Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO:
KRS
216.2925,
216.530,
216B.010,
216B.015,
216B.020(2)(c),
(3),
216B.040,
216B.042,
216B.045-216B.055,
216B.075,
216B.105-216B.131,
216B.185,
216B.990
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
216B.042(1)(a) requires the
Cabinet for Health and Family Services to promulgate administrative regulations
necessary for the proper administration of the licensure function and to
establish reasonable application fees for licenses. This administrative
regulation establishes the fee schedule and requirements for obtaining a
license to operate a health facility or health service, and establishes the
procedure for obtaining a variance.
Section
1. Definitions.
(1) "Adverse
action" means action taken by the Cabinet for Health and Family Services,
Office of Inspector General to deny, suspend, or revoke a health facility's or
health service's license to operate.
(2) "Cabinet" is defined by
KRS
216B.015(6).
(3) "Deemed hospital" means a hospital that
has had its accreditation accepted by the Office of Inspector General pursuant
to
KRS
216B.185(1) as evidence that
the hospital demonstrates compliance with the licensure requirements of KRS
Chapter 216B.
(4) "Health facility"
is defined by
KRS
216B.015(13).
(5) "Health services" is defined by
KRS
216B.015(14).
(6) "Inspector General" means the Inspector
General of the Cabinet for Health and Family Services or designee.
(7) "Significant financial interest" means
lawful ownership of a health facility or health service, whether by share,
contribution, or otherwise in an amount equal to or greater than twenty-five
(25) percent of total ownership of the health facility or health
service.
(8) "Variance" means the
written approval of the Inspector General authorizing a health facility to
depart from a required facility specification, upon meeting the conditions
established in Sections 4 and 5 of this administrative regulation.
Section 2. Licenses.
(1) Any person or entity, in order to
lawfully operate a health facility or health service, shall first obtain a
provisional license.
(2) A license
required by
KRS
216B.105(1), including a
provisional license, shall be conspicuously posted in a public area of the
health facility.
(3) An applicant
for provisional licensure or annual renewal of licensure as a health facility
or health service shall complete and submit to the Office of the Inspector
General the appropriate application as follows:
(a) Application for License to Operate a
Health Facility or Health Service;
(b) Application for License to Operate a
Chemical Dependency Treatment Service, Group Home, Psychiatric Residential
Treatment Facility, or Residential Hospice Facility;
(c) Application for License to Operate a
Hospital;
(d) Application for
License to Operate a Home Health Agency, Non-residential Hospice, or Private
Duty Nursing Agency;
(e)
Application for License to Operate a Renal Dialysis Facility, Freestanding or
Mobile Technology, or Hospital-owned Pain Management Clinic;
(f) Application for License to Operate a Long
Term Care Facility; or
(g)
Application for License to Operate a Family Care Home.
(4) Provisional License. Upon receipt of an
application for a license and appropriate licensure fee as established in
Section 3 of this administrative regulation, the Office of Inspector General
shall:
(a) Review the application for
completeness, including documentation related to:
1. Ownership;
2. Personnel;
3. Operations and administrative
policies;
4. The type of services
to be provided applicable to the license requested; and
5. if appropriate, plans and specifications
for construction or renovation; and
(b) Return the application and accompanying
licensure fee if:
1. An individual having a
significant financial interest in the health facility or health service has
had, within the seven (7) year period prior to the application date, a
significant financial interest in a facility or service that was licensed or
certified by the cabinet, and the license or certificate to operate was denied,
suspended, revoked, or voluntarily relinquished as the result of an
investigation or adverse action that placed patients, residents, or clients at
risk of death or serious harm; or
2. The cabinet finds that the applicant
misrepresented or submitted false information on the application.
(5) If an application is
determined complete and no statutory or regulatory deficiencies are identified,
the Office of Inspector General shall issue a provisional license to remain in
effect until:
(a) Completion of the on-site
inspection established in subsection (7) of this section; and
(b) Verification of compliance with each
statute and administrative regulation applicable to the license
requested.
