2014 Indiana Code TITLE 12. HUMAN SERVICES ARTICLE 23. ADDICTION SERVICES CHAPTER 18. METHADONE DIVERSION CONTROL AND OVERSIGHT PROGRAM
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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 in
Indiana unless:
(1) the opioid treatment program is specifically approved and
the opioid treatment facility is certified by the division; and
(2) the opioid treatment program is in compliance with state and
federal law.
(b) Separate specific approval and certification under this chapter
is required for each location at which an opioid treatment program is
operated.
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 standard
medical practice in opioid treatment of drug abuse, the division shall
adopt rules under IC 4-22-2 to establish and administer an opioid
treatment diversion control and oversight program to identify
individuals who divert opioid treatment medications from legitimate
treatment use and to terminate the opioid treatment of those
individuals.
(b) Rules adopted under subsection (a) must include provisions
relating to the following matters concerning opioid treatment
programs and patients who receive opioid treatment:
(1) Regular clinic attendance by the patient.
(2) Specific counseling requirements for the opioid treatment
program.
(3) Serious behavior problems of the patient.
(4) Stable home environment of the patient.
(5) Safe storage capacity of opioid treatment medications within
the patient's home.
(6) Medically recognized testing protocols to determine
legitimate opioid treatment medication use.
(7) The opioid treatment program's medical director and
administrative staff responsibilities for preparing and
implementing 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 opioid
treatment program must submit to the division a diversion control
plan 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 patient
during the patient's treatment by the program as required by
section 2.5 of this chapter.
(b) Not later than May 1 of each year, the division shall review
and 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 than
sixty (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 and
randomly test, including before receiving treatment, a patient for the
following 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 been
abused 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 the
patient has a prescription or that is part of the patient's treatment
plan at the opioid treatment program; or
(2) an illegal drug other than the drug that is part of the patient's
treatment plan at the opioid treatment program;
the opioid treatment program and the patient must comply with the
requirements under subsection (c).
(c) If a patient tests positive under a test for a controlled substance
or illegal drug that is not allowed under subsection (a), the following
conditions must be met:
(1) The opioid treatment program must refer the patient to the
onsite physician for a clinical evaluation that must be conducted
not more than ten (10) days after the date of the patient's
positive test. The physician shall consult with medical and
behavioral staff to conduct the evaluation. The clinical
evaluation must recommend a remedial action for the patient
that may include discharge from the opioid treatment program
or amending the treatment plan to require a higher level of
supervision.
(2) The opioid treatment program may not allow the patient to
take any opioid treatment medications from the treatment
facility until the patient has completed a clinical assessment
under subdivision (1) and has passed a random test. The patient
must report to the treatment facility daily, except when the
facility is closed, until the onsite physician, after consultation
with the medical and behavioral staff, determines that daily
treatment is no longer necessary.
(3) The patient must take a weekly random test until the patient
passes a test under subsection (a).
(d) An opioid treatment program must conduct all tests required
under this section in an observed manner to assure that a false sample
is not provided by the patient.
As added by P.L.116-2008, SEC.5. Amended by P.L.131-2014,
SEC.2.
IC 12-23-18-3
Opioid treatment program fees
Sec. 3. (a) By May 15 of each year, each opioid treatment program
shall submit to the division a fee that is:
(1) an amount established by the division by rule under
IC 4-22-2;
(2) not more than necessary to recover the costs of
administering this chapter; and
(3) not more than seventy-five dollars ($75) for each opioid
treatment program patient who was treated by the opioid
treatment program during the preceding calendar year.
(b) The fee collected under subsection (a) shall be deposited in the
fund.
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 opioid
treatment program fund established under subsection (b).
(b) The opioid treatment program fund is established to implement
this chapter. The fund shall be administered by the division.
(c) The expenses of administering the fund shall be paid from
money in the fund.
(d) The treasurer of state shall invest money in the fund in the
same manner as other public money may be invested.
(e) Money in the fund at the end of the state fiscal year does not
revert 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; annual
compliance assessment; report
Sec. 5. (a) The division shall adopt rules under IC 4-22-2 to
establish the following:
(1) Standards for operation of an opioid treatment program in
Indiana, including the following requirements:
(A) An opioid treatment program shall obtain prior
authorization from the division for any patient receiving
more than seven (7) days of opioid treatment medications at
one (1) time and the division may approve the authorization
only under the following circumstances:
(i) A physician licensed under IC 25-22.5 has issued an
order for the opioid treatment medication.
(ii) The patient has not tested positive under a drug test for
a drug for which the patient does not have a prescription
for a period of time set forth by the division.
(iii) The opioid treatment program has determined that the
benefit to the patient in receiving the take home opioid
treatment medication outweighs the potential risk of
diversion of the take home opioid treatment medication.
(B) Minimum requirements for a licensed physician's
regular:
(i) physical presence in the opioid treatment facility; and
(ii) physical evaluation and progress evaluation of each
opioid treatment program patient.
(C) Minimum staffing requirements by licensed and
unlicensed personnel.
(D) Clinical standards for the appropriate tapering of a
patient 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 of
21 CFR Part 291 and 42 CFR Part 8 be submitted for each
opioid treatment facility.
(3) Fees to be paid by an opioid treatment program for deposit
in the fund for annual certification under this chapter as
described in section 3 of this chapter.
The fees established under this subsection must be sufficient to pay
the cost of implementing this chapter.
(b) The division shall conduct an annual onsite visit of each opioid
treatment program facility to assess compliance with this chapter.
(c) Not later than April 1 of each year, the division shall report to
the general assembly in electronic format under IC 5-14-3 the number
of prior authorizations that were approved under subsection (a)(1)(A)
in the previous year and the time frame for each approval.
As added by P.L.11-2003, SEC.2. Amended by P.L.116-2008, SEC.8;
P.L.131-2014, SEC.3.
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 new
opioid treatment program. This section does not apply to applications
for 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 to
maintain information concerning each patient served by an opioid
treatment program.
(b) An opioid treatment program shall, at least monthly, provide
to the division information required by the division concerning
patients currently served by the opioid treatment program.
(c) Information that could be used to identify an opioid treatment
program 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
Repealed
(Repealed by P.L.28-2012, SEC.17.)
IC 12-23-18-5.8
Violations; penalties
Sec. 5.8. (a) The director of the division may take any of the
following 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 treatment
program.
(B) Certification of an opioid treatment facility.
(4) Impose a civil penalty in an amount not to exceed ten
thousand 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 illegal
act in an opioid treatment program facility.
(3) Conduct or practice found by the director to be detrimental
to 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.)
IC 12-23-18-7
Adoption of rules establishing standards and protocols; use of
alternative medication for treatment; explanation of side effects
Sec. 7. (a) The division shall adopt rules under IC 4-22-2 to
establish standards and protocols for opioid treatment programs to do
the following:
(1) Assess new opioid treatment program patients to determine
the most effective opioid treatment medications to start the
patient's opioid treatment.
(2) Ensure that each patient voluntarily chooses maintenance
treatment and that relevant facts concerning the use of opioid
treatment medications are clearly and adequately explained to
the patient.
(3) Have appropriate opioid treatment program patients who are
receiving methadone for opioid treatment move to receiving
other approved opioid treatment medications.
(b) An opioid treatment program shall follow the standards and
protocols adopted under subsection (a) for each opioid treatment
program patient.
(c) Subject to subsection (a), an opioid treatment program may use
any of the following medications as an alternative for methadone for
opioid treatment:
(1) Buprenorphine.
(2) Buprenorphine combination products containing naloxone.
(3) Any other medication that has been approved by:
(A) the federal Food and Drug Administration for use in the
treatment of opioid addiction; and
(B) the division under subsection (e).
(d) Before starting a patient on a new opioid treatment medication,
the opioid treatment program shall explain to the patient the potential
side effects of the new medication.
(e) The division may adopt rules under IC 4-22-2 to provide for
other medications as alternatives to methadone that may be used
under subsection (a).
As added by P.L.131-2014, SEC.4.
IC 12-23-18-8
"Dispense"; provision of information to division; annual report
Sec. 8. (a) As used in this section, "dispense" means to deliver a
controlled substance to an ultimate user.
(b) Subject to the federal patient confidentiality requirements
under 42 CFR Part 2, when an opioid treatment program dispenses a
controlled substance designated by the Indiana board of pharmacy
under IC 35-48-2-5 through 35-48-2-10, the opioid treatment
program shall provide the following information upon request from
the division:
(1) The medications dispensed by the program.
(2) The medication delivery process, which includes whether the
medication was in liquid, film, or another form.
(3) The number of doses dispensed of each medication.
(4) The dosage quantities for each medication.
(5) The number of patients receiving take home medications.
(6) The number of days of supply dispensed.
(7) Patient demographic information for each medication,
including gender, age, and time in treatment.
(8) The dispenser's United States Drug Enforcement Agency
registration number.
(c) An opioid treatment program shall provide the information
required under this section to the division in a manner prescribed by
the division.
(d) The division shall annually report the information collected
under this section to the legislative council in an electronic format
under IC 5-14-6 not later than October 1.
As added by P.L.131-2014, SEC.5.
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