10 
  Introduction 
The Top Management and Performance Challenges Facing HHS is an annual publication of the Department of Health and Human 
Services (HHS or the Department), Office of Inspector General (OIG).  In this edition, OIG has identified six top management and 
performance challenges (TMCs) that the Department faces as it strives to fulfill its mission to enhance the health and well-being of 
all Americans.    
In selecting these TMCs, OIG considered our oversight, enforcement, data analytics, and risk analysis work, as well as Department 
information and developments in law and HHSs responsibilities.  
The Department continues to face challenges in responding to Public Health Emergencies (PHEs), such as the COVID-19 pandemic 
and the monkeypox PHE.  Challenges related to the Departments COVID-19 and monkeypox responses are primarily addressed in 
TMCs 1 and 6 on public health.  However, responses to PHEs affect nearly every aspect of Department operations, and related 
challenges are addressed in other TMCs.  
Management and performance challenges are inherently crosscutting.  Multiple 
HIGHLIGHT: Challenge 
HHS Staff Divisions (StaffDivs) and Operating Divisions (OpDivs) must address 
these pressing issues.  Furthermore, the challenges themselves intersect.  For  Implementing New Legislation 
example, the challenge of safeguarding the well-being of people served by HHS  The Department must efficiently and 
programs highlighted in TMC 4 intersects with the challenge of delivering value, 
effectively implement the provisions 
quality, and improved outcomes in Medicare and Medicaid, which is the subject 
of new legislation, including most 
of TMC 3.  Some priority issues, such as improving nursing home care, raise 
recently the Bipartisan Safer 
multiple challenges.  Improving nursing home care is primarily addressed in 
TMC  4 because of serious, persistent quality-of-care vulnerabilities, but  Communities Act and the Inflation 
elements of this issue appear in other TMCs.  Given that challenges cross  Reduction Act of 2022.  This includes 
internal HHS boundaries and externally with Federal and State agencies, 
ensuring HHS has appropriate 
coordination among HHS divisions, with Tribal governments, and across the 
resources, data, technologies, and 
Government sector at all levels is integral to addressing these challenges, as set 
expertise.  The Department should 
out in TMC 6.    
consider program integrity when 
The six TMCs are not the only challenges that confront HHS.  OIG reports are a 
implementing and operating new 
key resource that highlight additional opportunities to improve HHS programs 
requirements and expanded 
and operations.  OIG also maintains a list of significant and unimplemented OIG 
recommendations, including legislative recommendations, that address  programs.   
vulnerabilities.  If implemented, these recommendations would, in OIGs view, 
positively affect HHS programs in terms of cost savings, program effectiveness 
and efficiency, and public health and safety.   
More information on OIGs work, including the reports mentioned in this publication, appears on our website at https://oig.hhs.gov. 
11 
   
 
Safeguarding the  
Safeguarding 
Well-Being of HHS 
Public Health 
Beneficiaries 
 
Harnessing and Protecting 
Ensuring the Financial 
Data and Technology To 
Integrity of HHS 
Improve the Health and 
Programs 
Well-Being of Individuals 
Delivering Value, Quality,  Strengthening 
and Improved Outcomes  Coordination for Better 
in CMS Programs  Programs and Services 
12 
  Table of Contents
 
Introduction ................................................................................................................................................................... 1 
1: Safeguarding Public Health ........................................................................................................................................ 5 
2: Ensuring the Financial Integrity of  HHS Programs .................................................................................................. 11 
3: Delivering Value, Quality, and Improved Outcomes in CMS Programs ................................................................... 18 
4: Safeguarding the Well-Being of HHS Beneficiaries .................................................................................................. 24 
5: Harnessing and Protecting Data and Technology To Improve the Health and  Well-Being of Individuals .............. 31 
6: Strengthening Coordination for Better Programs and Services .............................................................................. 36 
ENDNOTES ................................................................................................................................................................... 39 
 
 
 
13 
   
Acronyms 
ACF  Administration for Children and Families  IIJA  Infrastructure Investment and Jobs Act 
ADHD  Attention Deficit/Hyperactivity Disorder  IRA  Inflation Reduction Act 
AI/AN  American Indian/Alaska Native  IT  Information Technology 
AMP  Average Manufacturer Price  MA  Medicare Advantage 
API  Application Programming Interface  MAO  Medicare Advantage Organization 
APTC  Advance Premium Tax Credit  NIH  National Institutes of Health 
ASP  Average Sales Price  OIG  Office of Inspector General 
ASPR  Administration for Strategic Preparedness and   OMB  Office of Management and Budget 
Response 
OpDiv  Operating Division 
CCDF  Child Care and Development Fund 
ORR  Office of Refugee Resettlement 
CDC  Centers for Disease Control and Prevention 
OTP  Opioid Treatment Program 
CHIP  Childrens Health Insurance Program 
OUD  Opioid Use Disorder 
CIO  Chief Information Officer 
PERM  Payment Error Rate Measurement 
CMS  Centers for Medicare & Medicaid 
PHE  Public Health Emergency 
Services 
PMTA  Premarket Tobacco Product Application 
DHS  Department of Homeland Security 
PRF  Provider Relief Fund 
DME  Durable Medical Equipment 
REMS  Risk Evaluation and Mitigation Strategy 
EIS   Emergency Intake Sites 
SAMHSA  Substance Abuse and Mental Health Services 
EO  Executive Order 
Administration 
EUA  Emergency Use Authorization 
SFC  Sanitation Facilities Construction 
FAR  Federal Acquisition Regulation 
SNF  Skilled Nursing Facility 
FDA  Food and Drug Administration 
StaffDiv  Staff Division 
FFE  Federally Facilitated Exchange 
TANF  Temporary Assistance for Needy Families 
FFS  Fee-for-Service 
TEFCA  Trusted Exchange Framework and Common 
FY  Fiscal Year  Agreement 
GAO  Government Accountability Office  TMC  Top Management and Performance Challenge 
HAC  Hospital Acquired Condition  T-MSIS  Transformed Medicaid Statistical Information 
System 
HHS  Department of Health and Human Services 
UC  Unaccompanied Children 
HIPAA  Health Insurance Portability and Accountability 
Act of 1996  UIP  Uninsured Program 
HRSA  Health Resources and Services Administration   
IHS  Indian Health Service 
 
   
1: Safeguarding Public Health 
Relevant Agencies 
 All HHS  
Elements of the Challenge 
 Strengthening emergency preparedness and response capabilities 
 Providing adequate oversight of FDA-regulated products 
 Addressing the mental health and drug overdose crises 
 
Outbreaks of COVID-19 and monkeypox in 202022 tested the Departments capacity to safeguard public health.  As of October 4, 
2022, the United States had reported more than 96.25 million cases of COVID-19, losing more than 1.05 million people to the 
disease,1 and had confirmed more than 26,194 cases of monkeypox.2  In addition to infectious diseases, the United States continues 
to experience a variety of emergencies that require Federal assistance due to hurricanes, extreme heat, flooding, and wildfires.  HHS 
must be able to foresee and combat major outbreaks and provide public health and medical emergency assistance while effectively 
operating a range of programs and services that are essential to protecting individuals and communities.  This work includes 
effectively preparing for future emergencies while advancing response capabilities, ensuring that products regulated by the Food 
and Drug Administration (FDA) are safe and effective, and combating the mental health and drug overdose crises.  To operate 
effective public health programs, the Department must ensure that its OpDivs and StaffDivs coordinate efforts internally as well as 
with partners at all levels of Government and with other stakeholders.  (See TMC 6 for more information on the challenge the 
Department faces in coordinating with internal and external partners.) 
Strengthening emergency preparedness and response capabilities 
Public health emergencies can severely strain public health and medical infrastructure as well as lead to serious illness and loss of 
life.  According to the Centers for Disease Control and Prevention (CDC), from 2020 to 2021 life expectancy in the United States 
declined from 77.0 to 76.1 yearsits lowest level since 1996.  Declines in life expectancy since 2019 were driven largely by the 
COVID-19 pandemic.3  Pandemics such as COVID-19 are so extensive that they impact every aspect of every Americans life and alter 
the fabric of our society, with greater harm inflicted on vulnerable populations, such as those who are marginalized at a pandemics 
outset, have been historically disadvantaged, have less access to health care, or are dependent on health and social services, 
including those who reside in congregate care settings such as nursing homes.  There have been pronounced racial and ethnic 
disparities in COVID-19 infections, hospitalizations, death rates, and vaccination rates.4  HHS programs must address racial, 
socioeconomic, geographic, and other types of disparities, and the effects that such disparities have on public health.  (See TMCs 3 
and 4 for additional information related to equity and health disparities, including in nursing homes.)   
HHS has a leading role in preparing for, responding to, and recovering from the adverse health effects of PHEs including those 
related to infectious disease outbreaks, natural disasters, and chemical, biological, radiological, and nuclear events.  HHS is uniquely 
positioned to provide technical assistance, guidance, funding, and coordination to assist State, Tribal, local, and Territorial leaders to 
effectively and equitably plan for and respond to emergencies, as well as support sustained recovery and resilience-building efforts.  
As we look to the future, disasters are becoming more frequent and intense because of climate change, and occurrences of disease 
outbreaks are projected to increase.5  Recent experiencesincluding the spread of COVID-19 and monkeypox, and weather events 
5 
   
such as wildfires, winter storms, and hurricanesunderscore that HHS must be prepared to address multiple emergencies 
simultaneously with different response needs and challenges.      
A key challenge for HHS is having adequate planning and mechanisms in place prior to an emergency so that assets and relief can be 
deployed efficiently and rapidly to those in need of HHS resources and assistance.  This includes planning for controls and strategies 
to mitigate disaster preparedness and response risk.6  For instance, a 2021 OIG report looking at CMSs emergency preparedness 
guidance for hospitals found that CMSs controls were well-designed and implemented, but CMSs authority was insufficient for it to 
fulfill its responsibility to ensure that accredited hospitals would maintain quality and safety during an emerging infectious disease 
emergency.7  OIG is also assessing hospital compliance with CMS's emergency preparedness requirements including preventive 
measures hospitals are taking to minimize the spread of COVID-19 and monkeypox.8  Furthermore, OIG continues to conduct 
multiple reviews of nursing homes infection prevention and emergency preparedness.  Nursing homes have been acutely 
challenged in the face of both infectious disease and natural disaster emergencies.  OIG recently excluded seven Louisiana nursing 
homes and their owner from participating in Federal health care programs; the homes evacuated residents to a warehouse where 
they suffered inhumane and squalid conditions, and seven residents died.9  (See TMC 4 for more information related to nursing 
homes.) 
In addition, an effective emergency response requires a prepared public health workforce.  The American Rescue Plan Act of 2021 
provided HHS with additional funds including $7.6 billion to establish, expand, and sustain the public health workforce.10  HHS must 
use these resources effectively to support the public health workforce and build the capacity for addressing current and future 
emergencies. 
For infectious disease emergencies, multiple HHS divisions play critical roles in identifying, acquiring, developing, distributing, and 
administering medical countermeasures including vaccines, therapeutics, and diagnostics.  Playing particularly critical roles among 
HHSs divisions are the CDC, Administration for Strategic Preparedness and Response (ASPR),11 National Institutes of Health (NIH), 
Office of Global Affairs, and FDA.  For example, CDC is responsible for understanding outbreaks and implementing appropriate, 
equitable, and immediate early interventions and prevention strategies.  FDA may use its Emergency Use Authorization (EUA) 
authority and accelerated approval pathways to facilitate the availability of medical countermeasures during PHEs, as it did for 
COVID-19 diagnostics, vaccines, and therapeutics.   
HHS and its divisions have been subjected to public criticism for their handling of recent emergencies.  In January 2022, the 
Government Accountability Office (GAO) identified HHSs leadership and coordination of PHEs as at high risk due to persistent 
deficiencies in HHSs leadership role in preparing for and responding to PHEs.12  (See TMC 6 for more information on the challenge of 
coordination when preparing for and responding to PHEs.)  Subsequently, CDC acknowledged that it had made mistakes over the 
past few years, lost public trust, and needed to transform while refocusing on public health needs.13   
OIG work on prior outbreaks of communicable disease illustrates the importance of ongoing HHS readiness to detect, assess, and 
respond to new disease outbreaks and other emergencies.  For instance, an OIG report about HHSs response to the 2014 Ebola 
outbreak recommended that HHS develop departmentwide objectives and a strategic framework for responding to international 
PHEs.14  HHS concurred with the recommendations in the report but has not yet taken the actions necessary to implement them.   
In addition to coordinating emergency planning and response efforts with its program offices, HHS works with States, localities, and 
Tribes to facilitate planning and preparedness to address a wide range of health and human service needs, including the 
management and distribution of medical supplies, establishment of alternative care sites, and distribution of vaccines and antiviral 
drugs.  In an OIG survey of hospitals conducted in March 2021, hospitals reported that operating in survival mode for an extended 
period had created challenges with health care delivery, staffing, vaccinations, supplies, and finances.  Hospitals reported that the 
emergency exacerbated longstanding challenges in health care delivery, access, and health outcomes.15  Prior OIG work identified 
opportunities for health care facilities to improve emergency preparedness and response planning during infectious disease 
outbreaks and disasters.16  HHS should continue to support the development and maturation of health care coalitions as entities in 
6 
   
this diverse groupincluding hospitals, public health agencies, emergency 
Hospitals reported operating 
medical services, nursing facilities, and emergency management entities
work together to plan and coordinate emergency response.17, 18   in survival mode for an 
extended period created 
HHS must rely on up-to-date information to sustain and strengthen its 
emergency response, and provide effective health guidance to the American  challenges with health care 
public while building the publics trust.  As the COVID-19 emergency 
delivery, staffing, 
continues to evolve and the spread of monkeypox heightens concerns, new 
data provides a deeper understanding of topics such as transmission, testing,  vaccinations, supplies, and 
therapeutics, vaccines, vaccination programs, public health communication,  finances, exacerbating 
and short- and long-term health effects.  HHS faces the challenge of ensuring 
longstanding challenges in 
that as an organization it is continuously learning, charged with gathering 
data about threats that may be evolving and complex, evaluating the data,  health care delivery, access, 
and using the data to inform emergency responses and guide the public.   
and health outcomes.
 
Providing adequate oversight of FDA-regulated products 
FDA is charged with ensuring the safety, effectiveness, quality, and security of human and animal drugs, biological products, and 
medical devices; ensuring the safety of the nations food supply, cosmetics, and products that emit radiation; and regulating tobacco 
products.  These functions are critical to ensuring that Americans can trust the expansive array of products within FDAs purview.19  
FDA has the added challenge of facilitating emergency response efforts related to PHEs including, for example, reviewing scientific 
evidence and issuing EUAs and approvals for COVID-19 vaccines and other medical products; providing surveillance of medical 
product safety, effectiveness, and quality; and updating guidance based on emerging science.20   
Drugs, biologics, and medical devices    
FDA helps to ensure the safety, effectiveness, and quality of medical products through a number of activities, which include 
evaluating manufacturing facilities; reviewing drugs, devices, and biologics for safety, effectiveness, and quality; authorizing 
the use of investigational medical products; and conducting postmarket surveillance.  The public relies on FDA to be 
expeditious, independent, unbiased, and evidence-based when evaluating products and making decisions regarding 
approval for marketing in the United States.  OIG found more than one-third of drugs approved through the accelerated 
approval pathway have incomplete confirmatory trials.21  OIG work also illustrates FDAs challenge of balancing availability 
and quality in its EUA processes.22  FDAs task of assessing complex products has become more difficult as science and 
technology have evolved.  The drug, biologic, and medical device supply chain is becoming increasingly complex, and many 
of the products used in the United States are manufactured overseas or are dependent on raw materials that are produced 
overseas.  For all FDA-regulated drugs, 73 percent of the manufacturing facilities producing active pharmaceutical 
ingredients and 52 percent of the manufacturing facilities producing finished dosage forms of human drugs were located 
outside of the United States in 2022.  In addition, OIG found that FDA could improve its for-cause drug inspection process 
and recommended that FDA identify and implement ways to improve the timeliness of these inspections.23   
The rapid evolution of science and technology presents new oversight challenges for FDA, as does managing cybersecurity 
risks associated with increasing numbers of networked devices.  (See TMC 5 for additional information on the challenge of 
managing cybersecurity risks.) 
Food and infant formula 
The 2022 identification of Cronobacter sakazakii infections associated with infant formula and the corresponding recall 
resulted in supply shortages and the ongoing challenge of providing families access to a safe and adequate supply of infant 
formula.  The infant formula outbreak demonstrates the importance of FDA managing a robust food safety program.   
 
