Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO:
KRS
216B.015,
216B.040,
216B.062(1),
216B.085,
216B.095
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. This administrative regulation establishes the requirements
necessary for the orderly administration of the certificate of need
application, review, decision, and reconsideration process.
Section 1. Definitions.
(1) "Cabinet" is defined by
KRS
216B.015(6).
(2) "Certificate of Need Newsletter" means
the monthly newsletter that is published by the cabinet regarding certificate
of need matters and is available on the Office of Inspector General, Division
of Certificate of Need Web site at
https://chfs.ky.gov/agencies/os/oig/dcn.
(3) "Days" means calendar days, unless
otherwise specified.
(4) "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.
(5) "Nonsubstantive review" is defined by
KRS
216B.015(18).
(6) "Owner" means a person as defined in
KRS
216B.015(22) who is applying
for the certificate of need and will become the licensee of the proposed health
service or facility.
(7) "Person"
is defined by
KRS
216B.015(22).
(8) "Proposed service area" means the
geographic area the applicant proposes to serve.
(9) "Secretary" is defined by
KRS
216B.015(26).
(10) "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. Certificate of Need Application.
(1) An applicant for a certificate of need
shall file an application with the cabinet on the appropriate certificate of
need application form: CON -Form 2A, CON - Form 2B, or CON - Form 2C,
incorporated by reference in
900 KAR
6:055.
(2)
To file an application for certificate of need, the applicant shall file the
appropriate certificate of need application form together with the prescribed
fee set forth in
900 KAR
6:020 on or before the deadlines established by
900
KAR 6:060. The appropriate fee shall be received by
the Division of Certificate of Need before an application may be deemed
complete.
(3)
(a) For the purpose of completing the
application, neither the geographic area the applicant proposes to serve nor
the health service area in which the project is proposed to be located shall
include any area that is located outside of the Commonwealth of
Kentucky.
(b) A person located and
residing solely outside of the Commonwealth of Kentucky shall not qualify as an
affected person for the purpose of opposing an application.
(4) Formal or nonsubstantive
review of an application for a certificate of need shall not begin until the
application has been deemed complete by the cabinet.
(5) The cabinet shall deem an application
complete if the applicant has:
(a) Provided
the cabinet with all of the information necessary to complete the application;
or
(b) Declined to submit the
requested information and has requested that its application be reviewed as
submitted.
(6) Once an
application has been deemed complete, the applicant shall not submit additional
information regarding the application unless the information is introduced at a
public hearing.
(7) Once an
application has been deemed complete, it shall not be amended to:
(a) Increase the scope of the
project;
(b) Increase the amount of
the capital expenditure;
(c) Expand
the size of the proposed service area;
(d) Change the location of the health
facility or health service; or
(e)
Change the owner, unless the application involves a licensed health facility
and a change of ownership with appropriate notice has occurred after the
application was submitted.
(8) An application that has been deemed
complete may be amended at a public hearing to:
(a) Decrease the scope of the
project;
(b) Decrease the amount of
the capital expenditure; or
(c)
Decrease the proposed service area.
(9) An applicant that has had a certificate
of need approved under the nonsubstantive review provisions of
KRS
216B.095(3)(a) through (f)
may request that the cabinet change the specific location to be designated on
the certificate of need if:
(a) The facility
has not yet been licensed;
(b) The
location is within the county listed on the certificate of need application;
and
(c) The applicant files a
written request with the cabinet within 180 days of the date of issuance of the
certificate of need. A request shall include the reason why the change is
necessary.
(10) An
application that is not deemed complete within one (1) year from the date that
it is filed shall expire and shall not be placed on public notice or reviewed
for approval.
Section 3.
Certificate of Need Review.
(1) Prior to being
reviewed for the approval or denial of a certificate of need, an application
for certificate of need shall be reviewed for completeness pursuant to Section
4 of this administrative regulation.
(2) Unless granted nonsubstantive review
status under the criteria in
900
KAR 6:075, an application for a certificate of need
shall be reviewed for approval or denial according to the formal review
criteria set forth in
900
KAR 6:070.
(3) If granted nonsubstantive review status
under the criteria in
900
KAR 6:075, an application for a certificate of need
shall be reviewed for approval or denial of the certificate of need according
to the nonsubstantive review criteria set forth in
900
KAR 6:075.
Section 4. Completeness Review.
(1) Fifteen (15) days after the deadline for
filing an application in the appropriate batching cycle, the cabinet shall
conduct an initial review to determine if the application is complete for
formal review or nonsubstantive review requested pursuant to
KRS
216B.095(3)(a) through
(f).
