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 medicallynecessary" means drug prescribing, drug dispensing, and patientmedication usage in conformity with the criteria and standardsdeveloped 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 drugutilization 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 thoseresources widely accepted by the medical profession in theefficacious use of drugs, including the following sources:
(1) The American Hospital Formulary Services DrugInformation.
(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 activitiesconducted by a pharmacist to inform Medicaid recipients about theproper 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" hasthe 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 predeterminedand explicitly accepted elements that are used to measure drug useon an ongoing basis to determine if the use is appropriate, medicallynecessary, 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 isadversely 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 anoccurrence in which at least two (2) drugs taken by a recipient leadsto 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) orany 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 aretrospective and a prospective basis the proper use of outpatientdrugs 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 actiontaken by the board with a prescriber or pharmacist to inform about orto influence prescribing or dispensing practices or utilization ofdrugs.
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 orunderutilization" means the use of a drug in such quantities wherethe 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 individualwho 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 individualwho 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 thepart 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 problemsbased on explicit and predetermined criteria and standards thatare developed on an ongoing basis with professional input; and
(3) is to provide for the counseling of recipients about theproper 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 thepart of the drug utilization review program that assesses or measuresdrug use based on an historical review of drug use data againstpredetermined and explicit criteria and standards that are developedon 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 acceptablerange of deviation from the criteria that reflects local medicalpractice 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 surveillanceutilization 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 isconsistent with the criteria and standards developed under thischapter.
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 agentsprimarily characterized by a significant similarity of the biochemicalor 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" meansthe 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 andwhere 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 thestate responsible for providing or managing any part of the Medicaidoutpatient 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 careorganization 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 thepractice of medicine or osteopathic medicine in Indiana underIC 25-22.5.
(2) Four (4) individuals licensed under IC 25-26 and activelyengaged in the practice of pharmacy in Indiana.
(3) One (1) individual with expertise in therapeuticpharmacology who is neither a physician or a pharmacist.
(4) A representative of the office who shall serve as anex-officio nonvoting member of the board.
(5) One (1) individual who:
(A) is employed by a health maintenance organization thathas a pharmacy benefit; and
(B) has expertise in formulary development and pharmacybenefit administration.
The individual appointed under this subdivision may not beemployed by a health maintenance organization that is under
contract or subcontract with the state to provide services toMedicaid 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 therapeuticscommittee member shall fully disclose any potential conflicts ofinterest, financial or otherwise, relating to an issue that comes beforethe board or committee for recommendation or other action.
(b) A board member or therapeutics committee member may notvote on a recommendation or other action if the member or themember'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 maynot vote on a recommendation or other action under subsection (b)may still participate in any discussions regarding therecommendation 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 asubcommittee of the board.
(b) The chairperson of the board elected under section 25 of thischapter shall, with the approval of a majority of a quorum of theboard, appoint the members of the therapeutics committee.
(c) The therapeutics committee is composed of the followingmembers:
(1) Five (5) physicians licensed under IC 25-22.5, including:
(A) one (1) physician with expertise in the area of familypractice;
(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 internalmedicine and who specializes in the treatment of diabetes.
(2) Two (2) pharmacists who are licensed under IC 25-26 andwho have a doctor of pharmacy degree or an equivalent degree.
(d) Not more than three (3) of the individuals appointed by thechairperson under subsection (b) to the therapeutics committee mayalso 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, thissubsection does not apply to a physician or a pharmacist whose onlycontract with the state is a Medicaid provider agreement underIC 12-15-11 or a provider agreement under the children's healthinsurance 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 thecompletion of the member's term.
(h) The expenses of the therapeutics committee shall be paid bythe office.
(i) Each member of the therapeutics committee is entitled to theminimum salary per diem provided by IC 4-10-11-2.1(b). Themember is also entitled to reimbursement for traveling expenses asprovided under IC 4-13-1-4 and other expenses actually incurred inconnection with the member's duties as provided in the state policiesand procedures established by the Indiana department ofadministration and approved by the budget agency.
(j) The affirmative votes of a majority of a quorum of thetherapeutics committee are required for the committee to take actionon any measure. A quorum of the therapeutics committee consists offour (4) members.
(k) The therapeutics committee shall meet:
(1) upon the call of the chairperson of the therapeuticscommittee; and
(2) at least quarterly.
(l) The chairperson and the vice chairperson of the therapeuticscommittee:
(1) each serve for a term of one (1) year; and
(2) must be elected from the therapeutics committee'smembership at the therapeutics committee's first meeting eachcalendar year.
(m) A meeting held by the therapeutics committee must be opento the public in accordance with IC 5-14-1.5. However, thetherapeutics committee may meet in executive session only for thepurpose 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 thegovernor and serve a term of three (3) years.
(b) The governor shall fill a vacancy on the board by appointinga 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 moreof the following:
(1) Clinically appropriate prescribing of outpatient drugs.
(2) Clinically appropriate dispensing and monitoring ofoutpatient 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 shallprovide 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 reappointedupon 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 themembers of the board.
(b) The chairman may be re-elected to serve consecutive terms aschairman.
(c) A member of the board who is not a state employee is entitledto 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 travelingexpenses and other expenses actually incurred in connection with themember's duties as provided in the state travel policies andprocedures established by the Indiana department of administrationand the budget agency.
(d) Each member of the board who is a state employee is entitledto reimbursement for traveling expenses actually incurred inconnection with the member's duties, as provided in the state travelpolicies and procedures established by the Indiana department ofadministration 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 theboard.
(b) The secretary shall provide staff for the therapeuticscommittee.
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 theretrospective 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, inaccordance with the provisions of IC 4-22-2 and subject to anyoffice approval that is required by the federal Omnibus BudgetReconciliation Act of 1990 under Public Law 101-508 and itsimplementing regulations.
(2) The implementation of a Medicaid retrospective andprospective DUR program as outlined in this chapter, includingthe approval of software programs to be used by the pharmacistfor prospective DUR and recommendations concerning theprovisions of the contractual agreement between the state andany other entity that will be processing and reviewing Medicaiddrug claims and profiles for the DUR program under thischapter.
(3) The development and application of the predeterminedcriteria and standards for appropriate prescribing to be used inretrospective and prospective DUR to ensure that such criteriaand standards for appropriate prescribing are based on thecompendia and developed with professional input withprovisions for timely revisions and assessments as necessary.
(4) The development, selection, application, and assessment ofinterventions for physicians, pharmacists, and patients that areeducational and not punitive in nature.
(5) The publication of an annual report that must be subject topublic comment before issuance to the federal Department ofHealth and Human Services and to the Indiana legislativecouncil by December 1 of each year. The report issued to thelegislative council must be in an electronic format underIC 5-14-6.
(6) The development of a working agreement for the board toclarify the areas of responsibility with related boards oragencies, 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 forphysicians or pharmacists under this chapter.
(8) The publication and dissemination of educationalinformation to physicians and pharmacists regarding the boardand the DUR program, including information on the following: (A) Identifying and reducing the frequency of patterns offraud, abuse, gross overuse, or inappropriate or medicallyunnecessary care among physicians, pharmacists, andrecipients.
(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 toensure 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 individualphysicians, pharmacists, or recipients.
(10) The implementation of additional drug utilization reviewwith respect to drugs dispensed to residents of nursing facilitiesshall not be required if the nursing facility is in compliance withthe drug regimen procedures under 410 IAC 16.2-3.1 and 42CFR 483.60.
(11) The research, development, and approval of a preferreddrug 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 theoffice provides a prescription drug benefit and subject toIC 12-15-5; and
(D) the children's health insurance program underIC 12-17.6;
in consultation with the therapeutics committee.
(12) The approval of the review and maintenance of thepreferred drug list at least two (2) times per year.
(13) The preparation and submission of a report concerning thepreferred drug list at least two (2) times per year to the selectjoint commission on Medicaid oversight established byIC 2-5-26-3.
(14) The collection of data reflecting prescribing patternsrelated to treatment of children diagnosed with attention deficitdisorder or attention deficit hyperactivity disorder.
(15) Advising the Indiana comprehensive health insuranceassociation established by IC 27-8-10-2.1 concerningimplementation of chronic disease management andpharmaceutical management programs under IC 27-8-10-3.5.
(b) The board shall use the clinical expertise of the therapeuticscommittee in developing a preferred drug list. The board shall alsoconsider expert testimony in the development of a preferred drug list. (c) In researching and developing a preferred drug list undersubsection (a)(11), the board shall do the following:
(1) Use literature abstracting technology.
(2) Use commonly accepted guidance principles of diseasemanagement.
(3) Develop therapeutic classifications for the preferred druglist.
(4) Give primary consideration to the clinical efficacy orappropriateness of a particular drug in treating a specificmedical condition.
(5) Include in any cost effectiveness considerations the costimplications of other components of the state's Medicaidprogram and other state funded programs.
(d) Prior authorization is required for coverage under a programdescribed in subsection (a)(11) of a drug that is not included on thepreferred drug list.
(e) The board shall determine whether to include a single sourcecovered outpatient drug that is newly approved by the federal Foodand Drug Administration on the preferred drug list not later thansixty (60) days after the date on which the manufacturer notifies theboard in writing of the drug's approval. However, if the boarddetermines that there is inadequate information about the drugavailable to the board to make a determination, the board may havean additional sixty (60) days to make a determination from the datethat the board receives adequate information to perform the board'sreview. Prior authorization may not be automatically required for asingle source drug that is newly approved by the federal Food andDrug 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 notbeen reviewed by the board.
(f) The board may not exclude a drug from the preferred drug listbased solely on price.
(g) The following requirements apply to a preferred drug listdeveloped under subsection (a)(11):
(1) Except as provided by IC 12-15-35.5-3(b) andIC 12-15-35.5-3(c), the office or the board may require priorauthorization for a drug that is included on the preferred druglist under the following circumstances:
(A) To override a prospective drug utilization review alert.
(B) To permit reimbursement for a medically necessarybrand name drug that is subject to generic substitution underIC 16-42-22-10.
(C) To prevent fraud, abuse, waste, overutilization, orinappropriate utilization.
(D) To permit implementation of a disease managementprogram.
(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 includedon the preferred drug list.
(3) The office may add a drug that has been approved by thefederal Food and Drug Administration to the preferred drug listwithout prior approval from the board.
(4) The board may add a drug that has been approved by thefederal Food and Drug Administration to the preferred drug list.
(h) At least two (2) times each year, the board shall provide areport to the select joint commission on Medicaid oversightestablished by IC 2-5-26-3. The report must contain the followinginformation:
(1) The cost of administering the preferred drug list.
(2) Any increase in Medicaid physician, laboratory, or hospitalcosts or in other state funded programs as a result of thepreferred drug list.
(3) The impact of the preferred drug list on the ability of aMedicaid recipient to obtain prescription drugs.
(4) The number of times prior authorization was requested, andthe number of times prior authorization was:
(A) approved; and
(B) disapproved.
(i) The board shall provide the first report required undersubsection (h) not later than six (6) months after the board submitsan 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 section20.5 of this chapter shall do the following:
(1) Advise and make recommendations to the board in theboard's development and maintenance of a preferred drug listunder section 28 of this chapter.
(2) Submit to the board a proposed preferred drug list that hasbeen approved by a majority of a quorum of the therapeuticscommittee.
(3) Advise and make recommendations to the board in theboard'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 authorizationlimitation; rules
Sec. 28.7. (a) The board shall submit the initial approvedpreferred drug list to the office not later than August 1, 2002. (b) Except as permitted under subsection (g), the office may notfurther restrict the status of a drug in the Medicaid program or thechildren's health insurance program until the board reviews atherapeutic classification and the office implements the therapeuticclassification on the preferred drug list.
(c) The office shall provide advance notice to providers of thecontents of the preferred drug list submitted by the board undersubsection (a).
(d) Notwithstanding IC 12-15-13-6, the office shall implement anychange in the preferred drug list not later than thirty (30) days afterthe date the board submits the amended list to the office.
(e) Except as provided by section 28(g)(3) of this chapter, theoffice may not implement a preferred drug list or an amendment tothe preferred drug list that has not been approved by the board.
(f) The office may not require prior authorization for a drug thatis excluded from the preferred drug list unless the board has madethe determinations required under section 35 of this chapter.
(g) The office may adopt rules under IC 4-22-2 necessary to carryout 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 forprescribing
Sec. 29. (a) A quorum consists of six (6) voting members of theboard.
(b) DUR criteria and standards for appropriate prescribing mayonly be implemented with the approval of a majority of the quorumof the board. The majority vote must include at least three (3) of thefour (4) physician members of the board and may allow the board toaccept 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 section28(a)(3) of this chapter for appropriate prescribing that areimplemented must reflect the local practices of physicians to monitorthe 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) ofthis chapter that involves a physician must be approved by at leastthree (3) of the four (4) physician members of the board beforeimplementation.
(b) An intervention that involves a pharmacist must be approvedby at least three (3) of the four (4) pharmacist members of the boardbefore implementation.
(c) Interventions include the following:
(1) Information disseminated to physicians and pharmacists toensure that physicians and pharmacists are aware of the board'sduties and powers.
(2) Written, oral, or electronic reminders of recipient-specificor drug-specific information that are designed to ensurerecipient, physician, and pharmacist confidentiality, andsuggested changes in the prescribing or dispensing practicesdesigned to improve the quality of care.
(3) Use of face-to-face discussions between experts in drugtherapy and the prescriber or pharmacist who has been targetedfor educational intervention.
(4) Intensified reviews or monitoring of selected prescribers orpharmacists.
(5) The creation of an educational program using data providedthrough DUR to provide for active and ongoing educationaloutreach programs to improve prescribing and dispensingpractices.
(6) The timely evaluation of interventions to determine if theinterventions have improved the quality of care.
(7) The review of case profiles before the conducting of anintervention.
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 shallinclude information on the following:
(1) A description of the nature and scope of the prospectivedrug review program.
(2) A description of how pharmacies performing prospectiveDUR without computers are expected to comply with thestatutory requirement for written criteria.
(3) Detailed information on the specific criteria and standardsin use and any changes in criteria.
(4) A description of the nature and scope of the retrospectiveDUR program. (5) A summary of the educational interventions used and anassessment of the effect of these educational interventions onthe quality of care.
(6) An estimate of the cost savings generated as a result of theDUR program including savings to the Medicaid drug programattributable to the prospective and retrospective DUR.
(7) An overview of the fiscal impact of the DUR program onother areas of the Medicaid program.
(8) A quantifiable assessment of how DUR has improvedquality of care.
(9) A summary of the total number of prescriptions reviewed bydrug 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 cumulativenonidentifying information
Sec. 34. (a) Information that identifies an individual collectedunder this chapter is confidential and may not be disclosed by theboard.
(b) The board may have access to identifying information forpurposes of carrying out intervention activities. The identifyinginformation may not be released to anyone other than a member ofthe board.
(c) The board may release cumulative non-identifying informationfor 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 singlesource drug on prior approval, restrict the drug in its use, or establisha drug monitoring process or program to measure or restrictutilization of single source drugs other than in the SURS program,the board must meet the following conditions:
(1) Make a determination, after considering evidence andcredible information provided to the board by the office and thepublic, that placing a single source drug on prior approval orrestricting the drug's use will not:
(A) impede the quality of patient care in the Medicaidprogram; 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 singlesource drug after the office provides at least fifteen (15) daysnotification to the public that the board will review the
formulary or restriction on a single source drug at a particularboard meeting. The notification shall contain the followinginformation:
(A) A statement of the date, time, and place at which theboard meeting will be convened.
(B) A general description of the subject matter of the boardmeeting.
(C) An explanation of how a copy of the formulary to bediscussed at the meeting may be obtained.
The board shall meet to review the formulary or the restrictionon a single source drug at least fifteen (15) days but not morethan sixty (60) days after the notification.
(3) Ensure that:
(A) there is access to at least two (2) alternative drugs withineach therapeutic classification, if available, on theformulary; and
(B) a process is in place through which a Medicaid recipienthas access to medically necessary drugs.
(4) Reconsider the drug's removal from its restricted status orfrom prior approval not later than six (6) months after the singlesource drug is placed on prior approval or restricted in its use.
(5) Ensure that the program provides either telephone or FAXapproval or denial Monday through Friday, twenty-four (24)hours a day. The office must provide the approval or denialwithin twenty-four (24) hours after receipt of a prior approvalrequest. The program must provide for the dispensing of at leasta seventy-two (72) hour supply of the drug in an emergencysituation or on weekends.
(6) Ensure that any prior approval program or restriction on theuse of a single source drug is not applied to prevent acceptablemedical use for appropriate off-label indications.
(b) The board shall advise the office on the implementation of anyprogram 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 assistthe 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 implementationof a retrospective and prospective DUR program for Medicaidoutpatient drugs to ensure that the prescriptions are appropriate,medically necessary, and not likely to result in adverse medicaloutcomes.
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 beoperated under the guidelines and procedures established by theboard 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 informationretrieval system to analyze claims data to do the following:
(A) Identify patterns of fraud, abuse, gross overuse, andinappropriate or medically unnecessary care.
(B) Assess data on drug use against explicit predeterminedstandards that are based on the compendia and other sourcesto 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 guidelinesestablished by the board and must provide that prior to theprescription being filled or delivered a review will be conducted bythe pharmacist at the point of sale to screen for potential drug therapyproblems 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 arecovered 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 forpurposes of reviewing DUR data or to conduct or to discuss activityas provided for in IC 5-14-1.5-6.1.
(b) The board shall also conduct regular public meetings to gatherinput from the public on the operation of the DUR program.
(c) The board shall meet monthly to implement its duties underthis 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 pharmacistsas part of prospective DUR are confidential but may be released toprescribers or others according to procedures established by theboard.
As added by P.L.75-1992, SEC.19.
IC 12-15-35-43.5
Prohibiting the release of proprietary or confidential informationobtained under certain circumstances
Sec. 43.5. (a) The board, the therapeutics committee, or the officemay not release proprietary or confidential information obtained aspart of the development, implementation, or maintenance of apreferred drug list under this chapter.
(b) Information described in subsection (a) is confidential forpurposes 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 confidentialityprovisions under section 34 of this chapter commits a Class Amisdemeanor.
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 makerecommendations to the board on the development of a Medicaidoutpatient drug formulary.
(b) If the office decides to establish a Medicaid outpatient drugformulary, the formulary shall be developed by the board.
(c) A formulary, preferred drug list, or prescription drug benefitused by a Medicaid managed care organization is subject toIC 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 organizationthat enters into an initial contract with the office to be a Medicaidmanaged care organization after May 13, 1999.
(b) Before a Medicaid managed care organization described insubsection (a) implements a formulary, the managed careorganization shall submit the formulary to the office at leastthirty-five (35) days before the date that the managed careorganization implements the formulary for Medicaid recipients.
(c) The office shall forward the formulary to the board for theboard's review and recommendation.
(d) The office shall provide at least thirty (30) days notificationto the public that the board will review a Medicaid managed careorganization's proposed formulary at a particular board meeting. Thenotification shall contain the following information:
(1) A statement of the date, time, and place at which the boardmeeting will be convened.
(2) A general description of the subject matter of the boardmeeting.
(3) An explanation of how a copy of the formulary to bediscussed may be obtained.
The board shall meet to review the formulary at least thirty (30) daysbut 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 andcredible information provided to the board by the office and thepublic, that the use of the formulary will not:
(A) impede the quality of patient care in the Medicaidprogram; 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 withineach therapeutic classification, if available, on theformulary;
(B) a process is in place through which a Medicaid memberhas 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 shallmake a recommendation to the office regarding whether the proposedformulary should be approved, disapproved, or modified.
(h) The office shall rely significantly on the clinical expertise ofthe board. If the office does not agree with the recommendations ofthe board, the office shall, at a public meeting, discuss thedisagreement with the board and present any additional informationto the board for the board's consideration. The board's considerationof additional information must be conducted at a public meeting.
(i) Based on the final recommendations of the board, the officeshall approve, disapprove, or require modifications to the Medicaidmanaged care organization's proposed formulary. The office shallnotify the managed care organization of the office's decision withinfifteen (15) days of receiving the board's final recommendation.
(j) The managed care organization must comply with the office'sdecision within sixty (60) days after receiving notice of the office'sdecision.
(k) Notwithstanding the other provisions of this section, the officemay temporarily approve a Medicaid managed care organization'sproposed 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 aformulary used by a Medicaid managed care organization forMedicaid recipients:
(1) Removing one (1) or more drugs from the formulary.
(2) Placing new restrictions on one (1) or more drugs on theformulary.
(b) Before a Medicaid managed care organization makes a changedescribed in subsection (a), the managed care organization shallsubmit the proposed change to the office.
(c) The office shall forward the proposed change to the board forthe board's review and recommendation.
(d) The office shall provide at least thirty (30) days notificationto the public that the board will:
(1) review the proposed change; and
(2) consider evidence and credible information provided to theboard;
at the board's regular board meeting before making arecommendation to the office regarding whether the proposed changeshould be approved or disapproved.
(e) Based on the final recommendation of the board, the office
may approve or disapprove the proposed change. If a proposedchange is not disapproved within ninety (90) days after the date themanaged care organization submits the proposed change to theoffice, the managed care organization may implement the change tothe formulary.
(f) A Medicaid managed care organization:
(1) may add a drug to the managed care organization'sformulary without the approval of the office; and
(2) shall notify the office of any addition to the managed careorganization's formulary within thirty (30) days after makingthe 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 drugprogram; report
Sec. 48. (a) The board shall review the prescription drug programof a managed care organization that participates in the state'srisk-based managed care program at least one (1) time per year. Theboard's review of a prescription drug program must include thefollowing:
(1) An analysis of the single source drugs requiring priorauthorization, including the number of drugs requiring priorauthorization in comparison to other managed careorganizations' prescription drug programs that participate in thestate's Medicaid program.
(2) A determination and analysis of the number and the type ofdrugs 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 careorganization received for prior authorization, including thenumber of times prior authorization was approved and thenumber 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) monthperiod.
(b) A managed care organization described in subsection (a) shallprovide the board with the information necessary for the board toconduct its review under subsection (a).
(c) The board shall report to the select joint commission onMedicaid oversight established by IC 2-5-26-3 at least one (1) timeper 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 informationnecessary for the board to carry out its duties under this chapter.
(b) The office shall provide the information required undersubsection (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; pharmacyparticipation 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 theweb site any changes concerning the office's maximum allowablecost schedule for drugs.
(c) A change in the office's maximum allowable cost schedule fordrugs may not take effect less than thirty (30) days after the changeis posted on the office's Internet web site.
(d) The office is not required to mail a notice to providersconcerning a change in the office's maximum allowable costschedule for drugs.
(e) A pharmacy may determine not to participate in the Medicaidprogram because of a change to the office's maximum allowable costschedule for drugs if the pharmacy notifies the office not less thanthirty (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 advisorycommittee; members; reimbursement; duties
Sec. 51. (a) As used in this section, "advisory committee" refersto the mental health Medicaid quality advisory committee establishedby subsection (b).
(b) The mental health Medicaid quality advisory committee isestablished. The advisory committee consists of the followingmembers:
(1) The director of the office or the director's designee, whoshall serve as chairperson of the advisory committee.
(2) The director of the division of mental health and addictionor the director's designee.
(3) A representative of a statewide mental health advocacyorganization.
(4) A representative of a statewide mental health providerorganization.
(5) A representative from a managed care organization thatparticipates in the state's Medicaid program.
(6) A member with expertise in psychiatric researchrepresenting 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 theadvisory committee.
(c) The office shall staff the advisory committee. The expenses ofthe advisory committee shall be paid by the office.
(d) Each member