CHAPTER 18. METHADONE DIVERSION CONTROL AND OVERSIGHT PROGRAM
IC 12-23-18
Chapter 18. Methadone Diversion Control and Oversight Program
IC 12-23-18-0.5
Opioid treatment program; requirements for operation
Sec. 0.5. (a) An opioid treatment program shall not operate inIndiana unless:
(1) the opioid treatment program is specifically approved andthe opioid treatment facility is certified by the division; and
(2) the opioid treatment program is in compliance with state andfederal law.
(b) Separate specific approval and certification under this chapteris required for each location at which an opioid treatment program isoperated.
As added by P.L.116-2008, SEC.2. Amended by P.L.1-2009,SEC.108.
IC 12-23-18-1
Rules
Sec. 1. (a) Subject to federal law and consistent with standardmedical practice in opioid treatment of drug abuse, the division shalladopt rules under IC 4-22-2 to establish and administer an opioidtreatment diversion control and oversight program to identifyindividuals who divert opioid treatment medications from legitimatetreatment use and to terminate the opioid treatment of thoseindividuals.
(b) Rules adopted under subsection (a) must include provisionsrelating to the following matters concerning opioid treatmentprograms and patients who receive opioid treatment:
(1) Regular clinic attendance by the patient.
(2) Specific counseling requirements for the opioid treatmentprogram.
(3) Serious behavior problems of the patient.
(4) Stable home environment of the patient.
(5) Safe storage capacity of opioid treatment medications withinthe patient's home.
(6) Medically recognized testing protocols to determinelegitimate opioid treatment medication use.
(7) The opioid treatment program's medical director andadministrative staff responsibilities for preparing andimplementing a diversion control plan.
As added by P.L.11-2003, SEC.2. Amended by P.L.116-2008, SEC.3.
IC 12-23-18-2
Diversion control
Sec. 2. (a) Not later than February 28 of each year, each opioidtreatment program must submit to the division a diversion controlplan that:
(1) meets the requirements of section 1 of this chapter; and
(2) includes in the opioid treatment program's diversion control
plan the program's drug testing procedure for testing a patientduring the patient's treatment by the program as required bysection 2.5 of this chapter.
(b) Not later than May 1 of each year, the division shall reviewand approve a plan submitted under subsection (a).
(c) If the division denies a plan submitted under subsection (a),the opioid treatment program must submit another plan not later thansixty (60) days after the denial of the plan.
As added by P.L.11-2003, SEC.2. Amended by P.L.116-2008, SEC.4.
IC 12-23-18-2.5
Drug testing
Sec. 2.5. (a) An opioid treatment program must periodically andrandomly test, including before receiving treatment, a patient for thefollowing during the patient's treatment by the program:
(1) Methadone.
(2) Cocaine.
(3) Opiates.
(4) Amphetamines.
(5) Barbiturates.
(6) Tetrahydrocannabinol.
(7) Benzodiazepines.
(8) Any other suspected or known drug that may have beenabused by the patient.
(b) If a patient tests positive under a test described in subsection(a) for:
(1) a controlled substance other than a drug for which thepatient has a prescription or that is part of the patient's treatmentplan at the opioid treatment program; or
(2) an illegal drug other than the drug that is part of the patient'streatment plan at the opioid treatment program;
the opioid treatment program and the patient must comply with therequirements under subsection (c).
(c) If a patient tests positive under a test for a controlled substanceor illegal drug that is not allowed under subsection (b), the followingconditions must be met:
(1) The opioid treatment program must refer the patient to theonsite physician for a clinical evaluation that must be conductednot more than ten (10) days after the date of the patient'spositive test. The physician shall consult with medical andbehavioral staff to conduct the evaluation. The clinicalevaluation must recommend a remedial action for the patientthat may include discharge from the opioid treatment programor amending the treatment plan to require a higher level ofsupervision.
(2) The opioid treatment program may not allow the patient totake any opioid treatment medications from the treatmentfacility until the patient has completed a clinical assessmentunder subdivision (1) and has passed a random test. The patientmust report to the treatment facility daily, except when the
facility is closed, until the onsite physician, after consultationwith the medical and behavioral staff, determines that dailytreatment is no longer necessary.
(3) The patient must take a weekly random test until the patientpasses a test under subsection (b).
(d) An opioid treatment program must conduct all tests requiredunder this section in an observed manner to assure that a false sampleis not provided by the patient.
As added by P.L.116-2008, SEC.5.
IC 12-23-18-3
Opioid treatment program fees
Sec. 3. (a) By May 15 of each year, each opioid treatmentprogram shall submit to the division a fee that is:
(1) an amount established by the division by rule underIC 4-22-2;
(2) not more than necessary to recover the costs ofadministering this chapter; and
(3) not more than seventy-five dollars ($75) for each opioidtreatment program patient who was treated by the opioidtreatment program during the preceding calendar year.
(b) The fee collected under subsection (a) shall be deposited in thefund.
As added by P.L.11-2003, SEC.2. Amended by P.L.116-2008, SEC.6.
IC 12-23-18-4
Opioid treatment program fund
Sec. 4. (a) As used in this section, "fund" means the opioidtreatment program fund established under subsection (b).
(b) The opioid treatment program fund is established toimplement this chapter. The fund shall be administered by thedivision.
