CHAPTER 35.5. PRESCRIPTION DRUGS
IC 12-15-35.5
Chapter 35.5. Prescription Drugs
IC 12-15-35.5-1
Applicability
Sec. 1. This chapter applies to:
(1) the Medicaid program under this article; and
(2) the children's health insurance program under IC 12-17.6.
As added by P.L.6-2002, SEC.4. Amended by P.L.101-2005, SEC.5.
IC 12-15-35.5-2
"Cross-indicated drug" defined
Sec. 2. As used in this chapter, "cross-indicated drug" means adrug that is used for a purpose generally held to be reasonable,appropriate, and within the community standards of practice eventhough the use is not included in the federal Food and DrugAdministration's approved labeled indications for the drug.
As added by P.L.6-2002, SEC.4.
IC 12-15-35.5-2.5
"Unrestricted access" defined
Sec. 2.5. As used in this chapter, "unrestricted access" means theability of a recipient to obtain a prescribed drug without beingsubject to limits or preferences imposed by the office or the board forthe purpose of cost savings except as provided under section 7 of thischapter.
As added by P.L.107-2002, SEC.23. Amended by P.L.184-2003,SEC.10.
IC 12-15-35.5-2.6
"Waste"
Sec. 2.6. As used in this chapter, "waste" means inappropriate:
(1) overprescribing;
(2) underprescribing;
(3) overutilization;
(4) underutilization;
(5) recipient noncompliance with the prescribed regimen; or
(6) clinically unjustified utilization;
of a prescription drug.
As added by P.L.11-2010, SEC.2.
IC 12-15-35.5-3
Prohibits prior authorization of mental health drugs
Sec. 3. (a) Except as provided in subsection (b), the office mayestablish prior authorization requirements for drugs covered under aprogram described in section 1 of this chapter.
(b) The office may not require prior authorization for thefollowing single source or brand name multisource drugs:
(1) A drug that is classified as an antianxiety, antidepressant, orantipsychotic central nervous system drug in the most recent
publication of Drug Facts and Comparisons (published by theFacts and Comparisons Division of J.B. Lippincott Company).
(2) A drug that, according to:
(A) the American Psychiatric Press Textbook ofPsychopharmacy;
(B) Current Clinical Strategies for Psychiatry;
(C) Drug Facts and Comparisons; or
(D) a publication with a focus and content similar to thepublications described in clauses (A) through (C);
is a cross-indicated drug for a central nervous system drugclassification described in subdivision (1).
(3) A drug that is:
(A) classified in a central nervous system drug category orclassification (according to Drug Facts and Comparisons)that is created after March 12, 2002; and
(B) prescribed for the treatment of a mental illness (asdefined in the most recent publication of the AmericanPsychiatric Association's Diagnostic and Statistical Manualof Mental Disorders).
(c) Except as provided under section 7 of this chapter, a recipientenrolled in a program described in section 1 of this chapter shall haveunrestricted access to a drug described in subsection (b).
As added by P.L.6-2002, SEC.4. Amended by P.L.101-2005, SEC.6;P.L.1-2009, SEC.104.
IC 12-15-35.5-4
Prior authorization requirement parameters
Sec. 4. Prior authorization requirements developed under thischapter must:
(1) comply with all applicable state and federal laws, includingthe provisions of 405 IAC 5-3 and 42 U.S.C. 1396r-8(d)(5); and
(2) provide that the prior authorization number assigned to anapproved request be included on the prescription or drug order:
(A) issued by the prescribing practitioner; or
(B) if the prescription is transmitted orally, relayed to thedispensing pharmacist by the prescribing practitioner.
As added by P.L.6-2002, SEC.4. Amended by P.L.107-2002, SEC.24.
IC 12-15-35.5-5
Prior authorization procedures
Sec. 5. Before requiring prior authorization for a single sourcedrug, the office shall seek the advice of the drug utilization reviewboard, established by IC 12-15-35-19, at a public meeting of theboard.
As added by P.L.6-2002, SEC.4.
IC 12-15-35.5-6
Publication of prior authorization decision
Sec. 6. (a) The office shall publish the decision to require priorauthorization for a single source drug in a provider bulletin. (b) IC 12-15-13-6 applies to a provider bulletin described insubsection (a).
As added by P.L.6-2002, SEC.4.
IC 12-15-35.5-7
Limitations on drug refills; limitations on restrictions on certainmental health drugs
Sec. 7. (a) Subject to subsections (b) and (c), the office may placelimits on quantities dispensed or the frequency of refills for anycovered drug for the purpose of:
(1) preventing fraud, abuse, or waste;
(2) preventing overutilization, inappropriate utilization, orinappropriate prescription practices that are contrary to:
(A) clinical quality and patient safety; and
(B) accepted clinical practice for the diagnosis and treatmentof mental illness; or
(3) implementing a disease management program.
(b) Before implementing a limit described in subsection (a), theoffice shall:
(1) consider quality of care and the best interests of Medicaidrecipients;
(2) seek the advice of the drug utilization review board,established by IC 12-15-35-19, at a public meeting of the board;and
(3) publish a provider bulletin that complies with therequirements of IC 12-15-13-6.
(c) Subject to subsection (d), the board may establish and theoffice may implement a restriction on a drug described in section3(b) of this chapter if:
(1) the board determines that data provided by the officeindicates that a situation described in IC 12-15-35-28(a)(8)(A)through IC 12-15-35-28(a)(8)(K) requires an intervention to:
(A) prevent fraud, abuse, or waste;
(B) prevent overutilization, inappropriate utilization, orinappropriate prescription practices that are contrary to:
(i) clinical quality and patient safety; and
(ii) accepted clinical practice for the diagnosis andtreatment of mental illness; or
(C) implement a disease management program; and
(2) the board approves and the office implements an educationalintervention program for providers to address the situation.
(d) A restriction established under subsection (c) for any drugdescribed in section 3(b) of this chapter:
(1) must comply with the procedures described inIC 12-15-35-35;
(2) may include requiring a recipient to be assigned to one (1)practitioner and one (1) pharmacy provider for purposes ofreceiving mental health medications;
(3) may not lessen the quality of care; and
(4) must be in the best interest of Medicaid recipients. (e) Implementation of a restriction established under subsection(c) must provide for the dispensing of a temporary supply of the drugfor a prescription not to exceed seven (7) business days, if additionaltime is required to review the request for override of the restriction.This subsection does not apply if the federal Food and DrugAdministration has issued a boxed warning under 21 CFR 201.57(e)that applies to the drug and is applicable to the patient.
(f) Before implementing a restriction established under subsection(c), the office shall:
(1) seek the advice of the mental health Medicaid qualityadvisory committee established by IC 12-15-35-51; and
(2) publish a provider bulletin that complies with therequirements of IC 12-15-13-6.
(g) Subsections (c) through (f):
(1) apply only to drugs described in section 3(b) of this chapter;and
(2) do not apply to a restriction on a drug described in section3(b) of this chapter that was approved by the board andimplemented by the office before April 1, 2003.
As added by P.L.6-2002, SEC.4. Amended by P.L.184-2003, SEC.11;P.L.101-2005, SEC.7; P.L.8-2007, SEC.1; P.L.36-2009, SEC.3.
IC 12-15-35.5-8
Restriction of mental health drugs for individuals less than 18years of age
Sec. 8. In addition to the limits described in section 7 of thischapter, the office may restrict a mental health drug described insection 3 of this chapter that is prescribed for an individual who isless than eighteen (18) years of age if federal financial participationis not available for reimbursement for the prescription underIC 12-15-5-2.
As added by P.L.11-2010, SEC.3.