Kentucky Administrative Regulations
Title 201 - GENERAL GOVERNMENT CABINET
Chapter 9 - Board of Medical Licensure
Section 201 KAR 9:250 - Registration and oversight of pain management facilities
Universal Citation: 201 KY Admin Regs Service 9:250
Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO: KRS 218A.175, 311.530-311.620, 311.990
NECESSITY, FUNCTION, AND CONFORMITY: KRS 311.565(1)(a) authorizes the board to promulgate administrative regulations to regulate the conduct of its licensees. This administrative regulation establishes the requirements for registration and oversight for pain management facilities.
Section 1. Definitions.
(1) "Board" is defined by
KRS
311.550(1).
(2) "In good standing" means an active
license to practice medicine or osteopathy that is not currently subject to any
final order imposing any disciplinary sanction authorized by
KRS
311.595, agreed order, or letter of agreement
issued by or entered into with the board.
(3) "Pain management facility" is defined by
KRS
218A.175(1), and each
separate operating location of a physician's practice that meets the criteria
established by this definition shall be considered a separate pain management
facility.
(4) "Practitioner" means
a licensed or certified health care practitioner who is legally authorized to
prescribe or dispense controlled substances.
Section 2. Ownership or Investment Interest.
(1)
(a) A
physician who has an ownership or investment interest in a pain management
facility during any period when the physician is not licensed to practice
medicine or osteopathy within the Commonwealth of Kentucky shall be deemed to
be:
1. In violation of
KRS
311.595(12); and
2. Practicing medicine without a license and
subject to criminal sanctions.
(b) If the board determines that a physician
has maintained an ownership or investment interest in a pain management
facility during a period when that physician was not licensed to practice
medicine or osteopathy within the Commonwealth of Kentucky, it may deny an
application for licensing filed by that physician or may take appropriate
disciplinary action against a license previously issued to the
physician.
(2) A
physician who maintains an ownership or investment interest in a pain
management facility during any period when the physician's Kentucky license is
not in good standing shall be in violation of
KRS
311.595(12) and subject to
disciplinary action by the Board.
Section 3. Registration; Amended Registration; Fee; New Facility Registration.
(1) On or before September 1, 2012 and
September 1 of each succeeding year, every pain management facility operating
as the private office or clinic of a physician within the Commonwealth of
Kentucky shall register with the board, providing the following specific
information in writing:
(a) The name, business
address, profession, current professional licensing status, and nature and
extent of ownership or investment interest of each person who has or maintains
an ownership or investment interest in the pain management facility;
(b) The names and addresses of every pain
management facility in which the person has an ownership or investment
interest;
(c) The hours of
operation of every pain management facility in which the person has an
ownership or investment interest;
(d) The names and professional status of each
employee at each practice location owned and operated by that pain management
facility;
(e) The name,
professional license number, and practice address of the qualified physician
owner or owner's physician designee who will be physically present practicing
medicine in the pain management facility for at least fifty (50) percent of the
time patients are present at the facility. The facility shall also state its
plan for ensuring that the designated physician owner or owner's physician
designee will be physically present practicing medicine in the facility and, if
the facility owns and operates multiple practice locations, the plan to ensure
that a physician owner or owner's physician designee is physically present
practicing medicine in each practice location for at least fifty (50) percent
of the time that patients are seen at each pain management facility;
(f) For each owner's physician designee who
will fulfill the oversight responsibility, an attestation that the physician
designee is employed by the owner and the plan for owner supervision of the
physician designee; and
(g) An
attestation by the physician owner that the owner or owner's physician
designee:
1. Meets one (1) of the requirements
established in KRS
218A.175(3) and specifying
each qualification met by the physician owner or owner's physician designee;
or
2. Was an owner of that specific
pain management facility prior to and continuing through July 20, 2012 and
meets one (1) of the following qualifications:
a. Successfully completed a residency program
in physical medicine and rehabilitation, anesthesiology, addiction medicine,
neurology, neurosurgery, family practice, preventive medicine, internal
medicine, surgery, orthopedics, or psychiatry approved by the Accreditation
Council for Graduate Medical Education (ACGME) or American Osteopathic
Association Bureau of Osteopathic Specialists (AOABOS); or
b.
(i)
Registered the ownership or investment interest in that pain management
facility with this board on or before September 1, 2012;
(ii) Was eligible for and provided the board
with written verification that the licensee registered to complete the
certification examination offered by the American Board of Pain Medicine or the
American Board of Interventional Pain Physicians in April 2013; and
(iii) Became certified by the American Board
of Pain Medicine or by the American Board of Interventional Pain Physicians by
September 1, 2013.
(2) If the physician failed the certification
examination or failed to become certified by the American Board of Pain
Medicine or the American Board of Interventional Pain Physicians by September
1, 2013, the physician shall meet one (1) of the requirements established in
KRS
218A.175(3), to continue to
be qualified to provide the on-site supervision required by Section 5 of this
administrative regulation.
