Section 1. Definitions.
(1) "Approved controlled substance" means the
drugs methadone, buprenorphine, or other FDA-approved medication for opioid use
disorder (MOUD) used in the treatment of opioid addiction in a Narcotic
Treatment Program.
(2) "CHFS" or
"cabinet" means the Cabinet for Health and Family Services.
(3) "Central Registry" means a
cabinet-approved electronic system used to register patients at a licensed
narcotic treatment program (NTP) for the purpose of preventing simultaneous
enrollment in other NTPs, gathering program-compliance information, and
monitoring performance data.
(4)
"Correctional Facility" means a jail, prison, or other place of incarceration
by a government official.
(5)
"CSAT" means the Center for Substance Abuse Treatment.
(6) "DEA" means the Drug Enforcement
Administration.
(7) "Dose" means a
one (1) day quantity of an approved controlled substance administered on site
at a narcotic treatment program.
(8) "Drug screening" means the process by
which a program determines the presence or the absence of drugs in the body
fluids.
(9) "Main program" means
the location where all administrative and medical information related to a
narcotic treatment program is retained for the purpose of on-site reviews by
federal agencies or the state narcotic authority.
(10) "Medication station" means any dosing
location that is defined and authorized as a medication unit in
42 C.F.R.
8. Medication stations are not extension
sites as established in
908 KAR 1:370 Section
2(1)(c).
(11) "Mobile unit" means
means a narcotic treatment program (NTP) operating from a motor vehicle that:
(a) Serves as a mobile component for an
existing licensed NTP;
(b) Operates
under the registration of the NTP; and
(c) Engages in maintenance or detoxification
treatment with narcotic drugs in schedules II-V at a location or locations
remote from its registered and licensed location in Kentucky.
(12) "Program prescriber" means:
(a) A practitioner as defined in
KRS
218A.010(40); and
(b) Is authorized to prescribe Schedule II-V
controlled substances by state and federal requirements;
(13) "SNA" means the state narcotic authority
and is synonymous with state opioid treatment authority (SOTA). The Department
for Behavioral Health, Developmental and Intellectual Disabilities is the SNA,
or SOTA, for Kentucky.
(14)
"Take-home dose" means a quantity of an approved controlled substance, which
the patient is eligible to take off the premises of a narcotic treatment
program.
(15) "Treatment phase"
means a stage in the patient's progress through a narcotic treatment program's
sequential treatment system.
(16)
"Voluntary withdrawal management" means a medically supervised withdrawal from
the approved controlled substance requested by a patient of a narcotic
treatment program.
Section
2. Ambulatory Withdrawal Management.
(1) In addition to the licensing requirements
of
908 KAR 1:370, an outpatient AODE
that provides ambulatory withdrawal management or maintenance services shall
accept and provide services only to patients meeting the:
(a) Diagnostic criteria for a
substance-related disorder for alcohol, tobacco, and other drug use as
established by the most recent version of the Diagnostic and Statistical Manual
of Mental Disorders (DSM); and
(b)
Dimensional criteria for outpatient services as established in the most recent
version of The American Society of Addiction Medicine (ASAM)
Criteria.
(2) Ambulatory
withdrawal management services shall:
(a) Be
provided in regularly scheduled sessions;
(b) Be delivered in accordance with:
1. Clinical protocols established for
ambulatory withdrawal management in the most recent version of The ASAM
Criteria; or
2. Nationally
recognized, evidence-based clinical protocols approved by the cabinet;
and
(c) Include the
following features:
1. Specialized
psychological and psychiatric consultation and supervision for biomedical,
emotional, behavioral, and cognitive problems as indicated;
2. Completion of a comprehensive medical
history and physical examination of the patient at admission;
3. Affiliation with other levels of care,
including other levels of specialty addiction treatment for additional problems
identified through the comprehensive biopsychosocial assessment required by
908 KAR 1:370, Section
18;
4. Appropriate laboratory and
drug screening; and
5. Twenty-four
(24) hour access to emergency medical consultation services if
needed.
(3)
Staff shall include:
(a) Physicians and
licensed health practitioners acting within their scope of practice who, if not
present on-site at the time of admission, shall be readily available to
evaluate and confirm that ambulatory withdrawal management is safe for the
patient; and
(b) Clinical staff who
shall be knowledgeable about the biopsychosocial dimensions of alcohol,
tobacco, and other substance use disorders, including the signs and symptoms of
alcohol and other drug intoxication and withdrawal.
(4) Therapies offered by ambulatory
withdrawal management services shall include:
(a) Individual assessment;
(b) Medication or non-medication methods of
withdrawal management;
(c)
Monitoring, assessment, and management of signs and symptoms of intoxication
and withdrawal by a physician or licensed health practitioner acting within
their scope of practice;
(d)
Patient education;
(e)
Non-pharmacological clinical support;
(f) Involvement of family members or
significant others in the withdrawal management process; and
(g) Discharge or transfer planning, including
referral for counseling and involvement in community recovery support
groups.