(c) The expenses of administering the fund shall be paid frommoney in the fund.
(d) The treasurer of state shall invest money in the fund in thesame manner as other public money may be invested.
(e) Money in the fund at the end of the state fiscal year does notrevert to the state general fund.
As added by P.L.11-2003, SEC.2. Amended by P.L.116-2008, SEC.7.
IC 12-23-18-5
Standards for operation; diversion control plans; annualcompliance assessment
Sec. 5. (a) The division shall adopt rules under IC 4-22-2 toestablish the following:
(1) Standards for operation of an opioid treatment program inIndiana, including the following requirements:
(A) An opioid treatment program shall obtain priorauthorization from the division for any patient receivingmore than fourteen (14) days of opioid treatment
medications at one (1) time.
(B) Minimum requirements for a licensed physician'sregular:
(i) physical presence in the opioid treatment facility; and
(ii) physical evaluation and progress evaluation of eachopioid treatment program patient.
(C) Minimum staffing requirements by licensed andunlicensed personnel.
(D) Clinical standards for the appropriate tapering of apatient on and off of an opioid treatment medication.
(2) A requirement that, not later than February 28 of each year,a current diversion control plan that meets the requirements of21 CFR Part 291 and 42 CFR Part 8 be submitted for eachopioid treatment facility.
(3) Fees to be paid by an opioid treatment program for depositin the fund for annual certification under this chapter asdescribed in section 3 of this chapter.
The fees established under this subsection must be sufficient to paythe cost of implementing this chapter.
(b) The division shall conduct an annual onsite visit of eachopioid treatment program facility to assess compliance with thischapter.
As added by P.L.11-2003, SEC.2. Amended by P.L.116-2008, SEC.8.
IC 12-23-18-5.5
Prohibition of new opioid treatment program approval
Sec. 5.5. The division may not grant specific approval to be a newopioid treatment program. This section does not apply to applicationsfor new opioid treatment programs pending prior to March 1, 2007.
As added by P.L.210-2007, SEC.1. Amended by P.L.116-2008,SEC.9.
IC 12-23-18-5.6
Central registry
Sec. 5.6. (a) The division shall establish a central registry tomaintain information concerning each patient served by an opioidtreatment program.
(b) An opioid treatment program shall, at least monthly, provideto the division information required by the division concerningpatients currently served by the opioid treatment program.
(c) Information that could be used to identify an opioid treatmentprogram patient and that is:
(1) contained in; or
(2) provided to the division and related to;
the central registry is confidential.
As added by P.L.116-2008, SEC.10.
IC 12-23-18-5.7
Biennial reporting
Sec. 5.7. (a) The division shall, as part of the biennial report
required under IC 12-21-5-1.5(8), prepare and submit to thelegislative council in an electronic format under IC 5-14-6, the statedepartment of health, and the governor a report concerning treatmentoffered by opioid treatment programs. The report must contain thefollowing information for each of the two (2) previous calendaryears:
(1) The number of opioid treatment programs in Indiana.
(2) The number of patients receiving opioid treatment inIndiana.
(3) The length of time each patient received opioid treatmentand the average length of time all patients received opioidtreatment.
(4) The cost of each patient's opioid treatment and the averagecost of opioid treatment.
(5) The number of patients who were determined to be nolonger in need of services and are no longer receiving opioidtreatment.
(6) The number of individuals, by geographic area, who are ona waiting list to receive opioid treatment.
(7) The patient information reported to the central registryestablished under section 5.6 of this chapter.
(8) Any other information that the division determines to berelevant to the success of a quality opioid treatment program.
(9) The number of patients who tested positive under a test fora controlled substance or illegal drug not allowed under section2.5(b) of this chapter.
(b) Each opioid treatment program in Indiana shall provideinformation requested by the division for the report required by thissection.
(c) Failure of an opioid treatment program to submit theinformation required under subsection (a) may result in suspensionor termination of the opioid treatment program's specific approval tooperate as an opioid treatment program or the opioid treatmentfacility's certification.
(d) Information that could be used to identify an opioid treatmentprogram patient and that is:
(1) contained in; or
(2) provided to the division related to;
the report required by this section is confidential.
As added by P.L.116-2008, SEC.11.
IC 12-23-18-5.8
Violations; penalties
Sec. 5.8. (a) The director of the division may take any of thefollowing actions based on any grounds described in subsection (b):
(1) Issue a letter of correction.
(2) Reinspect an opioid treatment program facility.
(3) Deny renewal of, or revoke, any of the following:
(A) Specific approval to operate as an opioid treatmentprogram. (B) Certification of an opioid treatment facility.
(4) Impose a civil penalty in an amount not to exceed tenthousand dollars ($10,000).
(b) The director of the division may take action under subsection(a) based on any of the following grounds:
(1) Violation of this chapter or rules adopted under this chapter.
(2) Permitting, aiding, or abetting the commission of any illegalact in an opioid treatment program facility.
(3) Conduct or practice found by the director to be detrimentalto the welfare of an opioid treatment program patient.
(c) IC 4-21.5 applies to an action under this section.
As added by P.L.116-2008, SEC.12.
IC 12-23-18-6
Repealed
(Repealed by P.L.116-2008, SEC.13.)