U.S.  Department of Health and  Human Services  
Office of Inspector General  
For Medicaid-Enrolled  
Children Diagnosed With Lead  
Toxicity in Five States,  
Documentation Reviewed for 
Diagnoses and Treatment  
Services Raises  Concerns  
 
Ann  Maxwell  
Deputy  Inspector  General  for Evaluations  and  Inspections  
December  2022, OEI-07-18-00370   U.S. Department of Health and Human Services  
 
Office of Inspector General  
Report  in Brief  
December  2022, OEI-07-18-00370  
Why  OIG Did This Review   For  Medicaid-Enrolled  Children Diagnosed  
Lead toxicity is an environmental health 
With  Lead  Toxicity in Five States,  
concern that can have lasting effects on  
the lives of children.  Although there  is  no   Documentation  Reviewed  for  Diagnoses  
safe  level of lead exposure  for young 
children, exposure is preventable.    and  Treatment  Services  Raises  Concerns   
Childrens exposure to lead  can be  
minimized through actions such as  
Medicaid offers  comprehensive, preventive medical  screening services  
regular cleaning of the  home; washing of 
for  millions  of  children  annually  through the  Early  and  Periodic  
hands and toys; and preventive care to  
support early  detection of lead toxicity  Screening,  Diagnostic,  and  Treatment  (EPSDT)  benefit.   This  benefit  also  
and timely  followup testing  and treatment   includes  treatment  services  to  correct  issues  (e.g.,  lead toxicity)  
services.    identified through  
screenings  such  as  
An Office of Inspector General (OIG) 
Key Takeaway  
report issued in October 2021 found that   blood lead testing.  
more than one-third of Medicaid-enrolled  In  five States,  most  of the medical  When young  children 
children  in five States (California, New   records that  our  study reviewed for   with confirmed blood  
York, Ohio, Pennsylvania, and Texas) did   children  with a  lead  toxicity  diagnosis  in   lead levels  do  not  
not receive required blood lead screening  their  Medicaid claims  lacked adequate   receive  timely  followup  
tests during fiscal years (FYs) 20152018,   information  to confirm a  diagnosis  of   testing  and  treatment  
which potentially  left  children vulnerable   lead  toxicity,  highlighting  potential  services, they  could be 
to the toxic effects of lead exposure.  This   implications  for  oversight  of  the  Early   left  vulnerable to  
study expands on that work.   and Periodic  Screening,  Diagnostic,  and   continuing  lead  
How OIG Did This  Review   Treatment  (EPSDT)  program.  Among   exposure and  
For the same States noted above, we  children  for  whom  there was  sufficient   permanent  
reviewed Medicaid claims data for FYs   medical record  documentation to   developmental  effects.  
20152018.  From this data, we selected a   confirm  their  diagnosis,  many  did  not  
sample of  625 enrolled  children with  a   receive comprehensive  followup  testing   What OIG Found  
diagnosis indicating lead toxicity, and   and treatment  services,  as   In  this  evaluation  of  
reviewed childrens medical records from   recommended, for  their  identified blood  medical records  for  
the date of diagnosis through 6 months   lead level.     Medicaid-enrolled 
later.  The review examined  whether   children  with a  
children  received followup testing and  diagnosis  of  lead  toxicity  in Medicaid  claims,  medical  reviewers  could  
treatment services for their identified  not  identify  adequate  information to  confirm  that  diagnosis  in the  
blood  lead levels (FYs 20152019), as  
majority  of  records  (415 out  of  581 children).    
recommended by the Centers for  
Medicare  & Medicaid Services (CMS) and  It  is  unclear  why  this  many  medical records,  across  five  States,  lacked  
the Centers for Disease Control and  information to  confirm  the  diagnosis  of  lead  toxicity  identified  in  the  
Prevention  (CDC).  We also  collected   Medicaid  claims.   According to  the American  Academy  of Pediatrics,  
public  health data from  four  States to  it  could  be  a  matter  of  confusion about  appropriate  diagnosis  codes.   
account for services provided exclusive of  Nonetheless,  the  lack  of  documentation in the  medical  records  to  
Medicaid payment and received outside  
confirm childrens lead  toxicity diagnoses raises concerns regarding 
clinical settings, and we  asked medical  
the accuracy  of using Medicaid claims  data  to  identify  children  being  
reviewers to  consider the respective State  
treated for  lead  toxicity.   This  may  have  potential implications  for  
medical  management guidance.  Finally,  
State  and Federal  oversight,  including  States  annual  EPSDT  reporting  
we interviewed stakeholders regarding  
followup testing and treatment services 
for c hildren exposed to lead.     
to  CMS  regarding blood lead testing and treatment  services,  which  
are  calculated  using  claims  data.  
Because  there is  no  safe lead level  for  children,  even  very  low  blood 
lead levels  may  indicate,  in  some  instances, a  need for  treatment,  
based on  individual  factors  (e.g.,  age, environment,  increasing blood 
lead level  trend).  However,  without  adequate information  in  the 
medical record of a  blood lead level  at  or  above 5  g/dL, or  signs,  
symptoms, and/or  notes  regarding an  elevated blood lead level,  
medical reviewers  could not  objectively  distinguish children whose  
medical records  indicated a  need for  followup  testing  and treatment  
services  during the  6-month  review  period.   Similarly,  without  
accurate  data,  CMS  may be  unable  to  accurately  measure  EPSDT  
performance and ensure  that  Medicaid-enrolled  children  with lead  
toxicity  are  given  the  best  possible  health  care.    
Among the  166  children  with  sufficient  medical  record 
documentation  to  confirm  their  diagnoses,  medical  reviewers  
determined that  half of the children  did not  receive comprehensive 
followup  testing and treatment  services  (e.g.,  environmental  
assessments  to  determine the source of exposure), as  recommended.   
Medical reviewers  determined appropriate services  for  lead toxicity  
based on  each  childs  medical  record,  using  their  professional 
judgment,  with  reference to  followup  testing and treatment  services  
recommended by  CMS  and CDC,  and in  consideration  of  State 
medical management  guidance for  childrens  identified blood lead 
levels.  
What OIG  Recommends  
We recommend thatto  address  concerns  related to  the accuracy  of 
claims  data  for  Medicaid-enrolled children  diagnosed with  lead 
toxicity,  and related to  the treatment  component  of EPSDT  for  these 
childrenCMS:  
1.   explore the discrepancy  between  Medicaid claims  data  and 
medical  documentation  for  lead  toxicity  and  implement  solutions  
to  ensure  better  oversight  of  the  EPSDT program;  and  
2.   issue  guidance  to  reiterate  State  obligations  under  the  EPSDT 
benefit  to  ensure access  to  services  to  correct  or  ameliorate 
confirmed blood lead levels  identified during screenings.  
CMS  concurred with  both of  the  recommendations. 
   
 
TABLE OF  CONTENTS  
 
 
BACKGROUND ................................................................................................................................................  1  
FINDINGS .......................................................................................................................................................  10  
In 5 States, more than two-thirds of 581 medical records for Medicaid-enrolled children lacked  
adequate information to  confirm the diagnosis of lead toxicity in the Medicaid claims ............................ 10  
In 5 States, half of the 166 medical records for children with a confirmed  diagnosis of  lead toxicity did  
not include evidence of comprehensive followup testing and  treatment services, as recommended .. 12  
CONCLUSION AND RECOMMENDATIONS ...........................................................................................  16  
Explore  the  discrepancy  between  Medicaid  claims  data  and medical  documentation for lead toxicity 
and implement solutions to ensure better oversight of the EPSDT program  ................................................. 16  
Issue guidance to reiterate State obligations under the EPSDT benefit to  ensure access to services to  
correct or ameliorate confirmed blood lead  levels identified  during screenings  .......................................... 17  
AGENCY COMMENTS AND OIG RESPONSE  .........................................................................................  18  
DETAILED  METHODOLOGY ......................................................................................................................  20  
APPENDICES .................................................................................................................................................  25  
Appendix A: Federal Guidance and Recommendations Related to Followup Testing and Treatment  
Services Based on Identified Blood  Lead Levels .......................................................................................................... 25  
Appendix B: State Guidance on Medical Management of Childrens Identified Blood  Lead Levels ....... 28  
Appendix C: Results of the Medical  Record Review for 166 Children With  a Confirmed Diagnosis  of  
Lead Toxicity  ............................................................................................................................................................................. 31  
Appendix  D: Agency Comments ....................................................................................................................................... 36  
ACKNOWLEDGMENTS AND CONTACT  ................................................................................................  40  
Acknowledgments  .................................................................................................................................................................. 40  
Contact ........................................................................................................................................................................................ 40  
ABOUT THE OFFICE OF INSPECTOR GENERAL ..................................................................................... 41  
ENDNOTES  ...................................................................................................................................................  42  
   
BACKGROUND  
OBJECTIVE  
To determine the extent to which Medicaid-enrolled children diagnosed  with lead  
toxicity received followup testing  and treatment  services as recommended by the 
Centers for Medicare & Medicaid Services  and  the Centers for Disease Control  
and Prevention  during fiscal years (FYs) 20152019.  
 
