Title 911 | Chapter 001 | Regulation 085
SUPERSEDED
This document is no longer current.
PREVIOUS VERSION
The previous document that this document is based upon is available.
CABINET FOR HEALTH AND FAMILY SERVICES
Office for Children with Special Health Care Needs
Children with Special Health Care Needs Services
(Amendment)
911 KAR 1:085.Early Hearing Detection and Intervention Program.
Section 1.
Definitions.(1)
"AAA Guidelines" means the "Clinical Guidance Document Assessment of Hearing in Infants and Young Children"(2)
"ASHA Guidelines" means the "Guidelines for the Audiologic Assessment of Children from Birth to 5 Years of Age"(3)
"Audiologist" is defined by KRS 334A.020(5).(4)
"Audiology extern" means a student engaged in the clinical experience component of an audiology doctoral degree program.(5)
"Auditory brainstem response" or "ABR" means an objective electrophysiologic measurement of the brainstem's response to the ear when stimulated with a click sound or tone burst.(6)
"Automated auditory brainstem response" or "AABR" means an automatic ABR resulting in a pass/refer outcome.(7)
"JCIH Guidelines" means(8)
"Office for Children with Special Health Care Needs" or "OCSHCN" is defined by KRS 211.645(2).(9)
"Otoacoustic emissions" means an objective physiological test method for measuring responses elicited directly from the cochlea.Section 2.
Eligibility Criteria for Centers.(1)
In order to be eligible for designation as a Level 1 infant audiological assessment and diagnostic center, an entity located in Kentucky shall:(a)
Employ at least one (1) audiologist who:1.
Is currently licensed pursuant to KRS Chapter 334A;2.
Has experience testing children in the age range newborn to three (3) years; and3.
a.
Performs all evaluations; orb.
Directly supervises audiology externs performing evaluations;(b)
Possess the capacity to complete the following tests:1.
Otoscopic examination;2.
Tympanometry;3.
Ipsilateral acoustic reflex measurement;4.
Contralateral acoustic reflex measurement;5.
Ear-specific behavioral observation audiometry;6.
Speech awareness threshold;7.
Speech recognition or reception threshold;8.
Play audiometry; and9.
Either:a.
Otoacoustic emissions with diagnostic or screening capabilities; orb.
ABR screening;(c)
Annually calibrate all measuring and testing equipment; and(d)
Submit a complete application and assurance packet in accordance with Section 3 of this administrative regulation.(2)
In order to be eligible for designation as a Level 2 infant audiological assessment and diagnostic center, an entity located in Kentucky shall:(a)
Meet the requirements specified in subsection (1) of this section; and(b)
Possess the capacity to complete:1.
Otoacoustic emissions with diagnostic or screening capabilities;2.
Frequency-specific ABR;3.
Bone conduction ABR; and4.
Real ear measures.Section 3.
Application Process.(1)
An entity seeking designation as an infant audiological assessment and diagnostic center shall submit to OCSHCN a completed application packet containing:(a)
Completed and signed form OCSHCN-E106(b)
Copies of current professional licenses for audiologists performing evaluations;(c)
Copies of current calibration certificates for audiological testing equipment; and(d)
Copies of policies and procedures for tests and measures requested on the OCSHCN-E106(2)
OCSHCN shall review an entity's application within thirty (30) calendar days of receiving a complete packet submitted in accordance with subsection (1) of this section.(3)
Upon review of an entity's application packet, OCSHCN's executive director or designee shall approve the entity as a Level 1 Infant Audiological Assessment and Diagnostic Center if:(a)
The entity meets the requirements specified in Section 2(1) of this administrative regulation; and(b)
OCSHCN determines that the entity's policies and procedures conform to best practice standards as described in JCIH Guidelines and:1.
AAA Guidelines; or2.
ASHA Guidelines.(4)
Upon review of an entity's application packet, OCSHCN's executive director or designee shall approve the entity as a Level 2 Infant Audiological Assessment and Diagnostic Center if:(a)
The entity meets the requirements specified in Section 2(2) of this administrative regulation; and(b)
OCSHCN determines that the entity's policies and procedures conform to best practice standards as described in JCIH Guidelines and:1.
