Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

SECOND-GENERATION 

ANTIPSYCHOTIC DRUG USE 

AMONG MEDICAID-ENROLLED 

CHILDREN: QUALITY-OF-CARE 

CONCERNS 

Daniel R. Levinson 

Inspector General 

March 2015 

OEI-07-12-00320 
 

EXECUTIVE SUMMARY: SECOND-GENERATION ANTIPSYCHOTIC DRUG USE AMONG 

MEDICAID-ENROLLED CHILDREN: QUALITY-OF-CARE CONCERNS 

OEI-07-12-00320 

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 

The graphic below illustrates the percentages of quality-of-care concerns identified in the medical records 

associated with claims for SGAs prescribed to children. 

Medical reviewers identified multiple quality-of-care concerns for many claims. 

Source: OIG analysis of Medicaid claims in five states, 2014. 
 

 

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 

the Centers for Medicare & Medicaid Services (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. 
 

 

TABLE OF CONTENTS 

Objectives ....................................................................................................1 

Background..................................................................................................1 

Methodology................................................................................................6 

Findings........................................................................................................9 

In the five States studied, quality-of-care concerns were 

identified in the medical records for 67 percent of claims for 

SGAs prescribed to children ............................................................9 

In the five States studied, 8 percent of SGAs were prescribed 

for the limited number of medically accepted pediatric uses ........12 

Conclusion and Recommendations ............................................................15 

Agency Comments and Office of Inspector General Response .....16 

Appendixes ................................................................................................17 

A: FDA Boxed Warning Regarding Children on SGA
 

Product Labeling............................................................................17 

B: Sources of Guidance and Information on the Use of SGAs 

To Treat Children ...........................................................................18 

C: Detailed Methodology..............................................................21 

D: Descriptive Data on Population and Sampled Claims .............26 

E: Statistical Estimates and Confidence Intervals ........................29 

F: Agency Comments....................................................................31 

Acknowledgments......................................................................................35 
 

 

 

 

 

 

OBJECTIVES 

To determine the extent to which claims for second-generation antipsychotics 

(SGAs) prescribed to children enrolled in Medicaid in five selected States: 

1.	 presented quality-of-care concerns and 

2.	 were prescribed for indications other than medically accepted indications 

and/or in the presence of conditions specified in the Food and Drug 

Administration (FDA) boxed warning. 

BACKGROUND 

FDA Approval of SGAs 

FDA must approve drugs before companies can legally sell them in the United 

States.1

 If FDA determines that a drug’s benefits for its intended use outweigh its 

known risks, then FDA approves the drug for sale.2 At the time of our review, 

FDA had approved five SGAs for use by children in the treatment of 

schizophrenia, bipolar disorder, and irritability associated with autistic disorder.3, 4 

The five SGAs that FDA has approved for use by children are aripiprazole, 

olanzapine, paliperidone, quetiapine fumarate, and risperidone. Aripiprazole and 

risperidone are approved to treat all three of the diagnoses named above. 

Olanzapine and quetiapine fumarate are approved to treat schizophrenia and 

bipolar disorder. Paliperidone is approved to treat only schizophrenia. There are 

six additional SGAs with FDA-approved uses for adults.5 

Off-label uses of FDA-approved drugs. After FDA approves a drug for a specific 

use, physicians are permitted to prescribe that drug for other uses. Prescribing 

drugs for nonapproved uses is often referred to as “off-label prescribing.” 

Off-label prescribing is not uncommon, especially for drugs prescribed to 

____________________________________________________________ 

1

 FDA approval of a drug is based on the results of testing for safety and efficacy by the company 

wishing to sell the drug. FDA, Development and Approval Process (Drugs). Accessed at 

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm on May 12, 2014. 2

 FDA, Approved Drugs: Questions and Answers. Accessed at 

http://www.fda.gov/drugs/resourcesforyou/consumers/ucm054420.htm on May 12, 2014. 3

 Antipsychotic drugs are separated into two classes: first-generation (or conventional) and 

second-generation (or atypical). First-generation antipsychotic drugs were introduced in the 

1950s; SGAs were introduced in the 1990s. 

4

 These five SGAs are approved by FDA for use by children under age 18. For purposes of this 

study, we defined “children” to include those 0–17 years old during the review period to conform 

to the FDA’s age ranges. 

5 The six additional SGAs with FDA-approved uses for adults are asenapine, clozapine, 

iloperidone, lurasidone, olanzapine/fluoxetine, and ziprasidone. FDA, Atypical Antipsychotic 

Drugs Information. Accessed at http://www.fda.gov/Drugs/DrugSafety/ 

PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm on May 12, 2014. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 1 
 

 

 

 

 

 

 

children, as it is difficult to conduct the clinical trials needed for FDA approval of 

drugs for the pediatric population.6 

FDA boxed warning. If drug manufacturers and/or FDA determine that a drug 

may have severe or life-threatening risks when used to treat patients with specific 

conditions, FDA requires that the product’s labeling include a boxed warning 

describing those risks.7 However, 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. 

As of June 2012, three SGAs—aripiprazole, olanzapine/fluoxetine, and quetiapine 

fumarate—carried an FDA boxed warning specific to children. The warning 

describes the increased chance of suicidal thinking and behavior in children, 

adolescents, and young adults with major depressive disorder and other 

psychiatric disorders being treated with them. Two of these SGAs that carry the 

boxed warning—aripiprazole and quetiapine fumarate—are also among the five 

SGAs that have FDA-approved pediatric uses. See Appendix A for an example of 

the boxed warning for an SGA. 

Medicaid Coverage of Outpatient Prescription Drugs 

All State Medicaid programs cover outpatient prescription drugs.8 State Medicaid 

programs must pay for covered outpatient drugs prescribed for medically accepted 

indications and may pay for outpatient drugs not prescribed for medically 

accepted indications. 

Medically accepted indications. The Act defines “medically accepted 

indications” as both the uses approved by FDA and those uses, including off-label 

uses, that are supported by one or more of three compendia.9 At the time of our 

review, only one SGA—risperidone—had any medically accepted indications for 

pediatric use beyond those approved by FDA.10 For the other SGAs, there were 

____________________________________________________________ 

6

 FDA, Drug Research and Children. Accessed at http://www.fda.gov/Drugs/ResourcesForYou/ 

Consumers/ucm143565.htm on April 22, 2014. Institute of Medicine (US) Committee on Clinical 

Research Involving Children, Field and Berman, eds., Ethical Conduct of Clinical Research 

Involving Children, Washington, DC: National Academies Press, 2004; pp. 59 and 61. Accessed 

at http://www.ncbi.nlm.nih.gov/books/NBK25557/pdf/TOC.pdf on April 22, 2014. 7

 FDA, An FDA Guide to Drug Safety Terms. Accessed at 

http://www.fda.gov/forconsumers/consumerupdates/ucm107970.htm on May 12, 2014. 8

 Social Security Act (the Act) § 1905(a)(12); CMS, Medicaid Prescription Drugs Program. 

Accessed at http://www.medicaid.gov/Medicaid-CHIP-Program-Information/ByTopics/Benefits/Prescription-Drugs/Prescription-Drugs.html on May 12, 2014. 9

 Section 1927(g)(1)(B)(i)(I)–(III) of the Act. The three compendia are (1) the American Society 

of Health System Pharmacists, Inc.’s American Hospital Formulary Service Drug Information, 

(2) the United States Pharmacopeia—Drug Information (or its successor publications), and 

(3) DrugDEX Information System. 10 Medically accepted indications for risperidone include its FDA-approved uses as well as its use 

to treat (1) behavioral syndrome-mental retardation and (2) pervasive developmental disorder. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 2 
 

 

 

 

 

no medically accepted indications beyond the FDA-approved uses; the medically 

accepted indications and the FDA-approved uses are identical. 

Limitations on Medicaid coverage of drugs. Section 1927 of the Act establishes 

the permissible limitations on and exclusions of Medicaid coverage of outpatient 

drugs.11 Under section 1927, States can choose to limit or exclude coverage of 

outpatient drugs if the prescribed uses are not for medically accepted indications.12 

However, State Medicaid programs may choose to cover outpatient drugs not 

prescribed for medically accepted indications. Table 1 shows which SGAs have 

FDA-approved pediatric uses, which SGAs have medically accepted pediatric 

indications other than the FDA-approved pediatric uses, and which SGAs carry 

the FDA boxed warning specific to children. 