(3) At
the time of filing of the registration required by subsection (1) of this
section, each pain management facility operating as the private office or
clinic of a physician shall pay an annual fee of $500 for each pain management
facility to the board to defray the costs of registration and enforcement of
this administrative regulation.
(4)
If, during the effective period of the annual registration, a new or different
physician obtains an ownership or investment interest in the pain management
facility, or there is a change in the physician owner or physician designee who
will practice on-site at least fifty (50) percent of the time the facility is
open to patients, the facility shall file an amended registration with the
board identifying these physicians and providing the information required by
subsection (1) of this section about the new or different physicians, within
fourteen (14) calendar days of that change.
(5) Failure to file the required registration
or to pay the annual fee on or before September 1 of each year shall constitute
a violation of KRS
311.595(12) and shall serve
as a basis for discipline by the board against the license of any physician who
has an ownership or investment interest in the facility that failed to file the
required registration.
(6) If a new
pain management facility operating as the private office or clinic of a
physician comes into existence after September 1 of a calendar year but before
September 1 of the following calendar year, that new pain management facility
shall register with the board within fourteen (14) calendar days of its legal
formation, and shall meet each of the registration requirements of this
section.
Section 4. Identification and Qualifications of Prescribers Employed by the Facility; Notification of Changes.
(1) As part of its
initial or annual registration, the facility shall identify each practitioner,
who is employed by the facility in any capacity, who will be prescribing or
dispensing controlled substances to patients of the facility.
(2) Each licensed physician who will
prescribe or dispense controlled substances to patients of the facility as part
of the employment arrangement 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 the employment agreement
with the facility. This continuing medical education requirement shall satisfy
the requirement of
201 KAR 9:310.
(3) A licensed physician shall not prescribe
or dispense controlled substances to patients of the facility if the physician
has:
(a) Had an application for a license or
certificate to prescribe, dispense, or administer controlled substances denied
in any jurisdiction or by any governmental agency;
(b) Had a Drug Enforcement Administration
permit to prescribe, dispense, or administer controlled substances
revoked;
(c) Had the professional
ability or authority to prescribe or dispense controlled substances revoked,
restricted, or limited in any manner by a licensing authority of any state,
except as provided by subsection (4) of this section; or
(d) Been convicted of or entered a plea of
guilt, nolo contendere, or Alford plea, regardless of adjudication, to any
felony or misdemeanor relating to controlled substances, in any state or
federal court.
(4) The
prohibition established in subsection (3)(c) of this section shall not apply
if:
(a)
1.
The conduct requiring the revocation, restriction, or limitation was directly
related to the physician's impairment as a result of controlled substance abuse
or dependence;
2. The order
imposing the revocation, restriction, or limitation is no longer in
effect;
3. The physician has
achieved a level of recovery which provides the licensing authority sufficient
assurance that the physician will not likely engage in similar conduct while
practicing at the pain management facility; and
4. The board or its panel has specifically
approved the physician to practice in that specific pain management facility;
or
(b) The physician has
entered into an agreed order with terms and conditions requiring only remedial
education and monitoring.
(5) The facility shall notify the board in
writing within fourteen (14) days of each change in physician staffing of the
facility.
Section 5. On-site Supervision.
(1) If the physician
owner or qualified designee is not present in each practice location of a pain
management facility for at least fifty (50) percent of the time that patients
are present at the practice location for any given calendar week as required by
KRS
218A.175(3), the facility
shall immediately notify the board of that fact in writing and include the
reasons.
(2) Any violation of
KRS
218A.175(3) or this section
shall constitute a violation of
KRS
311.595(12) and (9), as
illustrated by KRS
311.597(3) and (4) by the
physician owner and, if applicable, the qualified designee who was responsible
for being present at the practice location during that period.
Section 6. Record-Keeping; Inspection.
(1) Each pain management facility
shall document on a weekly basis that a physician owner or an owner's physician
designee who is employed by and under the direct supervision of the owner was
physically present practicing medicine in the facility for at least fifty (50)
percent of the time that patients were present in the facility during that
week. This documentation shall include:
(a)
The name, practice address, and phone number of the physician owner or
physician designee who fulfilled this oversight function for that specific
week;
(b) The practice address of
each practice location owned and operated by that pain management
facility;
(c) The days and hours
each practice location of the pain management facility was open to patients
during that specific week; and
(d)
The days and hours the physician owner or physician designee was present in
each practice location for the pain management facility for that specific
week.
(2) Each pain
management facility shall maintain appropriate records of the patients
receiving treatment at that facility so that the board may determine the
identity and number of patients treated during any given time period.
(3) The pain management facility shall
maintain the weekly reports required by subsection (1) of this section and any
daily sign-in sheets maintained by the practice on site in a readily accessible
location for a minimum period of six (6) years.
(4) Upon request by an employee or agent of
the board, the pain management facility shall permit the board employee or
agent to inspect and copy the weekly reports and daily sign-in sheets
maintained on site.