(5) A program
shall establish an individualized treatment plan in accordance with
908 KAR 1:370, Section 19 that
includes:
(a) Problem identification in
dimensions two (2) through six (6) of the most recent version of The ASAM
Criteria;
(b) Development of
treatment goals and measurable treatment objectives;
(c) Activities designed to meet the treatment
objectives and management of withdrawal syndrome;
(d) Daily assessment of:
1. Progress during withdrawal management;
and
2. Any treatment
changes;
(e) Transfer and
discharge planning, beginning at the point of admission; and
(f) Referral and linkage arrangements for:
1. Counseling;
2. Medical care;
3. Psychiatric care; and
4. Continuing care.
(6) Progress notes shall:
(a) Be maintained in the patient record in
accordance with
908 KAR 1:370, Section
17(4)(h);
(b) Reflect
implementation of the treatment plan;
(c) Document the patient's response to
treatment; and
(d) Include each
amendment of the treatment plan.
(7) Withdrawal rating scale tables and flow
sheets that include tabulation of vital signs shall be used as
needed.
(8) Treatment of a patient
shall continue until:
(a) Withdrawal signs and
symptoms are sufficiently resolved so that the patient can participate in:
1. Self-directed recovery; or
2. Ongoing treatment without the need for
further medical or nursing withdrawal management monitoring;
(b) The patient's signs and
symptoms of withdrawal have:
1. Failed to
respond to treatment; and
2.
Intensified so that transfer to a more intensive level of withdrawal management
is indicated; or
(c)
Ambulatory withdrawal management is not adequate to meet the severity of the
patient's substance use disorder.
Section 6. Office-based Opioid Treatment
Services.
(1) Excluding methadone-based
treatment, a facility shall be licensed as an outpatient AODE that provides
office-based opioid treatment (OBOT) services if:
(a) Any individual with ownership interest in
the facility is not a Kentucky-licensed physician; and
(b) The facility employs or has an
affiliation with a physician, physician assistant, or advanced practice
registered nurse who prescribes FDA-approved medications for the treatment of
opioid use disorder to fifty (50) percent or more of the facility's
patients.
(2) In addition
to the licensing requirements of
908 KAR 1:370, an OBOT shall:
(a) Designate a medical director who shall:
1. Be responsible for the supervision of all
medical staff and the administration of all medical services at the facility,
including compliance with all federal, state, and local laws and administrative
regulations regarding the medical treatment of opioid use disorder;
2. Be physically present at the facility at
least twenty-five (25) percent of the time the facility is open to the public
each week;
3. Conduct a monthly
review of ten (10) percent of the medical charts for patients currently
admitted at the facility and document each chart review; and
4. Not serve as medical director of more than
three (3) OBOT facilities;
(b) Have sufficient medical staff on-site to
provide the medical treatment and oversight necessary to serve patient needs,
including a practitioner authorized to prescribe FDA-approved medicationsfor
the treatment of opioid use disorder on-site during fifty (50) percent of
clinic weekly hours of operation;
(c) Ensure that each practitioner authorized
to prescribe complies with the prescribing and dispensing standards in
accordance with
201 KAR 9:270 or
201 KAR 20:065 respectively for
FDA-approved medications used for the treatment of opioid addiction;
(d) Ensure that a practitioner authorized to
prescribedocuments in the patient's record whether or not the patient is
compliant with prescribed dosing as evidenced by the results of:
1. A KASPER report released in accordance
with KRS
218A.202(7)(e);
and
2. Drug
screening;
(e) Offer
individual and group outpatient therapy;
(f) Monitor compliance with recommended
non-medication therapies;
(g)
Provide case management or care coordination services; and
(h) Implement pre-employment and ongoing
random drug screening of all facility employees.
(3) Admission and discharge.
(a) Each patient shall be evaluated to
determine and document whether or not the patient meets the diagnostic criteria
for an opioid use disorder as defined in the most recent version of the
DSM.
(b) The OBOT facility shall
use evidence-based assessment and evaluation tools that have been peer reviewed
and validated, including the most recent edition of:
1. ASAM placement criteria;
2. Addiction Severity Index;
3. Substance Abuse and Mental Health Services
Administration (SAMHSA) Treatment Improvement Protocol; or
4. Any other equivalent assessment and
evaluation tool.
(c)
Prior to receiving treatment at the facility, the patient shall acknowledge in
writing having received education on:
1.
Treatment options, including withdrawal management, and the benefits and risks
associated with each treatment option;
2. The risk of neonatal abstinence syndrome
and use of voluntary long-acting reversible contraception for all female
patients of child-bearing age and potential;
3. Prevention and treatment of chronic viral
illnesses, such as HIV and hepatitis;
4. Expected therapeutic benefits and adverse
effects of treatment medication;
5.
Risks for overdose, including drug interactions with central nervous system
depressants, and return to use after a period of abstinence from opioids;
and
6. Overdose prevention and
reversal agents.
(d) An
OBOT facility shall not provide any type of reward to a third party for
referral of potential patients to the clinic.
(4) Comprehensive assessment. The facility
shall complete a comprehensive assessment in accordance with
908 KAR 1:370, Section 18 and in
accordance with peer-reviewed opioid use disorder treatment guidelines
developed by nationally recognized organizations, such as SAMHSA and the
American Society of Addiction Medicine.
(5) Treatment planning. An OBOT facility
shall complete an individualized treatment plan for each patient in accordance
with
908 KAR 1:370, Section 19,
featuring a plan for aftercare that includes the development of a list of
appropriate treatment resources available to the patient in their
community.
(6) Discharge.
(a) A discharge plan shall be completed at
the time of the patient's discharge by the staff person who has primary
responsibility for coordinating or providing for the care of the patient,
including a final assessment of the patient's status at the time of
discharge.
(b) If applicable, a
parent, guardian, family member, or responsible person may participate in
aftercare and discharge planning.
(c) The reason for any patient not
participating in aftercare and discharge planning shall be documented in the
patient's record.
(d) The OBOT
facility shall document if a patient discontinues services.
(e) Determination of the events that
constitute a patient's discontinuation of services at an OBOT shall be at the
discretion of the facility.
Section 7. Narcotic Treatment Programs.
(1) In addition to the licensing requirements
of
908 KAR 1:370, an outpatient AODE
that operates a narcotic treatment program (NTP) using an FDA-approved
medication to treat individuals with substance use disorder shall comply with:
(b) The requirements of this section;
and
(c) Submit and maintain all
required data to:
1. The Central Registry;
and
(2) An NTP requesting a change of location
shall:
(b) Provide information
regarding any:
1. Dosing procedural changes;
and
2. Drug distribution problems
that could occur due to the relocation.
(3) Organization and operation.
(a) In addition to meeting the requirements
of
908 KAR 1:370, Section 9, an NTP
shall develop and comply with policies and procedures that include:
1. Waiting list criteria;
2. Data collection for participation in the
program in accordance with
908 KAR 1:300;
3. A protocol that ensures the integrity of
the chain of custody for all drug screens;
4. A protocol for voluntary and involuntary
termination of a patient's participation in the program, including reasons for
termination for cause;
5.
Requirements for the preparation and labeling of patient doses in accordance
with the requirements of subsection (10) of this section;
6. Quality assurance and utilization
review;
7. A patient identification
system;
8. A system to prevent
multiple program registrations;
9.
Inventory maintenance;
10. A
protocol for daily dosing schedules; and
11. Drug screening procedures that utilize
random selection or unannounced collection.
(b) An NTP shall order approved controlled
substances from the manufacturer or approved wholesalers in accordance with 42
C.F.R. Part
8.
(c) Policies for
voluntary withdrawal management and involuntary termination from NTP treatment
shall be in accordance with 42 C.F.R. Part
8.12 .
(d) An NTP shall have and follow policies
that prohibit recruitment of new patients into the program by offering:
1. A bounty;
2. Monetary, equipment, or merchandise
rewards; or
3. Free services for
individuals.
(e) An NTP
shall implement the system of treatment phases established in subsection (12)
of this section.
(f) An NTP shall
be open for dosing services at least six (6) days a week with the optional
exception of:
1. New Year's Day, January
1;
2. Presidents Day;
3. Martin Luther King Day;
4. Easter Sunday;
5. Memorial Day, last Monday in
May;
6. Independence Day, July
4;
7. Labor Day, first Monday in
September;
8. Thanksgiving Day,
fourth Thursday in November;
9.
Christmas Day, December 25; and
10.
Any observed federal holiday.
(g) An NTP shall have dosing times sufficient
to meet the needs of its patients.
(h) An NTP shall have a written emergency
plan that complies with
908 KAR 1:370, Section 9,
establishing the course of action in the event of a natural or manmade disaster
or any sudden closing. The plan shall also include:
1. Alternate providers for each payment type
that the NTP accepts; and
2. A
communication plan to reach each patient and provide information and
instructions.
(i) The
initial drug screens and confirmatory tests for drugs tested on behalf of the
NTP shall meet federal standards for the following:
1. Cocaine metabolites;
2. Opioid metabolites;
3. Amphetamines;
4. Barbiturates;
5. Benzodiazepines;
(j) An NTP that dispenses buprenorphine
shall:
1. Have sufficient medical providers
on-site to provide the medical treatment and oversight necessary to serve
patient needs;
2. Ensure that each
practitioner authorized to prescribe or dispense complies with the prescribing
and dispensing standards in accordance with
201 KAR 9:270 or
201 KAR 20:065 respectively for
FDA-approved medications used for the treatment of opioid use
disorder;
3. Ensure that a
practitioner authorized to prescribe or dispense documents in the patient's
record whether or not the patient is compliant with prescribed dosing as
evidenced by the results of:
a. A KASPER
report released in accordance with
KRS
218A.202(7)(e);
and
b. Drug screening;
c. Provide patient dosing of buprenorphine
which is exempt from treatment protocol phasing as outlined in subsection (12)
of this section.
(4) Medication stations.
(a) Medication stations shall not require a
separate license.
(b) To establish
a medication station, the NTP shall submit to the SNA, an Application for
License to Operate a Nonhospital-based Alcohol and Other Drug Treatment Entity
(AODE) form incorporated by reference in
908 KAR 1:370.
(c) The medication station shall provide the
following services:
1. Dosing; and
2. Drug screen collection.
(d) The program director shall
develop a system to prevent patients from dosing at both the main NTP and the
medication station.
(5)
Personnel.
(a) An NTP shall have a program
director who shall:
1. Have at least two (2)
years of experience in the treatment of addiction; and
2.
a. Be
certified by the Board of Certification of Alcohol and Drug
Counselors;
b. Hold at least a
master's degree in the field of addiction or a related field; or
c. Be a physician, registered nurse,
physician assistant, pharmacist, or nurse practitioner certified by the
licensing subspecialty.
(b) The program director may be the program
sponsor as required by 42 C.F.R., Part
8.
(c) The program director shall:
1. Be responsible for ensuring compliance
with federal, state, and local laws and administrative regulations pertaining
to the operation of the facility;
2. Provide onsite supervision of
employees;
3. Ensure the laboratory
performing the testing required under this administrative regulation is
approved by the SNA and is certified by the Centers for Medicare and Medicaid
Services as a Clinical Laboratory Improvement Amendments (CLIA) certified
laboratory; and
4. Ensure that
initial drug screens and confirmatory tests for drugs tested on behalf of the
program meet the standards in subsection (3)(i) of this section.
(d) An NTP shall have a medical
director who shall be:
1. Licensed by the
Commonwealth of Kentucky to practice medicine within the Commonwealth;
and
2.
a. A board eligible psychiatrist with at
least three (3) years of experience in the provision of services to persons who
have a substance use disorder; or
b. Board-certified as an addiction medicine
specialist.
(e)
The medical director shall function autonomously within an NTP free from any
protocol imposed by an NTP, director, or any other entity except under the
guidelines established in 42 C.F.R. Part
8 and this administrative
regulation.
(f) The medical
director shall be responsible for the NTP's adherence to federal, state, and
local laws and administrative regulations pertaining to the operation of the
facility.
(g) An NTP may have a
program physician. If an NTP has a program physician, the physician shall be:
1. Licensed by the Commonwealth of Kentucky
to prescribe controlled substances; and
2.
a.
Board-certified as an addiction medicine specialist; or
b. A person who has at least one (1) year of
experience in providing service to individuals with a substance use
disorder.
(h) A
program physician shall be under the supervision of the medical director and
shall function autonomously within the NTP free from any protocol imposed by
any NTP, director, or any other entity except under the guidelines imposed by
42 C.F.R. Part
8 and this administrative regulation.
(i) An NTP may have a program prescriber. If
an NTP has a program prescriber, the program prescriber shall be:
1. Licensed by the Commonwealth of Kentucky
to prescribe controlled substances;
2. A person who has at least one (1) year of
experience in providing services to individuals with a substance use disorder;
and
3. Under the supervision of the
medical director or program physician.
(j) The medical director may be the program
physician.
(k) There shall be a
minimum of one (1) medical director, program physician, or program prescriber
on staff.
(l) The medical director,
program physician or prescriber shall:
1.
Ensure all patients admitted to the NTP meet the most recent version of DSM
criteria for opioid use disorder;
2. Ensure that any exceptions to admissions
criteria are approved by the SNA and documented in the patient's record before
the first dose is administered;
3.
Ensure that appropriate medical histories and physical examinations have been
performed before the first dose shall be administered;
4. Ensure that appropriate laboratory studies
have been performed;
5. Review all
laboratory testing results and documents;
6. Document, sign, or cosign all medical
orders, within forty-eight (48) hours, including the first dose of an approved
controlled substance;
7. Document,
sign, or cosign all subsequent medication orders within forty-eight (48) hours,
including dose increases and decreases, changes in frequency of take-home
doses, emergency situations, or special circumstances;
8. Ensure that a review and cosignature of
all telephone or other verbal orders are documented within forty-eight (48)
hours of the order;
9. Supervise
staff responsible for preparation and administration of the approved controlled
substances;
10. Ensure compliance
with program procedures and administrative regulations; and
11. Order through the licensed NTP all:
a. Initial doses; and
b. Increases or decreases.
(m) An NTP shall hire
dosing personnel who shall:
1. Hold a license
as a registered nurse, licensed practical nurse, or pharmacist; and
2. Not be dually assigned as
clinicians.
(n) An NTP
shall provide dosing personnel in sufficient numbers to meet the needs of the
patients during dosing hours.
(o)
Dosing prescribers and pharmacists shall comply with
KRS
218A.180 related to labeling if preparing
doses to be taken outside the program site.
(p) An NTP shall hire clinicians who meet the
requirements of
908 KAR 1:370, Section
11.
(q) There shall be at least one
(1) clinician for every fifty-five (55) patients in the
program.
(6) Security and
control.
(a) The program director and dosing
nurse supervisor or pharmacist shall conduct quarterly reviews to ensure
compliance with this subsection and 42 C.F.R. Part
8.12.
(b) Security of the controlled substance safe
and the building perimeter shall be checked at least quarterly with the
contracted security company.
(c)
The safe shall be locked at all times while staff are not obtaining,
restocking, or inventorying controlled substances.
(d)
1.
Inventory reconciliation shall be conducted at least quarterly;
2. All reconciliation documents shall be
retained by the program for at least five (5) years; and
3. All DEA and federal regulations concerning
inventory discrepancies shall be followed, and any inventory discrepancy
required to be reported to the DEA offices shall also be reported to the SNA
within forty-eight (48) hours of reconciliation.
(e) Dosing personnel shall count all new
bottles of controlled substance tablets before removing any for patient
doses.
(f) Any discrepancies in
controlled substance tablet count shall be reported to the SNA, DEA, CSAT, and
the cabinet within forty-eight (48) hours of the event.
(g) A system shall be in place to assure the
NTP completes the DEA biennial inventory of controlled substance on
hand.
