Title 900 | Chapter 005 | Regulation 020E
SUPERSEDED
This document is no longer current.
PREVIOUS VERSION
The previous document that this document is based upon is available.
STATEMENT OF EMERGENCY
900 KAR 5:020E
This emergency administrative regulation is necessary to update the State Health Plan to increase access to diagnostic cardiac catheterization procedures; increase access to Level III neonatal intensive care unit beds; and, consistent with changes in 900 KAR 6:075E filed concurrent with this regulation, grant nonsubstantive review status to certificate of need applications submitted by licensed health facilities: (1) seeking to establish a Class I ground ambulance service to provide nonemergency transport of individuals who are patients of the licensed health facility or a health facility under common ownership and the applicant agrees to the placement of certain restrictions on its proposed certificate of need and ground ambulance license; or (2) seeking to transfer acute care beds to a new facility in the same county if certain criteria are met. This emergency administrative regulation is deemed to be an emergency pursuant to KRS 13A.190(1)(a)1. in order to meet an imminent threat to public health, safety, and welfare. The State Health Plan was not updated with substantive changes to the review criteria during 2020 or 2021 due to the uncertainty created by the COVID-19 pandemic. The pandemic has significantly impacted and strained Kentucky’s healthcare system in unexpected ways. Updated changes to the State Health Plan are needed to immediately help promote access to healthcare across the state and to maintain consistency with the companion regulation filed concurrently, 900 KAR 6:075E, addressing nonsubstantive review of certificate of need applications. This emergency administrative regulation will be replaced by an ordinary administrative regulation in an effort to promote greater access to care across Kentucky, help provide relief to the commonwealth’s overburdened healthcare systems, and help prevent ongoing delays in nonemergency ambulance transportation. The companion ordinary administrative regulation is identical to this emergency administrative regulation.
ANDY BESHEAR, Governor
ERIC C. FRIEDLANDER, Secretary
CABINET FOR HEALTH AND FAMILY SERVICES
Office of Inspector General
Division of Certificate of Need
(Emergency Amendment)
900 KAR 5:020E.State Health Plan for facilities and services.
Section 1.
The(1)
Review a certificate of need application pursuant to KRS 216B.040; and(2)
Determine whether a substantial change to a health service has occurred pursuant to KRS 216B.015(29)(a) and 216B.061(1)(d).Section 2.
Incorporation by Reference.(1)
The "2022 Update to the(2)
This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office of Inspector General, Division of Certificate of Need, 275 East Main Street, 5E-A, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m. This material may also be viewed on the Office of Inspector General's Web site at: https://chfs.ky.gov/agencies/os/oig/dcn/Pages/cn.aspx.ADAM MATHER, Inspector General
ERIC C. FRIEDLANDER, Secretary
APPROVED BY AGENCY: January 25, 2022
FILED WITH LRC: January 27, 2022 at 11 a.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall, if requested, be held on March 21, 2022, 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 March 14, 2022, 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 March 31, 2022. 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; email CHFSregs@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Kara Daniel; Stephanie Brammer-Barnes
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation incorporates by reference the 2022 Update to the State Health Plan.
(b) The necessity of this administrative regulation:
This administrative regulation is necessary to comply with the content of the authorizing statutes, specifically KRS 216B.010, 216B.015(28), and 216B.040(2)(a)2.a.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
This administrative regulation conforms to the content of the authorizing statutes, KRS 216B.010, 216B.015(28), and 216B.040(2)(a)2.a., by establishing the State Health Plan’s review criteria used for determinations regarding the issuance and denial of certificates of need.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation assists in the effective administration of the statutes by establishing the review criteria for certificate of need determinations.
(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:
In response to suggestions and comments submitted to the cabinet by interested groups, the amendment to this administrative regulation makes the following changes to the State Health Plan (SHP): - Updates the title and edition date of the SHP on page i of the Plan; - Updates the page numbers listed in the Table of Contents on page ii to align with the new changes to the SHP; - Updates the title of the SHP on page iii of the Plan under the heading “Purpose”; - Adds new language to the review criteria on pages 2 and 3 to allow acute care hospitals to transfer existing acute care beds to a new hospital under common ownership if: the hospitals are located within the same county; the existing hospital’s overall rating by the Centers for Medicare and Medicaid Services Hospital Compare was three (3) stars or higher for three (3) of the last four (4) reported quarters preceding the date the application was filed; and no more than fifty (50) percent of the existing hospital’s acute care beds are transferred to the new facility. This change aligns with the proposed amendment of 900 KAR 6:075, Section 2(3)(e), filed concurrently with this administrative regulation to grant nonsubstantive review status to certificate of need applications for acute care hospitals that wish to transfer existing acute care beds to a new facility as described above; - Adds new language to the review criteria on page 15 to allow hospitals to convert existing Level II special care neonatal beds to Level III special care neonatal beds; - Revises the language of the review criteria on page 40 to clarify that the addition of a cardiac catheterization program at a hospital shall be based on the existing program’s utilization, rather than a specific laboratory’s utilization; and - Adds new language to the review criteria on page 52 to align with the proposed amendment of 900 KAR 6:075, Section 2(3)(d), filed concurrently with this administrative regulation.
