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.086 authorizes the revocation of
certificate of need, or portion thereof, for failure to implement the project
in accordance with timetables and standards established by administrative
regulation. This administrative regulation establishes the required timetables
and standards for implementation as well as requirements for biennial reviews
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) "Long-term
care beds" means nursing home beds, intermediate care beds, skilled nursing
beds, nursing facility beds, and Alzheimer nursing home beds.
(4) "Office of Inspector General" means the
office within the Cabinet for Health and Family Services that is responsible
for licensing and regulatory functions of health facilities and
services.
(5) "Show cause hearing"
means a hearing during which it is determined whether a person or entity has
violated provisions of KRS Chapter 216B.
Section 2. Standards for Implementation.
(1) As a condition for the issuance of a
certificate of need, a holder of a certificate of need shall submit progress
reports on the CON - Form 8, Certificate of Need Six Month Progress Report,
incorporated by reference in
900 KAR
6:055, at the six (6) month intervals specified in
this section.
(2) A notice
specifying the date each progress report is due shall be sent to every holder
of a certificate of need whose project is not fully implemented.
(3) The cabinet or its designee shall review
a progress report and shall determine:
(a) If
the required elements have been completed; and
(b) If the required elements have not been
completed, whether sufficient reasons for failure to complete have been
provided.
(4) A
certificate of need shall be deemed complete if:
(a) The project has been approved for
licensure or occupancy by the Office of Inspector General;
(b) A final cost breakdown has been
submitted; and
(c) The required
progress report fee pursuant to Section 3 of this administrative regulation has
been submitted.
(5)
Until a project is deemed complete by the cabinet, the cabinet may require:
(a) The submission of additional reports as
specified in subsections (16) through (18) of this section; or
(b) Progress reports in addition to those
required at six (6) month intervals under the provisions of this
section.
(6) Except for
a long-term care bed proposal, a certificate of need shall not be revoked for
failure to complete the items required during a six (6) month period if the
holder of the certificate of need establishes that the failure was due to
circumstances that:
(a) Could not reasonably
be anticipated and avoided by the holder; or
(b) Were not the result of action or inaction
of the holder.
(7) If
the cabinet determines that required elements have not been completed for
reasons other than those set forth in subsection (6) of this section, it shall
notify the holder of the certificate of need, in writing, that it has
determined to revoke the certificate of need.
(8) The revocation shall become final thirty
(30) days from the date of notice of revocation unless the holder requests a
hearing pursuant to
KRS
216B.086.
(9) The first progress report for any project
other than long-term care beds shall include:
(a) For a project for the addition of new
services or expansion of existing services that does not involve construction,
renovation, or the installation of equipment: plans for implementation of the
project;
(b) For a project for the
purchase of equipment only: a copy of the purchase order;
(c) For a project involving the acquisition
of real property: evidence of an option to acquire the site; or
(d) For a construction or renovation project:
evidence that schematic plans have been submitted to the Public Protection
Cabinet, Department of Housing, Buildings, and Construction, and the Office of
Inspector General, Division of Healthcare.
(10) For a project other than long-term care
beds not deemed complete, a second progress report shall include:
(a) For a project converting beds:
documentation that all beds are licensed;
(b) For a project for addition of new
services or expansion of existing services that do not involve construction,
renovation, or the installation of equipment: documentation of approval for
licensure and occupancy by the Office of Inspector General, Division of
Healthcare, or the Kentucky Board of Emergency Medical Services; or
(c) For a construction or renovation project:
the schedule for project completion, evidence of preliminary negotiation with a
financial agency, and evidence of preliminary negotiation with
contractors.
(11) For a
project other than long-term care beds not deemed complete, a third progress
report shall include:
(a) For a construction
or renovation project:
1. A copy of the deed
or lease of land;
2. Documentation
of the final enforceable financing agreement, if applicable;
3. Documentation that final plans have been
submitted to the Public Protection Cabinet, Department of Housing, Buildings,
and Construction, and the Office of Inspector General, Division of Healthcare;
and
4. An enforceable contract with
a construction contractor; or
(b) For a project for purchase of equipment
only: evidence of approval for licensure and occupancy by the Office of
Inspector General, Division of Healthcare.
(12) For a project other than long-term care
beds not deemed complete, a fourth progress report shall include documentation
of final plan approval by the Public Protection Cabinet, Department of Housing,
Buildings, and Construction, and the Office of Inspector General, Division of
Healthcare, and evidence that construction has begun.