(2) If the cabinet finds that the application
for formal review is complete, the cabinet shall:
(a) Notify the applicant in writing within
one (1) day that the application has been deemed complete and that review of
the application for the approval or denial of a certificate of need shall begin
upon public notice being given; and
(b) Give public notice in the next
appropriate Certificate of Need Newsletter, pursuant to the timetable set forth
in
900
KAR 6:060, that review of the application for approval
or denial of a certificate of need has begun.
(3) If the cabinet finds that the application
for nonsubstantive review is complete, the cabinet shall notify the applicant
in writing within ten (10) days that the application has been deemed complete
and that review of the application for the approval or denial of a certificate
of need shall begin upon public notice being given.
(4) A decision to grant or deny
nonsubstantive review status shall be made within ten (10) days of the date the
applicant is notified that the application has been deemed complete.
(5) The cabinet shall give public notice for
applications granted nonsubstantive review status under the provisions of
KRS
216B.095(3)(a) through (f)
in the next appropriate Certificate of Need Newsletter, pursuant to the
timetable set forth in
900
KAR 6:060, that status has been granted and that
review of the application for approval or denial of a certificate of need has
begun.
(6) If the cabinet finds
that the application is incomplete, the cabinet shall:
(a) Provide the applicant with written notice
of the information necessary to complete the application; and
(b) Notify the applicant that the cabinet
shall not deem the application complete unless within fifteen (15) days of the
date of the cabinet's request for additional information:
1. The applicant submits the information
necessary to complete the application by the date specified in the request;
or
2. The applicant requests in
writing that the cabinet review its application as submitted.
(7) If, upon the
receipt of the additional information requested, the cabinet finds that the
application for formal review is complete, the cabinet shall:
(a) Notify the applicant in writing that:
1. The application for formal review has been
deemed complete; and
2. Review of
the application for the approval or denial of a certificate of need shall begin
upon public notice being given; and
(b) Give public notice in the next
appropriate Certificate of Need Newsletter, pursuant to the timetable set forth
in
900
KAR 6:060, that review of the application for approval
or denial of a certificate of need has begun.
(8) If, upon the receipt of the additional
information requested, the cabinet finds that an application for nonsubstantive
review is complete, the cabinet shall:
(a)
Notify the applicant in writing that:
1. The
application has been deemed complete;
2. Review of the application for the approval
or denial of a certificate of need shall begin upon public notice being given;
and
3. A decision to grant or deny
nonsubstantive review status shall be made within ten (10) days of the date
that the application was deemed complete; and
(b) Give public notice in the next
appropriate Certificate of Need Newsletter, pursuant to the timetable set forth
in
900
KAR 6:060, for an application granted nonsubstantive
review status under the provisions of
KRS
216B.095(3)(a) through (f)
that status has been granted and that review of the application for approval or
denial of a certificate of need has begun.
(9) If the information submitted in response
to the cabinet's request for additional information is insufficient to complete
the application, the cabinet shall:
(a)
Request the information necessary to complete the application; and
(b) Inform the applicant that the application
shall not be deemed complete and shall not be placed on public notice until:
1. The applicant submits the information
necessary to complete the application; or
2. The applicant requests in writing that its
application be reviewed as submitted.
(10) Once an application has been deemed
complete, an applicant shall not submit additional information to be made part
of the public record unless:
(a) The
information is introduced at a public hearing;
(b) For a deferred application for formal
review, the additional information is submitted at least twenty (20) days prior
to the date that the deferred application is placed on public notice;
or
(c) For a deferred application
for nonsubstantive review, the additional information is submitted at least ten
(10) days prior to the date that the deferred application is placed on public
notice.
(11) A
determination that an application is complete shall:
(a) Indicate that the application is
sufficiently complete to be reviewed for approval or disapproval;
(b) Not be determinative of the accuracy of,
or weight to be given to, the information contained in the application;
and
(c) Not imply that the
application has met the review criteria for approval.
Section 5. Notice of Decision.
(1) The cabinet shall notify the applicant
and any party to the proceeding of the final action on a certificate of need
application within three (3) days.
(2) Notification of approval shall be in
writing and shall include:
(a) Verification
that the review criteria for approval have been met;
(b) Specification of any terms or conditions
limiting a certificate of need approval, including limitations regarding
certain services or patients. This specification shall be listed on the
facility or service's certificate of need and license;
(c) Notice of appeal rights; and
(d) The amount of capital expenditure
authorized, if applicable.
(3) Written notification of disapproval shall
include:
(a) The reason for the disapproval;
and
(b) Notice of appeal
rights.
(4) An identical
application for certificate of need that is disapproved shall not be refiled
for a period of twelve (12) months from the original date of filing, absent a
change in circumstances.