(b) The necessity of the amendment to this administrative regulation:
This amendment is necessary to address updates to the State Health Plan as required by KRS 216B.015(28).
(c) How the amendment conforms to the content of the authorizing statutes:
This amendment conforms to the contend of the authorizing statutes because it incorporates by reference the State Health Plan.
(d) How the amendment will assist in the effective administration of the statutes:
This amendment assists in the effective administration of the statutes by establishing the review criteria for certificate of need determinations.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
This administrative regulation affects entities that submit certificate of need applications and affected persons as defined by KRS 216B.015(3). A total of 70 certificate of need applications were submitted to the cabinet in calendar year 2021 and 60 certificate of need applications were submitted in calendar year 2020.
(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:
Entities that submit a certificate of need application are subject to the criteria set forth in the State Health Plan.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
. The certificate of need application filing fee for nonsubstantive review and formal review is established in a separate administrative regulation, 900 KAR 6:020.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Entities subject to certificate of need approval must demonstrate that their proposal is consistent with the State Health Plan pursuant to KRS 216B.040(2)(a)2.a.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
There are no additional costs to the Office of Inspector General for implementation of this amendment.
(b) On a continuing basis:
There are no additional costs to the Office of Inspector General for implementation of this amendment on a continuing basis.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
State general funds and agency monies are used to implement and enforce this administrative regulation.
(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:
No increase in fees or funding is necessary to implement this amendment.
(8) State whether or not this administrative regulation established any fees or directly or indirectly increased any fees:
This amendment does not establish or increase any fees.
(9) TIERING: Is tiering applied?
Yes, tiering is used as there are different certificate of need review criteria for each licensure category addressed in the State Health Plan.
FISCAL NOTE ON STATE OR LOCAL GOVERNMENT
(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?
This administrative regulation impacts the Cabinet for Health and Family Services, Office of Inspector General, and may impact any government owned or controlled health care facility.
(2) Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 216B.010, 216B.015(28), and 216B.040(2)(a)2.a.
(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.
(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 amendment will not generate additional revenue for state or local government.
(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 amendment will not generate additional revenue for state or local government during subsequent years.
(c) How much will it cost to administer this program for the first year?
This amendment imposes no additional costs on the administrative body.
(d) How much will it cost to administer this program for subsequent years?
This amendment imposes no additional costs on the administrative body during subsequent years.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Revenues (+/-):
See response above.
Expenditures (+/-):
This administrative regulation is anticipated to have minimal fiscal impact to the cabinet.
Other Explanation:
STATEMENT OF EMERGENCY
900 KAR 5:020E
This emergency administrative regulation is necessary to update the State Health Plan to increase access to diagnostic cardiac catheterization procedures; increase access to Level III neonatal intensive care unit beds; and, consistent with changes in 900 KAR 6:075E filed concurrent with this regulation, grant nonsubstantive review status to certificate of need applications submitted by licensed health facilities: (1) seeking to establish a Class I ground ambulance service to provide nonemergency transport of individuals who are patients of the licensed health facility or a health facility under common ownership and the applicant agrees to the placement of certain restrictions on its proposed certificate of need and ground ambulance license; or (2) seeking to transfer acute care beds to a new facility in the same county if certain criteria are met. This emergency administrative regulation is deemed to be an emergency pursuant to KRS 13A.190(1)(a)1. in order to meet an imminent threat to public health, safety, and welfare. The State Health Plan was not updated with substantive changes to the review criteria during 2020 or 2021 due to the uncertainty created by the COVID-19 pandemic. The pandemic has significantly impacted and strained Kentucky’s healthcare system in unexpected ways. Updated changes to the State Health Plan are needed to immediately help promote access to healthcare across the state and to maintain consistency with the companion regulation filed concurrently, 900 KAR 6:075E, addressing nonsubstantive review of certificate of need applications. This emergency administrative regulation will be replaced by an ordinary administrative regulation in an effort to promote greater access to care across Kentucky, help provide relief to the commonwealth’s overburdened healthcare systems, and help prevent ongoing delays in nonemergency ambulance transportation. The companion ordinary administrative regulation is identical to this emergency administrative regulation.
ANDY BESHEAR, Governor
ERIC C. FRIEDLANDER, Secretary
CABINET FOR HEALTH AND FAMILY SERVICES
Office of Inspector General
Division of Certificate of Need
(Emergency Amendment)
900 KAR 5:020E.State Health Plan for facilities and services.
Section 1.
The State Health Plan shall be used to:(1)
Review a certificate of need application pursuant to KRS 216B.040; and(2)
Determine whether a substantial change to a health service has occurred pursuant to KRS 216B.015(29)(a) and 216B.061(1)(d).Section 2.
