Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO:
KRS
45A.340,
216B.015,
216B.020(2)(a),
216B.040,
216B.062(1),
216B.095(1),
216B.990
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
216B.040(2)(a) 1. and (b)
require the Cabinet for Health and Family Services to administer Kentucky's
certificate of need program, to promulgate administrative regulations as
necessary for the program, and to conduct public hearings in respect to
certificate of need applications and revocations of certificates of need.
KRS
216B.085,
216B.086,
and
216B.090
establish requirements for certificate of need, revocation, and reconsideration
hearings. This administrative regulation establishes the requirements for
filing, hearing, and show cause hearings necessary for the orderly
administration of the certificate of need program.
Section 1. Definitions.
(1) "Affected person" is defined by
KRS
216B.015(3).
(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.
(4) "Days" means calendar days, unless
otherwise specified.
(5)
"Nonsubstantive review" is defined by
KRS
216B.015(18).
(6) "Notice" means notice given through the
cabinet's Certificate of Need Newsletter.
(7) "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.
(8) "Office or clinic"
means the physical location at which health care services are
provided.
(9) "Party to the
proceedings" is defined by
KRS
216B.015(20).
(10) "Person" is defined by
KRS
216B.015(22).
(11) "Proposed findings" means the submission
of a proposed final order by the applicant or an affected party for review and
consideration by the hearing officer.
(12) "Secretary" is defined by
KRS
216B.015(26).
(13) "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. Filing.
(1) The filing of documents required by this
administrative regulation shall be made with the Office of Inspector General,
Division of Certificate of Need, CHR Building, 5E-A, 275 East Main Street,
Frankfort, Kentucky 40621 on or before 4:30 p.m. Eastern time on the due
date.
(2) Filing of a document may
be made by facsimile transmission or email if the document is received by the
cabinet by facsimile transmission or email on or before 4:30 p.m. Eastern time
on the due date.
(3) The Office of
Inspector General, Division of Certificate of Need, shall endorse by file stamp
the date that each filing is received and the endorsement shall constitute the
filing of the document.
(4) In
computing any period of time prescribed by this administrative regulation, the
date of notice, decision, or order shall not be included.
(5)
(a)
Except as provided in paragraph (b) of this subsection, the last day of the
period so computed shall be included.
(b) If the last day is a Saturday, Sunday, or
legal state holiday, the period shall run until 4:30 p.m. Eastern time of the
first business day following the Saturday, Sunday, or legal state
holiday.
Section
3. Hearing.
(1)
(a) A hearing on a certificate of need
application or revocation of a certificate of need shall be held by a hearing
officer from the Cabinet for Health and Family Services, Division of
Administrative Hearings.
(b) A
hearing officer shall not act on any matter in which the hearing officer has a
conflict of interest as defined by
KRS
45A.340.
(c) A party may file with the cabinet a
petition for removal based upon a conflict of interest supported by
affidavit.
(2) The
hearing officer shall preside over the conduct of each hearing and shall
regulate the course of the proceedings in a manner that shall promote the
orderly and prompt conduct of the hearing.
(3) Notice of the time, date, place, and
subject matter of each hearing shall be:
(a)
Mailed to the applicant and each affected person who requested the hearing not
less than ten (10) days prior to the date of the hearing; and
(b) Published in the Certificate of Need
Newsletter, if applicable.
(4)
(a) By
motion, pursuant to
900 KAR
6:065, Section 2(3), an applicant may challenge the
standing of any person to request a hearing or participate in a public
hearing.
(b) If a motion
challenging the standing of a person is filed by an applicant, the hearing
officer shall conduct an evidentiary hearing on the matter and obtain sworn
testimony from the person. The applicant shall have the right to cross-examine
the person.
(c) If the hearing
officer determines that the person is located and residing solely outside of
the Commonwealth of Kentucky, the hearing officer shall prohibit further
participation by the person in the proceedings on the application at
issue.
(d) If the hearing officer
determines that the person is acting as a surrogate for another person who does
not qualify as an affected person, the hearing officer shall prohibit further
participation by the person in the proceedings on the application at
issue.
