HF 2038

as introduced - 93rd Legislature (2023 - 2024) Posted on 02/20/2023 12:21pm

A bill for an act
relating to health; changing provisions for federal compliance for over-the-counter
hearing aids; amending Minnesota Statutes 2022, sections 148.512, subdivisions
10a, 10b, by adding subdivisions; 148.513, subdivision 2a; 148.515, subdivision
6; 148.5175; 148.5195, subdivision 3; 148.5196, subdivision 1; 148.5197; 148.5198;
153A.13, subdivisions 3, 4, 5, 6, 7, 9, 10, 11, by adding subdivisions; 153A.14,
subdivisions 1, 2, 2h, 2i, 2j, 4, 4a, 4b, 4c, 4e, 6, 9, 11; 153A.15, subdivisions 1, 2,
4; 153A.17; 153A.175; 153A.18; 153A.20; repealing Minnesota Statutes 2022,
section 153A.14, subdivision 5.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2022, section 148.512, subdivision 10a, is amended to read:

Subd. 10a.

Hearing aid.

"Hearing aid" means an instrument a prescribed aid, or any of
its parts, worn in the ear canal and designed to or represented as being able to aid or enhance
human hearing. "Hearing aid" includes the aid's parts, attachments, or accessories, including,
but not limited to, ear molds and behind the ear (BTE) devices with or without an ear mold.
Batteries and cords are not parts, attachments, or accessories of a hearing aid. Surgically
implanted hearing aids, and assistive listening devices not worn within the ear canal, are
not hearing aids.

Sec. 2.

Minnesota Statutes 2022, section 148.512, subdivision 10b, is amended to read:

Subd. 10b.

Hearing aid dispensing.

"Hearing aid dispensing" means making ear mold
impressions, prescribing, or recommending a hearing aid, assisting the consumer in
prescription aid selection, selling hearing aids at retail, or testing human hearing in connection
with these activities regardless of whether the person conducting these activities has a
monetary interest in the dispensing of prescription hearing aids to the consumer. Hearing
aid dispensing does not include selling over-the-counter hearing aids.

Sec. 3.

Minnesota Statutes 2022, section 148.512, is amended by adding a subdivision to
read:

Subd. 10c.

Over-the-counter hearing aid or OTC hearing aid.

"Over-the-counter
hearing aid" or "OTC hearing aid" means an air-conduction hearing aid that does not require
implantation or other surgical intervention and is intended for use by a person age 18 or
older to compensate for perceived mild to moderate hearing impairment. The device, through
tools, tests, or software, allows the user to control the hearing aid and customize the hearing
aid to the user's hearing needs. The device may use wireless technology or may include
tests for self-assessment of hearing loss. The device is available over-the-counter, without
the supervision, prescription, or other order, involvement, or intervention of a licensed
person to consumers through in-person transactions, by mail, or online.

Sec. 4.

Minnesota Statutes 2022, section 148.512, is amended by adding a subdivision to
read:

Subd. 13a.

Prescription hearing aid.

"Prescription hearing aid" means a hearing aid
requiring a prescription from a certified hearing aid dispenser or licensed audiologist that
is not an OTC hearing aid.

Sec. 5.

Minnesota Statutes 2022, section 148.513, subdivision 2a, is amended to read:

Subd. 2a.

Hearing aid dispensers.

An audiologist must not hold out as a licensed
prescription hearing aid dispenser.

Sec. 6.

Minnesota Statutes 2022, section 148.515, subdivision 6, is amended to read:

Subd. 6.

Dispensing audiologist examination requirements.

(a) Audiologists are
exempt from the written examination requirement in section 153A.14, subdivision 2h,
paragraph (a), clause (1).

(b) After July 31, 2005, all applicants for audiologist licensure under sections 148.512
to 148.5198 must achieve a passing score on the practical tests of proficiency described in
section 153A.14, subdivision 2h, paragraph (a), clause (2), within the time period described
in section 153A.14, subdivision 2h, paragraph (c).

(c) In order to dispense prescription hearing aids as a sole proprietor, member of a
partnership, or for a limited liability company, corporation, or any other entity organized
for profit, a licensee who obtained audiologist licensure under sections 148.512 to 148.5198,
before August 1, 2005, and who is not certified to dispense prescription hearing aids under
chapter 153A, must achieve a passing score on the practical tests of proficiency described
in section 153A.14, subdivision 2h, paragraph (a), clause (2), within the time period described
in section 153A.14, subdivision 2h, paragraph (c). All other audiologist licensees who
obtained licensure before August 1, 2005, are exempt from the practical tests.

(d) An applicant for an audiology license who obtains a temporary license under section
148.5175 may dispense prescription hearing aids only under supervision of a licensed
audiologist who dispenses prescription hearing aids.

Sec. 7.

Minnesota Statutes 2022, section 148.5175, is amended to read:

148.5175 TEMPORARY LICENSURE.

(a) The commissioner shall issue temporary licensure as a speech-language pathologist,
an audiologist, or both, to an applicant who:

(1) submits a signed and dated affidavit stating that the applicant is not the subject of a
disciplinary action or past disciplinary action in this or another jurisdiction and is not
disqualified on the basis of section 148.5195, subdivision 3; and

(2) either:

(i) provides a copy of a current credential as a speech-language pathologist, an audiologist,
or both, held in the District of Columbia or a state or territory of the United States; or

(ii) provides a copy of a current certificate of clinical competence issued by the American
Speech-Language-Hearing Association or board certification in audiology by the American
Board of Audiology.

(b) A temporary license issued to a person under this subdivision expires 90 days after
it is issued or on the date the commissioner grants or denies licensure, whichever occurs
first.