(13) For a project other than long-term care
beds not deemed complete, a fifth progress report shall include documentation
that construction or renovation is progressing according to schedule.
(14) For a project other than long-term care
beds not deemed complete, a sixth progress report shall include documentation
that the project has been approved for licensure or occupancy by the Office of
Inspector General, Division of Healthcare, and, if required, that the
appropriate license has been approved for the health care service or
facility.
(15) For a project other
than long-term care beds not deemed complete after the sixth progress report,
the certificate holder shall, upon request, provide the cabinet or its designee
with a written statement showing cause why the certificate should not be
revoked. The cabinet may defer revocation action upon a showing by the
certificate holder that the project shall be completed on a revised schedule.
The cabinet or its designee may require additional progress reports.
(16) For a project involving long-term care
beds, the progress reports required by this subsection shall be submitted.
(a) The first progress report shall include:
1. A copy of the deed or lease of land for a
project requiring acquisition of real property; and
2. Evidence that final plans have been
submitted to the Public Protection Cabinet, Department of Housing, Buildings,
and Construction, and the Office of Inspector General, Division of
Healthcare.
(b) For a
project involving long-term care beds not deemed complete, a second progress
report shall include:
1. For a conversion of
bed project: documentation that the beds in the project are licensed;
or
2. For a construction project:
a. A schedule for project completion with
projected dates;
b. Documentation
of final financing;
c.
Documentation of final plan approval by the Public Protection Cabinet,
Department of Housing, Buildings, and Construction, and the Office of Inspector
General, Division of Healthcare; and
d. An enforceable construction
contract.
(17) For a project involving long-term care
beds not deemed complete, a third progress report shall include documentation
that construction or renovation is progressing according to the schedule for
project completion.
(18) For a
project involving long-term care beds not deemed complete, a fourth progress
report shall include documentation that the project has been appropriately
licensed and approved for occupancy by the Office of Inspector General,
Division of Healthcare.
(19) The
cabinet or its designee may grant no more than three (3) additional extensions
of six (6) months for good cause shown if the certificate holder of long-term
care beds has failed to comply with the relevant progress report requirements
established in this section.
(20)
If the project involves a capital expenditure, a final cost breakdown shall be
included in the final progress report.
(21) If the Office of Inspector General,
Division of Healthcare, discovers a violation of terms and conditions listed on
a certificate of need and license while it is conducting its annual licensure
inspection, it shall refer this violation for a show cause hearing in
accordance with
900
KAR 6:090, Section 4.
Section 3. Progress Report Fee.
(1) A progress report fee in the amount of
$100.00 or one (1) percent of the application fee assessed pursuant to
900 KAR
6:020, whichever amount is greater, shall be submitted
by the certificate of need holder with each semi-annual progress report filed
for each certificate of need that has been issued for more than three (3)
years.
(2) A certificate of need
shall be revoked for failure to submit the progress report fee.
Section 4. Voluntary Revocation of
a Certificate of Need. If a certificate of need holder requests revocation of a
certificate of need or a portion of a certificate of need and submits a new
application for the same proposed health facility or service within five (5)
years from the date of revocation, the cabinet shall apply the application fee
that was submitted for the revoked certificate of need or portion of a
certificate of need toward the fee assessed pursuant to
900 KAR
6:020 for the new application.
Section 5. Biennial Review.
(1) A certificate of need holder may be
subject to biennial review to determine if the holder is in compliance with the
terms as listed on the certificate of need.
(2) Biennial review may be conducted within
sixty (60) days of the second anniversary of the final progress report and at
twenty-four (24) month intervals thereafter.
(3) The cabinet or its designee shall provide
sixty (60) days' advance written notification to the subject of any biennial
review, including the following:
(a) When the
biennial review will be initiated;
(b) Request for information necessary for the
review to which the cabinet does not have ready access; and
(c) A deadline for a response to the request
for information.
(4) If
the cabinet finds that any of the terms and conditions of a certificate of need
approval and license have been violated, the review of, and any sanctions for,
this violation shall be conducted in accordance with
900
KAR 6:090, Section 4.
STATUTORY AUTHORITY:
KRS
194A.030(1)(c) 4.,
216B.040(2)(a)1, 216B.086