CHAPTER 35. DRUG UTILIZATION REVIEW
IC 12-15-35
Chapter 35. Drug Utilization Review
IC 12-15-35-1
"Appropriate and medically necessary" defined
Sec. 1. As used in this chapter, "appropriate and medically
necessary" means drug prescribing, drug dispensing, and patient
medication usage in conformity with the criteria and standards
developed under this chapter.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-2
"Board" defined
Sec. 2. As used in this chapter, "board" refers to the drug
utilization review board created under this chapter.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-3
"Compendia" defined
Sec. 3. As used in this chapter, "compendia" means those
resources widely accepted by the medical profession in the
efficacious use of drugs, including the following sources:
(1) The American Hospital Formulary Services Drug
Information.
(2) The U.S. Pharmacopeia-Drug Information.
(3) The American Medical Association Drug Evaluations.
(4) The peer-reviewed medical literature.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-4
"Counseling" defined
Sec. 4. As used in this chapter, "counseling" means the activities
conducted by a pharmacist to inform Medicaid recipients about the
proper use of drugs as required by the board under this chapter.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-4.5
"Covered outpatient drug" defined
Sec. 4.5. As used in this chapter, "covered outpatient drug" has
the meaning set forth in 42 U.S.C. 1396r-8(k)(2).
As added by P.L.107-2002, SEC.12.
IC 12-15-35-5
"Criteria" defined
Sec. 5. As used in this chapter, "criteria" means the predetermined
and explicitly accepted elements that are used to measure drug use
on an ongoing basis to determine if the use is appropriate, medically
necessary, and not likely to result in adverse medical outcomes.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-6
"Drug-disease contraindication" defined
Sec. 6. As used in this chapter, "drug-disease contraindication"
means an occurrence in which the therapeutic effect of a drug is
adversely altered by the presence of another disease condition.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-7
"Drug-drug interaction" defined
Sec. 7. As used in this chapter, "drug-drug interaction" means an
occurrence in which at least two (2) drugs taken by a recipient leads
to clinically significant toxicity that:
(1) is characteristic of one (1) or any of the drugs present; or
(2) leads to the interference with the effectiveness of one (1) or
any of the drugs.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-8
"Drug utilization review" or "DUR" defined
Sec. 8. As used in this chapter, "drug utilization review" or
"DUR" means the program designed to measure and assess on a
retrospective and a prospective basis the proper use of outpatient
drugs in the Medicaid program.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-9
"Intervention" defined
Sec. 9. As used in this chapter, "intervention" means an action
taken by the board with a prescriber or pharmacist to inform about or
to influence prescribing or dispensing practices or utilization of
drugs.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-10
"Overutilization or underutilization" defined
Sec. 10. As used in this chapter, "overutilization or
underutilization" means the use of a drug in such quantities where
the desired therapeutic goal is not achieved.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-11
"Pharmacist" defined
Sec. 11. As used in this chapter, "pharmacist" means an individual
who is licensed as a pharmacist in Indiana under IC 25-26.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-12
"Physician" defined
Sec. 12. As used in this chapter, "physician" means an individual
who is licensed to practice medicine in Indiana under IC 25-22.5.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-13
"Prospective DUR" defined
Sec. 13. As used in this chapter, "prospective DUR" means the
part of the drug utilization review program that:
(1) is to occur before the drug is dispensed;
(2) is designed to screen for potential drug therapy problems
based on explicit and predetermined criteria and standards that
are developed on an ongoing basis with professional input; and
(3) is to provide for the counseling of recipients about the
proper use of drugs.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-14
"Retrospective DUR" defined
Sec. 14. As used in this chapter, "retrospective DUR" means the
part of the drug utilization review program that assesses or measures
drug use based on an historical review of drug use data against
predetermined and explicit criteria and standards that are developed
on an ongoing basis with professional input.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-15
"Standards" defined
Sec. 15. As used in this chapter, "standards" means the acceptable
range of deviation from the criteria that reflects local medical
practice and that is tested on the Medicaid recipient database.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-16
"SURS" defined
Sec. 16. As used in this chapter, "SURS" refers to the surveillance
utilization review system of the Medicaid program.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-17
"Therapeutic appropriateness" defined
Sec. 17. As used in this chapter, "therapeutic appropriateness"
means drug prescribing based on rational drug therapy that is
consistent with the criteria and standards developed under this
chapter.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-17.5
"Therapeutic classification" or "therapeutic category" defined
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.
