PROPOSALMaryland
Register
Issue Date:
June 22, 2018
Volume
45 • Issue 13 • Pages 671—675
Title
10
MARYLAND DEPARTMENT OF HEALTH
Subtitle
09 MEDICAL CARE PROGRAMS
10.09.51
[Early and Periodic Screening, Diagnosis, and Treatment (EPSDT)] Audiology Services
Authority: Health-General
Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland
Notice of
Proposed Action
[18-156-P]
The Secretary of Health
proposes to amend Regulations .01, .02 and .04—.07,
repeal existing Regulation .03, and adopt new Regulation .03 under COMAR
10.09.51 Audiology Services.
Statement
of Purpose
The purpose of this action
is to update the language for audiology services and expand audiology services
to Maryland Medicaid participants 21 years old or older.
Comparison
to Federal Standards
There is no corresponding
federal standard to this proposed action.
Estimate
of Economic Impact
I. Summary of Economic
Impact. The
Department will expand the audiology program to include Maryland Medicaid
participants 21 years old or older. The net total fund expenditure for this
expansion is approximately $16,000,000 for FY 19.
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Revenue (R+/R-)
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II. Types of Economic Impact.
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Expenditure
(E+/E-)
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Magnitude
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A. On issuing agency:
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(E+)
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$16,000,000
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B. On other State agencies:
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NONE
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C. On local governments:
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NONE
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Benefit (+)
Cost (-)
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Magnitude
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|
|
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D. On regulated industries or trade groups:
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(+)
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$16,000,000
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E. On other industries or trade groups:
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NONE
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F. Direct and indirect effects on public:
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NONE
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III. Assumptions. (Identified by Impact Letter and Number from Section
II.)
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A. The State’s budget allocation for
Fiscal Year 2019 provides for $16,000,000 in total funds to pay for the
expansion of audiology services (hearing aids, cochlear implants) to Maryland
Medicaid participants 21 years of age or older.
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D. The proposed regulations expand
audiology services to include Maryland Medicaid participants 21 years of age
or older. Therefore, the Department anticipates that Medicaid participants
who are newly eligible for audiology services will seek services from
providers in Maryland. As a result, audiology providers will be able to be
reimbursed for service and experience a revenue positive impact of
$16,000,000.
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Economic
Impact on Small Businesses
The proposed action has a
meaningful economic impact on small business. An analysis of this economic
impact follows.
The goal of the proposed
action is to expand audiology services to Maryland Medicaid participants who
are 21 years old or older. Many of the providers that would be affected by the
changes in the regulations are small businesses and would benefit from the
intended changes.
Impact on
Individuals with Disabilities
The proposed action has an
impact on individuals with disabilities as follows:
The proposed action will
enable adults who are at risk for or have a hearing impairment to receive
hearing aids, cochlear implants, and auditory osseointegrated devices.
Opportunity
for Public Comment
Comments may be sent to
Michele Phinney, Director, Office of Regulation and Policy Coordination,
Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD
21201, or call 410-767-6499 (TTY 800-735-2258), or email to
mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through
July 23, 2018. A public hearing has not been scheduled.
.01
Definitions.
A. (text unchanged)
B. Terms Defined.
[(1) “Acquisition cost” means the actual cost of a product to a
provider.
(2) “At risk for hearing impairment” means the
condition of a recipient with a suspect or positive hearing screening or who
possesses a risk factor listed on the High Risk Questionnaire as defined in
COMAR 10.11.02.03.]
(1) “Audiologist” means a professional who is
licensed in accordance with Regulation .02 of this chapter who treats hearing
disorders and communication problems.
[(3)] (2) “[Audiological] 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.
[(4) “Audiological Center.
(a) “Audiological center”
means a multispecialty setting with all necessary equipment for audiological
services that operates for the purpose of providing preventive, diagnostic,
therapeutic, rehabilitative, and palliative audiological services and other
multispecialty services by or under the direction of a licensed practitioner.