Lead toxicity is an environmental health concern  that can have lasting  effects  on the 
lives of children.  Although there is no safe level  of lead exposure for young children, 
exposure  is preventable.1   Childrens exposure  to  lead can be minimized through 
actions such as regular cleaning of the home;  washing of hands and toys;  a healthy 
diet;  and preventive care to support early detection of lead toxicity and timely 
followup.2,  3  
Millions of children receive comprehensive, preventive medical screening services 
annually  as  part of  Medicaids Early and Periodic Screening, Diagnostic, and Treatment  
(EPSDT) benefit.4   Under this benefit, States must  provide  or arrange  for  screening  
services including blood lead  screening tests and  treatment  for  issues identified via  
screenings.5   When young children are screened  and  found to  have developmental  
delays, they can  also become eligible for  State  early intervention  services.6,  7    
When children with lead toxicity do  not receive timely followup testing  and treatment  
services, they could be left vulnerable to continuing exposure and serious,  permanent  
developmental  impacts of toxic lead exposure.  Children exposed to lead may suffer 
stunted cognitive development (e.g., reduced academic performance and increased  
impulsivity), slowed growth, and hearing and speech problems.8,  9, 10   Longer term, 
childhood lead exposure has  been linked to increased incidence of hypertension and  
coronary heart disease, and  higher rates of crime and arrests in adulthood. 11, 12   
Lasting  behavioral and  educational  benefits have been identified  for young children 
exposed to lead who receive treatment  services  in the form of public health  and early  
intervention  services (e.g., lead remediation, speech therapy).   Specifically, early 
interventions for lead exposure are associated with a decline in antisocial  behaviors 
such as absences and school crimes, and consequences such as suspensions and  
arrests.13   Research also  yields  broader academic and economic impacts associated  
with these types of  interventions.   Children exposed to lead  who received  such 
services scored  higher on  third-grade standardized tests.14   Similarly, each $1 invested  
in early interventions for children with confirmed  blood  lead  levels could yield a  
return of nearly $1.40  associated with test score improvements  and  crime reduction.15  
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for  Diagnoses and  
Treatment Services Raises Concerns, OEI-07-18-00370   Background  | 1     
Early and  Periodic  Screening,  Diagnostic,  and  Treatment  services  
for  children with  lead  toxicity  
Every State Medicaid program must offer the EPSDT benefit.   States share 
responsibility for implementing the benefit, along with CMS.  States have an 
affirmative obligation  to  make sure that Medicaid-enrolled children and their families  
are aware of EPSDT and  have access to required screenings and necessary treatment  
services.16   States  also have flexibility in determining how to best ensure that EPSDT  
services are provided, and may administer the benefit outright via  fee for service 
arrangements or contract with  managed care entitities  for service provision.  States 
must establish periodicity schedules for EPSDT  screening services  (e.g., blood lead  
screening tests)  and  must  consult with medical organizations involved in child health 
care to assist in the development of  State periodicity schedules.  
The Centers for Medicare and Medicaid Services (CMS) considers all  
Medicaid-enrolled children to be at risk of lead toxicity; therefore, blood lead  
screening tests are  a required  service  under EPSDT.17,  18   When screening  services  
indicate  a  need for further evaluation, CMS suggests that  children should receive a  
complete diagnostic evaluation  and  diagnostic services to evaluate any conditions 
discovered  by a  screening  (e.g., a  blood lead level).19   States are required to cover 
necessary health care and treatment  services  for  childrens  conditions  identified  
during EPSDT  screenings, including  services  not otherwise covered under State 
plans.20   Treatment  services for children with lead  toxicity  may include referrals to  
other Federal programs or State health agencies and community-based programs.21  
Diagnosis of elevated  blood lead levels  
In its  guidance,  CMS references  two distinct blood lead  levels related to  confirmatory  
testing, followup  and treatment  services for lead  toxicity.   First, the CMS State 
Medicaid Manual cites  to a  blood  lead level  of  10 g/dL  (micrograms per deciliter).  
The Manual  notes that if  a blood lead screening test result obtained by capillary 
specimen (fingerstick) identifies a blood lead level equal to or greater than 10 g/dL, 
the result must be confirmed using a venous blood sample.  Further, the Manual  
states that children with confirmed levels at or above 10  g/dL must be diagnosed  
with an  elevated  blood lead level in order for practitioners to receive reimbursement  
for some activities to determine the source of lead exposure.22   Second, a  2016 CMS  
informational bulletin  cites to the Centers for Disease Control and Prevention (CDC)  
blood  lead reference value as the threshold  level  at which the CDC recommended  
public health actions should be initiated.23   During our review period, the CDC blood  
reference level was 5  g/dL.   Following our review period,  in October 2021, CDC  
lowered the CDC blood lead reference value to 3.5  g/dL, CMS updated the lead  
screening web page on Medicaid.gov to reflect  CDCs  updated reference value, and  
CMS  highlighted the updated reference value during a call with Medicaid  medical  
directors.24, 25   The updated  reference value  was not  reflected in the CMS State 
Medicaid  Manual as of  December 2022.  
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for  Diagnoses and  
Treatment Services Raises Concerns, OEI-07-18-00370   Background  | 2     
Followup  testing  and treatment  services  for children diagnosed 
with  elevated  blood lead levels   
EPSDT provides for necessary health care, diagnostic services,  and  treatment  to 
correct  or  ameliorate any physical and mental illnesses or conditions  discovered by a  
screening  (e.g.,  a  blood  lead level  identified via  a  blood  lead screening test).26   The 
CMS State  Medicaid  Manual offers additional guidance for  treating  children with 
blood  lead levels  at or above 10 g/dL.   The Manual  notes  that  practitioners should  
use professional judgment  and  refer to  CDC guidelines for patient management and  
treatment, including  followup blood lead tests and investigations to determine the 
source of lead, where indicated.27   Practitioners are also advised to coordinate with  
other Federal partners such as the Special Supplemental  Nutrition  Program for 
Women, Infants,  and Children (WIC)  and Head Start, as well as private and public 
resources,  to help ensure comprehensive diagnosis and treatment for children 
diagnosed  with lead toxicity.   In some cases,  this  coordination  could include  States  
public health departments; the  Manual indicates  that public health departments  
childhood lead poisoning prevention programs may be available.   
Other guidance related  to  followup  testing  and  treatment  
services  for  lead  toxicity  
In the State Medicaid  Manual, CMS  suggests  that States  reference or adopt clinical 
practice guidelines such as guidance published by the CDC, or the  American Academy 
of Pediatrics  (AAPs)  Bright Futures: Guidelines for Health Supervision of  Infants, 
Children,  and Adolescents.28   State  public health departments  also establish 
State-specific guidance  for  practitioners related to  medical management of  childrens  
blood lead levels.  See Appendix A for  Federal  guidance and recommendations 
related to  followup testing and treatment  services  for lead  toxicity, and a  summary 
table of CDC-recommended  actions based on blood  lead  level.   See Appendix  B  for a 
table of guidance  from  States included in this review  related to medical  management  
of  childrens  identified  blood lead levels.  
CDC  
CDC publishes  recommendations for followup and case management of children with 
confirmed  blood lead levels (i.e., a capillary blood lead test confirmed with blood  
drawn by venipuncture).  CDC also  makes recommendations regarding the  blood lead  
reference value, which can  help identify children with higher levels of lead in their 
blood compared to  most children.29   CDC notes that  the blood lead  reference value 
serves as a guide to empower  public health partners to determine whether medical or 
environmental followup actions should be initiated for individual children, and to 
prioritize community prevention efforts.30   CDC has also developed recommended  
timelines for (1) obtaining a confirmatory venous blood sample, (2) early followup 
testing, and (3) later followup testing after a childs blood  lead level begins to decline 
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for  Diagnoses and  
Treatment Services Raises Concerns, OEI-07-18-00370   Background  | 3     
(see Exhibit  1 on the next page  for recommended timelines during our review  
period).31     
CDC-recommended  case management  services vary depending on a childs  identified  
blood  lead level.   Although CDC updated the blood lead reference value to 3.5  g/dL  
in October 2021, CDC used a blood lead reference value of 5 g/dL prior to October 
2021, and during our review period.32   Therefore, for children with blood lead  levels  
below  5  g/dL  during  our review period,  services  recommended by CDC  included  
routine assessments of nutritional and developmental milestones, anticipatory 
guidance about lead exposure  sources, and followup testing at age-based intervals.   
As blood  lead levels increase  above the reference value, CDC  recommended  more 
frequent testing, public health actions such as  environmental assessments and  
investigations, nutritional counseling, lab work to identify nutritional deficiencies, 
abdominal X-rays, neurological exams, and chelation therapy  (see Appendix  A).33   
Exhibit 1: During our review period, CDC  recommendations for followup and  
case management of children with confirmed blood lead levels included  
timeframes for  when  children  should  receive followup blood lead testing.  
AAP  
AAP guidance regarding screening children for lead exposure and followup for 
childrens blood lead levels emphasizes prevention and risk  assessment  as key factors 
in reducing childhood lead exposure.  One prevention effort is AAPs anticipatory 
guidance, which outlines discussion points to educate parents about lead exposure, 
minimize risks, and develop a plan to create a lead-safe environment for children.34     
During our review period, AAP recommended that when  practitioners identify blood  
lead levels of  5 g/dL  or greater in a  child,  they should  initiate services such as finding  
and removing environmental sources of lead, and  optimizing  the childs diet and  
nutritional status.35, 36    
State  medical management  guidance   
State  health departments  issue State-specific  guidance  related to  medical  
management  of  children exposed to  lead.  During our review period,  all  five  States  in  
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for  Diagnoses and  
Treatment Services Raises Concerns, OEI-07-18-00370   Background  | 4     
this review (California, New York, Ohio, Pennsylvania, and Texas)  offered  
recommendations for children based on identified  blood  lead level; these 
recommendations did not always align with guidance from CMS  and CDC  (see  
Detailed Methodology).  Although  these State recommendations  varied, for children 
with levels  below 5 g/dL, State-recommended  services typically  included  followup  
testing  at  specified  intervals, anticipatory guidance,  or  parent education, depending  
on the State.   For children with  blood lead levels above 5 g/dL, State  
recommendations included services such as more frequent  blood lead  testing;  
nutritional  counseling;  developmental  monitoring; and  environmental assessments 
and investigations, among others.  State guidance on early intervention services for 
children exposed to lead  also varied.  California recommended  that practitioners  
consider referrals to WIC  and encourage participation in early enrichment activities  for  
children with identified  blood  lead levels below  5  g/dL.  Ohio recommended  that 
children with blood  lead levels at  or above 5  g/dL receive referrals to WIC and  State  
early intervention services  if developmental delays were  identified.   See Appendix  B 
for additional details  on State  medical management  guidance.i 
CMS  oversight  of  State  reporting  on Early and  Periodic  Screening,  
Diagnostic,  and  Treatment  services   
Each year,  CMS requires States to submit  data  on the annual EPSDT report Form 
CMS-416, which tracks  the expected and actual  number of EPSDT screening services 
provided to  Medicaid-enrolled children in different age groups.37, 38   The  report  
demonstrates  State EPSDT participation ratios  and screening  goals.  Additionally, the  
report is used  to  identify trends and patterns that CMS notes  can  inform decisions  
and recommendations  to ensure that  Medicaid-enrolled children  are given the best  
possible health care.  
Form CMS-416 instructs  States to  report  annually, based on Medicaid claims data,  
certain medical screening procedures  including  blood  lead screening tests.  Form  
CMS-416 notes that States  may  count  as  blood lead screening tests instances of  a 
blood  lead test procedure  in  Medicaid  claims  when accompanied by  a diagnosis code  
to  indicate that  the test  was a blood  lead screening test (e.g.,  a well-child check  or  
exposure to lead  diagnosis code), among other methods.39   The instructions also note  
that Medicaid  claims with  a blood lead test procedure  and  a lead toxicity  diagnosis  
code  generally indicate that  a child has  already been diagnosed with, or is being  
treated for, lead  toxicity; followup tests  for children who are  being  treated for lead  
toxicity  should not  be counted toward the  total  number of  blood lead screening tests.   
In addition to tracking screening services, CMS  instructs  States to count the total  
number of children referred for corrective and/or treatment  services after an initial or 
_____________________________________________________________________________________________________________________________  
i  Although some  States  have incorporated elements  of their  guidance  into  regulation,  the  objective  of  this  review  
was  not  to  assess  compliance  with  legal requirements,  but  to  assess  the  extent  to  which  children  diagnosed  with 
lead toxicity  received recommended followup  testing  and  treatment  services  for  their  identified blood lead level.  
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Treatment Services Raises Concerns, OEI-07-18-00370   Background  | 5     
periodic screening (e.g.,  referred for  treatment services for a  blood  lead level  
identified during a screening  office  visit).    
Related  work  
This study follows  earlier OIG work  on  EPSDT services.  One  report, issued in October 
2021, found that  in  FYs 20152018, more  than one-third of 1 million children enrolled  
in Medicaid  did not receive a blood lead screening test at  ages  12 months and  
24  months, as required by Medicaids schedule.40   OIG  made three recommendations 
to CMS related to  monitoring  of  national EPSDT  performance data for blood lead  
screening  tests  to increase  tests  according to Medicaids schedule, ensuring  
consistency across CMS  guidance, and coordinating with partners to  develop and  
disseminate educational  materials on  requirements and schedules for blood lead  
screening tests.   An earlier OIG report on the completeness of  EPSDT medical 
screenings for Medicaid-enrolled children  also identified deficiencies in  blood lead  
screening tests for children ages 12 and 24 months.41   In response to this work, CMS  
convened a National EPSDT Improvement Workgroup to identify the most critical  
areas for improvement in EPSDT, discuss steps to increase the number of children 
who access EPSDT services, and improve data reporting.42  
Methodology  
This study includes a medical record  review  for  Medicaid-enrolled children with a  
diagnosis  of  lead toxicity in  Medicaid claims, in  five StatesCalifornia, New York,  
Ohio, Pennsylvania, and  Texasand  stakeholder interviews.  These States  had  among  
the greatest  numbers  of children  with  confirmed high  blood  lead levels  based on 
National Childhood Blood Lead Surveillance Data from  CDC and  were selected  to  
ensure that we had  a  large enough population to sample from for medical record  
review.43    
Data collection.  To examine followup testing  and treatment  services for  children 
diagnosed  with lead toxicity, we first collected  Medicaid  Management Information 
System data for  FYs  20152018  from the five selected States.  Specifically, we 
collected  all incurred  fee-for-service claims  and  managed care encounters, and  
eligibility  data.  We used the Medicaid data to identify a population of children with 
(1)a diagnosis  in Medicaid claims  indicating lead toxicity, as described in the 
Form-CMS 416 State reporting instructions, and (2) at least 6 months of continuous 
Medicaid enrollment following that  diagnosis.  From this population, we selected a  
simple random sample of 625 children125 children per State.  Of the 625 children in 
our sample who had a diagnosis of lead toxicity in their respective Medicaid claims, 
we received medical records for 581 children, a 93-percent overall  weighted  response 
rate (see Exhibit 2  on next page).    
The  medical record review  included records that we collected for each child,  from the 
date of  diagnosis in Medicaid claims  through the 6 months following their diagnosis, 
including  FYs  20152019.   We selected this period  in consideration of  recommended  
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for  Diagnoses and  
Treatment Services Raises Concerns, OEI-07-18-00370   Background  | 6     
Exhibit 2: Flowchart of Medicaid-enrolled children with  a 
diagnosis of lead  toxicity in Medicaid claims  who were 
included in our medical record review  
Source:  OIG analysis  of medical  record  documentation, 2022.  
timelines for followup blood lead testing from  CDC,  and  from the States selected for  
this review.  See the Detailed  Methodology for more  information  on  medical  record  
collection  timelines.  See Appendices A and B for details on recommended  followup  
testing timelines from CDC  and  the selected  States.   
We developed a medical record review instrument using  the guidance  noted above, 
and in collaboration  with  physician  toxicologist  reviewers (medical reviewers)  with  
experience in followup testing  and treatment  services for  children exposed to lead.    
The instrument was not  designed to  test for compliance with payment, coverage, or 
other legal requirements, but  was designed  to assess the extent to which  
recommended treatment services were provided to children diagnosed  with lead  
toxicity.    
All 581 medical records were reviewed first by contracted nurse abstractors, who  
flagged in the records documentation related to  followup testing or treatment  
services for childrens identified  blood lead  levels.  Medical reviewers then reviewed  
each abstracted record for evidence to  confirm  the diagnosis of  lead toxicity  in the 
Medicaid claims, and, for  confirmed  records, evidence of followup testing and  
treatment services in the 6 months following a childs diagnosis.  Of the 581 records 
received, medical  reviewers deemed  166  records  to include sufficient evidence to  
confirm  the diagnosis of lead toxicity.   These confirmed  records had either  evidence 
of  a blood lead level at  or above  5 g/dLthe CDCs blood  lead reference value in 
use during our review periodor  evidence of a blood  lead  level below 5  g/dL,  
accompanied by  documentation of signs, symptoms,  or  practitioner  notes regarding  
an elevated  blood  lead level.   The instrument incorporated the CDCs 5 g/dL  blood  
lead reference value  for confirming a diagnosis of lead toxicity so  that  medical 
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reviewers could objectively distinguish children  whose medical records indicated  a  
need for followup testing and  treatment  services  during the 6-month review  period, 
irrespective of variances among State  medical management  guidance.    
To account for public health and case management services that children diagnosed  
with lead toxicity may have received outside of clinical settingsservices that  may not 
show up in medical  recordswe  requested data and  documentation from State  
health departments for the 625 children selected for the medical record review.  State 
health departments in 4 StatesCalifornia, New  York, Ohio, and Texasreturned data  
and/or case file documentation for 144  children,  75 of whom  were among the 
166  children  whose lead  toxicity diagnoses our medical reviewers confirmed.    
To collect information regarding barriers and challenges in the provision of followup 
testing  and treatment  services for children with lead toxicity, we identified  medical  
reviewer notes from the medical record review and conducted stakeholder interviews.  
We interviewed stakeholders from government agencies and professional  
organizations regarding followup testing  and treatment  services for  
Medicaid-enrolled children exposed to lead.  
Data  analysis.  For the 166 medical  
records with a lead  toxicity diagnosis our 
medical reviewers were able to confirm, 
For this review, medical reviewers 
we analyzed  results of the review  to assess 
determined  appropriate services  
whether children received treatment  
for lead  toxicity  using their 
services for their identified  blood lead  
professional judgment, with 
levels.   Per  the CMS State Medicaid  
reference to:  
Manual, we asked  medical  reviewers to  
use their professional judgment,  with  
   followup testing and treatment  
reference to  followup testing and  
services  recommended by CMS  
treatment services recommended by CMS  
and  CDC;  and  
and  CDC.  The  Manual also suggests that 
   respective State  medical  
treatment for children diagnosed with lead  
management  guidance  for  
toxicity may include coordination  with  
childrens identified blood lead  
health departments; therefore,  we asked  
reviewers to consider  respective State  levels.  
medical management guidance for 
childrens identified blood lead  levels.   
Using  these criteria, medical reviewers determined whether children received  
appropriate services for lead toxicity.   Additionally, medical reviewers examined  the 
records to determine whether children with blood lead levels at or above 5  g/dL  
received  early followup blood lead  testing  as recommended by  the CDC  schedule  
during the review period, or whether there was evidence of any followup blood tests 
during childrens respective periods of review.    
We  reviewed data and case file documentation from  State health departments  to 
identify other  services that  children with  a  confirmed  diagnosis of  lead toxicity  may 
have received outside of  clinical  settings.  Specifically, we looked for dates of  services  
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and types of  case management and/or public health services that children received  to 
provide a sense of other possible followup care.    
Finally, we  analyzed  medical reviewer notes and  interview data to identify common 
themes  related to  the provision of followup  testing and treatment services for 
children exposed to lead.  See the Detailed  Methodology for more information  on  
data analysis.  
Limitations  
We identified diagnoses of  lead toxicity for this work using  incurred  (i.e., paid and  
unpaid)  Medicaid  claims; we did not  assess payment associated with this  diagnosis, 
nor  compliance with coverage requirements.  Our medical reviewers found that 415 of  
the 581 reviewed medical records contained insufficient information to  determine 
whether these children had the blood lead  levels and symptoms to  warrant further 
followup services.  Although the medical reviewers conducted a thorough 
examination of the remaining 166 medical records, the results of these medical record  
reviews are not projectable.    
Data  obtained from State health departments were limited and, as such, were not  
used by our medical reviewers to make their determinations as to whether 
appropriate services were provided.  That assessment was based solely on medical  
records.  The limited  data obtained  from State health departments only provide some 
awareness of the types of case management or public health services that children 
may receive outside of clinical settings.    
Standards  
We conducted this study in accordance  with the Quality Standards for Inspection  and  
Evaluation  issued by the Council  of the Inspectors General on Integrity and Efficiency. 
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FINDINGS  
In  5 States, more  than  two-thirds of  581 medical records  for 
Medicaid-enrolled  children lacked  adequate  information  to 
confirm  the  diagnosis  of  lead  toxicity  in  the  Medicaid  claims  
In this evaluation of medical records for 581 Medicaid-enrolled  children with a  
diagnosis of lead toxicity  in their Medicaid claims, medical reviewers could not find  
adequate information to  confirm a  diagnosis  of lead toxicity  in 415 childrens records 
(see Exhibit  3 below).   For these 415  children, medical reviewers could not identify 
(1)  evidence that a child  had a blood lead level at or above 5 g/dL, or (2) evidence of  
a blood lead level  below 5  g/dL, accompanied by (A) signs and symptoms of an 
elevated  blood lead  level, and/or (B)  notes from a practitioner regarding an elevated  
blood  lead level.   Because there is no safe lead level for children, even very low blood  
lead levels may indicate in some instances a need for treatment, based on individual  
factors (e.g., age, environment, increasing  blood  lead level  trend).  However, without  
adequate information in the  medical  records, medical reviewers were unable to  
determine the applicability of  recommended followup testing and treatment services 
for these children.44  
Exhibit 3: Medical records for the majority of the children (415 of 581)  did  
not contain  adequate information to  confirm the diagnosis of lead  
toxicity  in  the Medicaid claims.  
Source:  OIG  analysis of  medical record documentation,  2022.  
It is unclear why this many medical records, across five States, lacked information to  
confirm the diagnosis of lead toxicity identified in the Medicaid claims.  One possible 
explanation provided by AAP is that there may be confusion regarding different  
diagnosis codes.  There are several diagnosis codes that a practitioner could apply 
when screening a child  for a potential lead exposure;  when testing and confirming a  
blood  lead level;  and when treating a child for lead toxicity.   Stakeholders from AAP  
shared with OIG that a diagnosis of lead toxicity would typically be associated with 
serious cases, such as when a child is hospitalized for acute lead toxicity.  Otherwise, if  
a patient does not demonstrate toxic effects, AAP suggested,  a code that  indicates 
signs and symptoms, such as a diagnosis of  abnormal lead levels in the blood, would  
more often be used.  One clinical stakeholder suggested  that it is possible that some 
practitioners may use the lead toxicity code as a  means to order a blood  lead  
screening test during an EPSDT preventive care office visit.  Regardless of the reason, 
AAP shared that the number of cases that lacked adequate information to confirm  a 
diagnosis of lead toxicity was concerning.  
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There are possible  implications  for Federal oversight of  the EPSDT benefit  if an initial  
or periodic blood  lead screening test during an EPSDT office visit is mistakenly coded  
as lead toxicity, instead  of a well-child check.  Specifically, the  Medicaid  claim could  
be incorrectly excluded  from  State  reporting of blood lead screening tests to CMS, as 
CMS presumes this diagnosis to be  a flag of ongoing treatment and not an initial  
screening.   This  could result in an undercount  of  the total number of blood lead  
screening tests reported  by the States.  Further, this could  result in an overcount  of  
the  number of children referred for corrective and/or treatment services  that a  State  
reports to  CMS.   Without reliable claims data on blood  lead testing and treatment  
services for children with lead toxicity, CMS lacks  sufficient information to  oversee  
States  blood lead screening and remediation efforts for Medicaid-enrolled children 
exposed to lead.  
Among  children whose medical records  lacked  information to  
confirm a  diagnosis of lead  toxicity, 340 children had  blood lead  
levels  below the reference value, and the remaining 75  children 
had no recorded blood lead  levels  
For 340 of the 415 children with a diagnosis of lead toxicity in their Medicaid claims, 
medical reviewers frequently identified blood  lead levels below the blood  lead  
reference value  of  5 g/dL  that was in use during our review  period.  As such,  they  
could not establish a  justification for followup testing and treatment services for lead  
toxicity (see Exhibit 4).   
Further, blood lead  levels in the medical records for more than three quarters of these 
children (305 out of 340) had levels that fell below CDCs updated blood lead  
reference value of 3.5 g/dLthe value currently used to identify children with higher 
levels of  lead in their blood compared to most  other children.  Most of  the remaining  
35 children had a blood lead level between 3.5 and  4.9  g/dL.45    Medical reviewers 
often indicated in case notes for these children that a child (1) appeared to be a  
normal infant or  toddler;  (2) had a  low blood lead level and  no related signs or 
symptoms;  or (3) had  a low  blood lead  level associated with a routine preventive care 
office visit.   
Exhibit 4: Among the 415 children with medical records that lacked  
adequate information to  confirm a  diagnosis of lead toxicity, 340  children  
had blood  lead levels below 5 g/dL, and records for the remaining  
75  children  did not include evidence of  any blood lead level.  
 