(c) Upon application, a temporary license shall be renewed twice to a person who is able
to demonstrate good cause for failure to meet the requirements for licensure within the
initial temporary licensure period and who is not the subject of a disciplinary action or
disqualified on the basis of section 148.5195, subdivision 3. Good cause includes but is not
limited to inability to take and complete the required practical exam for dispensing
prescription hearing instruments aids.

(d) Upon application, a temporary license shall be issued to a person who meets the
requirements of section 148.515, subdivisions 2a and 4, but has not completed the
requirement in section 148.515, subdivision 6.

Sec. 8.

Minnesota Statutes 2022, section 148.5195, subdivision 3, is amended to read:

Subd. 3.

Grounds for disciplinary action by commissioner.

The commissioner may
take any of the disciplinary actions listed in subdivision 4 on proof that the individual has:

(1) intentionally submitted false or misleading information to the commissioner or the
advisory council;

(2) failed, within 30 days, to provide information in response to a written request by the
commissioner or advisory council;

(3) performed services of a speech-language pathologist or audiologist in an incompetent
or negligent manner;

(4) violated sections 148.511 to 148.5198;

(5) failed to perform services with reasonable judgment, skill, or safety due to the use
of alcohol or drugs, or other physical or mental impairment;

(6) violated any state or federal law, rule, or regulation, and the violation is a felony or
misdemeanor, an essential element of which is dishonesty, or which relates directly or
indirectly to the practice of speech-language pathology or audiology. Conviction for violating
any state or federal law which relates to speech-language pathology or audiology is
necessarily considered to constitute a violation, except as provided in chapter 364;

(7) aided or abetted another person in violating any provision of sections 148.511 to
148.5198;

(8) been or is being disciplined by another jurisdiction, if any of the grounds for the
discipline is the same or substantially equivalent to those under sections 148.511 to 148.5198;

(9) not cooperated with the commissioner or advisory council in an investigation
conducted according to subdivision 1;

(10) advertised in a manner that is false or misleading;

(11) engaged in conduct likely to deceive, defraud, or harm the public; or demonstrated
a willful or careless disregard for the health, welfare, or safety of a client;

(12) failed to disclose to the consumer any fee splitting or any promise to pay a portion
of a fee to any other professional other than a fee for services rendered by the other
professional to the client;

(13) engaged in abusive or fraudulent billing practices, including violations of federal
Medicare and Medicaid laws, Food and Drug Administration regulations, or state medical
assistance laws;

(14) obtained money, property, or services from a consumer through the use of undue
influence, high pressure sales tactics, harassment, duress, deception, or fraud;

(15) performed services for a client who had no possibility of benefiting from the services;

(16) failed to refer a client for medical evaluation or to other health care professionals
when appropriate or when a client indicated symptoms associated with diseases that could
be medically or surgically treated;

(17) had the certification required by chapter 153A denied, suspended, or revoked
according to chapter 153A;

(18) used the term doctor of audiology, doctor of speech-language pathology, AuD, or
SLPD without having obtained the degree from an institution accredited by the North Central
Association of Colleges and Secondary Schools, the Council on Academic Accreditation
in Audiology and Speech-Language Pathology, the United States Department of Education,
or an equivalent;

(19) failed to comply with the requirements of section 148.5192 regarding supervision
of speech-language pathology assistants; or

(20) if the individual is an audiologist or certified prescription hearing instrument aid
dispenser:

(i) prescribed or otherwise recommended to a consumer or potential consumer the use
of a prescription hearing instrument aid, unless the prescription from a physician or
recommendation from, an audiologist, or a certified dispenser is in writing, is based on an
audiogram that is delivered to the consumer or potential consumer when the prescription
or recommendation is made, and bears the following information in all capital letters of
12-point or larger boldface type: "THIS PRESCRIPTION OR RECOMMENDATION
MAY BE FILLED BY, AND PRESCRIPTION HEARING INSTRUMENTS AIDS MAY
BE PURCHASED FROM, THE LICENSED AUDIOLOGIST OR CERTIFIED DISPENSER
OF YOUR CHOICE";

(ii) failed to give a copy of the audiogram, upon which the prescription or
recommendation is based, to the consumer when the consumer requests a copy;

(iii) failed to provide the consumer rights brochure required by section 148.5197,
subdivision 3;

(iv) failed to comply with restrictions on sales of prescription hearing instruments aids
in sections 148.5197, subdivision 3, and 148.5198;

(v) failed to return a consumer's prescription hearing instrument aid used as a trade-in
or for a discount in the price of a new prescription hearing instrument aid when requested
by the consumer upon cancellation of the purchase agreement;

(vi) failed to follow Food and Drug Administration or Federal Trade Commission
regulations relating to dispensing prescription hearing instruments aids;

(vii) failed to dispense a prescription hearing instrument aid in a competent manner or
without appropriate training;

(viii) delegated prescription hearing instrument aid dispensing authority to a person not
authorized to dispense a prescription hearing instrument aid under this chapter or chapter
153A;

(ix) failed to comply with the requirements of an employer or supervisor of a prescription
hearing instrument aid dispenser trainee;

(x) violated a state or federal court order or judgment, including a conciliation court
judgment, relating to the activities of the individual's prescription hearing instrument aid
dispensing; or

(xi) failed to include on the audiogram the practitioner's printed name, credential type,
credential number, signature, and date.

Sec. 9.

Minnesota Statutes 2022, section 148.5196, subdivision 1, is amended to read:

Subdivision 1.

Membership.

