Introduced Version
SENATE BILL No. 157
_____
DIGEST OF INTRODUCED BILL
Citations Affected: IC 12-7-2-135.6; IC 12-23; IC 16-18-2-264.3;
IC 16-25.5.
Synopsis: Opioid treatment programs. Changes the term "methadone
treatment" to "opioid treatment" for purposes of the law concerning
certification of opiate addiction treatment programs. Requires
certification standards and certification and licensure related to opioid
treatment programs. Requires the establishment of certain fees and
amends other fees. 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
January 8, 2008, read first time and referred to Committee on Health and Provider
Services.
Introduced
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)IN0157.1.1. -->
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 C.F.R.
8.
SOURCE: IC 12-23-1-10; (08)IN0157.1.2. -->
SECTION 2. IC 12-23-1-10 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 10. (a) The division is
the state authority primarily responsible for prevention, control,
treatment and rehabilitation, education, research, and planning in the
field of addictions. All other agencies of state and local government
shall cooperate with the division to assist in the performance of the
division's functions.
(b) The division shall cooperate with the state department of
health in the performance of the state department's functions
under IC 16-25.5.
SOURCE: IC 12-23-18-0.5; (08)IN0157.1.3. -->
SECTION 3. 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 certified by the division;
(2) after June 30, 2009, the facility in which the opioid
treatment program is operated is licensed under IC 16-25.5;
and
(3) the opioid treatment program is in compliance with state
and federal law.
(b) Separate certification under this chapter is required for each
location at which an opioid treatment program is operated.
SOURCE: IC 12-23-18-1; (08)IN0157.1.4. -->
SECTION 4. 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)IN0157.1.5. -->
SECTION 5. 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)IN0157.1.6. -->
SECTION 6. 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:
(1) twenty dollars ($20) for each resident; and
(2) three hundred dollars ($300) for each nonresident; patient
of Indiana 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)IN0157.1.7. -->
SECTION 7. 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)IN0157.1.8. -->
SECTION 8. 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.
(2) Fees to be paid by an opioid treatment program for
deposit in the fund for annual certification under 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)IN0157.1.9. -->
SECTION 9. 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)IN0157.1.10. -->
SECTION 10. 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)IN0157.1.11. -->
SECTION 11. 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 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 rehabilitation rate of patients who received opioid
treatment.
(6) The number of patients who became addicted to opioid
treatment medication.
(7) The number of patients who were rehabilitated and are no
longer receiving opioid treatment.
(8) The number of individuals, by geographic area, who are
on a waiting list to receive opioid treatment.
(9) The patient information reported to the central registry
established under section 5.6 of this chapter.
(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 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 16-18-2-264.3; (08)IN0157.1.12. -->
SECTION 12. IC 16-18-2-264.3 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2008]: Sec. 264.3. "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 C.F.R.
8.
SOURCE: IC 16-25.5; (08)IN0157.1.13. -->
SECTION 13. IC 16-25.5 IS ADDED TO THE INDIANA CODE
AS A
NEW ARTICLE TO READ AS FOLLOWS [EFFECTIVE JULY
1, 2008]:
ARTICLE 25.5. OPIOID TREATMENT PROGRAM
FACILITIES
Chapter 1. General Provisions
Sec. 1. This article applies to all facilities in which an opioid
treatment program is operated.
Sec. 2. (a) The state department and the state health
commissioner shall enforce this article.
(b) The state department or the state health commissioner may
bring an action at law or in equity to enforce this article, and the
circuit and superior courts of the state have jurisdiction to compel
or enforce the provisions of this article by prohibitory or
mandatory injunction.
Chapter 2. Licensure and Regulation of Opioid Treatment
Program Facilities
Sec. 1. Not later than July 1, 2009, the state department shall
license and regulate all facilities in which an opioid treatment
program operates in Indiana.
Sec. 2. The state department shall adopt rules under IC 4-22-2
to do the following concerning opioid treatment program facilities:
(1) Establish minimum licensure qualifications, including
requirements for the following:
(A) Sanitation standards.
(B) Emergency equipment and procedures.
(C) Quality assurance standards.
(D) Certification under IC 12-23-18 of the opioid treatment
program operated in the facility.
(2) Prescribe the operating, supervision, and maintenance
policies concerning opioid treatment program patient records.
(3) Establish procedures for the issuance, renewal, denial, and
revocation of licenses under this chapter. The rules adopted
under this subdivision must address the following:
(A) The form and content of the license.
(B) The collection of an annual license fee.
(4) Prescribe the procedures and standards for inspections.
(5) Establish annual licensing fees in an amount sufficient to
pay the cost of implementing this article.
Sec. 3. A:
(1) person; or
(2) state, county, or local governmental unit;
shall obtain a license under this chapter before establishing,
advertising, or operating an opioid treatment program.
Sec. 4. (a) An applicant shall submit to the state department an
application for a license on a form prescribed by the state
department reflecting that the applicant is:
(1) of reputable and responsible character; and
(2) able to comply with the requirements of this chapter and
federal law.
(b) An application must contain the following additional
information:
(1) The name of the applicant.
(2) The location of the opioid treatment program facility.
(3) The name of the person responsible for the opioid
treatment program.
(4) Other information required by the state department.
Sec. 5. An application must be accompanied by a licensing fee at
the rate established by the state department under section 2 of this
chapter.
Sec. 6. The state health commissioner may:
(1) issue a license upon an application without further
evidence; or
(2) request additional information concerning an application
and conduct an investigation to determine whether a license
should be granted.
Sec. 7. A license issued under this chapter:
(1) expires one (1) year after the date of issuance;
(2) is not assignable or transferable;
(3) is issued only for the opioid treatment program facility
premises named in the application;
(4) must be posted in a conspicuous place in the opioid
treatment program facility; and
(5) may be renewed each year upon the payment of a renewal
fee at the rate established by the state department under
section 2 of this chapter.
Sec. 8. (a) The state department shall conduct an annual
licensure inspection of an opioid treatment program facility in
accordance with rules adopted under this chapter. The state
department shall conduct all health and sanitation inspections,
including inspections in response to an alleged breach of this
chapter. The division of fire and building safety shall make all fire
safety inspections.
(b) An employee of the state department who knowingly or
intentionally informs an individual who is involved in the operation
of an opioid treatment program of the exact date of an
unannounced inspection shall be suspended without pay for five (5)
days for a first offense and shall be dismissed for a subsequent
offense.
(c) A report of each inspection conducted under this section
must be in writing and sent to the opioid treatment program.
(d) A report of an inspection conducted under this section, and
records relating to the inspection, may not be released to the public
until the conditions set forth in IC 16-19-3-25 are satisfied.
Chapter 3. Violations
Sec. 1. The state health commissioner may take any of the
following actions based on any ground described in section 2 of this
chapter:
(1) Issue a letter of correction.
(2) Issue a probationary license.
(3) Reinspect the opioid treatment program facility.
(4) Deny renewal of a license.
(5) Revoke a license.
(6) Impose a civil penalty in an amount not to exceed ten
thousand dollars ($10,000).
Sec. 2. The state health commissioner may take action under
section 1 of this chapter based on any of the following grounds:
(1) Violation of this article or rules adopted under this article.
(2) Permitting, aiding, or abetting the commission of any
illegal act in an opioid treatment program facility.
(3) Conduct or practice found by the state health
commissioner to be detrimental to the welfare of an opioid
treatment program patient.
Sec. 3. IC 4-21.5 applies to an action under this chapter.
Chapter 4. Penalties
Sec. 1. The state department shall investigate a report of an
unlicensed opioid treatment program facility and report the
findings to the attorney general. The attorney general may seek
any of the following:
(1) An injunction in a court of jurisdiction in the county in
which the unlicensed opioid treatment program facility is
established, advertised, or operated or in the circuit or
superior court of Marion County.
(2) Relief under IC 4-21.5, including a civil penalty not to
exceed twenty-five thousand dollars ($25,000) for each day of
unlicensed operation.
(3) Criminal penalties.
Sec. 2. A person who:
(1) establishes;
(2) advertises the operation of; or
(3) operates;
an opioid treatment program facility that is not licensed under this
article commits a Class A misdemeanor.
SOURCE: IC 12-23-18-6; (08)IN0157.1.14. -->
SECTION 14. IC 12-23-18-6 IS REPEALED [EFFECTIVE JULY
1, 2008].