Section
6. Deferral of an Application.
(1)
(a)
Except as described in paragraph (b) of this subsection, an applicant may defer
review of an application a maximum of two (2) times by notifying the cabinet in
writing of its intent to defer review.
(b) An applicant shall not defer review of an
application filed pursuant to
900 KAR
6:080 to alleviate an emergency
circumstance.
(c)
1. If the application has been granted
nonsubstantive review status under the provisions of
KRS
216B.095(3)(a) through (f),
the notice to defer shall be filed pursuant to
900
KAR 6:090 no later than five (5) days prior to the
date that the decision is due on the application unless a hearing has been
scheduled.
2. If a hearing has been
scheduled, the notice to defer shall be filed pursuant to
900
KAR 6:090 no later than six (6) days prior to the date
of the hearing.
(d)
1. If the application is being reviewed under
formal review, the notice to defer shall be filed pursuant to
900
KAR 6:090 no later than ten (10) days prior to the
date that the decision is due on the application unless a hearing has been
scheduled.
2. If a hearing has been
scheduled, the notice to defer shall be filed pursuant to
900
KAR 6:090 no later than eight (8) days prior to the
date of the hearing.
(e)
If a hearing has been scheduled, the applicant shall also notify all parties to
the proceedings in writing of the applicant's intent to defer the
application.
(2) If a
notice to defer an application for formal review is filed, the application
shall be deferred to the next regular batching cycle and shall be placed on
public notice pursuant to the timetables set forth in
900
KAR 6:060.
(3) If an application for formal review is
deferred, an applicant may update its application by providing additional
information to the cabinet at least twenty (20) days prior to the date that the
deferred application is placed on public notice.
(4) If a notice to defer an application that
has been granted nonsubstantive review is filed, the application shall be
deferred and shall be placed on public notice in the Certificate of Need
Newsletter published the next calendar month following the date the request was
received.
(5) If an application for
nonsubstantive review is deferred, an applicant may update its application by
providing additional information to the cabinet at least ten (10) days prior to
the date that the deferred application is placed on public notice.
(6) In order for a hearing to be held on a
deferred application, a hearing shall be requested by either the applicant or
an affected person within:
(a) Ten (10) days
of the deferred application being placed on public notice if the application
has been granted nonsubstantive review status; or
(b) Fifteen (15) days of the deferred
application being placed on public notice if the application is being reviewed
under the provision of formal review.
Section 7. Withdrawal of an Application.
(1) An applicant may withdraw an application
for certificate of need by notifying the cabinet in writing of the decision to
withdraw the application prior to the entry of a decision to deny or approve
the application.
(2) If a hearing
has been scheduled or held on the application, the applicant shall also notify
all parties to the proceedings in writing of the applicant's decision to
withdraw the application.
Section
8. Location of New and Replacement Facilities. A certificate of
need approved for the establishment of a new facility or the replacement of an
existing facility shall be valid only for the location stated on the
certificate.
Section 9. Requests
for Reconsideration.
(1) A request for
reconsideration shall be filed, pursuant to
900
KAR 6:090, within fifteen (15) days of the date of the
notice of the cabinet's final decision relating to:
(a) Approval or disapproval of an application
for a certificate of need;
(b) An
advisory opinion entered after a public hearing;
(c) Revocation of a certificate of need;
or
(d) A show cause hearing
conducted in accordance with
900
KAR 6:090.
(2) A copy of the request for reconsideration
shall be served by the requester on all parties to the proceedings.
(3) A party to the proceedings shall have
seven (7) days from the date of service of the request for reconsideration to
file a response to the request with the cabinet.
(4) If a hearing was held pursuant to
subsection (1)(a), (b), or (c) of this section, the hearing officer that
presided over the hearing shall enter a decision to grant or deny a request for
reconsideration within thirty (30) days of the request being filed.
(5) If a hearing was held pursuant to
subsection (1)(d) of this section, the secretary shall enter a decision to
grant or deny a request for reconsideration within thirty (30) days of the
request being filed.
(6) If
reconsideration is granted, the hearing shall be held by the cabinet in
accordance with the applicable provisions of
900
KAR 6:090, Section 3 or 4, within thirty (30) days of
the date of the decision to grant reconsideration, and a final decision shall
be entered by the cabinet no later than thirty (30) days following the
conclusion of the hearing.
(7) If
reconsideration is granted on the grounds that a public hearing was not held
pursuant to
KRS
216B.085, the applicant shall have the right
to waive the reconsideration hearing if the deficiencies in the application can
be adequately corrected by submission of written documentation.
STATUTORY AUTHORITY:
KRS
194A.030(1)(c) 4.,
216B.040(2)(a)1