Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO:
KRS
216B.010,
216B.015,
216B.040,
216B.062,
216B.090,
216B.095,
216B.115,
216B.455,
216B.990
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
216B.040(2)(a) 1. requires
the Cabinet for Health and Family Services to administer Kentucky's Certificate
of Need Program and to promulgate administrative regulations as necessary for
the program. KRS
216B.095 authorizes the review of certificate
of need applications that are granted nonsubstantive status. This
administrative regulation establishes the requirements necessary for
consideration for nonsubstantive review of applications for the orderly
administration of the Certificate of Need Program.
Section 1. Definitions.
(1) "Ambulatory surgical center" is defined
by KRS
216B.015(4).
(2) "Cabinet" is defined by
KRS
216B.015(6).
(3) "Certificate of Need Newsletter" means
the monthly newsletter that is published by the cabinet regarding certificate
of need matters and is available on the Certificate of Need Web site at
https://chfs.ky.gov/agencies/os/oig/dcn/Pages/cn.Aspx.
(4) "Days" means calendar days, unless
otherwise specified.
(5) "Formal
review" means the review of an application for certificate of need that is
reviewed within ninety (90) days from the commencement of the review as
provided by KRS
216B.062(1) and that is
reviewed for compliance with the review criteria set forth at
KRS
216B.040 and
900 KAR 6:070.
(6) "Nonsubstantive review" is defined by
KRS
216B.015(18).
(7) "Public notice" means notice given
through the cabinet's Certificate of Need Newsletter.
Section 2. Nonsubstantive Review.
(1) The cabinet shall grant nonsubstantive
review status to an application to change the location of a proposed health
facility or to relocate a licensed health facility only if:
(a) There is no substantial change in health
services or bed capacity; and
(b)
1. The change of location or relocation is
within the same county; or
2. The
change of location or relocation is for a psychiatric residential treatment
facility.
(2)
The cabinet shall grant nonsubstantive review status to an application that
proposes to establish an ambulatory surgical center pursuant to the conditions
specified in KRS
216B.095(7).
(3) In addition to the projects specified in
KRS
216B.095(3)(a) through (e),
pursuant to KRS
216B.095(3)(f), the Office
of Inspector General shall grant nonsubstantive review status to an application
for which a certificate of need is required if:
(a) The proposal involves the establishment
or expansion of a health facility or health service for which there is not a
component in the State Health Plan;
(b) The proposal involves an application to
re-establish a licensed healthcare facility or service that was provided at a
hospital and was voluntarily discontinued by the applicant under the following
circumstances:
1. The termination or voluntary
closure of the hospital:
a. Was not the result
of an order or directive by the cabinet, governmental agency, judicial body, or
other regulatory authority;
b. Did
not occur during or after an investigation by the cabinet, governmental agency,
or other regulatory authority;
c.
Did occur while the facility was in substantial compliance with applicable
administrative regulations and was otherwise eligible for re-licensure;
and
d. Was not an express condition
of any subsequent certificate of need approval;
2. The application to re-establish the
healthcare facility or service that was voluntarily discontinued is filed no
more than one (1) year from the date the hospital last provided the service
that the applicant is seeking to re-establish;
3. A proposed healthcare facility shall be
located within the same county as the former healthcare facility and at a
single location; and
4. The
application shall not seek to re-establish any type of bed utilized in the care
and treatment of patients for more than twenty-three (23) consecutive
hours;
(c)
1. The proposal involves an application to
establish an ambulatory surgical center that does not charge its patients and
does not seek or accept commercial insurance, Medicare, Medicaid, or other
financial support from the federal government; and
2. The proposed ambulatory surgical center
shall utilize the surgical facilities of an existing licensed ambulatory
surgical center during times the host ambulatory surgical center is not in
operation;
(d) The
proposal involves an application to establish an industrial ambulance
service;
(e) Prior to July 1, 2026,
the proposal involves an application by:
1. An
ambulance service that is owned by a city or county government seeking to
provide ambulance transport services pursuant to
KRS
216B.020(9)(a) 1. or 2.;
or
2. A licensed hospital seeking
to provide transport from a location that is not a health care facility
pursuant to KRS
216B.020(9)(a) 3. and
(b);
(f) The proposal
involves an application to transfer acute care beds from one (1) or more
existing Kentucky-licensed hospitals to establish a new hospital under the
following circumstances:
1. The existing
hospital and new facility shall be under common ownership and located in the
same county;
2. No more than fifty
(50) percent of the existing hospital's acute care beds shall be transferred to
the new facility; and
3.