Table 1: FDA-Approved Pediatric Uses, Medically Accepted Pediatric Indications, 

and FDA Boxed Warnings on Second-Generation Antipsychotics 

Drug Name FDA-Approved 

Pediatric Use(s) 

Medically Accepted Pediatric 

Indication(s) Other Than 

FDA-Approved Pediatric Use(s) 

FDA Boxed Warning 

Specific to Children 

aripiprazole 

asenapine 

clozapine

iloperidone 

lurasidone 

olanzapine 

olanzapine/fluoxetine 

paliperidone 

quetiapine fumarate 

risperidone 

ziprasidone 

Yes 

No 

No 

No 

No 

Yes 

No 

Yes 

Yes 

Yes 

No 

No 

No 

No 

No 

No 

No 

No 

No 

No 

Yes 

No 

Yes 

No 

No 

No 

No 

No 

Yes 

No 

Yes 

No 

No 

Source: Office of Inspector General (OIG) analysis of compendia, 2014. 

Four of the five States included in this evaluation—California, Florida, Illinois, 

and Texas—covered drugs not prescribed for medically accepted indications. 

These States used information regarding medically accepted indications in 

making case-by-case coverage decisions, such as decisions on requests for prior 

____________________________________________________________ 

11 Section 1927(k)(2) of the Act defines “covered outpatient drugs” as drugs that are dispensed 

only upon prescription and that are approved for safety and effectiveness as prescription drugs 

under the Federal Food, Drug, and Cosmetic Act. 

12 Section 1927(d)(1)(B)(i) of the Act. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 3 
 

 

 

 

 

 

authorization.13 Of the five States reviewed, only New York limited coverage of 

drugs to those prescribed for medically accepted indications. 

Sources of Guidance and Information on the Use of SGAs To Treat 

Children 

There are no Federal Medicaid requirements regarding the appropriate prescribing 

of SGAs to children. However, a number of Federal and State agencies and 

professional associations have issued information and guidelines on the 

prescribing of such drugs to children.14 These guidelines and information include: 

	 AACAP practice parameter—The American Academy of Child and 

Adolescent Psychiatry’s (AACAP) practice parameter on the use of 

psychotropic medications to treat children identifies practices that may 

reduce the use of ineffective and inappropriate medications. These 

practices include developing monitoring plans, using adequate dosages 

and durations of treatment, and providing a clear rationale for the use of 

polypharmacy (the concurrent use of multiple drugs).15 

	 HEDIS measures—The National Committee for Quality Assurance 

(NCQA) publishes the Healthcare Effectiveness Data and Information Set 

(HEDIS), which is used to measure the performance of health plans.16 In 

July 2014, NCQA published new measures for HEDIS 2015 on the safe 

and judicious use of antipsychotics in children and adolescents. These 

measures assess the appropriate use and management of antipsychotic 

drugs in youth. Reporting on the new measures will begin in June 2015. 

	 ACF information memorandum—On April 11, 2012, the Administration 

for Children and Families (ACF) released an information memorandum 

entitled “Promoting the Safe, Appropriate, and Effective Use of 

Psychotropic Medication for Children in Foster Care.”17 This 

memorandum identifies three “outlier practices” that may indicate that 

issues other than clinical need are influencing the prescribing of SGAs: 

____________________________________________________________ 

13 States may require, as a condition of coverage or payment for a covered outpatient drug, that 

a drug be authorized before it is dispensed. This type of approval is known as prior authorization. 

Sections 1927(d)(1)(A) and (d)(5) of the Act. 

14 The guidance discussed here covers all psychotropic drugs—a category that includes SGAs and 

several other types of drugs. Other classes of psychotropic drugs include attention deficit/ 

hyperactivity disorder (ADHD) drugs, antianxiety drugs, antidepressants, first-generation 

antipsychotics, hypnotics, and mood stabilizers. This study focuses specifically on SGAs. 15 AACAP, “Practice Parameter on the Use of Psychotropic Medication in Children and 

Adolescents,” J. Am. Acad. Child Adolesc. Psychiatry, 2009; 48(9): 961–973. 16 State Medicaid programs may report voluntarily on the HEDIS measures. 17 ACF, Promoting the Safe, Appropriate, and Effective Use of Psychotropic Medication for 

Children in Foster Care, Log No. ACYF-CB-IM-12-03, April 11, 2012. Accessed at 

http://www.acf.hhs.gov/sites/default/files/cb/im1203.pdf on May 12, 2014. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 4 
 

 

 

 

 

 

 

prescribing too many concurrent drugs, prescribing dosages that are too 

high, and prescribing SGAs to children at too young an age. 

	 Report and Resource Guide—In 2010, a collaboration among 16 States, 

the Rutgers University Center for Education and Research on Mental 

Health Therapeutics (CERTs), and the Medicaid Medical Directors 

Learning Network (MMDLN) produced the Antipsychotic Medication Use 

in Medicaid Children and Adolescents: Report and Resource Guide From 

a 16-State Study (hereinafter referred to as the Report and Resource 

Guide).18 This guide contains information on utilization patterns and 

treatment practices that raise clinical concerns. Among the issues listed 

are polypharmacy, wrong dosages, and the prescribing of antipsychotic 

drugs to very young children.19 

	 State utilization guidelines—State agencies in Florida and Texas have 

each developed utilization guidelines that can help identify when further 

review of the treatment of children with SGAs is necessary. These States’ 

guidelines address issues such as polypharmacy, inadequate indications for 

use of drugs, excessive dosage, and prescribing of drugs to very young 

children. 

For detailed information on these sources of guidance, see Appendix B. 

Related Studies 

A 2011 Government Accountability Office (GAO) report found that in 2008, 

children in foster care in five selected States were prescribed psychotropic drugs, 

including antipsychotic drugs, at higher rates than children not in foster care. 

20 

The GAO report states that the higher rates of usage do not necessarily indicate 

inappropriate prescribing practices and notes that these higher rates could be due 

to the greater mental health needs of children in foster care and the challenges of 

coordinating their medical care. According to the GAO report, hundreds of 

children in the selected States had drug regimens consisting of five or more 

psychotropic drugs, although there is no medical evidence to support the 

concurrent use of this many drugs in children. 

____________________________________________________________ 

18 CERTs and MMDLN are both funded by the Agency for Healthcare Research and Quality. The 

16 States were Alabama, California, Colorado, Illinois, Indiana, Maine, Massachusetts, Missouri, 

New Hampshire, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, and 

Washington. Of these, California, Illinois, New York, and Texas are among the five States 

included in this evaluation. 

19 Antipsychotic Medication Use in Medicaid Children and Adolescents: Report and Resource 

Guide From a 16-State Study. MMDLN/Rutgers CERTs Publication No. 1, June 2010. 20 The five States included in GAO’s study were Florida, Massachusetts, Michigan, Oregon, and 

Texas. The children studied—both those in foster care and not in foster care—were enrolled in 

the Medicaid programs of the five States. GAO, Foster Children: HHS Guidance Could Help 

States Improve Oversight of Psychotropic Prescriptions (GAO-12-201), December 2011. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 5 
 

 

 

 

 

In 2011, OIG released a study on elderly nursing home residents’ use of SGAs. 

This study determined that 14 percent of elderly nursing home residents had 

Medicare claims for SGAs.21 Eighty-three percent of Medicare claims for SGAs 

for elderly nursing home residents were associated with off-label conditions, and 

88 percent were associated with the condition specified in the FDA boxed 

warning (i.e., dementia). 

METHODOLOGY 

State Selection 

We purposively selected five States for inclusion in this evaluation: California, 

Florida, Illinois, New York, and Texas. These States were selected because they 

represented approximately 39 percent of total Medicaid payments for SGAs in 

2011.22 

From these five States, we collected all fee-for-service Medicaid-paid claims for 

SGAs prescribed to children aged 0–17 years old between January 1 and 

June 30, 2011.23 We also collected information from each State regarding which 

children were enrolled in foster care and information on the States’ drug coverage 

policies. 