(5) A public
hearing shall be canceled if each person who has been determined to be acting
as a surrogate for another person or who requested the hearing withdraws the
request by giving written notification to the Office of Inspector General,
Division of Certificate of Need, that the hearing is no longer required. The
consent of each affected person who has not requested a hearing shall not be
required in order for a hearing to be canceled.
(6) A dispositive motion made by a party to
the proceedings shall be filed with the cabinet at least three (3) working days
prior to the scheduled date of the hearing.
(7) The hearing officer may convene a
preliminary conference.
(a) The purposes of
the conference shall be to:
1. Formulate and
simplify the issues;
2. Identify
additional information and evidence needed for the hearing; and
3. Dispose of pending motions.
(b) A written summary of the
preliminary conference and the orders thereby issued shall be made a part of
the record.
(c) The hearing officer
shall:
1. Record the conference; or
2. If requested by a party to the
proceedings, allow a court reporter to be present at the expense of the
requesting party.
(d)
During the preliminary conference, the hearing officer may:
1. Instruct the parties to:
a. Formulate and submit a list of genuine
contested issues to be decided at the hearing;
b. Raise and address issues that can be
decided before the hearing; or
c.
Formulate and submit stipulations to facts, laws, and other matters;
2. Prescribe the manner and extent
of the participation of the parties to the proceedings;
3. Rule on any pending motions for discovery
or subpoenas; or
4. Schedule dates
for the submission of prefiled testimony, further preliminary conferences, and
submission of briefs and documents.
(8) At least five (5) days prior to the
scheduled date of a nonsubstantive review hearing and at least seven (7) days
prior to the scheduled date of any other certificate of need hearing, each
affected person wishing to participate as a party to the proceeding shall file
with the cabinet the following for each affected application and serve copies
on all other known parties to the proceeding:
(a) CON - Form 3, Notice of Appearance,
incorporated by reference in
900 KAR
6:055;
(b)
CON - Form 4, Witness List, incorporated by reference in
900 KAR
6:055; and
(c) CON - Form 5, Exhibit List, incorporated
by reference in
900 KAR
6:055 and attached exhibits.
(9)
(a) If a
hearing is requested on an application that has been deferred from a previous
cycle and for which a hearing had previously been scheduled, parties shall:
1. File a new CON - Form 3, Notice of
Appearance; and
2. Either:
a. Incorporate previously-filed witness lists
(CON - Form 4) and exhibit lists (CON- Form 5); or
b. File an amended CON - Form 4 and CON -
Form 5.
(b) A
new party to the proceedings shall file an original CON - Form 3, CON - Form 4,
and CON - Form 5.
(c) Forms shall
be filed in accordance with subsection (7) of this section.
(10)
(a) If a party to the proceedings requests a
court reporter to be present during the hearing, the party shall:
1. Arrange for and bear the cost for a court
reporter to transcribe the hearing; and
2. File an original copy of the transcript
with the cabinet.
(b) If
all parties agree, the hearing may be recorded in lieu of a written
transcript.
(11) The
hearing officer shall convene the hearing and shall state the purpose and scope
of the hearing or the issues upon which evidence shall be heard. Each party
appearing at the hearing shall enter an appearance by stating the party's name
and address.
(12) Each party shall
have the opportunity to:
(a) Present its
case;
(b) Make an opening
statement;
(c) Call and examine
witnesses;
(d) Offer documentary
evidence into the record;
(e) Make
a closing statement; and
(f)
Cross-examine opposing witnesses on:
1.
Matters covered in direct examination; and
2. At the discretion of the hearing officer,
other matters relevant to the issues.
(13) A party that is a corporation shall be
represented by an attorney licensed to practice in the Commonwealth of
Kentucky.
(14) The hearing officer
may:
(a) Allow testimony or other evidence on
an issue not previously identified in the preliminary order that may arise
during the course of the hearing, including a petition for intervention that
may be filed;
(b) Act to exclude
irrelevant, immaterial, or unduly repetitious evidence; and
(c) Question any party or witness.
(15) The hearing officer shall not
be bound by the Kentucky Rules of Evidence. Relevant hearsay evidence may be
allowed at the discretion of the hearing officer.