(b) “Audiological center”
does not include the office of one or more private audiologists regardless of
whether the office is eligible or receives reimbursement from third-party
payers as an audiological center, if that office provides services only within
a single medical specialty or subspecialty.]
(3) Audiology Center.
(a) “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.
(b) “Audiology center” does
not include the office of one or more private audiologists.
[(5)] (4) “[Audiological] Audiology services”
means services delivered by an audiologist to eligible [recipients] participants in
order to diagnose and treat hearing problems [identified by an
EPSDT screening provider].
[(6) “Audiologist” means a professional who is licensed or
certified in accordance with Regulation .02 of this chapter who treats hearing
disorders and communication problems.
(7) “Auditory brainstem response (ABR)” means a
series of five or more evoked electrical potentials, generated within the
VIIIth cranial nerve and the central auditory pathways in the brainstem, the
measurement of which is used for hearing screening and audiological assessment,
depending upon the protocol used.]
(5) “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.
[(8)] (6) “[Binaural hearing aid] Bilateral”
means [separate amplification of,] relating to or involving both
ears [simultaneously, which usually means two hearing aids, one for
each ear].
(7) “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.
[(9)] (8) “Department” [has the
meaning stated in COMAR 10.09.36.01] 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.
(9) “Designee” means any entity designated to
act on behalf of the Department.
(10)—(11) (text unchanged)
[(12) “Experimental treatment” means an audiological or hearing aid
service that is clinically unproven.]
[(13)] (12) (text unchanged)
[(14)] (13) “Hearing aid dispenser” means a
person who is licensed in accordance with Regulation .02 of this chapter to
sell hearing aids or [provides] provide other
hearing aid services.
[(15)] (14) “Hearing aid evaluation” means
services provided to a [recipient] participant by
an audiologist for determining the benefit of hearing aids and, upon the
audiologist’s recommendation, the dispensing of hearing aids.
[(16) “Hearing screen” means the completed High Risk Questionnaire,
an audiometric, pure tone air conduction test, or tympanometry performed by a
physician, or certified nurse practitioner (CNP) to identify the
need for a referred hearing screening.
(17) “High Risk Questionnaire” means the list of
questions for delineating risk factors to identify neonates and infants who may
be at risk for hearing impairment as defined in COMAR 10.11.02.03.
(18) “Infant” means a Maryland resident who is
younger than 1 year old.
(19) “Jurisdiction” means a state or the
District of Columbia.]
[(20)] (15) “Maryland Medical
Assistance Program (Program)” [has the meaning stated
in COMAR 10.09.36.01.] means the program of comprehensive
medical and other health-related care for indigent and medically indigent
individuals.
[(21)] (16) (text unchanged)
[(22) “Monaural hearing aid” means a single hearing aid
for use in one ear.]
(17) “Participant” means an individual who is enrolled with
the Department to receive Medical Assistance services.
[(24)] (18) “Provider” means an
audiologist, [audiological] audiology center,
or hearing aid dispenser[:
(a) Licensed or certified
in the jurisdiction in which services are rendered to provide services to
recipients;
(b) That meets the
requirements of Regulation .03B(3) of this chapter; and
(c) That through an
appropriate agreement with the Department has been identified as a Program
provider by the issuance of an individual account number] 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.
[(25) “Recipient” has the meaning stated in COMAR 10.09.36.01.]
(19) “Unilateral” means relating to, involving,
or affecting one ear.
.02
Licensure [and Certification] Requirements.
A. In order to provide
services as an audiologist under this chapter, an audiologist[:
(1) Shall] 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 [audiological] audiology services
are performed[; or
(2) If providing services in a jurisdiction
without licensure, shall meet the current standards set forth in 42 CFR
§440.110, which is incorporated by reference].
B. (text unchanged)
.03
Conditions for Participation.
A. A provider shall meet
all conditions for participation as set forth in COMAR 10.09.36.03.
B. Specific requirements
for participation in the Program as an audiologist, audiology center or group,
or hearing aid dispenser are that the provider:
(1) Shall meet the licensure requirements in accordance
with Regulation .02 of this chapter; and
(2) 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.