AAA Guidelines; or2.
ASHA Guidelines.(5)
If OCSHCN's executive director or designee determines that the entity does not meet the requirements specified in Section 2 of this administrative regulation, OCSHCN shall:(a)
Advise the entity and request clarifying information; or(b)
Deny the designation as an Infant Audiological Assessment and Diagnostic Center and notify the entity of appeal rights pursuant to Section 8 of this administrative regulation.(6)
Approvals shall expire on December 31 of odd-numbered years. All entities seeking continued approval shall re-apply by December 1 of that year in accordance with this section.Section 4.
Publication of Approved List.(1)
In accordance with KRS 211.647, OCSHCN shall maintain a current listing of all approved Infant Audiological Assessment and Diagnostic Centers, with contact information.(2)
OCSHCN shall make the listing public through the following methods:(a)
Posting on its agency Web site, http://chfs.ky.gov/agencies/ccshcn;(b)
Providing to the Cabinet for Health and Family Services, Office of Administrative and Technology Services, for inclusion on the KY-CHILD electronic information system used by birthing hospitals and centers;(c)
Enclosing as an attachment to correspondence with parents; and(d)
Mailing a listing to birthing hospitals and centers upon request.Section 5.
Removal from Approved List and Updates Required.(1)
OCSHCN shall remove an entity from the approved list and notify the entity of the removal if the entity requests removal.(2)
If OCSHCN receives a complaint that an entity no longer meets the requirements of Section 2 of this administrative regulation, OCSHCN shall:(a)
Advise the entity of the complaint;(b)
Request clarifying information from the entity;(c)
Review any information received; and(d)
Determine whether the entity meets the eligibility requirements of Section 2 of this administrative regulation.(3)
If OCSHCN determines that the entity no longer meets the eligibility requirements, the office(a)
Notify the entity of appeal rights pursuant to Section 8 of this administrative regulation; and(b)
Remove the entity from the approved list.(4)
Following approval, an Infant Audiological Assessment and Diagnostic Center shall provide documentation via form OCSHCN-E107(a)
Employment or termination of employment of an audiologist;(b)
Change in licensure status of an audiologist;(c)
Relocation of agency, name change, or addition of a location; or(d)
Modification to policy or procedure with regard to evaluations described in Section 2 of this administrative regulation.Section 6.
Reporting Requirements.(1)
Upon completion of diagnostic testing of an infant or child aged birth to three (3) years described in KRS 211.647(5), an approved Infant Audiological Assessment and Diagnostic Center shall report to OCSHCN via form OCSHCN-E3:(a)
Identifying and demographic information;(b)
Results of the follow-up audiological evaluation; and(c)
Documentation of the referral required by KRS 211.647(5).(2)
An approved Infant Audiological Assessment and Diagnostic Center shall submit information specified in subsection (1) of this section electronically via the KY-CHILD electronic information system for permanent hearing loss, within forty-eight (48) hours(3)
Scheduled appointments which are not kept by families shall be marked in the KY-CHILD electronic information system as no-show within four (4) calendar days if not rescheduled.Section 7.
Resource and Informational Materials. OCSHCN shall make available to families of all newborns and children ages birth to three (3) years identified as having permanent hearing loss information provided by the Kentucky Commission on the Deaf and Hard of Hearing.Section 8.
Appeal Rights. An entity denied designation as an Infant Audiological Assessment and Diagnostic Center or which has been removed from the approved list may request an administrative hearing in accordance with 911 KAR 1:090Section 9.
Approved Methods of Auditory Screening for Newborn Infants and Children Ages Birth to Three (3) Years.(1)
Auditory screenings pursuant to KRS 216.2970(1) shall include at least one (1) of the following physiological tests:(a)
AABR; or(b)
Otoacoustic emissions.(2)
Auditory screening reports shall:(a)
Document the results of physiological tests conducted;(b)
Document the presence of any risk factors pursuant to KRS 211.645(5); and(c)
Be submitted via the KY-CHILD electronic information system.Section 10.