a. If the existing hospital is a state
university teaching hospital, the existing hospital exceeded, by at least one
(1), the minimum number of quality measures required to receive supplemental
university directed payments from Kentucky Medicaid for the state fiscal year
preceding the date the application was filed; or
b. If the existing hospital is not a state
university teaching hospital, the existing hospital's overall rating by the
Centers for Medicare and Medicaid Services Hospital Compare was three (3) stars
or higher on the most recent annual update to the overall star ratings
preceding the date the application was filed;
(g)
1. The
proposal involves an application from a Program of All-Inclusive Care for the
Elderly (PACE) program that:
a. Has met the
requirements of the State Readiness Review (SRR) according to a report
submitted by the Department for Medicaid Services (DMS) to the Centers for
Medicare and Medicaid Services (CMS);
b. Seeks to provide, directly to its members,
a health service that is not exempt from certificate of need (CON) under
KRS
216B.020(1); and
c. Ensures that all services authorized under
the PACE agreement are provided exclusively to its members who reside within
the service area. The service area shall be:
(i) Located within the Commonwealth of
Kentucky; and
(ii) Approved by both
CMS and DMS.
2. Only an approved PACE program operating
within the applicant's service area shall qualify as an affected person for the
purpose of opposing a PACE program application.
3. A PACE program shall not be required to
obtain certificate of need (CON) approval if the program:
a. Provides direct patient health services
that are exempt from CON under
KRS
216B.020(1) and provides
other services subject to CON approval through contracts with licensed
providers; or
b. Has already
obtained CON approval within the approved PACE service area to provide a health
service that is not exempt from CON; or
(h) The proposal involves an application to
establish an inpatient psychiatric unit in an existing licensed acute care
hospital under the following conditions:
1.
The hospital is located in a county that has no existing, freestanding
psychiatric hospital;
2. The
occupancy of acute care beds in the applicant's facility is less than seventy
(70) percent according to the most recent edition of the Kentucky Annual
Hospital Utilization and Services Report;
3.
a. All
of the proposed psychiatric beds are being converted from licensed acute care
beds; and
b. No more than
twenty-five (25) acute care beds will be converted to psychiatric
beds;
4. All of the
psychiatric beds will be implemented on-site at the applicant's existing
licensed facility; and
5. All of
the psychiatric beds shall be dedicated exclusively to the treatment of adult
patients, aged eighteen (18) to sixty-four (64).
(4) A certificate of need approved
for an application submitted under subsection (3)(c) of this section shall
state the limitations specified under subsection (3)(c)1. and 2. of this
section.
(5) If an application is
denied nonsubstantive review status by the Office of Inspector General, the
application shall automatically be placed in the formal review
process.
(6) If an application is
granted nonsubstantive review status by the Office of Inspector General, notice
of the decision to grant nonsubstantive review status shall be given to the
applicant and all known affected persons.
(7)
(a) If
an application is granted nonsubstantive review status by the Office of
Inspector General, any affected person who believes that the application is not
entitled to nonsubstantive review status or who believes that the application
should not be approved may request a hearing by filing a request for a hearing
within ten (10) days of the notice of the decision to conduct nonsubstantive
review.
(b) The provisions of
900 KAR 6:090 shall govern the
conduct of all nonsubstantive review hearings.
(c)
1.
Except as provided in subparagraph 2. of this paragraph, nonsubstantive review
applications shall not be comparatively reviewed.
2. If the capital expenditure proposed
involves the establishment or expansion of a health facility or health service
for which there is a component in the State Health Plan, the nonsubstantive
review applications shall be comparatively reviewed.
(d) Nonsubstantive review applications may be
consolidated for hearing purposes.
(8) If an application for certificate of need
is granted nonsubstantive review status by the Office of Inspector General,
there shall be a presumption that the facility or service is needed and a
presumption that the facility or service is consistent with the State Health
Plan.
