1. (1) Hearing aid services means services that are provided in compliance with article 37 of the General Business Law. These services include the selecting, fitting and dispensing of hearing aids, hearing aid checks following dispensing, and hearing aid repairs. Hearing aid products means hearing aids, earmolds, batteries, special fittings and replacement parts.
2. (2) Audiology services mean audiometric examinations or testing, hearing aid evaluations, conformity evaluations and hearing aid prescriptions or recommendations if indicated.
3. (3) Qualified audiologist means an audiologist that is licensed and currently registered to practice audiology in the State by the State Education Department.
4. (4) Qualified hearing aid dealer means any person, partnership, association or corporation engaged in the selecting, fitting and dispensing of hearing aids and currently registered in the State by the Department of State pursuant to article 37-A, section 789 of the General Business Law.
5. (b) Standards. All audiology services and hearing aid services and products must meet the requirements set forth in this Part and must be provided in accordance with the New York State Department of Health's regulations governing the provision of audiology services, audiometric screening and hearing aid services.

6. (c) Recommendation requirements.

   1. (1) All recommendations for hearing aids must be in writing and comply with article 37-A of the General Business Law.
   2. (2) The written recommendation must indicate the need for a hearing aid and include the results of pure tone speech audiometry or equivalent testing conducted in a sound treated room or test suite meeting the American National Standard Institute's specifications.
   3. (3) A prescription for a specific hearing aid requires a pure tone and sound field speech audiometry. The tests must be conducted by or under the direction and personal supervision of an otolaryngologist or qualified audiologist. When a specific device is prescribed, the hearing aid dealer must dispense as written.
   4. (4) When a general recommendation is made, the hearing aid dealer must perform tests and procedures necessary to determine the specific hearing aid which will be of maximum benefit to aid or improve the impaired hearing.

   5. (5) Hearing aids must be dispensed within six months of the date of the recommendation.

      (d) Source of recommendation.

   6. (1) All written recommendations for hearing aids for children under 21 years of age must be from speech and hearing centers approved to provide services under the Physically Handicapped Children's Program. The written recommendation must be signed by a qualified otolaryngologist or qualified audiologist. For persons under 21 residing in New York State Developmental Centers, the recommendation for a hearing aid may be from the developmental center.

   7. (2) Written recommendations for hearing aids for persons 21 years of age and older must be from a qualified otolaryngologist, a speech and hearing center approved to provide services under the Physically Handicapped Children's Program, a qualified audiologist, or a facility approved pursuant to Article 28 of the Public Health Law and certified to render speech and hearing or audiology services.

      (e) Prior approval requirements.

   8. (1) Prior approval of the local Physically Handicapped Children's Program medical director is required for all hearing aid services furnished to persons under 21 years of age.

   9. (2) Prior approval from the New York State Department of Health is required for hearing aids, dispensing and administrative fees as defined by regulations of the New York State Department of Health, and special fittings when the source of the recommendation is not a speech and hearing center approved to provide services under the Physically Handicapped Children's Program. Batteries not listed in the department's provider manual and repairs costing $70 or more require prior approval from the New York State Department of Health regardless of the source of the order.

      (f) Written statements required.

   10. (1) Audiology services, except for conformity evaluations (hearing aid checks), must be supported by a written referral by a licensed physician. The written referral must be maintained with the recipient record.

   11. (2) A statement of recipient rights and obligations must be provided to the recipient by the hearing aid dealer at the time the hearing aid is dispensed. The hearing aid dealer must also place a copy of the statement in the recipient's record. The statement must explain the 30 day trial period and the recipient's right to return to the dealer for all necessary adjustments and calibrations of the hearing aid during the 30 day trial period and to return an unsatisfactory hearing aid.

       (g) Review of claims.