Incorporation by Reference.(1)
The following material is incorporated by reference:(a)
"Clinical Guidance Document Assessment of Hearing in Infants and Young Children", 1/2020(b)
"OCSHCN-E106(c)
"OCSHCN-E107(d)
"Guidelines for the Audiologic Assessment of Children From Birth to 5 Years of Age"(e)
"Year 2019(f)
"OCSHCN-E3 Audiology Update Form (AUF) Worksheet", 6/2022.(2)
This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office for Children with Special Health Care Needs, 310 Whittington Parkway, Suite 200, Louisville, Kentucky 40222, Monday through Friday, 8 a.m. to 4:30 p.m. or online at the agency's Web site at https://chfs.ky.gov/agencies/ccshcn.IVANORA ALEXANDER, Executive Director
ERIC C. FRIEDLANDER, Secretary
FILED WITH LRC: November 15, 2022 at 10:20 a.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall, if requested, be held on January 23, 2023, at 9:00 a.m. using the CHFS Office of Legislative and Regulatory Affairs Zoom meeting room. The Zoom invitation will be emailed to each requestor the week prior to the scheduled hearing. Individuals interested in attending this virtual hearing shall notify this agency in writing by January 16,2023, five (5) workdays prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who attends virtually will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on this proposed administrative regulation until January 31, 2023. Send written notification of intent to attend the public hearing or written comments on the proposed administrative regulation to the contact person. Pursuant to KRS 13A.280(8), copies of the statement of consideration and, if applicable, the amended after comments version of the administrative regulation shall be made available upon request.
CONTACT PERSON: Krista Quarles, Policy Analyst, Office of Legislative and Regulatory Affairs, 275 East Main Street 5 W-A, Frankfort, Kentucky 40621; Phone: 502-564-6746; Fax: 502-564-7091; CHFSregs@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Krista Quarles
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This amended regulation helps provide guidance that follows the Early Hearing Detection and Intervention Act and state authority.
(b) The necessity of this administrative regulation:
This amended regulation is needed to ensure that agencies receiving Early Hearing Detection and Intervention Act funding are following the same guidance and outlines the identification process for infant hearing loss.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
This administrative regulation amendment uses the authorized statutes as a base to build the guidance provided in this regulation. This amended regulation allows Kentucky to provide more up-to-date, guidance for assessment and diagnostic audiological centers and revises the reference to "Commission" to "Office," which had been revised earlier. In 2018 Ky. Acts Ch. 114, sec. 1, the General Assembly renamed the "Commission for Children with Special Health Care Needs" as the "Office for Children with Special Health Care Needs." This regulation amends the time frame, when there is evidence of hearing loss, for return of form OCSHCN-E3 to 48 hours from 7 days, to be in compliance with KRS 211.647(5).
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This amended regulation allows Kentucky to provide more up-to-date guidance for assessment and diagnostic audiological centers. This regulation includes a provision to clarify that appeals will go to the Cabinet for Health and Family Services Office of Ombudsman and Administrative Hearings.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation:
This regulation amends the time frame, when there is evidence of hearing loss, for return of form OCSHCN-E3 to 48 hours, from 7 days. The amendment updates the American Academy of Audiology’s guidance document to "Clinical Guidance Document Assessment of Hearing in Infants and Young Children," which was published in 2020. The regulation includes an option for audiological centers to notify the office of a name change, by use of the modification form. Finally, the amendment updates references, including references in forms, to reflect "Office," as referenced in the rest of KAR Chapter 911, rather than "Commission."
(b) The necessity of the amendment to this administrative regulation:
This amendment is needed to comply with current guidelines relevant to the Early Hearing Detection Act.
(c) How the amendment conforms to the content of the authorizing statutes:
This amendment conforms to the existing statutes by updating materials incorporated by reference.