7 
   
Foodborne illness is a largely preventable threat to public health.  An estimated 1 in 6 Americans gets sick, 128,000 are 
hospitalized, and 3,000 die from contaminated foods each year.24  FDA is responsible for overseeing the Nations 
increasingly diverse and complex food system and supply chain.  The American public relies on FDA, which works in 
collaboration with other Federal agencies and State, local, and Territorial partners to help ensure the safety of both human 
and animal food.25  FDAs current approach to food safety includes goals to enhance traceability, improve predictive 
analytics, respond more rapidly to outbreaks, address new business models, reduce food contamination, and foster the 
development of stronger food safety cultures.26  FDA must continue to modernize the food safety system and respond 
effectively and efficiently when issues are identified.  FDA should conduct risk-based inspections of domestic and foreign 
food facilities within the timeframes required by the Food Safety Modernization Act, identify instances of failure to comply 
with good manufacturing practices, and take necessary steps when health risks are identified, including administrative and 
enforcement actions when warranted.27  FDA has made organizational changes to improve incident response through, for 
example, its Coordinated Outbreak Response and Evaluation Network and should continue to improve the timeliness and 
effectiveness of its processes, such as food recalls.  OIG is assessing whether FDA followed the inspections and recall 
process for infant formula per Federal requirements.28   
Tobacco 
Tobacco use is the leading cause of preventable death and disease in the United States.29  FDA regulates the manufacturing, 
marketing, sale, and distribution of tobacco products to protect public health and has committed to reducing harm from 
tobacco products, particularly among youth.  CDCs 2021 National Youth Tobacco Survey indicates that youth tobacco 
product use remains a public health threat, with approximately 1 in 4 students (24.1 percent) ever using a tobacco product, 
and approximately 1 in 10 students (9.3 percent) using a tobacco product during the previous 30 days.30  In 2021, 
e-cigarettes were the most-used tobacco product among both middle and high school students.31  FDA must continue 
efforts to reduce harm amid increasing concerns surrounding the use and detrimental health effects of electronic nicotine 
delivery systems, such as e-cigarettes and vape pens, that contain tobacco-derived nicotine and non-tobacco, or synthetic, 
nicotine.  OIG is assessing FDAs Premarket Tobacco Product Application (PMTA) process for electronic nicotine delivery 
systems.32  Through the PMTA process, FDA must determine whether a new tobacco product is appropriate for the 
protection of public health, taking into account the increased or decreased likelihood that existing users of tobacco 
products will stop using such products, and the increased or decreased likelihood that those who do not use tobacco 
products will start using such products. 
While working with CDC, FDA faces the challenge of better understanding the science of tobacco products and the most 
effective use of its authorities to regulate their manufacture, marketing, sale, and distribution, including premarket reviews 
and health warnings on packaging and advertisements.  OIG is assessing FDAs Tobacco Retailer Compliance Check 
Inspection program under which FDA contractors (generally States) carry out undercover-buy inspections of tobacco 
retailers to ensure compliance with restrictions on sales to minors.33 
Addressing the mental health and drug overdose crises 
Mental health crisis 
The United States faces a mental health crisis.  In 2020, 21 percent of all adults experienced mental illness.34  During the 
pandemic, that number is thought to have trended upward, with more than 30 percent of adults in the United States 
reporting symptoms of anxiety and/or depressive disorder.35  Additionally, more than 20 percent of school-aged children 
have experienced worsened mental or emotional health since the pandemic began.36  According to CDC, the United States 
had one death by suicide every 11 minutes in 2020.  
Many who experience mental health illness do not obtain treatment, and it is critically important that the crisis care 
system in America is transformed and people are provided timely access to quality help.37  HHS has committed resources 
toward enhancing the mental health workforce and connecting people to treatment, such as through Substance Abuse and 
8 
   
Mental Health Services Administrations (SAMHSAs) launch of 988the three-digit phone number for the National Suicide 
Prevention Lifeline.  OIG is currently evaluating the availability of behavioral health care in Medicare fee-for-service (FFS), 
Medicare Advantage (MA), and Medicaid managed care.38  Under the Bipartisan Safer Communities Act, HHS is responsible 
for administering $800 million in new grant funding to address the mental health care needs of adults and children.  As 
described in TMC 2, sound financial management of these grant funds is important to ensure that the government gets the 
quality of services and outcomes for which it is paying.39  
Overdose crisis 
In recent years illicit opioids, largely driven by fentanyl and its analogues, have become key contributors to the overdose 
crisis.  Other controlled substances, including benzodiazepines and stimulants (particularly methamphetamine), are also 
being used in combination with opioids.  Since 2017, HHS has declared an ongoing opioid PHE nationwide, and in the past 
few years our country has experienced heightened concerns about the prevalence and detrimental effects of substance use 
disorders, including those involving alcohol, tobacco, opioids, and other drugs.  Provisional data from CDC show that drug 
overdose deaths attributable to opioids as well as other categories of drugs have significantly increased since the start of 
the COVID-19 pandemic.40  For the 12-month period ending in March 2022, there were 104,671 reported drug overdose 
deaths, which was a 40-percent increase from the 74,679 reported drug overdose deaths during the 12-month period 
ending in March 2020.41  In early fiscal year (FY) 2022, HHS released an overdose prevention strategy.42  Current Federal 
priorities for drug policy include expanding access to evidence-based treatment for substance use disorder, advancing racial 
equity in the approach to drug policy, and reducing the supply of illicit substances.43   
Opioids prescribed by licensed medical professionals and paid for, in part, with Federal funds have contributed to the opioid 
crisis.  Moreover, OIG has found that opioid-related fraud encompasses a broad range of criminal activity, from prescription 
drug diversion to substance use disorder treatment schemes.  OIG investigations show that opioid drug diversionthe 
redirection of drugs prescribed for medical use to nonmedical purposesis on the rise.  Diverted opioid drugs present a 
high risk of inappropriate use and cause significant harm, such as overdoses.  Also, potentiator drugs (drugs that exaggerate 
euphoria and escalate the potential for misuse when combined with opioids) and drugs indicated to treat Opioid Use 
Disorders (OUDs) (including buprenorphine and methadone) are at high risk for diversion.   
More than 43,000 people enrolled in Medicare Part D overdosed on prescription opioids or illicit opioids during 2020.  
Overall, 1 in 4 Medicare patients enrolled in Part D received opioids during 2020.44  Unlike recent years, there was no 
growth in the number of people receiving prescriptions through Part D for the opioid overdose-reversal drug, naloxone.  
Access to naloxone is important: Naloxone used in response to an overdose can save a life.  Additionally, growth in the 
number of people receiving drugs through Part D to treat OUDs slowed.  Ensuring sufficient access to treatment is 
particularly important as we do not yet know the full extent to which the stressors of the COVID-19 pandemic may have 
increased both the prevalence of OUDS and the need for these treatments.  
The Department should continue to use the tools available across its divisions to address the ongoing overdose crisis while 
being mindful of patients needs to access appropriate management for acute and chronic pain, which may include the use 
of opioid analgesics.  FDA has key roles in ensuring the safe use of opioid analgesics including, for example, evaluating 
proposed new opioid analgesics and approving them for marketing in the United States only if their benefits outweigh 
risks.45  FDA also employs tools to mitigate risks associated with opioid analgesics, including requiring product labeling 
changes and Risk Evaluation and Mitigation Strategies (REMS) as needed.46  An OIG evaluation found that data quality 
issues made it challenging for FDA to determine whether two REMS for opioid analgesics had been effective and that REMS 
may not be well-suited to quickly address the opioid crisis.47  FDA must work to ensure that strategies it uses to mitigate the 
misuse and abuse of opioids achieve their intended impacts.  CMS and States should continue to follow up with prescribers 
with questionable prescribing patterns to ensure that Medicare Part D and Medicaid are not paying for unnecessary drugs 
being diverted for resale or recreational use.  In addition, the Department must guard against fraud in OUD treatment 
programs, including the submission of fraudulent insurance claims for purported OUD treatment and testing services.48   
9 
   
Ensuring access to effective substance use disorder treatment, especially in regions with greater risk for opioid misuse and 
overdose, remains crucial to combating the overdose crisis.49  Measures to address COVID-19 have further challenged 
access to treatment.  In a survey of 143 opioid treatment programs (OTPs), OIG identified various challenges OTPs 
encountered during the COVID-19 pandemic including maintaining pre-pandemic service levels, managing impacts on 
facility operations, and maintaining patient participation in opioid treatment program activities, among others.50  To ensure 
access to effective treatment, HHS needs data to continue building its ability to monitor access and unmet needs.  An OIG 
evaluation identified opportunities to enhance information about access and the need for medication to treat OUD through 
the Buprenorphine Waiver Program, one of the SAMHSAs key initiatives for combating the overdose crisis by expanding 
treatment services.51  In spring 2021, HHS released new buprenorphine practice guidelines designed to expand access to 
evidence-based treatment for OUD.52  
In addition, HHS must ensure that funding to address the overdose crisis is efficiently and effectively spent for its intended 
purpose.  In a series of OIG audits of Medicaid payments for OTP services, OIG found that Medicaid reimbursements for 
OTP services in some States did not meet Federal and State requirements.53, 54  Another OIG audit of a SAMHSA grant to 
combat OUD found that the recipient did not meet its goal for the number of naloxone kits distributed, nor could the 
recipient ensure that the naloxone kits were distributed to targeted populations.55 
   
10 
   
 
2: Ensuring the Financial Integrity of  
HHS Programs 
Relevant Agencies 
 All HHS  
Elements of the Challenge 
 Controlling costs by ensuring prudent payments for goods and services 
 Preventing, reducing, and recovering improper payments  
 Combating fraud, waste, and abuse  
 Monitoring and reporting on the integrity of HHS programs 
 
 
HHS is the largest civilian agency in the Federal government, with $2.9 trillion in budgetary resources.56, 57  Sound stewardship that 
ensures the transparency and accountability of HHS funds is paramount to making sure people served by HHS and the American 
public benefit from this substantial financial investment.58   
HHSs Medicare program is the Nations largest health insurer by expenditures and handles more than 1 billion claims per year.  
Medicaid is the largest health insurer in terms of lives covered, with nearly 89 million individuals enrolled in Medicaid and the 
Childrens Health Insurance Program (CHIP) as of May 2022.59  Spending for the Medicare and Medicaid programs (including State 
spending) represents 38 cents of every dollar spent on health care annually in the United States.60  Medicare expenditures totaled 
$857.1 billion and Medicaid expenditures totaled $521.8 billion in 2021.61  HHS is the largest grantmaking and second-largest 
contracting agency in the Federal government.  In FY 2021, HHS awarded $236.4 billion in grants (excluding CMS grants) and 
$38.9 billion in contracts.62  
The Department must protect the fiscal integrity of HHS funds and ensure that beneficiaries have access to the services they need.  
This is a growing challenge due to, among other factors, looming financial shortfalls in the Medicare program,63, 64 growth in the 
number of people enrolled in Medicaid, and massive COVID-19 funds that HHS is responsible for distributing and overseeing via 
grants and other mechanisms.  HHS must manage the efficient and effective use of funds internally and oversee the use of Federal 
funds by hundreds of thousands of external funding recipients. 
Controlling costs by ensuring prudent payments for goods and services 
Whether HHS is paying for medical services, prescription drugs, or human service programs, managing what the Department pays 
and recognizing and remedying problematic payment policies are critical to controlling costs.  
Prescription drug programs  
The Medicaid, CHIP, and Medicare programs accounted for 42 percent ($147 billion) of total U.S. prescription drug 
expenditures in 2020.65  The Medicare Part D program had net costs of $79.8 billion for FY 2021, and 48 million people 
relied on Part D for prescription drug coverage.66, 67  
11 
   