The commissioner shall appoint 12 persons to a
Speech-Language Pathologist and Audiologist Advisory Council. The 12 persons must
include:

(1) three public members, as defined in section 214.02. Two of the public members shall
be either persons receiving services of a speech-language pathologist or audiologist, or
family members of or caregivers to such persons, and at least one of the public members
shall be either a hearing instrument aid user or an advocate of one;

(2) three speech-language pathologists licensed under sections 148.511 to 148.5198,
one of whom is currently and has been, for the five years immediately preceding the
appointment, engaged in the practice of speech-language pathology in Minnesota and each
of whom is employed in a different employment setting including, but not limited to, private
practice, hospitals, rehabilitation settings, educational settings, and government agencies;

(3) one speech-language pathologist licensed under sections 148.511 to 148.5198, who
is currently and has been, for the five years immediately preceding the appointment,
employed by a Minnesota public school district or a Minnesota public school district
consortium that is authorized by Minnesota Statutes and who is licensed in speech-language
pathology by the Professional Educator Licensing and Standards Board;

(4) three audiologists licensed under sections 148.511 to 148.5198, two of whom are
currently and have been, for the five years immediately preceding the appointment, engaged
in the practice of audiology and the dispensing of prescription hearing instruments aids in
Minnesota and each of whom is employed in a different employment setting including, but
not limited to, private practice, hospitals, rehabilitation settings, educational settings, industry,
and government agencies;

(5) one nonaudiologist prescription hearing instrument aid dispenser recommended by
a professional association representing prescription hearing instrument aid dispensers; and

(6) one physician licensed under chapter 147 and certified by the American Board of
Otolaryngology, Head and Neck Surgery.

Sec. 10.

Minnesota Statutes 2022, section 148.5197, is amended to read:

148.5197 HEARING AID DISPENSING.

Subdivision 1.

Content of contracts.

Oral statements made by an audiologist or certified
dispenser regarding the provision of warranties, refunds, and service on the prescription
hearing aid or aids dispensed must be written on, and become part of, the contract of sale,
specify the item or items covered, and indicate the person or business entity obligated to
provide the warranty, refund, or service.

Subd. 2.

Required use of license number.

The audiologist's license number or certified
dispenser's certificate number must appear on all contracts, bills of sale, and receipts used
in the sale of prescription hearing aids.

Subd. 3.

Consumer rights information.

An audiologist or certified dispenser shall, at
the time of the recommendation or prescription, give a consumer rights brochure, prepared
by the commissioner and containing information about legal requirements pertaining to
dispensing of prescription hearing aids, to each potential consumer of a prescription hearing
aid. The brochure must contain information about the consumer information center described
in section 153A.18. A contract for a prescription hearing aid must note the receipt of the
brochure by the consumer, along with the consumer's signature or initials.

Subd. 4.

Liability for contracts.

Owners of entities in the business of dispensing
prescription hearing aids, employers of audiologists or persons who dispense prescription
hearing aids, supervisors of trainees or audiology students, and prescription hearing aid
dispensers conducting the transaction at issue are liable for satisfying all terms of contracts,
written or oral, made by their agents, employees, assignees, affiliates, or trainees, including
terms relating to products, repairs, warranties, service, and refunds. The commissioner may
enforce the terms of prescription hearing aid contracts against the principal, employer,
supervisor, or dispenser who conducted the transaction and may impose any remedy provided
for in this chapter.

Sec. 11.

Minnesota Statutes 2022, section 148.5198, is amended to read:

148.5198 RESTRICTION ON SALE OF PRESCRIPTION HEARING AIDS.

Subdivision 1.

45-calendar-day guarantee and buyer right to cancel.

(a) An audiologist
or certified dispenser dispensing a prescription hearing aid in this state must comply with
paragraphs (b) and (c).

(b) The audiologist or certified dispenser must provide the buyer with a 45-calendar-day
written money-back guarantee. The guarantee must permit the buyer to cancel the purchase
for any reason within 45 calendar days after receiving the prescription hearing aid by giving
or mailing written notice of cancellation to the audiologist or certified dispenser. If the buyer
mails the notice of cancellation, the 45-calendar-day period is counted using the postmark
date, to the date of receipt by the audiologist or certified dispenser. If the prescription hearing
aid must be repaired, remade, or adjusted during the 45-calendar-day money-back guarantee
period, the running of the 45-calendar-day period is suspended one day for each 24-hour
period that the prescription hearing aid is not in the buyer's possession. A repaired, remade,
or adjusted prescription hearing aid must be claimed by the buyer within three business
days after notification of availability, after which time the running of the 45-calendar-day
period resumes. The guarantee must entitle the buyer, upon cancellation, to receive a refund
of payment within 30 days of return of the prescription hearing aid to the audiologist or
certified dispenser. The audiologist or certified dispenser may retain as a cancellation fee
no more than $250 of the buyer's total purchase price of the prescription hearing aid.

(c) The audiologist or certified dispenser shall provide the buyer with a contract written
in plain English, that contains uniform language and provisions that meet the requirements
under the Plain Language Contract Act, sections 325G.29 to 325G.36. The contract must
include, but is not limited to, the following: in immediate proximity to the space reserved
for the signature of the buyer, or on the first page if there is no space reserved for the
signature of the buyer, a clear and conspicuous disclosure of the following specific statement
in all capital letters of no less than 12-point boldface type: "MINNESOTA STATE LAW
GIVES THE BUYER THE RIGHT TO CANCEL THIS PURCHASE FOR ANY REASON
AT ANY TIME PRIOR TO MIDNIGHT OF THE 45TH CALENDAR DAY AFTER
RECEIPT OF THE PRESCRIPTION HEARING AID(S). THIS CANCELLATION MUST
BE IN WRITING AND MUST BE GIVEN OR MAILED TO THE AUDIOLOGIST OR
CERTIFIED DISPENSER. IF THE BUYER DECIDES TO RETURN THE PRESCRIPTION
HEARING AID(S) WITHIN THIS 45-CALENDAR-DAY PERIOD, THE BUYER WILL
RECEIVE A REFUND OF THE TOTAL PURCHASE PRICE OF THE AID(S) FROM
WHICH THE AUDIOLOGIST OR CERTIFIED DISPENSER MAY RETAIN AS A
CANCELLATION FEE NO MORE THAN $250."