(d) How the amendment will assist in the effective administration of the statutes:
This amendment provides specific updates that follow the existing statutes to best serve the audiological centers seeking certification.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
Kentucky Office for Children with Special Health Care Needs; Children with special health care needs and their families; and Kentucky assessment and diagnostic audiological centers.
(4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:
(a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment:
The agencies above will need to ensure they meet the specified expectations in the updated reference materials. These amendments are to update practice reference materials that take into account newer procedural standards.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
The proposed amended regulation will cost the agencies a minimal amount if not an actual reduction in costs.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
This amended regulation should result in more updated practice references for providers.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
None. Services are currently in place and there is no additional cost.
(b) On a continuing basis:
None. Services are currently in place and there is no additional cost.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
Early Hearing Detection and Intervention Act funding, and State funds.
(7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment:
There will not be a need for an increase of funding requests to implement these proposed changes
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
No fees will be increased based on this amended regulation.
(9) TIERING: Is tiering applied?
There is no tiering for this program as there are no fees related to this program or regulation.
FEDERAL MANDATE ANALYSIS COMPARISON
(1) Federal statute or regulation constituting the federal mandate.
42 U.S.C. 280g-1
(2) State compliance standards.
KRS 194A.030(5), 194A.050(1), 211.647(3), 216.2970(1), 7.136(2)
(3) Minimum or uniform standards contained in the federal mandate.
42 U.S.C. 280g-1
(4) Will this administrative regulation impose stricter requirements, or additional or different responsibilities or requirements, than those required by the federal mandate?
This amendment to the administrative regulation is consistent with federal requirements and does not impose stricter requirements than the federal mandate.
(5) Justification for the imposition of the stricter standard, or additional or different responsibilities or requirements.
This amendment to the administrative regulation is consistent with federal requirements and does not impose stricter requirements than the federal mandate.
FISCAL NOTE
(1) What units, parts, or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation?
Kentucky Office for Children with Special Health Care Needs.
(2) Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS Chapter 211.647(3) and 42 U.S.C. 280g-1.
(3) Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect.
This amended regulation will not affect expenditures and revenue. Services are currently in place and there is no additional cost.
(a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year?
This amended regulation will not generate revenue.
(b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years?
This amended regulation will not generate revenue.
(c) How much will it cost to administer this program for the first year?
This amended regulation will not require additional costs.
(d) How much will it cost to administer this program for subsequent years?
This amended regulation will not require additional costs.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Revenues (+/-):
Expenditures (+/-):
0
Other Explanation:
0
(4) Estimate the effect of this administrative regulation on the expenditures and cost savings of regulated entities for the first full year the administrative regulation is to be in effect.
(a) How much cost savings will this administrative regulation generate for the regulated entities for the first year?
Minimal, in that an email is provided which would save postage.
(b) How much cost savings will this administrative regulation generate for the regulated entities for subsequent years?
Minimal, in that an email is provided which would save postage.
(c) How much will it cost the regulated entities for the first year?
Nothing.
(d) How much will it cost the regulated entities for subsequent years?
Nothing.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Cost Savings (+/-):
0
Expenditures (+/-):
0
Other Explanation:
(5) Explain whether this administrative regulation will have a major economic impact, as defined below.
"Major economic impact" means an overall negative or adverse economic impact from an administrative regulation of five hundred thousand dollars ($500,000) or more on state or local government or regulated entities, in aggregate, as determined by the promulgating administrative bodies. [KRS 13A.010(13)]. The regulation and forms will not have a major economic impact. The amendments are presented to update current authority, and to provide an email address on the forms.
CABINET FOR HEALTH AND FAMILY SERVICES
Office for Children with Special Health Care Needs
Children with Special Health Care Needs Services
(Amendment)
911 KAR 1:085.Early Hearing Detection and Intervention Program.
Section 1.
