Medicaid Prior Authorization Policies for Pediatric Use of Antipsychotic Medications

Over the past 2 decades, antipsychotic prescribing to youth, almost exclusively comprising atypical antipsychotic medications, was estimated to have increased from 0.16% in 1993-1998 to 1.07% in 2005-2009 in office-based physician visits.¹ Antipsychotic use is also 5-fold greater in Medicaid-insured youth than in privately insured youth,² and occurs mostly for youth with clinician-reported externalizing behavior disorders^1,2 rather than indications approved by the US Food and Drug Administration (FDA) and indications that are evidence-supported without FDA-approved labeling (eg, psychotic disorders, bipolar disorder, autism-related irritability, and tic disorders).³ The evidence for atypical antipsychotic use among preschoolers and younger children is particularly limited.³

In light of antipsychotic treatment-emergent cardiometabolic adverse events,⁴ several government reports called for efforts to improve pediatric psychotropic medication oversight in state Medicaid agencies.⁵ Such efforts include telephone access lines through which prescribers can consult with psychiatrists, letters to prescribers, and, recently, age-restricted prior authorization policies, which require clinicians to obtain preapproval from Medicaid agencies to prescribe atypical antipsychotics to children younger than a certain age as a condition for coverage.

A distinct subset of these age-restricted prior authorization policies, classified as peer review policies, brings clinical expertise into the review process by requiring contracted clinicians (peer reviewers) to adjudicate antipsychotic prescriptions for children. Several studies in adults have shown Medicaid prior authorization policies can reduce antipsychotic use. To facilitate empirical evaluation of these policies in youth, we identified state Medicaid programs with a prior authorization policy in effect for pediatric atypical antipsychotic prescribing and characterized these policies according to age-restriction criteria and whether a peer review process was present.

We reviewed antipsychotic-related Medicaid prior authorization policies for youth (<18 years) in 50 states plus the District of Columbia between June 2013 and August 2014. Two authors (I.S., M.B.) extracted information from web documents relating to prior authorization, including a basic policy description, the date it went into effect, the professionals involved in performing the review, and the age-restriction criteria. Incomplete or unclear information from 43 agencies was supplemented by email exchange. All authors agreed on interpretation of the collected data.

Thirty-one states have implemented prior authorization policies for atypical antipsychotic prescribing to children, mostly within the past 5 years (Table 1). Most states apply their policies to children younger than 5, 6, or 7 years of age. Only 7 states (Alabama, Kentucky, Maryland, Nevada, North Carolina, Pennsylvania, Tennessee) apply their policies to Medicaid-insured youth up to age 18 years. Seven other states (California, Colorado, Georgia, Mississippi, Nebraska, New York, Washington) have age-restriction criteria that vary by drug entity. Among these, Colorado, Georgia, and Mississippi set separate age restrictions for antipsychotic entities based on the FDA-approved minimum pediatric age and diagnosis criteria for these drugs.

Of the 31 states, 15 have incorporated a peer review process, wherein the adjudication process usually involves a psychiatrist or other physician specialty (Table 2). The programs without a peer review process use automated systems or nonphysician manual reviews for adjudication.

Overall, 31 state Medicaid agencies have implemented prior authorization policies targeting pediatric atypical antipsychotic use. Nearly half of these policies have incorporated a clinical peer review process. The findings may inform pediatric research to assess the effect of these policies on atypical antipsychotic use to ensure clinical appropriateness and to minimize unintended consequences. A recent study of a mid-Atlantic state has, however, shown minimal effect of such a policy in reducing antipsychotic use in children below the age restriction.⁶

Potential unintended consequences of these restrictive policies include inadequate treatment, substitution of potentially inappropriate, off-label psychotropic medication classes such as anticonvulsant mood stabilizers and antidepressants, and administrative burden on prescribers. Additionally, Medicaid oversight programs should be concerned not only with unnecessary antipsychotic use, but also should ensure adherence to appropriate cardiometabolic monitoring practices at baseline and during antipsychotic treatment, and support access to alternative evidence-based nonpharmacological treatments.

Our study does not provide additional details within specific programs (eg, criteria for antipsychotic dosage, concomitant pharmacotherapy, or the extent of clinical information required for adjudication), but does provide an impetus to learn if peer review, a novel approach, advances the quality of care.

Corresponding Author: Julie M. Zito, PhD, Department of Pharmaceutical Health Services Research, University of Maryland, 220 Arch St, Baltimore, MD 21201 (jzito@rx.umaryland.edu).

Author Contributions: Dr Zito had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: All authors.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Schmid, Burcu.

Critical revision of the manuscript for important intellectual content: All authors.

Administrative, technical, or material support: All authors.

Study supervision: Zito.

Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

Funding/Support: This study was funded by the US Food and Drug Administration (FDA). Mr Schmid was supported in part by a fellowship administered by the Oak Ridge Institute for Science and Education and funded by the US FDA.

Role of the Funder/Sponsor: The FDA had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation of the manuscript; and decision to submit the manuscript for publication. The FDA did participate in the review and approval of the manuscript; however, the study authors functioned as investigators without direction or interference by the FDA.

Disclaimer: The opinions expressed in this research letter are those of the authors and do not necessarily represent the opinions of the US government or the FDA.