Bill Summary – FastDemocracy

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68th Legislature 2023                                                                                                SB 456.1
                                                SENATE BILL NO. 456
                                            INTRODUCED BY T. VERMEIRE
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  A BILL FOR AN ACT ENTITLED: “AN ACT GENERALLY REVISING LAWS RELATED TO HEARING AID
  DISPENSERS; REORGANIZING AND CLARIFYING GENERALLY APPLICABLE ADMINISTRATIVE
  PROVISIONS; REMOVING REDUNDANT PROVISIONS; TRANSFERRING OVERSIGHT AUTHORITY FROM
  THE BOARD OF HEARING AID DISPENSERS TO A DEPARTMENT OF LABOR AND INDUSTRY
  PROGRAM; ELIMINATING REQUIRED LICENSURE OF A PERSON TO SELL OVER-THE-COUNTER
  HEARING AIDS, MEDICAL EVALUATION REQUIREMENTS, AND RIGHT TO CANCEL CONTRACT;
  EXTENDING RULEMAKING; AMENDING SECTIONS 37-1-401, 37-15-102, 37-15-103, 37-16-102, 37-16-103,
  37-16-202, 37-16-301, 37-16-303, 37-16-402, 37-16-408, AND 37-16-411, MCA; AND REPEALING SECTIONS
  2-15-1740, 37-16-201, 37-16-203, 37-16-304, 37-16-405, 37-16-406, AND 37-16-413, MCA.”
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          WHEREAS, the United States Food and Drug Administration amended regulations effective October
  17, 2022 (87 F.R. 50698, August 17, 2022), that preempt the Montana Code Annotated regulating the sale of
  over-the-counter hearing aids.
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  BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MONTANA:
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          Section 1. Section 37-1-401, MCA, is amended to read:
          "37-1-401.    Uniform regulation for licensing programs without boards -- definitions. As used in
  this part, the following definitions apply:
          (1)      "Complaint" means a written allegation filed with the department that, if true, warrants an
  injunction, disciplinary action against a licensee, or denial of an application submitted by a license applicant.
          (2)      "Department" means the department of labor and industry provided for in 2-15-1701.
          (3)      "Investigation" means the inquiry, analysis, audit, or other pursuit of information by the
  department, with respect to a complaint or other information before the department, that is carried out for the
  purpose of determining:
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68th Legislature 2023                                                                                                 SB 456.1
          (a)      whether a person has violated a provision of law justifying discipline against the person;
          (b)      the status of compliance with a stipulation or order of the department;
          (c)      whether a license should be granted, denied, or conditionally issued; or
          (d)      whether the department should seek an injunction.
          (4)      "License" means permission in the form of a license, permit, endorsement, certificate,
  recognition, or registration granted by the state of Montana to engage in a business activity or practice at a
  specific level in a profession or occupation governed by:
          (a)      Title 37, chapter 16, 35, 72, or 73; or
          (b)      Title 50, chapter 39, 74, or 76.
          (5)      "Profession" or "occupation" means a profession or occupation regulated by the department
  under the provisions of:
          (a)      Title 37, chapter 16, 35, 49, 72, or 73; or
          (b)      Title 50, chapter 39, 74, or 76."
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          Section 2. Section 37-15-102, MCA, is amended to read:
          "37-15-102. Definitions. As used in this chapter, the following definitions apply:
          (1)      "Audiologist" means a person who practices audiology and who meets the qualifications set
  forth in this chapter. A person represents to the public that the person is an audiologist by incorporating in any
  title or description of services or functions that the person directly or indirectly performs the words "audiologist",
  "audiology", "audiometrist", "audiometry", "audiological", "audiometrics", "hearing clinician", "hearing clinic",
  "hearing therapist", "hearing therapy", "hearing center", "hearing aid audiologist", or any similar title or
  description of services.
          (2)      "Audiology assistant" means any person meeting the minimum requirements established by the
  board of speech-language pathologists and audiologists who works directly under the supervision of a licensed
  audiologist.
          (3)      "Board" means the board of speech-language pathologists and audiologists provided for in 2-
  15-1739.
          (4)      "Department" means the department of labor and industry provided for in Title 2, chapter 15,
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68th Legislature 2023                                                                                                SB 456.1
  part 17.
             (5)      "Facilitator" means a trained individual who is physically present with the patient and facilitates
  telehealth at the direction of an audiologist or speech-language pathologist. A facilitator may be but is not
  limited to an audiology assistant or a speech-language pathology assistant.
             (6)      "Over-the-counter hearing aid" has the definition specified in 21 CFR 800.30 in effect on
  January 1, 2023.