.04
Covered Services.
The Program covers the
following medically necessary services [for EPSDT
recipients who are at risk for hearing impairment]:
A. [Medically
necessary audiological] Audiology services, as follows:
[Audiological] 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
[(2) Electrophysiological measures such as auditory brainstem
response (ABR), otoacoustic emissions, and brainstem auditory evoked response
for recipients, when one of the following criteria is met:
(a) Failure of the
recipient to provide consistent behavioral responses to auditory signals, using
procedures appropriate for the recipient’s developmental age;
(b) Presence of neuromotor
involvement or behavioral disorder, or both, which precludes observation of
consistent behavioral responses;
(c) Failure to respond to
test signal intensities appropriate for the recipient’s developmental age,
using developmentally appropriate test procedures;
(d) Presence of
inconsistencies in the results of tests administered during the audiological
assessment which suggest, but do not define, a hearing impairment;
(e) The Infant High Risk
Questionnaire delineates a need; or
(f) A physician refers the
infant for the service;]
[(3)] (2) 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
[(4) All services as listed on the Audiology Procedure Code and Fee
Schedule, Revision 2010, contained in the Medical Assistance Audiology Provider
Manual dated November, 2010; and]
B. [Medically
necessary hearing aid] Hearing amplification services,
as follows:
(1) [Hearing] Unilateral or bilateral
hearing aids which are medically necessary and are:
(a) (text unchanged)
(b) 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;
(c) Sold on a 30-day trial
basis; and
(d) Fully covered by
a [repair] manufacturer’s warranty for
a [period] minimum of 2 years, [at
least 1 year of which is provided by the manufacturer] at no cost
to the Program; [and]
[(e) Insured for loss or theft for a period of 2
years per hearing aid; and]
(2) Hearing aid accessories and services, as
listed below:
(a)—(b) (text unchanged)
[(c) Chest harnesses or belts;
(d) Replacement receivers
and cords;
(e) Tone hooks;
;
(g) Protective coverings
for hearing aids;
(h) Battery
testers;
(i) Dehumidification
kits;
(j) Hearing aid
stethoscopes;
(k) Other
amplification-related items recommended by an audiologist;]
[(l)] (c)—[(m)] (d) (text
unchanged)
[(n) Insurance policies as required by §B(1)(c)
and (d) of this regulation; and
(o) Extended repair
warranties.]
(e) Replacement of
unilateral or bilateral hearing aids every 5 years when determined to be
medically necessary; and
(f) Other hearing aid
accessories determined to be medically necessary;
(3) Cochlear implants and related services, as
listed below:
(a) Unilateral or bilateral
implantation of cochlear implant or implants which are medically necessary
including the cost of the device;
(b) Post-operative evaluation
and programming of the cochlear implant or implants;
(c) Aural rehabilitation
services; and
(d) Repair or replacement
of cochlear implant device components subject to the limitations in Regulation
.05 of this chapter; and
(4) Auditory osseointegrated device or devices
and related services, as listed below:
(a) Unilateral or bilateral
implantation of auditory osseointegrated devices which are medically necessary
including the cost of the device;
(b) Non-implantable or
softband device or devices for participants younger than 5 years old;
(c) Evaluation and
programming of the auditory osseointegrated device or devices; and
(d) Repair or replacement,
or both, of auditory osseointegrated device components subject to the
limitations in Regulation .05 of this chapter.
.05
Limitations.