To reduce the overall sample size, answer specific questions, and achieve precise 

estimates, we stratified the population into four groups based on foster care 

enrollment and payment amount. We selected a stratified random sample of 

687 claims. For a presentation of the stratified sample and detailed 

methodological information, see Appendix C. For detailed descriptive 

information on the population of claims and the sampled claims, see Appendix D. 

Development of Criteria for Medical Record Review. Because there are no 

Federal Medicaid requirements defining appropriate use of SGAs to treat 

children, we reviewed existing guidance and literature to identify criteria for 

determining whether quality-of-care concerns were present in children’s treatment 

with SGAs. (Specifically, we reviewed all of the sources listed on pages 4 and 5 

except for the HEDIS 2015 measures, which at the time had not yet been 

published.) We identified seven criteria related to quality of care in the treatment 

of children with SGAs; each criterion is supported by at least three of the sources 

____________________________________________________________ 

21 OIG, Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents 

(OEI-07-08-00150), May 2011. 

22 The 39-percent figure is based on 2011 claims data from the Medicaid Statistical Information
 

System (MSIS).
 23 The claims data collected included only fee-for-service claims. Initial discussions with 

Medicaid staff indicated that three of the five selected States had no managed-care coverage of
 

SGAs for children during our review period. The other two States indicated that managed-care 

coverage of these drugs for children represented a very small percentage of paid claims for drugs 

in the review period. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 6 
 

 

 

 

 

 

 

of guidance previously described. Table 2 describes each of the seven 

quality-of-care criteria we identified and shows which of the sources of guidance 

and information that we reviewed address the issue.24 

Table 2: Descriptions of and Support for Medical Record Review Criteria and Corresponding 

Quality-of-Care Concerns 

Criterion 

Source 

AACAP 

Practice 

Parameter 

ACF 

Memo 

Report and 

Resource 

Guide 

Florida Utilization 

Guidelines 

Texas Utilization 

Guidelines 

Dosage (wrong dose) 

Duration (taken too long) 

Indications for use (wrong treatment) 

Monitoring (poor monitoring) 

Polypharmacy (too many drugs) 

Patient age (too young) 

Side effects 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

Source: OIG analysis of guidance documents, 2014. 

Review of Medical Records and Claims Data 

The psychiatrists who performed the medical reviews were board-certified child 

and adolescent psychiatrists with extensive experience and expertise in treating 

children with mental health conditions. To ensure a consistent interpretation of 

the seven criteria, we provided the contracted psychiatrists with the same sources 

of guidance and information that we used to develop the criteria. The contracted 

psychiatrists determined whether quality-of-care concerns existed in each child’s 

SGA treatment, assessing each of the seven criteria using their clinical experience 

and judgment. They also identified the diagnosis/diagnoses or indication(s) that 

the SGAs were prescribed to treat. OIG staff used this diagnosis information, as 

well the children’s ages, to determine whether the drugs were prescribed for 

medically accepted indications. 

We received records for 485 of the 687 sampled claims for an overall weighted 

response rate of 75 percent. The remaining 202 claims were undocumented or 

insufficiently documented, or the providers could not be located to request the 

records. Specifically, we could not locate or contact the providers or facilities 

that had custody of the medical records for 170 sampled claims. Although we 

____________________________________________________________ 

24 Because the new HEDIS measures regarding the use of antipsychotic drugs by children had not 

been published at the time of our review, we could not include them in the sources of guidance we 

used to develop the medical record review criteria. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 7 
 

 

 

were able to contact the providers, we did not receive any medical records for 

7 sampled claims, and we received insufficient medical records for an additional 

25 claims. See Appendix C for details on the response rates and a nonresponse 

analysis. 

Limitations 

It is possible that the children in our sample received SGAs that were not paid for 

by Medicaid; therefore, these children’s use of SGAs may be underestimated. 

Additionally, the psychiatrists’ reviews were based solely on the medical record 

documentation received; some of the quality-of-care concerns identified could be 

the result of poor documentation rather than poor quality of care. 

Standards 

This study was conducted in accordance with the Quality Standards for Inspection 

and Evaluation issued by the Council of the Inspectors General on Integrity and 

Efficiency. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 8 
 

 

FINDINGS 

In the five States studied, quality-of-care concerns were 

identified in the medical records for 67 percent of claims for 

SGAs prescribed to children 

Quality-of-care concerns were identified in the medical records associated with 

67 percent of claims for SGAs prescribed to children; two or more quality-of-care 

concerns were identified in the medical records for 49 percent of claims. Chart 1 

below illustrates the percentages of claims for which concerns related to each 

medical record review criterion were identified in medical records; see Table D-5 

in Appendix D for estimated totals and percentages of claims with each 

quality-of-care concern. See Appendix E for all estimates and 95-percent 

confidence intervals for projections. 

Chart 1: Percentages of Medicaid Claims With Quality-of-Care Concerns 

Regarding Children’s Use of SGAs in 2011 

Medical reviewers identified multiple quality-of-care concerns for many claims. 

Source: OIG analysis of Medicaid claims in five States, 2014. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 9 
 

 

 

Medical reviewers identified many specific concerns related to each of the seven 

criteria for the medical record review. Below are four case studies that illustrate 

some of the quality-of-care concerns that medical reviewers identified regarding 

each criterion. 

Case Study 1 – a 10-year-old child diagnosed with ADHD 

Monitoring—The medical record lacked documentation of monitoring for side 

effects, including a lack of recognition of or monitoring for akathisia.25 

Indications for use (wrong treatment)—This child’s ADHD was clearly 

documented as being treated with a stimulant medication, but there was no 

documented reason for the child’s treatment with the SGA. 

Polypharmacy (too many drugs)—This child was prescribed three psychotropic 

drugs during the review period, one of which was an SGA. 

Duration (taken too long)—The medical reviewer stated: “The [SGA] should 

have been tapered down and possibly discontinued completely.” 

Dosage (wrong dose)—This child presented symptoms that appeared to worsen 

with the prescribed course of treatment with the SGA. When the dosage of the 

SGA was increased, the child’s symptoms worsened. The pattern of increasing 

dosage and worsening symptoms was repeated several times throughout the 

review period. 

Side effects—The medical reviewer stated: “It is very possible the [SGA] caused 

the side effect of akathisia, and increasing the dosage caused the patient to get 

worse instead of better.” 

Case Study 2 – a 4-year-old child diagnosed with ADHD and a mood disorder 

Monitoring—There was no evidence in the child’s medical records of any 

monitoring while the child was taking the sampled SGA. 

Indications for use (wrong treatment)—This child was placed in the custody of 

child protective services at 4 weeks old and had a history of abuse and neglect and 

severe psychosocial issues, such as aggression, anxiety, and mood swings. The 

reviewer stated that individual, family, and behavior therapy should have been 

attempted before initiating treatment with drugs. However, there was no evidence 

in the child’s medical record indicating that such therapies were attempted. 

Polypharmacy (too many drugs)—This child was prescribed four psychotropic 

drugs during the review period, of which two were SGAs. 

____________________________________________________________ 

25 Akathisia is “a pathologic condition characterized by restlessness and agitation, such as an 

inability to sit still,” and is a common side effect of many SGAs. Mosby’s Medical Dictionary, 

7th Ed. Mosby-Elsevier, 2006. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 10 
 

 

 

 

Dosage (wrong dose)—The reviewer noted that there is no appropriate dosage of 

the prescribed SGA for this child’s conditions. 

Age (too young)—The reviewer stated that treatment with SGAs was not 

appropriate for a 4-year-old. 

Case Study 3 – a 16-year-old child diagnosed with bipolar disorder 

Monitoring—This child experienced significant weight gain while taking the 

SGA, but there was no evidence in the child’s record of monitoring of blood 

sugar, cholesterol, or other hormone levels in response to the weight gain. 

Indications for use (wrong treatment)—The reviewer stated that the diagnosis 

which the SGA was prescribed to treat was poorly documented, saying, “Multiple 

antipsychotic agents were used with vague documentation of hallucinations [as 

the only explanation].” 

Polypharmacy (too many drugs)—This child was prescribed a total of six 

psychotropic drugs during the review period, of which three were SGAs. 

Duration (taken too long)—The SGA was prescribed to this child in response to 

a report of hallucinations. However, the medical reviewer stated: “When all 

medications were discontinued... hallucinations were not reported nor was the 

patient reporting suicidal ideation [i.e., suicidal thinking].” The SGA should have 

been discontinued as soon as it became apparent that its side effects were 

outweighing any treatment benefit. 

Side effects—This child experienced paranoia, hostility, unstable mood, 

hallucinations, and suicidal thoughts. This child also experienced significant side 

effects potentially resulting from the prescribed drugs, including a 22-pound 

weight gain, insomnia, and edema (swelling) of hands and feet. 

Case Study 4 – a 16-year-old child diagnosed with bipolar disorder and ADHD 

Monitoring—Although the child’s medical record indicated that laboratory 

testing was performed, there were no notes in the record of the results of that 

testing. The medical record also lacked any evidence of monitoring of the child’s 

height, weight, or vital signs. 

Polypharmacy (too many drugs)—This child was prescribed a total of six 

psychotropic drugs during the review period, of which two were SGAs. The 

medical reviewer noted that although the regimen of six psychotropic drugs might 

have been beneficial in treating the child’s diagnoses, the medical record lacked 

documentation to support why any of the drugs were chosen to treat the child and 

the symptoms these drugs were targeting. 

Dosage (wrong dose)—This child was prescribed double the maximum 

recommended dosage of the SGA to treat bipolar disorder. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 11 
 

 

 

 

Lack of monitoring was the most commonly identified quality-of-care 

issue 

In the five States we reviewed, quality-of-care concerns regarding lack of 

monitoring were identified in the medical records for 53 percent of claims for 

SGAs prescribed to children. Reviewers were concerned about a lack of 

monitoring for many physiological and behavioral changes. They especially 

noted that the following were not being regularly performed: measuring of 

height, weight, vital signs, and blood pressure; measuring of abnormal 

involuntary movements; laboratory testing (e.g., tests of liver function, measures 

of blood glucose levels, measures of lipid levels); and electrocardiograms. In all 

four case studies described above, reviewers identified a lack of monitoring, 

including a failure to recognize or manage side effects, such as akathisia, 

significant weight gain, insomnia, and edema. 

In the five States studied, 8 percent of SGAs were 

prescribed for the limited number of medically accepted 

pediatric indications 

Eight percent of claims for SGAs were for drugs prescribed for the limited 

number of medically accepted pediatric indications. As noted in the background, 

there are only five SGAs with medically accepted pediatric indications; most of 

those indications are limited to specific age ranges for each drug. Furthermore, 

physicians are not prohibited from prescribing SGAs for indications that are not 

medically accepted. See Table 3 for a list of medically accepted pediatric 

indications of SGAs. 

Among the 92 percent of claims that were not prescribed for medically accepted 

pediatric indications, common diagnoses that SGAs were prescribed to treat were 

bipolar disorder (20 percent), mood disorders (13 percent), and autism spectrum 

disorders (8 percent).26

 ____________________________________________________________ 

26 Although there are medically accepted indications for certain drugs to treat bipolar disorder and 

autistic disorder, the children who were prescribed these drugs for nonmedically accepted 

indications were (1) not in the age range specified and/or (2) were not diagnosed with the 

symptoms specified. For example, a child diagnosed with bipolar disorder may not have had 

mania or mixed episodes; a child diagnosed with autistic disorder may not have had irritability. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 12 
 

 

 

 

 

 

 

Table 3: Medically Accepted Pediatric Indications for SGAs 

SGA Medically Accepted Pediatric Indication(s)1 Age Range 

aripiprazole 

olanzapine 

paliperidone 

quetiapine fumarate 

risperidone 

Schizophrenia 

Mania or mixed episodes associated with bipolar I 

disorder

2 

Irritability associated with autistic disorder 

Schizophrenia 

13–17 years 

10–17 years 

6–17 years 

13–17 years 

Mania or mixed episodes associated with bipolar I disorder 

Schizophrenia 

Schizophrenia 

Mania associated with bipolar I disorder 

Schizophrenia 

Mania or mixed episodes associated with bipolar I disorder 

Irritability associated with autistic disorder 

Behavioral syndrome-mental retardation 

Pervasive developmental disorder 

13–17 years 

12–17 years 

13–17 years 

10–17 years 

13–17 years 

10–17 years 

5–16 years 

--3 

--3 

1

Medically accepted indications include both the uses approved by FDA and those uses, including off-label uses, 

supported by one or more of the compendia. 

2 Bipolar disorder is a brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to 

perform daily tasks. There are two primary forms of bipolar disorder: bipolar I disorder and bipolar II disorder. Each 

of these two types of bipolar disorder have distinct and separate symptoms. 

3The FDA-approved uses for risperidone have specific age ranges; the compendia-supported indications do not have 

specific age ranges, but are simply noted as “pediatric use.” 

Source: OIG analysis of compendia information, 2014. 

New York had a coverage policy stating that its Medicaid program would pay 

only for SGAs prescribed for medically accepted indications. However, at least 

3,366 claims totaling $773,607 were paid in violation of this policy.27 New York 

State Medicaid staff told us that because of the lack of diagnosis information on 

drug claims, this coverage policy is difficult to enforce without conducting a 

medical record review. 

Over a third of SGAs were prescribed for conditions described in the 

FDA boxed warning 

For drugs that may have severe or life-threatening risks when used to treat 

patients with specific conditions, FDA may require that the product’s labeling 

____________________________________________________________ 

27 To determine whether a drug is prescribed for a medically accepted pediatric indication, we 

must know the diagnosis it was prescribed to treat. However, diagnosis information is not 

included in drug claims data; it is available only from medical records. To identify claims that did 

not meet New York’s coverage policy, we identified all the claims in New York’s population data 

that were for the five SGAs that have no medically accepted pediatric indications: aripiprazole, 

paliperidone, risperidone, quetiapine fumarate, and olanzapine. There could be additional claims 

in the population data that were not prescribed for medically accepted pediatric indications and 

thus violate New York’s coverage policy but that we cannot identify without diagnosis 

information and/or medical review. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 13 
 

 

 

include a boxed warning describing those risks. Three of the SGAs included in 

this evaluation carried an FDA boxed warning describing the increased chance of 

suicidal thinking and behavior in children, adolescents, and young adults with 

major depressive disorder and other psychiatric disorders being treated with these 

SGAs. However, 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. 

Thirty-seven percent of claims for SGAs were prescribed for conditions described 

in the FDA boxed warning—i.e., for major depressive disorders and other 

psychiatric disorders. The language of the warning—particularly the phrase 

“other psychiatric disorders”—is broad and could apply to almost any child with a 

mental health condition. All children taking the three SGAs that carry this 

warning, regardless of their exact diagnoses or conditions, should be appropriately 

monitored for suicidal thoughts and other side effects. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 14 
 

 

 

CONCLUSION AND RECOMMENDATIONS 

SGAs are widely used to treat children enrolled in Medicaid who have mental 

health conditions. However, SGAs have been previously found to cause serious 

side effects and little clinical research has been conducted on the treatment of 

children with these drugs. Quality-of-care concerns were identified in the medical 

records for 67 percent of claims for SGAs prescribed to children. Lack of 

monitoring was the most commonly identified quality-of-care issue, being 

identified in just over half of the claims for SGAs. 

The high percentage of claims for which our reviewers identified quality-of-care 

concerns indicates that more needs to be done to ensure the quality of care 

provided to children receiving SGAs paid for by Medicaid. To ensure the quality 

of the care provided to these children, we recommend that CMS work with State 

Medicaid programs to: 

Perform utilization reviews of SGAs prescribed to children 

Utilization reviews could specifically focus on the children’s age, the duration of 

their treatment with SGAs, and their overall drug regimens. The previously 

described guidance and information on using SGAs to treat children—such as the 

utilization guidelines developed by the Florida and Texas Medicaid programs— 

may be of use to CMS and to other State Medicaid programs in developing 

guidelines for such utilization reviews. The medical review criteria that OIG 

developed for this evaluation may also be helpful in developing such guidelines. 