(6)
(a) Upon receipt of a provisional license,
the licensee shall begin providing health services as designated on the
licensure application.
(b) If a
provisional licensee does not begin providing services within ten (10) business
days after receipt of the provisional license, the licensee shall provide
written notification to the cabinet of the following:
1. The reason the licensee has not yet begun
providing services; and
2. The
anticipated date the licensee will begin operating.
(c) The licensee shall notify the cabinet
within three (3) business days after the licensee begins providing
services.
(7)
(a) Within three (3) months from the
effective date of a provisional license, the Office of Inspector General shall
conduct an unannounced, on-site inspection of the health facility or health
service to verify compliance with each statute and administrative regulation
applicable to the license requested.
(b) If the Office of Inspector General
identifies a statutory or regulatory violation or multiple violations during
the provisional licensure period, the health facility or health service shall
be subject to the correction process established in subsection (13) of this
section.
(8) A
provisional license shall expire on the date the Office of Inspector General
grants approval of or denies a license following the inspection described in
subsection (7) of this section.
(9)
If a provisional licensee receives notice from the Office of Inspector General
that a license is denied, the licensee shall cease providing services
immediately.
(10) Written notice
denying a license shall explain the reason for the denial, including:
(a) Substantial failure, as described by
KRS
216B.105(2), to comply with
the provisions of KRS Chapter 216B or any administrative regulation applicable
to the regular license;
(b)
Substandard care that places patients, residents, or clients at risk of death
or serious harm; or
(c) Denial of
access to the Office of Inspector General as described in subsection (12) of
this section.
(11) The
effective date of the license shall be backdated to the issuance date of the
provisional license and be subject to annual renewal within one (1) year from
the effective date.
(12) Licensure
inspections.
(a) Except for a health facility
subject to
KRS
216.530, a licensure inspection may be
unannounced.
(b)
1. A representative of the Office of
Inspector General shall have access to the health facility pursuant to
KRS
216B.042(2).
2. An applicant for licensure or a current
licensee shall not deny access to a representative of the Office of Inspector
General, after proper identification, to make an inspection for determining
compliance with the requirements of each applicable administrative regulation
for which the health facility or health service is licensed under 902 KAR
Chapter 20 or 906 KAR Chapter 1.
3.
a. Denial of access, including any effort to
delay, interfere with, or obstruct an effort by a representative of the Office
of Inspector General to enter the health facility or health service, or deny
access to records relevant to the inspection, unless deemed confidential by
42 U.S.C.
299b-22(a), shall result in disciplinary
action, including denial, revocation, modification, or suspension of the
license of the health facility or health service.
b. Denial, revocation, modification, or
suspension of a health facility's or health service's license shall be subject
to appeal pursuant to
KRS
216B.105.
(c) An inspection of a health facility or
health service licensed under 902 KAR Chapter 20 or 906 KAR Chapter 1 shall
comply as follows:
1. The inspection shall be
made at any time during the licensee's hours of operation;
2. The inspection shall be limited to ensure
compliance with the standards set forth in 902 KAR Chapter 20, 906 KAR Chapter
1, KRS Chapter 216, or KRS Chapter 216B; and
3. The inspection of a health facility or
health service based on a complaint or a follow-up visit shall not limit the
scope of the inspection to the basis of the complaint or the implementation of
a plan of correction.
(13) Violations.
(a) The Office of Inspector General shall
notify a health facility or health service in writing of a regulatory violation
identified during an inspection.
(b) The health facility or health service
shall submit to the Office of Inspector General, within ten (10) days of the
notice, a written plan for the correction of the regulatory violation.
1. The plan shall be signed by the health
facility's or health service's administrator, the licensee, or a person
designated by the licensee and shall specify:
a. The date by which the violation shall be
corrected;
b. The specific measures
to be utilized to correct the violation; and
c. The specific measures to be utilized to
ensure the violation will not recur.
