgery.
The device will be used in accordance with Food and Drug Administration (FDA)-approved labeling.
Community Care Implantation Criteria
For Community Care members and dates of service on or after September 1, 2024, Fallon Health uses the InterQual® criteria in effect on the date of service when making medical-necessity determinations for cochlear implantation.
Apply the applicable InterQual® criteria in effect on the date of service
InterQual® CP:Procedures, Cochlear Implantation (69930, L8614). InterQual® CP:Procedures, Unilateral Hybrid Cochlear Implantation (69930, L8614). InterQual® CP:Procedures, Cochlear Implantation (Pediatric) (69930, L8614). InterQual® CP:Procedures, Cochlear Implantation Internal Component Replacement (69930, 69949, L8614). InterQual® CP:Procedures, Cochlear Implantation Internal Component Replacement (Pediatric) (69930, L8614).
External Component Replacement Criteria
For dates of service on or after September 1, 2024, Fallon Health uses the applicable InterQual® replacement criteria in effect on the date of service for external component replacement.
ALL of the following
Apply InterQual® CP:Procedures, Cochlear Implantation External Component Replacement for the applicable service and member population.
For pediatric services, apply InterQual® CP:Procedures, Cochlear Implantation External Component Replacement (Pediatric).
Replacement of a functioning cochlear implant or implant component is not covered unless all applicable coverage criteria are met.
MassHealth External Component Replacement
MassHealth has Guidelines for Medical Necessity Determination for Cochlear Implantation; therefore, Fallon Health Clinical Coverage Criteria are not applicable to MassHealth members. For replacement of cochlear implant external components, refer to MassHealth Audiologist regulations at 130 CMR 426.416(K).
MassHealth external component replacement
Existing external speech processor is replaced only when at least one condition applies
The existing processor is obsolete because the manufacturer no longer supports repairs on it.
The existing processor is lost. A lost processor is replaced by the same make and model unless it is obsolete, in which case it is replaced by the replacement model.
The existing processor is beyond repair.
Existing external component other than the speech processor is replaced only when at least one condition applies
Medicare Clinical-Trial Exceptions
Medicare members who do not meet the cochlear implantation coverage criteria in the National Coverage Determination are not eligible for coverage, except in the following clinical-trial circumstances when applicable requirements are met.
ONE of the following exceptions
The cochlear implantation is performed in an FDA-approved Category B investigational device exemption (IDE) clinical trial as defined at 42 CFR § 405.201. For Medicare Advantage members enrolled in CMS-approved Category B IDE trials, Fallon Health covers routine care items and services and CMS-approved Category B devices under 42 CFR § 422.109(f); related claims should be submitted to Fallon Health. Billing and coding guidance is available in Fallon Health's Clinical Trials Payment Policy.
The cochlear implantation is a routine cost in a CMS-approved clinical trial under section 310.1 of the National Coverage Determinations Manual, Routine Costs in Clinical Trials. Original Medicare is responsible for coverage of routine costs and diagnosis and treatment of complications on a fee-for-service basis. Fallon Health reimburses the difference between Original Medicare cost-sharing and the member's in-network cost-sharing for the same category of items and services under 42 CFR § 422.109(e).
For MassHealth members, the member is generally excluded from coverage when younger than nine months of age. Rare cases requiring coverage before nine months will be considered on a case-by-case basis, such as meningitis with concern for cochlear ossification before the nine-month mark.
Cochlear implantation is not medically necessary when it is proposed as a form of treatment for tinnitus.
Cochlear implantation is not medically necessary when the member has an active middle-ear infection, infection of the mastoid cavity, or tympanic membrane perforation at the time of the prior-authorization request and/or on the day of the procedure.
Cochlear implantation is not medically necessary when the member's deafness is due to lesions of the eighth cranial nerve or absence of the eighth cranial nerve.
Supplies or accessories that are not necessary for functioning of the cochlear implant are not covered, including cell phone adapters, telecoils, carrying cases, keychain wallets, car charger adapters, and accessories or upgrades intended for personal convenience or deluxe use.
Not all services mentioned in this policy are covered for all products or employer groups.
Coverage is based on the terms of the member's particular benefit plan, which may contain specific provisions for coverage and exclusions regardless of medical necessity. The member's Evidence of Coverage should be consulted for exclusions or other benefit limitations applicable to the service or supply. If this policy conflicts with the member's benefit plan, the benefit plan governs. Applicable state mandates take precedence for fully insured plans and self-funded non-ERISA plans, including government, school board, and church plans. Unless specifically excluded, federal mandates apply to all plans.
For MassHealth members, Fallon Health Clinical Coverage Criteria are not applicable because MassHealth has Guidelines for Medical Necessity Determination for Cochlear Implantation. MassHealth may consider cochlear implantation not medically necessary when the member is younger than nine months, has tinnitus as the proposed treatment indication, has active middle-ear or mastoid infection or tympanic membrane perforation, or has deafness due to lesions of or absence of the eighth cranial nerve.