A. Covered audiology [and
postoperative cochlear implant] services, including hearing
aids, cochlear implants, and auditory osseointegrated devices are
limited to:
[(1) Recipients under 21 years old who are referred for the service
or have had cochlear implant surgery;]
[(2)] (1) [One audiological] Unless
the time limitation is waived by the Program, one audiology assessment
per year[, unless the time limitations are waived by the Program];
(2) The initial coverage of:
(a) Bilateral hearing aids
for children younger than 21 years old;
(b) Unilateral hearing aids
for participants 21 years old or older unless otherwise approved by the
Department or its designee;
(c) Bilateral cochlear
implants for participants younger than 21 years old;
(d) Unilateral cochlear
implants for participants 21 years old or older;
(e) Bilateral auditory
osseointegrated devices for participants younger than 21 years old; and
(f) Unilateral auditory
osseointegrated devices for participants 21 years old or older;
(3) [One monaural or binaural] Replacement
of unilateral or bilateral hearing [aid] aids once every [3] 5 years
unless the Program approves more frequent replacement;
(4) Replacement of hearing aids,
cochlear implants and auditory osseointegrated device components that
have been lost, stolen, or damaged beyond repair, after all warranties [and
insurance policies] have expired;
(5) Repairs and replacements that
take place after all warranties [and insurance policies] have
expired;
(6) A maximum of [48] 76 batteries
per [recipient] participant per [year] 12-month
period for a [monaural] unilateral hearing
aid[,] or osseointegrated devices, or [96] 152 batteries
per [recipient] participant per [year] 12-month
period for [a binaural] bilateralhearing [aid,] aids or
osseointegrated devices purchased from the Department not more
frequently than every 6 months, and in quantities of [24] 38 or
fewer for a [monaural] unilateral hearing
aid, or [48] 76 or fewer for a [binaural] bilateral hearing
aid;
(7) A maximum of [476] 180 disposable
batteries for a unilateral cochlear implant per
participant per [calendar year] 12-month
period [,] or 360 disposable batteries per
12-month period for a bilateral cochlear implant purchased not
more frequently than every 6 months, and in quantities
of [238] 90 or fewer for a
unilateral cochlear implant, or 180 or fewer for a bilateral cochlear implant;
(8) Two replacement cochlear implant component
rechargeable batteries per 12-month period for bilateral cochlear
implants, and a maximum of one replacement rechargeable battery for a
unilateral cochlear implant;
(9) 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;
(10) 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; [and]
(11) 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;
[(11)] (12) Charges for routine follow-ups
and adjustments which occur more than 60 days after the dispensing of a new
hearing aid[.];
(13) A maximum of two unilateral earmolds or
four bilateral earmolds per 12-month period for participants younger than 21
years old; and
(14) A maximum of one unilateral earmold or two
bilateral earmolds per 12-month period for participants 21 years old or older.
B. Services which are not
covered are:
(1)—(3) (text unchanged)
(4) Cochlear implant [audiological] audiology services
and external components provided less than 90 days after the surgery or covered
through initial reimbursement for the implant and the surgery;
(5) Spare or backup cochlear implant [speech
processors] components;
(6) [Upgrades to new generation
hearing aids, equipment, cochlear implant speech processors, and other
components if the existing devices are functional, repairable, and
appropriately correct or ameliorate the problem or condition] Spare
or back-up auditory osseointegrated device components;
(7) Replacement of hearing aids, equipment,
cochlear implant [speech processors] components, and
auditory osseointegrated device components [and other
components] if the existing devices are functional, repairable, and
appropriately correct or ameliorate the problem or condition;
(8) (text unchanged)
(9) Repairs to spare or backup hearing aids, cochlear
implants, auditory osseointegrated devices, equipment, or supplies;
(10) Investigational[,] or experimental[,
or ineffective] services or devices, or both;
[(11) Educationally or socially needed services or
equipment;]
[(12)] (11) Replacement of improperly
fitted earmold or earmolds unless the:
(a)—(b) (text unchanged)
[(13)] (12)—[(14)] (13) (text
unchanged)
.06
Preauthorization Requirements.
[A. The Department shall issue
preauthorization for EPSDT Audiology Services when the provider:
(1) Meets Program procedures and limitations;
and
(2) Submits to the Department adequate
documentation demonstrating that the services to be preauthorized are
necessary, as stated in COMAR 10.09.23.07.]