Subd. 2.

Itemized repair bill.

Any audiologist, certified dispenser, or company who
agrees to repair a prescription hearing aid must provide the owner of the prescription hearing
aid, or the owner's representative, with a bill that describes the repair and services rendered.
The bill must also include the repairing audiologist's, certified dispenser's, or company's
name, address, and telephone number.

This subdivision does not apply to an audiologist, certified dispenser, or company that
repairs a prescription hearing aid pursuant to an express warranty covering the entire
prescription hearing aid and the warranty covers the entire cost, both parts and labor, of the
repair.

Subd. 3.

Repair warranty.

Any guarantee of prescription hearing aid repairs must be
in writing and delivered to the owner of the prescription hearing aid, or the owner's
representative, stating the repairing audiologist's, certified dispenser's, or company's name,
address, telephone number, length of guarantee, model, and serial number of the prescription
hearing aid and all other terms and conditions of the guarantee.

Subd. 4.

Misdemeanor.

A person found to have violated this section is guilty of a
misdemeanor.

Subd. 5.

Additional.

In addition to the penalty provided in subdivision 4, a person found
to have violated this section is subject to the penalties and remedies provided in section
325F.69, subdivision 1.

Subd. 6.

Estimates.

Upon the request of the owner of a prescription hearing aid or the
owner's representative for a written estimate and prior to the commencement of repairs, a
repairing audiologist, certified dispenser, or company shall provide the customer with a
written estimate of the price of repairs. If a repairing audiologist, certified dispenser, or
company provides a written estimate of the price of repairs, it must not charge more than
the total price stated in the estimate for the repairs. If the repairing audiologist, certified
dispenser, or company after commencing repairs determines that additional work is necessary
to accomplish repairs that are the subject of a written estimate and if the repairing audiologist,
certified dispenser, or company did not unreasonably fail to disclose the possible need for
the additional work when the estimate was made, the repairing audiologist, certified
dispenser, or company may charge more than the estimate for the repairs if the repairing
audiologist, certified dispenser, or company immediately provides the owner or owner's
representative a revised written estimate pursuant to this section and receives authorization
to continue with the repairs. If continuation of the repairs is not authorized, the repairing
audiologist, certified dispenser, or company shall return the prescription hearing aid as close
as possible to its former condition and shall release the prescription hearing aid to the owner
or owner's representative upon payment of charges for repairs actually performed and not
in excess of the original estimate.

Sec. 12.

Minnesota Statutes 2022, section 153A.13, subdivision 3, is amended to read:

Subd. 3.

Hearing instrument aid.

"Hearing instrument aid" means an instrument, or
any of its parts, worn in the ear canal and designed to or represented as being able to aid or
enhance human hearing. "Hearing instrument" includes the instrument's parts, attachments,
or accessories, including, but not limited to, ear molds and behind the ear (BTE) devices
with or without an ear mold. Batteries and cords are not parts, attachments, or accessories
of a hearing instrument. Surgically implanted hearing instruments, and assistive listening
devices not worn within the ear canal, are not hearing instruments. as defined in section
148.512, subdivision 10a.

Sec. 13.

Minnesota Statutes 2022, section 153A.13, subdivision 4, is amended to read:

Subd. 4.

Hearing instrument aid dispensing.

"Hearing instrument aid dispensing"
means making ear mold impressions, prescribing, or recommending a hearing instrument,
assisting the consumer in instrument selection, selling hearing instruments at retail, or testing
human hearing in connection with these activities regardless of whether the person conducting
these activities has a monetary interest in the sale of hearing instruments to the consumer.
has the meaning given in section 148.512, subdivision 10b.

Sec. 14.

Minnesota Statutes 2022, section 153A.13, subdivision 5, is amended to read:

Subd. 5.

Dispenser of prescription hearing instruments aids.

"Dispenser of prescription
hearing instruments aids" means a natural person who engages in prescription hearing
instrument aid dispensing, whether or not certified by the commissioner of health or licensed
by an existing health-related board, except that a person described as follows is not a
dispenser of prescription hearing instruments aids:

(1) a student participating in supervised field work that is necessary to meet requirements
of an accredited educational program if the student is designated by a title which clearly
indicates the student's status as a student trainee; or

(2) a person who helps a dispenser of prescription hearing instruments aids in an
administrative or clerical manner and does not engage in prescription hearing instrument
aid dispensing.

A person who offers to dispense a prescription hearing instrument aid, or a person who
advertises, holds out to the public, or otherwise represents that the person is authorized to
dispense prescription hearing instruments aids, must be certified by the commissioner except
when the person is an audiologist as defined in section 148.512.

Sec. 15.

Minnesota Statutes 2022, section 153A.13, subdivision 6, is amended to read:

Subd. 6.

Advisory council.

"Advisory council" means the Minnesota Prescription
Hearing Instrument Aid Dispenser Advisory Council, or a committee of it the council,
established under section 153A.20.

Sec. 16.

Minnesota Statutes 2022, section 153A.13, subdivision 7, is amended to read:

Subd. 7.

ANSI.

"ANSI" means ANSI S3.6-1989, American National Standard
Specification for Audiometers from the American National Standards Institute. This
document is available through the Minitex interlibrary loan system as defined in the United
States Food and Drug Administration, Code of Federal Regulations, title 21, section
874.1050.

Sec. 17.

Minnesota Statutes 2022, section 153A.13, subdivision 9, is amended to read:

Subd. 9.

Supervision.

"Supervision" means monitoring activities of, and accepting
responsibility for, the prescription hearing instrument aid dispensing activities of a trainee.

Sec. 18.

Minnesota Statutes 2022, section 153A.13, subdivision 10, is amended to read:

Subd. 10.

Direct supervision or directly supervised.

