Title 908 | Chapter 001 | Regulation 374


908 KAR 1:374REG
A proposed version of this document exists.
View Proposed Version

908 KAR 1:374.Licensure of nonhospital-based outpatient alcohol and other drug treatment entities.

Section 1.

Definitions.

(1)

"Approved controlled substance" means the drugs methadone, buprenorphine, or other FDA-approved drug used in the treatment of narcotic addiction in a Narcotic Treatment Program.

(2)

"CHFS" or "cabinet" means the Cabinet for Health and Family Services.

(3)

"CSAT" means the Center for Substance Abuse Treatment.

(4)

"DEA" means the Drug Enforcement Administration.

(5)

"Dose" means a one (1) day quantity of an approved controlled substance, administered on site at a narcotic treatment program, in not less than one (1) fluid ounce of an oral solution, formulated to minimize misuse by injection.

(6)

"Drug screening" means the process by which a program determines the presence or the absence of drugs in the body fluids.

(7)

"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.

(8)

"Medication station" means any dosing location that obtains its drug supply from the main program site and retains all records (except dosing, drug screens) at the main location. Medication stations are not extension sites as established in 908 KAR 1:370 Section 2(1)(c).

(9)

"SNA" means the state narcotic authority. The Department for Behavioral Health, Developmental and Intellectual Disabilities is the SNA for Kentucky.

(10)

"Take-home dose" means a quantity of an approved controlled substance, which the client is eligible to take off the premises of a narcotic treatment program.

(11)

"Treatment phase" means a stage in the client's progress through a narcotic treatment program's sequential treatment system.

(12)

"Voluntary withdrawal management" means a medically supervised withdrawal from the approved controlled substance requested by a client 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 clients 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 client 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 client; 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 his or her 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 client record in accordance with 908 KAR 1:370, Section 17(4)(h);

(b)

Reflect implementation of the treatment plan;

(c)

Document the client'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 client shall continue until:

(a)

Withdrawal signs and symptoms are sufficiently resolved so that the client can participate in:

1.

Self-directed recovery; or

2.

Ongoing treatment without the need for further medical or nursing withdrawal management monitoring;

(b)

The client'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)

The client is unable to complete ambulatory withdrawal management despite an adequate trial, meaning the client is experiencing intense craving and evidencing insufficient coping skills to prevent continued alcohol or other drug use concurrent with the withdrawal management medication, indicating a need for more intensive services.

Section 3.

Outpatient Treatment Services.

(1)

In addition to the licensing requirements of 908 KAR 1:370, an outpatient AODE that offers outpatient treatment services:

(a)

Shall provide alcohol and other drug abuse counseling to each client, with counseling provided to no more than twelve (12) clients per clinician if provided in a group;

(b)

Shall provide each client with education regarding:

1.

The disease of addiction;

2.

The client's diagnosis;

3.

The effects of alcohol and other drug abuse;

4.

The risks of exposure to human immunodeficiency virus (HIV), hepatitis, and other health consequences of substance use disorder;

5.

Family issues related to substance use disorder; and

6.

Relapse prevention;

(c)

Shall refer each client to recovery support services specific to addiction recovery, which may include:

1.

Support groups;

2.

Peer support;

3.

Recovery housing;

4.

Community supports;

5.

Supported employment;

6.

Co-occurring disorders; and

7.

Medication assisted treatment;

(d)

Shall have a direct affiliation with, or close coordination through referral to more intensive levels of care and medication management;

(e)

Shall have a procedure to inform clients of the availability of emergency services available twenty-four (24) hours a day, seven (7) days a week; and

(f)

May provide additional therapies including:

1.

Motivational enhancement;

2.

Occupational and recreational therapy;

3.

Psychotherapy; or

4.

Medication assisted therapy.

