Section 440IAC10-4-13. OTP staff positions

   (a) Each OTP shall employ qualified individuals to fill the staff functions in this section.

  (b) An OTP shall have a medical director who shall meet the following requirements:

(1) The medical director shall have the following qualifications:

(A) Be licensed as a physician in Indiana.

(B) Meet at least one (1) of the following requirements:

(i) Have a minimum of one (1) year's experience as a physician in an OTP.

(ii) Be employed as a medical director of an OTP as of the effective date of this article.

(iii) Within one (1) year of the date of hiring, obtain ten (10) hours of training in opioid addiction treatment.

(2) Within thirty (30) days of the date of hiring, the medical director shall have or obtain admitting privileges at one (1) local hospital.

(3) The responsibilities of the medical director include, but are not limited to, the following:

(A) Ensuring that all medical protocols are:

(i) in writing; and

(ii) reviewed and approved by appropriate program officials on an annual basis.

(B) Ensuring that the manner in which medical functions may be delegated to other staff is clearly articulated in the protocols.

(C) Ensuring that individuals seeking admission to the OTP meet the admission criteria in 42 CFR Part 8 and in section 15 of this rule.

(D) Establishing clinical standards for the following:

(i) The induction of treatment medication for a patient upon admission.

(ii) The titration of a patient on treatment medication.

(iii) The tapering of a patient off of a treatment medication.

(E) Ensuring the following:

(i) Patients admitted to the OTP shall have a complete physical examination.

(ii) The results of the physical examination shall be documented in the patient's record.

(iii) Referrals are made for identified services not provided by the OTP.

(F) Ensuring the following:

(i) All patients voluntarily choose maintenance opioid addiction treatment.

(ii) All relevant facts concerning the use of a treatment medication are clearly and adequately explained to the patient.

(iii) Each patient provides written informed consent to treatment.

(G) Ensuring the signing or countersigning and dating of all medical orders as required by federal or state law.

(H) Ensuring that each patient's dose of treatment medication is appropriate for the patient's needs.

(I) Ensuring that appropriate laboratory tests or studies have been performed and reviewed.

(J) Ensuring that a justification is recorded in the patient's record for the following:

(i) Reducing the frequency of visits to the program for observed medication ingestion.

(ii) The prescribing of medication to address other problems.

(iii) Approving a patient's receipt of unsupervised doses of opioid treatment medication.

(iv) Approving exception requests for patients' unsupervised doses of opioid treatment medication.

(K) Ensuring that treatment plans are:

(i) reviewed at least every six (6) months; and

(ii) signed or countersigned and dated when reviewed.

(L) Ensuring that a clinical evaluation of a patient is conducted within ten (10) days of any positive drug screening.

(M) Ensuring that a face-to-face clinical evaluation of the patient's progress in treatment is conducted at least every six (6) months regarding the patient's need for the following:

(i) Continuing maintenance treatment with treatment medication.

(ii) A medication reduction protocol.

(N) Ensuring the administering of all medical services provided by the program, including an annual physical examination, which must include an assessment of risks or benefits of moving to other approved opioid treatment medications.

(O) Ensuring that the program complies with all federal, state, and local statutes, ordinances, and regulations regarding the treatment of opioid addiction.

(P) Ensuring that the core principle of OTP treatment is to work with each patient as follows:

(i) To arrive at the clinically appropriate dose of medication.

(ii) To eliminate the use of treatment medication as clinically appropriate.

(Q) When either the patient or the OTP determines that the reduction and elimination of treatment medication is in the best interest of the patient or the OTP, ensuring supervision as follows:

(i) To alleviate adverse effects incidental to withdrawal from medication.

(ii) To bring the individual to recovery.

  (c) An OTP shall have a program physician, who may also be the medical director. A program physician shall meet the following requirements:

(1) All program physicians shall:

(A) be licensed in the state of Indiana; and

(B) work under the supervision of the medical director.

(2) Program physicians who are not the medical director are responsible for OTP medical services as delegated by the medical director.

(3) Each OTP shall have one (1) program physician physically present in the facility for a minimum of one (1) full-time equivalent of forty (40) hours per week for every one thousand (1,000) enrolled patients; provided, however, that except for services required under this rule to be performed by a physician, fifty percent (50%) of the services of a program physician may be performed by an authorized health care professional.