"Direct supervision" or "directly
supervised" means the on-site and contemporaneous location of a supervisor and trainee,
when the supervisor observes the trainee engaging in prescription hearing instrument aid
dispensing with a consumer.

Sec. 19.

Minnesota Statutes 2022, section 153A.13, subdivision 11, is amended to read:

Subd. 11.

Indirect supervision or indirectly supervised.

"Indirect supervision" or
"indirectly supervised" means the remote and independent performance of prescription
hearing instrument aid dispensing by a trainee when authorized under section 153A.14,
subdivision 4a, paragraph (b).

Sec. 20.

Minnesota Statutes 2022, section 153A.13, is amended by adding a subdivision
to read:

Subd. 12.

Over-the-counter hearing aid or OTC hearing aid.

"Over-the-counter
hearing aid" or "OTC hearing aid" has the meaning given in section 148.512, subdivision
10c.

Sec. 21.

Minnesota Statutes 2022, section 153A.13, is amended by adding a subdivision
to read:

Subd. 13.

Prescription hearing aid.

"Prescription hearing aid" has the meaning given
in section 148.512, subdivision 13a.

Sec. 22.

Minnesota Statutes 2022, section 153A.14, subdivision 1, is amended to read:

Subdivision 1.

Application for certificate.

An applicant must:

(1) be 21 years of age or older;

(2) apply to the commissioner for a certificate to dispense prescription hearing instruments
aids on application forms provided by the commissioner;

(3) at a minimum, provide the applicant's name, Social Security number, business address
and phone number, employer, and information about the applicant's education, training,
and experience in testing human hearing and fitting prescription hearing instruments aids;

(4) include with the application a statement that the statements in the application are
true and correct to the best of the applicant's knowledge and belief;

(5) include with the application a written and signed authorization that authorizes the
commissioner to make inquiries to appropriate regulatory agencies in this or any other state
where the applicant has sold prescription hearing instruments aids;

(6) submit certification to the commissioner that the applicant's audiometric equipment
has been calibrated to meet current ANSI standards within 12 months of the date of the
application;

(7) submit evidence of continuing education credits, if required;

(8) submit all fees as required under section 153A.17; and

(9) consent to a fingerprint-based criminal history records check required under section
144.0572, pay all required fees, and cooperate with all requests for information. An applicant
must complete a new criminal background check if more than one year has elapsed since
the applicant last applied for a license.

Sec. 23.

Minnesota Statutes 2022, section 153A.14, subdivision 2, is amended to read:

Subd. 2.

Issuance of certificate.

(a) The commissioner shall issue a certificate to each
dispenser of prescription hearing instruments aids who applies under subdivision 1 if the
commissioner determines that the applicant is in compliance with this chapter, has passed
an examination administered by the commissioner, has met the continuing education
requirements, if required, and has paid the fee set by the commissioner. The commissioner
may reject or deny an application for a certificate if there is evidence of a violation or failure
to comply with this chapter.

(b) The commissioner shall not issue a certificate to an applicant who refuses to consent
to a criminal history background check as required by section 144.0572 within 90 days after
submission of an application or fails to submit fingerprints to the Department of Human
Services. Any fees paid by the applicant to the Department of Health shall be forfeited if
the applicant refuses to consent to the background study.

Sec. 24.

Minnesota Statutes 2022, section 153A.14, subdivision 2h, is amended to read:

Subd. 2h.

Certification by examination.

An applicant must achieve a passing score,
as determined by the commissioner, on an examination according to paragraphs (a) to (c).

(a) The examination must include, but is not limited to:

(1) A written examination approved by the commissioner covering the following areas
as they pertain to prescription hearing instrument aid selling:

(i) basic physics of sound;

(ii) the anatomy and physiology of the ear;

(iii) the function of prescription hearing instruments aids; and

(iv) the principles of prescription hearing instrument aid selection.

(2) Practical tests of proficiency in the following techniques as they pertain to prescription
hearing instrument aid selling:

(i) pure tone audiometry, including air conduction testing and bone conduction testing;

(ii) live voice or recorded voice speech audiometry including speech recognition
(discrimination) testing, most comfortable loudness level, and uncomfortable loudness
measurements of tolerance thresholds;

(iii) masking when indicated;

(iv) recording and evaluation of audiograms and speech audiometry to determine proper
selection and fitting of a prescription hearing instrument aid;

(v) taking ear mold impressions;

(vi) using an otoscope for the visual observation of the entire ear canal; and

(vii) state and federal laws, rules, and regulations.

(b) The practical examination shall be administered by the commissioner at least twice
a year.

(c) An applicant must achieve a passing score on all portions of the examination within
a two-year period. An applicant who does not achieve a passing score on all portions of the
examination within a two-year period must retake the entire examination and achieve a
passing score on each portion of the examination. An applicant who does not apply for
certification within one year of successful completion of the examination must retake the
examination and achieve a passing score on each portion of the examination. An applicant
may not take any part of the practical examination more than three times in a two-year
period.

Sec. 25.

Minnesota Statutes 2022, section 153A.14, subdivision 2i, is amended to read:

Subd. 2i.

Continuing education requirement.

On forms provided by the commissioner,
each certified dispenser must submit with the application for renewal of certification evidence
of completion of ten course hours of continuing education earned within the 12-month
period of November 1 to October 31, between the effective and expiration dates of
certification. Continuing education courses must be directly related to prescription hearing
instrument aid dispensing and approved by the International Hearing Society, the American
Speech-Language-Hearing Association, or the American Academy of Audiology. Evidence
of completion of the ten course hours of continuing education must be submitted by
December 1 of each year. This requirement does not apply to dispensers certified for less
than one year.

Sec. 26.

Minnesota Statutes 2022, section 153A.14, subdivision 2j, is amended to read:

Subd. 2j.

Required use of certification number.

The certification holder must use the
certification number on all contracts, bills of sale, and receipts used in the sale of prescription
hearing instruments aids.

