201 KAR 9:270. Professional standards for prescribing or dispensing Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone

Link to law: http://www.lrc.ky.gov/kar/201/009/270reg.htm
Published: 2015

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GENERAL GOVERNMENT CABINET

Kentucky Board of

Medical Licensure

(Amendment)

 

      201 KAR 9:270. Professional standards for prescribing or

dispensing Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone.

 

      RELATES TO: KRS 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 professional standards for physicians practicing in Kentucky

who prescribe or dispense Buprenorphine-Mono-Product or

Buprenorphine-Combined-with-Naloxone.

 

      Section 1. Minimum Qualifications for

Prescribing or Dispensing Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone.

A licensed physician shall not prescribe or dispense Buprenorphine-Mono-Product

or Buprenorphine-Combined-with-Naloxone unless that physician possesses the

minimum qualifications established in this section. (1) The physician shall obtain

and maintain in good standing a waiver and license as issued by the Drug

Enforcement Administration (DEA) to prescribe Buprenorphine-Mono-Product or

Buprenorphine-Combined-with-Naloxone for the treatment of opioid dependence in

the Commonwealth of Kentucky.

      (2) The physician shall successfully

complete the approved educational programs required by this subsection.

      (a)[1. If]

The prescribing physician shall be[was] a DEA-licensed

prescriber of Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone

and[prior to July 1, 2015, the physician] shall have obtained

Buprenorphine certification through completion of a Substance Abuse and Mental

Health Services Administration ("SAMHSA") certified course[or

through personal attendance and completion of a review course approved by the

American Society of Addiction Medicine ("ASAM") prior to July 1, 2015].

      [2. If the prescribing physician

becomes a DEA-licensed prescriber of Buprenorphine-Mono-Product or

Buprenorphine-Combined-with-Naloxone on or after July 1, 2015, the physician

shall obtain Buprenorphine certification through personal attendance and

completion of a review course approved by the American Society of Addiction

Medicine ("ASAM") before the physician prescribes or dispenses Buprenorphine-Mono-Product

or Buprenorphine-Combined-with-Naloxone.]

      (b) For each three (3) year continuing

education cycle, each DEA-licensed prescriber of Buprenorphine-Mono-Product or

Buprenorphine-Combined-with-Naloxone shall complete at least twelve (12) hours

of continuing medical education certified in Category I specific to

addiction medicine as part of the required continuing medical education hours

set forth in 201 KAR 9:310.

      (3) The physician shall enroll[and

participate] in the Kentucky Health Information Exchange to the extent

necessary to query and pull information from the Kentucky Health Information

Exchange. The physician shall not report the prescribing or dispensing of

Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone for

medically-supervised withdrawal or as maintenance treatment for a patient

diagnosed with opioid dependence into the Kentucky Health Information Exchange

unless otherwise required by law.

 

      Section 2. Professional Standards for

Prescribing or Dispensing Buprenorphine-Mono-Product or

Buprenorphine-Combined-with-Naloxone for Medically-Supervised Withdrawal or the

Treatment of Opioid Dependency. (1)(a) Except as provided in paragraph (b) of

this subsection, Buprenorphine-Mono-Product or

Buprenorphine-Combined-with-Naloxone shall only be prescribed or dispensed for

medically-supervised withdrawal or as a maintenance treatment for a patient

diagnosed with opioid dependence.

      (b) Transdermal delivery of

Buprenorphine-Mono-Product may be used for treatment of pain.

      (2) Buprenorphine-Mono-Product shall not

be prescribed or dispensed, except:

      (a) To a pregnant patient;

      (b) To a patient with demonstrated

hypersensitivity to naloxone; or

      (c) As an injectable treatment in a

physician’s office or other healthcare facility.

      (3)(a) Except as provided in paragraph

(b) of this section, Buprenorphine-Mono-Product or

Buprenorphine-Combined-with-Naloxone shall not be prescribed or dispensed to a

patient who is also being prescribed benzodiazepines, other sedative hypnotics,

stimulants or other opioids, without consultation of a physician who is

certified by the American Board of Addiction Medicine, the American Board of

Medical Specialties (ABMS) in psychiatry, or an American Osteopathic

Association (AOA) certifying board in addiction medicine or psychiatry.

      (b) A physician may prescribe or dispense

Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone to a patient

who is also being prescribed benzodiazepines, other sedative hypnotics,

stimulants, or other opioids, without consultation in order to address an

extraordinary and acute medical need not to exceed a combined period of thirty

(30) days.