(h) Order forms for
controlled substances, the dosing records, and inventory reconciliation records
shall conform with 42 C.F.R. Part
8.12 and shall be maintained in a locked,
secured area separate from the storage site of the controlled
substances.
(i) Quarterly, the
program director or designee shall review a ten (10) percent random sample of
patient records for:
1. A consent to treatment
form signed by the patient; and
2.
A release of information form signed by the patient that includes:
a. A description of the specific type of
confidential information to be obtained or released; and
b. The specific dates that the release is to
cover.
(j) If
the program director serves as a clinician, the medical director shall review a
ten (10) percent random sample of the program director's patient records for
inclusion of the documents listed in paragraph (i) of this
subsection.
(k) An NTP shall retain
on file documentation that quarterly reviews were conducted, which shall be
available for review by regulatory agencies for at least five (5)
years.
(7) Admission
policies.
(a) The admitting physician or
licensed health practitioners acting within their scope of practice for the NTP
shall comply with the admission requirements of 42 C.F.R. Part
8.12.
(b) When a patient applies for admission to
an NTP, the patient shall be required to sign a release of information that
authorizes a program to release or solicit information regarding the patient's
status in any other substance use disorder treatment program.
(c) In addition to complying with the
requirements of
908 KAR 1:370, Section 16, an NTP
shall:
1. Provide each patient written
information describing all facets of the program in a manner that the patient
understands; and
2. Explain the
contents of all required federal forms to the patient before he or she is asked
to sign.
(d) At
admission, readmission, and at six (6) month intervals for the first two (2)
years of treatment, and as indicated clinically after two (2) years, an NTP
shall give the patient information on communicable diseases including:
1. Tuberculosis;
2. Hepatitis;
3. Sexually transmitted diseases;
and
4. HIV/AIDS.
(e) A patient shall have access to
voluntary HIV testing at admission and if clinically indicated thereafter and
shall receive HIV/AIDS pre-test and post-test counseling if the patient elects
to be tested.
(f) In order for an
NTP to admit or continue to treat a patient who is pregnant, the medical
director, program physician, or program prescriber shall determine and document
in the patient's record that the patient is medically able to participate in
the program.
(g) Pregnant
individuals with an opioid use disorder shall be given priority for admission
and services if the NTP has a waiting list.
(8) Patient transfers and guest dosing.
(a) An NTP may accept patients transferring
from another NTP if the patient meets the criteria for admission in subsection
(7) of this section and in accordance with this subsection.
(b) The program prescriber, program
physician, or medical director at the receiving NTP shall review the patient's
records on an individual basis to determine the patient's placement on the
receiving program's patient listing. Reviews for proposed transfers shall
determine the patient's:
1. Need;
2. Program placement availability;
and
3. Circumstances for the
transfer request.
(c) If
a patient transfers from an existing narcotic treatment program, the NTP shall
ensure, if clinically indicated, the patient remains in their confirmed current
phase from the sending NTP.
(d) The
sending NTP shall:
1. Forward all relevant
patient records to the receiving NTP within seventy-two (72) hours of receipt
of a request to transfer, excluding any day the NTP is closed; and
2. Continue dosing until the patient is
enrolled at the receiving NTP.
(e) The receiving NTP shall:
1. Contact the sending NTP to confirm the
patient's enrollment prior to administering the patient's initial dose at the
receiving NTP; and
2. Include
documentation in the patient's medical record of the:
a. Date of receipt of the patient's records
from the sending NTP, including reason for transfer; and
b. Verification that the patient meets the
admission criteria in subsection (7) of this section.
(f) An NTP may provide guest
dosing to patients who are not eligible for take home doses.
(g) The NTP may develop policies based upon
federal guidelines and best practices.
(h) The NTP shall check the individual's
enrollment in the central registry.
(i) The NTP shall confirm and provide the
correct guest dosing arrangement with the home NTP.
(9) Drug screens.
(a) Drug screen sample collection policies
intended to prevent falsification shall be developed and followed.
(b) Drug screens shall be analyzed for the
following drugs:
1. Approved controlled
substance;
2. Cocaine;
3. Opioids;
4. Amphetamines;
5. Barbiturates;
6. Benzodiazepines;
7. Any other drug or drugs that has been
determined by the NTP or the SNA to be misused in that program's locality;
and
8. Any other drugs that could
have been misused by the patient.
(c) Drug screens shall be reviewed by the
treatment team monthly to determine the patient's reduction in the use of
unauthorized medications.
(d)
Controlled substance medications shall be considered unapproved usage if they
are being used by the patient without a valid prescription.
(e) A drug screen that is negative for the
approved controlled substances allowed to be used in the NTP shall be
considered positive for unauthorized drug use.
(f) An NTP shall not use drug screens as the
sole criteria for involuntarily terminating a patient's participation in the
program.
(g) When drug screening
results are used, presumptive laboratory results shall be distinguished in the
patient record from results that are definitive.
(h) Samples used for drug screening purposes
shall be handled in a manner that ensures patient confidentiality.
(10) Dosing requirements.
(a) The dose prepared for a patient shall be
the quantity of approved controlled substances that is indicated on the
patient's narcotic sheet within the medical record.
(b) The dose shall be labeled with the exact
quantity of narcotic drug ordered.
(c) Take-home doses shall be formulated in a
manner that reduces the likelihood of injecting the dose.