A top management challenge for HHS is implementation of the Inflation Reduction Act (IRA), which makes several changes 
to Medicare and provides certain complex new authorities.  Under IRA, CMS must negotiate prices on selected Medicare 
Part B and Part D brand-name drugs that account for the greatest program spending.  IRA also mandates rebates for Part B 
or Part D drugs for which prices increased at a rate exceeding the rate of inflation.  The law also changes the structure of 
the Part D program and caps annual out-of-pocket costs at $2,000 per enrollee.  Portions of the statute take effect as soon 
as January 2023.  OIGs prior work looking at drug spending in areas such as biosimilars and hepatitis drugs suggests that 
the Part D reforms could have a substantial impact.  Administering new and complex programs creates challenges and risks 
for CMS, including those tied to managing technical and regulatory complexity, meeting required timeframes, managing 
resources efficiently, issuing clear guidance, delivering program outcomes, designing and providing effective oversight, and 
preventing and detecting fraud and abuse.  More specifically with respect to implementing prescription drug provisions, 
OIG work has identified challenges in calculating inflation-indexed rebates in Part B and ensuring the completeness and 
accuracy of measures, such as average sales price (ASP) and average manufacturer price (AMP).  Furthermore, OIG work 
suggests that CMS must be attuned to ensuring accurate and complete reporting of manufacturer data, such as ASP and 
AMP data, required for effective and efficient program operations.  CMS must also provide effective oversight and, where 
appropriate, enforcement of manufacturer compliance with new program requirements. 
The way that Medicare and Medicaid pay and reimburse for drugs can impact prescription drug prices and costs for people 
and programs.  For example, in the Part B program OIG found that Medicare would have saved millions of dollars if 
dispensing fees for several drugs had been aligned with the rates that Part D and State Medicaid programs paid.68 Also, OIG 
looked at the impact of the least costly alternative policy in Part B, which based the payment amount for a group of 
clinically comparable products on that of the least costly product, on costs for certain prostate cancer drugs.  OIG found 
that when the least costly alternative policy was rescinded there was an increase in costs for the studied drugs.   
Furthermore, OIG work on the Part D program has raised concerns about whether the program design encourages the use 
of the highest value drugs.  OIG found that although there was a 17 percent decrease in Medicare Part D prescriptions for 
brand-name drugs between 2011 and 2015, there was a 77 percent increase in total reimbursements for these drugs, 
leading to greater overall Part D spending and higher enrollee out-of-pocket costs.69  OIG work looking at the use of lower 
cost biosimilar drugs that are clinically equivalent to their higher cost reference biological drugs found that the program and 
its enrollees could realize significant savings if biosimilar use were to increase, but the lack of biosimilar coverage on Part D 
formularies may limit increased use.70 
Additionally, manufacturers uses of reasonable assumptions when calculating AMPs and best pricesa practice OIGs work 
has established as commonrepresents a vulnerability in drug pricing for thousands of drugs used in the Medicaid 
program.71  HHS must endeavor to limit the impact of high prices on programs and beneficiaries while protecting access to 
medically necessary drugs.  The Department also should be prepared to address the coverage and reimbursement 
challenges of emerging technologies.  
Preventing, reducing, and recovering improper payments  
An improper payment is any payment that does not meet statutory, contractual, administrative, or other legally applicable 
requirements, and that may be an overpayment or underpayment.72  Reducing improper paymentssuch as payments to ineligible 
recipients or duplicate paymentsis critical to safeguarding Federal funds.  Due in part to their size and in part to some programs 
having error rates that exceed statutory benchmarks, HHS programs account for some of the largest estimated improper payments 
in the Federal Government.  Medicare, Medicaid, and CHIP together accounted for 55 percent, or $153.7 billion, of all 
governmentwide estimated improper payments reported in FY 2021.73  Furthermore, insufficient HHS oversight of grant programs 
and contracts poses risks of significant improper payments. 
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Medicare 
Original Medicare FFS and Medicare Part D (also known as 
Medicare Prescription Drug) accounted for $26.4 billion, 
or 17 percent, of the estimated improper payments that 
HHS reported in FY 2021.74  Notably, the Medicare FFS 
improper payment rate estimate during the past 3 years 
has decreased from 7.3 percent ($28.9 billion) in FY 2019, 
to 6.3 percent ($25.0 billion) in FY 2021.75  The 
improvements in Medicare FFS estimated improper 
payments represent positive momentum on which the 
Department and CMS can build.  However, some types of 
providers and suppliers pose heightened risks to the 
financial security of Medicare.  For instance, OIG and CMS 
have identified especially high rates of improper 
payments for home health, hospice, and skilled nursing 
facility (SNF) care; durable medical equipment (DME); 
drug testing services; and certain hospital services.76  CMS 
has taken corrective actions for Medicare FFS by focusing 
on specific service areas with high improper payment 
rates.  But more must be done.  The reduction in the 
improper payment rate was driven primarily by  Graphic adapted from PaymentAccuracy.gov. 
reductions in Part B and DME claims.  CMS should take 
further action to reduce improper payments among providers and suppliers.  
CMS must ensure appropriate billing for Medicare services and must monitor for indications that hospitals may be engaging 
in inappropriate billing practices, such as upcoding.77  For example, OIG found that hospitals increasingly billed for inpatient 
stays under Medicare severity diagnosis-related groups at the highest severityand most expensivelevel from FY 2014 
through FY 2019.  CMS should also ensure that it is prepared to detect and prevent improper payments in areas with 
growing utilization, such as telehealth and genetic testing.  When improper payments are identified, such as through OIG 
audits, CMS should continue its efforts to recover collectible overpayments.  OIG has recommended additional steps CMS 
could take to improve its ability to recover misspent funds.78 
MA allows people to receive Medicare benefits through private managed care plans.  HHS pays plans in part by adjusting 
the per-person amount to account for health status differences between enrolled people in order to determine the 
monthly payment amount, which means that plans receive higher payments for enrollees reported to have a poorer than 
average health status, and lower payments for enrollees reported to have better than average health status.  HHS reported 
an improper payment rate of 10.28 percent for MA, accounting for $23.2 billion, or 15 percent of the estimated improper 
payments HHS reported in FY 2021.79  As it exceeds 10 percent, the FY 2021 rate is not in compliance with the Payment 
Integrity Information Act.  As disclosed in the FY 2021 Agency Financial Report (AFR), contributing to the increase in the 
error rate was the rebasing of the measure to exclude MA payments not related to risk adjustment from the calculation.  
Nevertheless, the amount of improper payments in MA indicates further scrutiny is needed, especially considering the 
incentive to receive higher payments by misreporting diagnoses.  HHS should evaluate critical and feasible action steps to 
assist MA organizations with compliance efforts, specifically with organizations that have significant improper payments 
year-over-year to ensure that medical record documentation is sufficient and substantiates clinical diagnoses. 
Medicaid 
Medicaid is a Federal-State partnership through which the 50 States, District of Columbia, and 5 Territories each offers its 
own program, within certain Federal parameters, reflecting State and local needs and preferences.  CMSs Payment Error 
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Rate Measurement (PERM) program measures improper payments in Medicaid and CHIP, and produces a national improper 
payment rate for each program.  The estimated Medicaid improper payment rate increased from 21.4 percent in FY 2020 to 
21.7 percent in FY 2021, while CHIP increased from 27.0 percent to 31.8 percent.80  These increases were largely due to the 
continued re-introduction of beneficiary eligibility errors into the error rate calculation; inclusion of these errors had 
previously been paused while CMS updated the PERM eligibility component.81  Medicaid accounted for approximately 
$98.7 billion in estimated improper payments in FY 2021.  CMS attributes these increases to high levels of eligibility errors, 
such as those occurring when States maintain insufficient documentation to substantiate that income and other 
information were appropriately verified, failures in conducting timely and appropriate annual redeterminations, as well as 
errors when beneficiaries are claimed under incorrect eligibility categories that provide a Federal matching rate higher than 
appropriate.82   
OIG has long identified eligibility determinations as a significant risk area.  Medicaid expansion under the Affordable Care 
Act and mandated changes to Medicaid eligibility rules led to a significant increase in applications for Medicaid coverage.  
More recently, the Families First Coronavirus Response Act temporarily increased the Federal Governments share of 
Medicaid costs, with the condition that States accepting the additional funds are prohibited from making their Medicaid 
eligibility requirements more restrictive and from terminating peoples coverage during the COVID-19 PHE.  After the 
COVID-19 PHE ends, States will need to conduct renewals of eligibility for all individuals enrolled in Medicaid and CHIP, 
which could affect millions of people.  
Prior OIG audits found that some States did not always determine Medicaid eligibility for some beneficiaries per Federal 
and State requirements.  We determined that both human and system errors, as well as a lack of policies and procedures, 
contributed to improper or potentially improper payments.  We estimated that 4 States we audited made Federal Medicaid 
payments totaling almost $1.4 billion for more than 700,000 people whose eligibility could be considered because of the 
Affordable Care Act expansion but who did not meet or may not have met eligibility requirements.  Furthermore, States 
made Federal Medicaid payments totaling more than $5 billion on behalf of 5 million individuals who fit traditional 
Medicaid coverage groups but who did not meet or may not have met eligibility requirements.  As with Medicare, CMS 
faces other fiscal integrity challenges with Medicaid, such as collecting overpayments from State Medicaid agencies.  As of 
April 2022, CMS had not collected about $1.5 billion in overpayments identified in OIG audit reports.83       
Advanced Premium Tax Credit 
  The risk assessment process that HHS uses to estimate improper payments determined that the APTC program is 
susceptible to significant improper payments.  HHS has started the improper payment measurement program for the 
Federally Facilitated Exchange (FFE) and anticipates reporting an improper payment estimate for the FFE in the 
FY 2022 AFR.  HHS continues to develop the improper payment measurement methodology for State-based exchanges and 
will continue to update AFR with the measurement program development status. 
Grants and contracts 
Administering grant programs and contracts requires that HHS implement oversight and guidance to ensure that program 
goals are met and funds are used appropriately.  HHS is responsible for providing guidance and up-to-date policies to grant 
recipients and helping States and other grantees address financial management and internal control issues.  Without proper 
internal controls at the grantee level, funds may be misspent, duplication of services may occur, and subrecipients may not 
be adequately monitored.  OIG has identified grantee-level concerns in several HHS programs.  For example, OIG found that 
most NIH grantees failed to meet at least one Federal requirement related to investigators foreign interests and support 
and lacked oversight practices to ensure that all materials submitted to NIH were accurate.  OIG has identified a range of 
other problems with grants and contracts oversight.  For example, some grantees of the Office of Refugee Resettlement 
(ORR) Unaccompanied Children (UC) Program reported unallowable rental, construction, subcontractor, or other costs,84 
and ORR did not award or sufficiently manage a sole source contract in accordance with Federal requirements.85  
Additionally, it remains the responsibility of individual organizations within HHS to administer the Small Business Innovation 
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Research (SBIR) program.  OIG made two recommendations to address vulnerabilities in the SBIR program: (1) HHS should 
ensure awardee compliance with SBIR eligibility requirements and (2) HHS should improve procedures to check for 
duplicative awards.86  
HHS must track and report improper payment rates for its risk-susceptible grant programs and thus adhere to the Payment 
Integrity Information Act of 2019.87  However, since the inception of these reporting requirements HHS has not reported an 
improper payment estimate for the Temporary Assistance for Needy Families (TANF) program.  HHS stated in its 
FY 2021 AFR that it did not report an improper payment estimate for TANF because statutory limitations preclude HHS from 
requiring States to participate in a TANF improper payment measurement.  The Office of Management and Budget (OMB) 
identified TANF as a risk-susceptible program that must report estimated error rates and amounts.  HHS must continue to 
pursue legislative or other remedies to develop an appropriate methodology for measuring TANF payment accuracy and 
report an improper payment estimate for TANF.88 
Although HHS has taken steps to improve the contract management and closeout processes, the Department in terms of its 
oversight of contracts needs to take additional actions to ensure that it is meeting other Federal requirements.  For 
example, OIG found that, while some Federal Acquisition Regulation (FAR) were met, FDA did not always identify contracts 
eligible for closeout and did not always follow the FAR requirements for closing contracts in a timely manner.89  HHS must 
also improve its use and management of other transaction agreements, which carry a higher risk than traditional awards.  
OIG found that NIH did not fully comply with Federal requirements for awarding and administering other transactions.  NIH 
implemented the OIG recommendations to strengthen its internal controls.90   
COVID-19 funding 
Congress appropriated $484.0 billion to HHS for the COVID-19 response.91  This includes the Provider Relief Fund (PRF) to 
support health care providers affected by the COVID-19 pandemic and the Uninsured Program (UIP) to reimburse health 
care providers that have conducted COVID-19 testing, administered vaccines, or provided treatment for uninsured 
individuals with a COVID-19 primary diagnosis.92, 93  Both programs are administered by the Health Resources and Services 
Administration (HRSA).  PRF and UIP had to be rolled out quickly, which presented challenges and vulnerabilities in 
administering the programs.  A recent OIG audit found that HHSs and HRSAs controls related to selected PRF program 
requirements could be improved.  OIG found that HHS and HRSA did not have certain procedures related to supporting 
documentation, calculation of nonautomatic payments, and return of rejected payments.  Other procedures had 
weaknesses.  OIG recommended, and HRSA concurred, that HRSA seek repayment of overpayments and strengthen efforts 
as it fully implements postpayment quality control review processes.94  OIG is currently conducting additional audits and 
evaluations of PRF and UIP distributions, including PRF distributions made to nursing homes.95 
Combating fraud, waste, and abuse  
Fraud, waste, and abuse divert needed program resources to inappropriate, 
unauthorized, or illegal purposes.  Effectively fighting fraud, waste, and abuse 
requires vigilance and sustained focus on preventing problems from occurring in 
the first place, detecting problems promptly when they occur, and rapidly 
remediating detected problems through investigations, enforcement, and 
corrective actions.  The Department should apply a robust variety of program 
integrity strategies to protect HHS programs, including implementing systems and 
processes to detect and prevent fraud, as well as plans for addressing fraud when it 
occurs.  (For an additional discussion on combating fraud, waste, and abuse in CMS 
programs, see TMC 3.)  
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COVID-19 funds 
OIG has identified serious concerns related to fraud schemes that would divert funds intended for the COVID-19 response 
and recovery.  Law enforcement investigations have included allegations of providers falsely attesting to their eligibility for 
funds and providers using relief funds for impermissible personal expenses.  OIG has identified other serious fraud schemes 
that threaten programs and people.  These include schemes in which fraudsters offer unapproved and illegitimate 
COVID-19 tests and fake vaccination cards, often in exchange for personal details, including information that can be used to 
falsely bill Medicare or other payers.  HHS must apply effective internal controls and efficiently manage the collection, 
maintenance, and analysis of relevant data that are key to ensuring COVID-19 funds are used for their intended purposes.   
Furthermore, as with all HHS grant programs, it will be critical that the Department provide up-to-date policies to 
COVID-19-related grant recipients and help States and other grantees address their own financial management and internal 
control issues.  Without proper internal controls, funds may be misspent, duplication of services may occur, and 
subrecipients may lack adequate monitoring.  (See TMC 3 for additional details regarding COVID-19 flexibilities and the 
challenge of terminating these flexibilities at the end of the PHE.) 
Grants and Contracts  
Without adequate oversight and internal controls, HHS grants and contracts are vulnerable to fraud schemes including 
embezzlement and theft.96  HHS has worked to strengthen some of its program integrity efforts focused on grant programs.  
For instance, HHS issued guidance and developed tools to help its awarding OpDivs examine prospective grantee risk prior 
to awarding grants.97  This information enhanced awarding OpDivs assessments of prospective grant recipients integrity 
and potential performance.  Suspension and debarment programs help protect the integrity of Federal grants and 
contracts.  Most suspension and debarment referrals resulted in actions to protect funds.  Furthermore, most of the 
referrals came from HHS non-awarding entities, while many HHS awarding agencies made no referrals during the 5-year 
period we reviewed.  This suggests there were missed opportunities for additional referrals among these awarding 
agencies.  HHS has since made improvements in strengthening program integrity for its suspension and debarment 
programs.  HHS  implemented two of OIGs four recommendations to strengthen suspension and debarment programs by 
issuing the Discretionary Suspension and Debarment Handbook for Contracts and Grants and conducting ongoing training 
across the Department to encourage the use of suspension and debarment as a viable administrative remedy. 98 
Provider enrollment screening processes 
An effective provider enrollment screening process is an important tool for preventing Medicaid and Medicare fraud.  Such 
a process plays a vital role in identifying and preventing unscrupulous providers from enrolling in Medicaid and Medicare.  
OIG found that Medicaid is vulnerable to being defrauded by high-risk providers that were not properly screened.99  We 
also found that unscrupulous providers could exploit loopholes in the provider enrollment process to enroll in State 
Medicaid programs without undergoing these checks.100  In addition, OIG found 23 States had not enrolled all providers 
serving Medicaid beneficiaries in their respective Medicaid programs, exposing enrollees to potentially harmful providers 
that had not been screened for fraud and abuse.101  Despite legislative requirements in the 21st Century Cures Act designed 
to strengthen Medicaid program integrity, terminated providers continue to serve people enrolled in Medicaid.  We 
recommended that CMS: (1) ensure that all States fully implement fingerprint-based criminal background checks for high-
risk Medicaid providers and (2) work with States to ensure that they have the controls required to prevent unenrolled 
providers from participating in Medicaid. 
Monitoring and reporting on the integrity of HHS programs 
HHS must ensure the completeness, accuracy, and timeliness of financial and program information provided to other entities both in 
and external to the Federal Government.  Responsible stewardship of HHS programs is vital to operating a financial management 
and administrative infrastructure that employs appropriate safeguards to minimize risk and provide oversight to protect resources.  
Although HHS continues to maintain a clean opinion on its basic financial statements and has addressed most severe weaknesses in 
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financial management systems, OIG recommends that HHS focus on refreshing OpDivs understanding of departmental guidance and 
identifying those areas for which OpDiv training would be developed to prevent and detect future accuracy issues related to 
performance dates, award types, and award descriptions.   
In addition, financial management systems help OpDivs and StaffDivs ensure operational effectiveness and efficiency, financial 
reporting reliability, and compliance with applicable laws and regulations.  OIG continues to find deficiencies in internal controls 
over segregation of duties, configuration management for approved changes to HHS financial systems, and access to HHS financial 
systems.102  These deficiencies collectively constitute a significant deficiency in internal controls.  HHS must take additional actions 
to address and resolve these issues, including continuing to work to control user access, ensuring proper approval of and 
documentation supporting system changes, and ensuring appropriate segregation of duties.103    
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3: Delivering Value, Quality, and Improved 
Outcomes in CMS Programs 
Relevant Agency 
 CMS 
Elements of the Challenge 
 Aligning program incentives with quality, equity, and health outcomes 
 Strengthening program integrity 
 Ensuring smooth transitions when PHE waivers and flexibilities end 
 
CMS is tasked with administering the two largest Federal health care programs, Medicare and Medicaid, as well as CHIP and the 
Health Insurance Marketplaces.  More than 147 million people (43 percent of Americans) rely on Medicare and Medicaid for their 
health insurance including senior citizens, individuals with disabilities, low-income families and individuals, and individuals with 
end-stage renal disease.104 
Effectively and efficiently managing this complex suite of programs is a top HHS challenge.  These programs use multiple delivery 
models (including FFS, managed care, and value-based care); cover a broad array of health conditions, providers, services, settings, 
and insurance plans; and operate pursuant to intricate statutory directives and regulatory schemes.  Spending on these programs is 
massive, totaling $1.3 trillion in FY 2021.105  CMSs task is further complicated by the fact that it must administer portions of these 
programs collaboratively with States and private insurance companies.  For example, Medicaid is functionally more than 50 different 
Federal-State partnerships, with substantial State customization and variation in benefits and payment methodologies.  CMS 
programs rapidly change and evolve.  Most recently, for example, IRA enacted major changes including a new requirement to 
negotiate prescription drug prices for certain expensive Medicare Part B or Part D drugs, and an extension of subsidies available to 
purchasers of marketplace plans.  (For more information about implementing IRA, see TMC 2.) 
Administering these programs comes with an array of operational and program integrity risks and challenges, as well as promising 
opportunities for better care and health outcomes, improved access and health equity, lower costs, more transparency and choices 
for consumers, and reduced administrative burden.106  (Additional information regarding challenges related to costs and quality of 
care can be found in TMCs 2 and 4.)  To achieve better care at lower cost, HHS must maintain a steady focus on developing and 
refining effective, innovative, and evidence-driven payment and delivery models.  At the same time, CMS must be proactive in 
preventing and detecting fraud, waste, and abuse, including abuse and neglect in nursing homes and other care settings.  HHS must 
pay special attention to effectiveness and program integrity in nascent areas such as expanded benefits addressing social 
determinants of health and new uses of digital technology.  This is vitally important given the current and anticipated growth in the 
costs and numbers of people enrolled in Medicare and Medicaid.   
Meeting this challenge will enable the Department to expand the reach of dollars devoted to these programs, thereby abating some 
of the anticipated increases in program costs in coming decades and improving the lives and health outcomes of the people they 
serve. 
 
