SB 246-1_ Filed 04/22/2013, 16:01
Adopted 4/23/2013
CONFERENCE COMMITTEE REPORT
DIGEST FOR ESB 246
Citations Affected: IC 12-15-35-51; IC 25-22.5; IC 35-31.5-2-224; IC 35-48.
Synopsis: Controlled substances Conference committee report for Engrossed Senate Bill 246.
Defines "owner" for purposes of requiring an owner that employs or contracts with individuals
to dispense controlled substances to, beginning January 1, 2014, maintain a controlled substance
registration. Beginning January 1, 2014, allows the attorney general to petition the court to obtain
an injunction against an owner that violates the controlled substance registration and control
laws. Requires the medical licensing board to adopt emergency rules and permanent rules within
a specified period concerning: (1) standards and procedures for the attorney general to follow in
accessing physicians' records and inventory; and (2) standards and protocol for the prescribing
of controlled substances. During the 2013 legislative interim, requires the health finance
commission to study: (1) issues concerning pharmacy programs designed to take back and
dispose of old and expired prescription drugs; and (2) the use of methadone and opioids in
treatment programs and clinic settings. Requires the division on mental health and addiction to
provide the health finance commission specified information concerning opioid treatment in
Indiana. During the 2013 legislative interim, requires the commission on mental health and
addiction to study issues concerning treatment and recovery from prescription drug use
addiction. Resolves a conflict and corrects a cross reference. (This conference committee
report: Fixes a conflict between this bill and Senate Bill 414, and corrects a cross reference
in Senate Enrolled Act 536.)
Effective: Upon passage; July 1, 2013.
Text Box
Adopted Rejected
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CONFERENCE COMMITTEE REPORT
MR. SPEAKER:
Your Conference Committee appointed to confer with a like committee from the Senate
upon Engrossed House Amendments to Engrossed Senate Bill No. 246 respectfully reports
that said two committees have conferred and agreed as follows to wit:
that the Senate recede from its dissent from all House amendments and that
the Senate now concur in all House amendments to the bill and that the bill
be further amended as follows:
Delete everything after the enacting clause and insert the following:
SOURCE: IC 12-15-35-51; (13)CC024601.1. -->
SECTION 1. IC 12-15-35-51, AS ADDED BY P.L.36-2009,
SECTION 2, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
UPON PASSAGE]: Sec. 51. (a) As used in this section, "advisory
committee" refers to the mental health Medicaid quality advisory
committee established by subsection (b).
(b) The mental health Medicaid quality advisory committee is
established. The advisory committee consists of the following
members:
(1) The director of the office or the director's designee, who shall
serve as chairperson of the advisory committee.
(2) The director of the division of mental health and addiction or
the director's designee.
(3) A representative of a statewide mental health advocacy
organization.
(4) A representative of a statewide mental health provider
organization.
(5) A representative from a managed care organization that
participates in the state's Medicaid program.
(6) A member with expertise in psychiatric research representing
an academic institution.
(7) A pharmacist licensed under IC 25-26.
(8) The commissioner of the department of correction or the
commissioner's designee.
The governor shall make the appointments for a term of four (4) years
under subdivisions (3) through (7) and fill any vacancy on the advisory
committee.
(c) The office shall staff the advisory committee. The expenses of
the advisory committee shall be paid by the office.
(d) Each member of the advisory committee who is not a state
employee is entitled to the minimum salary per diem provided by
IC 4-10-11-2.1(b). The member is also entitled to reimbursement for
traveling expenses as provided under IC 4-13-1-4 and other expenses
actually incurred in connection with the member's duties as provided
in the state policies and procedures established by the Indiana
department of administration and approved by the budget agency.
(e) Each member of the advisory committee who is a state employee
is entitled to reimbursement for traveling expenses as provided under
IC 4-13-1-4 and other expenses actually incurred in connection with
the member's duties as provided in the state policies and procedures
established by the Indiana department of administration and approved
by the budget agency.
(f) The affirmative votes of a majority of the voting members
appointed to the advisory committee are required by the advisory
committee to take action on any measure.
(g) The advisory committee shall advise the office and make
recommendations concerning the
clinical use of mental health and
addiction medications, including the implementation of
IC 12-15-35.5-7(c), and consider the following:
(1) Peer reviewed medical literature.
(2) Observational studies.
(3) Health economic studies.
(4) Input from physicians and patients.
(5) Any other information determined by the advisory committee
to be appropriate.
(h) The office shall report recommendations made by the advisory
committee to the drug utilization review board established by section
19 of this chapter.
(i) The office shall report the following information to the select
joint commission on Medicaid oversight established by IC 2-5-26-3:
(1) The advisory committee's advice and recommendations made
under this section.
(2) The number of restrictions implemented under
IC 12-15-35.5-7(c) and the outcome of each restriction.
(3) The transition of individuals who are aged, blind, or disabled
to the risk based managed care program. This information shall
also be reported to the health finance commission established by
IC 2-5-23-3.
(4) Any decision by the office to change the health care delivery
system in which Medicaid is provided to recipients.
(j) Notwithstanding subsection (b), the initial members appointed
to the advisory committee under this section are appointed for the
following terms:
(1) Individuals appointed under subsection (b)(3) and (b)(4) are
appointed for a term of four (4) years.
(2) An individual appointed under subsection (b)(5) is appointed
for a term of three (3) years.
(3) An individual appointed under subsection (b)(6) is appointed
for a term of two (2) years.
(4) An individual appointed under subsection (b)(7) is appointed
for a term of one (1) year.
This subsection expires December 31, 2013.
SOURCE: IC 25-22.5-2-7; (13)CC024601.2. -->
SECTION 2. IC 25-22.5-2-7, AS AMENDED BY SEA 414,
SECTION 2, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2013]: Sec. 7. (a) The board shall do the following:
(1) Adopt rules and forms necessary to implement this article that
concern, but are not limited to, the following areas:
(A) Qualification by education, residence, citizenship,
training, and character for admission to an examination for
licensure or by endorsement for licensure.
(B) The examination for licensure.
(C) The license or permit.
(D) Fees for examination, permit, licensure, and registration.
(E) Reinstatement of licenses and permits.
(F) Payment of costs in disciplinary proceedings conducted by
the board.
(2) Administer oaths in matters relating to the discharge of its the
board's official duties.
(3) Enforce this article and assign to the personnel of the agency
duties as may be necessary in the discharge of the board's duty.
(4) Maintain, through the agency, full and complete records of all
applicants for licensure or permit and of all licenses and permits
issued.
(5) Make available, upon request, the complete schedule of
minimum requirements for licensure or permit.
(6) Issue, at the board's discretion, a temporary permit to an
applicant for the interim from the date of application until the
next regular meeting of the board.
(7) Issue an unlimited license, a limited license, or a temporary
medical permit, depending upon the qualifications of the
applicant, to any applicant who successfully fulfills all of the
requirements of this article.
(8) Adopt rules establishing standards for the competent practice
of medicine, osteopathic medicine, or any other form of practice
regulated by a limited license or permit issued under this article.
(9) Adopt rules regarding the appropriate prescribing of Schedule
III or Schedule IV controlled substances for the purpose of weight
reduction or to control obesity.
(10) Adopt rules establishing standards for office based
procedures that require moderate sedation, deep sedation, or
general anesthesia.
(11) Adopt rules or protocol establishing the following:
(A) An education program to be used to educate women with
high breast density.
(B) Standards for providing an annual screening or diagnostic
test for a woman who is at least forty (40) years of age and
who has been determined to have high breast density.
As used in this subdivision, "high breast density" means a
condition in which there is a greater amount of breast and
connective tissue in comparison to fat in the breast.
(12) Adopt rules establishing standards and protocols for the
prescribing of controlled substances.
(b) The board may adopt rules that establish:
(1) certification requirements for child death pathologists;
(2) an annual training program for child death pathologists under
IC 16-35-7-3(b)(2); and
(3) a process to certify a qualified child death pathologist.
SOURCE: IC 25-22.5-13; (13)CC024601.3. -->
SECTION 3. IC 25-22.5-13 IS ADDED TO THE INDIANA CODE
AS A
NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE
UPON PASSAGE]:
Chapter 13. Controlled Substance Rules
Sec. 1. (a) Before November 1, 2013, the board shall adopt
emergency rules in the manner provided under IC 4-22-2-37.1 to
establish standards and procedures to do the following:
(1) Receive and review petitions from the attorney general
seeking board authorization to examine a physician's records
and controlled substances inventory and materials to
investigate the physician's controlled substances prescribing
practices.
(2) Authorize, where appropriate, the attorney general to
examine records, materials, and inventory relating to the
physician's controlled substance prescribing practices.
(3) Provide safeguards and protections for physicians against
unreasonable and oppressive examination authorizations and
actions taken to carry out the authorizations, including
limitations on interference with regular practice operations
and other appropriate due process provisions.
(b) Before November 1, 2014, the board shall adopt permanent
rules under IC 4-22-2 to establish permanent rules for the
standards and procedures described in subsection (a).
(c) An emergency rule adopted under subsection (a) remains in
effect until the effective date of the permanent rules adopted under
subsection (b).
(d) The rules adopted under this section do not abrogate or
eliminate the attorney general's investigative authority under
IC 4-6-3-3, IC 4-6-10-3, IC 25-1-7-4, or any other applicable statute
or rule.
Sec. 2. (a) Consistent with standard medical practices in pain
management treatment, the medical licensing board shall:
(1) before November 1, 2013, adopt emergency rules in the
manner provided in IC 4-22-2-37.1; and
(2) before November 1, 2014, adopt rules under IC 4-22-2;
to establish standards and protocols for the prescribing of
controlled substances.
(b) An emergency rule adopted under subsection (a)(1) remains
in effect until the effective date of the permanent rule adopted
under subsection (a)(2).
Sec. 3. The state board of pharmacy or any licensing board,
commission, or agency that controls, authorizes, or oversees
controlled substance registrations under IC 35-48-3 shall adopt
rules necessary to complement the rules adopted by the medical
licensing board under this chapter.
Sec. 4. A board, commission, or agency required to adopt rules
under this chapter may adopt emergency rules in the manner
provided under IC 4-22-2-37.1 for the same purposes.
Sec. 5. For purposes of Executive Order 13-03, the predominate
purpose and effect of rules adopted under this chapter is to address
emergency matters of health and safety.
SOURCE: IC 35-31.5-2-224; (13)CC024601.4. -->
SECTION 4. IC 35-31.5-2-224, AS ADDED BY P.L.114-2012,
SECTION 67, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2013]: Sec. 224. (a) "Owner", for purposes of IC 35-43-1-3,
has the meaning set forth in IC 35-43-1-3(a).
(b) "Owner", for purposes of IC 35-48-3, has the meaning set
forth in IC 35-48-3-1.5.
(b) (c) "Owner", for purposes of IC 35-49, has the meaning set forth
in IC 35-49-1-6.
SOURCE: IC 35-48-3-1.5; (13)CC024601.5. -->
SECTION 5. IC 35-48-3-1.5 IS ADDED TO THE INDIANA CODE
AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY
1, 2013]: Sec. 1.5. (a) This section is effective beginning January 1,
2014.
(b) As used in this chapter, "owner" means a person that
employs or contracts with at least one (1) individual to dispense a
controlled substance in an office, facility, clinic, or location owned
or controlled by the person. The term does not include the
following:
(1) A person licensed by a board listed in IC 25-1-9.
(2) A dentist licensed under IC 25-14.
(3) A physician licensed under IC 25-22.5.
(4) An optometrist licensed under IC 25-24.
(5) A podiatrist licensed under IC 25-29.
(6) A community mental health center certified under
IC 12-21-2-3(5)(C).
(7) A private mental health institution or private psychiatric
hospital licensed under IC 12-25.
(8) A hospital or ambulatory outpatient surgical center
licensed under IC 16-21.
(9) A hospice licensed under IC 16-25.
(10) A home health agency licensed under IC 16-27-1.
(11) A health facility licensed under IC 16-28.
(12) A rural health clinic (as defined in 42 U.S.C. 1396d(l)(1)).
(13) A federally qualified health center (as defined in 42
U.S.C. 1396d(l)(2)(B)).
(14) A pharmacist or pharmacy licensed under IC 25-26.
(15) A community health center (as defined in IC 34-18-2-9).
(16) An affiliate, member, partner, or subsidiary of any
person described in subdivisions (6) through (15).
(17) A:
(A) corporation;
(B) partnership;
(C) joint venture;
(D) limited liability company; or
(E) professional corporation;
or any other entity in which more than fifty percent (50%) of
the owners, shareholders, partners, or members are persons
listed in subdivisions (1) through (16).
SOURCE: IC 35-48-3-3; (13)CC024601.6. -->
SECTION 6. IC 35-48-3-3 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2013]: Sec. 3. (a) Every person who
manufactures or distributes any controlled substance within this state
or who proposes to engage in the manufacture or distribution of any
controlled substance within this state, must obtain biennially a
registration issued by the board in accordance with
its the board's
rules.
(b) Every person who dispenses or proposes to dispense any
controlled substance within Indiana must have a registration issued by
the board in accordance with
its the board's rules. A registration
issued to a dispenser under this subsection expires whenever the
dispenser's license as a practitioner expires. The board shall renew a
dispenser's registration under this subsection concurrently with any
state license authorizing the dispenser to act as a practitioner.
(c) This subsection is effective January 1, 2014. An owner must
have a registration issued by the board in accordance with the
board's rules. An owner shall adopt reasonable procedures to
ensure that employed or contracted individuals who are dispensing
controlled substances in the office, facility, clinic, or location owned
or controlled by the owner dispense the controlled substances in a
manner that complies with laws, rules, and regulations.
(c) (d) Persons registered by the board under this article to
manufacture, distribute, dispense, or conduct research with controlled
substances may possess, manufacture, distribute, dispense, or conduct
research with those substances to the extent authorized by their
registration and in conformity with the other provisions of this chapter.
(d) (e) The following persons need not register and may lawfully
possess controlled substances under this article:
(1) An agent or employee of any registered manufacturer,
distributor, or dispenser of any controlled substance if
he the
agent or employee is acting in the usual course of
his the agent's
or employee's business or employment.
(2) A common or contract carrier or warehouseman, or an
employee thereof, whose possession of any controlled substance
is in the usual course of business or employment.
(3) An ultimate user or a person in possession of any controlled
substance under a lawful order of a practitioner or in lawful
possession of a schedule V substance.
(e) (f) The board may waive by rule the requirement for registration
of certain manufacturers, distributors, or dispensers if it finds it
consistent with the public health and safety.
(f) (g) A separate registration is required at each principal place of
business or professional practice where the applicant:
(1) manufactures, distributes, dispenses, or possesses controlled
substances; and
(2) employs or contracts with individuals to dispense
controlled substances. This subdivision is effective January 1,
2014.
(g) (h) The board may inspect the establishment of a registrant or
applicant for registration in accordance with the board's rules.
(i) Beginning January 1, 2014, the attorney general may file a
petition in circuit or superior court to obtain an injunction against
a violation of this chapter by an owner. In an action filed by the
attorney general under this subsection, the court may:
(1) issue an injunction;
(2) order the owner to pay a civil penalty not to exceed five
thousand dollars ($5,000);
(3) order the owner to pay the state the reasonable costs of the
attorney general's investigation and prosecution related to the
action; and
(4) provide the appointment of a receiver.