(16) The hearing officer shall have
discretion to designate the order of presentation of evidence and the burden of
proof as to persuasion.
(17) A
witness shall be examined under oath or affirmation.
(18) A witness may, at the discretion of the
hearing officer:
(a) Appear through deposition
or in person; and
(b) Provide
written testimony in accordance with the following:
1. The written testimony of a witness shall
be in the form of questions and answers or a narrative statement;
2. The witness shall authenticate the
document under oath; and
3. The
witness shall be subject to cross-examination.
(19) The hearing officer may accept
documentary evidence in the form of copies of excerpts if:
(a) The original is not readily
available;
(b) Upon request,
parties are given an opportunity to compare the copy with the original;
and
(c) The documents to be
considered for acceptance are listed on and attached to the party's Exhibit
List (CON- Form 5).
(20)
A document shall not be incorporated into the record by reference without the
permission of the hearing officer. Each referenced document shall be precisely
identified.
(21) The hearing
officer may take official notice of facts that are not in dispute or of
generally-recognized technical or scientific facts within the agency's special
knowledge.
(22) The hearing officer
may permit a party to offer, or request a party to produce, additional evidence
or briefs of issues as part of the record within a designated time after the
conclusion of the hearing. During this period, the hearing record shall remain
open. The conclusion of the hearing shall occur when the additional information
is timely filed or at the end of the designated time period, whichever occurs
first.
(23) The hearing officer
may, upon the agreement of the applicant, extend the review deadlines
established by
KRS
216B.062(1) and
216B.095(1).
(24) If all parties agree to waive the
established decision date, the hearing officer shall render a decision within
sixty (60) days of the filing of proposed findings.
(25) The cabinet shall forward a copy of the
hearing officer's final decision by U.S. mail to each party to the proceedings.
The original hearing decision shall be filed in the administrative record
maintained by the cabinet.
Section
4. Show Cause Hearing.
(1) The
cabinet may conduct a show cause hearing on its own initiative or at the
request of an affected person, to include hearings requested pursuant to Humana
of Kentucky v. NKC Hospitals, Ky., 751 S.W.2d 369 (1988), in order to determine
if a person:
(a) Has established or is
operating a health facility or health service in violation of:
1. The provisions of KRS Chapter
216B;
2. The provisions of 900 KAR
Chapter 6; or
3. The terms or
conditions that are a part of a certificate of need approval and license held
by that person; or
(b)
Is subject to the penalties provided by
KRS 216B.990 for
specific violations of the provisions of KRS Chapter 216B.
(2) The cabinet shall conduct a show cause
hearing if a complaint investigation or licensure inspection by the Office of
the Inspector General or the Kentucky Board of Emergency Medical Services
reveals a possible violation of KRS Chapter 216B.
(3) Unless initiated by the cabinet, in order
for a show cause hearing to be held, a request for a show cause hearing
submitted by an affected person shall be accompanied and corroborated by
credible, relevant, and substantial evidence, including an affidavit or other
documentation that demonstrates probable cause to believe that a person:
(a) Has established, or is operating, a
health facility or health service in violation of:
1. The provisions of KRS Chapter
216B;
2. The provisions of 900 KAR
Chapter 6; or
3. The terms and
conditions that were a part of a certificate of need approval and license held
by that person; or
(b)
Is subject to the penalties provided by
KRS 216B.990 for
specific violations of the provisions of KRS Chapter 216B.
(4) If a show cause hearing is requested by
an affected person, the cabinet shall provide a copy of the request for show
cause hearing to the person alleged to be in violation and the person shall
have fourteen (14) days in which to file a response to the request and
supporting documentation.
(5) Based
upon the materials accompanying the request for a show cause hearing, and any
subsequent response to the allegations, the cabinet shall determine if
sufficient cause exists to conduct a hearing.
(6) Prior to convening a show cause hearing,
the cabinet shall give the parties not less than twenty (20) days' notice of
its intent to conduct a hearing and notice shall be published in the
Certificate of Need Newsletter, if applicable.
