Indiana Code 12-15-35-28. Duties of the board; preferred drug list; report
(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.
Terms Used In Indiana Code 12-15-35-28
- board: refers to the drug utilization review board created under this chapter. See Indiana Code 12-15-35-2
- compendia: means those resources widely accepted by the medical profession in the efficacious use of drugs, including the following sources:
Indiana Code 12-15-35-3
- covered outpatient drug: has the meaning set forth in Indiana Code 12-15-35-4.5
- 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. See Indiana Code 12-15-35-5
- 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. See Indiana Code 12-15-35-8
- Fraud: Intentional deception resulting in injury to another.
- in writing: include printing, lithographing, or other mode of representing words and letters. See Indiana Code 1-1-4-5
- pharmacist: means an individual who is licensed as a pharmacist in Indiana under IC 25-26. See Indiana Code 12-15-35-11
- physician: means an individual who is licensed to practice medicine in Indiana under Indiana Code 12-15-35-12
- prospective DUR: means the part of the drug utilization review program that:
Indiana Code 12-15-35-13
- standards: means the acceptable range of deviation from the criteria that reflects local medical practice and that is tested on the Medicaid recipient database. See Indiana Code 12-15-35-15
- SURS: refers to the surveillance utilization review system of the Medicaid program. See Indiana Code 12-15-35-16
- Testimony: Evidence presented orally by witnesses during trials or before grand juries.
- Year: means a calendar year, unless otherwise expressed. See Indiana Code 1-1-4-5
(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 C.F.R. § 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) 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 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.
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; P.L.3-2012, SEC.3; P.L.205-2013, SEC.205; P.L.53-2014, SEC.105; P.L.210-2015, SEC.50; P.L.152-2017, SEC.27; P.L.130-2018, SEC.48.