Definitions.(1)
"AAA Guidelines" means the "Clinical Guidance Document Assessment of Hearing in Infants and Young Children" published by the American Academy of Audiology.(2)
"ASHA Guidelines" means the "Guidelines for the Audiologic Assessment of Children from Birth to 5 Years of Age" published by the American Speech-Language-Hearing Association.(3)
"Audiologist" is defined by KRS 334A.020(5).(4)
"Audiology extern" means a student engaged in the clinical experience component of an audiology doctoral degree program.(5)
"Auditory brainstem response" or "ABR" means an objective electrophysiologic measurement of the brainstem's response to the ear when stimulated with a click sound or tone burst.(6)
"Automated auditory brainstem response" or "AABR" means an automatic ABR resulting in a pass/refer outcome.(7)
"JCIH Guidelines" means "Year 2019 Position Statement: Principles and Guidelines for Early Hearing Detection and Intervention Programs" published by the Joint Committee on Infant Hearing.(8)
"Office for Children with Special Health Care Needs" or "OCSHCN" is defined by KRS 211.645(2).(9)
"Otoacoustic emissions" means an objective physiological test method for measuring responses elicited directly from the cochlea.Section 2.
Eligibility Criteria for Centers.(1)
In order to be eligible for designation as a Level 1 infant audiological assessment and diagnostic center, an entity located in Kentucky shall:(a)
Employ at least one (1) audiologist who:1.
Is currently licensed pursuant to KRS Chapter 334A;2.
Has experience testing children in the age range newborn to three (3) years; and3.
a.
Performs all evaluations; orb.
Directly supervises audiology externs performing evaluations;(b)
Possess the capacity to complete the following tests:1.
Otoscopic examination;2.
Tympanometry;3.
Ipsilateral acoustic reflex measurement;4.
Contralateral acoustic reflex measurement;5.
Ear-specific behavioral observation audiometry;6.
Speech awareness threshold;7.
Speech recognition or reception threshold;8.
Play audiometry; and9.
Either:a.
Otoacoustic emissions with diagnostic or screening capabilities; orb.
ABR screening;(c)
Annually calibrate all measuring and testing equipment; and(d)
Submit a complete application and assurance packet in accordance with Section 3 of this administrative regulation.(2)
In order to be eligible for designation as a Level 2 infant audiological assessment and diagnostic center, an entity located in Kentucky shall:(a)
Meet the requirements specified in subsection (1) of this section; and(b)
Possess the capacity to complete:1.
Otoacoustic emissions with diagnostic or screening capabilities;2.
Frequency-specific ABR;3.
Bone conduction ABR; and4.
Real ear measures.Section 3.
Application Process.(1)
An entity seeking designation as an infant audiological assessment and diagnostic center shall submit to OCSHCN a completed application packet containing:(a)
Completed and signed form OCSHCN-E106, Potential Infant Audiological Assessment and Diagnostic Center Questionnaire;(b)
Copies of current professional licenses for audiologists performing evaluations;(c)
Copies of current calibration certificates for audiological testing equipment; and(d)
Copies of policies and procedures for tests and measures requested on the OCSHCN-E106, Potential Infant Audiological Assessment and Diagnostic Center Questionnaire.(2)
OCSHCN shall review an entity's application within thirty (30) calendar days of receiving a complete packet submitted in accordance with subsection (1) of this section.(3)
Upon review of an entity's application packet, OCSHCN's executive director or designee shall approve the entity as a Level 1 Infant Audiological Assessment and Diagnostic Center if:(a)
The entity meets the requirements specified in Section 2(1) of this administrative regulation; and(b)
OCSHCN determines that the entity's policies and procedures conform to best practice standards as described in JCIH Guidelines and:1.
AAA Guidelines; or2.
ASHA Guidelines.(4)
Upon review of an entity's application packet, OCSHCN's executive director or designee shall approve the entity as a Level 2 Infant Audiological Assessment and Diagnostic Center if:(a)
The entity meets the requirements specified in Section 2(2) of this administrative regulation; and(b)
OCSHCN determines that the entity's policies and procedures conform to best practice standards as described in JCIH Guidelines and:1.