Source: OIG analysis of  medical record documentation,  2022.  
For the remaining 75 of  the 415 children with a  diagnosis of lead toxicity in their 
Medicaid claims, medical reviewers could not  find evidence in the medical record of  
any documented blood lead level during a childs period of review (see Exhibit 4,  
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above).  For 32 of these children for whom medical reviewers included case notes, 
medical reviewers indicated that the record contained minimal documentation to  
review (e.g., orders for blood lead tests but no lab results recorded in the record; 
minimal practitioner notes or documentation of  visits).   
In  5 States, half  of the  166  medical  records  for children with  a  
confirmed  diagnosis  of  lead  toxicity did  not  include evidence of  
comprehensive followup  testing  and  treatment  services, as  
recommended   
Among the 166 Medicaid-enrolled children with sufficient documentation to  confirm  
a diagnosis  of  lead toxicity  in  their Medicaid claims, medical reviewers determined  
whether children received appropriate followup testing and treatment services.  For 
the purposes of this review, medical reviewers determined appropriate services for 
lead toxicity using  their professional  judgment, with reference to followup testing and  
treatment services recommended by CMS and CDC, and in consideration of  respective 
State medical management guidance for childrens identified blood  lead levels  (see  
Appendices A and B).  Therefore, recommended services that reviewers looked for in 
the records varied  according to a childs blood lead level  and State.   These 
recommended services ranged  from routine developmental and nutritional  
assessments for children with low levels to neurological examinations for children with 
high levels.  
 
Medical reviewers determined that  85 of the 166 children with a  confirmed  diagnosis  
did not receive appropriate followup testing and treatment services for childrens 
identified blood lead levels  while  81 children received appropriate followup testing  
and treatment services.  A greater proportion of  children with blood  lead levels less 
than 5  g/dL, for whom  medical  reviewers also identified  signs, symptoms,  and/or  
notes in the medical record, received  appropriate services than did children with 
blood  lead levels at or above 5  g/dL.   See Exhibit 5 below for the blood lead level  
ranges of the 166  children  and whether each received appropriate services.   See  
Appendix  C  for results of the medical record review.   
Exhibit 5: Of the 166 children, 85 children  did not receive services as 
recommended for  their identified blood lead  level, and  81 children  received  
appropriate services, as recommended.  
Source: OIG analysis of  medical record documentation,  2022.  
 
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Among  the 85 children who did not receive appropriate services, medical reviewers 
found  documentation demonstrating  that nearly two-thirds of the 85 children 
received some services; however, they determined  that the  services did  not meet  
recommendations for  followup testing or treatment services from  CMS,  CDC, and  
medical management  guidance  from childrens respective States.  Specifically,  medical 
reviewers found that  51  children had no medical record  documentation of  early 
followup blood  lead testing as recommended by the CDC schedule for their identified  
blood  lead levels.46   Further, 32 of these children  had no medical record  
documentation of  followup tests at all during their respective periods of review.   
Medical reviewers also found  that more than three-quarters  of the 85 children did not  
receive environmental services (e.g., assessments or investigations to  identify 
potential sources of exposure) or referrals for services, as recommended  by CDC.   In 
nearly half of the records for children with blood  lead levels at or above 10 g/dL, 
medical reviewers identified a  lack of services such as nutritional counseling and/or 
lab work to  assess iron status, as recommended  by CDC.  Medical reviewers 
determined that nearly a  quarter of the 85 children  did not receive any  services or 
treatment  recommended by CMS, CDC, and  medical management  guidance from the 
childrens respective States.  In  the absence of recommended services for their 
identified  blood lead levels, children could miss out on critical early interventions to  
help mitigate ongoing exposure and to identify nutritional  and developmental issues 
related to  lead exposures.    
In the medical record for one child with a blood lead level of  10 g/dL, 
the reviewer  did not identify  recommended  followup tests and  
treatment services in  the record.   The reviewer indicated that the 
child did not receive any followup testing to see if their blood  lead level  
was declining until 6 months later.  Further, the child did not  receive 
recommended assessments to identify nutritional deficiencies, 
developmental delays, or environmental sources of lead exposure.  
Instead, the child received an abdominal X-ray and a bone lead survey;  
the reviewer noted that these tests  were done unnecessarily.  
For 81 of the 166 children with a  confirmed  diagnosis, medical reviewers determined  
that children received appropriate services to treat their identified blood  lead levels  
that met recommendations from CMS, CDC, and  medical management  guidance  from  
childrens respective States.   In contrast to the 85 children who  did not receive 
appropriate followup testing and  treatment services, these 81 children received a  
variety of services and treatments.  Two-thirds of the children for whom the CDC  
schedule recommended early followup testing within 3 months received testing as 
recommended.47   Moreover, nearly all  of these children received a followup blood  
lead test during their respective periods of review.  Almost all of the 81 children 
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received assessments 
of nutrition and  
In the medical record of  another child with a blood  
developmental  
milestones.  These  lead level  of 10 g/dL, a  reviewer identified  
children also more  followup tests and treatment services, as 
frequently received   recommended.   In this case, the reviewer found  
environmental  
that the child received subsequent tests to monitor 
services to identify 
blood  lead levels throughout the review period.  The 
potential sources  of  
record also  noted involvement of the health 
lead exposure and  
department to identify  the source of lead exposure 
were more often 
in the childs home, and nutritional  and  
referred for 
developmental services.  
recommended  
services than were 
children who did not  
receive appropriate services.  Reviewer notes for these children indicated referrals for  
services such as speech therapy;  developmental assessment;  neurology;  dietary 
counseling;  and health department or environmental health clinic involvement.  These 
types of recommended public health interventions and services are associated with 
long-term behavioral and educational benefits for young children with  identified  
blood  lead levels.  
In  four  of the  five  States, State health department  data 
demonstrated  that children  diagnosed with lead toxicity may 
receive public health services outside of clinical settings   
For children with confirmed  blood  lead levels, public health resources can help 
facilitate important services such as  lead remediation efforts in the home.  Because 
health department data  were  only obtained from four of the five  States in this review  
and  were  not comparable to the medical record  review  data (see Detailed  
Methodology),  medical reviewers did not review  and assess this data to help make 
their determinations as to whether children received appropriate  services  for their  
identified blood lead levels  from payors other than Medicaid.  Still, the identification  of  
these public health services demonstrates that case management and coordination of  
care for blood lead  levels can,  at times,  occur outside clinical settings.  These data  
may have complemented the medical care that  children received in clinical settings.    
For example,  among the  166 children with a  confirmed  diagnosis, we found evidence  
of  at least  1  public health service for just under half  of the children during their 
respective periods of review.   For the previously mentioned 85 children who did not  
receive appropriate followup testing and treatment services according to  the medical  
record review, we identified in State health department data that  33  children in 
California, New  York,  and  Ohio  had  1  or 2  documented  services during  their  respective 
review periods;  11  children had  3  or more  services (e.g., blood lead testing, 
environmental, nutritional, or  parent  education services)  documented  in health 
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department data.  For the 81 children who medical reviewers determined had  
received appropriate followup testing and treatment  services, we also  identified at  
least  1  public health service for more  than one-third of  these children  in New York, 
Ohio, and Texas.  Specifically, 26  of these 81 children had  1  or  2  documented  services 
during their review period,  and 5 children had  3  or more services  documented in 
health department  data.  
These public health data  included additional services for children diagnosed with lead  
toxicity;  however,  a lack of corresponding medical record documentation could  
present a challenge to coordination of care.  A child with lead toxicity may benefit  
from public health services such as  followup blood lead testing or an environmental  
investigation conducted by a local health department, but if such services are not  
documented in the medical record, future case management and followup care for 
identified blood lead levels could suffer.    
 
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CONCLUSION AND  RECOMMENDATIONS  
Our review  underscores  the importance for  CMS  to focus  its attention  on two aspects  
of EPSDT:  State reporting  of  Medicaid claims data that CMS  uses to measure  EPSDT  
program participation  each year, and the treatment component of EPSDT  for children 
diagnosed with lead toxicity.  For the majority of children in this evaluation, medical  
reviewers could not find  adequate information to  confirm a diagnosis of lead toxicity  
in the Medicaid claims.  It is  unclear why this many medical records, across five  States,  
lacked information to confirm  the diagnosis of  lead toxicity  in childrens  Medicaid  
claims.  Regardless of the reason, this  raises concerns about the accuracy of the 
Medicaid claims data  and annual State EPSDT reporting to  CMS.   Without accurate 
claims data,  CMS may be  unable to accurately measure States  EPSDT performance 
and ensure that Medicaid-enrolled children with lead toxicity are given the best  
possible health care.  
Among the children for whom medical records confirmed  the diagnosis, medical 
reviewers determined  that half of the children did not receive  comprehensive 
followup blood lead testing and treatment services (e.g., environmental assessments 
to determine the source of exposure), as recommended by CMS, CDC, and  respective 
State  medical management  guidance for a childs identified  blood  lead level.  In a few  
cases, children had no followup testing or treatment services for their identified blood  
lead levels documented in their medical record.  However, half of the 85 children who  
did not receive appropriate followup testing and treatment according  to the medical  
record review did receive at least  1  public health service for lead toxicity during their 
respective period of review.  This suggests that treatment for blood  lead  levels can 
occur outside of clinical  settings.  Nonetheless, the fact that public health  services 
may not be  not captured in medical documentation could  present challenges for case 
management and coordination of care.    
We recommend that CMS:  
Explore  the  discrepancy  between  Medicaid  claims  data  and  
medical documentation for lead  toxicity and  implement  
solutions  to  ensure better oversight  of  the EPSDT  program  
Given that the majority of medical records in our review lacked adequate information  
to confirm the diagnoses of lead toxicity in childrens Medicaid claims, CMS should  
explore this discrepancy to identify root causes, examine potential impacts, and  
identify solutions to  address the issue.  CMS could accomplish this by convening a  
workgroup similar to the National EPSDT Improvement Workgroup that includes  State  
Medicaid  agency representatives, childrens health providers, and other experts in 
Medicaid, data analysis, and environmental health issues such as lead toxicity.  CMS  
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could  also  accomplish this by using an existing  workgroup or standing  meeting  
structure to hold a  webinar or information sharing session with similar experts.  CMS  
could share the findings from OIGs report with this group and engage the group to  
determine the root causes for the discrepancy between the Medicaid claims data and  
the medical  records.  CMS could also  engage the group to examine potential  impacts 
on oversight of the EPSDT program and identify solutions to address the issue.  CMS  
could then work to implement  solutions based on the groups determinations.  
Issue guidance to  reiterate  State  obligations  under the EPSDT  
benefit to  ensure access  to  services  to  correct  or ameliorate 
confirmed  blood  lead  levels  identified during  screenings   
To ensure that  Medicaid-enrolled  children  with illnesses and conditions  identified  
during EPSDT screenings  (e.g.,  a confirmed blood  lead level  following a blood lead  
screening test)  receive necessary treatment  services, CMS should issue guidance to  
States.  The guidance should  remind States of  EPSDT  service  requirements related to  
treatment  and  corrective services  for illnesses and conditions  identified  during  
screenings.  The guidance should also  reaffirm  Medicaid coverage for services such as 
followup  blood lead  testing or investigations to determine the source of  lead  
exposure for children with confirmed  blood lead levels.  The guidance could promote 
case management and coordination of care among the practitioner community, 
health departments, and other local resources when treating children for  conditions 
including lead toxicity.  
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AGENCY  COMMENTS  AND  OIG  RESPONSE  
CMS concurred with both of  OIGs recommendations.  
In response to our first recommendationthat  CMS  explore the discrepancy between  
Medicaid claims data and medical documentation for lead  toxicity and implement  
solutions to  ensure better oversight of the EPSDT  programCMS stated  that  it would  
collaborate  with other Federal partners and AAP to share the findings from OIGs 
report  with State Medicaid  agency  medical directors.  Additionally,  CMS  stated that it 
would remind  States of their obligations to provide clinical  and coding guidance to  
their providers.    
Although OIG  views  CMSs  planned  response to the first recommendation  as  positive, 
we do not consider these  activities sufficient to  close this  recommendation.   Because  
CMS lacks  complete  information to determine the cause of the discrepancy that OIG  
identified,  we urge  CMS  to  engage the appropriate experts and State Medicaid  
agencies in determining the root causes of the discrepancy between the claims and  
the medical  records;  examining potential  impacts;  and identifying and implementing  
solutions.   We look forward to updates in CMSs Final Management Decision on any 
activities  related to  this collaborative effort, and any conclusions that the group 
reaches regarding root  causes for the discrepancy between Medicaid claims data  and  
medical documentation for lead  toxicity.  If, after CMS engages in this effort, CMS  
comes to the conclusion that the root cause is a coding issue, then CMSs planned  
action  to remind States of their obligations to provide clinical and coding guidance 
may help demonstrate movement toward meeting the intent of the recommendation.    
In response  to our second recommendationthat CMS  issue guidance to reiterate 
State obligations under the EPSDT benefit to ensure access to services to correct or 
ameliorate confirmed blood lead levels identified during screeningsCMS stated that 
it would  issue guidance to States reminding  them of their obligations under the 
EPSDT benefit to provide comprehensive and preventive health care services for 
children under age 21.  Further, CMS  stated that it will remind States that  they are  
required to furnish all Medicaid coverable, appropriate, and medically necessary 
services needed to correct and ameliorate health  conditions.    
We appreciate CMSs proposed  actions  for  the second recommendation to  remind  
States of  EPSDT service requirements related to treatment and corrective services for 
illnesses and conditions identified during screenings.  In this report, we recommend  
that CMS  include in its guidance to States  a discussion of  Medicaid coverage for 
services such as followup blood  lead testing and investigations to determine the 
source of lead exposure  for children with confirmed blood  lead levels.  We also  
encourage CMS to promote case management and  coordination of care when 
treating  children for conditions including lead toxicity.   After CMS takes these actions, 
we look  forward to updates in CMSs Final Management Decision regarding CMSs 
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guidance to  States on EPSDT service requirements for treatment and corrective 
services  for  lead toxicity.  
For the full text of  CMSs comments, see Appendix D.    
 
 
 
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DETAILED  METHODOLOGY  
State  selection  
For this medical record review of followup testing and treatment  services and  
treatment for children diagnosed with lead toxicity, we selected five States: California, 
New York, Ohio, Pennsylvania, and Texas.  These States had among the highest  
number of children with  confirmed  elevated  blood lead levels based on National 
Childhood Blood  Lead Surveillance Data  from CDC.  We selected these States to  
ensure that we had  a  large enough population of children diagnosed with lead  
toxicity to sample from for our medical record review.   
Medicaid  claims analysis   
Population  selection  
This study included  Medicaid-enrolled children from California, New York, Ohio, 
Pennsylvania, and Texas.   These States had a total of  21,353  children under 3 years of  
age  who had a diagnosis that indicated lead toxicity in their Medicaid claims  and  
6  months of continuous Medicaid eligibility  following diagnosis.  See Exhibit  7  for the 
number of children  in our population  from each State.   We examined  the population 
of children, born between January 1, 2013, and December 31, 2016, with at least  
6  months of  continuous Medicaid enrollment after receiving a diagnosis indicating  
lead toxicity.    
Data collection  
We collected  from each  State  Medicaid Management Information System 
fee-for-service claims  and managed care encounters  from  FYs 20152018, as well as 
all dates of  Medicaid eligibility for the defined population in the selected States.   The  
data included eligibility information and all  incurred outpatient claims (i.e., all claims 
that practitioners submitted) for our population of children.   
Claims analysis  
Eligibility.   From the Medicaid claims, we identified children who had at least  
6  months of continuous enrollment in Medicaid  after receiving a diagnosis that  
indicated lead toxicity.  For instance, a child diagnosed with lead toxicity  at  24  months 
of age had to have been continuously enrolled in Medicaid until reaching 30 months 
of age.  This approach provided a reasonable buffer for children to receive some 
recommended services, such as early followup blood  lead testing for confirmed  blood 
lead  levels  (see Appendices  A and B for criteria that we used  to  develop the  review  
instrument for this study).  Children with a populated date of death variable were 
excluded from all analyses.  
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Data analysis.   To identify children in the  Medicaid claims data with  lead toxicity  
diagnoses, we referenced the Form  CMS-416 annual  EPSDT  reporting instructions for 
States.  The Form  CMS-416 instructions 
note that claims in which a  blood lead   Exhibit 6: Criteria used to identify  
test procedure is accompanied by a   in Medicaid claims a  sample of  
lead toxicity diagnosis generally  children with a lead toxicity  
indicate that a child receiving the test   diagnosis for inclusion in the  
has been diagnosed  with  or is being  
medical record review  
treated for lead poisoning.   The 
instructions also reference a series of  
Blood  lead test  
diagnosis codes that are used to  
procedure,  
describe toxic effects of lead.48   Using  
Identify  procedure  accompanied by 
this series of codes, we conducted pilot  
testing and limited the series to only  
those diagnoses that we  determined  
Diagnosis  indicating   
would aid in the identification of initial  
toxic  effects of  lead,  
occurrences  for children diagnosed with 
Identify  qualifying  
and 
lead toxicity.   We then applied  these   diagnosis 
criteria  to select  a simple random 
sample of 125 Medicaid-enrolled  
6 months of  
children in each of the selected States 
continuous Medicaid  
(625 children total) for our medical 
eligibility following  
record review.   Of  the 625 children 
Identify  eligibility 
diagnosis 
initially selected, 19 children were 
excluded from review because we were 
unable to identify in claims data  
referring practitioners for blood  lead  
Source: OIG review  of  2700.4 Instructions for  
test orders.  This resulted in a final   Completing Form CMS-416:  Annual Early and Periodic  
Screening, Diagnostic, and Treatment (EPSDT)  
sample of 606 unique children.  Our  
Participation Report, 2022.  
review included records from FYs  2015 
2019 that we collected for each child for the 6 months following their diagnosis.  
Data validation and  quality  assurance  
We performed data validation and  quality assurance checks, including:     
    null analysis of selected variables compared to Medicaid Statistical Information 
System (MSIS)  threshold tolerances;49   and  
    independent, peer review, and quality assurance checks of analyses.  
Through this validation process, we concluded that the data were usable for the 
analyses conducted for this study.    
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Medical  record  review  
Collection of  medical records  from  the date of diagnosis through  
6 months later (including  FYs 20152019)  
We developed a letter that  our medical review contractor used  to  request medical  
records from the practitioners identified  in the Medicaid claims data  for  FYs 2015 
2018.  The contractor sent the initial  mailing  for the records request in June 2019  and 
ceased collection efforts in December 2020; therefore, practitioners had from 
8  months to more than 72 months to finalize documentation in the medical records 
related to childrens diagnoses of lead toxicity.  If a practitioner did not respond to  
this initial request  letter, the contractor sent up to two additional letters, and followed  
up by telephone.  Practitioners who  did not respond to three letters and  followup  
phone calls were marked as non-responders.   See Exhibit  7  for the final response 
rates.    
Exhibit 7: Population, sample sizes,  and  response rates    
 
 
 
 
*The weighted  response  rate, based on responses  within each State, was 93  percent.  
Source:  OIG analysis  of medical  record request  respondents, 2022.  
Review of  medical records   
Development of medical record review criteria.   We collaborated with contracted  
physician toxicologists (medical reviewers)  to develop the medical record review  
instrument.  The review instrument criteria included  recommendations from CMS, 
CDC, and State-specific medical management  guidance  for followup  testing  and  
treatment  services for identified  blood lead  levels.  Because  these recommendations  
did not always align,  the medical reviewers  were instructed to  review records using  
their professional  judgment, in consideration  of the criteria noted above.  See 
Appendices  A  and  B  for  these criteria.   
Pretest of medical review  instrument.  To test and refine the medical review  
instrument, we pretested it using  five  cases selected by the medical review contractor.  
We asked  contracted nurse abstractors and  medical reviewers  to complete the 
medical review instrument and used reviewers feedback to improve the instrument  
before initiating the medical review.  
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Record review and quality assurance activities.   To ensure consistent interpretation 
of the  medical review  criteria, we developed training materials and guidance 
documents for contracted nurse abstractors and  medical  reviewers.   All medical 
records were reviewed first by the contracted nurse abstractors, who  identified for 
further review  any documentation related to followup testing or treatment services for 
childrens identified  blood lead  levels.  Medical  reviewers then reviewed the  
abstracted records for evidence to  confirm  the diagnosis of lead toxicity  in the 
Medicaid claims, and evidence of followup testing and treatment services for the 
6  months following a childs diagnosis.  Throughout the medical review, we engaged  
the medical reviewers  in quality assurance activities  to ensure consistent reviews of  
the records.   Per the CMS State Medicaid Manual, we asked medical reviewers to use 
their professional  judgment and to refer to followup testing and treatment services 
recommended by CMS  and CDC.  The Manual  also suggests that treatment for 
children diagnosed with lead toxicity may include coordination with health 
departments; therefore, we asked reviewers to consider respective State medical  
management guidance for childrens identified blood lead levels.  In  some cases,  State  
guidance  may have included  more stringent  recommendations  for followup  services  
than CDC  recommendations (e.g., for children with blood  lead levels less than 
5  g/dL, California   recommended   that   practitioners consider a   referral   to   the Special  
Supplemental Nutrition Program for Women, Infants, and Children  (WIC).   Using these 
criteria, medical  reviewers determined whether children received appropriate followup 
testing and treatment services for their identified  blood  lead  levels.  
Analysis of  medical record review  data.   We  examined  the data collected during  
the medical  record review to  identify  the proportion of children that  medical 
reviewers determined  received appropriate followup testing  and treatment  services 
for their identified blood lead level, as recommended by CMS  and  CDC, and  in  
consideration of  State  medical management  guidance.   During the study period, CDC  
recommendations included a published schedule for early followup testing of children 
with blood   lead levels at or above 5   g/dL.   
Additionally, we examined reviewer notes to  identify potential themes, as well  as any 
challenges  and barriers in the provision of  followup testing  and treatment  services for  
children exposed to lead.  
State  health  department  data analysis  
Data collection.   Medicaid-enrolled  children may receive public health and case 
management services for lead toxicity that are not documented in medical records.  
To account for these types of services, we requested additional data and  
documentation from State health departments.  Specifically, we sent  unique identifiers 
for the 625 children selected for this medical record review to their respective State  
health departments.  We received  data on public health and case management  
services for our sample from  State health departments in four  StatesCalifornia, New  
York,  Ohio, and Texas.  From the Ohio  health department, we also received case file 
documentation.  The State  health department in  Pennsylvania shared that  
lead-related case management services were not  recorded in the States public health 
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data system, and that  it  was unable to meet  our request.   From  the 4 responding  
States, we received  data for 144  of  the selected  children.  
Data analysis.   For the 166 children who were eligible for the medical record review  
analysis, we looked  for evidence of public health and case management services in 
the State health department data.   Specifically, we looked for evidence of dates of  
service  and types of services received.  The data we  received from the State health 
departments were  not comparable to the medical record review data  or  to the data 
from  other States; therefore,  we were not able to use the health department data to  
determine whether children diagnosed with lead toxicity received appropriate 
followup  testing  and treatment  services.  Instead, we were only  able to determine 
whether a public health service occurred.  
Interviews  with  subject  matter  experts  and  stakeholder groups  
To gather information regarding  followup  testing, treatment  services, and public 
health services  for children exposed to lead, and  to gain insights related to our  
medical record review for children diagnosed  with lead toxicity, we conducted  
structured interviews with subject matter experts and stakeholder groups.  
Specifically, we interviewed  specialists from the Pediatric Environmental Health 
Specialty Unit Network and Agency for Toxic Substances and Disease Registry, and  
officials from the American Academy of Pediatrics, selected  State health departments,  
and the Childrens Environmental Health Network.   
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APPENDICES  
Appendix A:  Federal Guidance and  Recommendations  Related  
to  Followup  Testing  and  Treatment  Services  Based  on  Identified  
Blood  Lead  Levels  
Table A-1: Overview of  guidance  from CMS and CDC related to blood lead  
levels, followup testing, and treatment services for childrens identified  
blood lead levels   
  Blood  lead  reference value   Followup  test   Treatment  service  
CMS State   10 g/dL.      If a  child is found to  have blood  
Medicaid  lead levels equal  to or greater  
ManualI   than 10  g/dL, providers are  to  
use their professional  judgment,  
with reference to CDC guidelines  
covering patient management  
and treatment, including  followup  
blood tests and initiating  
investigations  to determine the  
source of lead,  where indicated.   
Coordination with the Special  
Supplemental Nutrition Program  
for Women, Infants, and  Children  
(WIC);  Head Start;  and other 
private and  public resources  
enables elimination of  duplicate  
testing and ensures  
comprehensive diagnosis and  
treatment.   Public health  
agencies childhood lead  
poisoning prevention programs  
may be available.   These agencies 
may have the authority and  
ability to investigate a  
lead-poisoned childs  
environment and to  require  
remediation.  
CMS 2016  The bulletin references  the  CDC       
Informational   blood lead reference value of 
BulletinII   5  g/dL  as  the  threshold  level at  
which CDC recommended  that  
public health actions be  initiated,  
at the  time of our review.  
CMS Lead   Following our review period, CMS      
Screening web  updated the  Lead  Screening web 
pageIII   page  on Medicaid.gov to  
reference  CDCs updated blood  
lead reference value of 3.5  g/dL  
as the threshold level at which 
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Treatment Services Raises Concerns, OEI-07-18-00370   Appendix A  | 25     
CDC recommends that  public  
health actions be initiated.  
CDCIV   During our review period, CDC   During our review period,   During our review period, CDC  
used a  blood lead reference value   CDC provided a schedule   provided  recommendations for 
of 5 g/dL.   In October 2021,   with recommended   followup and case management  
following our review period, CDC   timelines for followup   of children based on confirmed  
lowered the blood lead reference  blood lead testing for   blood lead levels ranging from  
value from 5  g/dL to 3.5 g/dL.   blood lead levels ranging   <5 g/dL   to   70 g/dL   (see 
The current  blood lead reference   from  5   g/dL to   summary of recommendations  
value  is based on the 97.5th  45   g/dL.V   In October   from CDC, Table A-2).V   In  
percentile of the  blood lead   2021,  following our  October 2021,  following our  
values  among  U.S. children ages   review period,  CDC  review period, CDC provided  
15 years from the 20152016  provided  an updated   updated  recommendations for 
and  20172018 National  Health   schedule  with   followup and case management  
and Nutrition Examination Survey   recommended timelines   of children based on confirmed  
(NHANES) cycles.     for followup blood lead   blood lead levels ranging from  
testing for blood lead   <3.5 g/dL  to   45g/dL.VI  
levels ranging from  
3.5  g/dL  to  
45   g/dL.VI  
Sources:  
I) CMS,  Chapter  5:  Early  and  Periodic  Screening,  Diagnostic  and  Treatment  Services,  The  State  Medicaid  Manual,  5123.2,  D,  09-98.   
Accessed at  https://go.usa.gov/xU2VG  on February 28, 2022.  
II) CMS,  Coverage  of  Blood  Lead  Testing  for  Children  Enrolled  in  Medicaid  and  the  Childrens  Health Insurance Program,  CMCS  
Informational  Bulletin.  Accessed at  https://go.usa.gov/xHF8p  on February 28, 2022.  
III) CMS,  Lead  Screening.  Accessed  at  https://www.medicaid.gov/medicaid/benefits/early-and-periodic-screening- 
diagnostic-and-treatment/lead-screening/index.html  on August 17, 2022.  
IV) CDC,  Update  of  the  Blood  Lead  Reference  ValueUnited  States,  2021,  Morbidity  and  Mortality  Weekly  Report,  October 2021.  
Accessed at  https://www.cdc.gov/mmwr/volumes/70/wr/mm7043a4.htm?s_cid=mm7043a4_w  on June 29, 2022.  
V) CDC,  Recommended Actions Based on Blood Lead Level, December 2017.  Accessed at  
http://web.archive.org/web/20200713205506/https://www.cdc.gov/nceh/lead/advisory/acclpp/actions-blls.htm  on  August 17,  
2022.  
VI) CDC, Recommended  Actions  Based  on  Blood  Lead  Level,  October  2021.  Accessed  at  https://go.usa.gov/xz4ab  on  February 28,  
2022.  
 
 
 
 
 
 
 
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Table  A-2: Summary of CDC recommendations for followup and case 
management of children based on confirmed blood lead levels,  during our  
review period  
g/dL   CDC recommended  actionsI  
Routine assessment of  nutritional and developmental milestones,  anticipatory guidance about common 
sources of  lead exposure, followup blood lead testing at  recommended  intervals  based on childs age.   
    
<5  
Routine assessment of  nutritional and developmental milestones, environmental exposure history to identify  
potential  sources of lead and environmental investigation of the home to identify  potential  sources  of lead  (as  
required  according  to  local  conditions  based on jurisdictional  requirements and available resources),  
5-9   nutritional  counseling related to calcium and  iron intake, early followup blood lead  monitoring (2-4 tests after  
identification) within 3 months, later followup testing after blood lead level  declining within 6-9 months.  
Routine assessment of  nutritional and developmental  milestones, environmental exposure history to identify  
potential  sources of lead and environmental investigation of the home to identify  potential  sources  of lead  (as  
required according  to  local  conditions  based on jurisdictional  requirements and available  resources),  
10-19   nutritional  counseling related to calcium and iron intake, consider lab work  to assess iron status, early  
followup blood  lead monitoring (2-4 tests after identification) within 1-3 months, later followup testing after  
blood lead level  declining within 3-6 months.  
Complete  history and physical exam with neurodevelopmental assessment, environmental investigation of  the  
home and lead hazard  reduction,  lab work  including iron status and hemoglobin or hematocrit, abdominal  X-
ray (with bowel decontamination if indicated), early followup blood lead monitoring (2-4 tests after  
20-24   identification) within 1-3 months,  later followup testing after blood  lead level  declining within 1-3 months.  
Complete  history and physical exam with neurodevelopmental assessment, environmental investigation of  the  
home and lead hazard  reduction,  lab work  including iron status and hemoglobin or hematocrit, abdominal  
X-ray (with bowel decontamination if indicated), early followup blood lead monitoring (2-4 tests after  
25-44   identification) within 2 weeks to 1  month,  later followup testing after blood  lead  level  declining within 
1  month.  
Complete history and physical exam with  neurodevelopmental assessment and complete neurological  exam,  
environmental investigation of the home and  lead hazard  reduction, lab work including  iron status and  
hemoglobin or hematocrit, abdominal  X-ray  (with bowel decontamination if indicated), oral  chelation  therapy  
45-69   may be  considered in consultation with a medical  toxicologist  or  a  pediatric environmental health specialty  
unit (consider hospitalization,  if lead-safe home environment cannot be assured),  early followup blood lead  
monitoring (2-4 tests after identification)  as soon as possible, later followup testing after blood  lead level  
declining  as soon as possible.  
Hospitalize  and  commence chelation therapy in consultation with a  medical toxicologist or a  pediatric  
environmental  health specialty unit,   complete history and physical  exam with neurodevelopmental  
assessment and  complete  neurological exam, environmental investigation and  lead  hazard reduction, lab 
70    work including iron status and hemoglobin or hematocrit, abdominal  X-ray (with bowel decontamination if  
indicated), early followup blood  lead monitoring (2-4 tests after identification) as  soon as possible, later 
followup testing  after blood  lead level declining as  soon as possible.  
Source:   
I)  CDC, Recommended Actions  Based on  Blood Lead Level, December 2017.  Accessed at  
http://web.archive.org/web/20200713205506/https://www.cdc.gov/nceh/lead/advisory/acclpp/actions-blls.htm  on August  
17, 2022.  
 