      (4) Each licensed physician who

prescribes or dispenses Buprenorphine-Mono-Product or

Buprenorphine-Combined-with-Naloxone for medically-supervised withdrawal or for

the treatment of Opioid dependence shall fully comply with the professional

standards established in this subsection.

      (a) Prior to initiating treatment, the

prescribing or dispensing physician shall:

      1. Obtain and record a complete and

appropriate evaluation of the patient which shall at a minimum include:

      a. The patient’s history of present

illness;

      b. The patient’s history of substance

use;

      c. The patient’s social and family

history;

      d. The patient’s past medical and

psychiatric histories;

      e. A physical examination of the patient;

      f. The patient’s injection use history,

which shall include screening for HIV and hepatitis serology; and

      g. Appropriate laboratory tests, which

shall include a CBC, a drug screen, and a CMP;

      2. Obtain the patient’s consent and

authorizations in order to obtain the patient’s prior medical records.

      a. Upon receipt of the medical records,

the prescribing or dispensing physician shall review and incorporate the

information from the records into the evaluation and treatment of the patient.

      b. If the prescribing or dispensing

physician is unable, despite best efforts, to obtain the patient’s prior

medical records, the physician shall document those efforts in the patient’s

chart;

      3. Obtain and review a KASPER report for

that patient for the twelve (12) month period immediately preceding the initial

patient encounter and appropriately utilize that information in the evaluation

and treatment of the patient;

      4. Explain treatment alternatives and the

risks and the benefits of treatment with Buprenorphine-Mono-Product or

Buprenorphine-Combined-with-Naloxone to the patient;

      5. Obtain written informed consent from

the patient in a manner that meets professional standards; and

      6. If the patient is a female of

child-bearing age and ability, meet the requirements of paragraph (b) of this

subsection.

      (b) The requirements of this paragraph

shall apply to the treatment of a female of child-bearing age and ability.

      1. Prior to initiating treatment, the

physician shall require that the patient first submit to a pregnancy test and

the physician shall provide counseling as to the risk of neonatal abstinence

syndrome which shall be consistent with patient education material on neonatal

abstinence syndrome from the American Congress of Obstetricians and

Gynecologists, American Academy of Pediatrics, American Society of Addiction

Medicine and the Kentucky Department for Public Health, and offer means to

prevent pregnancy.

      2.a. A physician shall not prescribe or

dispense Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone to

a patient who is pregnant or breastfeeding unless the prescribing physician

first obtains and documents consultation with another physician for an opinion

as to whether the potential benefit of Buprenorphine-Mono-Product or

Buprenorphine-Combined-with-Naloxone use outweighs the potential risk of use.

      b. The consultation shall be obtained

from a physician who is certified by the American Board of Addiction Medicine,

the American Board of Medical Specialties (ABMS) in psychiatry, or an American

Osteopathic Association (AOA) certifying board in addiction medicine or

psychiatry or from an obstetrician or maternal-fetal medicine specialist who is

also qualified to prescribe buprenorphine.

      (c) Except as provided by paragraph (d)

of this subsection, while initiating treatment with Buprenorphine-Mono-Product

or Buprenorphine-Combined-with-Naloxone, the prescribing or dispensing

physician shall comply with the requirements of this paragraph.

      1. The prescribing or dispensing

physician shall recommend to the patient an in-office observed induction

protocol.

      a. Except as provided in clause b. of

this subparagraph, the prescribing or dispensing physician shall conduct the

in-office observed induction protocol.

      b. If an in-office observed induction

does not occur, the prescribing or dispensing physician shall appropriately

record the circumstances in the patient chart and shall implement a

SAMHSA-recognized or ASAM-recognized home-based induction protocol.

      2. The prescribing or dispensing

physician shall document the presence of opioid withdrawal before the first

dose is given by using a standardized instrument, such as the clinic opioid

withdrawal scale (COWS) or other similarly recognized instrument.

      3. The prescribing or dispensing

physician shall initiate treatment with a dose not to exceed the dose

equivalency of four (4) milligrams buprenorphine generic tablet, which:

      a. May be followed by subsequent doses if

withdrawal persists and is not improving; and

      b. Shall not exceed the dose equivalency

of sixteen (16) milligrams buprenorphine generic tablet on the first day of

treatment.