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Aligning program incentives with quality, equity, and health outcomes 
Developing effective incentives, policies, and safeguards to drive better quality, equity, and health outcomes is a significant 
challenge given the complexities of health care, the evolving science of quality measurement, the broad range of providers and 
others who furnish services, and the varying needs and circumstances of the populations served by CMS programs.  One of the main 
ways that CMS tests potential quality incentives is through the CMS Innovation Center.  In a report to Congress, CMS estimated that 
more than 27.8 million people enrolled in Medicare and Medicaid and individuals with private insurance in multipayer model tests 
had been included in Innovation Center models and initiatives as of September 30, 2020.107  Estimated payments for model tests and 
initiatives (excluding reimbursement for covered services) totaled about $13 billion for FY 201020.  
Reforming health care payment and delivery models gives rise to risk-management challenges in CMS programs.  CMS must 
maintain a steady focus on quality of care and health outcomes.  This is particularly true during a PHE if normal guardrails and 
conditions are adjusted to address exigent public health circumstances and if providers may temporarily be unable to meet optimal 
care guidelines.  (See TMC 4 for further discussion of quality-of-care challenges.)  
Quality measurement 
The Department is undertaking initiatives to streamline, improve, and target quality measures more precisely and to move 
from process measures to outcome measures.  In March 2021, CMS launched Meaningful Measures 2.0: Moving from 
Reduction to Modernization to reduce the number of measures in its programs and further shape the entire ecosystem 
of quality measures that drive value-based care.108  CMS recently announced its first set of quality measures for 
Medicaid-funded home and community-based services.109 
Moving forward, HHS should ensure that its programs use effective, evidence-based measures to monitor quality of care 
and beneficiary outcomes.  CMS must clearly define actionable and meaningful quality and outcomes measures for its 
programs and ensure their reliability, accuracy, and utility.  CMS should continue, where appropriate, to align its efforts 
with other HHS divisions that use quality measurements to enhance efficiency and strengthen quality measurement.  CMS 
outlined a range of steps it is taking in its 2021 annual report to Congress on Identification of Quality Measurement 
Priorities.110  
Aligning payment incentives 
In managing its portfolio of FFS, managed care, and value-based 
In managing its portfolio of 
payment models, CMS must ensure that payment mechanisms are 
driving high-quality, efficient care.  OIG work has identified many  FFS, managed care, and 
opportunities for better alignment of incentives and outcomes.  For 
value-based payment 
example, an OIG report examined inpatient rehabilitation facility 
models, CMS must ensure 
(IRF) transfer payment policy for early discharges to home health and 
found that CMSs transfer payment policy was not aligned with costs,  that payment mechanisms 
which may have provided IRFs with a financial incentive to admit 
are driving high-quality, 
patients inappropriately.111  In response, CMS reported to OIG that it 
is developing an IRF Review Choice Demonstration and collaborating  efficient care. 
with ASPE to develop a prototype and recommendations for a 
unified, post-acute care payment system to more closely align Medicare post-acute care payments with the post-acute car e   
needs of Medicare beneficiaries.  Some policies result in Medicare and enrollees paying more for care provided in certain 
settings than for the same care provided in other settings.  A 2021 study found that Medicare and enrollees who receive 
outpatient services and then are admitted for inpatient care for the same condition shortly afterward pay more if the 
outpatient services provider is affiliated with the admitting hospital than if the outpatient service provider is wholly owned 
by the admitting hospital.112  CMS should be attentive to nursing home payments to ensure appropriate incentives to 
deliver high-quality care.  For example, understanding SNF costs is crucial to understanding the factors that contribute to 
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nursing home performance and how nursing homes deliver care to beneficiaries.  OIG is assessing whether SNFs are 
reporting related-party costs as per Federal regulations and will determine whether SNF allocations of Medicare funds 
could impact beneficiary care, such as whether overhead costs might have increased while allocations for patient care 
decreased, potentially reducing care. 
Another recent OIG report, discussed in more detail in TMC 4, revealed continued high rates of patient harm in hospitals 
and recommended that CMS broaden its lists of hospital-acquired conditions (HACs) to capture common, preventable, and 
high-cost harm events.113  This expansion would have the effect of reducing payments for a broader array of HACs, thus 
more appropriately aligning payment with quality of care.  CMS has observed challenges in aligning payment and desired 
outcomes in some models being tested by the Innovation Center.  In a July 2022 analysis of certain acute and specialty care 
models, CMS noted that generous financial incentive payments spurred robust participation in the models but made it 
difficult for many models to demonstrate net savings.114  CMS must continue to monitor the results of its range of models 
and remain attuned to opportunities to better align payments with quality and efficient care. 
Nontraditional services 
Value-based models typically pay, in full or part, based on health outcomes achieved for patients and reductions in health 
care costs.  Providers are paid for a set or bundle of services, often provided across a continuum of care settings, with 
accountability for outcomes and costs expected over an established period.  To meet care and cost goals, providers in 
value-based models (as with managed care) often furnish a range of services not typically paid under volume-based, 
traditional FFS.  These might include social services, care coordination, or health technology.  Especially when 
nontraditional services affect the payment amount, HHS should be attentive to ensuring that such services contribute to 
achieving quality, equity, and efficiency in outcomes.  Because these interventions are not reflected in normal claims data, 
CMS should ensure it has the available data necessary to understand the services provided and evaluate their effectiveness.  
This may require that CMS partner with other HHS divisions and Federal agencies that support social services.  Operation 
and oversight of models that integrate traditional health and other services may be hampered by data silos both within HHS 
and across the Federal Government.  (See TMC 5 on data sharing.)  There is a heightened program integrity risk if add-on, 
nontraditional services are offered to patients for marketing purposes (e.g., to induce them to obtain medically 
unnecessary services), rather than to foster improvements in patient health outcomes, efficiencies, or equity. 
Equity 
Access to care and health equity are longstanding 
challenges that have been exacerbated by the 
COVID-19 pandemic.  OIG work has long identified 
access issues in Medicare and Medicaid.  For 
example, a report examining provider shortages and 
limited availability of behavioral health services in 
New Mexicos Medicaid managed care program 
provides insights into challenges likely shared by 
other States.  Identified challenges included an 
uneven distribution of licensed providers across the 
State, staff retention, poor care coordination, and a 
lack of transportation and broadband services.  
Promising initiatives to increase availability of 
Graphic adapted from OIG report COVID-19 Had A Devastating Impact on 
behavioral health services included open-access 
Beneficiaries in Nursing Homes During 2020. 
scheduling, a treat first clinical model, care 
integration, and telehealth.115               
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Ensuring that programs have accurate demographic and other data is a requisite step in identifying, understanding causes 
of, and addressing health disparities.  An OIG analysis of Medicare claims data showed that in 2020 the COVID-19 pandemic 
did not affect nursing home residents equally.  About half of Black, Hispanic, and Asian nursing home residents had or likely 
had COVID-19, compared to 41 percent of White residents.116  OIG also found that dually eligible, Black, Hispanic, and older 
beneficiaries were disproportionately hospitalized with COVID-19 during surges in six localities.  Another OIG report found 
that inaccuracies in Medicares race and ethnicity data hinder CMSs ability to assess health disparities and recommended 
steps CMS should take to improve this data.117 
Strengthening program integrity 
HHS must be attentive across its programs to combating fraud, waste, and abuse.  The nature of fraud and abuse risk differs 
depending on how Medicare and Medicaid pay for services.  Traditional FFS risks, arising from volume-sensitive payments, include 
inappropriate increased utilization, increased program costs, and improper patient steering.  In managed care, a capitated payment 
system could lead to potential risks such as: (1) stinting on care to reduce costs; (2) discriminating against expensive patients; or 
(3) manipulating or falsifying data used to measure performance, outcomes, acuity, or diagnoses for risk adjustment.  In addition, 
OIGs oversight and enforcement work has revealed opportunities for downstream fraud and abuse in managed care by providers 
paid by plans on an FFS basis.  In nontraditional health care models that marry FFS payments with value-based payments, such as 
shared savings or partial capitation payments, elements of both FFS and managed care risks may be present.  In evaluating and 
managing risks for a specific value-based program or model, CMS must consider the range of incentives in the model.    
Managed care 
HHS faces a significant challenge in conducting oversight of managed care programs and protecting against fraud, waste, 
and abuse.  Managed care is the primary delivery system for Medicaid, covering at least some services for more than 
80 percent of all enrollees.118  In Medicare, nearly half of beneficiaries are currently enrolled in Medicare Advantage 
Organizations (MAOs). 
The MA program is vulnerable to fraud, waste, and abuse perpetrated by MAOs to inappropriately inflate payments they 
receive from Medicare or inappropriately deny care they are obligated to provide.  For example, OIG has found 
risk-adjustment data that MAOs submitted to CMS for use in the risk-adjustment program were not always supported by 
medical records.  OIG has recommended that certain MAOs refund overpayments and enhance their policies and 
procedures to prevent, detect, and correct noncompliance with Federal requirements.119  OIG also found that billions of 
dollars in estimated MA risk-adjusted payments supported solely through chart reviews or diagnoses reported only on 
health risk assessments raise concerns about the completeness of payment data submitted to CMS, the validity of 
diagnoses on chart reviews and health risk assessments, and the quality of care provided to beneficiaries.120, 121  OIG has 
recommended CMS improve its oversight of MAOs so that MAOs will ensure practices drive better carenot just higher 
profitsas well as enact policies and procedures to improve the integrity and usefulness of payment data.  (See TMC 2 for 
additional information on program integrity related to managed care and Medicaid eligibility determinations.)   
Additionally, significant concerns have been raised that the capitated payment model used in MA may provide a potential 
incentive for MAOs to inappropriately deny access to services and payments to increase their profits.  Recent OIG work 
showed that MAOs sometimes delayed or denied enrollees access to medical services, even though the requested care was 
medically necessary and met Medicare coverage rules.  These denials likely prevented or delayed needed care for 
beneficiaries.122  OIG also found that high numbers of overturned denials upon appeal and performance problems identified 
by CMS audits raise concerns that some beneficiaries and providers may not be getting services and payments that MAOs 
are required to provide.123   
Value-based models 
In testing and implementing value-based models, CMS must continue to focus on program integrity risks, incorporating 
safeguards to reduce and strategies to correct these risks.  Focusing on program integrity risk is especially important for 
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models that introduce new payment incentives, which could lead to new fraud schemes, and for models for which 
customary payment, coverage, or fraud and abuse laws do not apply due to waivers, exceptions, or safe harbors.  Additional 
risks may arise from novel flexibilities granted because of the COVID-19 PHE.   
Many value-based models promote care in home and community settings through in-person home visits, remote 
monitoring, and other technologies.  These services are often preferred by patients.  OIG work in areas such as hospice 
care, home health, and personal care services consistently demonstrates that patients may be vulnerable to fraud and 
abuse in home and community-based settings.  Ensuring that home-based services meet quality of care requirements 
remains important.  (See TMC 4 for further information on quality of care.) 
Marketplaces 
The Department must be attuned to ensuring that payments for advance premium tax credits (APTCs) for consumers 
enrolled in marketplace insurance are accurate.  There was an estimated 20 percent increase in people eligible for 
subsidized marketplace coverage after passage of the American Rescue Plan Act of 2021 and an estimated $35.5 billion 
increase in premium tax credits.124  With passage of the IRA, a further increase in the volume of APTC is possible.  OIG work 
has found weaknesses in State and Federal marketplace systems for ensuring correct eligibility determinations and accurate 
APTC payments.  For example, a recent OIG audit determined that APTC payments were paid on behalf of enrollees who did 
not make required premium payments and recommended improvements to processes and data collection and sharing with 
the Internal Revenue Service.125  
Additional risks to program integrity across Medicare and Medicaid are covered in more detail in other TMCs. 
Ensuring smooth transitions when PHE waivers and flexibilities end 
When the President declares a national emergency or major disaster and the Secretary declares a PHE, the Secretary is authorized 
under section 1135 of the Social Security Act to temporarily modify or waive certain Medicare, Medicaid, CHIP, and Health Insurance 
Portability and Accountability Act of 1996 (HIPAA) requirements to ensure sufficient health care items and services are available to 
meet the needs of beneficiaries and to ensure providers of such items and services in good faith may be reimbursed and exempted 
from sanctions.  In some cases, the Department can issue blanket waivers; in others, providers or States ask for individual waivers.  
In implementing, administering, and terminating waivers and flexibilities, CMS must strive to ensure timeliness, continuity, and 
quality of care, as well as to ensure equity for people served by its programs.    
CMS implemented hundreds of waivers and flexibilities addressing coverage and payment for items and services in response to the 
COVID-19 PHE.  For example, CMS suspended or reduced the scope of many program integrity safeguards, such as provider 
enrollment screening, in an effort to ensure access to care in exigent circumstances.  However, these waivers and flexibilities also 
raised the risk of fraud, waste, or abuse.  CMS should take steps to ensure that funds are paid only to eligible recipientsin correct 
amountsand used per program requirements.   
CMS must plan for and manage risks associated with termination of these waivers and flexibilities when the COVID-19 PHE ends.  
CMS must be attuned to the impacts of unwinding on enrollees, providers, State agencies, and health care delivery, as well as on 
program payments, effectiveness, and outcomes.  The Department has indicated that it will provide at least 60 days notice before 
terminating the PHE.  Even with such notice, as a practical matter States, providers, contractors, and others may be challenged to 
shift business operations rapidly and effectively.  They will need clear, timely guidance from CMS.     
As a condition for receiving a temporary increase in Medicaid funding as authorized under the Families First Coronavirus Response 
Act (FFCRA), States must maintain enrollments of most people enrolled in Medicaid as of March 18, 2020, through the end of the 
month in which the PHE ends.  In large part due to this condition, Medicaid and CHIP enrollment increased between February 2020 
and May 2022 by 25.9 percent.126  After the COVID-19 PHE ends, States will be required to redetermine eligibility for millions of 
people covered through Medicaid and CHIP during the PHE.  CMS has issued guidance giving States up to 12 months to initiate and 
22 
   
