In this chapter, the following terms have the meanings indicated. Terms Defined. “Audiologist” means a professional who is licensed in accordance with Regulation .02 of this chapter who treats hearing disorders and communication problems. “Audiology assessment” means procedures performed by an audiologist to evaluate and monitor the status of the peripheral auditory system, auditory nerve, and central auditory system, or to establish the site of the auditory disorder by using procedures to quantify and qualify hearing loss by site of lesion, on the basis of perceptual, physiological, or electrophysiological responses to acoustic stimuli, and to describe any communicative disorders. Audiology Center. “Audiology center” means a multispecialty setting with all necessary equipment for audiology services that operates for the purpose of providing preventive, diagnostic, therapeutic, and rehabilitative audiology services, and other multispecialty services by or under the direction of a licensed physician or audiologist. “Audiology center” does not include the office of one or more private audiologists. “Audiology services” means services delivered by an audiologist to eligible participants in order to diagnose and treat hearing problems. “Auditory osseointegrated device” means a device implanted in the skull that replaces the function of the middle ear and provides mechanical energy to the cochlea via a mechanical transducer. “Bilateral” means relating to or involving both ears. “Cochlear implant” means a device that is implanted under the skin that picks up sounds and converts them to impulses transmitted to electrodes placed in the cochlea, restoring some hearing to people with a hearing impairment. “Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Designee” means any entity designated to act on behalf of the Department. “Early and Periodic Screening, Diagnosis, and Treatment (EPSDT)” means the provision of preventive health care under 42 CFR §441.50 et seq., including medical and dental services, in order to assess growth and development and to detect and treat health problems in Medical Assistance eligible individuals under 21 years old. “EPSDT screening provider” means a physician, audiologist, or an authorized practitioner under Health Occupations Article, Annotated Code of Maryland. “Hearing aid” means an instrument or device that is designed for improving or correcting impaired human hearing, or any part or accessory of the instrument or device. “Hearing aid dispenser” means a person who is licensed in accordance with Regulation .02 of this chapter to sell hearing aids or provide other hearing aid services. “Hearing aid evaluation” means services provided to a participant by an audiologist for determining the benefit of hearing aids and, upon the audiologist’s recommendation, the dispensing of hearing aids. “Maryland Medical Assistance Program (Program)” means the program of comprehensive medical and other health-related care for indigent and medically indigent individuals. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with currently accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Participant” means an individual who is enrolled with the Department to receive Medical Assistance services. “Program” has the meaning stated in COMAR 10.09.36.01. “Provider” means an audiologist, audiology center, or hearing aid dispenser that is licensed and that, through an agreement with the Department, has been identified as a Program provider by the issuance of a provider number. “Unilateral” means relating to, involving, or affecting one ear. In order to provide services as an audiologist under this chapter, an audiologist shall be licensed by the State Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists to practice audiology, as defined in Health Occupations Article, Title 2, Annotated Code of Maryland, or by the appropriate licensing body in the jurisdiction in which the audiology services are performed. In order to provide services as a hearing aid dispenser under this chapter, a hearing aid dispenser shall be licensed by the: State Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists to dispense hearing aids and hearing aid accessories, as defined in Health Occupations Article, Title 2, Annotated Code of Maryland; or Appropriate licensing body in the jurisdiction in which the hearing aids are dispensed. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. Specific requirements for participation in the Program as an audiologist, audiology center or group, or hearing aid dispenser are that the provider: Shall meet the licensure requirements in accordance with Regulation .02 of this chapter; and May not knowingly employ another person to provide services to Maryland Medical Assistance Program participants after that person has been disqualified from the Program unless prior approval has been received from the Department. The Program covers the following medically necessary services: Audiology services, as follows: For participants who are at risk for or have a hearing impairment, audiology assessments using procedures appropriate for the participant’s developmental age and abilities; and Hearing aid evaluations and routine