Sec. 27.

Minnesota Statutes 2022, section 153A.14, subdivision 4, is amended to read:

Subd. 4.

Dispensing of prescription hearing instruments aids without
certificate.

Except as provided in subdivisions 4a and 4c, and in sections 148.512 to
148.5198, it is unlawful for any person not holding a valid certificate to dispense a
prescription hearing instrument aid as defined in section 153A.13, subdivision 3. A person
who dispenses a prescription hearing instrument aid without the certificate required by this
section is guilty of a gross misdemeanor.

Sec. 28.

Minnesota Statutes 2022, section 153A.14, subdivision 4a, is amended to read:

Subd. 4a.

Trainees.

(a) A person who is not certified under this section may dispense
prescription hearing instruments aids as a trainee for a period not to exceed 12 months if
the person:

(1) submits an application on forms provided by the commissioner;

(2) is under the supervision of a certified dispenser meeting the requirements of this
subdivision;

(3) meets all requirements for certification except passage of the examination required
by this section; and

(4) uses the title "dispenser trainee" in contacts with the patients, clients, or consumers.

(b) A certified prescription hearing instrument aid dispenser may not supervise more
than two trainees at the same time and may not directly supervise more than one trainee at
a time. The certified dispenser is responsible for all actions or omissions of a trainee in
connection with the dispensing of prescription hearing instruments aids. A certified dispenser
may not supervise a trainee if there are any commissioner, court, or other orders, currently
in effect or issued within the last five years, that were issued with respect to an action or
omission of a certified dispenser or a trainee under the certified dispenser's supervision.

Until taking and passing the practical examination testing the techniques described in
subdivision 2h, paragraph (a), clause (2), trainees must be directly supervised in all areas
described in subdivision 4b, and the activities tested by the practical examination. Thereafter,
trainees may dispense prescription hearing instruments aids under indirect supervision until
expiration of the trainee period. Under indirect supervision, the trainee must complete two
monitored activities a week. Monitored activities may be executed by correspondence,
telephone, or other telephonic devices, and include, but are not limited to, evaluation of
audiograms, written reports, and contracts. The time spent in supervision must be recorded
and the record retained by the supervisor.

Sec. 29.

Minnesota Statutes 2022, section 153A.14, subdivision 4b, is amended to read:

Subd. 4b.

Prescription hearing testing protocol.

A dispenser when conducting a hearing
test for the purpose of prescription hearing instrument aid dispensing must:

(1) comply with the United States Food and Drug Administration warning regarding
potential medical conditions required by Code of Federal Regulations, title 21, section
801.420 801.422;

(2) complete a case history of the client's hearing;

(3) inspect the client's ears with an otoscope; and

(4) conduct the following tests on both ears of the client and document the results, and
if for any reason one of the following tests cannot be performed pursuant to the United
States Food and Drug Administration guidelines, an audiologist shall evaluate the hearing
and the need for a prescription hearing instrument aid:

(i) air conduction at 250, 500, 1,000, 2,000, 4,000, and 8,000 Hertz. When a difference
of 20 dB or more occurs between adjacent octave frequencies the interoctave frequency
must be tested;

(ii) bone conduction at 500, 1,000, 2,000, and 4,000 Hertz for any frequency where the
air conduction threshold is greater than 15 dB HL;

(iii) monaural word recognition (discrimination), with a minimum of 25 words presented
for each ear; and

(iv) loudness discomfort level, monaural, for setting a prescription hearing instrument's
aid's maximum power output; and

(5) include masking in all tests whenever necessary to ensure accurate results.

Sec. 30.

Minnesota Statutes 2022, section 153A.14, subdivision 4c, is amended to read:

Subd. 4c.

Reciprocity.

(a) A person who has dispensed prescription hearing instruments
aids in another jurisdiction may dispense prescription hearing instruments aids as a trainee
under indirect supervision if the person:

(1) satisfies the provisions of subdivision 4a, paragraph (a);

(2) submits a signed and dated affidavit stating that the applicant is not the subject of a
disciplinary action or past disciplinary action in this or another jurisdiction and is not
disqualified on the basis of section 153A.15, subdivision 1; and

(3) provides a copy of a current credential as a prescription hearing instrument aid
dispenser held in the District of Columbia or a state or territory of the United States.

(b) A person becoming a trainee under this subdivision who fails to take and pass the
practical examination described in subdivision 2h, paragraph (a), clause (2), when next
offered must cease dispensing prescription hearing instruments aids unless under direct
supervision.

Sec. 31.

Minnesota Statutes 2022, section 153A.14, subdivision 4e, is amended to read:

Subd. 4e.

Prescription hearing aids; enforcement.

Costs incurred by the Minnesota
Department of Health for conducting investigations of unlicensed prescription hearing aid
dispensers dispensing shall be apportioned between all licensed or credentialed professions
that dispense prescription hearing aids.

Sec. 32.

Minnesota Statutes 2022, section 153A.14, subdivision 6, is amended to read:

Subd. 6.

Prescription hearing instruments aids to comply with federal and state
requirements.

The commissioner shall ensure that prescription hearing instruments aids
are dispensed in compliance with state requirements and the requirements of the United
States Food and Drug Administration. Failure to comply with state or federal regulations
may be grounds for enforcement actions under section 153A.15, subdivision 2.

Sec. 33.

Minnesota Statutes 2022, section 153A.14, subdivision 9, is amended to read:

Subd. 9.

Consumer rights.

A prescription hearing instrument aid dispenser shall comply
with the requirements of sections 148.5195, subdivision 3, clause (20); 148.5197; and
148.5198.

Sec. 34.

Minnesota Statutes 2022, section 153A.14, subdivision 11, is amended to read:

Subd. 11.

Requirement to maintain current information.

