(a)The board has the following duties:
(1)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.
(2)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
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(a) The board has the following duties:
(1) 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.
(2) 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.
(3) The development, selection, application, and assessment of
interventions for physicians, pharmacists, and patients that are
educational and not punitive in nature.
(4) 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.
(5) 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.
(6) The establishment of a grievance and appeals process for
physicians or pharmacists under this chapter.
(7) 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.
(8) 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.
(9) 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.
(10) The research, development, and approval of a preferred drug
list for:
(A) Medicaid's fee for service program;
(B) a risk based managed care program, if the office provides
a prescription drug benefit and subject to IC 12-15-5; and
(C) the children's health insurance program under IC 12-17.6;
in consultation with the therapeutics committee.
(11) The approval of the review and maintenance of the preferred
drug list at least two (2) times per year.
(12) The preparation and submission of a report concerning the
preferred drug list at least one (1) time per year to the interim
study committee on public health, behavioral health, and human
services established by IC 2-5-1.3-4 in an electronic format under
IC 5-14-6.
(13) The collection of data reflecting prescribing patterns related
to treatment of children diagnosed with attention deficit disorder
or attention deficit hyperactivity disorder.
(14) 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)(10), 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)(10) 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)(10):
(1) 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) 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.
(3) 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 one (1) time each year, the board shall provide a report
to the interim study committee on public health, behavioral health, and
human services established by IC 2-5-1.3-4 in an electronic format
under IC 5-14-6. 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.
(5) Any recommendations received from the mental health
Medicaid quality advisory committee under section 51(h) of this
chapter.
(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.