As added by P.L.107-2002, SEC.13.
IC 12-15-35-18
"Therapeutic duplication" defined
Sec. 18. As used in this chapter, "therapeutic duplication" means
the prescribing and dispensing of:
(1) the same drug; or
(2) at least two (2) drugs from the same therapeutic class;
where overlapping periods of drug administration are involved and
where such prescribing or dispensing is not medically indicated.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-18.5
Application of chapter
Sec. 18.5. This chapter applies to any contractor or vendor of the
state responsible for providing or managing any part of the Medicaid
outpatient drug program.
As added by P.L.76-1994, SEC.2.
IC 12-15-35-18.7
Formulary requirements
Sec. 18.7. A formulary established by a Medicaid managed care
organization is subject to sections 46 and 47 of this chapter.
As added by P.L.231-1999, SEC.2.
IC 12-15-35-19
Drug utilization review board; establishment
Sec. 19. The drug utilization review board is established.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-20
Membership of board
Sec. 20. The board is composed of the following:
(1) Four (4) individuals licensed and actively engaged in the
practice of medicine or osteopathic medicine in Indiana under
IC 25-22.5.
(2) Four (4) individuals licensed under IC 25-26 and actively
engaged in the practice of pharmacy in Indiana.
(3) One (1) individual with expertise in therapeutic
pharmacology who is neither a physician or a pharmacist.
(4) A representative of the office who shall serve as an
ex-officio nonvoting member of the board.
(5) One (1) individual who:
(A) is employed by a health maintenance organization that
has a pharmacy benefit; and
(B) has expertise in formulary development and pharmacy
benefit administration.
The individual appointed under this subdivision may not be
employed by a health maintenance organization that is under
contract or subcontract with the state to provide services to
Medicaid recipients under this article.
(6) One (1) individual who is a health economist.
As added by P.L.75-1992, SEC.19. Amended by P.L.231-1999,
SEC.3.
IC 12-15-35-20.1
Conflicts of interest
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.
As added by P.L.231-1999, SEC.4. Amended by P.L.107-2002,
SEC.14.
IC 12-15-35-20.5
Therapeutics committee established; members; limitations; terms;
votes; meetings
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) Five (5) physicians licensed under IC 25-22.5, including:
(A) one (1) physician with expertise in the area of family
practice;
(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;
and
(E) one (1) physician with expertise in the area of internal
medicine and who specializes in the treatment of diabetes.
(2) Two (2) pharmacists who are licensed under IC 25-26 and
who have a doctor of pharmacy degree or an equivalent degree.
(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;
the state or a pharmaceutical manufacturer or labeler. However, this
subsection does not apply to a physician or a pharmacist whose only
contract with the state is a Medicaid provider agreement under
IC 12-15-11 or a provider agreement under the children's health
insurance program under IC 12-17.6.
(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 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) The affirmative votes of a majority of a quorum of the
therapeutics committee are required for the committee to take action
on any measure. A quorum of the therapeutics committee consists of
four (4) members.
(k) The therapeutics committee shall meet:
(1) upon the call of the chairperson of the therapeutics
committee; and
(2) at least quarterly.
(l) The chairperson and the vice chairperson of the therapeutics
committee:
(1) each serve for a term of one (1) year; and
(2) must be elected from the therapeutics committee's
membership at the therapeutics committee's first meeting each
calendar year.
(m) A meeting held by the therapeutics committee must be open
to the public in accordance with IC 5-14-1.5. However, the
therapeutics committee may meet in executive session only for the
purpose of reviewing confidential or proprietary information.
As added by P.L.107-2002, SEC.15.
IC 12-15-35-21
Board; appointment; term
Sec. 21. (a) The members of the board shall be appointed by the
governor and serve a term of three (3) years.
(b) The governor shall fill a vacancy on the board by appointing
a new member to serve the remainder of the unexpired term.
(c) The governor may remove a member for cause.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-22
Qualifications of board members
Sec. 22. Board members must have expertise in one (1) or more
of the following:
(1) Clinically appropriate prescribing of outpatient drugs.
(2) Clinically appropriate dispensing and monitoring of
outpatient drugs.
(3) Drug utilization review, evaluation, and intervention.
(4) Medical quality assurance.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-23
Physician appointments; geographic balance
Sec. 23. In making the physician appointments, the governor shall
provide for geographic balance.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-24
Reappointment of members
Sec. 24. An individual appointed to the board may be reappointed
upon the completion of the individual's term.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-25
Chairman; compensation; expenses
Sec. 25. (a) The board shall annually elect a chairman from the
members of the board.
(b) The chairman may be re-elected to serve consecutive terms as
chairman.
(c) A member of the board who is not a state employee is entitled
to the minimum salary per diem as provided by IC 4-10-11-2.1(b).
Each member of the board is entitled to reimbursement for traveling
expenses and other expenses actually incurred in connection with the
member's duties as provided in the state travel policies and
procedures established by the Indiana department of administration
and the budget agency.
(d) Each member of the board who is a state employee is entitled
to reimbursement for traveling expenses actually incurred in
connection with the member's duties, as provided in the state travel
policies and procedures established by the Indiana department of
administration and approved by the budget agency.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-26
Additional staff
Sec. 26. (a) The secretary shall provide additional staff to the
board.
(b) The secretary shall provide staff for the therapeutics
committee.
As added by P.L.75-1992, SEC.19. Amended by P.L.291-2001,
SEC.162; P.L.107-2002, SEC.16.
IC 12-15-35-27
Retrospective and prospective DUR program responsibility
Sec. 27. The board is responsible for the oversight of the
retrospective and prospective DUR program.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-28
Duties of board
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. The report issued to the
legislative council must be in an electronic format under
IC 5-14-6.
(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 16.2-3.1 and 42
CFR 483.60.
(11) The research, development, and approval of a preferred
drug list for:
(A) Medicaid's fee for service program;
(B) Medicaid's primary care case management program;
(C) Medicaid's risk based managed care program, if the
office provides a prescription drug benefit and subject to
IC 12-15-5; and
(D) the children's health insurance program under
IC 12-17.6;
in consultation with the therapeutics committee.
(12) The approval of the review and maintenance of the
preferred drug list at least two (2) times per year.
(13) The preparation and submission of a report concerning the
preferred drug list at least two (2) times per year to the select
joint commission on Medicaid oversight established by
IC 2-5-26-3.
(14) The collection of data reflecting prescribing patterns
related to treatment of children diagnosed with attention deficit
disorder or attention deficit hyperactivity disorder.
(15) Advising the Indiana comprehensive health insurance
association established by IC 27-8-10-2.1 concerning
implementation of chronic disease management and
pharmaceutical management programs under IC 27-8-10-3.5.
(b) The board shall use the clinical expertise of the therapeutics
committee in developing a preferred drug list. The board shall also
consider expert testimony in the development of a preferred drug list.
(c) In researching and developing a preferred drug list under
subsection (a)(11), the board shall do the following:
(1) Use literature abstracting technology.
(2) Use commonly accepted guidance principles of disease
management.
(3) Develop therapeutic classifications for the preferred drug
list.
(4) Give primary consideration to the clinical efficacy or
appropriateness of a particular drug in treating a specific
medical condition.
(5) Include in any cost effectiveness considerations the cost
implications of other components of the state's Medicaid
program and other state funded programs.
(d) Prior authorization is required for coverage under a program
described in subsection (a)(11) of a drug that is not included on the
preferred drug list.
(e) The board shall determine whether to include a single source
covered outpatient drug that is newly approved by the federal Food
and Drug Administration on the preferred drug list not later than
sixty (60) days after the date on which the manufacturer notifies the
board in writing of the drug's approval. However, if the board
determines that there is inadequate information about the drug
available to the board to make a determination, the board may have
an additional sixty (60) days to make a determination from the date
that the board receives adequate information to perform the board's
review. Prior authorization may not be automatically required for a
single source drug that is newly approved by the federal Food and
Drug Administration, and that is:
(1) in a therapeutic classification:
(A) that has not been reviewed by the board; and
(B) for which prior authorization is not required; or
(2) the sole drug in a new therapeutic classification that has not
been reviewed by the board.
(f) The board may not exclude a drug from the preferred drug list
based solely on price.
(g) The following requirements apply to a preferred drug list
developed under subsection (a)(11):
(1) Except as provided by IC 12-15-35.5-3(b) and
IC 12-15-35.5-3(c), the office or the board may require prior
authorization for a drug that is included on the preferred drug
list under the following circumstances:
(A) To override a prospective drug utilization review alert.
(B) To permit reimbursement for a medically necessary
brand name drug that is subject to generic substitution under
IC 16-42-22-10.
(C) To prevent fraud, abuse, waste, overutilization, or
inappropriate utilization.
(D) To permit implementation of a disease management
program.
(E) To implement other initiatives permitted by state or
federal law.
(2) All drugs described in IC 12-15-35.5-3(b) must be included
on the preferred drug list.
(3) The office may add a drug that has been approved by the
federal Food and Drug Administration to the preferred drug list
without prior approval from the board.
(4) The board may add a drug that has been approved by the
federal Food and Drug Administration to the preferred drug list.
(h) At least two (2) times each year, the board shall provide a
report to the select joint commission on Medicaid oversight
established by IC 2-5-26-3. The report must contain the following
information:
(1) The cost of administering the preferred drug list.
(2) Any increase in Medicaid physician, laboratory, or hospital
costs or in other state funded programs as a result of the
preferred drug list.
(3) The impact of the preferred drug list on the ability of a
Medicaid recipient to obtain prescription drugs.
(4) The number of times prior authorization was requested, and
the number of times prior authorization was:
(A) approved; and
(B) disapproved.
(i) The board shall provide the first report required under
subsection (h) not later than six (6) months after the board submits
an initial preferred drug list to the office.
As added by P.L.75-1992, SEC.19. Amended by P.L.76-1994, SEC.3;
P.L.107-2002, SEC.17; P.L.184-2003, SEC.7; P.L.193-2003, SEC.2;
P.L.28-2004, SEC.104; P.L.97-2004, SEC.51; P.L.2-2005, SEC.50;
P.L.101-2005, SEC.3.
IC 12-15-35-28.5
Therapeutics committee duties
Sec. 28.5. The therapeutics committee established under section
20.5 of this chapter shall do the following:
(1) Advise and make recommendations to the board in the
board's development and maintenance of a preferred drug list
under section 28 of this chapter.
(2) Submit to the board a proposed preferred drug list that has
been approved by a majority of a quorum of the therapeutics
committee.
(3) Advise and make recommendations to the board in the
board's review and maintenance of a preferred drug list.
As added by P.L.107-2002, SEC.18.
IC 12-15-35-28.7
Submitting initial preferred drug list; limitations on restrictions;
advance notice to providers; implementation; prior authorization
limitation; rules
Sec. 28.7. (a) The board shall submit the initial approved
preferred drug list to the office not later than August 1, 2002.
(b) Except as permitted under subsection (g), the office may not
further restrict the status of a drug in the Medicaid program or the
children's health insurance program until the board reviews a
therapeutic classification and the office implements the therapeutic
classification on the preferred drug list.
(c) The office shall provide advance notice to providers of the
contents of the preferred drug list submitted by the board under
subsection (a).
(d) Notwithstanding IC 12-15-13-6, the office shall implement any
change in the preferred drug list not later than thirty (30) days after
the date the board submits the amended list to the office.
(e) Except as provided by section 28(g)(3) of this chapter, the
office may not implement a preferred drug list or an amendment to
the preferred drug list that has not been approved by the board.
(f) The office may not require prior authorization for a drug that
is excluded from the preferred drug list unless the board has made
the determinations required under section 35 of this chapter.
(g) The office may adopt rules under IC 4-22-2 necessary to carry
out this chapter.
As added by P.L.107-2002, SEC.19. Amended by P.L.184-2003,
SEC.8.
IC 12-15-35-29
Quorum; majority vote on DUR criteria and standards for
prescribing
Sec. 29. (a) A quorum consists of six (6) voting members of the
board.
(b) DUR criteria and standards for appropriate prescribing may
only be implemented with the approval of a majority of the quorum
of the board. The majority vote must include at least three (3) of the
four (4) physician members of the board and may allow the board to
accept deviations from the standards on a case-by-case basis.
As added by P.L.75-1992, SEC.19. Amended by P.L.231-1999,
SEC.5.
IC 12-15-35-30
Local practices; monitoring
Sec. 30. The criteria and standards developed under section
28(a)(3) of this chapter for appropriate prescribing that are
implemented must reflect the local practices of physicians to monitor
the following:
(1) Therapeutic appropriateness.
(2) Overutilization or underutilization.
(3) Therapeutic duplication.
(4) Drug-disease contraindications.
(5) Drug-drug interactions.
(6) Incorrect drug dosage or duration of drug treatment.
(7) Clinical abuse and misuse.
As added by P.L.75-1992, SEC.19. Amended by P.L.3-2008, SEC.95.
IC 12-15-35-31
Intervention; approval; requisites
Sec. 31. (a) An intervention developed under section 28(a)(4) of
this chapter that involves a physician must be approved by at least
three (3) of the four (4) physician members of the board before
implementation.
(b) An intervention that involves a pharmacist must be approved
by at least three (3) of the four (4) pharmacist members of the board
before implementation.
(c) Interventions include the following:
(1) Information disseminated to physicians and pharmacists to
ensure that physicians and pharmacists are aware of the board's
duties and powers.
(2) Written, oral, or electronic reminders of recipient-specific
or drug-specific information that are designed to ensure
recipient, physician, and pharmacist confidentiality, and
suggested changes in the prescribing or dispensing practices
designed to improve the quality of care.
(3) Use of face-to-face discussions between experts in drug
therapy and the prescriber or pharmacist who has been targeted
for educational intervention.
(4) Intensified reviews or monitoring of selected prescribers or
pharmacists.
(5) The creation of an educational program using data provided
through DUR to provide for active and ongoing educational
outreach programs to improve prescribing and dispensing
practices.
(6) The timely evaluation of interventions to determine if the
interventions have improved the quality of care.
(7) The review of case profiles before the conducting of an
intervention.
As added by P.L.75-1992, SEC.19. Amended by P.L.3-2008, SEC.96.
IC 12-15-35-32
Repealed
(Repealed by P.L.76-1994, SEC.7.)
IC 12-15-35-32.1
Annual report contents
Sec. 32.1. The annual report under section 28 of this chapter shall
include information on the following:
(1) A description of the nature and scope of the prospective
drug review program.
(2) A description of how pharmacies performing prospective
DUR without computers are expected to comply with the
statutory requirement for written criteria.
(3) Detailed information on the specific criteria and standards
in use and any changes in criteria.
(4) A description of the nature and scope of the retrospective
DUR program.
(5) A summary of the educational interventions used and an
assessment of the effect of these educational interventions on
the quality of care.
(6) An estimate of the cost savings generated as a result of the
DUR program including savings to the Medicaid drug program
attributable to the prospective and retrospective DUR.
(7) An overview of the fiscal impact of the DUR program on
other areas of the Medicaid program.
(8) A quantifiable assessment of how DUR has improved
quality of care.
(9) A summary of the total number of prescriptions reviewed by
drug therapeutic class.
As added by P.L.76-1994, SEC.4.
IC 12-15-35-33
Repealed
(Repealed by P.L.1-1993, SEC.132.)
IC 12-15-35-34
Confidential identifying information; release of cumulative
nonidentifying information
Sec. 34. (a) Information that identifies an individual collected
under this chapter is confidential and may not be disclosed by the
board.
(b) The board may have access to identifying information for
purposes of carrying out intervention activities. The identifying
information may not be released to anyone other than a member of
the board.
(c) The board may release cumulative non-identifying information
for purposes of legitimate research.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-35
Prior approval program for outpatient drugs; standards
Sec. 35. (a) Before the board develops a program to place a single
source drug on prior approval, restrict the drug in its use, or establish
a drug monitoring process or program to measure or restrict
utilization of single source drugs other than in the SURS program,
the board must meet the following conditions:
(1) Make a determination, after considering evidence and
credible information provided to the board by the office and the
public, that placing a single source drug on prior approval or
restricting the drug's use will not:
(A) impede the quality of patient care in the Medicaid
program; or
(B) increase costs in other parts of the Medicaid program,
including hospital costs and physician costs.
(2) Meet to review a formulary or a restriction on a single
source drug after the office provides at least fifteen (15) days
notification to the public that the board will review the
formulary or restriction on a single source drug at a particular
board meeting. The notification shall contain the following
information:
(A) A statement of the date, time, and place at which the
board meeting will be convened.
(B) A general description of the subject matter of the board
meeting.
(C) An explanation of how a copy of the formulary to be
discussed at the meeting may be obtained.
The board shall meet to review the formulary or the restriction
on a single source drug at least fifteen (15) days but not more
than sixty (60) days after the notification.
(3) Ensure that:
(A) there is access to at least two (2) alternative drugs within
each therapeutic classification, if available, on the
formulary; and
(B) a process is in place through which a Medicaid recipient
has access to medically necessary drugs.
(4) Reconsider the drug's removal from its restricted status or
from prior approval not later than six (6) months after the single
source drug is placed on prior approval or restricted in its use.
(5) Ensure that the program provides either telephone or FAX
approval or denial Monday through Friday, twenty-four (24)
hours a day. The office must provide the approval or denial
within twenty-four (24) hours after receipt of a prior approval
request. The program must provide for the dispensing of at least
a seventy-two (72) hour supply of the drug in an emergency
situation or on weekends.
(6) Ensure that any prior approval program or restriction on the
use of a single source drug is not applied to prevent acceptable
medical use for appropriate off-label indications.
(b) The board shall advise the office on the implementation of any
program to restrict the use of brand name multisource drugs.
(c) The board shall consider:
(1) health economic data;
(2) cost data; and
(3) the use of formularies in the non-Medicaid markets;
in developing its recommendations to the office.
As added by P.L.75-1992, SEC.19. Amended by P.L.76-1994, SEC.5;
P.L.231-1999, SEC.6; P.L.6-2002, SEC.3; P.L.107-2002, SEC.20;
P.L.1-2003, SEC.58.
IC 12-15-35-36
Advisory committees
Sec. 36. The board may establish advisory committees to assist
the board in carrying out the board's duties under this chapter.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-37
Medicaid state plan; inclusion of retrospective and prospective
DUR program
Sec. 37. The board shall, in cooperation with the secretary,
include in the Medicaid state plan the creation and implementation
of a retrospective and prospective DUR program for Medicaid
outpatient drugs to ensure that the prescriptions are appropriate,
medically necessary, and not likely to result in adverse medical
outcomes.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-38
DUR program guidelines and procedures
Sec. 38. The retrospective and prospective DUR program shall be
operated under the guidelines and procedures established by the
board under section 29 of this chapter.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-39
Retrospective DUR requisites
Sec. 39. Retrospective DUR must:
(1) be based on the guidelines established by the board; and
(2) use the mechanized drug claims processing and information
retrieval system to analyze claims data to do the following:
(A) Identify patterns of fraud, abuse, gross overuse, and
inappropriate or medically unnecessary care.
(B) Assess data on drug use against explicit predetermined
standards that are based on the compendia and other sources
to monitor the following:
(i) Therapeutic appropriateness.
(ii) Overutilization or underutilization.
(iii) Therapeutic duplication.
(iv) Drug-disease contraindications.
(v) Drug-drug interactions.
(vi) Incorrect drug dosage or duration of drug treatment.
(vii) Clinical abuse and misuse.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-40
Prospective DUR requisites
Sec. 40. Prospective DUR must be based on the guidelines
established by the board and must provide that prior to the
prescription being filled or delivered a review will be conducted by
the pharmacist at the point of sale to screen for potential drug therapy
problems resulting from the following:
(1) Therapeutic duplication.
(2) Drug-drug interactions.
(3) Incorrect dosage and duration of treatment.
(4) Drug-allergy interactions.
(5) Clinical abuse and misuse.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-41
Board activities under IC 34-30-15
Sec. 41. The activities of the board in carrying out this chapter are
covered under IC 34-30-15.
As added by P.L.75-1992, SEC.19. Amended by P.L.1-1998,
SEC.103.
IC 12-15-35-42
Meetings
Sec. 42. (a) The board may meet in an executive session for
purposes of reviewing DUR data or to conduct or to discuss activity
as provided for in IC 5-14-1.5-6.1.
(b) The board shall also conduct regular public meetings to gather
input from the public on the operation of the DUR program.
(c) The board shall meet monthly to implement its duties under
this chapter.
As added by P.L.75-1992, SEC.19. Amended by P.L.291-2001,
SEC.163.
IC 12-15-35-43
Confidentiality; pharmacist data and information
Sec. 43. Confidential data or information obtained by pharmacists
as part of prospective DUR are confidential but may be released to
prescribers or others according to procedures established by the
board.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-43.5
Prohibiting the release of proprietary or confidential information
obtained under certain circumstances
Sec. 43.5. (a) The board, the therapeutics committee, or the office
may not release proprietary or confidential information obtained as
part of the development, implementation, or maintenance of a
preferred drug list under this chapter.
(b) Information described in subsection (a) is confidential for
purposes of IC 5-14-3-4(a)(1).
As added by P.L.107-2002, SEC.21. Amended by P.L.184-2003,
SEC.9.
IC 12-15-35-44
Confidentiality; violations; penalty
Sec. 44. A person who does not comply with the confidentiality
provisions under section 34 of this chapter commits a Class A
misdemeanor.
As added by P.L.75-1992, SEC.19. Amended by P.L.1-1993,
SEC.133.
IC 12-15-35-45
Outpatient drug formulary; requirements
Sec. 45. (a) The chairman of the board, subject to the approval of
the board members, may appoint an advisory committee to make
recommendations to the board on the development of a Medicaid
outpatient drug formulary.
(b) If the office decides to establish a Medicaid outpatient drug
formulary, the formulary shall be developed by the board.
(c) A formulary, preferred drug list, or prescription drug benefit
used by a Medicaid managed care organization is subject to
IC 12-15-5-5, IC 12-15-35.5, and sections 46 and 47 of this chapter.
As added by P.L.76-1994, SEC.6. Amended by P.L.231-1999, SEC.7;
P.L.101-2005, SEC.4.
IC 12-15-35-46
Review of proposed formulary
Sec. 46. (a) This section applies to a managed care organization
that enters into an initial contract with the office to be a Medicaid
managed care organization after May 13, 1999.
(b) Before a Medicaid managed care organization described in
subsection (a) implements a formulary, the managed care
organization shall submit the formulary to the office at least
thirty-five (35) days before the date that the managed care
organization implements the formulary for Medicaid recipients.
(c) The office shall forward the formulary to the board for the
board's review and recommendation.
(d) The office shall provide at least thirty (30) days notification
to the public that the board will review a Medicaid managed care
organization's proposed formulary at a particular board meeting. The
notification shall contain the following information:
(1) A statement of the date, time, and place at which the board
meeting will be convened.
(2) A general description of the subject matter of the board
meeting.
(3) An explanation of how a copy of the formulary to be
discussed may be obtained.
The board shall meet to review the formulary at least thirty (30) days
but not more than sixty (60) days after the notification.
(e) In reviewing the formulary, the board shall do the following:
(1) Make a determination, after considering evidence and
credible information provided to the board by the office and the
public, that the use of the formulary will not:
(A) impede the quality of patient care in the Medicaid
program; or
(B) increase costs in other parts of the Medicaid program,
including hospital costs and physician costs.
(2) Make a determination that:
(A) there is access to at least two (2) alternative drugs within
each therapeutic classification, if available, on the
formulary;
(B) a process is in place through which a Medicaid member
has access to medically necessary drugs; and
(C) the managed care organization otherwise meets the
requirements of IC 27-13-38.
(f) The board shall consider:
(1) health economic data;
(2) cost data; and
(3) the use of formularies in the non-Medicaid markets;
in developing its recommendation to the office.
(g) Within thirty (30) days after the board meeting, the board shall
make a recommendation to the office regarding whether the proposed
formulary should be approved, disapproved, or modified.
(h) The office shall rely significantly on the clinical expertise of
the board. If the office does not agree with the recommendations of
the board, the office shall, at a public meeting, discuss the
disagreement with the board and present any additional information
to the board for the board's consideration. The board's consideration
of additional information must be conducted at a public meeting.
(i) Based on the final recommendations of the board, the office
shall approve, disapprove, or require modifications to the Medicaid
managed care organization's proposed formulary. The office shall
notify the managed care organization of the office's decision within
fifteen (15) days of receiving the board's final recommendation.
(j) The managed care organization must comply with the office's
decision within sixty (60) days after receiving notice of the office's
decision.
(k) Notwithstanding the other provisions of this section, the office
may temporarily approve a Medicaid managed care organization's
proposed formulary pending a final recommendation from the board.
As added by P.L.231-1999, SEC.8.
IC 12-15-35-47
Review of changes to formulary
Sec. 47. (a) This section applies to the following changes to a
formulary used by a Medicaid managed care organization for
Medicaid recipients:
(1) Removing one (1) or more drugs from the formulary.
(2) Placing new restrictions on one (1) or more drugs on the
formulary.
(b) Before a Medicaid managed care organization makes a change
described in subsection (a), the managed care organization shall
submit the proposed change to the office.
(c) The office shall forward the proposed change to the board for
the board's review and recommendation.
(d) The office shall provide at least thirty (30) days notification
to the public that the board will:
(1) review the proposed change; and
(2) consider evidence and credible information provided to the
board;
at the board's regular board meeting before making a
recommendation to the office regarding whether the proposed change
should be approved or disapproved.
(e) Based on the final recommendation of the board, the office
may approve or disapprove the proposed change. If a proposed
change is not disapproved within ninety (90) days after the date the
managed care organization submits the proposed change to the
office, the managed care organization may implement the change to
the formulary.
(f) A Medicaid managed care organization:
(1) may add a drug to the managed care organization's
formulary without the approval of the office; and
(2) shall notify the office of any addition to the managed care
organization's formulary within thirty (30) days after making
the addition.
As added by P.L.231-1999, SEC.9.
IC 12-15-35-48
Board's review of a managed care organization's prescription drug
program; report
Sec. 48. (a) The board shall review the prescription drug program
of a managed care organization that participates in the state's
risk-based managed care program at least one (1) time per year. The
board's review of a prescription drug program must include the
following:
(1) An analysis of the single source drugs requiring prior
authorization, including the number of drugs requiring prior
authorization in comparison to other managed care
organizations' prescription drug programs that participate in the
state's Medicaid program.
(2) A determination and analysis of the number and the type of
drugs subject to a restriction.
(3) A review of the rationale for:
(A) the prior authorization of a drug described in subdivision
(1); and
(B) a restriction on a drug.
(4) A review of the number of requests a managed care
organization received for prior authorization, including the
number of times prior authorization was approved and the
number of times prior authorization was disapproved.
(5) A review of:
(A) patient and provider satisfaction survey reports; and
(B) pharmacy-related grievance data for a twelve (12) month
period.
(b) A managed care organization described in subsection (a) shall
provide the board with the information necessary for the board to
conduct its review under subsection (a).
(c) The board shall report to the select joint commission on
Medicaid oversight established by IC 2-5-26-3 at least one (1) time
per year on the board's review under subsection (a).
As added by P.L.107-2002, SEC.22.
IC 12-15-35-49
Information provided by office
Sec. 49. (a) The office shall provide the board with information
necessary for the board to carry out its duties under this chapter.
(b) The office shall provide the information required under
subsection (a):
(1) when requested by the board; and
(2) in a timely manner.
As added by P.L.291-2001, SEC.164.
IC 12-15-35-50
Maximum allowable cost schedule for drugs; pharmacy
participation in Medicaid program
Sec. 50. (a) IC 12-15-13-6 does not apply to this section.
(b) The office shall maintain an Internet web site and post on the
web site any changes concerning the office's maximum allowable
cost schedule for drugs.
(c) A change in the office's maximum allowable cost schedule for
drugs may not take effect less than thirty (30) days after the change
is posted on the office's Internet web site.
(d) The office is not required to mail a notice to providers
concerning a change in the office's maximum allowable cost
schedule for drugs.
(e) A pharmacy may determine not to participate in the Medicaid
program because of a change to the office's maximum allowable cost
schedule for drugs if the pharmacy notifies the office not less than
thirty (30) days after the changes take effect.
As added by P.L.187-2007, SEC.8.
IC 12-15-35-51
Establishment of mental health Medicaid quality advisory
committee; members; reimbursement; duties
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