201 KAR 9:250. Registration and oversight of
pain management facilities.
RELATES TO: KRS 218A.175,
311.530-311.620, 311.990
STATUTORY AUTHORITY: KRS 311.565(1)(a)
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. Divestiture of Ownership or
Investment Interest. (1) A physician who has an ownership or investment
interest in a pain management facility shall immediately divest that ownership
or investment interest if:
(a) The physician’s Kentucky license is
no longer active for any reason; or
(b) The physician’s Kentucky license
becomes 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.
(2)(a) If a physician fails to immediately
divest the ownership or investment interest in the pain management facility as
required by subsection (1) of this section, the board may institute an action
for injunctive relief pursuant to KRS 311.605(3) and (4) to require the
physician to immediately divest the ownership or investment interest in the
pain management facility.
(b) An unlawful ownership or investment
interest in a pain management facility shall be considered the unlawful
practice of medicine and shall be considered to cause irreparable injury to the
Commonwealth, acting through this board.
Section 4. 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) Is eligible for and has provided the
board with written verification that the licensee has 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) Becomes 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 fails the
certification examination or fails 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 6 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 5. 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) 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;
(b) The order imposing the revocation,
restriction, or limitation is no longer in effect;
(c) 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
(d) The board or its panel has
specifically approved the physician to practice in that specific pain
management facility.
(5) The facility shall notify the board
in writing within fourteen (14) days of each change in physician staffing of
the facility.
Section 6. 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 311.595(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 7. 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 8. 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 9. 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 10. 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. (39 Ky.R. 667; 1173; 1664; eff.
3-4-2013.)