             (6)(7)   "Patient" means a consumer of services from an audiologist, a speech-language pathologist, a
  speech-language pathology assistant, or an audiology assistant, including a consumer of those services
  provided through telehealth.
             (7)(8)   "Practice of audiology" means nonmedical diagnosis, assessment, and treatment services
  relating to auditory and vestibular disorders as provided by board rule and includes the selling, dispensing, and
  fitting of hearing aids.
             (8)(9)   "Practice of speech-language pathology" means nonmedical diagnosis, assessment, and
  treatment services relating to speech-language pathology as provided by board rule.
             (10)     "Prescription hearing aid" has the definition specified in 21 CFR 801.422 in effect on January 1,
  2023. The term does not include an over-the-counter hearing aid.
             (9)(11) "Speech-language pathologist" means a person who practices speech-language pathology and
  who meets the qualifications set forth in this chapter. A person represents to the public that the person is a
  speech-language pathologist by incorporating in any title or description of services or functions that the person
  directly or indirectly performs the words "speech pathologist", "speech pathology", "speech correctionist",
  "speech corrections", "speech therapist", "speech therapy", "speech clinician", "speech clinic", "language
  pathologist", "language pathology", "voice therapist", "voice therapy", "voice pathologist", "voice pathology",
  "logopedist", "logopedics", "communicologist", "communicology", "aphasiologist", "aphasiology", "phoniatrist",
  "language therapist", "language clinician", or any similar title or description of services or functions.
             (10)(12) "Speech-language pathology assistant" means a person meeting the minimum requirements
  established by the board who works directly under the supervision of a licensed speech-language pathologist.
             (11)(13) "Telehealth" has the meaning provided in 37-2-305."
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68th Legislature 2023                                                                                               SB 456.1
          Section 3. Section 37-15-103, MCA, is amended to read:
          "37-15-103.    Exemptions -- rulemaking. (1) This chapter does not prevent a person licensed in this
  state under any other law from engaging in the profession or business for which that person is licensed.
          (2)      This chapter does not restrict or prevent activities of a speech-language pathology or audiology
  nature or the use of the official title of the position for which the activities were performed on the part of a
  speech-language pathologist or audiologist employed by federal agencies.
          (3)      Those persons performing activities described in subsection (2) who are not licensed under this
  chapter may perform those activities only within the confines of or under the jurisdiction of the organization in
  which they are employed and may not offer speech-language pathology or audiology services to the public for
  compensation over and above the salary they receive for performance of their official duties with organizations
  by which they are employed. However, without obtaining a license under this chapter, these persons may
  consult or disseminate their research findings and scientific information to other accredited academic
  institutions or governmental agencies. They also may offer lectures to the public for a fee without being licensed
  under this chapter.
          (4)      This chapter does not restrict the activities and services of a student in speech-language
  pathology or audiology from pursuing a course of study in speech-language pathology or audiology at an
  accredited or approved college or university or an approved clinical training facility. However, these activities
  and services must constitute a part of a supervised course of study, and a fee may not accrue directly or
  indirectly to the student. These students must be designated by the title "speech-language pathology or
  audiology intern", "speech-language pathology or audiology trainee", or a title clearly indicating the training
  status appropriate to the level of training.
          (5)      This chapter does not restrict a person from another state from offering speech-language
  pathology or audiology services in this state if the services are performed for not more than 5 days in any
  calendar year and if the services are performed in cooperation with a speech-language pathologist or
  audiologist licensed under this chapter. However, by securing a temporary license from the board subject to
  limitations that the board may impose, a person not a resident of this state who is not licensed under this
  chapter but who is licensed under the law of another state that has established licensure requirements at least
  equivalent to those established by this chapter may offer speech-language pathology or audiology services in
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68th Legislature 2023                                                                                               SB 456.1
  this state for not more than 30 days in any calendar year if the services are performed in cooperation with a
  speech-language pathologist or audiologist licensed under this chapter.
             (6)      This chapter does not restrict a person holding a class A certificate issued by the conference of
  executives of American schools of the deaf from performing the functions for which the person qualifies.
             (7)      This chapter does not restrict a person who is licensed in this state as a hearing aid dispenser
  from performing the functions for which the person qualifies and that are described in Title 37, chapter 16.
             (8)      (a) An audiologist who sells, dispenses, or fits prescription hearing aids is exempt from the
  licensing requirements or other provisions of Title 37, chapter 16, except for the provisions of 37-16-304.
             (b)      The board may adopt rules pertaining to the selling, dispensing, and fitting of prescription
  hearing aids and prescription hearing aid parts, attachments, and accessories."