follow-up for participants with an identified hearing impairment, who currently use or are being considered for hearing aids; and Hearing amplification services, as follows: Unilateral or bilateral hearing aids which are medically necessary and are: Not used or rebuilt, and which meet the current standards set forth in 21 CFR §§801.420 and 801.421, which are incorporated by reference; Recommended and fitted by an audiologist in conjunction with written medical clearance from a physician who has performed a medical examination within the past 6 months; Sold on a 30-day trial basis; and Fully covered by a manufacturer’s warranty for a minimum of 2 years, at no cost to the Program; Hearing aid accessories and services, as listed below: Ear molds; Batteries; Routine follow-ups and adjustments; Repairs after all warranties have expired; Replacement of unilateral or bilateral hearing aids every 5 years when determined to be medically necessary; and Other hearing aid accessories determined to be medically necessary; Cochlear implants and related services, as listed below: Unilateral or bilateral implantation of cochlear implant or implants which are medically necessary including the cost of the device; Post-operative evaluation and programming of the cochlear implant or implants; Aural rehabilitation services; and Repair or replacement of cochlear implant device components subject to the limitations in Regulation .05 of this chapter; and Auditory osseointegrated device or devices and related services, as listed below: Unilateral or bilateral implantation of auditory osseointegrated devices which are medically necessary including the cost of the device; Non-implantable or softband device or devices which are medically necessary; Evaluation and programming of the auditory osseointegrated device or devices; and Repair or replacement, or both, of auditory osseointegrated device components subject to the limitations in Regulation .05 of this chapter. Covered audiology services, including hearing aids, cochlear implants, and auditory osseointegrated devices are limited to: Unless the time limitation is waived by the Program, one audiology assessment per year; The initial coverage of unilateral or bilateral hearing aids, cochlear implants, or auditory osseointegrated devices when the Department’s medical necessity criteria have been met; One replacement of unilateral or bilateral hearing aids: Every 5 years for participants younger than 21 years old, unless the Program approves more frequent replacement; or Every 5 years for participants 21 years old or older, unless the Program approves more frequent replacement, but no more than 1 replacement extraneous to the devices’ warranty; Replacement of hearing aids, cochlear implants and auditory osseointegrated device components that have been lost, stolen, or damaged beyond repair, after all warranties have expired; Repairs and replacements that take place after all warranties have expired; A maximum of 76 batteries per participant per 12-month period for a unilateral hearing aid or osseointegrated devices, or 152 batteries per participant per 12-month period for bilateral hearing aids or osseointegrated devices purchased from the Department not more frequently than every 6 months, and in quantities of 38 or fewer for a unilateral hearing aid, or 76 or fewer for a bilateral hearing aid; A maximum of 238 disposable batteries for a unilateral cochlear implant per participant per 12-month period or 476 disposable batteries per 12-month period for a bilateral cochlear implant purchased not more frequently than every 6 months, and in quantities of 119 or fewer for a unilateral cochlear implant, or 238 or fewer for a bilateral cochlear implant; Four replacement cochlear implant component rechargeable batteries per 12-month period for bilateral cochlear implants, and a maximum of two replacement rechargeable batteries for a unilateral cochlear implant per 12-month period; Two cochlear implant replacement transmitter cables per 12-month period for bilateral cochlear implants, and a maximum of one replacement transmitter cable for a unilateral cochlear implant per 12-month period; Two cochlear implant replacement headset cables per 12-month period for bilateral cochlear implants, and a maximum of one replacement headset cable for a unilateral cochlear implant per 12-month period; Two replacement cochlear implant transmitting coils per 12-month period for bilateral cochlear implants, and a maximum of one replacement transmitting coil for a unilateral cochlear implant per 12-month period; Charges for routine follow-ups and adjustments which occur more than 60 days after the dispensing of a new hearing aid; and A maximum of two unilateral earmolds or four bilateral earmolds per 12-month period unless a larger number is determined to be medically necessary. Services which are not covered are: Services not medically necessary; Hearing aids and accessories not medically necessary; Cochlear implant services and external components not medically necessary; Cochlear implant services and external components provided less than 90 days after the surgery which are covered through the initial reimbursement; Spare or backup