(d) Take-home doses of the approved
controlled substances shall be packaged in containers in accordance with
15 U.S.C.
1471.
(e) The label of take-home doses shall
include the:
1. Name of the program;
2. Address and telephone number of the
program;
3. Name of the controlled
substance;
4. Name of the
patient;
5. Name of the prescriber
ordering the substance;
6. Quantity
of the controlled substance, unless the patient has requested in writing that
the quantity of the substance not be revealed to him or her;
7. Date of filling order; and
8. Instructions for medicating, including
dosage amount and dates medication is to be taken.
(f) Dosing personnel shall not alter patient
doses without the medical director, program physician, or program prescriber's
order.
(g) Verbal dosing orders
shall be reduced to writing and signed by the medical director, program
physician, or program prescriber within forty-eight (48) hours of the order's
receipt.
(h) The medical record
shall indicate any reason for dose changes and shall be signed by the medical
director, program physician, or program prescriber within forty-eight (48)
hours of the order's receipt.
(11) Patients who are pregnant.
(a) If the medical director, program
physician, or program prescriber does not accept the responsibility for
providing prenatal care for the term of the patient's pregnancy, then the
medical director, program physician, or program prescriber shall refer the
patient to:
1. A primary care physician who
practices obstetrics; or
2. An
obstetrician.
(b) The
medical director, program physician, or program prescriber shall inform the
prescriber accepting the referral of the patient's participation in the
NTP.
(c) The medical director,
program physician, or program prescriber shall ensure that appropriate
arrangements have been made for the medical care of both the patient and the
child following the birth of the child.
(d) The medical director, program physician,
or program prescriber shall notify the pregnant patient's primary care
physician or obstetrician of any changes in the patient's treatment.
(e) The program shall ensure that the
following services are available for pregnant individuals and are a part of the
treatment plan:
1. Nutritional counseling;
and
2. Parenting training that
includes information about:
a. Newborn
care;
b. Handling a
newborn;
c. Newborn health;
and
d. Newborn safety.
(12) Treatment
protocol phases.
(a) In accordance with 42
C.F.R. Part
8.12 , NTPs shall comply with the treatment phase system as
outlined in paragraphs (e) through (j) of this subsection for the dosing of
methadone for treatment of opioid use disorder.
(b) Program infractions shall include:
1. Disruptive behavior at the clinic site;
or
2. Threats to staff or other
patients.
(c) Program
non-compliance shall include:
1. Non-compliant
drug screens; or
2. Failure to
attend scheduled dosing or counseling appointments.
(d) Patient treatment plans shall be:
1. Established, reviewed, and updated in
accordance with
908 KAR 1:370, Section 19;
and
2. Reflect a patient's current
needs for:
a. Medical, social, and
psychological services; and
b.
Education, vocational rehabilitation, and employment
services.
(e)
The medical director, program physician, or program prescriber shall sign the
treatment plan within thirty (30) days.
(f) A patient shall successfully complete
current treatment protocol phase before entering the subsequent treatment
protocol phase with no non-compliance issues, unless excused pursuant to
paragraph (n) of this subsection, for at least ninety (90) consecutive
days.
(g) Phase one (1). Days one
(1) to ninety (90) in treatment, all patients shall:
1. Attend clinic six (6) times each week for
observed ingestion of an approved controlled substance at the clinic
site;
2. Be eligible to receive a
one (1) day take-home dose of an approved controlled substance;
3. Be provided counseling sessions to support
the implementation of their treatment plan as clinically indicated;
4. Be informed about appropriate support
groups; and
5. Provide a drug
screen sample one (1) time per month on a random basis.
(h) Phase two (2). Days ninety-one (91) to
180.Once the patient enters phase two (2) the patient shall:
1. Attend clinic five (5) times each week for
observed ingestion of an approved controlled substance;
2. Be eligible to receive a two (2) day
take-home dose of an approved controlled substance;
3. Be provided counseling sessions to support
the implementation of their treatment plan as clinically indicated;
4. Provide a drug screen sample on a random
basis at least monthly or more frequently if their treatment plan requires;
and
5. Be encouraged to attend
appropriate support groups.
(i) Phase three (3). Days 181 to 270.
1. In order for a patient to enter phase
three (3)[t, the patient shall have successfully completed phase two
(2).
2. Patients in phase three (3)
shall:
a. Attend clinic four (4) times each
week for observed ingestion of an approved controlled substance;
b. Be eligible to receive up to three (3)
days of take-home doses of an approved controlled substance;
c. Provide a drug screen sample randomly on a
monthly basis, or more frequently if their treatment plan requires;
d. Be provided counseling sessions, as
clinically indicated; and
e. Be
encouraged to attend appropriate support groups outside the clinic.
(j) Phase 4. Days 271 to
365.
1. In order for the patient to enter
phase four (4), the patient shall:
a. Have
completed phase 3; and
b. Have met
the same entry criteria requirements as established in phase three
(3).
2. Patients in phase
four (4) shall:
a. Attend clinic one (1) time
each week for observed ingestion of an approved controlled substance;
b. Be eligible to receive up to six (6) days
of take-home doses of an approved controlled substance;
c. Provide eight (8) random drug screen
samples within a twelve (12) month period, or more frequently if their
treatment plan requires;
d. Be
provided counseling sessions, as clinically indicated; and
e. Be encouraged to attend appropriate
support groups outside the clinic.