(5) For the
purpose of enforcing the provisions of this administrative regulation, an agent
of the board shall have the power and authority to:
(a) Enter upon professional premises during
periods when those premises are otherwise open to patients or the
public;
(b) Obtain evidence,
including psychiatric or nonpsychiatric patient records, by consent or pursuant
to a subpoena or search warrant;
(c) Interview all persons including owners,
employees, or patients; and
(d)
Require the production of books, papers, documents, or other documentary
evidence either by consent or pursuant to a subpoena or search
warrant.
Section 7. Proof of Operation of a Pain Management Facility.
(1) The board may establish sufficient proof
that a clinic, practice, or facility is a pain management facility subject to
the provisions of this administrative regulation by establishing that:
(a) The facility has filed a registration
with the board as a pain management facility; or
(b)
1. For
any selected thirty (30) day period, the majority of patients receiving medical
treatment from the clinic, practice, or facility received controlled substances
or a prescription for controlled substances during that period; and
2. One (1) of the following additional
conditions was present during that thirty (30) day period as required by
KRS
218A.175(1)(a):
a. A primary component of the practice was
the treatment of pain; or
b. The
facility advertised in any medium for any type of pain management
services.
(2) The board may establish sufficient proof
that the majority of patients treated in the facility for any specified thirty
(30) day period received controlled substances or a prescription for controlled
substances on their visit by comparing the names on the sign-in sheet to the
KASPER report for that thirty (30) day period.
Section 8. Violations; Enforcement; Emergency Action.
(1) Any violation of the requirements
of this administrative regulation shall constitute a violation of
KRS
311.595(12) and (9), as
illustrated by KRS
311.597(4) and may
constitute a violation of
KRS
311.595(9), as illustrated
by KRS
311.597(3) given the
circumstances.
(2) In order to
lawfully prescribe or dispense controlled substances within the Commonwealth of
Kentucky while practicing at a pain management facility, a licensee shall
practice in a lawful pain management facility.
(3) A pain management facility shall be
considered an unlawful pain management facility if it:
(a) Permits an unqualified person to gain or
maintain an ownership or investment interest in the pain management facility;
or
(b) Fails to ensure that a
qualified physician owner or physician designee is physically present
practicing medicine in the facility for at least fifty (50) percent of the time
that patients are present in the facility.
(4) Prescribing or dispensing controlled
substances within the Commonwealth of Kentucky while employed by or practicing
in an unlawful pain management facility within the Commonwealth of Kentucky
shall constitute a violation of
KRS
311.595(9) and (12) which
constitutes an immediate danger to the public health, safety, or welfare of the
public, for the purposes of
KRS
311.592 and
13B.125.
(5) If the board receives proof that a
licensed physician is prescribing or dispensing a controlled substance while
employed by or practicing in an unlawful pain management facility within the
Commonwealth of Kentucky, the appropriate inquiry panel or its chair shall
promptly issue an emergency order restricting that licensee from prescribing or
dispensing a controlled substance within the Commonwealth of Kentucky until the
licensee has provided sufficient proof that the licensee is no longer employed
by or practicing in an unlawful pain management facility.
(6) An emergency order restricting a licensee
from prescribing or dispensing a controlled substance within the Commonwealth
of Kentucky issued pursuant to subsection (5) of this section shall remain
valid and in effect until the board has received sufficient proof that the
licensee is no longer employed by or practicing in an unlawful pain management
facility. Upon receipt of that proof, the panel or its chair shall immediately
issue an order terminating the emergency order issued pursuant to subsection
(5) of this section.
(7) If a
licensee who is affected by an emergency order issued pursuant to subsection
(5) of this section requests an emergency hearing pursuant to
KRS
13B.125(3), the hearing
officer conducting the emergency hearing shall affirm the emergency order if
presented with substantial evidence that the licensee was prescribing or
dispensing controlled substances within an unlawful pain management
facility.
(8) If a licensee
prescribes or dispenses a controlled substance within the Commonwealth of
Kentucky during any period when the licensee is employed by or practicing in an
unlawful facility, each instance of prescribing or dispensing shall constitute
a separate violation of
KRS
311.595(12) and (9), as
illustrated by KRS
311.597(1)(b), and shall
serve as the basis for disciplinary sanctions pursuant to
KRS
311.595.
Section 9. Periodic KASPER Reviews.
(1) The board shall have the authority
pursuant to KRS
218A.202 and
218A.240 to obtain KASPER
reports and analyses for each practitioner practicing in a pain management
facility.
(2) At least once each
year, the board shall obtain a KASPER review and analysis for each physician
who has or maintains an ownership or investment interest in, or is employed by,
or practices in, a pain management facility to determine whether improper,
inappropriate, or illegal prescribing is occurring. If the board determines
that there is evidence to indicate that improper, inappropriate, or illegal
prescribing is occurring, it shall initiate an investigation of that physician
and notify the appropriate agencies of its investigation.
STATUTORY AUTHORITY: KRS 311.565(1)(a)
Disclaimer: These regulations may not be the most recent version. Kentucky may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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