2. The Office of Inspector General shall
review the plan and notify the health facility or health service in writing of
the decision to:
a. Accept the plan;
b. Not accept the plan; or
c. Deny, suspend, or revoke the license for a
substantial regulatory violation in accordance with
KRS
216B.105(2).
3. The notice specified in
subparagraph 2.b. of this paragraph shall:
a.
State the specific reasons the plan is unacceptable; and
b. Require an amended plan of correction
within ten (10) days of receipt of the notice.
4. The Office of Inspector General shall
review the amended plan of correction and notify the health facility or health
service in writing of the decision to:
a.
Accept the plan;
b. Deny, suspend,
or revoke the license for a substantial regulatory violation in accordance with
KRS
216B.105(2); or
c. Require the health facility or health
service to submit an acceptable plan of correction.
5. A health facility or health service that
fails to submit an acceptable amended plan of correction may be notified that
the license will be denied, suspended, or revoked in accordance with
KRS
216B.105(2).
(14) A license shall:
(a) Expire one (1) year from the effective
date, unless otherwise expressly provided in the license certificate;
and
(b) Be renewed in the form of a
validation letter if the licensee:
1. Submits
a completed licensure application;
2. Pays the prescribed fee;
3. Has no pending adverse action;
and
4. Unless exempted, has
responded to requests from the cabinet for:
a.
Annual utilization surveys; and
b.
Requests for information regarding health services provided.
(15) Except
for a Level I psychiatric residential treatment facility licensed pursuant to
the exception established in
902
KAR 20:320, Section 3(2), more than one (1) license
shall not be issued or renewed for a particular licensure category at a
specific location.
(16) Written
notice shall be filed with the Office of Inspector General within thirty (30)
calendar days of the effective date of a change of ownership. A change of
ownership for a license shall:
(a) Be deemed
to occur if more than twenty-five (25) percent of an existing health facility
or health service or equity or voting rights of a legal entity is purchased,
leased, or otherwise acquired by one (1) or more persons or legal entity from
another; and
(b) Not require the
issuance of a provisional license.
(17) The licensee shall fully disclose to the
cabinet the name, mailing address, email address, and phone number, or a change
in the name, mailing address, email address, or phone number of:
(a) Each person or legal entity having an
ownership interest in the health facility or health service; and
(b)
1. Each
officer or director if organized as a corporation, limited liability company,
or other legal entity; or
2. Each
partner if organized as a partnership.
(18) An individual, shareholder, partner,
member, or legal entity shall not acquire a significant financial interest in
any licensed health facility or health service if that individual, shareholder,
partner, member, or legal entity previously held a significant financial
interest in a licensed facility that had its license or certificate to operate
denied, suspended, revoked, or voluntarily relinquished, within the preceding
seven (7) years, as the result of an investigation or adverse action that
placed patients, residents, or clients at risk of death or serious
harm.
(19) An unannounced
inspection shall be conducted:
(a) In response
to a relevant complaint or allegation; and
(b) According to procedures established in
subsection (12) of this section.
(20) A licensee that does not have a pending
adverse action, but fails to submit a completed licensure application annually
shall cease operating the health facility or health service unless:
(a) The items required under subsection
(14)(b) of this section have been tendered; and
(b) The Office of Inspector General has
provided the health facility or health service with a notice granting temporary
authority to operate pending submission of the application.
(21) Credentialing and
Re-credentialing. A licensed health facility or health service that is required
by
KRS
216B.155(2) to assess the
credentials of health care professionals applying for privileges shall use Form
KAPER-1, Part B, incorporated by reference in
806 KAR
17:480.
(22) Licensure exemptions.
(a) A facility shall be exempt from licensure
if it meets the criteria established by
KRS
216B.020(2) or
(3).
(b) A federally certified rural health clinic
or a federally qualified health center that provides services to patients with
behavioral health or psychiatric conditions, including substance use disorders,
shall:
1. Be exempt from licensure in
accordance with
KRS
216B.020(2) and (3);
and
2. Not be subject to licensure
in a separate category under 902 KAR Chapter 20 or 908 KAR Chapter 1.