A dispenser must notify the
commissioner in writing within 30 days of the occurrence of any of the following:

(1) a change of name, address, home or business telephone number, or business name;

(2) the occurrence of conduct prohibited by section 153A.15;

(3) a settlement, conciliation court judgment, or award based on negligence, intentional
acts, or contractual violations committed in the dispensing of prescription hearing instruments
aids by the dispenser; and

(4) the cessation of prescription hearing instrument aid dispensing activities as an
individual or a business.

Sec. 35.

Minnesota Statutes 2022, section 153A.15, subdivision 1, is amended to read:

Subdivision 1.

Prohibited acts.

The commissioner may take enforcement action as
provided under subdivision 2 against a dispenser of prescription hearing instruments aids
for the following acts and conduct:

(1) dispensing a prescription hearing instrument aid to a minor person 18 years or younger
unless evaluated by an audiologist for hearing evaluation and prescription hearing aid
evaluation;

(2) being disciplined through a revocation, suspension, restriction, or limitation by
another state for conduct subject to action under this chapter;

(3) presenting advertising that is false or misleading;

(4) providing the commissioner with false or misleading statements of credentials,
training, or experience;

(5) engaging in conduct likely to deceive, defraud, or harm the public; or demonstrating
a willful or careless disregard for the health, welfare, or safety of a consumer;

(6) splitting fees or promising to pay a portion of a fee to any other professional other
than a fee for services rendered by the other professional to the client;

(7) engaging in abusive or fraudulent billing practices, including violations of federal
Medicare and Medicaid laws, Food and Drug Administration regulations, or state medical
assistance laws;

(8) obtaining money, property, or services from a consumer through the use of undue
influence, high pressure sales tactics, harassment, duress, deception, or fraud;

(9) performing the services of a certified prescription hearing instrument aid dispenser
in an incompetent or negligent manner;

(10) failing to comply with the requirements of this chapter as an employer, supervisor,
or trainee;

(11) failing to provide information in a timely manner in response to a request by the
commissioner, commissioner's designee, or the advisory council;

(12) being convicted within the past five years of violating any laws of the United States,
or any state or territory of the United States, and the violation is a felony, gross misdemeanor,
or misdemeanor, an essential element of which relates to prescription hearing instrument
aid dispensing, except as provided in chapter 364;

(13) failing to cooperate with the commissioner, the commissioner's designee, or the
advisory council in any investigation;

(14) failing to perform prescription hearing instrument aid dispensing with reasonable
judgment, skill, or safety due to the use of alcohol or drugs, or other physical or mental
impairment;

(15) failing to fully disclose actions taken against the applicant or the applicant's legal
authorization to dispense prescription hearing instruments aids in this or another state;

(16) violating a state or federal court order or judgment, including a conciliation court
judgment, relating to the activities of the applicant in prescription hearing instrument aid
dispensing;

(17) having been or being disciplined by the commissioner of the Department of Health,
or other authority, in this or another jurisdiction, if any of the grounds for the discipline are
the same or substantially equivalent to those in sections 153A.13 to 153A.18;

(18) misrepresenting the purpose of hearing tests, or in any way communicating that the
hearing test or hearing test protocol required by section 153A.14, subdivision 4b, is a medical
evaluation, a diagnostic hearing evaluation conducted by an audiologist, or is other than a
test to select a prescription hearing instrument aid, except that the prescription hearing
instrument aid dispenser can determine the need for or recommend the consumer obtain a
medical evaluation consistent with requirements of the United States Food and Drug
Administration;

(19) violating any of the provisions of sections 148.5195, subdivision 3, clause (20);
148.5197; 148.5198; and 153A.13 to 153A.18; and

(20) aiding or abetting another person in violating any of the provisions of sections
148.5195, subdivision 3, clause (20); 148.5197; 148.5198; and 153A.13 to 153A.18.

Sec. 36.

Minnesota Statutes 2022, section 153A.15, subdivision 2, is amended to read:

Subd. 2.

Enforcement actions.

When the commissioner finds that a dispenser of
prescription hearing instruments aids has violated one or more provisions of this chapter,
the commissioner may do one or more of the following:

(1) deny or reject the application for a certificate;

(2) revoke the certificate;

(3) suspend the certificate;

(4) impose, for each violation, a civil penalty that deprives the dispenser of any economic
advantage gained by the violation and that reimburses the Department of Health for costs
of the investigation and proceeding resulting in disciplinary action, including the amount
paid for services of the Office of Administrative Hearings, the amount paid for services of
the Office of the Attorney General, attorney fees, court reporters, witnesses, reproduction
of records, advisory council members' per diem compensation, department staff time, and
expenses incurred by advisory council members and department staff;

(5) censure or reprimand the dispenser;

(6) revoke or suspend the right to supervise trainees;

(7) revoke or suspend the right to be a trainee;

(8) impose a civil penalty not to exceed $10,000 for each separate violation; or

(9) any other action reasonably justified by the individual case.

Sec. 37.

Minnesota Statutes 2022, section 153A.15, subdivision 4, is amended to read:

Subd. 4.

Penalties.

Except as provided in section 153A.14, subdivision 4, a person
violating this chapter is guilty of a misdemeanor. The commissioner may impose an automatic
civil penalty equal to one-fourth the renewal fee on each prescription hearing instrument
seller aid dispenser who fails to renew the certificate required in section 153A.14 by the
renewal deadline.

Sec. 38.

Minnesota Statutes 2022, section 153A.17, is amended to read:

153A.17 EXPENSES; FEES.

(a) The expenses for administering the certification requirements, including the complaint
handling system for prescription hearing aid dispensers in sections 153A.14 and 153A.15,
and the Consumer Information Center under section 153A.18, must be paid from initial
application and examination fees, renewal fees, penalties, and fines. The commissioner shall
only use fees collected under this section for the purposes of administering this chapter.
The legislature must not transfer money generated by these fees from the state government
special revenue fund to the general fund. Surcharges collected by the commissioner of health
under section 16E.22 are not subject to this paragraph.