(k) Phase 5. Days 365 to 730.
1. In order for the patient to enter phase
five (5), the patient shall have:
a.
Successfully completed phase four (4); and
b. Adhered to the requirements of the
maintenance treatment program for at least 365 days.
2. Patient in phase five (5) shall:
a. Be dosed at the clinic site at least once
every fifteen (15) days for observed ingestion of an approved controlled
substance;
b. Be eligible for up to
fourteen (14) days of take-home doses of an approved controlled
substance;
c. Be provided an
appropriate number of counseling sessions, which shall be based on the clinical
judgement of the program physician and program staff; and
d. Provide eight (8) random drug screen
samples within a twelve month period, or more frequently if their treatment
plan requires.
(l) Phase 6. Days 731 and up.
1. In order for the patient to enter phase
six (6), the patient shall have:
a.
Successfully completed phase five (5); and
b. Adhered to the requirements of the
maintenance treatment program for at least 731 days.
2. Patients[C in phase six (6) shall:
a. Be dosed at the clinic site at least one
(1) day per month for observed ingestion of an approved controlled
substance;
b. Be eligible for up to
thirty one days of take-home doses of an approved controlled
substance;
c. Be provided an
appropriate number of counseling sessions, which shall be based on the clinical
judgement of the program prescriber and program staff; and
d. Provide eight (8) random drug screen
samples within a twelve month period, or more frequently if their treatment
plan requires.
(m) The medical director may excuse a
non-compliance issue on a case-by-case basis focusing on the following:
1. The interactions between a positive drug
screen and the medication used for treatment;
2. Past history of non-compliance
issues;
3. Employment issues;
and
4. Length of time in
program.
(n) If the
medical director excuses a non-compliance issue, as specified in paragraph (m)
of this subsection, the non-compliance issue excused shall not be used to:
1. Move a patient out of a phase;
or
2. Keep a patient from advancing
phases.
(o) The medical
director shall document the non-compliance excuse in the patient's medical
record.
(13) Take home
dose restrictions and terminations.
(a) In
determining the patient's take-home medications, the medical director, program
physician, or program prescriber shall act in accordance with
42 C.F.R. Part
8.12 and subsections (7) through (12) of this
section.
(b) An NTP shall restrict
a patient's take-home dosage by moving the patient back on the take-home dosage
schedule if the medical director, program physician, or program prescriber
concludes that the patient is no longer a suitable candidate for take-home
privileges as presently scheduled.
(c) An NTP shall revoke a patient's take-home
privileges for not less than thirty (30) days and shall require the patient to
ingest each dosage at the facility for any of the following reasons:
1. The patient's drug screening discloses an
absence of the controlled substance prescribed by the program;
2. The patient is discovered to be misusing
medication, as established in subparagraph 5. of this paragraph;
3. The patient attempts to enroll in another
NTP;
4. The patient alters or
attempts to alter a drug screen; or
5. The patient is not satisfactorily adhering
to the requirements of the NTP by the following:
a. The patient has not complied with the
rules of the NTP;
b. The patient is
sharing, giving away, selling, or trading their approved controlled substance
dosage; or
c. The patient is not
ingesting their approved controlled substance dose in accordance with treatment
program rules.
(d) A patient whose daily dosage is
twenty-five (25) milligrams or less shall be exempt from paragraph (c). of this
subsection.
(e) A patient whose
take-home privileges were revoked or restricted may regain take-home privileges
according to the following schedule:
1. Phase
one (1) - satisfactory adherence for at least thirty (30) days;
2. Phase two (2) - satisfactory adherence for
at least thirty (30) days after regaining phase one (1) privileges;
3. Phase three (3) - satisfactory adherence
for at least thirty (30) days after regaining phase two (2)
privileges;
4. Phase four (4) -
satisfactory adherence for at least thirty (30) days after regaining phase
three (3) privileges;
5. Phase five
(5) - satisfactory adherence for at least thirty (30) days after regaining
phase four (4) privileges; and
6.
Phase six (6) - satisfactory adherence for at least thirty (30) days after
regaining phase five (5) privileges.
(f) This subsection shall not be used to
circumvent the requirements of this administrative regulation. A patient shall
not be advanced to a phase level pursuant to this subsection unless the patient
has previously been at that phase level after having satisfied the requirements
of each phase.
(g) Treatment shall
be continued as long as it is medically necessary based upon the clinical
judgment of the medical director, program physician, or program prescriber and
staff.
(h) Scheduled withdrawal
shall be under the immediate direction of the medical director, program
physician, or program prescriber and shall be individualized.
(i) A patient may voluntarily terminate
participation in an NTP even if termination is against the advice of the
NTP.
(j) Except as established in
subsection (15)(e) of this section, either voluntary or involuntary termination
shall take place over a period of time not less than fifteen (15) days, unless:
1. The medical director, program physician,
or program prescriber deems it clinically necessary to terminate participation
sooner and documents the reason in the patient's record; or
2. The patient requests in writing a shorter
termination period.
(k)
Patients who are voluntarily and involuntarily terminated shall be offered the
following prior to discharge:
1. Overdose
education;
2.
a. A Federal Drug Administration approved
opioid overdose reversal agent; or
b. A Federal Drug Administration approved
opioid overdose reversal agent prescription; and
3. Referral with appointment to the
level-of-care appropriate and accessible to the patient.