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Appendix B: State  Guidance  on Medical  Management  of  
Childrens  Identified  Blood  Lead  Levels   
Table B-1 : General overview of guidance from the five States that medical 
reviewers considered when reviewing followup testing and treatment 
services for childrens identified blood lead levels during the review period  
g/dL   CAI   NYII   OHIII   PAIV   TXV  
Testing:  Routine  test at   Testing: Routine  test at   Testing:  Retest at   Testing: If test result is   Testing:   Routine test  
12 and 24 months of   12 and 24 months of   24  months  if first test   <10  g/dL, followup   at 12 and 24 months  
age  based on certain  age.  Followup test  not   is at 12 months.    test every 6 months.    of age.  
factors.  Followup test   required.     Consider retest  if child   After 2 subsequent    
in 6-12 months, if     moves to a home,  consecutive   Case  Management:  
indicated.  Retest for   Case Management:   daycare, etc., built   measurements are  May screen for  risk of  
indicated risk must  be   Provide parent   before 1978.   <10  g/dL or 3 are   lead exposure and  
venous.   education.      15  g/dL, decrease  provide anticipatory  
    Case Management:   testing  to 1 time  per  guidance.  
Case Management:   Discuss exposure risks,   year.  
<5  
Provide anticipatory   monitor neurological,    
guidance, encourage   psychosocial, and   Case  Management:  
good  nutrition and   language   N/A  
early  enrichment   development.    
activities, consider  
referral to  Special  
Supplemental  
Nutrition  Program for 
Women, Infants,  and  
Children (WIC).  
Testing: Venous   Testing:  If  blood lead   Testing:  Venous   Testing: If test result is  Testing: Venous  
followup test  in   level  is approaching   followup test every   <10  g/dL, followup   followup test  in  
1-3  months; retest  in   10  g/dL, more  3  months for first   test every 6 months.    3-6  months.  
3  months  and   frequent testing  might   2-4  tests, then  after   After 2 subsequent    
thereafter based  on   be appropriate (i.e., in  4  tests,  every   consecutive   Case Management:  
venous blood lead   3-6 months).   6-9  months until  blood   measurements are  Dietary and  
level trend.     lead  level drops below   <10  g/dL or 3 are   environmental lead  
    Case Management:   5  g/dL.   15  g/dL, decrease  education, continued  
Case Management:   Manage as for <5  and     testing  to 1 time  per  blood lead level 
Manage as for <5  and   monitor development,   Case Management:   year.   monitoring.  
counsel on nutrition,   consider child  at risk   Manage as for <5  and    
refer to  WIC, treat iron  for developmental   provide lead   Case management:  
insufficiency, note   delays and  behavior  education, monitor  N/A  
elevated  blood lead   problems.   blood lead level  until it  
level in medical  record,   remains <5 for at least  
5-9  
refer to early   6 months,  complete 
enrichment, consider  history and  physical  
medical  referral and   exam, assess  iron  
testing  for other   status, obtain  
children and  pregnant   abdominal X-ray if  
and lactating  women   lead ingestion  
in the  home, and   suspected and bowel  
coordinate  with local   decontamination if  
Childhood Lead   lead ingestion  
Poisoning Prevention   indicated, refer to WIC,  
Program (CLPPP)  or   refer to Help Me Grow  
state  Childhood Lead   for developmental  
Poisoning  Prevention   delay,  refer to Children 
Branch (CLPPB).   with Medical  
   Handicaps program.  
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g/dL   CA   NY   OH   PA   TX  
Testing: Venous   Testing: Venous followup   Testing:  Venous   Testing: Followup  Testing: Venous  
followup test  in 1-3  test every 3  months until   followup test  within   test in 3-4 months   followup test  in  
months to be sure   blood lead level  is   1 month.   or more  often if  3  months.  
blood lead level  is  not   declining; retest  every 6     indicated.    
rising;  if  blood lead   months thereafter until   Case Management:     Case Management:  
levels  are stable or   blood lead level  is <10.    Manage as for 5-9.   Case Management:   Manage as for 5-9  and  
decreasing,  retest in     Provide education  environmental lead  
3  months  and   Case Management:   and nutritional   investigation if blood  
thereafter based  on   Conduct  lead exposure   counseling, take  a   lead  level  persists at  
10-14   venous blood lead level   assessment, provide  detailed   least 12  weeks following  
trend.   education and nutritional   environmental   diagnostic venous test.  
  c ounseling.   history.  
Case Management:    
Manage as for 5-9 and  
If blood lead level  
persists for 30  days  or  
more, contact local  
CLPPP for full case 
management services.  
Testing: Venous   Testing:   Venous followup  Testing: Venous   Testing: Followup   Testing: Venous  
followup test  within 1-4  test every 1-3  months until   followup test  within   test in 3-4 months   followup test  in  
weeks to be sure blood   blood lead level  is   1 month.   or more often if   1-3  months.  
lead level  is not rising;   declining; retest  every 3     indicated.    
retest 1-3  months and   months thereafter until   Case Management:     Case Management:  
thereafter based  on   blood lead level  is <15.    Manage as for 5-9.   Case Management:   Manage as for 10-14  
venous blood lead level     Manage as for   and  if blood lead level  
trend.   Case Management:   10-14 and  discuss  persists at least  
  Confirm that local health  interventions to   12  weeks following  
Case Management:   department is  conducting   reduce lead levels.    diagnostic venous test,  
Manage as for 10-14  environmental   If blood lead level   conduct complete  
15-19  
and  consider gut   investigation and followup   persists, conduct   history and  physical  
decontamination if   services,  conduct lead   environmental   exam, lab work,  
foreign bodies   exposure assessment,   investigation and   environmental lead  
consistent with lead are   provide education,   abatement.   investigation, lead  
found on  X-ray, contact   nutritional assessment   hazard reduction,  
local CLPPP for full case   including iron status,   neurodevelopmental  
management services   developmental screening,   monitoring, abdominal  
for a  single  blood lead   consult Regional  Lead   X-ray if lead ingestion 
 level in this range.    R esource Center  (RLRC).   suspected and bowel  
decontamination if lead  
ingestion indicated.  
Testing: Venous   Testing: For blood lead   Testing: Venous   Testing: Venous   Testing: Venous  
followup test  in 1-4  levels 20-24, venous   followup test  within   confirmation,  then  followup test  in  
weeks to be sure blood   followup test every   1 month.   followup test  every  1-3  months.  
lead level  is not rising;   1-3  months until  blood     3-4 months or    
then,  if stable or  lead level  is declining, then  Case Management:   more often  if  Case Management:  
decreasing,  retest every   retest every 3  months  Manage as for 5-9.   indicated.   Manage as for 15-19  
2-4 weeks  and   thereafter until blood  lead     and  conduct complete  
thereafter based  on   level is <15.  For  blood   Case Management:   history and  physical  
venous blood lead level   lead levels 25-44, venous   Manage as for   exam, lab work,  
20-44  
trend.   followup test every 2-4  15-19 and  medical   environmental lead  
  weeks until blood  lead   evaluation, and   investigation, lead  
Case Management:    level is declining, then   followup.   hazard reduction,  
Manage as for 15-19  every month thereafter   neurodevelopmental  
and  consider referral to   until  blood lead level is   monitoring, abdominal  
California Childrens   <25.     X-ray if lead ingestion 
Services, consider    suspected and bowel  
referral for medical   Case Management:    decontamination if lead  
nutrition therapy.    Manage as for 15-19.   ingestion indicated.  
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g/dL   CA   NY   OH   PA   TX  
Testing: For blood   Testing: For blood lead   Testing: For blood lead   Testing:  Venous   Testing: Venous  
lead levels 45-59,   levels 45-59, venous   levels > 45, followup   confirmation,  then  followup test as soon  
venous followup  test   followup test  within   testing as soon as  every 3-4 months or  as possible.  
in 48 hours; for blood   48  hours; for blood   possible.   more often  if   
lead levels 60-69,   lead levels 60-69,     indicated.   Case Management:  
venous  followup test   venous followup  test   Case Management:      Manage as for 20-44  
in 24  hours, venous   within 24  hours,  further  Manage as for 5-9 and   Case Management:   and  chelation therapy.  
retest every 2-4  weeks   followup testing  as per   confirm results by   Manage as for 20-44 
thereafter based  on   RLRC  instruction.   venous sample  and  urgent medical  
venous blood lead     immediately, conduct   and environmental  
level trend.   Case Management:   lab work, immediately   followup.  
  Notify local health  remove child from  
Case Management:   department within  exposure source,  
45-69  
Manage as for 20-44  24  hours for  consider  
and  obtain abdominal   environmental   hospitalization and  
X-ray,  perform gut   investigation and   chelation therapy.  
decontamination, if   followup services,  
indicated, before   consult RLRC  within  
chelation, consider  24  hours, conduct lead  
hospitalization,   exposure assessment,  
immediately contact   provide education,  
local  CLPPP  or state  nutritional assessment,  
C LPPB.   developmental  
screening, hospital  
discharge  to lead-safe 
housing.  
Testing: Immediately   Testing: Immediately   Testing:  For blood   Testing: Venous   Testing: Venous  
confirm  initial  BLL   confirm  with a  venous  lead levels > 45,   followup test   followup test as  soon  
with  venous test,   test, followup  testing as   followup testing  as   immediately.   as possible.  
venous retest every 2- per RLRC instruction.   soon as possible.      
4 weeks thereafter       Case Management:   Case Management:  
based on venous   Case Management:  Case Management:    Manage as for 45-69  Manage as for 45-69 
blood lead level trend.   Manage as for 45-69  Manage as for 5-9 and   and  immediate  and  hospitalize and  
  and  consult RLRC   confirm results by   inpatient chelation  commence chelation  
70    Case Management:   immediately and   venous sample  therapy.   therapy.  
Manage as for 45-69  immediately  admit  to a   immediately, conduct  
and  hospitalize to   hospital for chelation.   lab work, immediately  
stabilize, chelate,   remove child from  
reduce exposure  and   exposure source,  
monitor, immediately   consider  
contact CLPPP  or  hospitalization and  
state CLPPB.   chelation therapy.  
  
Sources:   
I)  California Department of  Public Health,  California Management  Guidelines on Childhood Lead Poisoning for Health Care Providers, 
September 2017.  Accessed at  
https://www.cdph.ca.gov/Programs/CCDPHP/DEODC/CLPPB/CDPH%20Document%20Library/Lead_HAGs_Table.pdf  on  October 12, 2018.  
II)  New York State Department of Health,  New York State Department of Health Guidelines for the Identification and Management of Lead 
Exposure in Children,  October 2011.  Accessed at  https://www.health.ny.gov/publications/2501/  on  October 12, 2018.  
III) Ohio Department  of Health,  Medical Management Recommendations for Ohio Children Receiving Blood Lead Tests, February 2018.   
Accessed at  https://odh.ohio.gov/wps/wcm/connect/gov/718d4ebf-c78a-4f64-b250-cd7190c3bfbe/Medical-Management-
Guidelines.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=ROOTWORKSPACE.Z18_M1HGGIK0N0JO00QO9DDDDM3000-718d4ebf-
c78a-4f64-b250-cd7190c3bfbe-mstQ9jD  on October 12, 2018.  
IV)  55 Pa. Code  Part  III, Chapter  1241, Appendix E, Guidelines  on Childhood Lead Poisoning Prevention.   Accessed at  
https://www.pacode.com/secure/data/055/chapter1241/chap1241toc.html  on September 10, 2018.  
V)  Texas  Department of State Health Services,  Reference for Blood  Lead Retesting and Medical Case Management.  Accessed at   
https://www.dshs.texas.gov/lead/pdf_files/pb_109_physician_reference.pdf  on August  17, 2018.   
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for  Diagnoses and  
Treatment Services Raises Concerns, OEI-07-18-00370   Appendix  B | 30     
Appendix C: Results  of  the Medical Record  Review  for  166 
Children  With  a Confirmed  Diagnosis of  Lead  Toxicity  
Table C-1: Blood lead level ranges for 166 children in the medical record  
review with a confirmed diagnosis of lead toxicity, and the number of  
children in the medical record review who received or did not receive 
appropriate followup testing and treatment services for their identified  
blood lead level, as recommended by CMS, CDC, and  medical management 
guidance from childrens respective States  
State   Less than   5- 9  g/dL   10- 19  g/dL   20- 44  g/dL   Total  cases  
5 g/dL   reviewed  
Did  not receive  appropriate  followup  testing  and  treatment services  for  their  
identified blood lead level*  
CA   0   2   0   0   2  
NY   0   11   9   1   21  
OH   3   17   12   4   36  
PA   1   6   9   1   17  
TX   1   5   2   1   9  
Subtotal   5   41   32   7    85  
Received  appropriate  followup  testing  and  treatment services  for  their  identified  
blood lead level  
CA   0   0   0   0   0  
NY   6   12   7   1   26  
OH   9   8   4   4   25  
PA   1   9   2   2   14  
TX   8   4   3   1   16  
Subtotal   24   33   16   8   81  
Total   29   74    48   15   166  
*Among the 85  children who  did  not  receive appropriate followup  testing and treatment services,  reviewers  
identified that  56 children received  some services,  but services were not appropriate  to treat  childrens identified  
blood lead levels.  Reviewers found that 20  children did not receive  any followup testing and treatment  services  
during their period of review, and reviewers were unable to  determine whether identified  services  were  
appropriate for the remaining 9  children.   
Source:  OIG analysis  of medical  record review data, 2022.  
 
 
 
 
 
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for  Diagnoses and  
Treatment Services Raises Concerns, OEI-07-18-00370   Appendix C | 31     
 
The following tables display  information on the treatment  services provided to  each 
of  the  166 children based on blood lead  levels  and State of residence.   The  
recommended services differ based  on  blood lead levels.  Each table contains a 
compilation of  services for childrens identified blood lead levels  recommended by 
CDC  and  State  medical management  guidance.  
Table  C-2: Identified recommended services among the 29 children in the 
medical record review with blood lead levels less than 5  g/dL  
Routine   Anticipatory  
assessment of  guidance  about  Referrals  for 
 
nutritional  and   common  public  health 
developmental   sources  of lead   services  and  Total  cases  
milestones   exposure   programs   reviewed  
CA   0   0   0   0  
NY   6   4   2   6  
OH   10   9   4   12  
PA   2  0  0  2 
TX   7   7   0   9  
Total   25   20   6   29  
Source:  OIG analysis  of medical  record review data, 2022.  
Table  C-3: Identified recommended services among the 74 children in the 
medical record review with blood lead levels between 5-9 g/dL  
Environmental  
assessment/ 
environmental   Nutritional   Referrals  
  Routine   investigation   counseling   for public  
assessment of  to identify   related to   health 
nutritional  and   potential   calcium   services  Total  
developmental   sources  of  and  iron  and  cases 
milestones   lead exposure   intake   programs   reviewed  
CA   1   0   1   2   2  
NY   17   8   12   6   23  
OH   22   8   18   3   25  
5  
PA   9  3  0  15 
TX   9   6   6   1   9  
Total   58   25   42   12   74   
Source:  OIG analysis  of medical  record review data, 2022.  
 
 
 
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for  Diagnoses and  
Treatment Services Raises Concerns, OEI-07-18-00370   Appendix C | 32     
Table  C-4: Identified recommended services among the 48  children in the 
medical record review with blood lead levels between 10-19 g/dL  
Environmental   Nutritional 
assessment/  counseling  
environmental   related to   Referrals  
  Routine   investigation   calcium   for public  
assessment of  to identify   and  iron  health 
nutritional  and   potential   intake/ lab   services  Total  
developmental   sources  of  work  to  and  cases 
milestones   lead exposure   assess  iron   programs   reviewed  
CA   0   0   0   0   0  
NY   16   6   12   7   16  
OH   11   8   10   3   16  
PA   8  4      6  2  11 
TX   4   2   2   2   5  
Total   39   20   30   14   48  
Source:  OIG analysis  of medical  record review data, 2022.  
Table  C-5: Identified recommended services among  the  15 children in the 
medical record review with blood lead levels between 20-44 g/dL  
Referrals  
Complete   Investigation  for public  
  history   of home   health 
and  Neuro- environment   services  Total  
physical  developmental   /lead  hazard   Lab   and  cases 
exam   assessment   reduction   work   X- ray   programs   reviewed  
CA   0   0   0   0   0   0   0  
NY   2   2   1   2   0   0   2  
OH   8   6   6   7   0   5   8  
PA   3  2      2  2  0  0  3 
TX   2   1   1   1   1   0   2  
Total   15   11   10   12   1   5   15  
Source:  OIG analysis  of medical  record review data, 2022.  
 
 
 
 
 
 
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for  Diagnoses and  
Treatment Services Raises Concerns, OEI-07-18-00370   Appendix C | 33     
Of the 166 children, there were 137 children for whom  followup blood  lead testing  
was recommended  during  their  review period based on their identified blood lead  
level at  or above 5 g/dL.   The tables below  display information as to  whether 
children received followup testing as recommended by the CDC schedule and  at any  
time  during the 6 months  following a diagnosis  indicating lead toxicity  within our 
review period.  
Table  C-6:  Among  the  137 children in the medical record review with blood  
lead levels at or above 5  g/dL, those who  received early followup blood  
lead testing as recommended by the CDC schedule*  
Followup  testing   Followup  testing   Total  number  
 
received as   not  received as   of cases  
recommended   recommended   reviewed  
CA   0   2   2  
NY   21   19   40  
OH   25   22   47  
PA   11  17  28 
TX   6   10   16  
Total   63   70    133*  
*Records for  four  children in the  medical record review from New  York, Ohio, and Pennsylvania  
indicated blood lead levels at or above 5  g/dL  but did  not identify in the record a  numeric  blood  
lead value associated with the  diagnosis of  lead toxicity.  These records were excluded from  the  
followup testing  analysis.  
 Source:  OIG analysis  of medical  record review data, 2022.  
Table  C-7:  Among  the  137 children in the medical record review with blood  
lead levels at or above 5  g/dL, those who  received a followup blood lead  
test during the 6 months following a diagnosis indicating lead toxicity*  
Followup  testing   Followup  testing   Total  number  
 
received during  not  received during  of cases  
review  period   review  period   reviewed  
CA   1   1   2  
NY   28   12   40  
OH   35   12   47  
PA   18  10  28 
TX   12   4   16  
Total   94   39   133*  
*Records for  four  children in the  medical record review from New  York, Ohio, and Pennsylvania  
indicated blood lead levels at or above 5  g/dL  but did  not identify in the record a  numeric  blood  
lead value associated with the  diagnosis of  lead toxicity.  These records were excluded from  the  
followup testing  analysis.  
 Source:  OIG analysis  of medical  record review data, 2022.  
 
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for  Diagnoses and  
Treatment Services Raises Concerns, OEI-07-18-00370   Appendix C | 34     
Table  C-8:  For 75 children in 4 States, identified types of public health  
services that children received during their respective periods of  review*  
Blood   Parent  Total  
 
lead  education  Environmental   Case  Developmental   Nutritional   cases 
test   /guidance   service   management   service   service   reviewed  
CA   2   0   0   0   0   0   2  
NY   6   12   7   1   0   4   18  
OH   53   18   22   9   5   5   53  
TX   0   2   2   0   0   0   2  
Total   61   32   31   10   5   9   75   
*The State health department  in Pennsylvania shared that lead-related case management services were not recorded  in the States  public  
health data  system, and that it was  unable to meet our request.  
Source:  OIG analysis  of medical  record review data, 2022.  
 
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for  Diagnoses and  
Treatment Services Raises Concerns, OEI-07-18-00370   Appendix C | 35     
Appendix D:  Agency Comments  
Following this page are the official comments from CMS.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for  Diagnoses and  
Treatment Services Raises Concerns, OEI-07-18-00370   Appendix D |  36     
 
 
DATE:    November  21,  2022  
 
TO:                  Ann  Maxwell  
                        Deputy Inspector  for  Evaluation  and Inspections  
                        Office  of  Inspector  General  
                         
FROM:   Chiquita Brooks-LaSure  
    Administrator  
    Centers  for  Medicare &  Medicaid Services  
 
SUBJECT:   Office  of  Inspector  General  (OIG)  Draft  Report:  For  Medicaid-Enrolled Children  
Diagnosed with  Lead Toxicity in  Five States,  Documentation  Reviewed for  
Diagnoses  and Treatment  Services  Raises  Concerns  (OEI-07-18-00370)  
 
The Centers  for  Medicare &  Medicaid Services  (CMS)  appreciates  the opportunity to review  and 
comment  on  the Office  of  Inspector  Generals  (OIG)  draft  report.  CMS  is  committed to working 
with  federal  and state partners  to ensure that  children  with  elevated blood lead levels  (EBLLs)  
enrolled in  Medicaid  and the Childrens  Health  Insurance  Program  (CHIP)  receive necessary  
medical  and environmental  follow-up services.  
 
The amount  of  lead in  blood is  referred to as  the blood lead level,  which  is  measured in  
micrograms  of  lead per  deciliter  of  blood (g/dL).  Currently  the  Centers  for  Disease Control  and 
Prevention  (CDC)  recommends  a blood lead reference  value of  3.5  g/dL  to identify children  
with  EBLLs.1  Lead exposure can  affect  nearly every system  in  the body and often  goes  
undetected because,  at  low  levels  of  exposure,  it  may display no obvious  symptoms.  
Comprehensive screening and surveillance  ensures  that  lead-poisoned infants  and children  
receive necessary medical  and environmental  follow-up as  soon  as  possible,  and also allows  for  
the development  of  neighborhood-based efforts  to prevent  lead poisoning.  While the CDC  
recommends  certain  follow-up and case management  activities  for  children  with  EBLLs,  it  is  the 
responsibility of  state health  departments  to set  a blood lead reference  value  and establish  clinical  
treatment  standards  for  providers. Further,  CMS has  not  established a blood lead reference  value,  
does  not  establish  clinical  guidelines  for  children  with  EBLLs,  and does  not  have the authority to 
require state  Medicaid agencies  to adopt  CDCs  recommendations.  
 
The Early and Periodic Screening,  Diagnostic and Treatment  (EPSDT)  benefit  provides  
comprehensive and preventive health  care services  for  children  under  age  21 who are enrolled in  
Medicaid.  Under  the EPSDT  benefit  states  are required to provide comprehensive services  and 
furnish  all  Medicaid coverable,  appropriate,  and medically necessary services  needed to correct  
and ameliorate health  conditions,  based on  certain  federal  guidelines.  This  means  that  in  addition  
to covering  blood lead screening tests,  the EPSDT  benefit  also ensures  that  children  with  EBLLs  
                                               
1  CDC, Recommended Actions Based on Blood Lead Level. 2022. Accessed at:  
https://www.cdc.gov/nceh/lead/advisory/acclpp/actions-blls.htm  
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for Diagnoses and 
Treatment Services Raises Concerns, OEI-07-18-00370  Appendix D | 37  receive  medically necessary follow-up and treatment  services. While states  have broad flexibility 
when  administering the EPSDT  benefit,  they have an  affirmative obligation  to ensure that  
children  and their  families  are aware of  the services  that  are a part  of  the benefit,  and that  they 
have access  to required screenings  and necessary treatment  services.  In  addition,  Medicaid can  
provide reimbursement  for  lead investigations  in  the home or  primary residence  of  a child with  
an  EBLL,  if  the investigation  is  conducted by a credentialed health  practitioner  who meets  the 
qualifications  established by the state,  and is  undertaken  to identify the source  of  lead exposure.   
 
As  noted in  the OIGs  report,  state Medicaid agencies  are required to submit  EPSDT  data 
annually to CMS using the Form  CMS-416,  which  includes  reporting for  the number  of  blood 
lead screening tests  for  children  enrolled in  Medicaid  from  birth  to age  six.  According to data 
reported on  the Form  CMS-416,  the number  of  children  enrolled in  Medicaid who receive blood 
lead screening tests  varies  considerably from  state to state.  Further,  because the Form  CMS-416 
only captures  Medicaid claims  and encounter  based data,  it  underrepresents  the actual  number  of  
children  who received blood lead screening tests.  For  example,  it  does  not  capture screenings  
that  are not  paid for  by Medicaid,  such  as  screenings  performed by clinics  using CDC  funding or  
funded by state health  departments.  While CMS appreciates  the OIGs  efforts  to collect  data 
from  the state health  departments  in  their  selected states  under  review,  by ultimately excluding 
blood lead screening and follow-up services  administered by state health  departments,  the report  
does  not  provide an  accurate representation  of  the services  the selected children  received.   
 
In  support  of  state efforts  to improve blood lead screening rates  for  children,  CMS issued an  
informational  bulletin2  in  November  2016 to remind states  of  the screening and treatment  
requirements  for  children  enrolled in  Medicaid and CHIP.  The informational  bulletin  included 
information  on  steps  that  states  could take  to improve lead screening efforts,  while also noting 
that  states  need to think beyond screening,  and ensure that  guidance  and resources  are available 
to support  providers,  families  and other  stakeholders  who work to obtain  appropriate services  for  
children  with  EBLLs.  In  addition  to reminding states  of  the requirement  to furnish  all  medically 
necessary services  needed to correct  and ameliorate health  conditions  under  the EPSDT  benefit, 
CMS also informed states  that  case management  can  be used to provide services  to children  with  
EBLLs.  Case management  benefits  include services  that  assist  eligible individuals  to gain  access  
to needed medical,  social,  and educational  services,  and must  include a comprehensive 
assessment  of  an  eligible individual,  the development  of  a specific care plan,  referrals  to needed 
services,  and monitoring activities.  In  addition,  in  May 2022,  CMS and CDC  held a call  with  
state Medicaid Medical  Directors  and State Health  Officials  to remind them  of  Medicaids  blood 
lead screening requirements  and of  the EPSDT  requirement  to furnish  all  medically necessary 
services  needed to correct  and ameliorate health  conditions.  
 
OIGs  recommendations  and CMS's  responses  are below.  
 
 
 
                                               
2  CMS, Coverage of Blood Lead  Testing for Children Enrolled in Medicaid and the Childrens  Health Insurance  
Program.  2016.  Accessed at:https://www.medicaid.gov/federal-policy-guidance/downloads/cib113016.pdf  
 
 
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for Diagnoses and 
Treatment Services Raises Concerns, OEI-07-18-00370  Appendix D | 38  OIG  Recommendation  
 
Explore the discrepancy between  Medicaid claims  data and medical  documentation  for  lead 
toxicity and implement  solutions  to ensure better  oversight  of  the EPSDT  program.  
 
CMS Response  
 
CMS concurs  with  this  recommendation.  In  collaboration  with  other  federal  partners  and the 
American  Academy of  Pediatrics  (AAP),  CMS will  share the findings  from  the OIGs  report  
with  State Medicaid Agency medical  directors,  and will  remind states  of  their  obligations  to 
provide clinical  and coding guidance  to their  providers.   
 
OIG  Recommendation  
 
Issue guidance  to reiterate State obligations  under  the  EPSDT  benefit  to ensure access  to services  
to correct  or  ameliorate confirmed blood lead levels  identified during screenings.  
 
CMS Response  
 
CMS concurs  with  this  recommendation.  CMS will  issue guidance  to states  reminding them  of  their  
obligations  under  the EPSDT  benefit  to provide comprehensive and preventive health  care services  
for  children  under  age  21.  Specifically,  CMS will  remind states  that  they  are required to furnish  all  
Medicaid coverable,  appropriate,  and medically necessary services  needed to correct  and ameliorate 
health  conditions.  
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for Diagnoses and 
Treatment Services Raises Concerns, OEI-07-18-00370  Appendix D | 39   
ACKNOWLEDGMENTS  AND CONTACT  
Acknowledgments  
Dana Squires served as the team leader for this study.  Others in the Office of  
Evaluation and Inspections who conducted the study include Katharine Fry and Haley 
Lubeck.  Office of Evaluation and Inspections staff who provided support include 
Althea Hosein, Kevin Manley, and Christine Moritz.   
We would also like to acknowledge the contributions of other Office of Inspector 
General staff including Lonie Kim, Julie Taitsman, and Amber Jessup.  
This report was prepared under the direction of  Brian Whitley, Regional Inspector 
General for Evaluation and Inspections in the Kansas City regional  office, and Abbi  
Warmker, Deputy Regional Inspector General.  
Contact  
To obtain additional information concerning this report, contact the Office of Public 
Affairs at Public.Affairs@oig.hhs.gov.  OIG reports and other information can be found  
on the OIG website at  oig.hhs.gov.  
Office of Inspector General  
U.S. Department of Health and Human Services  
330 Independence Avenue, SW  
Washington, DC 20201  
 
 
 
 
 
 
   
 
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for  Diagnoses and  
Treatment Services Raises Concerns, OEI-07-18-00370   Acknowledgments and Contact | 40     
ABOUT THE  OFFICE  OF INSPECTOR  GENERAL  
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:  
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 audits help reduce waste, abuse, and mismanagement and promote economy 
and efficiency throughout HHS.  
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.  
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.  
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 OIGs 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. 
For Medicaid-Enrolled Children Diagnosed With  Lead Toxicity in Five States, Documentation  Reviewed for  Diagnoses and  
Treatment Services Raises Concerns, OEI-07-18-00370   About  the Office of Inspector  General  | 41     
ENDNOTES  
 