14 months after the end of the PHE to complete all redeterminations, and OIG is planning oversight of this process.  A 50-State 
survey of State Medicaid and CHIP officials in January 2022 found that many State Medicaid programs had not made key decisions 
on how to resume eligibility determinations, and only half of the States had a plan for doing so.127  States reported wide variances 
among anticipated approaches.  In April 2022, CMS published best and promising practices from States based on discussions with 
every State and Territory related to renewal planning and preparation for unwinding.  In June 2022, CMS published Top 10 
Fundamental Actions to Prepare for Unwinding and Resources to Support State Efforts.128  The stakes are high for this transition 
because of the risk of unnecessary disruptions in insurance coverage and patient care.  CMS has indicated that it plans to streamline 
Medicaid and marketplace enrollment to ensure individuals can receive coverage in the program for which they are eligible.129  At 
the conclusion of the PHE, it will be important for CMS to ensure that States complete pending eligibility and enrollment actions per 
CMS requirements.  (See TMC 2 for additional discussion of Medicaid eligibility determinations and improper payments.)   
Also challenging may be the termination of waivers and flexibilities through which CMS expanded Medicare access to a wide range 
of services that could be delivered by telehealth.  These waivers and flexibilities proved effective in aiding providers and patients in 
furnishing and obtaining health care beyond the more limited range of telehealth services ordinarily covered by Medicare.  To the 
extent possible, CMS must ensure that new, post-PHE telehealth policiesincluding any extensions of existing waivers or 
flexibilitiesare designed to improve care and enhance access while also protecting patients and programs from fraud and abuse.  A 
new OIG evaluation found that certain people enrolled in Medicare, such as urban residents and Hispanic people, were more likely 
than others to use telehealth during the first year of the COVID-19 pandemic.130  This report concluded that as CMS, HHS, Congress, 
and other stakeholders consider permanent changes to Medicare telehealth services, it is important to balance concerns about 
issues such as access, quality of care, health equity, and program integrity.  The report recommended CMS take appropriate steps to 
enable a successful transition from current pandemic-related flexibilities to well-considered long-term policies for the use of 
telehealth.  (See TMC 5 for additional information on telehealth.)  
Looking forward, to the extent flexibilities and waivers are needed to address new or existing PHEs, CMS should mitigate risks by 
incorporating guardrails into their design, monitor implementation of flexibilities for any abuse, and take prompt action to correct 
problems and hold wrongdoers accountable.   
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4: Safeguarding the Well-Being of HHS 
Beneficiaries 
Relevant Agencies 
 ACF, CMS, IHS, HRSA, SAMHSA 
Elements of the Challenge 
 Promoting health and safety in nursing homes 
 Ensuring safety and quality of care for beneficiaries of Federal health care programs 
 Protecting the health and safety of children served by HHS programs 
 Preventing abuse and neglect 
 
HHS programs provide critical services to diverse populations across a broad range of settings including hospitals, clinics, child care 
facilities, shelters, nursing homes, and peoples own homes.  Services are directly provided by HHS personnel, delivered via HHS 
grant programs, delivered by contractors supporting HHS, or rendered by professionals chosen by individuals who then claim 
reimbursements from Federal programs.  Services include health care, education, child care, and in limited circumstances taking 
legal custody for select populations.  Ensuring that intended beneficiaries receive appropriate services that meet standards for 
quality, are free from abuse or neglect, and are not exposed to infectious agents represents a major challenge for the Department.  
This imperative is particularly pronounced for nursing home care that serves many Americans whose health is most fragile.  As the 
Department supports the Nations efforts to respond to and recover from the COVID-19 pandemic, there will be challenges to 
ensuring safety and quality for beneficiaries receiving all varieties of care and services. 
Promoting health and safety in nursing homes 
The administration has prioritized improving nursing home care and the Department continues efforts to improve the 
quality of services and the information available to beneficiaries and their families when selecting a care provider.131  A 
longstanding Department effort is CMSs Five-Star Quality Rating System that is intended to facilitate informed comparisons 
of nursing homes.  CMS also issued guidance to improve safety and quality of care for long-term care residents, including 
measures such as steps to reduce crowding.132  As the Nation strives to recover from the COVID-19 pandemic, it is 
important that residents and their families have accurate and timely information about infection rates in nursing homes 
and the vaccination status of staff.   
The COVID-19 pandemicthe first in a century for which a nationwide PHE was declaredposed unprecedented challenges 
to the Departments and other stakeholders efforts to protect the health and safety of nursing home residents.  Nursing 
home residents were prioritized for COVID-19 vaccinations, but this vulnerable population sustained an outsized toll from 
the disease, especially early in the pandemic.  In 2020, 42 percent of Medicare nursing home residents were diagnosed with 
or likely had COVID-19, with rates of disease even higher for Black, Hispanic, and Asian residents.133  The COVID-19 
pandemic also highlighted the importance of good infection control practices for COVID-19 and other infectious diseases.  
Quality Improvement Organizations have conducted education and outreach to nursing homes in ways such as by providing 
assistance with COVID-19 infection control and promoting vaccinations for residents and staff.  Initiatives to vaccinate 
nursing home staff against COVID-19 have resulted in a vaccination rate above 90 percent.134  
24 
   
As the COVID-19 pandemic has taken a heavy toll on nursing 
An 8-State review identified 
home residents, longstanding staffing and quality-of-care 
concerns remain pressing.  Staffing issues have long  more than 2,200 areas of 
complicated nursing homes ability to provide safe and high-
noncompliance with life safety 
quality care, and CMS now includes additional staffing data in 
and emergency preparedness 
nursing homes inspections.  As part of the administrations 
priority focus on improving quality of nursing home care, CMS  requirements after 
launched a new effort to establish minimum staffing 
unannounced visits to 
requirements which included issuing a Request for Information 
and conducting a study it plans to issue in spring 2023.135   150 nursing homes. 
Planned revisions to the nursing home survey process aim to 
improve complaint investigations and facility-reported incidents.136  Additionally, nursing homes were charged with 
implementing new infection control imperatives needed to maintain operations during natural disasters, utility service 
disruptions, and other occurrences that complicate delivery of care.  OIG is continuing its series of audits to assess nursing 
home compliance with health and safety regulations.  An 8-State review identified more than 2,200 areas of potential 
noncompliance with life safety and emergency preparedness requirements after unannounced visits to 150 nursing 
homes.137   
Ensuring effective front-line oversight of nursing homes by State survey agencies is another longstanding challenge that was 
exacerbated by the COVID-19 pandemic.  In the early months of the COVID-19 PHE, CMS directed State agencies to focus on 
infection control surveys and serious complaint investigations and halt comprehensive standard surveys.  However, these 
infection control surveys identified few deficiencies despite significant COVID-19 outbreaks at many nursing homes during 
that timeframe, and backlogs of standard surveys mounted.138, 139  These rising backlogs put further pressure on an already 
strained system, as many States were failing to investigate serious complaints in a timely manner even before the 
pandemic.140  Furthermore, appropriate surveyor oversight has long been a concern, with just over half of the States failing 
to meet survey performance measures in 3 or 4 consecutive years from FY 2015 to FY 2018.141  CMS has expressed its 
commitment to clearing these backlogs.  OIG has recommended CMS safeguard the health and safety of nursing home 
residents by ensuring facility correction of deficiencies.142  Government enforcement actions have stopped some poorly 
performing nursing homes from rendering deficient services.  One nursing home chain charged with rendering grossly 
substandard care to people enrolled in Medicare and Medicaid agreed to repay $18 million and abide by the terms of a 
corporate integrity agreement to ensure that it delivers appropriate care going forward.143     
25 
   
Pressing changes are needed to nursing home care beyond those associated with the COVID-19 pandemic.  For example, 
OIG continues looking at the use of antipsychotic drugs and recommended improved data to better ensure that patients do 
not receive inappropriate medications.144  OIG has also evaluated facility-initiated discharges and will continue to urge 
further attention to ensure adequate safeguards against inappropriately moving residents against their wishes or 
interests.145  In June 2022, CMS released updated long-term care surveyor guidance and training related to facility-initiated 
discharge.146 
Looking forward, CMS will need to consider the full range of potential contributors to poor nursing home performance 
including, for example, the potential impacts of private equity and other ownership structures and fragmented 
reimbursement for nursing home care.  Ensuring that nursing homes prioritize quality of care and quality of life for 
residents remains important.  CMS must continue to take steps to ensure that it and the States can detect problems at 
nursing homes quickly and insist on rapid remediation.  Improving nursing home care will require partnerships and 
sustained commitment from Government and private stakeholders to achieve positive change.  OIG is prioritizing improving 
nursing home care and continuing to conduct a substantial number of audits and evaluations addressing an array of nursing 
home topics. 
 
Ensuring safety and quality of care for people enrolled in Federal health care programs 
Federal health care programs cover specific health care services that may include hospital care, physician services, prescription 
drugs, immunizations, hospice care, home and community-based care, DME, and skilled nursing care.   
Delivering covered services 
Ensuring access to and use of care that meets quality and safety 
OIG found more than 500,000 
standards remains a challenge.  Even when Federal health care 
programs cover care, many people do not actually receive the  children with ADHD who were 
care they need.  For example, OIG found that more than  Medicaid-enrolled did not 
500,000 children with attention deficit/hyperactivity disorder 
receive timely followup care, and 
(ADHD) who were Medicaid-enrolled did not receive timely 
followup care, and that more than 50,000 such children did not  more than 50,000 such children 
receive behavioral therapy as recommended by professional 
did not receive behavioral 
guidelines.147  Moreover, hospice care is a growing health care 
therapy as recommended by 
sector serving people and their families at an extremely 
vulnerable time near end-of-life.  OIG found that more than 80  professional guidelines. 
percent of hospice providers had quality-of-care deficiencies.148  
Additionally, fixed daily payment structures may incentivize hospices to enroll people for longer time periods but provide 
insufficient care.  At times, the greatest barrier to care derives from a persons own behavior and beliefs.  The Department 
is currently working to overcome substantial vaccine hesitancy that has hampered COVID-19 vaccination efforts, despite 
ample supplies of and an adequate ability to distribute and administer multiple, safe, and effective vaccines.149  
 
 
 
 
 
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Improving quality of care 
Although the Department has made progress, more work remains to improve access to and quality of all types of care.  
Oversight work revealed that patients experience significant rates of adverse events (patient harm as a result of medical 
care) in health care facilities.  Specifically, in a series of studies looking at patient care from 2010 to 2014, OIG found that 
25 percent of people enrolled in Medicare were harmed during stays in acute-care hospitals (2010), 33 percent in SNFs 
(2011), 29 percent in rehabilitation hospitals (2012), and 46 percent in long-term care hospitals (2014).150  OIG also found 
that hospitals did not identify when harm occurred in their facilities, in part due to confusion over guidance from HHS and 
other Government agencies regarding how to define and report adverse events.151  OIG re-examined the harm rate for 
Medicare beneficiaries in hospitals in 2018 and found that the rate was similar to that in OIGs prior study for 2010.152 
 
 
Source: OIG analysis of hospital stays for 770 Medicare patients in October 2018. 
* The rate and number of patients who experienced temporary harm events involve patients who experienced at least one temporary 
harm event and no adverse events.   
 The rate and number of patients who experienced adverse events involve patients who experienced at least one adverse event.  Four 
percent of patients (41,708) in this group also experienced temporary harm. 
 
Indian Health Service (IHS).  To address longstanding quality-of-care concerns in IHS-operated hospitals,153 IHS created a 
Quality Framework and Office of Quality to provide better guidance and oversight to its facilities and clinical staff.154  IHS is 
also working to establish a nationwide compliance program to address several OIG recommendations and improve care for 
people receiving benefits.  However, some longstanding challenges, such as recruiting and retaining qualified staff, persist.  
IHS continues efforts to combat the longstanding problem of OUD and can take additional steps to better protect people 
receiving benefits.155  There is also a pressing need to protect patientsespecially childrenfrom predators who may be 
within the ranks of health care and service providers.  To continue improvements at IHS, OIG has recommended IHS 
prioritize developing and implementing a staffing program to ensure sufficient qualified staff at facilities, enhance training 
for staff and hospital leaders, intervene quickly and effectively when quality problems are identified, and establish better 
procedures, including improved external communications.156  (See TMC 6 for more information on crosscutting 
Government efforts to keep patients safe). 
Protecting the health and safety of children served by HHS programs  
HHS operates or funds many programs that provide child care, education, and residential care in addition to health care for children, 
including some especially vulnerable children such as children living in foster care and children in the UC Program.  The Head Start 
programadministered by the Administration for Children and Families (ACF)promotes school readiness for nearly 900,000 
children in low-income families,157 and the Child Care and Development Fund (CCDF) provides child care assistance for about 
1.5 million children in low-income families.158  The importance of properly vetting program staff to ensure child safety is discussed 
below.   
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Operating the UC Program 
By law, UC who enter the United States without lawful immigration status are referred to the care and custody of ORR.  
ORRs UC Program merits specific discussion as it is uniquely mandated to assume care and custody of children.  Through 
the UC Program, ORR places children in shelters and other facilities operated by grantees or contractors.  These facilities 
provide food and shelter as well as medical and mental health care and other services.  Children remain in these 
placements until a sponsor (usually a parent or family member) is found to whom the child may be safely released, the 
childs immigration status is resolved, or the child turns 18 years old and ages out of the program.  Since ORR began 
operating the UC Program in 2002, it has served more than 410,000 children.159  As of April 20, 2022, more than 9,800 UC 
were in HHS custody.160  
During the previous administration, ORR was called upon to care for more children who were separated from parents or 
guardians by the Department of Homeland Security (DHS) at or after arriving in the United States.  OIGs work has shown 
that neither ORR care provider facilities nor DHS had kept adequate records about separated families, impeding efforts to 
identify and reunite them.  Prior to recent reform efforts, OIG found that ORR and DHS were not able to systemically 
automate, collect, or reconcile information about separated children across both agencies.161  Limitations in data about 
separated children complicate HHSs ability to ensure appropriate placement and may cause children to spend more time in 
HHS custody.  Issues related to identifying and vetting appropriate sponsors may also contribute to the amount of time 
children spend in HHS care facilities.  During a 2018 audit, OIG found two key vulnerabilities with Influx Care Facilities (ICFs): 
(1) limited staff background checks and (2) insufficient clinical staff to serve childrens mental health needs.162  In prior 
evaluations of the UC Program, OIG also found: (1) a lack of routine oversight concerning whether facilities regular use of 
inspection checklists ensuring required physical security measures were present and working163 and (2) that ORRs incident 
reporting system lacked designated fields to capture information to protect the safety of children.164  OIG also found areas 
for improvement in HHS intra-agency coordination and communication with ORR about UC.165  (See TMC 5 for information 
about the UC portal.)   
The number of children entering the United States fluctuates.  The Department prepares to serve additional children at 
times of increased need.  In response to approximately 122,000 referrals of UC in FY 2021, compared to 16,000 referrals in 
FY 2020, ORR opened 1 ICF and 14 Emergency Intake Sites (EISs) to provide services and additional space when the capacity 
of standard shelters was exceeded.  ORR opened these facilities in an effort to avoid having children spend prolonged 
periods of time in border facilities operated by DHS.  ORR established these facilities during a time when ORRs total 
available bed capacity across its standard care provider network had been reduced by up to 40 percent due to COVID-19 
mitigation measures and staffing shortages.  At the same time, nearly 6,000 children were in DHS custody awaiting transfer 
to and placement in an ORR facility, with more than 4,000 of these transfers exceeding the 72-hour limit (for an average of 
138 hours).  OIG found that operational challenges within ORR and the ORR EIS at Fort Bliss hindered case management for 
children.166  Although HHS has closed or transitioned all EIS to ICFs, OIG has recommended ORR take a number of measures 
to help ensure children receive quality case management services that prioritize their safety and well-being, including 
during an influx.   
The Department must work to ensure that UC Program-funded facilities meet all safety requirements, including infection 
control priorities related to COVID-19, and provide adequate medical and mental health care.  As discussed below, HHS 
must also enhance efforts to ensure that all staff with unsupervised and direct access to children have passed required 
background checks.   
Preventing abuse and neglect 
HHS funds and oversees many types of services for a broad range of people.  Thousands of HHS-funded providers hold positions of 
trust that bring them into close contact with individuals, often behind closed doors and at especially vulnerable times.  The vast 
28 
   