Section 3. Fee
Schedule.
(1)
(a) Fees for review of plans and
specifications for construction or renovation of health facilities shall be as
follows:
License Type
|
Rate
|
(a) Hospitals plans and specifications review
|
$.10 per sq. ft.
|
(initial through final)
|
$200 minimum
|
(b) All other health facilities plans and
specifications review
|
$.10 per sq. ft.
|
(initial through final)
|
$200 minimum
|
(b) A
request for review of plans and specifications shall be submitted on the
Program Review Fee - Worksheet Health Facility Identification form, accompanied
by payment described in paragraph (a) of this subsection.
(2) Initial and Annual fees. The initial and
annual licensure fee for health facilities and services shall be as follows:
License Type
|
Rate
|
(a) Freestanding birth center
|
$500
|
(b) Alzheimer's nursing home
|
For Alzheimer's nursing facilities with 50 beds or
less, $750 + $25 per bed; For Alzheimer's nursing facilities with 51 or more
beds, $1,000 + $25 per bed
|
(c) Ambulatory surgical center
|
$750
|
(d) Chemical dependency treatment service
|
$1,000 + $25 per bed
|
(e) Community mental health center
|
$1,500
|
(f) Day health care
|
$170
|
(g) Family care home
|
$42
|
(h) Group home for individuals with an intellectual
or developmental disability
|
$100
|
(i) Home health agency
|
$500
|
(j) Hospice
|
$500
|
(k) Hospital
|
1 Deemed hospital
|
For deemed hospitals with 25 beds or less, $750 + $25
per bed. For deemed hospitals with 26 or more beds, $1,000+ $25 per bed
|
2 Non-deemed hospital
|
For non-deemed hospitals with 25 beds or less, $750 +
$25 per bed.
For non-deemed hospitals with 26 or more beds, $1,000
+ $25 per bed
|
(l) intermediate care facility
|
For intermediate care facilities with 50 beds or
less, $750 + $25 per bed.
For intermediate care facilities with 51 or more
beds, $1,000 + $25 per bed
|
(m) ICF/IID facility
|
For ICFs/IID with 50 beds or less, $750 + $25 per
bed. For ICFs/IID with 51 or more beds, $1,000 + $25 per bed
|
(n) Nursing facility
|
For nursing facilities with 50 beds or less, $750 +
$25 per bed. For nursing facilities with 51 or more beds, $1,000+ $25 per
bed
|
(o) Nursing home
|
For nursing homes with 50 beds or less, $750 + $25
per bed; For nursing homes with 51 or more beds, $1,000 + $25 per bed
|
(p) Ambulatory care clinic
|
$500
|
(q) Personal care home
|
$100 + $5 per bed
|
(r) Psychiatric hospital
|
1. Deemed hospital
|
For deemed psychiatric hospitals with 25 beds or
less, $750 + $25 per bed; For deemed psychiatric hospitals with 26 or more
beds, $1,000 + $25 per bed
|
2. Non-deemed hospital
|
For non-deemed psychiatric hospitals with 25 beds or
less, $750 + $25 per bed; For non-deemed psychiatric hospitals with 26 or more
beds, $1,000 + $25 per bed
|
(s) Psychiatric residential treatment facility
|
$500
|
(t) Renal dialysis facility
|
$35 per station + $350 per facility
|
(u) Hospital-owned pain management clinic
|
$500
|
(v) Freestanding or mobile technology
|
$500
|
(w) Comprehensive physical rehabilitation
hospital
|
1. Deemed hospital
|
For deemed hospitals with 25 beds or less, $750 + $25
per bed; For deemed hospitals with 26 or more beds, $1,000 + $25 per bed
|
2. Non-deemed
|
For non-deemed hospitals with 25 beds or less, $750 +
$25 per bed;
For non-deemed hospitals with 26 or more beds, $1,000
+ $25 per bed
|
(x) Critical access hospital
|
$750 + $25 per bed
|
(y) Private duty nursing agency
|
$500
|
(z) Residential hospice facility
|
$500
|
(aa) Prescribed Pediatric Extended Care
Facility
|
$500
|
(bb) Outpatient health care center
|
$500
|
(3)
Change in status of a licensed health facility.