Conduct periodic reviews of medical records associated with claims 

for SGAs prescribed to children 

Periodic reviews of medical records could ensure that (1) there are clear rationales 

for prescribing the SGAs, (2) children are being properly monitored, and 

(3) children’s dosages are properly adjusted. 

Consider other methods of enhanced oversight of SGAs prescribed 

to children 

Some of the other methods of enhanced oversight that CMS and State Medicaid 

programs could consider include: 

	 implementing peer review programs through which prescribers encourage 

one another to improve quality of care and 

	 undertaking voluntary reporting of the HEDIS measures regarding 

children’s use of antipsychotic drugs or adopting the HEDIS measures in 

State oversight of SGAs. 

In addition to making these recommendations, we have forwarded to CMS the 

information on the undocumented claims identified in our sample, so that it may 

take appropriate action. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 15 
 

 

AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 

RESPONSE 

CMS concurred with all three of our recommendations. 

In responding to our first recommendation, CMS stated that it would work with 

States through the Medicaid Drug Utilization Review Program to monitor 

children’s use of antipsychotic drugs and provide feedback to States regarding any 

quality-of-care concerns identified using the criteria we established. 

In responding to our second recommendation, CMS stated that it would encourage 

States with managed care programs to request that their External Quality Review 

Organizations conduct periodic reviews of medical records of children treated 

with SGAs. We suggest that CMS also consider methods of periodically 

reviewing medical records of children who receive SGAs paid through 

fee-for-service arrangements. 

In response to our third recommendation, CMS plans to take a number of actions. 

In general, CMS will: 

	 share our report to spur conversation about how to promote safe treatment 

of children with SGAs, 

	 promote best practices in appropriate oversight of treatment of children 

with mental or behavioral health issues, 

	 use measures regarding the safe and judicious treatment of children and 

adolescents with antipsychotics, and 

	 engage with other Federal agencies to improve access to screening and 

treatment for children with substance use or mental health disorders. 

We support CMS’s effort to ensure quality of care in children’s treatment with 

SGAs and its commitment to engaging with Federal partners and other 

stakeholder organizations. For the full text of CMS’s comments, see Appendix F. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 16 
 

 

Antidepressants increased the risk compared to placebo of suicidal thinking and 

behavior (suicidality) in children, adolescents, and young adults in short-term 

studies of major depressive disorder (MDD) and other psychiatric disorders. 

Anyone considering the use of [drug name] or any other antidepressant in a 

child, adolescent, or young adult must balance this risk with the clinical need. 

Short-term studies did not show an increase in the risk of suicidality with 

antidepressants compared to placebo in adults beyond age 24; there was a 

reduction in risk with antidepressants compared to placebo in adults aged 65 and 

older. Depression and certain other psychiatric disorders are themselves associated 

with increases in the risk of suicide. Patients of all ages who are started on 

antidepressant therapy should be monitored appropriately and observed closely 

for clinical worsening, suicidality, or unusual changes in behavior. Families and 

caregivers should be advised of the need for close observation and communication 

with the prescriber. [Drug name] is not approved for use in pediatric patients with 

depression [see WARNINGS AND PRECAUTIONS (5.2)].

APPENDIX A 

FDA Boxed Warning Regarding Children on SGA Product Labeling 

Three SGAs carry an FDA boxed warning regarding suicidality when used by 

children, adolescents, and young adults who have major depressive disorders or 

other psychiatric disorders. In recent years, FDA has approved these three SGAs 

to treat depression; therefore, the boxed warning has been applied to these SGAs 

and refers to their use as antidepressants. The text of the warning, which is shown 

in Figure A-1, is the same for all three SGAs.28 

Figure A-1: SGA Boxed Warning Regarding Children 

 ____________________________________________________________ 

28 The name of the drug has been elided from the warning. 

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APPENDIX B 

Sources of Guidance and Information on the Use of SGAs To Treat 

Children 

To develop the criteria for the medical record review in this evaluation, we 

reviewed the following documents issued by Federal and State agencies and by 

professional psychiatric associations.29 

1.	 AACAP practice parameter. AACAP’s practice parameter identifies 

practices that may reduce the use of ineffective and inappropriate 

medications. These practices include conducting complete psychiatric and 

medical evaluations, developing treatment and monitoring plans, 

educating patients and their families about treatment and obtaining 

consent for treatment, using adequate dosages and durations of treatment, 

assessing responses to treatment, and providing a clear rationale for the 

use of polypharmacy. 

2.	 ACF information memorandum. On April 11, 2012, ACF released an 

information memorandum titled “Promoting the Safe, Appropriate, and 

Effective Use of Psychotropic Medication for Children in Foster Care.”30 

This memorandum identifies three “outlier practices” that may indicate 

that issues other than clinical need are influencing the prescribing of 

SGAs, including: 

	 Polypharmacy. ACF identifies the following patterns as being of 

issue: use of three or more concurrent drugs, two or more concurrent 

drugs in the same class for more than 30 days, and use of multiple 

concurrent drugs before testing the effectiveness of a single drug. 

	 Dosages of drugs that are too high. ACF notes that because so few 

SGAs have received FDA approval for pediatric populations, there are 

no recommended dosages for children for most SGAs. They note that 

the lack of this information reinforces the need for effective 

monitoring of children receiving SGAs for off-label uses. 

	 Children being prescribed SGAs at too young an age. ACF notes the 

dramatic rise in the use of SGAs among very young children and 

concludes that because this population may be especially vulnerable to 

adverse effects, careful management and oversight are necessary.

 ____________________________________________________________ 

29 The guidance discussed here covers all psychotropic drugs—a category that includes SGAs and 

several other types of drugs. Other classes of psychotropic drugs include ADHD drugs, 

antianxiety drugs, antidepressants, first-generation antipsychotics, hypnotics, and mood stabilizers. 

This study focuses specifically on SGAs. 

30 ACF, Promoting the Safe, Appropriate, and Effective Use of Psychotropic Medication for 

Children in Foster Care, Log No. ACYF-CB-IM-12-03, April 11, 2012. Accessed at 

http://www.acf.hhs.gov/sites/default/files/cb/im1203.pdf on May 12, 2014. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 18 
 

 

3.	 Report and Resource Guide. The Rutgers University CERTs, the 

MMDLN, and 16 States collaborated in 2010 to produce a publication for 

State Medicaid programs and other stakeholders concerned with care of 

children and youth. This publication is entitled Antipsychotic Medication 

Use in Medicaid Children and Adolescents: Report and Resource Guide 

From a 16-State Study.

31 It contains background on issues about the use of 

antipsychotic drugs by children, data from the 16 States reflecting use of 

antipsychotic drugs by children, and information on how the 16 States are 

managing the use of antipsychotic drugs.32 Among the issues listed are 

polypharmacy, dosages, and the prescribing of antipsychotic drugs to very 

young children. 

4.	 State utilization guidelines. State agencies in Florida and Texas have 

each developed utilization guidelines that can help identify when further 

review of the prescribing of SGAs to children is necessary. Florida and 

Texas’ guidelines address concerns such as polypharmacy (the concurrent 

use of multiple drugs), inadequate indications for use of drugs, excessive 

dosage, prescribing of drugs to very young children, and prescribing by a 

primary care provider who has not received previous specialty training.33 

NCQA publishes the HEDIS, a set of measures used to assess the performance 

of health plans.34 In July 2014, NCQA adopted the new measures for HEDIS 

2015 regarding the safe and judicious use of antipsychotics in children and 

adolescents; reporting on the new HEDIS measures will begin in June 2015. 

We did not use the HEDIS measures in developing our medical record review 

criteria because the measures had not yet been adopted. We include 

information on the measures here to provide additional context to our 

____________________________________________________________ 

31 CERTs and MMDLN are both funded by the Agency for Healthcare Research and Quality. 

The 16 States were Alabama, California, Colorado, Illinois, Indiana, Massachusetts, Maine, 

Missouri, New Hampshire, New York, Oregon, Oklahoma, Pennsylvania, Tennessee, Texas, and 

Washington. Of these, California, Illinois, New York, and Texas are among the five States we 

included in this evaluation. 