majority of providers seek to serve peoples best interests.  However, some providers may harm people, and HHS must protect 
people enrolled in its programs from abuse and neglect.  For example, a former IHS pediatrician is currently serving a prison 
sentence for sexually assaulting boys he treated as patients.  This disturbing case commanded extensive attention, and the 
Department committed to collaborating with a Presidential Task Force on Protecting Native American Children in the IHS system 
established in March 2019.167  The task force released a report in July 2020 detailing its investigation of institutional and systemic 
breakdowns that resulted in failure to protect children from abuse.168  (See TMC 6 regarding protecting IHS patients.)  Better 
attention to protecting vulnerable people of all ages in all HHS care settings is also needed.  
Vetting providers and staff 
Although even the most thorough vetting may not completely prevent all potential predators from abusing Federal 
programs to gain access to victims, background checks remain a useful prevention tool.  OIG identified a lack of uniformity 
across UC facilities in conducting all required background checks for staff whose jobs entailed direct access to and 
supervision of children.169  OIG is currently reviewing whether the UC Programs ICFs and previously instituted EISs, which 
are not State-licensed and are established during periods of UC influx, conducted required background checks before hiring 
employees.  This review also seeks to determine whether mitigation strategies have since been implemented to ensure the 
safety and well-being of children.170 
Conducting adequate background checks has been a problem in other HHS-funded child care programs as well.  In several 
audits, OIG found that some States have not fully implemented CCDF requirements to conduct comprehensive criminal 
background checks on current and prospective staff.171  Additionally, some IHS-funded, Tribe-run health centers failed to 
conduct required background checks on employees working with American Indian children.172  Implementing background 
checks for long-term care providers remains a challenge as well.173  Along with demonstrating job-specific competency and 
qualifications, ensuring that staff pass all required background checks is an important safety measure. 
The Department should improve efforts to ensure only staff who have passed required background checks have access to 
patients in various health care settings and to children in the UC Program and CCDF-funded programs.  The Department is 
working to support States implementing the CCDF background check requirements.  The Department should continue to 
work with States to ensure that implementation of the Child Care and Development Block Grant Act of 2014 background 
check requirements align with the statutorily required effective dates and allowable timelines described in the CCDF Final 
Rule.174 
Identifying and reporting abuse and neglect 
People in all care settings are at risk of abuse and neglect.  Home and community-based services allow many Medicaid 
beneficiaries opportunities to avoid undesired facility care.  However, some beneficiaries have been abused or neglected by 
individuals such as family members who were paid by Federal health care programs to care for the beneficiary at home.  
Group homes provide care to many especially vulnerable people, including adults with developmental disabilities.  OIGs 
work found extensive failures in the proper handling of critical incidents, including the suspected abuse and neglect of 
group home residents.175  The Department, in coordination with OIG, has created several resources to better address the 
abuse and neglect of residents in group homes.  These resources include model practices for: (1) State incident 
management and investigation, (2) State incident management audits, (3) State mortality reviews, and (4) State quality 
assurance.176  CMS has also published additional resources and training materials regarding health and welfare issues in 
Medicaid home and community-based services.177  
About 1.8 million people enrolled in Medicare receive care in SNFs each year.178  OIG has identified cases of substantial 
failure to report incidents of potential abuse or neglect of Medicare beneficiaries living in SNFs who require treatment in 
hospital emergency departments.179  CMSs June 2022 Updated Guidance for Nursing Home Resident Health and Safety 
clarifies reporting requirements.180  In addition, OIG work identified cases of potential abuse of people enrolled in Medicare 
who were in hospice care and for whom hospices failed to act in some instances.181  These cases revealed vulnerabilities in 
29 
   
beneficiary protections that CMS must address to better ensure that beneficiary harm is identified, reported, addressed, 
and ultimately prevented.   
All States have enacted mandatory reporting laws that require certain individuals, such as schoolteachers or nursing home 
staff, to report suspected abuse or neglect targeting vulnerable individuals.  Despite State and Federal requirements, many 
instances of abuse and neglect go unreported, making it harder to help victims and hold wrongdoers accountable.182  
Failure to conduct adequate screening, including failure to adequately screen for sex trafficking children who went missing 
from foster care, may also cause abuse and neglect to go undetected.183  
The case files of many children in OIGs review had no documentation of a screening to identify whether 
they were victims of sex trafficking, as required.  
Source: OIG analysis of documentation in foster care case files, 2022.  Our review included 74 children from Pennsylvania, 91 children from 
Minnesota, 88 children from Massachusetts, 62 children from Illinois, and 98 children from Texas. 
It is important to prevent harm by identifying providers and facilities that are subjecting beneficiaries to abuse or neglect.  
States and other partners should use claims data to better identify unreported abuse and neglect.  OIG created a resource 
guide to help accomplish this goal.184  OIG has also explored Medicaid claims data as an additional way to identity potential 
child abuse and neglect.185  Additional efforts would help improve reporting.  For example, CMS should compile a list of 
diagnosis codes that indicate potential abuse or neglect, conduct periodic data extracts, and encourage States to better use 
data to facilitate compliance with mandatory reporting laws.   
CMS should work to ensure that its reporting requirements sufficiently protect individuals in all care settings and are 
adequately enforced.  Protecting people from abuse and neglect is a critical responsibility requiring attention and 
cooperation from all stakeholders.  
   
30 
  5: Harnessing and Protecting Data and 
Technology To Improve the Health and 
Well-Being of Individuals 
Relevant Agencies 
 All HHS
Elements of the Challenge
 Expanding and improving HHSs capacity to collect, use, and exchange data to support evidence-
based policymaking, management, and program improvement
 Securing HHS data and systems to positively impact the cybersecurity posture of HHS and the
sectors HHS influences
The Department continues to improve how it collects, manages, shares, and secures its data.  In parallel, HHS is refining its approach 
to influence and shape how other entities use technology.  Yet HHS faces significant challenges to both protect data and technology 
from persistent cybersecurity threats and improve how the Department and related entities share large amounts of critical data 
from disparate sources, including public health data, on an unprecedented scale.  The importance of managing these challenges is 
highlighted by critical issues such as addressing inequities across health and human service programs, which often requires 
foundational improvements to data collection and analysis to better understand the effects on disadvantaged individuals and 
communities.  Continued modernization of HHS data and technology capabilities is needed for HHS and its divisions to fulfill their 
missions, improve situational awareness, and better prepare for future public health threats and emergencies.   
HHSs authorities and policies also shape how technology and individuals data are used and protected by other private and public 
entities.  These authorities are increasingly important in a technology-enabled health and human services delivery system.  HHS has 
made progress; however, the ability to access quality data quickly and easily remains a challenge within the Department and in the 
health care and public health systems.  Data collection challenges also hinder better understanding of racial and geographical 
population disparities.  (See TMC 3 for more information on longstanding access to care and health equity challenges.)  Continued 
progress on these challenges must happen as the Department continues to respond to multiple, simultaneous emergencies and 
while the quantity, frequency, and sophistication of cybersecurity risks rapidly increase.    
Expanding and improving HHSs capacity to collect, use, and share data to support evidence-based 
policymaking, management, and program improvement 
Data are central to every HHS program, and the Department and its programs are continually seeking to improve their ability to 
collect, use, and exchange data from disparate sources.  Collecting large amounts of data does not automatically translate to 
efficient and effective use, particularly as much of HHSs data is unstructured and not standardized.  The Department is finalizing its 
HHS Data Strategy, which is intended to focus on addressing challenges related to data sharing, security, privacy, and governance. 
31   
Improving HHS data governance and standardization is critical for effective program operations  
Improving the governance, standardization, and structure of data collected and used by HHS is fundamental to making HHS 
programs more effective and efficient.  However, data governance practices are not consistent across HHS.  HHSs need to 
improve data governance is not unique to the Department and is a requirement for all Federal agencies.186  Although 
progress has been made, the Department must effectively operationalize its data governance plans.  Hurdles HHS must 
overcome include the continued effect of data silos and legacy technology that do not easily support modern data 
governance and standardization.   
Most significantly, HHS faces challenges in how it manages and leverages data across its programs.  Most HHS divisions 
primarily collect data to administer their own programs.  The ability of OpDivs and StaffDivs to quickly access and use 
actionable data from other programs remains a challenge because data are often housed within a single HHS divisions data 
silo.187  Eliminating or reducing data silos within the Department and within HHS programs, ensuring that standardized data 
sets are developed, and increasing appropriate access across programs are essential to improving program management, 
evidence-based decision making, and benefiting from new technologies.  (See TMC 6 for more information on HHSs 
coordination challenges.)   
The effect of these data silos was seen during the response to the pandemic, limiting how HHS and its partners gained 
insight about COVID-19.  Achieving a mature, public health reporting system that can respond to future public health 
threats requires extensive collaboration among Federal, State, local, and Tribal entities.  It requires interoperability and 
security across a range of systems to allow for the exchange of data in a timely fashion and data collection that is accurate, 
timely, and efficient to track and thwart emerging health threats.  To address these challenges, CDC is taking steps to 
modernize its operations, including developing new internal systems, processes, and policies to enhance bidirectional 
communication.188   
Some HHS programs rely on decades-old, legacy IT systems with limited data capabilities, which may exacerbate the effect 
of data silos.189  Legacy systems can limit operational effectiveness by acting as a significant barrier to modern data analysis 
and sharing tools.  These are often custom software projects that require significant manual work to communicate with 
other systems.  In the ORR UC Program, deficiencies with the UC Portals search capabilities impeded case managers ability 
to reliably determine whether potential sponsors were sponsoring other children, and ORR staff have had to engage in 
significant efforts to receive and reconcile data from other Federal agencies.190, 191  (See TMC 4 for more information on 
challenges associated with the UC Program.)  While HHS is making progress in updating its critical legacy systems, these 
efforts are complex and can take years.  However, failure to take on these projects poses a greater long-term risk, and HHS 
must continue to invest in the long-term modernization of its IT systems.    
Improving access to HHS data  
Although much of HHSs data are publicly available, some are not easy to use or barriers, such as a lack of standardization, 
limit access, understanding, or use of the data by stakeholders and the public.192  These barriers hinder public access to and 
use of data vital for public health and welfare and data that may lead to innovation and improvement in health and human 
service systems.  HHS external stakeholders rely on effective dissemination of data collected by departmental programs.  
Currently, in many instances HHS does not use contemporary approaches, such as application programming interfaces 
(APIs), to provide users access to actionable data from HHS systems.  Some OpDivs, in collaboration with the private sector, 
have deployed the Fast Healthcare Interoperability Resources API, which enables health data to be quickly and efficiently 
exchanged to support a more seamless flow and integration of data across systems.   
HHS must ensure any progress made in improving access and use of its internally generated data also applies to data 
generated by external entities and received and managed by the Department.  CMS has made significant improvements to 
the national Medicaid data set, the Transformed Medicaid Statistical Information System (T-MSIS).193  Now that all States 
report in T-MSIS, CMS is able to leverage T-MSIS for programmatic insights, including insight about COVID-19 treatment and 
32 
   
testing and how the PHE affected Medicaid service utilization.194  Although CMS has made public some T-MSIS information 
(mainly metrics on State data quality and some research files), additional work is needed to make T-MSIS an effective data 
tool for States and other stakeholders.195   
Encouraging data sharing among health care providers, patients, and payers   
The health care system and patients in general have not fully realized and benefited from contemporary approaches to the 
seamless flow of electronic health information.  Two key goals of HHSs Information Technology Strategic Plan aim to 
improve health information exchange.  The goals are to enhance data and interoperability, and to improve IT management 
and governance.196  The potential is great for HHS to improve the availability and interoperability of electronic health 
information by updating regulations that  advance certified electronic health record technology.  Although there are signs 
of recent progress in improving interoperability and access, routine and robust health information exchange among 
providers remains a challenge across the health care system.197  In May 2020, CMS published the Interoperability and 
Patient Access final rule that continued to build on and expand the use of health IT standards to emphasize improving 
health information exchange and facilitating appropriate and necessary patient, provider, and payer access to information 
in health records.  In January 2022, the Office of the National Coordinator for Health Information Technology published the 
Trusted Exchange Framework and Common Agreement (TEFCA), which outlines a common set of principles, terms, and 
conditions to facilitate network-to-network electronic health information sharing in a timely and secure manner.  HHS is 
faced with translating TEFCAs authorities and other initiatives into more widespread improvements across the health care 
industry and public health systems.  This will require further engagement and efforts to ensure progress is not limited to 
those health care entities with resources to implement modern technologies and data practices, which would only serve to 
broaden the digital divide.    
Securing HHS data and systems to positively impact the cybersecurity posture of HHS and the sectors 
HHS influences   
As HHS expands its technological capabilities, increases data sharing among HHS programs and the public, and improves data 
interoperability in the broader health care and public health systems, it must take crucial steps to modernize its approach to 
cybersecurity.  The importance of improving cybersecurity posture across the Federal Government has been recognized by the 
President, such as in the May 2021 Executive Order (EO) Improving the Nations Cybersecurity, which directed Federal agencies to 
fundamentally and systemically change their approach to cybersecurity.  In support, the HHS Office of Information Security is 
finalizing its Strategic Plan.  HHS efforts will require significant investments in resources as well as cultural and organizational 
change.  To operationalize the EO, OMB directed agencies including HHS to meet specific cybersecurity standards and objectives by 
the end of FY 2024.  These include adopting a zero trust security architecture approach.  This method requires meaningful 
organizational change in how HHS implements security across its divisions and programs so that the Department protects the 
enterprise anytime, anywhere regardless of where its assets and resources are located.198   
Persistent and growing cybersecurity threats exacerbate the challenges facing HHS associated with data and technologies used to 
carry out the vital health and human service missions of HHS divisions.  These threats, if not mitigated, can put critical HHS program 
operations at risk and potentially impact the health and welfare of individuals served by HHS.  It is common practice for adversaries 
to continuously conduct reconnaissance for discovering new systems under development, often to gain understanding of the 
underlying technologies, data, and potential vulnerabilities that may be exploited.   
This challenge is multifaceted and complex because program needs and timeliness often compete with cybersecurity controls and 
capabilities.  To overcome this challenge, HHS will need to ensure that its divisions and programs establish and use a risk-based 
approach to rapid system development and deployment.  This includes understanding the value of protecting technology and data 
and the risk presented by cybersecurity threats.     
33 
   