(2)

Staff who provide outpatient treatment services:

(a)

Shall be able to obtain and interpret information regarding the client's biopsychosocial needs;

(b)

Shall be knowledgeable about the biopsychosocial dimensions of alcohol, tobacco, and other substance use disorders, including assessment of the client's stage of readiness to change;

(c)

Shall be capable of monitoring stabilized mental health problems and recognizing any instability in a client with co-occurring disorders; and

(d)

May include physicians and other licensed health care practitioners acting within their scope of practice on staff if medication assisted therapy is provided.

(3)

Progress notes shall:

(a)

Be maintained in the client record in accordance with 908 KAR 1:370, Section 17(4)(h);

(b)

Reflect implementation of the treatment plan;

(c)

Document the client's response to therapeutic interventions for all disorders treated; and

(d)

Include each amendment of the treatment plan.

(4)

The client's discharge summary shall be completed within thirty (30) calendar days of discharge.

Section 4.

Intensive Outpatient Program.

(1)

In addition to the licensing requirements of 908 KAR 1:370 and Section 3 of this administrative regulation, an outpatient AODE that offers intensive outpatient services shall ensure that the program provides a multi-modal, multi-disciplinary structured approach to services that:

(a)

Are more intensive than outpatient treatment services; and

(b)

Provide a minimum of services:

1.

For adults:

a.

Nine (9) hours per week; and

b.

Given on no less than three (3) days per week; or

2.

For adolescents:

a.

Six (6) hours per week; and

b.

Given on no less than two (2) days per week.

(2)

Services shall include:

(a)

Individual outpatient therapy;

(b)

Group outpatient therapy;

(c)

Family outpatient therapy, unless contraindicated;

(d)

Crisis intervention; and

(e)

Psycho-education during which the client or client's family member shall be provided with information regarding:

1.

The client's diagnosis;

2.

Reasons why a particular treatment might be effective for reducing symptoms; and

3.

How to cope with the client's diagnosis or condition in a successful manner.

(3)

A program shall:

(a)

Maintain a client-to-staff ratio of no more than ten (10) clients to one (1) staff;

(b)

Establish an individualized treatment plan for each client in accordance with 908 KAR 1:370, Section 19 that focuses on stabilization and transition to a lower level of care;

(c)

Provide access to a:

1.

Board-certified or board-eligible psychiatrist for consultation, which may be delivered through the use of telehealth technology; and

2.

Psychiatrist, other physician, or advanced practice registered nurse for medication prescribing and monitoring; and

(d)

Provide each client with a schedule of all planned therapeutic activities or otherwise ensure that the schedule is conspicuously posted in a public area of the facility.

(4)

(a)

If the program prepares meals on-site for a client who receives services for at least five (5) or more consecutive hours, the program shall be subject to inspection in accordance with 902 KAR 45:005.

(b)

If clients prepare their own meals on-site or are otherwise responsible for their meals, a food service permit shall not be required.

Section 5.

Partial Hospitalization.

(1)

In addition to the licensing requirements of 908 KAR 1:370, an outpatient AODE that offers partial hospitalization services shall be fully accredited by at least one (1) of the following:

(a)

Joint Commission;

(b)

Commission on Accreditation of Rehabilitation Facilities;

(c)

Council on Accreditation; or

(d)

Other nationally recognized accrediting organization with comparable standards.

(2)

Partial hospitalization services shall:

(a)

Be short-term, four (4) to six (6) weeks on average;

(b)

Meet the same standards required for intensive outpatient services, except for Section 4(1)(b) of this administrative regulation;

(c)

Be provided at least five (5) hours a day and at least four (4) days per week; and

(d)

Provide access to educational services for adolescent clients.

(3)

An AODE program that provides partial hospitalization shall comply with 902 KAR 45:005 if the program provides meals directly to its clients.

Section 6.

Office-based Opiate Treatment Services.

(1)

Excluding methadone-based treatment, a facility shall be licensed as an outpatient AODE that provides office-based opiate 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 or advanced practice registered nurse who prescribes products containing buprenorphine or other FDA-approved drugs 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 products containing buprenorphine or other FDA-approved drugs for the treatment of opioid use disorder on-site during all hours of operation;

(c)

Ensure that each physician or advanced practice registered nurse complies with the prescribing and dispensing standards in accordance with 201 KAR 9:270 or 201 KAR 20:065 respectively for FDA-approved drugs used for the treatment of opioid addiction;

(d)

Ensure that a physician or advanced practice registered nurse documents 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)

Prior to admission to the OBOT facility, each prospective 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. A prospective patient shall not be admitted unless he or she meets those criteria.

(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 relapse 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 medication assisted 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 his or her 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, 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 methadone to treat individuals with substance use disorder shall comply with:

(a)

42 C.F.R. Part 8; and

(b)

The requirements of this section.

(2)

An NTP requesting a change of location shall:

(a)

Comply with 908 KAR 1:370, Section 4; and

(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 client's participation in the program, including reasons for termination for cause;

5.

Requirements for the preparation and labeling of client doses in accordance with the requirements of subsection (10) of this section;

6.

Quality assurance and utilization review;

7.

A client 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 clients 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 seven (7) 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; and

9.

Christmas Day, December 25.

(g)

An NTP shall have dosing times sufficient to meet the needs of its clients.

(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 client and provide information and instructions.

(i)

The initial drug screens and confirmatory tests for drugs tested on behalf of the NTP shall meet the following standards:

1.

Marijuana metabolites:

a.

Initial screen 50ng/ml; and

b.

Confirmation test 15ng/ml;

2.

Cocaine metabolites:

a.

Initial screen 300ng/ml; and

b.

Confirmation test 150ng/ml;

3.

Opiates metabolites:

a.

Initial screen 300ng/ml; and

b.

Confirmation test 300ng/ml;

4.

Amphetamines:

a.

Initial screen 1000ng/ml; and

b.

Confirmation test of amphetamine 500ng/ml and methamphetamine confirmation test 500ng/ml;

5.

Barbiturates:

a.

Initial screen 300ng/ml; and

b.

Confirmation test 300ng/ml; and

6.

Benzodiazepines:

a.

Initial screen 300ng/ml; and

b.

Confirmation test 300ng/ml.

(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)

A medication station shall be located between forty-five (45) miles and ninety (90) miles from the main NTP.

(d)

The medication station shall obtain its supply of approved controlled substances from the stocks of the main NTP.

(e)

The medication station shall provide the following services:

1.

Dosing; and

2.

Drug screen collection.

(f)

The program director shall develop a system to prevent clients from dosing at both the main NTP and the medication station.

(g)

Other services shall not be provided at the medication station without prior approval of the CSAT and SNA.

(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 program physician shall be:

1.

Licensed by the Commonwealth of Kentucky to practice medicine within the Commonwealth; 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)

A program physician shall be responsible for the NTP's compliance with federal, state, and local laws and administrative regulations pertaining to the operation of the facility.

(j)

The medical director may be the program physician.

(k)

There shall be a minimum of one (1) medical director or program physician on staff for every 300 clients, or fraction thereof, enrolled in an NTP.

(l)

The medical director or program physician shall:

1.

Ensure there is evidence of physiologic dependence on narcotics for all clients admitted to the NTP;

2.

Ensure there is a history of addiction, or that any exceptions to admissions criteria are approved by the SNA and documented in the client'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 clients during dosing hours.

(o)

Dosing physicians 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 forty (40) clients 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 narcotic 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.

Five (5) percent or more of any inventory discrepancies shall be reported to the SNA and the DEA offices within forty-eight (48) hours of reconciliation.

(e)

Dosing personnel shall count all new bottles of narcotic tablets before removing any for client doses.

(f)

Any discrepancies in narcotic 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 narcotic drugs 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 client records for:

1.

A consent to treatment form signed by the client; and

2.

A release of information form signed by the client 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 client 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 for the NTP shall comply with the admission requirements of 42 C.F.R. Part 8.12.

(b)

When a client applies for admission to an NTP, the client shall be required to sign a release of information that authorizes a program to release or solicit information regarding the client's status in any other substance abuse program.

(c)

In addition to complying with the requirements of 908 KAR 1:370, Section 16, an NTP shall:

1.

Provide each client written information describing all facets of the program in a manner that the client understands; and

2.

Explain the contents of all required federal forms to the client 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 client information on communicable diseases including:

1.

Tuberculosis;

2.

Hepatitis;

3.

Sexually transmitted diseases; and

4.

HIV/AIDS.

(e)

A client 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 client elects to be tested.

(f)

In order for an NTP to admit or continue to treat a client who is pregnant, the medical director or program physician shall determine and document in the client's record that the client is medically able to participate in the program.

(g)

Pregnant individuals with an opiate use disorder shall be given priority for admission and services if the NTP has a waiting list.

(8)

Client transfers.

(a)

An NTP may accept clients transferring from another NTP if the client meets the criteria for admission in subsection (7) of this section and in accordance with this subsection.

(b)

The program physician or medical director at the receiving NTP shall review the client's records on an individual basis to determine the client's placement on the receiving program's client listing. Reviews for proposed transfers shall determine the client's:

1.

Need;

2.

Program placement availability; and

3.

Circumstances for the transfer request.

(c)

If a client from an out-of-state, medication-assisted treatment program transfers to an NTP located in Kentucky, the NTP shall designate the client as a new admission or "entry phase" as established in subsection (12) of this section unless other phase levels are approved by the SNA.

(d)

The sending NTP shall:

1.

Forward all relevant client records to the receiving NTP within seventy-two (72) hours of receipt of a request to transfer; and

2.

Continue dosing until the client is enrolled at the receiving NTP.

(e)

The receiving NTP shall:

1.

Contact the sending NTP to confirm the client's enrollment prior to administering the client's initial dose at the receiving NTP; and

2.

Include documentation in the client's medical record of the:

a.

Date of receipt of the client's records from the sending NTP, including reason for transfer; and

b.

Verification that the client meets the admission criteria in subsection (7) of this section.

(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.

Opiates;

4.

Amphetamines;

5.

Barbiturates;

6.

Tetrahydrocannabinol;

7.

Benzodiazepines;

8.

Any other drug or drugs that has been determined by the NTP or the SNA to be abused in that program's locality; and

9.

Any other drugs that could have been abused by the client.

(c)

Drug screens shall be reviewed by the treatment team monthly to determine the client's reduction in the use of unauthorized medications.

(d)

Controlled substance medications shall be considered unapproved usage if they are being used by the client 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 client's participation in the program.

(g)

When drug screening results are used, presumptive laboratory results shall be distinguished in the client record from results that are definitive.

(h)

Samples used for drug screening purposes shall be handled in a manner that ensures client confidentiality.

(10)

Dosing requirements.

(a)

The dose prepared for a client shall be the quantity of approved controlled substances that is indicated on the client'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 client;

5.

Name of the physician ordering the substance;

6.

Quantity of the controlled substance, unless the client 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 client doses without the medical director or program physician's order.

(g)

Verbal dosing orders shall be reduced to writing and signed by the medical director or program physician 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 or program physician within forty-eight (48) hours of the order's receipt.

(11)

Clients who are pregnant.

(a)

If the medical director or program physician does not accept the responsibility for providing prenatal care for the term of the client's pregnancy, then the medical director or program physician shall refer the client to:

1.

A primary care physician who practices obstetrics; or

2.

An obstetrician.

(b)

The medical director or program physician shall inform the physician accepting the referral of the client's participation in the NTP.

(c)

The medical director or program physician shall ensure that appropriate arrangements have been made for the medical care of both the client and the child following the birth of the child.

(d)

The medical director or program physician shall notify the pregnant client's primary care physician of any changes in the client'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)

NTPs shall comply with the treatment phase system in paragraphs (e) through (j) of this subsection to achieve the goals of:

1.

Reduced health problems;

2.

Reduced criminal activity;

3.

Increased productivity;

4.

Stabilization of family life; and

5.

Eventual drug-free living.

(b)

Program infractions shall include:

1.

Failed drug screens;

2.

Disruptive behavior at the clinic site;

3.

Threats to staff or other clients; or

4.

Failure to attend scheduled dosing or counseling appointments.

(c)

Client treatment plans shall be established, reviewed, and updated in accordance with 908 KAR 1:370, Section 19.

(d)

The medical director or program physician shall sign the treatment plan within thirty (30) days.

(e)

Entry phase. During the first ninety (90) days of treatment, all clients shall:

1.

Attend clinic seven (7) times each week for observed ingestion of an approved controlled substance at the clinic site;

2.

Be provided weekly counseling sessions to support the implementation of their treatment plan;

3.

Be informed about appropriate support groups; and

4.

Provide an observed drug screen sample one (1) time per week on a random basis.

(f)

Phase one (1).

1.

In order for a client to enter phase one (1), the client shall:

a.

Have participated in the "entry phase" for at least ninety (90) consecutive days; and

b.

Not have committed any program infractions for at least ninety (90) consecutive days.

2.

Once the client enters phase one (1) the client shall:

a.

Attend clinic six (6) times each week for observed ingestion of an approved controlled substance;

b.

Be eligible to receive a one (1) day take-home dose of an approved controlled substance;

c.

Be provided weekly counseling sessions to support the implementation of their treatment plan;

d.

Provide an observed drug screen sample on a random basis at least every other week; and

e.

Be encouraged to attend an appropriate support group.

(g)

Phase two (2).

1.

In order for a client to enter phase two (2), the client shall:

a.

Have participated in phase one (1) for at least ninety (90) consecutive days;

b.

Not have committed any program infractions for at least ninety (90) consecutive days;

c.

Be:

(i)

Pursuing or engaged in gainful employment;

(ii)

Pursuing vocational training;

(iii)

Attending school;

(iv)

Engaged in volunteer work;

(v)

Attending parenting classes if they are a parent at home with children; or

(vi)

A client with disabilities or other circumstances that might make compliance with this clause unattainable, if the client submitted a written waiver request to the SNA justifying specific reasons for the request that was not denied; and

d.

Have a treatment plan to meet any special needs, including disabilities.

2.

Clients in phase two (2) shall:

a.

Attend clinic five (5) times each week for observed ingestion of an approved controlled substance;

b.

Be eligible to receive up to two (2) days of take-home doses of an approved controlled substance;

c.

Provide an observed drug screen sample randomly on a monthly basis, or more frequently if their treatment plan requires;

d.

Be provided monthly counseling sessions, or more frequently if their treatment plan requires; and

e.

Be encouraged to attend appropriate support groups outside the clinic.

(h)

Phase three (3).

1.

In order for the client to enter phase three (3), the client shall:

a.

Have participated in phase two (2) for at least ninety (90) consecutive days:

b.

Not have committed any program infractions for at least ninety (90) consecutive days; and

c.

Have met the same entry criteria requirements as established in phase two (2).

2.

Clients in phase three (3) shall:

a.

Attend clinic three (3) times each week for observed ingestion of an approved controlled substance;

b.

Be eligible to receive up to two (2) days of take-home doses of an approved controlled substance;

c.

Provide an observed drug screen sample randomly on a monthly basis, or more frequently if their treatment plan requires;

d.

Be provided monthly counseling sessions, or more frequently if their treatment plan requires; and

e.

Be encouraged to attend appropriate support groups outside the clinic.

(i)

Phase four (4).

1.

In order for the client to enter phase four (4), the client shall have:

a.

Successfully completed phase three (3); and

b.

Adhered to the requirements of the maintenance treatment program for at least twelve (12) consecutive months.

2.

Clients in phase four (4) shall:

a.

Be dosed at the clinic site two (2) days per week for observed ingestion of an approved controlled substance;

b.

Be eligible for up to three (3) days of take-home doses of an approved controlled substance;

c.

Be provided an appropriate number of counseling sessions, which shall be:

(i)

Based on the clinical judgement of the program physician and program staff; and

(ii)

No less than one (1) per month; and

d.

Provide an observed drug screen sample randomly on a monthly basis, or more frequently if their treatment plan requires.

3.

Prior to successful completion of phase four (4), a plan shall be developed that shall assist the client toward a drug free treatment regimen for continued support.

(j)

Phase five (5).

1.

In order for the client to enter phase five (5), the client shall have:

a.

Successfully completed phase four (4); and

b.

Adhered to the requirements of the maintenance treatment program for at least two (2) consecutive years.

2.

Clients in phase five (5) shall:

a.

Be dosed at the clinic site one (1) day per week for observed ingestion of an approved controlled substance;

b.

Be eligible for up to six (6) days of take-home doses of an approved controlled substance;

c.

Be provided an appropriate number of counseling sessions, which shall be:

(i)

Based on the clinical judgement of the program physician and program staff; and

(ii)

No less than one (1) per month; and

d.

Provide an observed drug screen sample on a random basis, no less than eight (8) times per year, or more frequently if their treatment plan requires.

(13)

Take home dose restrictions and terminations.

(a)

In determining the client's take-home medications, the medical director or program physician 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 client's take-home dosage privileges by moving the client back at least one (1) phase level on the schedule for take-home dosages if the client's drug screening results disclose the unauthorized presence any substance established in subsection (9)(b) of this section.

(c)

An NTP shall restrict a client's take-home dosage by moving the client back on the take-home dosage schedule if the medical director or program physician concludes that the client is no longer a suitable candidate for take-home privileges as presently scheduled.

(d)

An NTP shall revoke a client's take-home privileges for not less than thirty (30) days and shall require the client to ingest each dosage at the facility for any of the following reasons:

1.

The client's drug screening discloses an absence of the controlled substance prescribed by the program;

2.

The client is discovered to be misusing medication, as established in subparagraph 5. of this paragraph;

3.

The client attempts to enroll in another NTP;

4.

The client alters or attempts to alter a drug screen; or

5.

The client is not satisfactorily adhering to the requirements of the NTP by the following:

a.

The client has not complied with the rules of the NTP;

b.

There is indication that the client has repeatedly used drugs improperly;

c.

The client is sharing, giving away, selling, or trading his or her approved controlled substance dosage;

d.

The client is not ingesting his or her approved controlled substance dose in accordance with treatment program rules;

e.

There is indication that the client is selling, distributing, or otherwise involved with illicit drugs and their use; or

f.

The client is not participating in an educational, vocational, or home-making activity.

(e)

A client whose daily dosage is twenty-five (25) milligrams or less shall be exempt from paragraph (d)1. of this subsection.

(f)

A client 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; and

5.

Phase five (5) – satisfactory adherence for at least thirty (30) days after regaining phase four (4) privileges.

(g)

This subsection shall not be used to circumvent the requirements of this administrative regulation. A client shall not be advanced to a phase level pursuant to this subsection unless the client has previously been at that phase level after having satisfied the requirements of each phase.

(h)

Treatment shall be continued as long as it is medically necessary based upon the clinical judgment of the medical director or program physician and staff.

(i)

Scheduled withdrawal shall be under the immediate direction of the medical director or program physician and shall be individualized.

(j)

A client may voluntarily terminate participation in an NTP even if termination is against the advice of the NTP.

(k)

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 or program physician deems it clinically necessary to terminate participation sooner and documents the reason in the client's record; or

2.

The client requests in writing a shorter termination period.

(14)

Exceptions.

(a)

The medical director or program physician may grant an exception to the criteria for take-home dosages for any of the following reasons:

1.

The client has a serious physical disability that would prevent frequent visits to the program facility; or

2.

a.

The client 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 client record.

(c)

If a client is required to travel out of the program area, the medical director or program physician shall attempt to arrange for the client's daily dosage to be received at another program in lieu of increasing take-home dosages.

(d)

The medical director or program physician shall document in the client'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.

Client's standing in program phases;

d.

Client's adherence to program policies; and

e.

Total length of time the client has been enrolled at the NTP.

(15)

Client program compliance.