      (d) If the patient is transferred from

another treatment provider and has previously experienced withdrawal without a

relapse, the prescribing or dispensing physician shall:

      1. Document that fact;

      2. Educate the patient about the

potential for precipitated withdrawal; and

      3. Continue maintenance treatment of the

patient on the same dosage as established by the previous treatment provider

and then as provided in paragraph (e) of this subsection.

      (e) After initial induction of

Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone, the

prescribing or dispensing physician shall meet the requirements established in

this paragraph.

      1. If the physician prescribes or

dispenses Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone

medication, the physician shall implement a treatment plan that requires

objective behavioral modification by the patient. The behavioral modification

shall include the patient’s participation in a behavioral modification program

that may include counseling or a twelve (12) step facilitation.

      2. The physician shall prescribe or

dispense to the patient an amount of Buprenorphine-Mono-Product or

Buprenorphine-Combined-with-Naloxone that:

      a. Is necessary to minimize craving and

opiate withdrawal;

      b. Does not produce opiate sedation;

      c. Is to be taken no more frequently than

once daily; and

      d. Is able only to supply the patient

until the next physician visit, which shall be scheduled as required by

subparagraph 3. of this paragraph.

      3.a. The prescribing or dispensing

physician shall ensure that the patient is seen by the physician:

      (i) No later than ten (10) days after

induction and then at intervals of no more than ten (10) days for the first

month after induction; and

      (ii) At intervals of no more than

fourteen (14) days for the second month after induction.

      b.(i) If the patient demonstrates

objective signs of positive treatment progress, the prescribing or dispensing

physician shall ensure that the patient is seen at least once monthly

thereafter.

      (ii) If

two (2) years after initiation of treatment, the patient is being prescribed

Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone for opioid

dependence and the patient has demonstrated objective signs of positive

treatment progress, including documented evidence that the patient has been

compliant with the treatment plan and all treatment directives for at least two

(2) years, then the prescribing or dispensing physician may require that the

patient be seen only by the prescribing or dispensing physician at least once

every three (3) months.

      (iii) The prescribing or

dispensing physician shall see the patient in shorter intervals if the patient

demonstrates any noncompliance with the treatment plan.

      c. If extenuating circumstances arise

that require a patient to unexpectedly reschedule a physician visit, the

prescribing or dispensing physician shall make best efforts to see the patient

as soon as possible and document the circumstances in the patient chart.

      4. Every three (3) months after

initiation of treatment, the prescribing or dispensing physician shall evaluate

the patient to determine whether the patient’s dosage should be continued or

modified and shall appropriately document that evaluation and clinical

reasoning in the patient’s chart.

      5. At least once every three (3) months,

the prescribing or dispensing physician shall obtain KASPER reports to help

guide the treatment plan.

      a. If the KASPER indicates any abnormal

findings, the prescribing or dispensing physician shall incorporate those

findings into appropriate clinical reasoning to support the continuation or

modification of treatment and shall accurately document the same in the patient

record.

      b. Appropriate clinical reasoning may

include adjustment of dose strength or frequency of visits, increased

screening, a consultation with a specialist, or an alternative treatment.

      c. Every twelve (12) months following

initiation of treatment, if a patient’s prescribed daily therapeutic dosage

exceeds the dose equivalency of sixteen (16) milligrams buprenorphine generic

tablet per day and the prescribing or dispensing physician is not certified by

the American Board of Addiction Medicine, the American Board of Medical

Specialties (ABMS) in psychiatry, or an American Osteopathic Association (AOA)

certifying board in addiction medicine or psychiatry, then the prescribing or

dispensing physician shall refer the patient for consultation by a physician

who is certified by the American Board of Addiction Medicine, the American

Board of Medical Specialties (ABMS) in psychiatry, or an American Osteopathic

Association (AOA) certifying board in addiction medicine or psychiatry for an

opinion as to whether continued treatment and dosage is appropriate and shall

accurately document the results of that consultation in the patient chart.

      d. The prescribing or dispensing

physician shall adjust dosages according to the individual patient’s condition

and within acceptable and prevailing medical standards, with the goal of

improving the patient’s quality of life and ability to function in the

community.

      e. Every twelve (12) months following

initiation of treatment, the prescribing or dispensing physician shall evaluate

for and document the medical necessity for continued treatment at the

established dose.

      f. The prescribing or dispensing

physician shall obtain at least eight (8) drug screens from the patient within

each twelve (12) month period of treatment in order to help guide the treatment

plan. For patients who have demonstrated objective signs of positive

treatment progress for at least two (2) years from the date of initiation of

treatment, including documented evidence that the patient has been compliant

with the treatment plan and all treatment directives, the prescribing or

dispensing physician shall obtain at least six (6) drug screens from the

patient within each twelve (12) month period of treatment in order to help

guide the treatment plan.

      (i) At least two (2) of the drug screens

shall be random and shall be coupled with a pill count.

      (ii) Each drug screen shall at a minimum

screen for buprenorphine, methadone, oxycodone, other opioids, THC, benzodiazepines,

amphetamines, and cocaine.

      (iii) If a drug screen indicates any

abnormal findings, the prescribing or dispensing physician shall incorporate

those findings into appropriate clinical reasoning to support the continuation

or modification of treatment and shall accurately document the same in the

patient record.

      (iv) Appropriate clinical reasoning may

include adjustment of dose strength or frequency of visits, increased

screening, a consultation with a specialist, or an alternative treatment.

      6. The prescribing or dispensing

physician shall document a plan for handling any lost or stolen medication,

which:

      a. Shall not provide for the automatic

replacement of medication prior to the specified interval date; and

      b. If the prescribing or dispensing

physician determines that it is necessary to minimize improper or illegal

diversion of medications under the circumstances, shall require the patient to

first report the lost or stolen medications to police or other law enforcement

agencies.

 

      Section 3. Violations. Failure to comply

with or a violation of the professional standards established in Section 2 of

this administrative regulation shall constitute a "departure from, or

failure to conform to the standards of acceptable and prevailing medical practice

within the Commonwealth of Kentucky," in 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), subjecting the licensed physician

to sanctions authorized by KRS 311.595.

 

PRESTON P. NUNNELLEY, M.D., President

      APPROVED BY AGENCY: November 10, 2015

      FILED WITH LRC: November 12, 2015 at 4

p.m.

      PUBLIC HEARING AND PUBLIC COMMENT PERIOD:

A public hearing on this administrative regulation shall be held on December

23, 2015 at 10:00 a.m., at the offices of the Kentucky Board of Medical

Licensure, 310 Whittington Parkway, Suite 1B, Louisville, Kentucky 40222.

Individuals interested in being heard at this hearing shall notify this agency

in writing by December 16, 2015, five (5) workdays prior to the hearing, of

their intent to attend. If no notification of intent to attend the hearing was

received by that date, the hearing may be cancelled. This hearing will not be transcribed

unless a written request for a transcript is made. If you do not wish to be

heard at the public hearing, you may submit written comments on the proposed

administrative regulation. Written comments shall be accepted until close of

business on January 4, 2016. Send written notification of intent to be heard at

the public hearing or written comments on the proposed administrative

regulation to the contact person.

      CONTACT PERSON: Leanne K. Diakov, General

Counsel, Kentucky Board of Medical Licensure, 310 Whittington Parkway, Suite

1B, Louisville, Kentucky 40222, phone (502) 429-7150, fax (502) 429-7118.

 

REGULATORY IMPACT

ANALYSIS AND TIERING STATEMENT

 

Contact Person: Leanne K. Diakov

      (1) Provide a brief summary of:

      (a) What this administrative regulation

does: This administrative regulation establishes the requirements for

prescribing or dispensing Buprenorphine-Mono-Product or

Buprenorphine-Combined-with-Naloxone in the Commonwealth of Kentucky.

      (b) The necessity of this administrative

regulation: It is necessary to promulgate this regulation to establish the

requirements for prescribing or dispensing Buprenorphine-Mono-Product or

Buprenorphine-Combined-with-Naloxone in the Commonwealth of Kentucky.

      (c) How this administrative regulation

conforms to the content of the authorizing statutes: This administrative

regulation acts specifically to establish the requirements for prescribing or

dispensing Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone

in the Commonwealth of Kentucky.

      (d) How this administrative regulation

currently assists or will assist in the effective administration of the

statutes: This administrative regulation acts specifically to establish the

requirements for prescribing or dispensing Buprenorphine-Mono-Product or

Buprenorphine-Combined-with-Naloxone in the Commonwealth of Kentucky.