SOURCE: IC 35-48-4-11.5; (13)CC024601.7. -->
SECTION 7. IC 35-48-4-11.5 AS ADDED BY SEA 536-2013,
SECTION 24, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
UPON PASSAGE]: Sec. 11.5. (a) As used in this section, "synthetic
drug lookalike substance" has the meaning set forth in
IC 35-31.5-2-321.5(a)(3). IC 35-31.5-2-321.5(a)(2).
(b) A person who possesses a synthetic drug or synthetic drug
lookalike substance commits possession of a synthetic drug or synthetic
drug lookalike substance, a Class B infraction.
(c) A person who knowingly or intentionally possesses a synthetic
drug or synthetic drug lookalike substance commits possession of a
synthetic drug or synthetic drug lookalike substance, a Class A
misdemeanor. However, the offense is a Class D felony if the person
has a prior unrelated conviction under this section or under section 10.5
of this chapter.
SOURCE: ; (13)CC024601.8. -->
SECTION 8. [EFFECTIVE JULY 1, 2013] (a) As used in this
SECTION, "commission" refers to the health finance commission
established by IC 2-5-23-3.
(b) During the 2013 legislative interim, the commission shall
study issues concerning pharmacy programs designed to take back
and dispose of old and expired prescription drugs. The commission
shall examine existing obstacles that pharmacies encounter in
operating a prescription drug take-back program and recommend
solutions that would allow consumers to dispose of old and expired
prescription drugs at local pharmacies without difficulty.
(c) This SECTION expires December 31, 2013.
SOURCE: ; (13)CC024601.9. -->
SECTION 9. [EFFECTIVE JULY 1, 2013]
(a) As used in this
SECTION, "commission" refers to the Indiana commission on
mental health and addiction established by IC 12-21-6.5-2.
(b) During the 2013 legislative interim, the commission shall
study issues concerning treatment and recovery from prescription
drug use addiction. The commission shall study and make
recommendations concerning the following:
(1) Use of the Indiana health care professional recruitment
and retention fund established by IC 16-46-5-8 to provide loan
repayment for student loans incurred by addiction
professionals.
(2) Criteria for Medicaid reimbursement for detoxification
and rehabilitation services for addiction treatment.
(3) Best practice treatment for pregnant mothers and
newborns with prescription pain medication dependencies
and addictions.
(c) This SECTION expires December 31, 2013.
SOURCE: ; (13)CC024601.10. -->
SECTION 10. [EFFECTIVE JULY 1, 2013] (a) As used in this
SECTION, "commission" refers to the health finance commission
established by IC 2-5-23-3.
(b) During the 2013 legislative interim, the commission shall
study the use of methadone and opioids in treatment programs and
clinic settings.
(c) Not later than September 1, 2013, the division of mental
health and addiction shall provide the commission with the
following information in writing:
(1) The number of patients served in Indiana opioid treatment
programs certified under IC 12-23-18.
(2) The opioid treatment medications provided to patients,
including the dosage.
(3) The drug testing protocol of Indiana opioid treatment
programs.
(4) The number of opioid treatment program patients who
have tested positive for other controlled substances during a
drug test for a controlled substance provided under an opioid
treatment program.
(5) The number of opioid treatment program patients who are
subsequently determined to no longer need the assistance of
the opioid treatment program and released from treatment.
(6) Any other information that is requested by the commission
or determined by the division of mental health and addiction
to be relevant to the study described in this SECTION.
(d) This SECTION expires December 31, 2013.
SOURCE: ; (13)CC024601.11. -->
SECTION 11.
An emergency is declared for this act.
(Reference is to Engrossed Senate Bill 246 as printed March 26,
2013.)
Conference Committee Report
on
Engrossed Senate Bill 246
S
igned by:
____________________________ ____________________________
Senator GroomsRepresentative Davisson
Chairperson
____________________________ ____________________________
Senator BreauxRepresentative Stemler
Senate Conferees House Conferees