Cybersecurity challenges in a federated environment  
Although the Department continues to improve its overall cybersecurity posture, OIG and GAO have identified challenges 
and systemic weaknesses.  One persistent challenge is the federated nature of IT and cybersecurity environments across 
HHS with its vast network of interdependent, increasingly digital health, social, and administrative services.  The large scale 
of HHSs mission and IT environments dictates that the Department must simultaneously address a range of dynamic 
cybersecurity requirements along with the specific data and technological needs for each division or program.  For example, 
24 of NIHs 28 entities receive individual funding from Congress and administer their own budgets.  Each NIH entity 
designates its own chief information officer (CIO) who coordinates with the NIH CIO.199  IHS also has a decentralized 
environment with a headquarters, area offices, and individual hospitals and clinics that often have additional health care 
mandates because they provide direct patient care.  This type of environment poses challenges to IHSs ability to assess, 
manage, and respond to cybersecurity threats, as well as modernize cybersecurity approaches in order to become resilient 
in the face of persistent threats.200     
The challenges posed by HHSs federated nature are exacerbated by the complexity of ensuring that thousands of HHS 
contractors, grantees, and other partners have appropriate cybersecurity capabilities and implement the best-of-breed 
security solutions.  For many HHS grant programs, both an OpDiv and a grantee have responsibilities for protecting sensitive 
data, such as data generated from research that is the intellectual property of the United States.  As datasets continue to 
grow, the ability to prevent bad actors from directly and indirectly inferring personally identifiable information is a 
challenge.  Ownership of data (whether the owner is Federal or a grantee) in some cases is unclear, resulting in some 
challenges regarding the applicability of specific data protections.  However, both HHS and its grantees have faced 
challenges to consistently adopting controls to address the growing cybersecurity risks facing these programs.  HHS and its 
divisions must make additional progress to ensure grantees, as well as other HHS contractors and partners, have adequate 
data protections in place and are developing a risk-based approach that can be effectively implemented across a wide range 
of OpDiv and StaffDiv missions.               
Maintaining vigilance is critical to protecting HHS and health system infrastructure security 
HHSs cybersecurity defenses continue to be tested as cyberthreats persist and adversaries continue to increase their levels 
of sophistication and maliciousness.  In 2022, HHS OpDivs experienced numerous sophisticated phishing and business email 
compromise attacks on employees.  In response, HHS issued an Advisory Notification to mitigate risk for the entire 
Department.  The Department as well as the health care and public health sectors must maintain vigilance.  Future 
sophisticated and novel methods of social engineering, coupled with technical threats, will present cybersecurity challenges 
and opportunities for cyberattacks. 
In 2021, 45 million people were affected by cyberattacks on health care providers and related entities, up from 34 million in 
2020.201  The average total cost of a breach in the health care industry increased almost 10 percent from $9.2 million in 
2021 to $10.1 million in 2022.202  Threat communication has improved through public-private partnerships spearheaded by 
the HHS Healthcare Cybersecurity and Coordination Center and the Department of Homeland Security Cybersecurity and 
Infrastructure Security Agency.  These partnerships have increased the health care sectors awareness of the impacts 
ransomware could have on operations, including having to move patients to other facilities, loss of access to electronic 
health records, potential fraud, and the compromising of electronic health information and other sensitive information.       
This challenge is widely expected to increase as new technologies are developed and introduced into the market.  These 
technologies include the expansion of telehealth and other remote patient monitoring modalities, AI, precision medicine 
technologies, and future digital treatments and therapies.  In particular, FDA and the health care industry must continue to 
improve cybersecurity for networked medical devices (such as infusion pumps and pacemakers that use internet 
connectivity).203  To address cybersecurity threats and reduce patient risks, FDA has issued guidance to help support 
premarket and postmarket processes related to cybersecurity impacts for devices.  Additionally, FDA has sought additional 
funding and authorities to support its ongoing efforts to help device manufacturers and the ecosystem combat 
34 
   
cybersecurity threats.204  FDA should continue to take steps to enhance its ability to receive relevant information as well as 
securely share information with key stakeholders.205  HHS may have additional options to assess the cybersecurity of 
devices once in use by health care providers; however, there has been limited progress to assess this issue as part of the 
existing oversight mechanisms, such as the survey and certification process for Medicare-participating hospitals.206   
The Department plays a significant role in ensuring the privacy of individual data such as personal health information, 
genetic information, and other sensitive data.  The HIPAA Privacy Rules requirements, established nearly 20 years ago, may 
not adequately address current issues related to privacy concerns.  Patients and providers continue to have questions about 
how best to protect data while navigating the requirements and constraints of HIPAA.  The Departments challenge is to be 
responsive to changes in the health care industry, including nontraditional health care delivery approaches that may impact 
patient privacy.  Moving in this direction, the Office for Civil Rights has begun data collection to learn from the health care 
community which changes are needed to enable HIPAA to support present-day requirements. 
   
35 
   
6: Strengthening Coordination for Better 
Programs and Services  
Relevant Agencies 
 All HHS 
Elements of the Challenge 
 Preparing for and responding to PHEs 
 Reducing health disparities in American Indian and Alaska Native communities 
 Protecting children 
 Keeping patients safe 
 
The importance of HHSs mission and the breadth of its programs and authorities put the Department at the center of some of the 
largest and most complex problems facing the Nation.  To solve these problemsand address issues on the horizonHHS needs to 
coordinate, collaborate, and communicate effectively across HHS programs and with other Federal agencies as well as outside the 
Federal Government with Tribal, State, and local Governments, international entities, industry, and other stakeholders.    
Strengthening HHSs coordination, collaboration, and communication can help Americans receive more efficient, higher quality 
health programs and human services and benefit from greater advances in the sciences underlying them.  Interagency efforts led by 
the Department such as the HHS Task Force to Prevent Human Trafficking and the Behavioral Health Coordinating Council provide 
opportunities for HHS programs to work more efficiently and in closer alignment.207, 208  Collaboration among HHS experts also helps 
the Department bring forward the best evidence to develop multifaceted strategies, such as the HHS Overdose Prevention 
Strategy.209  Proactive engagement with integrity partners, such as OIG, can help HHS programs consider practices that mitigate risks 
of fraud, waste, and abuse when launching new or expand programs.210, 211   
Effective partnerships with other Federal agencies help ensure that critical initiatives and resources, such as those for emergency 
preparedness and response or law enforcement investigations, are working in concert.  Established networks of information 
exchange with State, Tribal, and local Governments can better allow HHS programs to reflect community needs and support 
culturally responsive public health efforts.212  HHSs capacity to mitigate drug overdose risk through its Opioid Rapid Response 
Program, for example, relies on timely communication and coordination across OpDivs and StaffDivs and with State public health 
agencies.213  
Engagement with HHSs vast array of nongovernmental stakeholdersfrom health care providers to food and drug manufacturers, 
health systems, nursing homes, hospices, professional associations, scientists, consumers, and community nonprofits, to name a 
fewis essential to delivering the best services and care to the American people and supporting HHS programs in achieving their 
intended outcomes.  HHSs initiatives to ensure that the U.S. supply of safe and nutritionally adequate infant formula meets 
demand, for example, requires new engagements with companies that import, sell, and distribute infant formula, and those seeking 
to enter the formula market for the first time.214  HHSs efforts to strengthen and protect the public health supply chain and 
industrial base cannot be accomplished without an array of industry partners, as well as strategic coordination among Federal, 
Tribal, State, Territorial, and local entities to prevent the maldistribution of critical resources in an emergency, such as personal 
36 
   
protective equipment, diagnostics, vaccines, and therapeutics.215  HHSs ability to ensure that callers to 988, the National Suicide 
Prevention Lifeline, receive appropriate help at times of crisis requires collaboration with local organizations as well as States.216  
Preparing for and responding to PHEs  
In January 2022, GAO identified HHSs leadership and coordination of PHEs as a high-risk area in need of transformation.  Although 
the unprecedented nature of the COVID-19 pandemic presented new coordination challengesfrom medical supply shortages to 
the distribution of funds through new programs and large-scale vaccination programsGAOs designation stemmed from 
deficiencies in HHSs emergency preparation and response leadership for more than a decade including during the H1N1 influenza 
pandemic, Zika, Ebola, and extreme weather emergencies, as well as during the COVID-19 pandemic.  The GAO report pointed to 
HHSs coordination challenges as impediments to its leadership, specifically in establishing roles and responsibilities, communicating 
effectively with partners and the public at large, and understanding the parameters of its partners capabilities.217  In July 2022, HHS 
elevated leadership for emergency preparedness and response from StaffDiv, ASPR, to OpDiv, ASPR.218  An early responsibility of the 
new agency was making vaccines available through the Strategic National Stockpile to mitigate the spread of monkeypox as the 
Nation confronted the monkeypox PHE.219  Using lessons learned from COVID-19, CDC announced in August 2022 a reorganization 
designed to, among other goals, improve collaboration and communication and focus on a customer-centric structure.220  
Decades of OIG reports have identified challenges to HHSs emergency preparedness and response and have provided 
recommendations to address these challenges.221  A June 2022 OIG report found that some of the same challenges related to 
communication with partners and partner capabilities as identified by GAO heightened the risk of exposure to COVID-19 in facilities 
providing care to unaccompanied children.222  Deficiencies in safety procedures occurred, in part, because the ORR was rapidly 
expanding capacity, setting up new emergency intake facilities, and developing COVID-19 protocols and guidance for their use.  
However, ORR did not have a process in place for widely disseminating the guidance and frequent updates to appropriate staff.   
Information sharing across public health entities can lead to better decisions.  Ensuring appropriate data access across HHS 
stakeholders is especially important in emergencies.  Without access to data, public health decisionmakers lack timely information 
to develop the most effective response and allocate scarce resources.  The Tribal Health Data Improvement Act of 2021 required 
HHS to establish a strategy for providing access to public health care data to Indian Tribes and Tribal epidemiology centers.223  
During the COVID-19 pandemic, however, Tribal epidemiology centers were unable to readily access critical data maintained by HHS.  
Both GAO and OIG have recommended that HHS address issues blocking Tribal epidemiology centers from timely access to all public 
health data to which they are entitled.224, 225 
Reducing health disparities in American Indian and Alaska Native communities 
Ensuring Tribal epidemiology centers have access to data is key not only to an effective pandemic response but also to addressing 
health disparities affecting American Indian and Alaska Native (AI/AN) communities, which were disproportionally negatively 
impacted by COVID-19.226, 227  Health disparities are health status differences across various socioeconomic, ethnic, and racial 
groups.  People of color experience disparities in areas such as access to care and quality of care.228  Such disparities have profound 
implications for the health and well-being of these individuals.   
Access to safe drinking water and adequate waste disposal facilities are essential for healthy populations as these prevent disease.  
To address sanitation deficiencies in AI/AN communities, the Infrastructure Investment and Jobs Act (IIJA) allocated $3.5 billion to 
the IHS Sanitation Facilities Construction (SFC) Program.229  Through effective collaboration and communication with Tribal entities 
and other stakeholders, HHS has an opportunity to assist AI/AN communities in addressing challenges associated with managing the 
rapid increase in SFC funding provided under the IIJA, and ultimately to reduce disparities in access for AI/AN communities to 
adequate sanitation and in health outcomes.   
37 
   
Protecting children 
As described in TMC 4, a Top Management Challenge for HHS is safeguarding the well-being of people served by HHS programs, 
including children.  Recent OIG reviews highlight areas in which better collaboration, coordination, and communication could help 
address program vulnerabilities that put children at risk.   
OIG reviews of children missing from foster care demonstrate opportunities for better collaboration between HHS and State 
agencies to improve outcomes for the thousands of children missing from their placements nationwide and reduce episodes of 
missing children and associated risk, including the risk of being trafficked.230, 231, 232  A 2022 OIG evaluation found a lack of 
communication among HHS divisions regarding unaccompanied children during the development and early implementation of CDCs 
Title 42 order to suspend the entries of certain persons into the United States due to COVID-19 risks.  Based on this finding, as well 
as prior findings related to the UC Program,233 OIG recommended that HHS take steps to improve internal coordination and 
communication about unaccompanied children and ensure that CDC coordinates with ORR when making future decisions that could 
affect the number of unaccompanied children placed in ORRs care.234   
Keeping patients safe 
OIG reports have identified issues with HHS coordination with, and outreach to, external partners that may leave patients at risk of 
harm.  For example, OIG found that more than half of the States repeatedly failed to meet one or more performance measures
most commonly, timeliness requirementsfor conducting nursing home surveys.  Nevertheless, CMS rarely reached out to senior 
State officials, such as Governors or health department directors, to raise concerns about State survey performance.  OIG 
recommended that CMS engage with senior State officials earlier and more frequently when it identifies persistent or egregious 
performance problems.  Earlier and more frequent contact may underscore the importance of requirements for protecting the 
health and safety of nursing home residents, build a greater understanding of the urgency to resolve performance problems and 
their implications for nursing home residents, and provide opportunities for State officials or other stakeholders to develop solutions 
before problems become critical.235  (See TMC 4 for more information on nursing homes and patient safety.)  
HHS coordination internally and with medical organizations is a key recommendation in an OIG review that found children enrolled 
in Medicaid in five States did not receive important blood lead screening tests on schedule.  Specifically, more than one-third of the 
1 million children who were required to receive a 12-month and a 24-month blood lead screening test received neither test.  The 
OIG review recommended that CMS coordinate with Federal agencies, such as CDC, and medical organizations, such as the American 
Academy of Pediatrics, to develop educational materials for State Medicaid agencies that clearly communicate Medicaids 
requirements and testing schedule, and highlight the current actionable blood lead reference value.236 
As described in TMC 1, OIG work raises concerns about people enrolled in Medicare receiving treatment for OUD.  OIG has 
recommended several collaborative approaches to increase the number of people receiving treatment, such as CMS outreach to 
enrollees, engagement to increase the number of providers and opioid treatment programs, and assisting SAMHSA with data.237   
Conclusion 
To run effective and efficient programs, HHS must consider issues and impacts outside a single program or mission for any one of its 
agencies.  Barriers to coordination include navigating a wide breadth of HHS stakeholders with different goals and authorities and 
varying logistic, economic, and workforce pressures, as well as the scope and complexity of the problems for which HHS needs 
partnerships to resolve and the ever-changing landscape of the health and human services sectors.  Overcoming these barriers 
requires HHS to engage in intentional, sustained, and forward-looking efforts toward building strategic partnerships both 
domestically and internationally, communicating effectively, managing collaborative work, and maintaining accountability. 
   
38 
   
ENDNOTES  
 
1 CDC, COVID Data Tracker.  Available at https://covid.cdc.gov/covid-data-tracker.  
 
2 CDC, 2022 U.S. Map & Case Count.  Available at https://www.cdc.gov/poxvirus/monkeypox/response/2022/us-map.html. 
 
3 CDC, Life Expectancy in the U.S. Dropped for the Second Year in a Row in 2021, August 2022.  Available at 
https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2022/20220831.htm. 
 
4 ASPE, Health Disparities by Race and Ethnicity during the COVID-19 Pandemic: Current Evidence and Policy Approaches.  Available at 
https://aspe.hhs.gov/reports/health-disparities-race-ethnicity-during-covid-19-pandemic-current-evidence-policy-approaches.  Additionally, an 
OIG report found that dually eligible peoplethose enrolled in Medicare and Medicaidas well as Black, Hispanic, and older Medicare enrollees 
have been disproportionately hospitalized with COVID-19.  See OIG, Medicare Beneficiaries Hospitalized With COVID-19 Experienced a Wide Range 
of Serious, Complex Conditions, OEI-02-20-00410, August 2021.  Available at https://oig.hhs.gov/oei/reports/OEI-02-20-00410.asp. 
 
5 According to the National Oceanic and Atmospheric Administration (NOAA), in 2021 there were 20 weather or climate disaster events affecting 
the United States with losses exceeding $1 billion.  During 19802021, there were 7.4 events on average per year; however, the annual average for 
the most recent 5 years (201721) increased to 17.2 events.  NOAA, National Centers for Environmental Information, Billion-Dollar Weather and 
Climate Disasters.  Available at https://www.ncdc.noaa.gov/billions/.  The United Nations 2021 Intergovernmental Panel on Climate Change 
Report projects climate change will result in increases in extreme events.  Intergovernmental Panel on Climate Change Sixth Assessment Report, 
Climate Change 2021: The Physical Science Basis.  Available at: https://www.ipcc.ch/report/ar6/wg1/.  Additionally, some researchers have 
conducted work that suggests increased occurrence of outbreaks may be expected in the future.  Baker, R.E., et al., Infectious disease in an era of 
global change, Nature Reviews Microbiology 20, October 13, 2021.  Available at https://doi.org/10.1038/s41579-021-00639-z.  Marani Marco, 
et. al., Intensity and frequency of extreme novel epidemics.  Proceedings of the National Academy Sciences, August 23, 2021.  Available at 
https://www.pnas.org/doi/10.1073/pnas.2105482118.  
 
6 OIG, The Substance Abuse and Mental Health Services Administration Generally Had Controls and Strategies for Mitigating Disaster Preparedness 
and Response Risks, A-04-20-02026, May 2021.  Available at https://oig.hhs.gov/oas/reports/region4/42002026.asp.  
 
7 OIG, CMSs Controls Related to Hospital Preparedness for an Emerging Infectious Disease Were Well-Designed and Implemented but Its Authority 
Is Not Sufficient for It To Ensure Preparedness at Accredited Hospitals, A-02-21-01003, June 2021.  Available at 
https://www.oig.hhs.gov/oas/reports/region2/22101003.asp.  
 
8 OIG, CMS's Internal Controls Over Hospital Preparedness for Emerging Infectious Disease Epidemics Such as Coronavirus Disease 2019.  Available 
at https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000455.asp.  
 
9 OIG, HHS-OIG Issues Notice of Exclusion to Owner of 7 Louisiana Nursing Homes, May 23, 2022.  Available at https://oig.hhs.gov/newsroom/news-
releases-articles/nursing-home-exclusion/. 
 
