MR. PRESIDENT:
The Senate Committee on Health and Provider Services, to which was referred Senate Bill
No. 228, has had the same under consideration and begs leave to report the same back to the
Senate with the recommendation that said bill be AMENDED as follows:
SOURCE: Page 1, line 12; (02)CR022801.1. -->
Page 1, between lines 12 and 13, begin a new paragraph and insert:
SOURCE: IC 12-7-2-190.6; (02)CR022801.3. -->
"SECTION 3.
IC 12-7-2-190.6
IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE UPON PASSAGE]: Sec. 190.6. "Therapeutic
classification" or "therapeutic category", for purposes of
IC 12-15-35
, has the meaning set forth in
IC 12-15-35-17.5.
SOURCE: IC 12-15-35-17.5; (02)CR022801.4. -->
SECTION 4.
IC 12-15-35-17.5
IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE UPON PASSAGE]: Sec. 17.5. As used in this chapter,
"therapeutic classification" or "therapeutic category" means a
group of pharmacologic agents primarily characterized by a
significant similarity of the biochemical or physiological
mechanism by which these agents result in the intended clinical
outcome.
SOURCE: IC 12-15-35-20.1; (02)CR022801.5. -->
SECTION 5.
IC 12-15-35-20.1
, AS ADDED BY P.L.231-1999,
SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
UPON PASSAGE]: Sec. 20.1. (a) Each board member and each
therapeutics committee member shall fully disclose any potential
conflicts of interest, financial or otherwise, relating to an issue that
comes before the board or committee for recommendation or other
action.
(b) A board member or therapeutics committee member may not
vote on a recommendation or other action if the member or the
member's employer has a conflict of interest, financial or otherwise, in
the outcome of the vote.
(c) A board member or therapeutics committee member who may
not vote on a recommendation or other action under subsection (b) may
still participate in any discussions regarding the recommendation or
other action.
SOURCE: IC 12-15-35-20.5; (02)CR022801.6. -->
SECTION 6.
IC 12-15-35-20.5
IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE UPON PASSAGE]: Sec. 20.5. (a) The therapeutics
committee is established as a subcommittee of the board.
(b) The chairperson of the board elected under section 25 of this
chapter shall, with the approval of a majority of a quorum of the
board, appoint the members of the therapeutics committee.
(c) The therapeutics committee is composed of the following
members:
(1) Six (6) physicians licensed under IC 25-22.5, including:
(A) one (1) physician with expertise in the area of
infectious diseases;
(B) one (1) physician with expertise in the area of
pediatrics;
(C) one (1) physician with expertise in the area of
geriatrics;
(D) one (1) physician with expertise in psychiatric
medicine;
(E) one (1) physician with expertise in the area of internal
medicine and who specializes in the treatment of diabetes;
and
(F) one (1) physician with expertise in the area of
cardiovascular medicine.
(2) Five (5) pharmacists licensed under IC 25-26, including:
(A) one (1) pharmacist who has experience in pharmacy
benefit management and is employed by a health
maintenance organization that has a pharmacy benefit;
(B) one (1) pharmacist who is employed or has been
employed by a hospital pharmacy or a retail pharmacy;
(C) one (1) pharmacist who is employed or has been
employed in the area of long term care pharmacy;
(D) two (2) pharmacists who have a doctor of pharmacy
degree or an equivalent degree and who have either:
(i) completed a residency in drug information; or
(ii) had at least three (3) years of recent experience in
prescription drug formulary management, including
therapeutic category review.
(d) Not more than three (3) of the individuals appointed by the
chairperson under subsection (b) to the therapeutics committee
may also be members of the board.
(e) At least three (3) of the members described in subsection
(c)(1) and appointed under subsection (b) must have at least three
(3) years of recent experience in prescription drug formulary
management, including therapeutic category review.
(f) A member of the therapeutics committee may not:
(1) be employed by; or
(2) contract with;
a pharmaceutical manufacturer or labeler.
(g) The term of a member of the therapeutics committee is three
(3) years. A member may be reappointed to the committee upon
the completion of the member's term.
(h) The expenses of the therapeutics committee shall be paid by
the office.
(i) Each member of the therapeutics 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.
(j) Each member of the therapeutics committee who is a state
employee is entitled to reimbursement for traveling expenses as
provided under
IC 4-13-1-4
and any 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.
(k) The affirmative votes of a majority of the voting members
appointed to the therapeutics committee are required for the
committee to take action on any measure.
SOURCE: IC 12-15-35-26; (02)CR022801.7. -->
SECTION 7.
IC 12-15-35-26
, AS AMENDED BY P.L.291-2001,
SECTION 162, IS AMENDED TO READ AS FOLLOWS
[EFFECTIVE UPON PASSAGE]: Sec. 26. (a) The secretary shall
provide additional staff to the board.
(b) The secretary shall provide staff for the therapeutics
committee.
SOURCE: IC 12-15-35-28; (02)CR022801.8. -->
SECTION 8.
IC 12-15-35-28
IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE UPON PASSAGE]: Sec. 28. (a) The board
has the following duties:
(1) The adoption of rules to carry out this chapter, in accordance
with the provisions of
IC 4-22-2
and subject to any office
approval that is required by the federal Omnibus Budget
Reconciliation Act of 1990 under Public Law 101-508 and its
implementing regulations.
(2) The implementation of a Medicaid retrospective and
prospective DUR program as outlined in this chapter, including
the approval of software programs to be used by the pharmacist
for prospective DUR and recommendations concerning the
provisions of the contractual agreement between the state and any
other entity that will be processing and reviewing Medicaid drug
claims and profiles for the DUR program under this chapter.
(3) The development and application of the predetermined criteria
and standards for appropriate prescribing to be used in
retrospective and prospective DUR to ensure that such criteria
and standards for appropriate prescribing are based on the
compendia and developed with professional input with provisions
for timely revisions and assessments as necessary.
(4) The development, selection, application, and assessment of
interventions for physicians, pharmacists, and patients that are
educational and not punitive in nature.
(5) The publication of an annual report that must be subject to
public comment before issuance to the federal Department of
Health and Human Services and to the Indiana legislative council
by December 1 of each year.
(6) The development of a working agreement for the board to
clarify the areas of responsibility with related boards or agencies,
including the following:
(A) The Indiana board of pharmacy.
(B) The medical licensing board of Indiana.
(C) The SURS staff.
(7) The establishment of a grievance and appeals process for
physicians or pharmacists under this chapter.
(8) The publication and dissemination of educational information
to physicians and pharmacists regarding the board and the DUR
program, including information on the following:
(A) Identifying and reducing the frequency of patterns of
fraud, abuse, gross overuse, or inappropriate or medically
unnecessary care among physicians, pharmacists, and
recipients.
(B) Potential or actual severe or adverse reactions to drugs.
(C) Therapeutic appropriateness.
(D) Overutilization or underutilization.
(E) Appropriate use of generic drugs.
(F) Therapeutic duplication.
(G) Drug-disease contraindications.
(H) Drug-drug interactions.
(I) Incorrect drug dosage and duration of drug treatment.
(J) Drug allergy interactions.
(K) Clinical abuse and misuse.
(9) The adoption and implementation of procedures designed to
ensure the confidentiality of any information collected, stored,
retrieved, assessed, or analyzed by the board, staff to the board, or
contractors to the DUR program that identifies individual
physicians, pharmacists, or recipients.
(10) The implementation of additional drug utilization review
with respect to drugs dispensed to residents of nursing facilities
shall not be required if the nursing facility is in compliance with
the drug regimen procedures under 410 IAC 16.2-3-8 and 42
CFR 483.60.
(11) The research, development, and approval of a preferred
drug list for Medicaid's fee for service program and primary
care case management program in consultation with the
therapeutics committee.
treatment with a psychotropic medication is appropriate
for the child.
(c) In addition to the actions listed under section 4 of this
chapter that subject a practitioner to the exercise of disciplinary
sanctions, a practitioner described in subsection (a) is subject to the
exercise of disciplinary sanctions under section 9 of this chapter if,
after a hearing, the board regulating the practitioner's profession
finds that the practitioner has violated subsection (b).
SOURCE: ; (02)CR022801.15. -->
SECTION 15. [EFFECTIVE UPON PASSAGE] The chairperson
shall make the appointments required under
IC 12-15-35-20.5
, as
added by this act, not more than thirty (30) days after the effective
date of this act.
SOURCE: ; (02)CR022801.16. -->
SECTION 16. [EFFECTIVE UPON PASSAGE] Upon the effective
date of this act, any drug that is included on the preferred drug list
implemented by the drug utilization review board under
IC 12-15-35-28
, as amended by this act, may not require prior
authorization.
SOURCE: ; (02)CR022801.17. -->
SECTION 17. [EFFECTIVE UPON PASSAGE] (a) As used in this
SECTION, "committee" refers to the therapeutics committee
established by
IC 12-15-35-20.5
, as added by this act.
(b) The initial terms of office for the members of the committee
are as follows:
(1) Of the members appointed under
IC 12-15-35-20.5
(c)(1),
as added by this act:
(A) two (2) members shall be appointed for a term of one
(1) year;
(B) two (2) members shall be appointed for a term of two
(2) years; and
(C) two (2) members shall be appointed for a term of three
(3) years.
(2) Of the members appointed under
IC 12-15-35-20.5
(c)(2),
as added by this act:
(A) one (1) member shall be appointed for a term of one (1)
year;
(B) two (2) members shall be appointed for a term of two
(2) years; and
(C) two (2) members shall be appointed for a term of two
(2) years.
(c) This SECTION expires December 31, 2003.".
Renumber all SECTIONS consecutively.
(Reference is to SB 228 as introduced.)
and when so amended that said bill do pass.
Committee Vote: Yeas 10, Nays 0.
Miller
CR022801/DI 104 2002