Current through Register Vol. 50, No. 9, March 1, 2024
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.040(2)(a) 2 requires
the cabinet to promulgate an administrative regulation establishing the
criteria for issuance and denial of certificates of need. This administrative
regulation establishes the requirements necessary for the consideration for
formal review of applications for the orderly administration of the Certificate
of Need Program.
Section 1.
Definitions.
(1) "Cabinet" is defined by
KRS
216B.015(6).
(2) "Days" means calendar days, unless
otherwise specified
(3) "Formal
review" means the review of an application for certificate of need which is
reviewed within ninety (90) days from the commencement of the review as
provided by
KRS
216B.062(1) and which is
reviewed for compliance with the review criteria set forth at
KRS
216B.040 and in this administrative
regulation.
(4) "Public information
channels" means the Office of Communication and Administrative Review in the
Cabinet for Health and Family Services.
(5) "Public notice" means notice given
through:
(a) Public information channels;
or
(b) The cabinet's Certificate of
Need Newsletter.
Section
2. Considerations for Formal Review. In determining whether to
approve or deny a certificate of need, the cabinet's review of an application
under formal review shall be limited to the considerations established in this
section.
(1) Consistency with plans.
(a) To be approved, a proposal shall be
consistent with the State Health Plan established in
900 KAR
5:020.
(b)
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.
(c) 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 which
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.
(d) An
application seeking to re-establish a licensed healthcare facility or service
that was provided at the healthcare facility and which was voluntarily
discontinued by the applicant shall be considered consistent with the State
Health Plan under the following circumstances:
1. The termination or voluntary closure of
the former healthcare service or facility:
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 relicensure;
d. Was not an express condition of any
subsequent certificate of need approval; and
e. Did not occur less than twenty-four (24)
months prior to the submission of the application to re-establish;
2. The proposed healthcare service
shall be provided within the same geographic service area as the former
healthcare service;
3. The 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.
(2) Need. The cabinet shall determine:
(a) If the applicant has identified a need
for the proposal in the geographic service area defined in the application;
and
(b) If the applicant has
demonstrated that it is able to meet the need identified in the geographic
service area defined in the application.
(3) Accessibility. The cabinet shall
determine if the health facility or health service proposed in the application
will be accessible in terms of timeliness, amount, duration, and personnel
sufficient to provide the services proposed.
(4) Interrelationships and linkages. The
cabinet shall determine:
(a) If the proposal
shall serve to accomplish appropriate and effective linkages with other
services, facilities, and elements of the health care system in the region and
state; and
(b) If the proposal is
accompanied by assurance of effort to achieve comprehensive care, proper
utilization of services, and efficient functioning of the health care
system.
(5) Costs,
economic feasibility, and resource availability. The cabinet shall determine:
(a) If it is economically feasible for the
applicant to implement and operate the proposal; and
(b) If applicable, if the cost of alternative
ways of meeting the need identified in the geographic area defined in the
application would be a more effective and economical use of
resources.
(6) Quality
of services.
(a) The cabinet shall determine
if the applicant:
1. Is prepared to, and
capable of undertaking and carrying out, the responsibilities involved in the
proposal in a manner consistent with appropriate standards and requirements
established by the cabinet; and
2.
Has the ability to comply with applicable licensure requirements.
(b) Absence of an applicable
licensure category shall not constitute grounds for disapproving an
application.