[B.] A. The [Program] Department requires
preauthorization for the following [audiology] services:
(1) [Certain] All hearing
aids;
[(2) Unlisted hearing aid accessories; and
(3) Unlisted post-cochlear implant external
components.]
(2) Certain hearing aid accessories;
(3) All cochlear implant devices and replacement
components except microphone, transmitter cables, and transmitting coils;
(4) All auditory osseointegrated devices; and
(5) Repairs for hearing aids, cochlear implants,
and auditory osseointegrated components exceeding $500.
[C.] B. Preauthorization [for
audiology services expires] is valid:
(1) For services rendered or initiated
within 6 months [from
the authorized span of time that is issued by the Department and is valid if
the recipient is eligible at the time the service is rendered to the recipient.] from
the date the preauthorization was issued; and
(2) If the patient is an eligible participant at
the time the service is rendered.
[D.] C. The following written
documentation shall be submitted by the provider to the Department or
its designee with each request or preauthorization of hearing [aid
that requires preauthorization] aids, cochlear implants, or
auditory osseointegrated devices:
(1) Audiology report documenting medical
necessity of the hearing aids, cochlear implants or auditory osseointegrated
devices;
[(2) Audiogram; and
(3) Written medical approval by a physician.]
(2) Interpretation of the audiogram; and
(3) Medical evaluation by a physician supporting
the medical necessity of the hearing aids, cochlear implants, or auditory
osseointegrated devices within 6 months of the preauthorization request.
.07
Payment Procedures.
[A. Providers shall submit requests for payment
for audiology services as stated in COMAR 10.09.36.04.]
A. To obtain compensation
from the Department for covered services, the provider shall submit a request
for payment using the format designated by the Department.
B. Audiology services are
reimbursed [according to] in accordance with COMAR
10.09.23.01-1.
[C. Audiologists, audiological centers, and hearing
aid dispensers shall charge the Program customary charges, not exceeding those
charged to the general public for similar professional services. If the service
is free to individuals not covered by Medicaid:
(1) The provider:
(a) May charge the Program;
and
(b) Shall be reimbursed in
accordance with §B of this regulation; and
(2) The provider’s reimbursement is not limited
to the provider’s customary charge.
D. The provider shall
charge the Program the acquisition cost for certain hearing aids, accessories,
external cochlear implant accessories, and supplies.
E. The provider shall
itemize all hearing aid and external cochlear implant charges including
accessories, supplies, shipping or handling, or both, insurance, and
warranties.
F. The provider shall
submit the request for payment on the form designated by the Department.]
C. The provider shall be
paid the lesser of:
(1) The provider’s customary charge to the
general public, unless the service is free to individuals not covered by
Medicaid; or
(2) The rate in accordance with the Department’s
fee schedule.
[G.] D. The provider may
not bill the Department or participant for:
(1)—(3) (text unchanged)
[H.] E. [Audiological] 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.
[I.] F. The provider
shall refund to the [Program] Department payment
for hearing aids, supplies, or both, that have been returned to the
manufacturer within the 30-day trial period.
[J.] G. The provider
shall give the [Program] Department the
full advantage of any and all manufacturer’s [warranty] warranties and
trade-ins offered on hearing aids, equipment, or both.
[K. The Program shall reimburse for
covered services at the lesser of:
(1) The provider’s customary charge to the
general public unless the service is free to individuals not covered by
Medicaid; or
(2) The Program’s fee schedule; or
(3) The provider’s acquisition cost for the
following services:
(a) Hearing aids,
accessories, and supplies; and
(b) External cochlear
implant accessories and supplies.
L. The Program
reserves the right to return to the provider, before payment, all invoices not
properly signed, completed, and accompanied by properly completed forms
required by the Department.]
[M.] H. Unless preauthorization
has been granted by the [Program] Department or its
designee, the [Program] Department is
not responsible for any reimbursement to a provider for any service provided
which requires preauthorization.
[N.] I. The [Program] Department may
not make direct payment to [recipients] participants.
[O.] J. (text unchanged)
ROBERT R. NEALL
Secretary of Health