(14) Exceptions.
(a) The medical director, program physician,
or program prescriber may grant an exception to the criteria for take-home
dosages for any of the following reasons:
1.
The patient has a serious physical disability that would prevent frequent
visits to the program facility; or
2.
a. The
patient is subject to an exceptional circumstance such as acute illness, family
crisis, or necessary travel; and
b.
Hardship would result from requiring exact compliance with the phase level
schedule established in subsection (12) of this section.
(b) Exception to the criteria for
take-home dosages shall:
1. Be subject to the
limitations in this administrative regulation; and
2. Have written approval from the SNA that
shall be filed in the patient record.
(c) If a patient is required to travel out of
the program area, the medical director, program physician, or program
prescriber shall attempt to arrange for the patient's daily dosage to be
received at another program in lieu of increasing take-home dosages.
(d) The medical director, program physician,
or program prescriber shall document in the patient's record the granting of
any exception and the facts justifying the exception.
(e) Each program shall maintain a separate
record for all exceptions granted.
(f) The SNA shall not grant additional
exceptions, except in cases of medical emergency or natural disaster, such as
fire, flood, or earthquake.
(g)
Patient take home exceptions shall be entered into the Substance Abuse and
Mental Health Services Administration's system in accordance with the system's
requirements.
(h) Emergency Dosing.
1. Under emergency conditions a program may
issue take-home doses in accordance with this subsection.
2. Within forty-eight (48) hours after
administration of the first emergency dose, an NTP shall:
a. Notify the SNA in writing;
b. Submit justification of the emergency dose
or doses; and
c. Request permission
for any subsequent dose after the first two (2) doses.
3. Subsequent emergency doses shall not be
given unless permission is received by the SNA.
4. This request shall include the:
a. Number of take-home doses
requested;
b. Reason for the
request;
c. Patient's standing in
program phases;
d. Patient's
adherence to program policies; and
e. Total length of time the patient has been
enrolled at the NTP.
(15) Patient[C program compliance and
infractions.
(a) If a patient has a
non-compliance issue as described in section 7(12)(c) of this administrative
regulation, the counseling staff shall review and modify the treatment plan to
assist the patient in complying with program policies.
(b) If a patient continues to have
non-compliance issues and the medical director, program physician, or program
prescriber determines additional intervention is warranted, the director,
program physician, or prescriber may:
1. Move
the patient back to an earlier treatment phase;
2. Limit or revoke the patient's take-home
privileges;
3. Increase the
frequency of counseling sessions;
4. Increase the frequency of drug screen
samples; or
5. Increase the
medication dose to reduce cravings.
(c) If a patient commits a program infraction
as described in section 7(12)(b) of this administrative regulation, the patient
may be involuntarily terminated from the program based on the recommendation of
the medical director, program physician, or program prescriber.
(d) A patient's participation in an NTP may
be involuntarily terminated for cause. Cause shall include:
1. Polydrug use if risk of co-use outweighs
risk of overdose death following termination of methadone treatment;
2. Diversion of an approved controlled
substance;
3. Violence or threat of
violence to program staff or other patients in the program; or
4. Dual enrollment in another NTP.
(e) If the medical director,
program physician, or program prescriber determines that the patient's
continued participation in the program creates a physically threatening
situation for the staff or other patients, the patient's participation may be
terminated immediately.
(f) A
patient shall be given written notice of a decision to terminate their
participation in the program, which shall include the reasons for the
termination.
(16) Program
monitoring. If an NTP fails to comply with the requirements in this
administrative regulation, the SNA may take action in accordance with
908 KAR 1:370, Sections 5 and 20.
In addition to the authority to deny, suspend, or revoke a license in
accordance with
908 KAR 1:370, the SNA may:
(a) Order the NTP to discontinue all or part
of the take-home doses of any approved controlled substance used in the
NTP;
(b) Restrict the NTP's
take-home procedures to the provision of emergency take-home doses in
accordance with subsection (14) of this section; or
(c) Order the NTP to discontinue the
utilization of any drug approved for use in narcotic treatment
programs.
(17) Waivers.
(1) The cabinet may grant a waiver to any
part of this administrative regulation if:
(a)
The governor declares a state of emergency; or
(b) [(2)] An NTP may request a waiver in
accordance to 42C.F.R
8.11(h) from the SNA from
any requirement of this administrative
regulation.
(18)
(a)
This application for a waiver shall:
1. Be in
the form of a letter to the SNA;
2.
Identify the specific sections of this administrative regulation for which a
waiver is being sought; and
3. Give
the rationale for the request.
(b) If a waiver pertains to a client, a copy
of a waiver request and response shall become part of the client's permanent
record.
(c) An application for a
waiver request shall be mailed to: Kentucky State Narcotic Authority Department
for Behavioral Health, Developmental and Intellectual Disabilities, 275 East
Main Street, Frankfort, Kentucky 40621.
(d) Approval or denial of a waiver shall be
based upon a review of the merits of the request, taking into consideration:
1. Public safety;
2. Practicality; and
3. The purpose of the requirement for which a
waiver is requested.
(e)
A waiver shall expire twelve (12) months from the date he waiver is granted
unless the SNA gives an earlier expiration date.