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:
