PURPOSE: This rule describes the specific functions, policies and practices required for a methadone treatment program.

1. (1) Eligibility for Certification and Service Delivery. Prior to delivering opioid treatment services, an agency must apply for and receive provisional certification from the department.

   1. (A) The agency must document the need for new services and must demonstrate community acceptance of the proposed site(s).

      1. 1. Determination of the need for new

services shall be at the department’s sole discretion as the designated state authority responsible for opioid treatment. The determination of need shall be based on applicable data, such as waiting lists, emergency room visits, arrest data, and federal drug use forecasting data.

1. 2. A new site cannot be located within

fifty (50) miles of an existing opioid treatment site, unless otherwise indicated by a determination of need.

1. 3. Community acceptance must be

solicited within a one (1)-mile radius of any proposed new site. Assurance must be provided to the department of community acceptance, as well as letters of support from local authorities.

1. (B) An agency applying for provisional certification as an opioid treatment program in the state of Missouri must have provided other certified alcohol and drug services within the state for two (2) years prior to the application. Agencies responding to a department-funded request for proposal will be exempt from this requirement.
2. (C) In order to be certified as an opioid treatment program, the program shall comply with applicable local, state and federal laws and regulations including those under the jurisdiction of the Food and Drug Administration and the Drug Enforcement Administration.

1. (2) Treatment Goals and Performance Outcomes. Opioid treatment services shall be organized to achieve key goals and performance outcomes.

   1. (A) Key goals shall include—

      1. 1. Developing positive and stable func-

tioning in the community with reduced criminal activity and improved employment status;

1. 2. Reducing or eliminating the use of

illicit drugs;

1. 3. Stabilizing emotional and behavioral

functioning;

1. 4. Improving social and family relation-

ships; and

1. 5. Improving health status and reducing

the spread of infectious disease.

1. (B) Performance outcomes related to these goals shall be measured in a consistent manner. Measures shall include, but are not limited to—

   1. 1. Increasing employment and produc-

tive activities. Clients should be involved in employment or other productive activities. For those persons who have been in opioid treatment for six (6) months or longer, seventy percent (70%) shall be working, attending job training or school, be a homemaker, or have a medically documented disability; and

1. 2. Reducing or eliminating the use of

illicit drugs. Random drug screening shall be used to measure the program’s effectiveness in helping clients’ progress toward this goal.

1. A. The following aggregate results

shall be expected from random drug screening conducted each month—

1. (I) For all clients tested, seventy

percent (70%) shall be free of all drugs; and

1. (II) For those clients tested who

have been in opioid treatment for one (1) consecutive year or longer, eighty percent (80%) shall be free of opiates.

1. B. In calculating these performance

outcomes, the following categories of clients may be exempted—

1. (I) Persons admitted to the program

within the past ninety (90) days;

1. (II) Persons undergoing administra-

tive withdrawal due to program infraction(s) or other circumstance; and

1. (III) Persons undergoing withdraw-

al against medical advice.

1. (C) If a program does not meet a performance outcome listed in subsection (2)(B) of this rule for three (3) consecutive months, it shall be considered a significant deficiency related to quality of care. The department shall—

   1. 1. Place the program on administrative

review, require submission of a written plan of correction, and monitor performance for at least ninety (90) days; or

1. 2. Issue conditional certification under

the provisions of 9 CSR 10-7.130.

1. (3) Medical Director. The program shall have a medical director who is a physician licensed in Missouri. Responsibilities of the medical director include, but are not limited to:

   1. (A) Ensuring that clients meet admission criteria and receive the required physical examination and laboratory testing;
   2. (B) Prescribing methadone with client input; and
   3. (C) Reviewing and signing the client’s initial treatment plan and the comprehensive treatment plan on an annual basis.

2. (4) Services. The program shall provide a range of treatment and rehabilitation services to address the therapeutic needs of persons served.

   1. (A) Services shall include:

      1. 1. Individual counseling, group educa-

tion, and counseling, family therapy, community support;

1. 2. Medical evaluations;
2. 3. Use of methadone for medically

supervised withdrawal from narcotics and for ongoing opioid treatment.

1. A. Medically supervised withdrawal

means the dispensing of methadone in decreasing doses to an individual in order to alleviate adverse physiological or psychological effects incidental to withdrawal from the continuous or sustained use of narcotics and in order to bring the individual to a drug-free state within a one hundred eighty (180)-day time period.

1. B. Ongoing opioid treatment means

the dispensing of methadone for more than one hundred eighty (180) days in the treatment of an individual for dependence on heroin or other morphine-like drug; and

1. 4. Medical director shall insure that

dosage is appropriate to the patient’s need.

1. (B) While eventual withdrawal from the use of all drugs, including methadone, may be an appropriate treatment goal, some clients may remain in opioid treatment for relatively long periods of time.

   1. 1. Periodic consideration shall be given

to withdrawing from continued opioid treatment, when appropriate to the individual’s progress and goals.

1. 2. Such consideration and decisions

shall be determined by the client and the program staff as part of an individualized treatment planning process.

1. (C) The program shall offer services at least six (6) days per week. Services shall be available during early morning or evening so that clients who are employed or otherwise involved in productive, daily activities can access services.
2. (D) Programs in the same geographical area shall work together to maximize hours of operation and treatment accessibility.

1. (5) Admission Criteria. The program shall provide treatment and rehabilitation, which includes the use of methadone, to those persons who demonstrate physiologic dependence to heroin and other morphine-like drugs. Priority for admission shall be given to women who are pregnant and to persons who are Human Immunodeficiency Virus

2. (HIV) positive. Persons who are not residents of the state of Missouri shall comprise no more than twenty percent (20%) of the clients of the program.

   1. (A) In order to qualify for medically supervised withdrawal, the applicant must demonstrate physiologic dependence to narcotics. Documentation must indicate clinical signs of dependence, such as needle marks, constricted or dilated pupils, etc.

   2. (B) In order to qualify for initial admission to ongoing opioid treatment, the applicant must demonstrate physiologic dependence and continuous or episodic addiction for the one (1)-year period immediately prior to application for admission. Documentation must indicate clinical signs of dependence, past use patterns and treatment history, etc. The following exceptions may be made to the minimum admission requirements for opioid treatment:

      1. 1. The program may place a pregnant

applicant on a methadone treatment regimen, regardless of age, if the applicant has had a documented dependency on heroin or other morphine-like drugs in the past and may be in direct jeopardy of returning to such dependency, with its attendant dangers during pregnancy. The applicant need not show evidence of current physiologic dependence if a program physician certifies the pregnancy and, in his/her reasonable clinical judgment, justifies opioid treatment;

1. 2. For an applicant who is under the age

of eighteen (18), the program shall document two (2) unsuccessful attempts at drug-free treatment prior to admission to ongoing opioid treatment. The program shall not admit any person under the age of sixteen (16) to a program without the prior approval of the Division of Alcohol and Drug Abuse; and

1. 3. An applicant who has been residing

in a correctional institution for one (1) month or longer may enroll in a program within fourteen (14) days before release or discharge or within six (6) months after release from such an institution without evidence of current physiologic dependence on narcotics provided that prior to institutionalization the client would have met the one (1)-year admission criteria.

1. (C) In order to qualify for readmission to opioid treatment, the applicant must demonstrate current physiologic dependence.

   1. 1. The program may waive this require-

ment if it documents prior opioid treatment of six (6) months or more and discharge within the past two (2) years.

1. 2. At the discretion of its medical direc-

tor, the program may require an applicant who has received administrative detoxification due to an infraction of program rules to wait a minimum of thirty (30) days prior to applying for readmission.

1. (D) The medical director may refuse the admission of an applicant and/or opioid treatment to a particular client if, in the reasonable clinical judgment of the medical director, the person would not benefit from such treatment. Prior to such a decision, appropriate staff should be consulted and the reason(s) for the decision must be documented by the medical director.

1. (6) Admission and Assessment Protocol. The opioid treatment program shall—

   1. (A) Verify the applicant is not currently enrolled in another methadone program;
   2. (B) Obtain the applicant’s signature on a consent to treatment, ensuring that the client understands the risks and benefits of opioid treatment and the possibility of administrative detoxification for infractions of program rules;
   3. (C) Conduct a complete medical history and physical examination to determine symptoms of withdrawal and the possibility of infectious disease; and

   4. (D) Obtain laboratory testing to determine—

      1. 1. Blood count and differential and

chemical profile;

1. 2. Serological test for sexually transmit-

ted disease;

1. 3. Routine and microscope urinalysis;
2. 4. Pregnancy test;
3. 5. Toxicology screening for drugs;
4. 6. Intradermal Purified Protein Deriva-

tive (PPD) test, administered and interpreted by medical staff; and

1. 7. A chest X-ray, pap smear, or screen-

ing for sickle cell disease if the examining medical personnel request these tests.

1. (E) A complete medical history, physical examination, and laboratory testing shall not be required for a client who has had such medical evaluation within the prior thirty (30) days. The program shall have documentation of the medical evaluation and any significant findings.

1. (7) Continued Placement and Utilization Criteria. The program shall utilize a structured approach in providing treatment and rehabilitation services and shall use established criteria for determining client progress. Client progress and movement between the structured phases of treatment shall be based on the following criteria:

   1. (A) Absence of the use of alcohol and other drugs, except as medically prescribed;
   2. (B) Social, vocational, legal, family, emotional and behavioral functioning;
   3. (C) Program attendance as scheduled; and
   4. (D) Other individual goals and accomplishments related to the client’s treatment plan.

2. (8) Phases of Treatment. The program shall utilize six (6) structured phases of treatment and rehabilitation to indicate client progress and to establish requirements regarding client attendance and service participation. The requirements listed below for each phase are minimum requirements and the frequency and extent of treatment and rehabilitation services shall be adjusted, based on individual client needs.

   1. (A) Phase I consists of a minimum ninety (90)-day period in which the client attends the program for observation of opioid treatment daily or at least six (6) days a week. Take-home dosage is limited to a single dose each week.

      1. 1. During the initial ninety (90) days,

the client shall participate in at least four (4) hours of counseling per month with at least two (2) of the hours being individual counseling.

1. 2. During the initial ninety (90) days,

the treatment plan shall be reviewed and updated on at least a monthly basis.

1. 3. Prior to client moving to Phase II or

receiving take-home medication, the client shall demonstrate a level of stability as evidenced by absence of alcohol and other drug abuse, regularity of program attendance, absence of significant behavior problems, absence of recent criminal activities, and employment, actively seeking employment or attending school if not retired, disabled, functioning as a homemaker, or otherwise economically stable.

1. (B) Phase II is designated for clients who have been admitted more than ninety (90) days, but less than two hundred seventy (270) days and who have successfully met Phase I criteria.

   1. 1. During the first ninety (90) days of 9 CSR 30-3

Phase II, the program may issue no more than two (2) take-home doses of methadone at a time.

1. 2. The client shall participate in at least

two (2) hours of counseling per month during the first three (3) months of Phase II, with at least one (1) of the hours being individual counseling.

1. 3. During the second ninety (90) days of

Phase II, the client shall participate in at least one (1) hour of individual counseling per month, and the program may issue no more than three (3) take-home doses of methadone plus closed and holiday days.

1. 4. The treatment plan shall be reviewed

and updated at least every three (3) months during Phase II.

1. (C) Phase III is designated for clients who have been admitted more than nine (9) months but less than one (1) year and who have successfully met progressive Phase II criteria.

   1. 1. During Phase III, the program may

issue no more than six (6) take-home doses of methadone plus closed and holiday days.

1. 2. The client shall participate in at least

one (1) hour of individual counseling per month during Phase III.

1. 3. The treatment plan shall be reviewed

and updated at least every six (6) months during Phase III, or more frequently if circumstances warrant.

1. (D) Phase IV is designated for clients who have been admitted more than one (1) year but less than two (2) years and who have successfully met progressive Phase III criteria.

   1. 1. During Phase IV, the program may

issue two (2) week take-home doses plus closed and holiday days.

1. 2. The client shall participate in at least

one (1) hour of individual counseling per month during this phase.

1. 3. The treatment plan shall be reviewed

and updated at least every six (6) months during this phase.

1. (E) Phase V is designated for clients who have been admitted for more than two (2) years.

   1. 1. During Phase V, the program may

issue one (1) month maximum take-home doses.

1. 2. The client shall participate in at least

one (1) hour of individual counseling per month during this phase.

1. 3. The treatment plan shall be reviewed

and updated at least every six (6) months during this phase.

1. (F) Phase VI is designated for clients who voluntarily seek medically supervised withdrawal and abstinence from all drugs, including methadone as prescribed. A client may enter this phase at any time in the treatment and rehabilitation process.

   1. 1. During Phase VI, the medical direc-

tor determines take-home doses based on stability.

1. 2. During Phase VI, the counselor

determines the frequency of counseling sessions with input from the client. At the onset of Phase V, the client may require an increased level of counseling and other support services.

1. 3. The counselor and patient develop an

after care plan prior to the successful completion of treatment.

1. (9) Program Rules. In order to remain in the program and to successfully progress through the phases of treatment and rehabilitation, a client shall demonstrate progress and shall comply with program rules.

   1. (A) An infraction of program rules by a client may result in administrative medical withdrawal from methadone and termination from the program.
   2. (B) For the purpose of these standards, an infraction means threats of violence or actual bodily harm to staff or another client, disruptive behavior, community incidents (loitering, diversion of methadone, sale or purchase of drugs), continued unexcused absences from counseling and other support services, involvement in criminal activities and other serious rule violations.
   3. (C) A client who either relapses or ceases to meet the progressive phase criteria for which they have been granted may, at the discretion of the medical director, be moved to a phase that the medical director determines is necessary to reestablish stability.
   4. (D) Administrative medical withdrawal shall be scheduled in such a way as to minimize the psychological and physical effects of such withdrawal. Administrative medical withdrawal shall be completed in a manner appropriate to the client’s level of medication and the circumstances justifying such action. Programs may facilitate a transfer to another program or referral to a medical facility in lieu of administrative medical withdrawal.

2. (10) Safety and Health. The program shall establish and implement policies, procedures, and practices which ensure access to its services and which address the safety and health of its clients. The provider shall—

   1. (A) Ensure continued opioid treatment in the event of emergency or natural disaster;
   2. (B) Ensure treatment to persons regardless of sero status, HIV-related conditions, acquired immunodeficiency syndrome (AIDS), or tuberculosis (TB);
   3. (C) Provide information and education to clients regarding HIV and AIDS;
   4. (D) Provide or arrange HIV testing and pre-test and post-test counseling for clients;
   5. (E) Provide or arrange testing for tuberculosis and sexually transmitted diseases upon admission and at least annually thereafter;
   6. (F) Provide medical evaluations to clients upon admission and at least annually thereafter;
   7. (G) Utilize infection control procedures consistent with Occupational Safety and Health Administration guidelines;
   8. (H) Arrange for medical care to clients during pregnancy, when necessary, and document the arrangements made and the client’s compliance.
3. (11) Staff Training. All direct service and medical staff shall receive training relevant to service delivery in an opioid treatment setting. Each staff member shall participate in fourteen (14) clock hours of such training during a two (2)-year period.

4. (12) Drug Testing. The program shall use drug testing as a performance measure and as a clinical tool for the purpose of diagnosis and treatment planning.

   1. (A) Each sample shall be analyzed for opiates, methadone, marijuana, cocaine, barbiturates, and benzodiazepines. Testing shall include other drugs as may be indicated by a client’s use patterns. In addition, if any other drug or drugs have been determined by a program to be abused in that program’s locality, or as otherwise indicated, each test or analysis must include any such drugs.
   2. (B) Drug testing shall be done upon admission, and random drug testing of each client shall be conducted at least eight (8) times during a twelve (12)-month period.
   3. (C) Following admission, the results of a single drug test shall not be the sole basis to determine significant treatment decisions.
   4. (D) A program with thirty percent (30%) or more of its client population having positive drug test results shall be placed on administrative review and the agency shall develop an action plan to bring its program into compliance with this performance expectation.

5. (13) Take-Home Doses. The program shall implement practices in accordance with the principle that take-home doses of methadone is a privilege given only to those individuals who will benefit from it and who have demonstrated responsibility in taking methadone as prescribed.

   1. (A) The requirement of time in treatment as outlined elsewhere in this rule is a minimum reference point after which a client may be considered for take-home medication privileges. The time reference does not mean that a client in treatment for a particular time has a specific right to take-home medication.
   2. (B) Programs must educate the client regarding safe transportation and storage of methadone as well as emergency procedures in case of accidental ingestion.
   3. (C) Before take-home privileges are allowed, the client must have a lock box for transportation of methadone and home storage.
   4. (D) The program shall have policies that address the responsibilities of patients granted take-home medications. The policies shall include methods of assuring client’s appropriate use and storage of medication.
   5. (E) The program shall have policies in place addressing the return of take-home bottles. Policies shall include bottles returned with labels intact and consequences of unreturned bottles.
   6. (F) Regardless of time in treatment, the medical director, in his/her reasonable judgment, may deny or rescind the take-home medication privileges of a client.

6. (14) Methadone Storage and Security. The program shall ensure the security of its methadone supply and shall account for all methadone.

   1. (A) The program shall meet the requirements of the Drug Enforcement Administration.
   2. (B) The program shall maintain an acceptable security system, and its system shall be checked on a quarterly basis to ensure its continued safe operation.
   3. (C) The program shall physically separate the narcotic storage and dispensing area from other parts of its facility used by clients.
   4. (D) The program shall implement written policies and procedures to ensure positive identification of the client before methadone is administered.
   5. (E) The program shall implement written policies and procedures regarding the recording of client medication intake and a daily methadone inventory.
7. (15) Emergency Medication. The medical director may, based on his/her reasonable judgment, grant emergency take-home doses of methadone based on emergency circumstances related to medical, criminal justice, family or employment. The circumstances and basis for the action must be documented in the client record and should address the concerns outlined in section (13). Take-home doses for in-state emergencies is limited to a maximum of three (3) doses and out-of-state is limited to a maximum of five (5) doses. Additional take-home doses must be authorized through the exception request process.
8. (16) Vacation Medication. The program medical director may, based on his/her reasonable judgment grant vacation take-home doses of methadone for up to two (2) weeks per calendar year. The circumstances and basis for the action must be documented in the client record and should address the concerns outlined in section (13). Additional take-home medication must be authorized through the exception request process.

AUTHORITY: sections 630.655 and 631.102, RSMo 2000.* This rule originally filed as 9 CSR 30-3.610. Original rule filed May 13, 1983, effective Sept. 13, 1983. Rescinded and readopted: Filed May 3, 1994, effective Nov. 30, 1994. Amended: Filed July 29, 1997, effective Jan. 30, 1998. Moved to 9 CSR 30- 3.132 and amended: Filed Feb. 28, 2001, effective Oct. 30, 2001. Amended: Filed Oct. 15, 2001, effective April 30, 2002. Amended: Filed March 8, 2002, effective Sept. 30, 2002. Amended: Filed July 1, 2003, effective Dec. 30, 2003. Emergency amendment filed Nov. 8, 2004, effective Nov. 18, 2004, expired May 16, 2004. Amended: Filed Nov. 8, 2004, effective April 30, 2005. Amended: Filed Feb. 1, 2005, effective July 30, 2005.

*Original authority: 630.655, RSMo 1980 and 631.102, RSMo 1997.