32 Antipsychotic Medication Use in Medicaid Children and Adolescents: Report and Resource 

Guide From a 16-State Study. MMDLN/Rutgers CERTs Publication No. 1, June 2010. 33 University of South Florida, Bipolar I Acute or Mixed Mania—6–17 Years. Accessed at 

http://medicaidmentalhealth.org/ViewGuideline.cfm?GuidelineID=32 on June 6, 2014. University 

of South Florida, Principles of Practice Regarding the Use of Psychotropic Medication under 

Age 6. Accessed at http://medicaidmentalhealth.org/ViewGuideline.cfm?GuidelineID=32 on 

May 23, 2014. Texas Department of Family and Protective Services, Psychotropic Medication 

Utilization Parameters for Foster Children, December 2010. Accessed at 

http://www.dfps.state.tx.us/documents/about/pdf/txfostercareparameters-december2010.pdf on 

May 12, 2014. Health Information Designs, Texas Prior Authorization Program—Clinical Edit 

Criteria: Antipsychotics. Accessed at https://paxpress.txpa.hidinc.com/antipsychotics.pdf on 

May 6, 2014. 34 State Medicaid programs also report on the HEDIS measures, but their HEDIS reporting is 

voluntary. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 19 
 

 

 

recommendations. The HEDIS measures regarding the safe and judicious use 

of antipsychotics in children and adolescents are: 

 use of higher-than-recommended doses of antipsychotics in children 

and adolescents, 

 use of multiple concurrent antipsychotics in children and adolescents, 

 use of first-line psychosocial care for children and adolescents on 

antipsychotics, 

 followup visits for children and adolescents on antipsychotics, 

 metabolic screenings for children and adolescents newly on 

antipsychotics, and 

 metabolic monitoring for children and adolescents on antipsychotics. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 20 
 

 

 

 

 

APPENDIX C 

Detailed Methodology 

We stratified the sample by foster care enrollment, with the intention of 

determining whether there were differences in quality of care between children 

enrolled in foster care and those not enrolled in foster care. However, we were 

unable to test for such differences because of the low response rate among the 

providers associated with the claims in the foster care stratum, as described in the 

section on response rates below. We also stratified the sample by payment 

amount, in order to enhance the precision of our statistical estimates. Table C-1 

provides details on the population and sample sizes by strata. 

Table C-1: Population, Strata, and Sample Size 

Stratum Claims in Population Claims in Sample 

Claims for children who were in foster care on the service date of 

the claim 

Claims for children who were not in foster care on the service date 

of the claim and for which the paid amount was less than or equal 

to $187 

Claims for children who were not in foster care on the service date 

of the claim and for which the paid amount was greater than $187 

but did not exceed $557 

Claims for children who were not in foster care on the service date 

of the claim and for which the paid amount was greater than $557 

49,058

173,596 

99,419

28,460 

147 

92 

267 

181 

Total 350,533 687 

Source: OIG analysis of 2011 MMIS claims data from five States, 2014. 

Identification of FDA-Approved Uses and Medically Accepted 

Indications 

To identify FDA-approved uses and medically accepted pediatric indications for 

the 11 SGAs, we obtained copies of the compendium publications that would 

have been the most recent available during our review period.35 Specifically, we 

obtained the 2011 version of the American Hospital Formulary Service Drug 

Information and the June 2011 DrugPoints. 

36 

Collection of Medical Records 

We developed a letter for our medical review contractor’s use in requesting 

medical records from the prescribing providers identified on the sampled claims. 

____________________________________________________________ 

35 FDA-approved uses are included in the definition of medically accepted indications and 

therefore are listed among the medically accepted indications in the compendia. 36 The Act lists three compendia: (1) American Hospital Formulary Service Drug Information, 

(2) the United States Pharmacopeia—Drug Information (or its successor publications), and 

(3) DrugDEX Information System. However, we obtained copies of only the first and third of 

these. The second compendium listed in the Act, the United States Pharmacopeia—Drug 

Information, is no longer published. Its successor publication is DrugPoints, which contains 

information derived from DrugDEX—the third compendium. 

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For each of these providers, the contractor sent a letter requesting the medical 

records associated with the sampled claim(s). If a provider did not respond to this 

initial letter, the contractor sent up to two followup letters at predetermined time 

intervals. For providers that did not respond to the initial letter or two followup 

letters, the contractor followed up by telephone. We considered any provider that 

had not submitted the requested records after being contacted at least five times 

(three letters and two telephone calls) to be a nonresponder. 

Response Rates 

Table C-2 shows how the response rate for the 485 claims for which we received 

medical records were distributed among the 4 strata. Response rates varied by 

stratum. 

Table C-2: Response Rates by Stratum 

Stratum Response Rate 

Claims for children who were in foster care on the service date of the claim 62% 

Claims for children who were not in foster care on the service date of the claim 

and for which the paid amount was less than or equal to $187 80% 

Claims for children who were not in foster care on the service date of the claim 

and for which the paid amount was greater than $187 but did not exceed $557 73% 

Claims for children who were not in foster care on the service date of the claim 

and for which the paid amount was greater than $557 69% 

Source: OIG analysis of sampled claims and medical records received, 2014. 

Nonresponse Analysis 

Our findings are based on estimates made solely from medical records collected 

for the associated sampled claims. We did not statistically adjust our results on 

the basis of any assumptions about nonrespondent claims. 

We performed a nonresponse analysis to determine the representation of 

subpopulations in respondent claims and to determine the extent of the potential 

nonresponse bias. We compared whether the respondents and nonrespondents 

differed with regard to two variables that are available for the entire population 

and that may be associated with response: (1) foster care enrollment and (2) State 

of residence. We looked to see whether the response rates were significantly 

different at the 95-percent confidence level. We estimated the proportion of 

respondent and nonrespondent claims within these variables and performed 

Rao-Scott chi-square tests of significance. 

We found significant differences in response rates for these two variables. 

Records for children in foster care were less likely to have been submitted 

(62 percent) compared with those for children not enrolled in foster care 

(77 percent). Further, records for children residing in California were less likely 

to have been submitted (65 percent) compared to those for children residing in the 

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other four States (79 percent). Therefore, claims for children in foster care and 

claims from California are underrepresented among the respondent claims. 

Potential Effects of Nonresponse on Estimates. To explore the effects that the 

nonrespondent claims could have had on our results, we imputed and estimated 

the following: 

	 the percentage of claims that would have had at least 1 quality-of-care 

concern if none of the 202 nonrespondent claims had had any 

quality-of-care concerns and 

	 the percentage of claims that would have been for drugs prescribed for 

medically accepted uses if all of the 202 nonrespondent claims had been 

for drugs prescribed for medically accepted uses. 

If none of the 202 nonrespondent claims had had any quality-of-care concerns, the 

percentage of all claims with at least 1 quality-of-care concern would still have 

been at least 50 percent. If all of the 202 nonrespondent claims had been 

prescribed for medically accepted uses, the percentage of all claims for drugs 

prescribed for medically accepted uses would have been approximately 

31 percent. See Table C-3 for 95-percent confidence intervals for these new 

estimates based on the assumptions of errors in the nonrespondent claims. 

Table C-3: Potential Effects of Nonresponse on Main Findings 

Estimate Description Sample 

Size 

Point 

Estimate 

95-Percent Confidence 

Interval 

Percentage of claims that would have had at least 

1 quality-of-care issue if none of the 202 claims for 

which we did not receive responses had had any 

quality-of-care concerns 

687 50.2% 44.7%–55.6% 

Percentage of claims that would have been for drugs 

prescribed for medically accepted uses if all of the 

202 claims for which we did not receive responses had 

been for drugs prescribed for medically accepted uses 

687 31.5% 26.7%–36.7% 

Source: OIG analysis of sampled claims and medical records received, 2014. 

Review of Medical Records 

Pretest of Medical Review Instrument. To test and refine the medical review 

instrument, we pretested it with six randomly sampled claims from the MMIS 

claims data from the selected States. For the pretest, we requested medical 

records from the prescribing providers for the six sampled claims and asked the 

medical reviewers to complete the medical review instrument. We then used the 

reviewers’ feedback to improve the medical review instrument. 

Determination of Medically Accepted Indications and Conditions Described in 

the FDA Boxed Warning. Using (1) the diagnosis and behavior information that 

the reviewers compiled from the medical records, (2) the age of each child with a 

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sampled claim, and (3) the compendia information, we determined whether each 

claimed SGA was prescribed: 

	 for medically accepted indications and/or 

	 in the presence of conditions specified in the FDA boxed warning. 

Development of Medical Record Review Criteria. Appendix B describes the 

documents we reviewed to determine medical record review criteria for whether 

children’s treatment with SGAs posed one or more quality-of-care concerns. The 

criteria we identified include: 

	 Dosage—All five documents support the idea that dosage needs to be 

appropriate. Specifically, they say that children’s treatment should start 

with the lowest effective dose; the dose should be adjusted and targeted; 

and the dosage should not exceed any recommended dosage guidelines, 

such as those for the FDA-approved uses. 

	 Duration of use—Three of the five documents support the idea that 

treatment with SGAs should be of appropriate duration. Specifically, they 

say that a dose reduction should be planned after several months of 

treatment, that the treatment plan should include a plan for discontinuing 

the drug, and that medication trials should be of adequate duration to 

assess the effects of the drug. 

	 Indications for use—Four of the five documents support the idea that the 

prescribed drug should be consistent with the child’s diagnosis. The 

documents also say that there should be thorough and complete 

evaluations of all aspects of a child’s condition and situation—including a 

complete medical history and a psychiatric evaluation—and that the target 

symptoms and diagnosis for each drug that a child is prescribed should be 

clearly documented. In most instances, psychosocial interventions should 

be tried before starting treatment with drugs. 

	 Monitoring—Four of the five documents support the idea that a 

monitoring plan should be developed before the child starts taking an 

SGA. The documents say that ongoing monitoring requires assessment of 

the child’s clinical response to the drug; regular observation of 

physiological changes, such as in height, weight, vital signs, or changes in 

the results of bloodwork; and observation of any side effects experienced 

by the patient, such as involuntary movements, insomnia, and other 

physical and mental effects. The documents also say that that lack of 

clinical drug trials and evidence-based data for pediatric uses of SGAs 

reinforces the need for close monitoring of children taking these drugs. 

	 Polypharmacy—All five documents support the idea that treatment with 

a single drug should be tried before treatment with multiple drugs. They 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 24 
 

 

say that there needs to be a clearly documented rationale regarding the 

need for each drug when a child is treated with multiple drugs. 

	 Side effects—All five documents support the idea that the use of SGAs 

can have side effects. Some sources outlined specific measures to monitor 

side effects, such as taking baseline and ongoing measures for height, 

weight, blood pressure, and body mass index, as well as measuring 

baseline and ongoing blood glucose and lipid levels. 

	 Patient age—Four of the five documents support the idea that the 

treatment of young children with SGAs should be rare and carefully 

managed. Two of these four documents defined “young children” as those 

under 4 years of age, another defined them as those under 6 years of age, 

and the remaining document did not define an age. 

To ensure a consistent interpretation of the seven criteria, we provided the 

contracted psychiatrists with the same sources of guidance and information that 

we reviewed to develop the criteria. The psychiatrists reviewed the medical 

records for each sampled claim for an SGA and determined whether there were 

quality-of-care concerns about the child’s treatment with the SGA with regard to 

the seven criteria. Using their clinical experience and judgment, the psychiatrists 

described any concerns they identified about the children’s treatment with regard 

to any of the seven criteria. 

Determination of Violations of State Coverage Policies 

New York is the only State included in this evaluation that had a coverage policy 

based on the compendia. New York’s policy limits Medicaid coverage to drugs 

prescribed for medically accepted indications. To determine the extent of 

compliance with this policy, we identified all New York claims in the population 

data that were for the five SGAs for which there were no pediatric medically 

accepted indications. 

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APPENDIX D 

Descriptive Data on Population and Sampled Claims 

Tables D-1 through D-3 present descriptive information on the population of 

claims, including the number of claims per State, each State’s foster-care 

enrollment, and the SGAs prescribed. Table D-4 presents information on the 

types and specialties of the prescribing providers in the sample of claims. Table 

D-5 presents estimates of the percentages and total numbers of claims in the five 

States for which reviewers identified quality-of-care concerns. 

Table D-1: Number of Claims and Children in Population 

by State of Residence 

State Number of Children Number of Claims for 

With Claims for SGAs SGAs in Population 

California 23,344 104,598 

Florida 7,016 26,990 

Illinois 15,704 74,329 

New York 15,919 67,429 

Texas 22,671 77,187

 Total: 84,654 350,533 

Source: OIG analysis of population claims data from five State MSIS systems, 2014. 

Table D-2: Number of Children Enrolled in Foster Care With Claims in Population by State of 

Residence 

State 

California 

Florida

Illinois 

New York 

Texas 

Number of Children 

With Claims While Not 

in Foster Care 

18,856 

6,673 

13,960 

13,463 

22,274 

Number of Children 

With Claims While in 

Foster Care 

4,110 

281 

1,635 

2,456 

192 

Number of Children With Claims 

Both While in Foster Care and 

While Not in Foster Care 

378 

62 

109 

0 

205 

 Total: 75,226 (89%) 8,674 (10%) 754 (1%) 

Source: OIG analysis of population claims data from five State MSIS systems, 2014. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 26 
 

 

 

 

 

The table below provides information regarding the total number and 

percentage of claims in the population for each of the 11 SGAs. Three 

SGAs—risperidone, quetiapine fumarate, and aripiprazole—represented 

nearly all claims in the population. This high representation is not 

unexpected. These three SGAs were among the first SGAs to be approved 

by FDA. Additionally, these drugs are three of the five SGAs that have 

been approved by FDA for specific pediatric indications. Furthermore, the 

FDA-approved indications for two of these drugs—quetiapine fumarate 

and aripiprazole—have been expanded to include the treatment of 

depression associated with bipolar disorder and major depressive disorder. 

These factors likely contributed to the wider use of these three drugs over 

other SGAs. 

Table D-3: Claims in the Population by SGA 

Drug Total 

Claims 

Percentage of 

Claims 

risperidone* 164,636 47.0% 

quetiapine fumarate* 91,830 26.2% 

aripiprazole 49,360 14.1% 

ziprasidone 21,924 6.3% 

olanzapine 17,832 5.1% 

paliperidone 1,650 0.5% 

clozapine 1,482 0.4% 

asenapine 1,296 0.4% 

olanzapine/fluoxetine 330 0.1% 

iloperidone 179 0.1% 

lurasidone 14 0.0%

 Total: 350,533 100.0% 

*Includes an additional formulation, such as extended release, of the 

drug. 

Source: OIG analysis of population claims data from five State MSIS 

systems, 2014. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 27 
 

 

 

Table D-4: Prescribing Provider Type for Sampled Claims 

Provider Type/Specialty Number in Sample Percentage of 

Sample 

Psychiatrist

Nonpsychiatrist MD 

Non-MD*

Unknown 

 Total: 

494 

129 

43 

21 

687 

71.9% 

18.8% 

6.3% 

3.0%

100.0% 

*Examples of non-MD prescribing provider types included nurse practitioners, 

physician assistants, prescribing psychologists, and social workers. 

Source: OIG analysis of sampled-claims data from five State MSIS systems and 

provider type and specialty information from the National Provider Identifier Registry, 

2014. 

 Table D-5: Estimated Percentages of and Total Claims for SGAs with 

 Quality-of-Care Concerns for the Five States Reviewed 

Medical Record Review Criteria Percentages of Claims 

With Concern (n=485)* 

Number of Claims 

With Concern 

Monitoring

Indications for use 

Polypharmacy

Duration of treatment 

Dosage

Patient age 

Side effects 

52.8% 

40.6% 

37.3% 

34.1% 

22.5% 

16.7% 

6.8% 

138,679 

106,674 

97,986 

89,542 

59,123 

43,924 

17,773 

*Percentages do not total 100% because medical reviewers identified multiple quality-of-care 

concerns for many claims. 

Source: OIG analysis of Medicaid claims data from five States and medical record reviews, 2014. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 28 
 

 

APPENDIX E 

Statistical Estimates and Confidence Intervals 

Table E-1: Sample Sizes, Point Estimates, and Confidence Intervals 

Estimate Description Sample 

Size 

Point 

Estimate 

95-Percent Confidence 

Interval 

Quality-of-Care Concerns (Percentages of Claims) 

Percentage of SGA claims with at least one quality-of-care 

concern 485 67.0% 60.6%–72.9% 

Percentage of SGA claims with multiple quality-of-care 

concerns 485 49.0% 42.5%–55.5% 

Percentage of SGA claims with quality-of-care concerns 

related to monitoring 485 52.8% 46.3%–59.3% 

Percentage of SGA claims with quality-of-care concerns 

related to indications for use 485 40.6% 34.5%–47.1% 

Percentage of SGA claims with quality-of-care concerns 

related to polypharmacy 485 37.3% 31.3%–43.8% 

Percentage of SGA claims with quality-of-care concerns 

related to duration of treatment 485 34.1% 28.2%–41.0% 

Percentage of SGA claims with quality-of-care concerns 

related to dosage 485 22.5% 18.0%–27.8% 

Percentage of SGA claims with quality-of-care concerns 

related to patient age 485 16.7% 13.0%–21.3% 

Percentage of SGA claims with quality-of-care concerns 

related to side effects 485 6.8% 4.2%–11.0% 

Medically Accepted Indications and Boxed Warning 

Percentage of claims for SGAs prescribed for medically 

accepted indications 485 8.5% 5.2%–13.6% 

Percentage of claims for SGAs not prescribed for medically 

accepted indications 485 91.5% 86.4%–94.8% 

Percentage of claims for SGAs prescribed in the presence 

of conditions listed in the FDA boxed warning 485 37.4% 32.3%–43.0% 

Percentage of claims for SGAs that (1) were not prescribed 

for medically accepted uses and (2) were prescribed to 

treat bipolar disorder 

459 20.1% 15.4%–25.9% 

Percentage of claims for SGAs that (1) were not prescribed 

for medically accepted uses and (2) were prescribed to 

treat mood disorders 

459 13.0% 9.2%–17.9% 

Percentage of claims for SGAs that (1) were not prescribed 

for medically accepted uses and (2) were prescribed to 

treat autism spectrum disorders 

459 8.4% 5.6%–12.5% 

continued on the next page 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 29 
 

 

Table E-1: Sample Sizes, Point Estimates, and Confidence Intervals (Continued) 

Quality-of-Care Concerns (Numbers of Claims) 

Number of SGA claims with quality-of-care concerns 

related to monitoring 485 138,679 119,568–157,790 

Number of SGA claims with quality-of-care concerns 

related to indications for use 485 106,674 88,875–124,474 

Number of SGA claims with quality-of-care concerns 

related to polypharmacy 485 97,986 80,469–115,502 

Number of SGA claims with quality-of-care concerns 

related to duration of treatment 485 89,542 72,442–106,642 

Number of SGA claims with quality-of-care concerns 

related to dosage 485 59,123 46,057–72,189 

Number of SGA claims with quality-of-care concerns 

related to patient age 485 43,924 32,944–54,905 

Number of SGA claims with quality-of-care concerns 

related to side effects 485 17,773 9,111–26,434 

Source: OIG analysis of claims data and medical records, 2014. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 30 
APPENDIX F 

Agency Comments 

.1-"P''~ 

(~J_"" DEPAR1MENT OF HEALTH & HUMAN SERVICES Centers for Medicare & MediCaid Services 

......... 
 Administrator 

Washington, DC 20201 

JAN 1"6 2015 

DATE: 

TO: 	 Daniel R. Levinson 


lnspectpr General 


FROM: 	 Marilyn Ta~enner 

Administrator 


SUBJECT: 	 Second-Generation Antipsychotic Drug Use Among Medicaid-Enrolled 

Children: Quality of Care Concerns OEI-07-12-00320 

The Centers for Medicare & Medicaid Services (CMS) appreciates the opportunity to review and 

comment on the above subject draft report. This study provides CMS with important new 

information to further our efforts to improve the quality of care provided to children with mental, 

developmental, and/or behavioral health problems. CMS is committed to working with states, 

other federal partners, and providers to address the significant quality of care issues identified in 

the report. 

As the draft report notes, during the period of January through June 30, 2011, the OIG examined 

medical records from a stratified random sample of 687 Medicaid fee-for-service paid claims to 

determine the extent to which second-generation antipsychotics (SGAs) prescribed to children 

enrolled in Medicaid in five selected states1 

: 1) presented at least one quality of care issue; and 

2) were prescribed for medically accepted indications and/or prescribed despite the Food and 

Drug Administration (FDA) boxed warning. 

The OIG found that the medical records for 67 percent of claims for SGAs prescribed to children 

presented at least one quality of care issue in the five states reviewed. Lack of monitoring was 

the most commonly identified quality of care issue; 53 percent of claims for SGAs prescribed to 

children lacked documentation of monitoring in the five States reviewed. Furthem1ore, only 8 

percent of SGAs were prescribed for medically accepted pediatric uses in the five states 

reviewed; over one-third of SGAs were prescribed for conditions described in the FDA blackboxwaming. 

CMS has been working over the past two years with its many partners, including the Medicaid 

Medical Directors Network (MMDN), as well as other federal agencies such as the 

Administration for Children and Families (ACF) and the Substance Abuse and Mental Health 

Services Administration (SNvfi-ISA), to strengthen oversight and monitoring ofpsychotropic 

medications use an1ong children. Examples of these efforts include: 

1 California, Florida, lllinois, New York, and Texas 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 31 
 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 32 
 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 33 
 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 34 
 

 

ACKNOWLEDGMENTS 

This report was prepared under the direction of Brian T. Whitley, Regional 

Inspector General for Evaluation and Inspections in the Kansas City regional 

office. 

Michala Walker served as the team leader for this study. Other Office of 

Evaluation and Inspections staff from the Kansas City regional office who 

conducted the study include Michael Barrett and Rae Hutchison. Central office 

staff who provided support include Eddie Baker, Berivan Demir Neubert, 

Althea Hosein, Kevin Manley, Christine Moritz, Jessica Swanstrom, and 

Julie Taitsman, M.D. 

SGA Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns (OEI-07-12-00320) 35 
Office of Inspector General

http://oig.hhs.gov 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 

amended, is to protect the integrity of the Department of Health and Human Services 

(HHS) programs, as well as the health and welfare of beneficiaries served by those 

programs. This statutory mission is carried out through a nationwide network of audits, 

investigations, and inspections conducted by the following operating components: 

Office of Audit Services 

The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting 

audits with its own audit resources or by overseeing audit work done by others. Audits 

examine the performance of HHS programs and/or its grantees and contractors in carrying 

out their respective responsibilities and are intended to provide independent assessments of 

HHS programs and operations. These assessments help reduce waste, abuse, and 

mismanagement and promote economy and efficiency throughout HHS. 

Office of Evaluation and Inspections 

The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 

HHS, Congress, and the public with timely, useful, and reliable information on significant 

issues. These evaluations focus on preventing fraud, waste, or abuse and promoting 

economy, efficiency, and effectiveness of departmental programs. To promote impact, OEI 

reports also present practical recommendations for improving program operations. 

Office of Investigations 

The Office of Investigations (OI) conducts criminal, civil, and administrative investigations 

of fraud and misconduct related to HHS programs, operations, and beneficiaries. With 

investigators working in all 50 States and the District of Columbia, OI utilizes its resources 

by actively coordinating with the Department of Justice and other Federal, State, and local 

law enforcement authorities. The investigative efforts of OI often lead to criminal 

convictions, administrative sanctions, and/or civil monetary penalties. 

Office of Counsel to the Inspector General 

The Office of Counsel to the Inspector General (OCIG) provides general legal services to 

OIG, rendering advice and opinions on HHS programs and operations and providing all 

legal support for OIG’s internal operations. OCIG represents OIG in all civil and 

administrative fraud and abuse cases involving HHS programs, including False Claims Act, 

program exclusion, and civil monetary penalty cases. In connection with these cases, OCIG 

also negotiates and monitors corporate integrity agreements. OCIG renders advisory 

opinions, issues compliance program guidance, publishes fraud alerts, and provides other 

guidance to the health care industry concerning the anti-kickback statute and other OIG 

enforcement authorities.