AAA Guidelines; or2.
ASHA Guidelines.(5)
If OCSHCN's executive director or designee determines that the entity does not meet the requirements specified in Section 2 of this administrative regulation, OCSHCN shall:(a)
Advise the entity and request clarifying information; or(b)
Deny the designation as an Infant Audiological Assessment and Diagnostic Center and notify the entity of appeal rights pursuant to Section 8 of this administrative regulation.(6)
Approvals shall expire on December 31 of odd-numbered years. All entities seeking continued approval shall re-apply by December 1 of that year in accordance with this section.Section 4.
Publication of Approved List.(1)
In accordance with KRS 211.647, OCSHCN shall maintain a current listing of all approved Infant Audiological Assessment and Diagnostic Centers, with contact information.(2)
OCSHCN shall make the listing public through the following methods:(a)
Posting on its agency Web site, http://chfs.ky.gov/agencies/ccshcn;(b)
Providing to the Cabinet for Health and Family Services, Office of Administrative and Technology Services, for inclusion on the KY-CHILD electronic information system used by birthing hospitals and centers;(c)
Enclosing as an attachment to correspondence with parents; and(d)
Mailing a listing to birthing hospitals and centers upon request.Section 5.
Removal from Approved List and Updates Required.(1)
OCSHCN shall remove an entity from the approved list and notify the entity of the removal if the entity requests removal.(2)
If OCSHCN receives a complaint that an entity no longer meets the requirements of Section 2 of this administrative regulation, OCSHCN shall:(a)
Advise the entity of the complaint;(b)
Request clarifying information from the entity;(c)
Review any information received; and(d)
Determine whether the entity meets the eligibility requirements of Section 2 of this administrative regulation.(3)
If OCSHCN determines that the entity no longer meets the eligibility requirements, the office shall:(a)
Notify the entity of appeal rights pursuant to Section 8 of this administrative regulation; and(b)
Remove the entity from the approved list.(4)
Following approval, an Infant Audiological Assessment and Diagnostic Center shall provide documentation via form OCSHCN-E107, Infant Audiological Assessment and Diagnostic Center Program Modification, if the changes in circumstances occur:(a)
Employment or termination of employment of an audiologist;(b)
Change in licensure status of an audiologist;(c)
Relocation of agency, name change, or addition of a location; or(d)
Modification to policy or procedure with regard to evaluations described in Section 2 of this administrative regulation.Section 6.
Reporting Requirements.(1)
Upon completion of diagnostic testing of an infant or child aged birth to three (3) years described in KRS 211.647(5), an approved Infant Audiological Assessment and Diagnostic Center shall report to OCSHCN via form OCSHCN-E3:(a)
Identifying and demographic information;(b)
Results of the follow-up audiological evaluation; and(c)
Documentation of the referral required by KRS 211.647(5).(2)
An approved Infant Audiological Assessment and Diagnostic Center shall submit information specified in subsection (1) of this section electronically via the KY-CHILD electronic information system for permanent hearing loss, within forty-eight (48) hours of evaluation, via form OCSHCN-E3.(3)
Scheduled appointments which are not kept by families shall be marked in the KY-CHILD electronic information system as no-show within four (4) calendar days if not rescheduled.Section 7.
Resource and Informational Materials. OCSHCN shall make available to families of all newborns and children ages birth to three (3) years identified as having permanent hearing loss information provided by the Kentucky Commission on the Deaf and Hard of Hearing.Section 8.
Appeal Rights. An entity denied designation as an Infant Audiological Assessment and Diagnostic Center or which has been removed from the approved list may request an administrative hearing in accordance with 911 KAR 1:090.Section 9.
Approved Methods of Auditory Screening for Newborn Infants and Children Ages Birth to Three (3) Years.(1)
Auditory screenings pursuant to KRS 216.2970(1) shall include at least one (1) of the following physiological tests:(a)
AABR; or(b)
Otoacoustic emissions.(2)
Auditory screening reports shall:(a)
Document the results of physiological tests conducted;(b)
Document the presence of any risk factors pursuant to KRS 211.645(5); and(c)
Be submitted via the KY-CHILD electronic information system.Section 10.
