201 KAR 9:250. Registration and oversight of pain management facilities

Link to law: http://www.lrc.ky.gov/kar/201/009/250.htm
Published: 2015

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      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.)