(a)

If a client commits a program infraction, the counseling staff shall review and modify the treatment plan to assist the client in complying with program policies.

(b)

If a client continues to commit infractions and the medical director or program physician determines additional intervention is warranted, the director or physician may:

1.

Move the client back to an earlier treatment phase; or

2.

Limit or revoke the client's take-home privileges.

(c)

If the client continues to commit program infractions, the client may be involuntarily terminated from the program based on the recommendation of the medical director or program physician.

(d)

A client's participation in an NTP may be involuntarily terminated for cause. Cause shall include:

1.

Polydrug abuse;

2.

Diversion of an approved controlled substance;

3.

Violence or threat of violence to program staff or other clients in the program; or

4.

Dual enrollment in another NTP.

(e)

If the medical director or program physician determines that the client's continued participation in the program creates a physically threatening situation for the staff or other clients, the client's participation may be terminated immediately.

(f)

A client shall be given written notice of a decision to terminate his or her 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. An NTP may request a waiver from the SNA from any requirement of this administrative regulation.

(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 the 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 the waiver is requested.

(e)

A waiver shall expire twelve (12) months from the date the waiver is granted unless the SNA gives an earlier expiration date.

(f)

A waiver given prior to January 1, 2020 shall expire on January 1, 2020.

Section 8.

Physical Environment.

(1)

Accessibility. An outpatient AODE shall meet requirements for making buildings and facilities accessible to and usable by individuals with physical disabilities in accordance with KRS 198B.260 and 815 KAR 7:120.

(2)

Fire safety. An outpatient AODE shall be approved by the State Fire Marshal's office prior to initial licensure or if the AODE changes location.

(3)

Physical location and overall environment.

(a)

An outpatient AODE shall:

1.

Comply with building codes, ordinances, and administrative regulations that are enforced by city, county, or state jurisdictions;

2.

Display a sign that can be viewed by the public that contains the facility name, hours of operation, and a street address;

3.

Have a publicly listed telephone number;

4.

Have a dedicated phone number to send and receive faxes with a fax machine that shall be operational twenty-four (24) hours per day or use encrypted electronic messaging technology;

5.

Have a reception and waiting area;

6.

Provide a restroom for client use; and

7.

Have an administrative area.

(b)

The condition of the physical location and the overall environment shall be maintained in such a manner that the safety and well-being of clients, personnel, and visitors shall be assured.

(4)

Additional requirements for NTPs.

(a)

The building used for the NTP shall meet the requirements of 21 C.F.R. 1301.74(j).

(b)

The waiting area shall be separated from the dosing area to permit each client privacy and confidentiality at the time of dosing.

(c)

The dosing area shall be clean and sanitary and shall contain:

1.

A sink;

2.

Hot and cold running water; and

3.

Pill-counting trays if tablets are being used.

(d)

The security and floor plan of the dosing area shall be in accordance with 21 C.F.R. 1301.72.

(e)

The facility shall have two (2) restrooms, which shall be accessible to clients with disabilities.

(f)

Restrooms available to clients to provide urine specimens shall be:

1.

Secure;

2.

Clean; and

3.

Sanitary.

(g)

The building shall be secured by a local security company approved by the DEA and the SNA.

(h)

There shall be a minimum of two (2) panic buttons or similar devices for each NTP with:

1.

One (1) in the reception area; and

2.

One (1) in the dosing area.

(i)

There shall be a telephone with an outside line accessible in the dosing area.

(j)

Internal security shall meet the requirements of 21 C.F.R. 1301.74(b), (h), (i), (j), (k); 1301.91; 1301.92 and shall be installed only after consultation with the DEA and the SNA.

(k)

Parking spaces at the clinic site shall be adequate to accommodate the maximum number of clients expected to be at the clinic site at one (1) time.

HISTORY: (45 Ky.R. 2546, 3222, 46 Ky.R. 464; eff. 8-19-2019; TAm eff. 3-18-2020.)

7-Year Expiration: 8/19/2026

Last Updated: 8/8/2022


Page Generated: 8/19/2022, 12:42:07 PM