Incorporation by Reference.(1)
The following material is incorporated by reference:(a)
"Clinical Guidance Document Assessment of Hearing in Infants and Young Children", 1/2020;(b)
"OCSHCN-E106, Potential Infant Audiological Assessment and Diagnostic Center Questionnaire", 6/2022;(c)
"OCSHCN-E107, Infant Audiological Assessment and Diagnostic Center Program Modification", 6/2022;(d)
"Guidelines for the Audiologic Assessment of Children From Birth to 5 Years of Age" 2004 American Speech-Language-Hearing Association;(e)
"Year 2019 Position Statement: Principles and Guidelines for Early Hearing Detection and Intervention Programs" Joint Committee on Infant Hearing; and(f)
"OCSHCN-E3 Audiology Update Form (AUF) Worksheet", 6/2022.(2)
This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office for Children with Special Health Care Needs, 310 Whittington Parkway, Suite 200, Louisville, Kentucky 40222, Monday through Friday, 8 a.m. to 4:30 p.m. or online at the agency's Web site at https://chfs.ky.gov/agencies/ccshcn.IVANORA ALEXANDER, Executive Director
ERIC C. FRIEDLANDER, Secretary
FILED WITH LRC: November 15, 2022 at 10:20 a.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall, if requested, be held on January 23, 2023, at 9:00 a.m. using the CHFS Office of Legislative and Regulatory Affairs Zoom meeting room. The Zoom invitation will be emailed to each requestor the week prior to the scheduled hearing. Individuals interested in attending this virtual hearing shall notify this agency in writing by January 16,2023, five (5) workdays prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who attends virtually will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on this proposed administrative regulation until January 31, 2023. Send written notification of intent to attend the public hearing or written comments on the proposed administrative regulation to the contact person. Pursuant to KRS 13A.280(8), copies of the statement of consideration and, if applicable, the amended after comments version of the administrative regulation shall be made available upon request.
CONTACT PERSON: Krista Quarles, Policy Analyst, Office of Legislative and Regulatory Affairs, 275 East Main Street 5 W-A, Frankfort, Kentucky 40621; Phone: 502-564-6746; Fax: 502-564-7091; CHFSregs@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Krista Quarles
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This amended regulation helps provide guidance that follows the Early Hearing Detection and Intervention Act and state authority.
(b) The necessity of this administrative regulation:
This amended regulation is needed to ensure that agencies receiving Early Hearing Detection and Intervention Act funding are following the same guidance and outlines the identification process for infant hearing loss.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
This administrative regulation amendment uses the authorized statutes as a base to build the guidance provided in this regulation. This amended regulation allows Kentucky to provide more up-to-date, guidance for assessment and diagnostic audiological centers and revises the reference to "Commission" to "Office," which had been revised earlier. In 2018 Ky. Acts Ch. 114, sec. 1, the General Assembly renamed the "Commission for Children with Special Health Care Needs" as the "Office for Children with Special Health Care Needs." This regulation amends the time frame, when there is evidence of hearing loss, for return of form OCSHCN-E3 to 48 hours from 7 days, to be in compliance with KRS 211.647(5).
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This amended regulation allows Kentucky to provide more up-to-date guidance for assessment and diagnostic audiological centers. This regulation includes a provision to clarify that appeals will go to the Cabinet for Health and Family Services Office of Ombudsman and Administrative Hearings.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation:
This regulation amends the time frame, when there is evidence of hearing loss, for return of form OCSHCN-E3 to 48 hours, from 7 days. The amendment updates the American Academy of Audiology’s guidance document to "Clinical Guidance Document Assessment of Hearing in Infants and Young Children," which was published in 2020. The regulation includes an option for audiological centers to notify the office of a name change, by use of the modification form. Finally, the amendment updates references, including references in forms, to reflect "Office," as referenced in the rest of KAR Chapter 911, rather than "Commission."
