January 25, 2008
SENATE BILL No. 157
_____
DIGEST OF SB 157
(Updated January 23, 2008 2:38 pm - DI 104)
Citations Affected: IC 12-7; IC 12-23.
Synopsis: Opioid treatment programs. Changes the term "methadone
treatment" to "opioid treatment" for purposes of the law concerning
certification of opiate addiction treatment facilities. Requires the
division of mental health and addiction to adopt rules on: (1) standards
for operation of an opioid treatment program; (2) a requirement that the
opioid treatment facilities submit a current diversion control plan; and
(3) fees to be paid by an opioid treatment facility. Specifies violations
and penalties. Repeals the expiration of current law requiring a
methadone diversion control and oversight program. (The introduced
version of this bill was prepared by the health finance commission.)
Effective: July 1, 2008.
Miller
, Sipes
January 8, 2008, read first time and referred to Committee on Health and Provider
Services.
January 24, 2008, amended, reported favorably _ Do Pass.
January 25, 2008
Second Regular Session 115th General Assembly (2008)
PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
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SENATE BILL No. 157
A BILL FOR AN ACT to amend the Indiana Code concerning
health.
Be it enacted by the General Assembly of the State of Indiana:
SOURCE: IC 12-7-2-135.6; (08)SB0157.1.1. -->
SECTION 1. IC 12-7-2-135.6 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2008]: Sec. 135.6. "Opioid treatment
program" means a program through which opioid agonist
medication is dispensed to an individual in the treatment of opiate
addiction and for which certification is required under 42 CFR
Part 8.
SOURCE: IC 12-23-18-0.5; (08)SB0157.1.2. -->
SOURCE: IC 12-23-18-0.5. -->
SECTION 2. IC 12-23-18-0.5 IS ADDED TO THE INDIANA
CODE AS A
NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2008]:
Sec. 0.5. (a) An opioid treatment
program shall not operate in Indiana unless:
(1) the opioid treatment program is specifically approved and
the opiate 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.
SOURCE: IC 12-23-18-1; (08)SB0157.1.3. -->
SECTION 3. IC 12-23-18-1 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 1. (a) Subject to federal
law and consistent with standard medical practice in methadone opioid
treatment of drug abuse, the division shall adopt rules under IC 4-22-2
to establish and administer a methadone an opioid treatment diversion
control and oversight program to identify individuals who divert
controlled substances opioid treatment medications from legitimate
treatment use and to terminate the methadone opioid treatment of those
individuals.
(b) Rules adopted under subsection (a) must include provisions
relating to the following matters concerning methadone providers
opioid treatment programs and individuals patients who receive
opioid treatment:
(1) Regular clinic attendance by the patient.
(2) Specific counseling requirements for the methadone provider
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 methadone provider's opioid treatment program's
medical director and administrative staff responsibilities for
preparing and implementing a diversion control plan.
SOURCE: IC 12-23-18-2; (08)SB0157.1.4. -->
SECTION 4. IC 12-23-18-2 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 2. (a) Not later than
February 28 of each year, each methadone provider opioid treatment
program must submit to the division a diversion control plan required
under that meets the requirements of section 1(b)(7) 1 of this
chapter.
(b) Not later than May 1 of each year, the division shall review and
approve plans a plan submitted under subsection (a).
(c) If the division denies a plan submitted under subsection (a), the
methadone provider opioid treatment program must submit another
plan not later than sixty (60) days after the denial of the plan.
SOURCE: IC 12-23-18-3; (08)SB0157.1.5. -->
SECTION 5. IC 12-23-18-3 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 3. (a) By May 15 of
each year, each
methadone provider opioid treatment program shall
submit to the division a fee
of: that is:
(1) twenty dollars ($20) for each nonresident; patient
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 methadone
provider opioid treatment program during the preceding
calender calendar year.
(b) The fee collected under subsection (a) shall be deposited in the
methadone diversion control and oversight program fund. established
under section 4 of this chapter.
SOURCE: IC 12-23-18-4; (08)SB0157.1.6. -->
SECTION 6. IC 12-23-18-4 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 4. (a) As used in this
section, "fund" means the methadone opioid treatment diversion
control and oversight program fund established under subsection (b).
(b) The methadone opioid treatment diversion control and
oversight program fund is established to administer and carry out the
purposes of 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.
SOURCE: IC 12-23-18-5; (08)SB0157.1.7. -->
SECTION 7. IC 12-23-18-5 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2008]: 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 fourteen (14) days of opioid treatment
medications at one (1) time.
(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
methadone provider opioid treatment program facility to assess
compliance with the plan approved under this chapter.
SOURCE: IC 12-23-18-5.5; (08)SB0157.1.8. -->
SECTION 8. IC 12-23-18-5.5, AS ADDED BY P.L.210-2007,
SECTION 1, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2008]: Sec. 5.5. (a) 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.
(b) This section expires December 31, 2008.
SOURCE: IC 12-23-18-5.6; (08)SB0157.1.9. -->
SECTION 9. IC 12-23-18-5.6 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2008]: 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.
SOURCE: IC 12-23-18-5.7; (08)SB0157.1.10. -->
SECTION 10. IC 12-23-18-5.7 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2008]: 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 the legislative council in an electronic format under
IC 5-14-6, the state department of health, and to the governor a
report concerning treatment offered by opioid treatment
programs. The report must contain the following information for
each of the two (2) previous calendar years:
(1) The number of opioid treatment programs in Indiana.
(2) The number of patients receiving opioid treatment in
Indiana.
(3) The length of time each patient received opioid treatment
and the average length of time all patients received opioid
treatment.
(4) The cost of each patient's opioid treatment and the
average cost of opioid treatment.
(5) The number of patients who were determined to be no
longer in need of services and are no longer receiving opioid
treatment.
(6) The number of individuals, by geographic area, who are
on a waiting list to receive opioid treatment.
(7) The patient information reported to the central registry
established under section 5.6 of this chapter.
(8) Any other information that the division determines to be
relevant to the success of a quality opioid treatment program.
(b) Each opioid treatment program in Indiana shall provide
information requested by the division for the report required by
this section.
(c) Failure of an opioid treatment program to submit the
information required under subsection (a) may result in suspension
or termination of the opioid treatment program's specific approval
to operate as an opioid treatment program or the opioid treatment
facility's certification.
(d) Information that could be used to identify an opioid
treatment program patient and that is:
(1) contained in; or
(2) provided to the division related to;
the report required by this section is confidential.
SOURCE: IC 12-23-18-5.8; (08)SB0157.1.11. -->
SECTION 11. IC 12-23-18-5.8 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2008]: 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 the 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 the 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.
SOURCE: IC 12-23-18-6; (08)SB0157.1.12. -->
SECTION 12. IC 12-23-18-6 IS REPEALED [EFFECTIVE JULY
1, 2008].