(a) Name change or change of facility
administrator. If a health facility changes the name of the facility as set
forth on its license or the facility administrator changes, the licensee shall
notify the Office of Inspector General of the facility's new name or new
administrator within ten (10) calendar days of the effective date of the name
change or administrator change.
(b)
Change of location.
1. If a health facility or
one (1) of its extensions or satellites changes location and certificate of
need approval is not required prior to relocation, the licensee shall notify
the Office of Inspector General of the new location within ten (10) calendar
days of the effective date of the change.
2. The Office of Inspector General shall
conduct an on-site inspection for a change of location if the facility is one
(1) of the following levels of care:
a.
Freestanding birth center;
b.
Alzheimer's nursing home;
c.
Ambulatory surgical center;
d.
Chemical dependency treatment service;
e. Group home;
f. Non-deemed hospital;
g. Intermediate care facility;
h. Intermediate care facility for individuals
with an intellectual or developmental disability (ICF/IID);
i. Nursing facility;
j. Nursing home;
k. Personal care home;
l. Psychiatric residential treatment
facility;
m. Renal dialysis
facility;
n. Residential hospice
facility;
o. Outpatient health care
clinic; or
p. Abortion
facility.
(4)
(a)
Failure to renew a license by the annual renewal date shall result in a late
penalty equal to twenty (20) percent of the renewal fee or twenty-five (25)
dollars, whichever amount is greater.
(b) Continual failure to submit a completed
and accurate renewal application or fee by the date specified by the cabinet
may result in an enforcement action.
Section 4. Existing Facilities With Waivers.
(1) The Inspector General shall deem an
existing health facility to be in compliance with a facility specification
requirement, even though the health facility does not meet fully the applicable
requirement, if:
(a) The Inspector General has
previously granted, to the health facility, a waiver for the
requirement;
(b) The health
facility is licensed by the cabinet;
(c) The health facility is in good standing;
and
(d) The waived requirement does
not adversely affect the health, safety, or welfare of a resident or
patient.
(2) If the
Inspector General determines that the waived requirement has adversely affected
patient or resident health, safety or welfare, then:
(a) The Inspector General shall notify the
health facility of the findings and the need to comply with the applicable
administrative regulations; and
(b)
The health facility shall submit a written plan to ensure compliance, pursuant
to Section 2(13)(b) of this administrative regulation.
Section 5. Variances.
(1) The Inspector General may grant a health
facility a variance from a facility specification requirement if the facility
establishes that the variance will:
(a)
Improve the health, safety, or welfare of a resident or patient; or
(b) Promote the same degree of health,
safety, or welfare of a resident or patient as would prevail without the
variance.
(2) A health
facility shall submit a request for a variance, in writing, to the Office of
Inspector General. The request shall include:
(a) All pertinent information about the
facility;
(b) The specific
provision of the administrative regulation affected;
(c) The specific reason for the request;
and
(d) Evidence in support of the
request.
(3) The
Inspector General shall review and approve or deny the request for variance.
The Inspector General may request additional information from the health
facility as is necessary to render a decision. A variance may be granted with
or without a stipulation or restriction.
(4) The Inspector General shall revoke a
variance previously granted if the Inspector General determines the variance
has not:
(a) Improved the health, safety, or
welfare of a patient or resident; or
(b) Promoted the same degree of health,
safety, or welfare of a patient or resident that would prevail without the
variance.
1. The Inspector General shall
notify the health facility of a decision to revoke a variance and the need to
comply with the applicable regulatory requirement.
2. The health facility shall submit a written
plan to ensure compliance, pursuant to Section 2(13)(b) of this administrative
regulation.
Section 6. Variance Hearings.
(1)
(a) A
health facility dissatisfied with a decision to deny, modify, or revoke a
variance or a request for a variance may file a written request for a hearing
with the Secretary of the Cabinet for Health and Family Services.
(b) The request shall be received by the
secretary within twenty (20) days of the date the health facility receives
notice of the decision to deny, modify, or revoke the variance or request for a
variance.
(2) An
administrative hearing shall be conducted in accordance with KRS Chapter
13B.
Section 7. Adverse
Action Procedures.
(1) A health facility or
health service that has received a preliminary order to close or other notice
of adverse action:
(a) Shall receive a
duplicate license from the Office of Inspector General indicating that the
health facility or health service has an adverse action pending;
(b) Shall post the duplicate license in place
of the original license;
(c) Shall
be subject to periodic inspections by the inspecting agency to investigate
complaints and ensure patient safety; and
(d) May continue to operate under duplicate
license pending completion of the adverse action process, if patients and
residents are not subjected to risk of death or serious harm.
(2) Until all appeals pursuant to
KRS
216B.105 of the pending adverse action have
been exhausted, the health facility or health service shall not have its:
(a) License renewed; or
(b) Duplicate license replaced.
Section 8. Denial and
Revocation.
(1) The cabinet shall deny or
revoke a license if it finds that:
(a) In
accordance with
KRS
216B.105(2), there has been
a substantial failure by the health facility or health service to comply with
the provisions of:
1. KRS Chapter 216B;
or
2. The administrative
regulations applicable to the health facility's or health service's
license;
(b) The health
facility or health service fails to submit an acceptable plan of correction or
fails to submit an acceptable amended plan of correction within the timeframes
required by Section 2(13) of this administrative regulation;
(c) The health facility or health service
fails to comply with the annual renewal process described by Section 2(14) of
this administrative regulation; or
(d) The health facility or health service
denies access to the Office of Inspector General pursuant to Section 2(12)(b)
of this administrative regulation.
(2) The denial or revocation of a health
facility's or health service's license shall be issued pursuant to
KRS
216B.105(2).
(3) Notice of the denial or revocation shall
set forth the particular reasons for the action.
(4) In accordance with
KRS
216B.105(2), the denial or
revocation shall become final and conclusive thirty (30) days after notice is
given, unless the applicant or licensee, within the thirty (30) day period,
files a request in writing for a hearing with the cabinet.
(5) Pursuant to
KRS
216B.050, the cabinet may compel obedience to
its lawful orders.
Section
9. Incorporation by Reference.
(1) The following material is incorporated by
reference:
(a) Form OIG 001, "Application for
License to Operate a Health Facility or Health Service", July 2018;
(b) Form OIG 002, "Application for License to
Operate a Chemical Dependency Treatment Service, Group Home, Psychiatric
Residential Treatment Facility, or Residential Hospice Facility", January
2017;
(c) Form OIG 003,
"Application for License to Operate a Hospital", January 2017;
(d) Form OIG 004, "Application for License to
Operate a Home Health Agency, Non-Residential Hospice, or Private Duty Nursing
Agency", January 2017;
(e) Form OIG
005, "Application for License to Operate a Renal Dialysis Facility,
Freestanding or Mobile Technology, or Hospital-owned Pain Management Clinic",
July 2018;
(f) Form OIG 006,
"Application for License to Operate a Long Term Care Facility", January
2017;
(g) Form OIG 007,
"Application for License to Operate a Family Care Home", January 2017;
and
(h) Form OIG PR-1, "Program
Review Fee - Worksheet Health Facility Identification Form", June
2014.
(2) This material
may be inspected, copied, or obtained, subject to applicable copyright law, at
the Office of the Inspector General, 275 East Main Street, Frankfort, Kentucky
40621, Monday through Friday, 8 a.m. to 4:30 p.m.