  (d) An OTP shall have a program director who meets the following requirements:

(1) The program director shall have at least one (1) of the following qualifications:

(A) One (1) year of work experience providing services to individuals with addiction problems.

(B) A minimum of a bachelor's degree.

(C) Three (3) years of work experience in administration or personnel supervision in human services.

(D) A division-approved credential in addiction counseling under 440 IAC 4.4.

(2) The program director is responsible for the following:

(A) The:

(i) day-to-day operations of the OTP; and

(ii) delivery of treatment services.

(B) The supervision of OTP staff.

(C) Managing all other functions delegated by the medical director.

  (e) An OTP shall have nurses that meet the following requirements:

(1) All nurses are required to maintain appropriate licenses to perform delegated and assigned nursing functions.

(2) A nurse qualified by education, training, and experience shall do the following:

(A) Supervise the administering of medication to OTP patients.

(B) Perform other functions delegated by the medical director or a program physician.

(3) A registered nurse or licensed practical nurse may administer opioid treatment medication only under the following circumstances:

(A) When acting as the agent of a practitioner licensed under state law and registered under the appropriate state and federal laws to administer opioid treatment medication.

(B) When supervised by, and under the order of, a practitioner licensed under state law and registered under the appropriate state and federal laws to administer opioid treatment medication.

(4) An OTP shall employ one (1) nurse for a minimum of one (1) full-time equivalent of forty (40) hours per week for every two hundred (200) enrolled patients.

  (f) An OTP shall have counselors that meet the following requirements:

(1) An OTP counselor shall be qualified by education, training, or experience to do the following:

(A) Assess the psychological and sociological background of patients.

(B) Contribute to the appropriate treatment plan for the patient.

(C) Monitor patient progress toward identified treatment goals.

(2) OTP counselors shall be provided an orientation to opioid addiction treatment, including the diversion control plan. The orientation shall be documented in the counselor's personnel record and shall meet the following requirements:

(A) Be for not less than four (4) hours prior to assuming counseling duties for counseling staff lacking experience in opioid addiction treatment.

(B) Be for a minimum of one (1) hour prior to assuming counseling duties for counseling staff experienced in opioid addiction treatment.

(3) Counselors shall be credentialed as any of the following:

(A) A licensed clinical social worker (IC 25-23.6-5).

(B) A licensed mental health counselor (IC 25-23.6-8.5).

(C) A licensed marriage and family therapist (IC 25-23.6-8).

(D) A licensed clinical addiction counselor (IC 25-23.6-10.5).

(E) A psychologist (IC 25-33).

(F) A physician (IC 25-22.5-2).

(G) A physician assistant (IC 25-27.5), a nurse practitioner (IC 25-23-1), or a clinical nurse specialist (IC 25-23-1).

(H) An individual credentialed in addictions counseling by a nationally recognized credentialing body approved by the division.

(4) A counselor who lacks a credential shall obtain a credential listed in subdivision (3) within three (3) years of the effective date of this article.

(5) Counselors are responsible for providing counseling, educational, and referral services to enrolled patients and their families as defined by OTP protocols. Counseling services shall include individual, group, and family counseling.

(6) An OTP shall employ one (1) full-time counselor for a minimum of forty (40) hours per week for every fifty-five (55) enrolled patients.

  (g) An OTP shall have a clinical supervisor that meets the following requirements:

(1) A clinical supervisor shall have either of the following qualifications:

(A) Have a division-approved credential under subsection (f)(3).

(B) Be licensed by the state in any of the following:

(i) Social work (IC 25-23.6-5).

(ii) Marriage and family therapy (IC 25-23.6-8).

(iii) Mental health counseling (IC 25-23.6-8.5).

(2) A clinical supervisor shall have a minimum of three (3) years of experience in providing addiction treatment services.

(3) A clinical supervisor is responsible for supervising the work of the counselors.

(4) For every ten (10) counselors or portion thereof, an OTP shall employ the proportionate equivalent of one (1) full-time clinical supervisor for a minimum of forty (40) hours per week.

(5) A clinical supervisor may carry a patient caseload proportionate to the number of counselors supervised.

(Division of Mental Health and Addiction; 440 IAC 10-4-13; filed Dec 30, 2009, 2:00 p.m.: 20100127-IR-440080412FRA; filed Feb 16, 2015, 1:02 p.m.: 20150318-IR-440140343FRA; readopted filed May 10, 2016, 11:24 a.m.: 20160608-IR-440160134RFA)