      (2) If this is an amendment to an

existing administrative regulation, provide a brief summary of:

      (a) How the amendment will change this

existing administrative regulation: This administrative regulation amendment

expands the training opportunities by which physicians may become qualified to

prescribe or dispense Buprenorphine-Mono-Product or

Buprenorphine-Combined-with-Naloxone in the Commonwealth of Kentucky; clarifies

how physicians may monitor their patients’ compliance with treatment directives

through use of Kentucky Health Information Exchange without violating federal

confidentiality laws in regard to mental health/addiction issues; and allows

physicians to extend patient visits out to 3-month intervals for patients with

long-term demonstrated progress and compliance with treatment.

      (b) The necessity of the amendment to

this administrative regulation: It was necessary to amend the regulation in

order to clarify and address concerns raised by licensees in regard to (1) training/education,

(2) protecting patient confidentiality and (3) frequency of visits for

long-term patients being prescribed or dispensed Buprenorphine-Mono-Product or

Buprenorphine-Combined-with-Naloxone in the Commonwealth of Kentucky.

      (c) How the amendment conforms to the

content of the authorizing statutes: This amended regulation acts specifically

to further clarify the acceptable and prevailing medical practices for

prescribing or dispensing Buprenorphine-Mono-Product or

Buprenorphine-Combined-with-Naloxone in the Commonwealth of Kentucky.

      (d) How the amendment will assist in the

effective administration of the statutes: This amended regulation acts

specifically to further clarify the acceptable and prevailing medical practices

for prescribing or dispensing Buprenorphine-Mono-Product or

Buprenorphine-Combined-with-Naloxone in the Commonwealth of Kentucky.

      (3) List the type and number of

individuals, businesses, organizations, or state and local governments affected

by this administrative regulation: This amendment will affect all physicians

licensed in the Commonwealth of Kentucky who prescribe or dispense

Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone.

      (4) Provide an analysis of how the

entities identified in question (3) will be impacted by either the

implementation of this administrative regulation, if new, or by the change, if

it is an amendment, including:

      (a) List the actions that each of the

regulated entities identified in question (3) will have to take to comply with

this administrative regulation or amendment: Physicians will be required to

follow the professional standards for prescribing or dispensing

Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone in the

Commonwealth of Kentucky.

      (b) In complying with this administrative

regulation or amendment, how much will it cost each of the entities identified

in question (3): There is no cost associated with the requirements of this

administrative regulation known to the Board.

      (c) As a result of compliance, what

benefits will accrue to the entities identified in question (3): Benefits to

the physician including having professional standards for prescribing or

dispensing Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone

which will help curb the prescription drug epidemic in the Commonwealth of

Kentucky.

      (5) Provide an estimate of how much it

will cost to implement this administrative regulation:

      (a) Initially: None.

      (b) On a continuing basis: None.

      (6) What is the source of the funding to be

used for the implementation and enforcement of this administrative regulation: None.

      (7) Provide an assessment of whether an

increase in fees or funding will be necessary to implement this administrative

regulation, if new, or by the change, if it is an amendment: No increase of

fees or funding will be necessary.

      (8) State whether or not this

administrative regulation establishes any fees or directly or indirectly

increases any fees: This administrative regulation does not establish any fees

nor does it directly or indirectly increase any fees.

      (9) TIERING: Is tiering applied? Tiering

was not appropriate in this administrative regulation because the

administrative regulation applies equally to all those individuals regulated by

it.

 

FISCAL NOTE ON STATE OR

LOCAL GOVERNMENT

 

      1. What units, parts or divisions of

state or local government (including cities, counties, fire departments, or

school districts) will be impacted by this administrative regulation? The

Kentucky Board of Medical Licensure will be impacted by this administrative

regulation.

      2. Identify each state or federal statute

or federal regulation that requires or authorizes the action taken by the

administrative regulation. KRS 311.565(1)(a)

      3. Estimate the effect of this

administrative regulation on the expenditures and revenues of a state or local

government agency (including cities, counties, fire departments, or school

districts) for the first full year the administrative regulation is to be in

effect. None

      (a) How much revenue will this

administrative regulation generate for the state or local government (including

cities, counties, fire departments, or school districts) for the first year? None

      (b) How much revenue will this

administrative regulation generate for the state or local government (including

cities, counties, fire departments, or school districts) for subsequent years? None

      (c) How much will it cost to administer

this program for the first year? None

      (d) How much will it cost to administer

this program for subsequent years? None

      Note: If specific dollar estimates cannot

be determined, provide a brief narrative to explain the fiscal impact of the

administrative regulation.

      Revenues (+/-):

      Expenditures (+/-):

      Other Explanation: