Section 12-15-35.5-7 - Limitations on drug refills; limitations on restrictions on certain mental health drugs(a) Subject to subsections (b) and (c), the office may place limits on quantities dispensed or the frequency of refills for any covered drug as required by law or for the purpose of:(1) preventing fraud, abuse, or waste;(2) preventing overutilization, inappropriate utilization, or inappropriate prescription practices that are contrary to:(A) clinical quality and patient safety; and(B) accepted clinical practice for the diagnosis and treatment of mental illness and the considerations specified in subsection (h); or(3) implementing a disease management program.(b) Before implementing a limit described in subsection (a), the office shall: (1) consider quality of care and the best interests of Medicaid recipients;(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 the requirements of IC 12-15-13-6.(c) Subject to subsection (d), the board may establish and the office may implement a restriction on a drug described in section 3(b) of this chapter if: (1) the board determines that data provided by the office indicates that a situation described in IC 12-15-35-28(a)(7)(A) through IC 12-15-35-28(a)(7)(K) requires an intervention to:(A) prevent fraud, abuse, or waste;(B) prevent overutilization, inappropriate utilization, or inappropriate prescription practices that are contrary to:(i) clinical quality and patient safety; and(ii) accepted clinical practice for the diagnosis and treatment of mental illness; or(C) implement a disease management program; and(2) the board approves and the office implements an educational intervention program for providers to address the situation.(d) A restriction established under subsection (c) for any drug described in section 3(b) of this chapter: (1) must comply with the procedures described in IC 12-15-35-35;(2) may include requiring a recipient to be assigned to one (1) practitioner and one (1) pharmacy provider for purposes of receiving 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 drug for a prescription not to exceed seven (7) business days, if additional time is required to review the request for override of the restriction. This subsection does not apply if the federal Food and Drug Administration has issued a boxed warning under 21 CFR 201.57(c)(1) 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 quality advisory committee established by IC 12-15-35-51; and(2) publish a provider bulletin that complies with the requirements 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 section 3(b) of this chapter that was approved by the board and implemented by the office before April 1, 2003.(h) Restrictions referred to in subsection (c) to prevent overutilization, inappropriate utilization, or inappropriate prescription practices that are contrary to accepted clinical practices may include the implementation of the following: (1) Encouraging dosages that enhance recipient adherence to a drug regimen.(2) Encouraging monotherapy with limitations on the number of drugs from a specific drug class that a recipient may be taking at any one (1) time when there is no documentation of the severity and intensity of the target symptoms.(3) Limiting the total number of scheduled psychiatric medications that a recipient may be taking at any one (1) time, when such limit is based on:(A) established best practices; or(B) guidelines implemented by the division of mental health and addiction for mental health state operated facilities.(4) Encouraging, in accordance with IC 16-42-22-10, generic substitution when such a substitution would result in a net cost savings to the Medicaid program.(i) Restrictions under subsection (h) may be overridden through the prior authorization review process in cases in which the prescriber demonstrates medical necessity for the prescribed medication.Amended by P.L. 210-2015, SEC. 51, eff. 7/1/2015.Amended by P.L. 7-2015, SEC. 35, eff. 7/1/2015.Amended by P.L. 229-2011, SEC. 145, eff. 7/1/2011.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.