(7) The notice shall include:
(a) The allegations against the person
suspected or alleged to be in violation;
(b) Any facts determined to exist that
support the existence of the allegation;
(c) The statute or administrative regulation
alleged to have been violated;
(d)
The person's response to the allegations, if any; and
(e) Notice of the time, date, place, and
subject matter of the hearing.
(8) At least seven (7) days prior to a show
cause hearing required or requested pursuant to KRS Chapter 216B, all persons
or entities wishing to participate as a party to the proceedings shall file the
following with the cabinet and serve copies on all other known parties to the
proceedings:
(a) CON - Form 3, Notice of
Appearance;
(b) CON - Form 4,
Witness List; and
(c) CON - Form 5,
Exhibit List.
(9) A show
cause hearing shall be conducted in accordance with the provisions of Section 3
of this administrative regulation.
(10) If a show cause hearing is held, the
person alleged to be in violation of KRS Chapter 216B shall have the burden of
showing that the person:
(a) Has not
established, or is not operating, a health facility or health service in
violation of:
1. The provisions of KRS Chapter
216B;
2. The provisions of 900 KAR
Chapter 6; or
3. The terms and
conditions that are a part of a certificate of need approval and license held
by that person; or
(b)
Is not subject to the penalties provided by
KRS 216B.990 for
specific violations of the provisions of KRS Chapter 216B.
(11) If it is alleged that an office or
clinic offering services or equipment covered by the State Health Plan was
established or is operating in violation of
KRS
216B.020(2)(a), the hearing
officer shall base his or her recommended findings of fact, conclusions of law,
and recommended decision on whether the clinic or office meets the physician
exemption criteria established in
900
KAR 6:130.
(12) Within thirty (30) days of the
conclusion of the hearing, the hearing officer shall tender findings of fact
and a recommended decision to the Office of Inspector General, Division of
Certificate of Need for submission to the secretary. A copy of the findings of
fact and recommended decision shall be forwarded to each party and the party's
legal representative by the Division of Certificate of Need.
(13) Each party shall have fifteen (15) days
from the date the recommended decision is forwarded by the cabinet to file
exceptions to the findings of fact and recommended decision with the Office of
Inspector General, Division of Certificate of Need, for submission to the
secretary and the hearing officer.
(14) Within thirty (30) days of the receipt
of any exceptions, the secretary shall either accept the hearing officer's
recommended decision or request changes. The hearing officer shall then prepare
a final decision for the secretary's signature.
(15) The Office of Inspector General,
Division of Certificate of Need shall mail a copy of the final decision to each
party and his or her legal representative with the original hearing decision
filed in the administrative record maintained by the cabinet.
(16) If a violation is found to have occurred
as a result of a show cause hearing conducted pursuant to subsection (1) of
this section, the cabinet shall take action as provided by KRS Chapter
216B.
(17) If the person is found
to have violated any of the terms or conditions of any certificate of need
approval and license as a result of a show cause hearing conducted pursuant to
subsection (1) or (2) of this section, the cabinet shall take the action
required by this subsection.
(a) If the person
had not previously been found to be in violation of the terms and conditions
that were made a part of the person's certificate of need approval and license,
the person shall be given a period of time, not to exceed sixty (60) days after
issuance of the cabinet's decision, in which to demonstrate that the violation
has been corrected. At the conclusion of this period, the cabinet shall verify
that the facility or service is operating in compliance with the terms or
conditions of the certificate of need and license at issue.
(b) If the cabinet is unable to verify that
the facility or service has corrected the violation in accordance with
paragraph (a) of this subsection, or if a person who had previously been found
to be in violation of the terms and conditions that were a part of the person's
certificate of need approval and license is found in a subsequent show cause
hearing conducted pursuant to this section to be in violation of the terms and
conditions again, the matter shall be referred to the Office of Inspector
General for appropriate action.
(18) The deadlines established with respect
to hearings shall be modified if agreed to by all parties and the hearing
officer.
STATUTORY AUTHORITY:
KRS
194A.030(1)(c) 4.,
216B.040(2)(a)1., (b), 216B.085, 216B.086,
216B.090