(9) If each applicable review
criterion in the State Health Plan has been met, there shall be a presumption
that the facility or service is needed unless the presumption of need has been
rebutted by clear and convincing evidence by an affected party.
(10) Unless a hearing is requested pursuant
to 900 KAR 6:090, the Office of
Inspector General shall approve each application for a certificate of need that
has been granted nonsubstantive review status if the exception established in
subsection (11)(a) of this section does not apply.
(11) The cabinet shall disapprove an
application for a certificate of need that has been granted nonsubstantive
review if the cabinet finds that the:
(a)
Application is not entitled to nonsubstantive review status; or
(b) Presumption of need or presumption that
the facility or service is consistent with the State Health Plan provided for
in subsection (8) of this section has been rebutted by clear and convincing
evidence by an affected party.
(12) In determining whether an application is
consistent with the State Health Plan, the cabinet, in making a final decision
on an application, shall apply the latest criteria, inventories, and need
analysis figures maintained by the cabinet and the version of the State Health
Plan in effect at the time of the public notice of the application.
(13) In determining whether an application is
consistent with the State Health Plan following a reconsideration hearing
pursuant to KRS
216B.090 or a reconsideration hearing that is
held by virtue of a court ruling, the cabinet shall apply the latest criteria,
inventories, and need analysis figures maintained by the cabinet and the
version of the State Health Plan in effect at the time of the reconsideration
decision or decision following a court ruling.
(14) A decision to approve or disapprove an
application that has been granted nonsubstantive review status shall be
rendered within thirty-five (35) days of the date that nonsubstantive review
status has been granted, as required by
KRS
216B.095(1). A hearing
officer shall prioritize rendering decisions regarding applications granted
nonsubstantive review status pursuant to Section 2(3)(g) of this administrative
regulation.
(15) If a certificate
of need is disapproved following nonsubstantive review, the applicant may:
(a) Request that the cabinet reconsider its
decision pursuant to KRS 216B.090 and
900 KAR 6:065;
(b) Request that the application be placed in
the next cycle of the formal review process; or
(c) Seek judicial review pursuant to
KRS
216B.115.
Section 3. Exemption from Certificate of
Need.
(1) A city or county government-owned
ambulance service that meets the criteria established by
KRS
216B.020(8) shall not be
required to obtain a certificate of need to provide emergency ambulance
transport services.
(2) A
hospital-owned ambulance service shall not be required to obtain a certificate
of need to provide non-emergency or emergency transport that originates from
its hospital pursuant to
KRS
216B.020(7).
(3)
(a) If
a hospital-owned ambulance service has certificate of need approval prior to
the most recent effective date of this administrative regulation to provide
transport services from another health facility to its hospital, the service
shall not be required to obtain authorization in accordance with paragraph (b)
of this subsection.
(b) A
hospital-owned ambulance service that is exempt from certificate of need under
KRS
216B.020(7) may provide
transport services from another health facility to its hospital if authorized
as set out in KRS
311A.025(4).
(c)
1. As
used in paragraph (b) of this subsection, a hospital is authorized to provide
inter-facility transport of a patient if:
a.
The hospital contacts by phone at least one (1) ground ambulance provider with
jurisdiction in the territory in which the other health facility is located,
using contact information from the most recent edition of the agency directory
maintained by the Kentucky Board of Emergency Medical Services at the following
link (
https://kbems.kctcs.edu/legal/EMS%20Directory.Aspx);
and
b. The ground ambulance
provider:
(i) Declines the hospital's request
for patient transport; or
(ii) Is
not able to initiate the patient's transport within four (4) hours of receiving
the hospital's request.
2. For purposes of this paragraph, a provider
initiates transport when it arrives at the hospital to transport the
patient.
3. The hospital shall
document the ambulance service contacted and the reason for authorization to
provide transport from another health facility to its hospital.
(4)
(a) In accordance with
KRS
216B.020(12)(a), the
provisions of this section and Section 2(3)(e) of this administrative
regulation shall expire on July 1, 2026.
(b) In accordance with
KRS
216B.020(12)(b), a
certificate of need exemption granted to an ambulance service under this
section of this administrative regulation shall remain in effect on and after
July 1, 2026.