 
1  Centers for Disease Control and Prevention (CDC),  Childhood Lead Poisoning Prevention, January 2022.  Accessed at 
https://go.usa.gov/xU2VH  on February 28, 2022.  
2  CDC, National  Lead Poisoning Prevention Week,  Lead Poisoning Prevention  Week 2020 Partner Kit, October 2020.  
3  U.S. Environmental Protection Agency,  Fight Lead Poisoning with a Healthy Diet, October 2019.  Accessed at 
https://go.usa.gov/xzvRv  on March 22, 2022.   
4  In fiscal year (FY) 2019, over 41  million  children were eligible to receive Medicaids Early and Periodic Screening, Diagnostic,  
and Treatment (EPSDT) benefit, almost 4.5 million of which children  were ages 12 to 24  months.  Centers for Medicare  &  
Medicaid Services (CMS),  Early and Periodic Screening, Diagnostic & Treatment,  2019 Annual Reporting  Data Files. 
Accessed at https://go.usa.gov/xzvQU  on February 28, 2022.  
5  Screening services covered under the  EPSDT benefit  include  a blood lead level assessment appropriate for age  and risk  
factors, as well as other necessary health care, diagnostic services, and treatment to correct or ameliorate  issues discovered 
by a screening.   The Social Security Act (the Act)  1905(r)(1)(B); the Act  1905(r)(5); the Act  1902(a)(43).  
6  Under the Individuals with Disabilities Education Act (IDEA), the U.S. Department of Education awards grants annually to 
States to support early intervention (EI) services for infants and toddlers with disabilities or developmental delays.   20 USC   
1431  and 1432(5); U.S. Department of Education,  State Formula Grants.  Accessed at  https://go.usa.gov/xSaxp  on May 23,  
2022.  
7  A survey of State requirements found that in 18 States, exposure to lead  meets the medical criteria for automatic eligibility  
in an Early Intervention Program; 4 other States include a  blood lead level  as a risk factor  that may contribute to potential  
delays in development.  Nicole Hamp, MD, et al., Advocating for Automatic Eligibility for  Early  Intervention Services for  
Children Exposed to Lead,  Pediatric Annals,  Vol. 47, No. 10, 2018.  Accessed at https://doi:10.3928/19382359-20180924-01  
on March 21, 2022.   
8  The first signs of lead toxicity in children are  often subtle neurobehavioral  problems that may affect classroom behavior and  
social interaction.  Hearing, speech, and other developmental milestones should be carefully evaluated and documented.   
Agency for Toxic Substances and Disease Registry,  Lead Toxicity: Clinical AssessmentSigns and Symptoms, July 2019.   
Accessed at  https://go.usa.gov/xzFjK  on March 29, 2022.  
9  U.S. Environmental Protection Agency,  Integrated Science Assessment  (ISA)  for Lead, June  2022.  Accessed at  
https://go.usa.gov/xUgUs  on April 22, 2021.  
10  CDC,  Health Effects of Lead Exposure, January 2022.  Accessed at https://go.usa.gov/xz4Cq  on February 28, 2022.   
11  Brian Boutwell, et al., Aggregate-Level  Lead Exposure,  Gun Violence,  Homicide, and Rape,  PLoS One, Vol. 12, No.  11, 2017.   
Accessed at  https://doi.org/10.1371/journal.pone.0187953  on April 22, 2021.  
12  John Wright, et al., Association of Prenatal  and Childhood  Blood Lead Concentrations with Criminal Arrests in Early  
Adulthood.  PLoS Med, Vol. 5,  No. 5, 2008.  Accessed at https://doi.org/10.1371/journal.pmed.0050101  on April 22, 2021.  
13  Stephen Billings and Kevin Schnepel, Life after Lead: Effects of Early Interventions for Children Exposed to Lead,  American 
Economic Journal: Applied Economics, Vol. 10, No. 3, July 2018.  Accessed at https://doi.org/10.1257/app.20160056  on April  
22, 2021.  
14  In a New York City study of longitudinal development, young children with blood lead levels of 4 g/dL   or greater who   
received  at least one early intervention (EI) service before  age 3 were 16 percent more  likely to meet test-based standards in  
English language arts on third-grade   standardized testing.    Children   with   blood lead levels   of   10   g/dL or greater who  
received EI services before age 3 were 38 percent more likely  to meet test-based standards in English language arts than  
were  children who did not receive services.  Jeanette Stingone, et al., Receipt of Early Intervention Services Before Age  3 
Years and Performance on Third-Grade Standardized Tests Among Children Exposed to Lead,  Journal  of  the American  
 
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for  Diagnoses and  
Treatment Services Raises Concerns, OEI-07-18-00370   Endnotes | 42     
 
Medical  Association Pediatrics,  published online March 7, 2022.  Accessed at https://doi.org/10.1001/jamapediatrics.2022.0008  
on March 21, 2022.   
15  Stephen Billings and Kevin Schnepel, Life after Lead: Effects of  Early Interventions for Children Exposed  to Lead,  American 
Economic Journal: Applied Economics, Vol. 10, No. 3, July 2018.  Accessed at https://doi.org/10.1257/app.20160056  on April  
22, 2021.  
16  CMS,  EPSDT  A Guide for States: Coverage in the Medicaid Benefit for Children and Adolescents.   Accessed at  
https://www.medicaid.gov/sites/default/files/2019-12/epsdt_coverage_guide.pdf  on November 29, 2022.  
17  The Act  1905(r)(1)(B)(iv).  
18  The CMS State Medicaid Manual schedule requires enrolled children to receive blood lead screening tests at 12  and 24 
months of age.  Children between the ages of 36 months and 72 months should also receive a blood  lead test if they have  
not been previously screened  for lead  poisoning.  CMS,  Chapter 5: Early and Periodic Screening, Diagnostic and Treatment  
Services, The  State  Medicaid  Manual,  5123.2, D1, 09-98.  Accessed at  https://go.usa.gov/xU2VG  on February 28, 2022.  
19  CMS,  Chapter 5: Early and Periodic Screening, Diagnostic and Treatment Services,  The State Medicaid Manual, 5124, A,  
04-90.  Accessed at  https://go.usa.gov/xU2VG  on February 28, 2022.  
20  The Act  1905(r)(5).  
21  42 CFR  441.61.  Accessed at https://www.law.cornell.edu/cfr/text/42/441.61  on September 24, 2020.  
22  CMS,  Chapter 5: Early and Periodic Screening, Diagnostic and Treatment Services, The State Medicaid Manual,  5123.2,  
D.1a, 09-98.  Accessed at  https://go.usa.gov/xU2VG  on February 28, 2022.  
23  Center for Medicaid & Childrens Health Insurance Program (CHIP) Services,  Coverage of Blood Lead Testing for Children 
Enrolled in Medicaid and the Childrens Health Insurance Program, November 2016.  Accessed at https://go.usa.gov/xzwQX  on 
February 28, 2022.  
24  CDC,  CDC Updates Blood Lead Reference Value to 3.5 g/dL,  January 2022.   Accessed at https://go.usa.gov/xz4Cv  on 
February 28, 2022.  
25   CMS,  Lead Screening.  Accessed at   https://www.medicaid.gov/medicaid/benefits/early-and-periodic-screening-diagnostic-
and-treatment/lead-screening/index.html  on August 17, 2022.  
26  The Act  1905(r)(5).  
27  CMS,  Chapter 5: Early and Periodic Screening, Diagnostic and Treatment Services, The State Medicaid Manual, 5123.2,  
D.1a, 09-98.  Accessed at  https://go.usa.gov/xU2VG  on February 28, 2022.  
28  CMS,  Chapter 5: Early and Periodic Screening, Diagnostic and Treatment  Services, The State Medicaid Manual,  5123.2, D,  
09-98.  Accessed at  https://go.usa.gov/xU2VG  on February 28, 2022.  
29  The blood lead reference value is based on the 97.5th percentile of blood  lead  values  among the U.S. population of  
children, 1 to 5 years of age,  obtained from the National Health and Nutrition Examination Survey cycles.  Children with blood  
lead levels at  or above the  blood lead reference value are among the top  2.5 percent of  U.S. children with the highest blood  
lead levels.  CDC,  Blood Lead Levels in Children, December  2022.   Accessed at  https://go.usa.gov/xz4a2  on December 1,  2022.  
30  CDC,  Update of the Blood Lead Reference ValueUnited States, 2021,  Morbidity and Mortality Weekly  Report, October 
2021.  Accessed at https://www.cdc.gov/mmwr/volumes/70/wr/mm7043a4.htm?s_cid=mm7043a4_w  on June 29, 2022.   
31  CDC,  Recommended Actions  Based on Blood Lead Level, October 2021.  Accessed at https://go.usa.gov/xz4ab   on February  
28, 2022.   
32  CDC,  CDC Updates Blood Lead Reference Value to 3.5 g/dL,  January 2022.   Accessed at https://go.usa.gov/xz4Cv  on 
February 28, 2022.  
33  CDC, Recommended Actions  Based on  Blood Lead Level, December 2017.  Accessed at  
http://web.archive.org/web/20200713205506/https://www.cdc.gov/nceh/lead/advisory/acclpp/actions-blls.htm  on August 17,  
2022.  
 
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for  Diagnoses and  
Treatment Services Raises Concerns, OEI-07-18-00370   Endnotes | 43     
 
34  Joseph F.  Hagan, Jr., M.D., FAAP, et al., AAP, Bright Futures:  Guidelines for Health Supervision of Infants, Children, and  
Adolescents (Fourth Edition), 2017.  
35  AAP,  Treatment of Lead Poisoning, July 2021.  Accessed at https://www.aap.org/en/patient-care/lead-exposure/treatment-
of-lead-poisoning/  on February 28, 2022.  
36  Following our  review period, in October 2021, AAP acknowledged the updated CDC blood lead reference value  of 
3.5  g/dL.  For children with  levels  below the  updated reference value, AAP suggested that clinicians may  need to retest  
children depending on age and other factors  and reassess the childs environment in the future.  For children with levels  
above the  updated reference value, AAP suggested  that clinicians should retest to establish a trend, discuss possible sources  
of lead exposure, consider an  environmental assessment, and follow health department guidelines for public health  
intervention.  AAP,  Revised Blood Lead Reference Value: Pprogress, but More Work to Be  Done, AAP News,  October 2021.   
Accessed at  https://publications.aap.org/aapnews/news/17767  on June 15, 2022.  
37  The Act  1902(a)(43)(D);  CMS,  Chapter 5: Early and Periodic Screening, Diagnostic and Treatment Services,  The State  
Medicaid Manual, 5320.2.C.  Accessed at https://go.usa.gov/xU2VG  on February 28, 2022.  
38  CMS,  2700.4 Instructions for Completing Form CMS-416:  Annual Early and  Periodic Screening, Diagnostic, and Treatment  
(EPSDT) Participation Report, effective for the reporting period federal fiscal year 2020.  Accessed at  https://go.usa.gov/xHF9x  
on June 4, 2021.  
39  CMS,  2700.4  Instructions for Completing Form CMS-416: Annual Early and  Periodic Screening, Diagnostic, and Treatment  
(EPSDT)  Participation Report, effective for the reporting period federal fiscal year 2020, section E, Line14a-14b.   Accessed at  
https://go.usa.gov/xHF9x  on June 4, 2021.   
40  OIG,  More Than One-Third of  Medicaid-Enrolled Children in Five States Did Not Receive Required Blood Lead Screening Tests, 
October 2021.  Accessed at https://oig.hhs.gov/oei/reports/OEI-07-18-00371.pdf  on May  16, 2022.  
41  OIG,  Most Medicaid Children in Nine States Are Not Receiving All Required Preventive Screening Services,  May 2010.   
Accessed at  https://go.usa.gov/xU4gG  on July 6, 2022.  
42  The National EPSDT Improvement Workgroup included State  representatives, childrens  health providers, consumer  
representatives, and other experts in the areas of maternal and child health, Medicaid, and data analysis.   OIG,  
Recommendation Followup Memorandum Report: CMS Needs To Do More To Improve Medicaid Childrens Utilization of 
Preventive Screening Services,  November 2014.  Accessed at https://go.usa.gov/xSacU  on July 8, 2022.  
43  The population included 21,353 children across the 5 States.  
44  For  21 of the 415 children for  whom medical records lacked adequate information for medical reviewers  to  confirm  the  
diagnosis of lead toxicity, we identified a service in  State health department data  during childrens respective periods of  
review.  Specifically, for 19  of the 21 children, we identified  in  State  health department data  a blood lead test associated with  
the childs date of diagnosis  that was also  identified in Medicaid claims data.  For  the  remaining  children, we identified in 
State health department data  a parent education service  during the  childs respective  review period.  
45  Reviewer notes identified that 29 children had a blood lead level between 3.5 and 4.9 g/dL; reviewers  indicated  low,  
normal,  or negative  levels for the remaining 6 children.  
46  Of the 85 children who did not receive services as recommended, 5 children had a blood lead level below 5  g/dL  and 
reviewer notes  for 3 additional children indicated blood lead levels at or  above 5  g/dL, but did not identify in the records  
numeric blood lead values associated with the diagnosis of lead toxicity.  These eight cases were  excluded from the followup  
testing analysis.  
47  Of the 81 children who received services as recommended,  24 children had a blood lead level below 5  g/dL  and reviewer  
notes for 1 additional child indicated blood lead levels at or  above 5  g/dL, but did not identify in the record a numeric blood  
lead value  associated with the  diagnosis of lead toxicity.  These 25 cases were  excluded from the followup testing analysis.  
48  CMS, 2700.4 Instructions for Completing Form CMS-416: Annual Early and  Periodic Screening, Diagnostic, and Treatment  
(EPSDT) Participation Report, 2020.  Accessed at https://go.usa.gov/xHF9x   on June 4, 2021.  
49  Medicaid Statistical Information System (MSIS) threshold error tolerances  allow  between 0.1 and 5.0 percent missing,  
unknown, or invalid codes for  the variables used in this analysis.   CMS,  MSIS File Specifications and Data Dictionary, 2012.  
For Medicaid-Enrolled Children Diagnosed With Lead Toxicity in Five States, Documentation Reviewed for  Diagnoses and  
Treatment Services Raises Concerns, OEI-07-18-00370   Endnotes | 44