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             Section 4. Section 37-16-102, MCA, is amended to read:
             "37-16-102. Definitions. Unless the context requires otherwise, in this chapter, the following
  definitions apply:
             (1)   "Board" means the board of hearing aid dispensers provided for in 2-15-1740.
             (2)(1)   "Department" means the department of labor and industry provided for in Title 2, chapter 15,
  part 17.
             (3)   "Hearing aid" means an instrument or device designed for or represented as aiding or improving
  defective human hearing and parts, attachments, or accessories of the instrument or device.
             (4)   "License" means a regular or trainee license.
             (2)      "Licensed hearing aid dispenser" is an individual who fits, sells, and dispenses prescription
  hearing aids.
             (3)      "Over-the-counter hearing aid" has the definition specified in 21 CFR 800.30 in effect on
  January 1, 2023.
             (5)(4)   "Permanent place of business" means the primary site in this state at which a person licensed
  under this chapter conducts testing and fitting of prescription hearing aids and related devices and that is open
  to the public at least 5 days a week.
             (6)   "Place of practice" means either a permanent place of business or a location on record with the
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68th Legislature 2023                                                                                               SB 456.1
  department at which a person licensed under this chapter makes occasional visits. A place of practice must be
  affiliated with a permanent place of business.
          (7)(5)   "Practice of selling, dispensing, and fitting prescription hearing aids" means the evaluation or
  measurement of the powers or range of human hearing by means of an audiometer and a visual examination of
  the ear and canal or by any other means devised and the consequent selection, adaption, sale, dispensing, or
  fitting of prescription hearing aids intended to compensate for hearing loss, including eyeglass prescription
  hearing aids and their fittings, and the making of an impression of the ear and the subsequent selection of a
  proper ear mold, but does not include batteries, cords, or accessories.
          (6)      "Prescription hearing aid" has the definition specified in 21 CFR 801.422 in effect on January 1,
  2023. The term does not include an over-the-counter hearing aid."
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          Section 5. Section 37-16-103, MCA, is amended to read:
          "37-16-103.    Exemptions. This chapter does not apply to a person who is:
          (1)      a physician licensed to practice by the state board of medical examiners;
          (2)      engaged in the practice of fitting prescription hearing aids if the person's practice is part of the
  academic curriculum of an accredited institution of higher education or part of a program conducted by a public
  agency; or
          (3)      licensed as an audiologist under the provisions of Title 37, chapter 15, except that the
  provisions of 37-16-304 apply to licensed audiologists."
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          Section 6. Section 37-16-202, MCA, is amended to read:
          "37-16-202.    Powers and duties -- licensed hearing aid dispenser program. (1) The powers and
  duties of the board are to The department may:
          (a)   license persons who apply and are qualified to practice the fitting of hearing aids;
          (b)   establish a procedure to initiate or receive, investigate, and process complaints from any source
  concerning the activities of persons licensed under this chapter;
          (c)(1)   adopt rules necessary to carry out this chapter;
          (d)(2)   require the periodic inspection and calibration of audiometric testing equipment; and
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68th Legislature 2023                                                                                              SB 456.1
          (e)   initiate legal action to enjoin from operation a person engaged in the sale, dispensing, or fitting of
  hearing aids in this state that is not licensed under this chapter;
          (f)   adopt rules consistent with the provisions of 37-16-301, 37-16-303, 37-16-304, 37-16-402, 37-16-
  405, 37-16-408, and 37-16-411; and
          (g)(3)   establish and adopt minimum requirements for the form of bills of sale and receipts.
          (2)   Rules adopted by the board pursuant to subsection (1)(f) may include but are not limited to rules
  defining the term "related devices" and other rules necessary to implement 37-16-301, 37-16-303, 37-16-304,
  37-16-402, 37-16-405, 37-16-408, and 37-16-411."
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          Section 7. Section 37-16-301, MCA, is amended to read:
          "37-16-301.    Permanent place of business in state necessary -- records -- notice -- designation
  of licensee in charge. (1) A person who is actively engaged in dispensing hearing aids and related devices as
  a business licensed hearing aid dispenser must have a permanent place of business in this state that will be
  opened to serve the public, having the necessary testing, fitting, and hearing aid accessories needed by the
  hard-of-hearing public in the wearing of hearing aids and related devices. All licensed hearing aid dispensers
  shall identify their permanent place of business in all advertising public notices and in all consumer
  correspondence, both written and verbal. More than one hearing aid dispenser licensee may work from a
  permanent place of business.
          (2)   The department shall keep a record of the places of practice of persons who hold regular licenses
  or trainee licenses. A notice required to be given by the board or department to a person who holds a regular or
  tra