cochlear implant components; Spare or back-up auditory osseointegrated device components; Replacement of hearing aids, equipment, cochlear implant components, and auditory osseointegrated device components if the existing devices are functional, repairable, and appropriately correct or ameliorate the problem or condition; Spare or backup hearing aids, equipment, or supplies; Repairs to spare or backup hearing aids, cochlear implants, auditory osseointegrated devices, equipment, or supplies; Investigational or experimental services or devices, or both; Replacement of improperly fitted earmold or earmolds unless the: Replacement service is administered by someone other than the original provider; and Replacement service has not been claimed before; Additional professional fees and overhead charges for a new hearing aid when a dispensing fee claim has been made to the Program; and Loaner hearing aids. The Department requires preauthorization for the following services: All hearing aids; Certain hearing aid accessories; All cochlear implant devices and replacement components except microphone, transmitter cables, and transmitting coils; All auditory osseointegrated devices; and Repairs for hearing aids, cochlear implants, and auditory osseointegrated components exceeding $500. Preauthorization is valid: For services rendered or initiated within 6 months from the date the preauthorization was issued; and If the patient is an eligible participant at the time the service is rendered. The following written documentation shall be submitted by the provider to the Department or its designee with each request or preauthorization of hearing aids, cochlear implants, or auditory osseointegrated devices: Audiology report documenting medical necessity of the hearing aids, cochlear implants or auditory osseointegrated devices; Interpretation of the audiogram; and Medical evaluation by a physician supporting the medical necessity of the initial hearing aids, cochlear implants, or auditory osseointegrated devices within 6 months of the preauthorization request. To obtain compensation from the Department for covered services, the provider shall submit a request for payment using the format designated by the Department. Audiology services are reimbursed in accordance with COMAR 10.09.23.01-1. The provider shall be paid the lesser of: The provider’s customary charge to the general public, unless the service is free to individuals not covered by Medicaid; or The rate in accordance with the Department’s fee schedule. The provider may not bill the Department or participant for: Completion of forms and reports; Broken or missed appointments; or Professional services rendered by mail or telephone. Audiology centers licensed as a part of a hospital may charge for and be reimbursed according to rates approved by the Health Services Cost Review Commission (HSCRC), set forth in COMAR 10.37.03. The provider shall refund to the Department payment for hearing aids, supplies, or both, that have been returned to the manufacturer within the 30-day trial period. The provider shall give the Department the full advantage of any and all manufacturer’s warranties and trade-ins offered on hearing aids, equipment, or both. Unless preauthorization has been granted by the Department or its designee, the Department is not responsible for any reimbursement to a provider for any service provided which requires preauthorization. The Department may not make direct payment to participants. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. Recovery and reimbursement requirements are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. Appeal procedures are as set forth in COMAR 10.09.36.09. State regulations are interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: August 16, 1993 (20:16 Md. R. 1277) Chapter revised effective June 21, 2004 (31:12 Md. R. 911) Regulation .01B amended effective July 18, 2005 (32:14 Md. R. 1275); January 16, 2006 (33:1 Md. R. 36); October 22, 2018 (45:21 Md. R. 973) Regulation .02A amended effective January 16, 2006 (33:1 Md. R. 36); October 22, 2018 (45:21 Md. R. 973) Regulation .03 repealed and new Regulation .03 adopted effective October 22, 2018 (45:21 Md. R. 973) Regulation .04 amended effective April 4, 2011 (38:7 Md. R. 431); October 22, 2018 (45:21 Md. R. 973) Regulation .04A amended effective January 16, 2006 (33:1 Md. R. 36) Regulation .05 amended effective July 18, 2005 (32:14 Md. R. 1275); October 22, 2018 (45:21 Md. R. 973) Regulation .05A amended effective December 27, 2021 (48:26 Md. R. 1111) Regulation .05B amended effective January 16, 2006 (33:1 Md. R. 36) Regulation .06 amended effective October 22, 2018 (45:21 Md. R. 973) Regulation .06A amended effective July 18, 2005 (32:14 Md. R. 1275) Regulation .06B, C amended effective January 16, 2006 (33:1 Md. R. 36) Regulation .06B, D amended effective April 4, 2011 (38:7 Md. R. 431) Regulation .07 amended effective January 16, 2006 (33:1 Md. R. 36); April 4, 2011 (38:7 Md. R. 431); October 22, 2018 (45:21 Md. R. 973) Regulation .07B amended effective April 21, 2008 (35:8 Md. R. 805); February 27, 2017 (44:4 Md. R. 253) Regulation .07C, G, K amended effective July 4, 2016 (43:13 Md. R. 712)