Second-Generation Antipsychotic Drug Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns
Michala Walker, a team leader for the Office of Evaluation and Inspections in Kansas City, is interviewed by Brian Whitley, Regional Inspector General for the Office of Evaluation and Inspections.
WHY WE DID THIS STUDY
Second-generation antipsychotics (SGAs) are a class of drugs used to treat psychiatric disorders, such as schizophrenia, bipolar disorder, and psychotic depression. SGAs are widely used to treat children enrolled in Medicaid who have mental health conditions. However, SGAs can have serious side effects and little clinical research has been conducted on the safety of treating children with these drugs. Consequently, children's treatment with SGAs needs careful management and monitoring. This evaluation examines the quality of care provided to children receiving SGAs that were paid for by Medicaid.
HOW WE DID THIS STUDY
We selected a sample of 687 claims for SGAs prescribed to children in California, Florida, Illinois, New York, and Texas. These States represented approximately 39 percent of total Medicaid payments for SGAs in 2011. Board-certified child and adolescent psychiatrists reviewed medical records related to the sampled claims using seven criteria related to quality-of-care concerns (see the chart below for the criteria). We established these criteria on the basis of information and guidelines issued by various Federal and State agencies and professional associations regarding the prescribing of psychotropic drugs to children.
WHAT WE FOUND
In the five States, 8 percent of SGAs were prescribed for the limited number of medically accepted pediatric indications. There are only five SGAs with medically accepted pediatric indications. It is not uncommon for doctors to prescribe, or Medicaid to pay for, SGAs for children for indications that are not medically accepted. Medically accepted indications include both uses of drugs approved by the Food and Drug Administration (FDA) and uses supported by one or more of three drug compendia. It is difficult to conduct the clinical trials needed to obtain FDA approval or compendia support for pediatric uses of drugs.
Three of the eleven SGAs carry an FDA boxed warning regarding increased chances of suicidal thinking and behavior in pediatric patients. We found that over a third of SGAs were prescribed in the presence of conditions described in the FDA boxed warning. Physicians are not prohibited from prescribing a drug for a patient who has the condition(s) specified in the FDA boxed warning if the physician judges that the benefits may outweigh the risks.
WHAT WE RECOMMEND
To ensure the quality of the care provided to children receiving SGAs, we made three recommendations to CMS. First, we recommended that CMS work with State Medicaid programs to perform utilization reviews of SGAs prescribed to children. Second, we recommended that CMS work with State Medicaid programs to conduct periodic reviews of medical records associated with claims for SGAs prescribed to children. Third, we recommended that CMS work with States to consider other methods of enhanced oversight of SGAs prescribed to children, such as implementing peer review programs. CMS concurred with all three recommendations.