(b) The necessity of the amendment to this administrative regulation:
This amendment is needed to comply with current guidelines relevant to the Early Hearing Detection Act.
(c) How the amendment conforms to the content of the authorizing statutes:
This amendment conforms to the existing statutes by updating materials incorporated by reference.
(d) How the amendment will assist in the effective administration of the statutes:
This amendment provides specific updates that follow the existing statutes to best serve the audiological centers seeking certification.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
Kentucky Office for Children with Special Health Care Needs; Children with special health care needs and their families; and Kentucky assessment and diagnostic audiological centers.
(4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:
(a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment:
The agencies above will need to ensure they meet the specified expectations in the updated reference materials. These amendments are to update practice reference materials that take into account newer procedural standards.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
The proposed amended regulation will cost the agencies a minimal amount if not an actual reduction in costs.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
This amended regulation should result in more updated practice references for providers.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
None. Services are currently in place and there is no additional cost.
(b) On a continuing basis:
None. Services are currently in place and there is no additional cost.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
Early Hearing Detection and Intervention Act funding, and State funds.
(7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment:
There will not be a need for an increase of funding requests to implement these proposed changes
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
No fees will be increased based on this amended regulation.
(9) TIERING: Is tiering applied?
There is no tiering for this program as there are no fees related to this program or regulation.
FEDERAL MANDATE ANALYSIS COMPARISON
(1) Federal statute or regulation constituting the federal mandate.
42 U.S.C. 280g-1
(2) State compliance standards.
KRS 194A.030(5), 194A.050(1), 211.647(3), 216.2970(1), 7.136(2)
(3) Minimum or uniform standards contained in the federal mandate.
42 U.S.C. 280g-1
(4) Will this administrative regulation impose stricter requirements, or additional or different responsibilities or requirements, than those required by the federal mandate?
This amendment to the administrative regulation is consistent with federal requirements and does not impose stricter requirements than the federal mandate.
(5) Justification for the imposition of the stricter standard, or additional or different responsibilities or requirements.
This amendment to the administrative regulation is consistent with federal requirements and does not impose stricter requirements than the federal mandate.
FISCAL NOTE
(1) What units, parts, or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation?
Kentucky Office for Children with Special Health Care Needs.
(2) Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS Chapter 211.647(3) and 42 U.S.C. 280g-1.
(3) Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect.
This amended regulation will not affect expenditures and revenue. Services are currently in place and there is no additional cost.
(a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year?
This amended regulation will not generate revenue.
(b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years?
This amended regulation will not generate revenue.
(c) How much will it cost to administer this program for the first year?
This amended regulation will not require additional costs.
(d) How much will it cost to administer this program for subsequent years?
This amended regulation will not require additional costs.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Revenues (+/-):
Expenditures (+/-):
0
Other Explanation:
0
(4) Estimate the effect of this administrative regulation on the expenditures and cost savings of regulated entities for the first full year the administrative regulation is to be in effect.
(a) How much cost savings will this administrative regulation generate for the regulated entities for the first year?
Minimal, in that an email is provided which would save postage.
(b) How much cost savings will this administrative regulation generate for the regulated entities for subsequent years?
Minimal, in that an email is provided which would save postage.
(c) How much will it cost the regulated entities for the first year?
Nothing.
(d) How much will it cost the regulated entities for subsequent years?
Nothing.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Cost Savings (+/-):
0
Expenditures (+/-):
0
Other Explanation:
(5) Explain whether this administrative regulation will have a major economic impact, as defined below.
"Major economic impact" means an overall negative or adverse economic impact from an administrative regulation of five hundred thousand dollars ($500,000) or more on state or local government or regulated entities, in aggregate, as determined by the promulgating administrative bodies. [KRS 13A.010(13)]. The regulation and forms will not have a major economic impact. The amendments are presented to update current authority, and to provide an email address on the forms.