(b) The fees are as follows:

(1) the initial certification application fee is $772.50;

(2) the annual renewal certification application fee is $750;

(3) the initial examination fee for the practical portion is $1,200, and $600 for each time
it is taken, thereafter; for individuals meeting the requirements of section 148.515, subdivision
2, the fee for the practical portion of the prescription hearing instrument aid dispensing
examination is $600 each time it is taken;

(4) the trainee application fee is $230;

(5) the penalty fee for late submission of a renewal application is $260; and

(6) the fee for verification of certification to other jurisdictions or entities is $25.

(c) The commissioner may prorate the certification fee for new applicants based on the
number of quarters remaining in the annual certification period.

(d) All fees are nonrefundable. All fees, penalties, and fines received must be deposited
in the state government special revenue fund.

(e) Hearing instrument dispensers who were certified before January 1, 2018, shall pay
a onetime surcharge of $22.50 to renew their certification when it expires after October 31,
2020. The surcharge shall cover the commissioner's costs associated with criminal
background checks.

Sec. 39.

Minnesota Statutes 2022, section 153A.175, is amended to read:

153A.175 PENALTY FEES.

(a) The penalty fee for holding oneself out as a prescription hearing instrument aid
dispenser without a current certificate after the credential has expired and before it is renewed
is one-half the amount of the certificate renewal fee for any part of the first day, plus one-half
the certificate renewal fee for any part of any subsequent days up to 30 days.

(b) The penalty fee for applicants who hold themselves out as prescription hearing
instrument aid dispensers after expiration of the trainee period and before being issued a
certificate is one-half the amount of the certificate application fee for any part of the first
day, plus one-half the certificate application fee for any part of any subsequent days up to
30 days. This paragraph does not apply to applicants not qualifying for a certificate who
hold themselves out as prescription hearing instrument aid dispensers.

(c) The penalty fee for practicing prescription hearing instrument aid dispensing and
failing to submit a continuing education report by the due date with the correct number or
type of hours in the correct time period is $200 plus $200 for each missing clock hour.
"Missing" means not obtained between the effective and expiration dates of the certificate,
the one-month period following the certificate expiration date, or the 30 days following
notice of a penalty fee for failing to report all continuing education hours. The certificate
holder must obtain the missing number of continuing education hours by the next reporting
due date.

(d) Civil penalties and discipline incurred by certificate holders prior to August 1, 2005,
for conduct described in paragraph (a), (b), or (c) shall be recorded as nondisciplinary penalty
fees. Payment of a penalty fee does not preclude any disciplinary action reasonably justified
by the individual case.

Sec. 40.

Minnesota Statutes 2022, section 153A.18, is amended to read:

153A.18 CONSUMER INFORMATION CENTER.

The commissioner shall establish a Consumer Information Center to assist actual and
potential purchasers of prescription hearing aids by providing them with information
regarding prescription hearing instrument aid sales. The Consumer Information Center shall
disseminate information about consumers' legal rights related to prescription hearing
instrument aid sales, provide information relating to complaints about dispensers of
prescription hearing instruments aids, and provide information about outreach and advocacy
services for consumers of prescription hearing instruments aids. In establishing the center
and developing the information, the commissioner shall consult with representatives of
prescription hearing instrument aid dispensers, audiologists, physicians, and consumers.

Sec. 41.

Minnesota Statutes 2022, section 153A.20, is amended to read:

153A.20 PRESCRIPTION HEARING INSTRUMENT AID DISPENSER
ADVISORY COUNCIL.

Subdivision 1.

Membership.

(a) The commissioner shall appoint seven persons to a
Prescription Hearing Instrument Aid Dispenser Advisory Council.

(b) The seven persons must include:

(1) three public members, as defined in section 214.02. At least one of the public members
shall be a prescription hearing instrument aid user and one of the public members shall be
either a prescription hearing instrument aid user or an advocate of one;

(2) three prescription hearing instrument aid dispensers certified under sections 153A.14
to 153A.20, each of whom is currently, and has been for the five years immediately preceding
their appointment, engaged in prescription hearing instrument aid dispensing in Minnesota
and who represent the occupation of prescription hearing instrument aid dispensing and
who are not audiologists; and

(3) one audiologist licensed as an audiologist under chapter 148 who dispenses
prescription hearing instruments aids, recommended by a professional association
representing audiologists and speech-language pathologists.

(c) The factors the commissioner may consider when appointing advisory council
members include, but are not limited to, professional affiliation, geographical location, and
type of practice.

(d) No two members of the advisory council shall be employees of, or have binding
contracts requiring sales exclusively for, the same prescription hearing instrument aid
manufacturer or the same employer.

Subd. 2.

Organization.

The advisory council shall be organized and administered
according to section 15.059. The council may form committees to carry out its duties.

Subd. 3.

Duties.

At the commissioner's request, the advisory council shall:

(1) advise the commissioner regarding prescription hearing instrument aid dispenser
certification standards;

(2) provide for distribution of information regarding prescription hearing instrument aid
dispenser certification standards;

(3) review investigation summaries of competency violations and make recommendations
to the commissioner as to whether the allegations of incompetency are substantiated; and

(4) perform other duties as directed by the commissioner.

Sec. 42. REPEALER.

Minnesota Statutes 2022, section 153A.14, subdivision 5, is repealed.

APPENDIX

Repealed Minnesota Statutes: 23-00414

153A.14 REGULATION.

Subd. 5.

Rulemaking authority.

The commissioner shall adopt rules under chapter 14 to implement this chapter. The rules may include procedures and standards relating to the certification requirement, the scope of authorized practice, fees, supervision required, continuing education, career progression, disciplinary matters, and examination procedures.