   12. (1) The identity of the physician, audiologist, speech and hearing center approved to provide services under the Physically Handicapped Children's Program, or the facility approved pursuant to Article 28 of the Public Health Law and certified to render speech and hearing or audiology services which ordered the hearing aid service or product must be recorded by the hearing aid dealer on the claim for payment by entering in the license or MMIS provider ID number of the orderer where indicated.
   13. (2) The identity of the referring physician must be recorded on the claim for payment for audiology services by entering the license or MMIS provider ID number of the physician where indicated.
   14. (3) Written statements referring persons for audiology services and recommendations or prescriptions for hearing aid services and products must be maintained by the provider submitting the claim for audit by the department or other authorized agency for six years from the date of payment.
   15. (4) Hearing aid dealers must also maintain at each of their business locations the records specified in 19 NYCRR 191.13.

   16. (5) The financial liability of the referring or ordering provider for any audiology services or hearing aid services or products determined on audit not to be medically necessary is set forth in Part 518 of this Title.

       (h) Payment.

   17. (1) Hearing aid services and products payment.

       1. (i) Payment for hearing aid services and products is limited to providers enrolled in the medical assistance program as hearing aid dealers, speech and hearing centers approved by the Physically Handicapped Children's Program to provide speech and hearing services, or facilities approved pursuant to Article 28 of the Public Health Law and certified to render speech and hearing or audiology services.
       2. (ii) Hearing aids must be provided for a trial period of at least 30 days.

       3. (iii) The dispensing and administrative fees, as defined by regulations of the New York State Department of Health, are reimbursable to for-profit hearing aid dealers only.

          1. (a) Payment for hearing aids must not exceed the lower of:

             1. (1) the maximum reimbursable amount for the item, as shown in the fee schedule for hearing aid/audiology services and as determined by the department based on the average cost of products representative of that item; or
             2. (2) the usual and customary price charged to the general public for the same or similar items.

          2. (b) When there is no maximum reimbursable amount listed in the fee schedule for hearing aid/audiology services, payment for hearing aids must not exceed the lower of:

             1. (1) the acquisition cost, net of any discounts or rebates, supported by a copy of the invoice, which must include the brand, model, and serial number of the dispensed hearing aid; or
             2. (2) the usual and customary price charged to the general public for the same or similar items.

          (iv)

       4. (v) Reimbursement for dispensing and administrative fees, batteries, earmolds, and replacement parts is based on the fee schedule for hearing aid/audiology services. The fee schedule for hearing aid/audiology services is available at the Medicaid fiscal agent’s website.

   18. (2) Audiology payment.

       1. (i) Payment is available for audiology services for those providers enrolled in the medical assistance program as audiologists, speech and hearing centers approved by the Physically Handicapped Children's Program to provide speech and hearing services, facilities approved under article 28 of the Public Health Law and certified to render speech and hearing or audiology services, or audiology services which are part of the development of, or furnished pursuant to, an individualized education program or an interim or final individualized family services plan and which are provided by audiologists employed by, or under contract to, a school district, an approved pre-school, a county in the State or the city of New York, an approved early intervention program, or a municipality in the State.
       2. (ii) Reimbursement to qualified audiologists or hearing aid dealers that employ qualified audiologists for audiology services is based on the fee schedule for hearing aid/audiology supplies and services. The fee schedule for hearing aid/audiology supplies and services is available from the department and is also contained in the MMIS Provider Manual (Hearing Aid/Audiology Services). Copies of the manual may be obtained by writing Computer Sciences Corporation, Health and Administrative Services Division, 800 North Pearl St., Albany, NY 12204. Copies may also be obtained from the Department of Social Services, 40 North Pearl St., Albany, NY 12243. The manual is provided free of charge to every provider of audiology services at the time of enrollment in the MA program.
       3. (iii) Reimbursement to facilities approved under article 28 of the Public Health Law and certified to render speech and hearing or audiology services is limited to the rates set by the New York State Department of Health for speech and hearing or audiology services.
       4. (iv) Payment is available for audiology services which are part of the development of, or furnished pursuant to, an individualized education program and are provided by audiologists employed by, or under contract to, a school district, an approved pre-school, or on behalf of a county in the State or the city of New York. Reimbursement for such services must be made in accordance with the provider agreement.
       5. (v) Payment for audiology services which are part of the development of, or furnished pursuant to, an interim or final individualized family services plan and are provided by audiologists employed by, or under contract to, an approved early intervention program or a municipality in the State. Reimbursement for such services must be made in accordance with the provider agreement.

(a) Definitions.