Incorporation by Reference.(1)
The "2022 Update to the State Health Plan", January 2022 , is incorporated by reference.(2)
This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office of Inspector General, Division of Certificate of Need, 275 East Main Street, 5E-A, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m. This material may also be viewed on the Office of Inspector General's Web site at: https://chfs.ky.gov/agencies/os/oig/dcn/Pages/cn.aspx.ADAM MATHER, Inspector General
ERIC C. FRIEDLANDER, Secretary
APPROVED BY AGENCY: January 25, 2022
FILED WITH LRC: January 27, 2022 at 11 a.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall, if requested, be held on March 21, 2022, 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 March 14, 2022, 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 March 31, 2022. 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; email CHFSregs@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Kara Daniel; Stephanie Brammer-Barnes
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation incorporates by reference the 2022 Update to the State Health Plan.
(b) The necessity of this administrative regulation:
This administrative regulation is necessary to comply with the content of the authorizing statutes, specifically KRS 216B.010, 216B.015(28), and 216B.040(2)(a)2.a.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
This administrative regulation conforms to the content of the authorizing statutes, KRS 216B.010, 216B.015(28), and 216B.040(2)(a)2.a., by establishing the State Health Plan’s review criteria used for determinations regarding the issuance and denial of certificates of need.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation assists in the effective administration of the statutes by establishing the review criteria for certificate of need determinations.
(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:
In response to suggestions and comments submitted to the cabinet by interested groups, the amendment to this administrative regulation makes the following changes to the State Health Plan (SHP): - Updates the title and edition date of the SHP on page i of the Plan; - Updates the page numbers listed in the Table of Contents on page ii to align with the new changes to the SHP; - Updates the title of the SHP on page iii of the Plan under the heading “Purpose”; - Adds new language to the review criteria on pages 2 and 3 to allow acute care hospitals to transfer existing acute care beds to a new hospital under common ownership if: the hospitals are located within the same county; the existing hospital’s overall rating by the Centers for Medicare and Medicaid Services Hospital Compare was three (3) stars or higher for three (3) of the last four (4) reported quarters preceding the date the application was filed; and no more than fifty (50) percent of the existing hospital’s acute care beds are transferred to the new facility. This change aligns with the proposed amendment of 900 KAR 6:075, Section 2(3)(e), filed concurrently with this administrative regulation to grant nonsubstantive review status to certificate of need applications for acute care hospitals that wish to transfer existing acute care beds to a new facility as described above; - Adds new language to the review criteria on page 15 to allow hospitals to convert existing Level II special care neonatal beds to Level III special care neonatal beds; - Revises the language of the review criteria on page 40 to clarify that the addition of a cardiac catheterization program at a hospital shall be based on the existing program’s utilization, rather than a specific laboratory’s utilization; and - Adds new language to the review criteria on page 52 to align with the proposed amendment of 900 KAR 6:075, Section 2(3)(d), filed concurrently with this administrative regulation.
(b) The necessity of the amendment to this administrative regulation:
This amendment is necessary to address updates to the State Health Plan as required by KRS 216B.015(28).
(c) How the amendment conforms to the content of the authorizing statutes:
This amendment conforms to the contend of the authorizing statutes because it incorporates by reference the State Health Plan.
(d) How the amendment will assist in the effective administration of the statutes:
This amendment assists in the effective administration of the statutes by establishing the review criteria for certificate of need determinations.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
This administrative regulation affects entities that submit certificate of need applications and affected persons as defined by KRS 216B.015(3). A total of 70 certificate of need applications were submitted to the cabinet in calendar year 2021 and 60 certificate of need applications were submitted in calendar year 2020.
(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:
Entities that submit a certificate of need application are subject to the criteria set forth in the State Health Plan.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
. The certificate of need application filing fee for nonsubstantive review and formal review is established in a separate administrative regulation, 900 KAR 6:020.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Entities subject to certificate of need approval must demonstrate that their proposal is consistent with the State Health Plan pursuant to KRS 216B.040(2)(a)2.a.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
There are no additional costs to the Office of Inspector General for implementation of this amendment.
(b) On a continuing basis:
There are no additional costs to the Office of Inspector General for implementation of this amendment on a continuing basis.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
State general funds and agency monies are used to implement and enforce this administrative regulation.
(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:
No increase in fees or funding is necessary to implement this amendment.
(8) State whether or not this administrative regulation established any fees or directly or indirectly increased any fees:
This amendment does not establish or increase any fees.
(9) TIERING: Is tiering applied?
Yes, tiering is used as there are different certificate of need review criteria for each licensure category addressed in the State Health Plan.
FISCAL NOTE ON STATE OR LOCAL GOVERNMENT
(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?
This administrative regulation impacts the Cabinet for Health and Family Services, Office of Inspector General, and may impact any government owned or controlled health care facility.
(2) Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 216B.010, 216B.015(28), and 216B.040(2)(a)2.a.
(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.
(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 amendment will not generate additional revenue for state or local government.
(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 amendment will not generate additional revenue for state or local government during subsequent years.
(c) How much will it cost to administer this program for the first year?
This amendment imposes no additional costs on the administrative body.
(d) How much will it cost to administer this program for subsequent years?
This amendment imposes no additional costs on the administrative body during subsequent years.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Revenues (+/-):
See response above.
Expenditures (+/-):
This administrative regulation is anticipated to have minimal fiscal impact to the cabinet.
Other Explanation: