Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO:
KRS
198B.260, 216B.010-216B.131,
216B.990,
218A.175,
311, 314,
29 C.F.R.
1910.1030(d)(2)(vii),
21
U.S.C. 801 -
971
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
216B.042 requires the Cabinet for Health and
Family Services to promulgate administrative regulations necessary for the
proper administration of the licensure function, which includes establishing
licensure standards and procedures to ensure safe, adequate, and efficient
health facilities and health services.
KRS
216B.105 authorizes the cabinet to promulgate
administrative regulations to deny, revoke, modify, or suspend a license issued
by the cabinet, if it finds that there has been a substantial failure to comply
with the provisions of KRS Chapter 216B or this administrative regulation.
KRS
218A.175 imposes a physician-ownership or
investment requirement on all pain management facilities except for those
health facilities operating as a pain management facility on April 24, 2012,
unless there is an administrative sanction or criminal conviction relating to
controlled substances imposed on the facility or any person employed by the
facility for an act or omission done within the scope of the facility's license
or the person's employment. This administrative regulation establishes the
minimum licensure requirements for the operation of a pain management facility
that is exempt from the physician-ownership requirement of
KRS
218A.175.
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 pain management
facility's license to operate.
(2)
"License" means an authorization issued by the cabinet for the purpose of
operating a pain management facility.
(3) "Licensee" means the owner, individual,
agency, partnership, or corporation, in which the ultimate responsibility and
authority for the conduct of the pain management facility, or a satellite
facility, is vested.
(4) "National
and State Background Check Program" means an initiative implemented by the
cabinet pursuant to
906 KAR
1:190 for the performance of:
(a) Registry checks; and
(b) Fingerprint-supported criminal background
checks performed by the Department of Kentucky State Police and the Federal
Bureau of Investigation.
(5) "Pain management facility" or "facility"
is defined by
KRS
218A.175(1)
(6) "Satellite facility" means a pain
management facility permitted by
KRS
218A.175(2)(b) to open and
operate under the license of a parent pain management facility that:
(a) Is licensed under this administrative
regulation pursuant to the physician-ownership exemption of
KRS
218A.175(2)(a);
and
(b) Does not have a pending
adverse action.
(7)
"Unencumbered license" means a license that has not been restricted by the
state professional licensing board due to an administrative sanction or
criminal conviction relating to a controlled substance.
Section 2. Satellite Facilities. A satellite
facility shall comply with the requirements established by this administrative
regulation for parent pain management facilities, including background checks,
administration, staffing, equipment, and physical environment.
Section 3. Ownership.
(1) A facility licensed pursuant to this
administrative regulation shall be immediately disqualified from the
physician-ownership exemption of
KRS
218A.175, and the cabinet shall revoke the
facility's license pursuant to Section 11(3) of this administrative regulation
if:
(a) An administrative sanction or criminal
conviction relating to a controlled substance is imposed on the parent or
satellite facility or any person contracted or employed by the parent or
satellite facility for an act or omission done within the scope of the
facility's licensure or the person's employment; or
(b) A change of ownership occurs, except for
a transfer of whole or partial ownership as permitted by
KRS
218A.175(2)(b).
(2)
(a) A change of ownership shall be deemed to
occur if any ownership interest, or capital stock or voting rights of a
corporation is purchased, leased, or otherwise acquired by one (1) person from
another for an existing facility licensed pursuant to this administrative
regulation.
(b) The pain management
facility's license shall not be transferred to a new owner, except for a
transfer of whole or partial ownership interest in the facility as permitted by
KRS
218A.175(2)(b).
Section 4. Background
Checks and Prohibition Against Employment.
(1)
(a) All owners, operators, and employees,
including contract employees of a pain management facility, shall submit to a
fingerprint-supported national and state criminal background check.
(b) A facility may use Kentucky's National
and State Background Check Program established by
906 KAR
1:190 to satisfy the criminal background check
requirement of paragraph (a) of this subsection.
(2) A facility shall not be licensed if owned
in part by, contracts with, or employs a physician or prescribing practitioner:
(a) Whose Drug Enforcement Administration
number has ever been revoked;
(b)
Whose application for a license to prescribe, dispense, or administer a
controlled substance has been denied by any jurisdiction;
(c) Who has had any disciplinary limitation
placed on his or her license by:
1. The
Kentucky Board of Medical Licensure;
2. The Kentucky Board of Nursing;
3. The Kentucky Board of Dentistry;
4. The Kentucky Board of Optometric
Examiners;
5. The State Board of
Podiatry;
6. Any other board that
licenses or regulates a person who is entitled to prescribe or dispense
controlled substances to humans; or
7. A licensing board of another state if the
disciplinary action resulted from illegal or improper prescribing or dispensing
of controlled substances; or
(d) Who has been convicted of or pleaded
guilty or nolo contendere to, regardless of adjudication, an offense that
constitutes a felony for receipt of illicit and diverted drugs, including a
controlled substance listed as Schedule I, Schedule II, Schedule III, Schedule
IV, or Schedule V in this state or the United States.
(3) In addition to physicians and prescribing
practitioners, a facility shall not employ any individual directly, or by
contract, who has been convicted of or pleaded guilty or nolo contendere to,
regardless of adjudication, a drug-related offense as described in subsection
(2)(d) of this section.
Section
5. Licensure Application, Fee, and Renewal.
(1) A licensee which elects to open and
operate no more than two (2) additional satellite facilities shall:
(a) As a condition precedent to adding a
satellite facility to the parent pain management facility's license, ensure
that the satellite facility is in compliance with this administrative
regulation and
KRS
218A.175, which may be determined through an
on-site inspection of the satellite facility; and
(b) Submit a completed Application for
License to Operate a Pain Management Facility prior to opening the satellite
facility accompanied by a fee of $2,000 per each satellite facility.
(2) A license shall:
(a) Expire one (1) year from the date of
issuance; and
(b) Be renewed if the
licensee:
1. Submits a completed Application
for License to Operate a Pain Management Facility accompanied by an annual
re-licensure fee of $2,000, plus a fee of $2,000 per satellite facility;
and
2. Has no pending adverse
action.
(3) A
pain management facility that does not have a pending adverse action but has
failed to renew its license on or before the expiration date shall cease
operating the facility unless:
(a) The items
required under subsection (2)(b) of this section have been submitted;
and
(b) The Office of Inspector
General has provided the facility with a notice granting temporary authority to
operate pending completion of the renewal process.
Section 6. Facility Patients. To
determine if the majority of patients of the practitioners at the facility are
provided treatment for pain that includes the use of controlled substances, the
Office of Inspector General:
(1) Shall have
access to the facility pursuant to
KRS
216B.042, including the facility's patient
records;
(2) Shall calculate the
majority of patients based upon the number of unduplicated patients treated in
a one (1) month time period; and
(3) May use data from the Kentucky All
Schedule Prescription Electronic Reporting (KASPER) Program to determine if the
majority of the patients of the facility's practitioners are prescribed
controlled substances.
Section
7. Administration Requirements for Parent and Satellite Pain
Management Facilities.
(1) A facility shall be
located in a fixed site.
(2) Each
facility shall post the license conspicuously in a public area of the
facility.
(3) Licensee.
(a) The licensee shall be legally responsible
for:
1. All activities within the facility,
including the actions of the physicians and prescribing practitioners;
and
2. Compliance with federal,
state, and local laws and administrative regulations pertaining to the
operation of the facility, including the Drug Abuse Prevention and Control Act
(21
U.S.C. 801 to
971
et. seq.) and KRS Chapter 218A, 902 KAR Chapter 20, and 902 KAR Chapter
55.
(b) The licensee
shall establish lines of authority and designate an administrator who:
1. May serve in a dual role as the facility's
medical director; and
2. Shall be
principally responsible for the daily operation of the facility.
(4) Policies. The
facility shall establish and follow written administrative policies covering
all aspects of operation, including:
(a) A
description of organizational structure, staffing, and allocation of
responsibility and accountability;
(b) A description of linkages with inpatient
facilities and other providers;
(c)
Policies and procedures for the guidance and control of personnel
performances;
(d) A written program
narrative describing in detail each service offered, methods and protocols for
service delivery, qualifications of personnel involved in the delivery of the
services, and goals of each service;
(e) A description of the administrative and
patient care records and reports;
(f) Procedures to be followed if the facility
performs any functions related to the storage, handling, and administration of
drugs and biologicals; and
(g)
Procedures for compliance with
KRS
218A.175(4).
(5) Referral. If an individual
seeks or is in need of care and treatment beyond the scope of services offered
by the facility, the facility:
(a) Shall
immediately advise the individual that he or she should seek services
elsewhere; and
(b) May make a
referral on behalf of the individual.
(6) Personnel.
(a) Prescribers. Each prescriber employed or
contracted by a facility shall be board certified and have a full, active, and
unencumbered license to practice in the commonwealth issued under KRS Chapter
311 or 314.
(b) Medical director.
The facility's medical director shall:
1. Be
responsible for complying with all requirements related to the licensure and
operation of the facility;
2. Be
physically present practicing medicine in the facility for at least fifty (50)
percent of the time that patients are present in the facility;
3. Be board certified and have a full,
active, and unencumbered license to practice medicine in the commonwealth
issued under KRS Chapter 311; and
4. Not be permitted to serve in a dual role
as the medical director of both the parent facility and a satellite
facility.
(c) Medical
director's qualifications. The facility's medical director shall meet one (1)
of the requirements established in
KRS
218A.175(3)(a) through
(e).
(d) Within ten (10) calendar days after
termination of the medical director, the facility shall notify the cabinet of
the identity of the individual designated as medical director, including the
identity of any interim medical director, until a permanent director is secured
for the facility.
(e) The
facility's medical director shall sign and submit the Pain Management Facility
Data Reporting Form to the cabinet within thirty (30) calendar days of the
quarter ending March 31, June 30, September 30, and December 31 of each year.
The medical director shall document the following on the Pain Management
Facility Data Reporting Form:
1. The number of
new and repeat patients seen and treated at the facility who are prescribed
controlled substance medications for the treatment of chronic, nonmalignant
pain;
2. The number of patients
discharged due to drug abuse;
3.
The number of patients discharged due to drug diversion; and
4. The number of patients treated at the
facility whose domicile is located somewhere other than in Kentucky. A
patient's domicile shall be the patient's fixed or permanent home to which he
or she intends to return even though he or she may temporarily reside
elsewhere.
(f) The
medical director shall, within ten (10) days after the facility hires a
prescriber of controlled substances or ten (10) days after termination of a
prescriber of controlled substances, notify the cabinet in writing and report
the name of the prescriber.
(7) Staffing. At least one (1) physician and
one (1) practical nurse, licensed practical nurse, or registered nurse shall be
on duty in the facility during all hours the facility is operational.
(8) Job descriptions. There shall be a
written job description for each position which shall be reviewed and revised
as necessary.
(9) Personnel
records. Current personnel records shall be maintained for each employee and
include the following:
(a) Name, address, and
social security number;
(b)
Evidence of current certification or licensure of personnel;
(c) Records of training and
experience;
(d) Records of each
performance evaluation; and
(e)
Annual verification of certification or licensure.
(10) In-service training.
(a) All personnel shall participate in
orientation and annual in-service training programs relating to their
respective job activities.
(b) All
licensed prescribers in a facility shall comply with the professional standards
established by their respective licensing boards for the completion of
continuing professional education. Each licensed physician who prescribes or
dispenses a controlled substance to a patient in the facility as part of his or
her employment agreement with the facility shall successfully complete a
minimum of ten (10) hours of Category I continuing medical education in pain
management during each registration period throughout his or her employment
agreement with the facility.
(11) Quality assurance program.
(a) Each facility shall have an ongoing
quality assurance program that:
1. Monitors
and evaluates the quality and appropriateness of patient care;
2. Evaluates methods to improve patient
care;
3. Identifies and corrects
deficiencies within the facility;
4. Alerts the designated physician or
prescribing practitioner to identify and resolve recurring problems;
and
5. Provides for opportunities
to improve the facility's performance and to enhance and improve the quality of
care provided to the public.
(b) The medical director shall establish a
quality assurance program that includes the following components:
1. The identification, investigation, and
analysis of the frequency and causes of adverse incidents to
patients;
2. The identification of
trends or patterns of incidents;
3.
The development and implementation of measures to correct, reduce, minimize, or
eliminate the risk of adverse incidents to patients; and
4. The documentation of these functions and
periodic review no less than quarterly of this information by the designated
physician or prescribing practitioner.
(12) Medical records. Each facility shall
maintain accurate, readily accessible, and complete medical records that
conform to the professional standards established by the respective licensing
board for prescribers of controlled substances in the facility.
(13) Professional standards for prescribing
and dispensing controlled substances.
(a) Each
licensed prescriber in a facility shall comply with the professional standards
relating to the prescribing and dispensing of controlled substances established
by the respective professional licensing board.
(b) A representative from the Office of
Inspector General shall review facility records, including the facility's
patient records, to verify facility compliance with administrative regulations
promulgated by professional licensing boards pursuant to
KRS
218A.205 which establish standards for
licensees authorized to prescribe or dispense controlled substances.
(14) Kentucky Health Information
Exchange (KHIE). Each facility shall participate in KHIE pursuant to the
requirements of
900 KAR
9:010.
Section 8. Equipment. Equipment used for
direct patient care by a facility shall comply with the requirements
established in this section.
(1) The licensee
shall establish and follow a written preventive maintenance program to ensure
that equipment shall be operative and properly calibrated.
(2) All personnel engaged in the operation of
diagnostic equipment shall have adequate training and be currently licensed,
registered, or certified in accordance with applicable state statutes and
administrative regulations.
(3) A
written plan shall be developed and maintained to provide for training of
personnel in the safe and proper usage of the equipment.
Section 9. Physical Environment.
(1) Accessibility. The facility shall meet
requirements for making buildings and facilities accessible to and usable by
the physically handicapped pursuant to
KRS
198B.260 and administrative regulations
promulgated thereunder.
(2) Fire
safety. A new license to operate a satellite facility or a new license to
operate a facility upon approval of a change of location shall not be issued
before the facility obtains approval from the State Fire Marshal's office for
the satellite facility or new location.
(3) Physical location and overall
environment.
(a) The facility shall:
1. Comply with building codes, ordinances,
and administrative regulations which are enforced by city, county, or state
jurisdictions;
2. Display a sign
that can be viewed by the public that contains the facility name, hours of
operation, and a street address;
3.
Have a publicly listed telephone number and a dedicated phone number to send
and receive faxes with a fax machine that shall be operational twenty-four (24)
hours per day;
4. Have a reception
and waiting area;
5. Provide a
restroom;
6. Have an administrative
area, including room for storage of medical records, supplies, and
equipment;
7. Have private patient
examination rooms;
8. Have
treatment rooms, if treatment is being provided to the patients; and
9. Display a printed sign located in a
conspicuous place in the waiting room viewable by the public with the name and
contact information of the facility's medical director and the names of all
physicians and prescribers practicing in the facility.
(b) The condition of the physical location
and the overall environment shall be maintained so that the safety and
well-being of patients, personnel, and visitors are assured.
(4) Housekeeping and maintenance
services.
(a) The facility shall maintain a
clean and safe facility free of unpleasant odors.
(b) Odors shall be eliminated at their source
by prompt and thorough cleaning of commodes, urinals, bedpans, and other
sources.
(c)
1. The facility shall provide a hand washing
facility in each exam room with:
a. Hot and
cold water and blade type operating handles;
b. Knee or foot controls; or
c. Motion activated
technology.
2. A soap
dispenser, disposable towels or electronic hand dryers, and a waste receptacle
shall be provided at each hand washing sink.
(d) The premises shall be well kept and in
good repair. Requirements shall include:
1.
The facility shall ensure that the grounds are well kept and the exterior of
the building, including the sidewalks, steps, porches, ramps, and fences are in
good repair;
2. The interior of the
building including walls, ceilings, floors, windows, window coverings, doors,
plumbing, and electrical fixtures shall be in good repair. Windows and doors
which can be opened for ventilation shall be screened;
3. Garbage and trash shall be stored in areas
separate from those used for the preparation and storage of food and shall be
removed from the premises regularly. Containers shall be cleaned regularly;
and
4. A pest control program shall
be in operation in the facility. Pest control services shall be provided by
maintenance personnel of the facility or by contract with a pest control
company. The compounds shall be stored under lock.
(5) The facility shall develop
written infection control policies that are consistent with Centers for Disease
Control guidelines and include:
(a) Prevention
of disease transmission to and from patients, visitors, and employees,
including:
1. Universal blood and body fluid
precautions;
2. Precautions against
airborne transmittal of infections;
3. Work restrictions for employees with
infectious diseases; and
4.
Cleaning, disinfection, and sterilization methods used for equipment and the
environment; and
(b)
Annual in-service education programs on the cause, effect, transmission,
prevention, and elimination of infections.
(6) Hazardous cleaning solutions, compounds,
and substances shall be:
(a)
Labeled;
(b) Stored in closed metal
containers;
(c) Kept separate from
other cleaning materials; and
(d)
Kept in a locked storage area apart from the exam room.
(7) The facility shall be kept free from
insects and rodents, and their nesting places.
(8) Garbage and trash:
(a) Shall be removed from the premises
regularly; and
(b) Containers shall
be cleaned daily.
(9) A
facility shall establish and maintain a written policy for the handling and
disposal of wastes, including any infectious, pathological, or contaminated
wastes, which shall include the requirements established in this subsection.
(a) Sharp wastes shall be segregated from
other wastes and placed in puncture-resistant containers immediately after
use.
(b) A needle or other
contaminated sharp shall not be recapped, purposely bent, broken, or otherwise
manipulated by hand as a means of disposal, except as permitted by the Centers
for Disease Control and the Occupational Safety and Health Administration
guidelines at
29 C.F.R.
1910.1030(d)(2)(vii).
(c) A sharp waste container shall be
incinerated on or off-site or rendered nonhazardous.
(d) Any nondisposable sharps shall be placed
in a hard walled container for transport to a processing area for
decontamination.
(10)
(a) Disposable waste shall be:
1. Placed in a suitable bag or closed
container so as to prevent leakage or spillage; and
2. Handled, stored, and disposed of in such a
way as to minimize direct exposure of personnel or patients to waste
materials.
(b) The
facility shall establish specific written policies regarding handling and
disposal of waste material.
Section 10. Inspections.
(1) The cabinet shall conduct unannounced
inspections of the pain management facility no less than annually, including a
review of the patient records, to ensure that the facility complies with the
provisions of this administrative regulation and
KRS
218A.175.
(2) A representative from the Office of
Inspector General shall have access to the facility and the facility's records
pursuant to
KRS
216B.042.
(3) Violations.
(a) The Office of Inspector General shall
notify the pain management facility in writing of a regulatory violation
identified during an inspection.
(b) The facility 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 facility's administrator, the licensee, or the
medical director and shall specify:
a. The
date by which the violation shall be corrected;
b. The specific measures utilized to correct
the violation; and
c. The specific
measures utilized to ensure the violation will not recur.
2. The Office of Inspector General shall
review the plan and notify the facility 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 facility 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 facility to submit an
acceptable plan of correction.
5. A facility that fails to submit an
acceptable amended plan of correction shall be notified that the license shall
be denied, suspended, or revoked in accordance with
KRS
216B.105(2).
(4) Complaints. An
unannounced inspection shall be conducted:
(a)
In response to a credible, relevant complaint or allegation; and
(b) According to procedures established in
this section.
Section
11. Denial and Revocation.
(1)
The cabinet shall deny an Application for License to Operate a Pain Management
Facility at the time of annual renewal or the addition of a satellite facility
if:
(a) The facility fails to comply with
Section 4(2) and (3), or 7(6) of this administrative regulation;
(b) Any person with ownership interest in the
facility has had previous ownership interest in a health care facility which
had its license revoked or voluntarily relinquished its license as the result
of an investigation or pending disciplinary action;
(c) An administrative sanction or criminal
conviction relating to controlled substances has been imposed on the facility
or any person employed by the facility for an act or omission done within the
scope of the facility's license or the person's employment; or
(d) The facility fails to submit an
acceptable plan of correction or fails to submit an acceptable amended plan of
correction within the timeframes required by Section 10(3) of this
administrative regulation.
(2) If during inspection of the pain
management facility the cabinet has probable cause to believe that a physician
or other prescriber practicing at the facility may be engaged in the improper,
inappropriate, or illegal prescribing or dispensing of a controlled substance,
the cabinet shall:
(a) Refer the physician or
other prescriber practicing at the pain management facility to the appropriate
professional licensing board and appropriate law enforcement agency;
and
(b) Suspend a facility's
license pending resolution of any investigation into the matter by a licensing
board or law enforcement agency, and resolution of the appeals process if
applicable.
(3) The
cabinet shall revoke a license if it finds that:
(a) In accordance with
KRS
216B.105(2), there has been
a substantial failure by the facility, or its satellite facility, to comply
with the provisions of this administrative regulation;
(b) An administrative sanction or criminal
conviction relating to controlled substances is imposed on the facility or any
person employed by the facility for an act or omission done within the scope of
the facility's license or the person's employment;
(c) A change of ownership has occurred,
except for a transfer of whole or partial ownership as permitted by
KRS
218A.175(2)(b);
(d) The facility fails to accept private
health insurance as one (1) of the facility's allowable forms of payment for
goods or services provided, or the facility fails to accept payment for
services rendered or goods provided only from the patient or the patient's
insurer, guarantor, spouse, parent, guardian, or legal custodian;
(e) The facility fails to submit an
acceptable plan of correction or fails to submit an acceptable amended plan of
correction within the timeframes required by Section 10(3) of this
administrative regulation; or
(f)
The facility fails to comply with Section 4(2) and (3), 7(6)(a), (b), or (c),
or 7(7) of this administrative regulation.
(4) The denial or revocation of a facility's
license shall be mailed to the applicant or licensee, by certified mail, return
receipt requested, or by personal service. Notice of the denial or revocation
shall set forth the particular reasons for the action.
(5) 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.
(6) Emergency action to suspend a license.
(a) The cabinet shall take emergency action
to suspend a pain management facility's license if the cabinet has probable
cause to believe that:
1. The continued
operation of the facility would constitute a danger to the health, welfare, or
safety of the facility's patients or of the general public; or
2. A physician or other prescriber practicing
at the facility may be engaged in the improper, inappropriate, or illegal
prescribing or dispensing of a controlled substance.
(b)
1. The
pain management facility shall cease operating immediately on the date the
facility is served with the notice of emergency suspension.
2. Notice of the emergency suspension shall
set forth the particular reasons for the action.
(c) If the cabinet issues an emergency
suspension of the facility's license pursuant to paragraph (a)2 of this
subsection, the cabinet shall refer the physician or other prescriber
practicing at the pain management facility to the appropriate professional
licensing board and appropriate law enforcement agency.
(7) Notice of an emergency suspension shall
be served on the facility by certified mail, return receipt requested, or by
personal service.
(8)
(a) Any facility required to comply with an
emergency suspension issued under subsection (6) of this section may submit a
written request for an emergency hearing within five (5) calendar days of
receipt of the notice to determine the propriety of the suspension.
(b) The cabinet shall conduct an emergency
hearing within ten (10) working days of the request for hearing.
(c) Within five (5) working days of
completion of the hearing, the cabinet's hearing officer shall render a written
decision affirming, modifying, or revoking the emergency suspension.
(d) The emergency suspension shall be
affirmed if there is substantial evidence of an immediate danger to the public
health, safety, or welfare.
(9) The decision rendered under subsection
(8) of this section shall be a final order of the agency on the matter, and any
party aggrieved by the decision may appeal to circuit court.
(10) If the cabinet issues an emergency
suspension, the cabinet shall take action to revoke the facility's license
pursuant to subsection (3) of this section if:
(a) The facility fails to submit a written
request for an emergency hearing within five (5) calendar days of receipt of
notice of the emergency suspension;
(b) The decision rendered under subsection
(8) of this section affirms that there is substantial evidence of an immediate
danger to the public health, safety, or welfare; or
(c) Referral to a professional licensing
board and law enforcement agency in accordance with subsection (6)(c) of this
section results in an administrative sanction or criminal conviction relating
to controlled substances against a physician or prescribing practitioner
employed by, or under contract with, the facility.
(11) Pursuant to
KRS
216B.050, the cabinet may compel obedience to
its lawful orders.
Section
12. Incorporation by Reference.
(1) The following material is incorporated by
reference:
(a) OIG 20:240, "Application for
License to Operate a Pain Management Facility", June 2015 edition;
and
(b) OIG 20:240-1, "Pain
Management Facility Data Reporting Form", June 2012 edition.
(2) This material may be
inspected, copied, or obtained, subject to applicable copyright law, at the
Office of Inspector General, 275 East Main Street, Frankfort, Kentucky 40621,
Monday through Friday, 8 a.m. to 4:30 p.m.
STATUTORY AUTHORITY:
KRS
216B.042,
216B.105,
218A.175