10 117th Congress (20212022), H.R.1319 - American Rescue Plan Act of 2021.  Available at https://www.congress.gov/bill/117th-congress/house-
bill/1319/text.  
 
11 ASPR was formerly known as the Office of the Assistant Secretary for Preparedness and Response. 
 
12 GAO, COVID-19: Significant Improvements Are Needed for Overseeing Relief Funds and Leading Responses to Public Health Emergencies.  
Available at https://files.gao.gov/reports/GAO-22-105291/index.html#appendix18.   
 
13 PBS, CDC director discusses efforts to reform the agency amid COVID, monkeypox criticisms, August 25, 2022.  Available at 
https://www.pbs.org/newshour/show/cdc-director-discusses-efforts-to-reform-the-agency-amid-covid-monkeypox-criticisms.  
 
14 OIG, HHS Did Not Always Efficiently Plan and Coordinate Its International Ebola Response Efforts, A-04-16-03567, August 2019.  Available at 
https://oig.hhs.gov/oas/reports/region4/41603567.asp.  
 
15 OIG, Hospitals Reported That the COVID-19 Pandemic Has Significantly Strained Health Care Delivery, OEI-09-21-00140, March 2021.  Available at 
https://oig.hhs.gov/oei/reports/OEI-09-21-00140.asp.  
 
 
39 
   
 
16 OIG, Toolkit: Insights for Health Care Facilities From OIGs Historical Work on Emergency Response, July 2022.  Available at 
https://oig.hhs.gov/reports-and-publications/featured-topics/response/toolkit-healthcare.asp. 
 
17 OIG, The Puerto Rico Department of Healths Implementation of Its Emergency Preparedness and Response Activities Before and After Hurricane 
Maria Was Not Effective, A-02-18-02002, July 2021.  Available at https://oig.hhs.gov/oas/reports/region2/21802002.asp.  
 
18 OIG, Selected Health Care Coalitions Increased Involvement in Whole Community Preparedness But Face Developmental Challenges Following 
New Requirements in 2017, OEI-04-18-00080, April 2020.  Available at https://oig.hhs.gov/oei/reports/oei-04-18-00080.asp.  
 
19 FDA, Fact Sheet: FDA at a Glance.  Available at https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance. 
 
20 FDA, COVID-19 Vaccines, Emergency Use AuthorizationVaccines.  Available at https://www.fda.gov/emergency-preparedness-and-
response/coronavirus-disease-2019-covid-19/covid-19-vaccines#eua-vaccines.  
 
21 OIG, Delays in Confirmatory Trials for Drug Applications Granted FDA's Accelerated Approval Raise Concerns, OEI-01-21-00401, September 2022.  
Available at https://oig.hhs.gov/oei/reports/OEI-01-21-00401.pdf.  
 
22 OIG, FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing, OEI-01-20-00380, September 
2022.  Available at https://oig.hhs.gov/oei/reports/OEI-01-20-00380.pdf.  
 
23 OIG, The Food and Drug Administrations Foreign For-Cause Drug Inspection Program Can Be Improved To Protect the Nations Drug Supply, 
A-01-19-01500, June 2022.  Available at https://oig.hhs.gov/oas/reports/region1/11901500.asp.   
 
24 FDA, What You Need to Know about Foodborne Illnesses.  Available at https://www.fda.gov/food/consumers/what-you-need-know-about-
foodborne-illnesses.  
 
25 FDA, What does FDA regulate?  Available at https://www.fda.gov/about-fda/fda-basics/what-does-fda-regulate.  
 
26 FDA, New Era of Smarter Food Safety Frequently Asked Questions.  Available at https://www.fda.gov/food/new-era-smarter-food-safety/new-
era-smarter-food-safety-frequently-asked-questions.  
 
27 OIG, Challenges Remain in FDA's Inspections of Domestic Food Facilities, OEI-02-14-00420, September 2017.  Available at 
https://www.oig.hhs.gov/oei/reports/oei-02-14-00420.asp.  See also OIG, The Food and Drug Administration's Food-Recall Process Did Not Always 
Ensure the Safety of the Nation's Food Supply, A-01-16-01502, December 2017.  Available at 
https://oig.hhs.gov/oas/reports/region1/11601502.asp. 
 
28 OIG, Food and Drug Administration's Actions Regarding the Abbott Infant Formula Recall.  Available at  https://oig.hhs.gov/reports-and-
publications/workplan/summary/wp-summary-0000708.asp.  
 
29 FDA, Center for Tobacco Products Overview.  Available at https://www.fda.gov/tobacco-products.  
 
30 CDC, Tobacco Product Use and Associated Factors Among Middle and High School Students  National Youth Tobacco Survey, United States, 
2021.  Available at https://www.cdc.gov/mmwr/volumes/71/ss/ss7105a1.htm?s_cid=ss7105a1_w.  
 
31 Ibid. 
 
32 OIG, Audit of the Food and Drug Administration's Premarket Tobacco Product Application Process for Electronic Nicotine Delivery System 
Products.  Available at https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000632.asp. 
 
33 OIG, FDAs Tobacco Retailer Compliance Check Inspection Program.  Available at https://oig.hhs.gov/reports-and-
publications/workplan/summary/wp-summary-0000441.asp.   
 
34 SAMHSA, 2020 National Survey of Drug Use and Health (NSDUH) Releases.  Available at https://www.samhsa.gov/data/release/2020-national-
survey-drug-use-and-health-nsduh-releases.  
 
35 KFF, Mental Health and Substance Use State Fact Sheets.  Available at https://www.kff.org/statedata/mental-health-and-substance-use-state-
fact-sheets/. 
 
 
40 
   
 
36 Ibid. 
 
37 OIG has ongoing work on States' and Medicaid Managed Care Organizations' compliance with mental health parity requirements and the 
availability of behavioral health in Medicare fee-for-service, Medicare Advantage, and Medicaid Managed Care.  See OIG, Work Plan.  Available at 
https://oig.hhs.gov/reports-and-publications/workplan/.  
  
38 OIG, Availability of Behavioral Health in Medicare Fee-For-Service, Medicare Advantage, and Medicaid Managed Care.  Available at 
https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000644.asp. 
 
39 Congressional Research Service, Mental Health Funding in the Bipartisan Safer Communities Act.  Available at 
https://crsreports.congress.gov/product/pdf/IN/IN11970.  
  
40 CDC, National Center for Vital Statistics, Vital Statistics Rapid Release, Provisional Drug Overdose Death Counts.  Available at 
https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm. 
 
41 Ibid. 
 
42 HHS, Overdose Prevention Strategy.  Available at https://www.hhs.gov/overdose-prevention/. 
 
43 Executive Office of the President, Office of National Drug Control Policy, The Biden-Harris Administrations Statement of Drug Policy Priorities for 
Year One.  Available at https://www.whitehouse.gov/wp-content/uploads/2021/03/BidenHarris-Statement-of-Drug-Policy-Priorities-April-1.pdf. 
 
44 OIG, Concerns Persist About Opioid Overdoses and Medicare Beneficiaries Access to Treatment and Overdose-Reversal Drugs, OEI-02-20-00401, 
August 2021.  Available at https://oig.hhs.gov/oei/reports/OEI-02-20-00401.pdf. 
 
45 FDA, Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework, Guidance for Industry.  Available at 
https://www.fda.gov/media/128150/download.  See also FDA, Healthy Innovation, Safer Families: FDAs 2018 Strategic Policy Roadmap.  Available 
at https://www.fda.gov/media/110587/download.  
 
46 FDA, Opioid Medications.  Available at https://www.fda.gov/drugs/information-drug-class/opioid-medications.  FDA, Information about 
Medication-Assisted Treatment (MAT).  Available at https://www.fda.gov/drugs/information-drug-class/information-about-medication-assisted-
treatment-mat. 
 
47 OIG, FDAs Risk Evaluation and Mitigation Strategies: Uncertain Effectiveness in Addressing the Opioid Crisis, OEI-01-17-00510, September 2020.  
Available at https://oig.hhs.gov/oei/reports/OEI-01-17-00510.asp.  
 
48 See, e.g., Testimony of OIG Office of Investigations Special Agent in Charge Maureen Dixon, Examining Efforts to Prevent Opioid Overutilization 
and Misuse in Medicare and Medicaid, pp. 45.  Available at https://oig.hhs.gov/testimony/docs/2018/dixon-testimony052918.pdf. 
 
49 OIG, Opioids in Medicaid: Concerns About Opioid Use Among Beneficiaries in Six Appalachian States, OEI-05-19-00410, December 2020.  Available 
at https://oig.hhs.gov/oei/reports/OEI-05-19-00410.asp.  
 
50 OIG, Opioid Treatment Programs Reported Challenges Encountered During the COVID-19 Pandemic and Actions Taken To Address Them, 
A-09-20-01001, November 2020.  Available at https://www.oig.hhs.gov/oas/reports/region9/92001001.asp.  
 
51 OIG, SAMHSA Is Missing Opportunities To Better Monitor Access to Medication Assisted Treatment Through the Buprenorphine Waiver Program, 
OEI-BL-20-00260, June 2021.  Available at https://oig.hhs.gov/oei/reports/OEI-BL-20-00260.asp.   
 
52 Federal Register, Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder.  Available at 
https://www.federalregister.gov/documents/2021/04/28/2021-08961/practice-guidelines-for-the-administration-of-buprenorphine-for-treating-
opioid-use-disorder.  
 
53 OIG, Medicaid Claims for Opioid Treatment Program Services.  Available at https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-
summary-0000234.asp.  
 
54 OIG, Oklahomas Oversight of Medicaid Outpatient Services for Opioid Use Disorder Was Generally Effective, A-06-20-08000, August 2021.  
Available at https://oig.hhs.gov/oas/reports/region6/62008000.asp. 
 
 
41 
   
 
55 OIG, Louisiana Faced Compliance and Contracting Challenges in Implementing Opioid Response Grant Programs, A-06-20-07003, April 2022.  
Available at https://oig.hhs.gov/oas/reports/region6/62007003.asp. 
 
56 USAspending.gov, Agency Profile: Department of Health and Human Services.  Available at https://www.usaspending.gov/agency/806.  
 
57 HHS, TAGGS, Grants By OPDIV.  Available at https://taggs.hhs.gov/ReportsGrants/GrantsByOPDIV.  
 
58 As of June 14, 2021, HHS had awarded $74.6 billion for contractual services and supplies.  See USAspending.gov, Spending Explorer, Contractual 
services and supplies.  Available at https://www.usaspending.gov/explorer/object_class.  
 
59 CMS, April 2022 Medicaid and CHIP Enrollment Snapshot.  Available at https://www.medicaid.gov/medicaid/national-medicaid-chip-program-
information/downloads/april-2022-medicaid-chip-enrollment-trend-snapshot.pdf.  See also, CMS, 2021 Annual Financial Report, p. 12.  CHIP 
represents an additional 10 million children who are projected by CMS to be enrolled for at least 1 month during the year.  Available at 
https://www.cms.gov/files/document/cms-financial-report-fiscal-year-2021.pdf.  
 
60 As of September 30, 2021, HHS had obligated $236.4 billion in grants (excluding CMS).  See USAspending.gov, Spending Explorer, Department of 
Health and Human Services (HHS), Award Spending.  Available at https://www.usaspending.gov/agency/department-of-health-and-human-
services?fy=2021.   
 
61 CMS, Financial Report, fiscal year 2021.  See pp. 46-47, Note 10: Net Costs of Operations.  Available at 
https://www.cms.gov/files/document/cms-financial-report-fiscal-year-2021.pdf. 
 
62 HHS, TAGGS, Grants By OPDIV.  Available at https://taggs.hhs.gov/ReportsGrants/GrantsByOPDIV.  
 
63 Trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds stated that the Federal Hospital Insurance 
Trust Fund is expected to be depleted in 2026.  See CMS, 2020 Annual Report of the Boards of Trustees of the Federal Hospital Insurance and 
Federal Supplementary Medical Insurance Trust Funds.  Available at https://www.cms.gov/files/document/2020-medicare-trustees-report.pdf. 
 
64 GAO, Financial Audit: FY 2019 and FY 2018 Consolidated Financial Statements of the U.S. Government.  Available at 
https://www.gao.gov/products/GAO-20-315R. 
 
65 CMS, National Health Expenditure Data.  Available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-
Reports/NationalHealthExpendData/NationalHealthAccountsHistorical. 
 
66 CMS, Financial Report, fiscal year 2021.  Available at https://www.cms.gov/files/document/cms-financial-report-fiscal-year-2021.pdf. 
 
67 KFF, Key Facts About Medicare Part D Enrollment, Premiums, and Cost Sharing in 2021.  Available at https://www.kff.org/medicare/issue-
brief/key-facts-about-medicare-part-d-enrollment-premiums-and-cost-sharing-in-2021/. 
 
68 Specifically at issue were inhalation drugs administered through DME and supplying fees for immunosuppressive drugs associated with organ 
transplant, oral anticancer chemotherapeutic drugs, and oral antiemetic drugs used as part of an anticancer chemotherapeutic regimen.  See OIG, 
Medicare Part B Prescription Drug Dispensing and Supplying Fee Payment Rates Are Considerably Higher Than the Rates Paid by Other Government 
Programs, A-06-12-00038, September 2014.  Available at https://oig.hhs.gov/oas/reports/region6/61200038.asp. 
 
69 OIG, Increases in Reimbursement for Brand-Name Drugs in Part D, OEI-03-15-00080, June 2018.  Available at https://oig.hhs.gov/oei/reports/oei-
03-15-00080.asp.  
 
70 OIG, Medicare Part D and Beneficiaries Could Realize Significant Spending Reductions With Increased Biosimilar Use, OEI-05-20-00480, March 
2022.  Available at https://oig.hhs.gov/oei/reports/OEI-05-20-00480.asp.  
 
71 OIG, Reasonable Assumptions in Manufacturer Reporting of AMPs and Best Prices, OEI-12-17-00130, September 2019.  Available at 
https://oig.hhs.gov/oei/reports/oei-12-17-00130.asp.  
 
72 31 USC  3351(4). 
 
 
 
 
42 
   
 
73 According to PaymentAccuracy.gov, the total estimated government improper payment amount for FY 2020 was $206.4 billion.  Available at 
https://www.paymentaccuracy.gov/payment-accuracy-the-numbers/.  See also (for Medicare and Medicaid estimated improper payment rates) 
CMS, 2020 Estimated Improper Payment Rates for Centers for Medicare & Medicaid Services (CMS) Programs.  Available at 
https://www.cms.gov/newsroom/fact-sheets/2020-estimated-improper-payment-rates-centers-medicare-medicaid-services-cms-programs.   
 
74 HHS, Agency Financial Report, fiscal year 2021.  Available at https://www.hhs.gov/sites/default/files/fy-2021-hhs-agency-financial-report.pdf.  
 
75 CMS, Comprehensive Error Rate Testing (CERT).  Available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-
Programs/Improper-Payment-Measurement-Programs/CERT.  See also HHS, Agency Financial Report, fiscal year 2021.  Available at 
https://www.hhs.gov/sites/default/files/fy-2021-hhs-agency-financial-report.pdf. 
 
76 See endnote 69. 
 
77 OIG, Trend Toward More Expensive Inpatient Hospital Stays in Medicare Emerged Before COVID-19 and Warrants Further Scrutiny, 
OEI-02-18-00380, February 2021.  Available at https://oig.hhs.gov/oei/reports/OEI-02-18-00380.asp.  
 
78 OIG, CMS Reported Collecting Just Over Half of the $498 Million in Medicare Overpayments Identified by OIG Audits, A-04-18-03085, July 2022.  
Available at https://oig.hhs.gov/oas/reports/region4/41803085.asp.  
 
79 CMS, Financial Report, fiscal year 2021.  Available at https://www.cms.gov/files/document/cms-financial-report-fiscal-year-2021.pdf. 
 
80 PaymentAccuracy.gov, Annual Improper Payments Datasets.  Available at https://www.paymentaccuracy.gov/payment-accuracy-the-numbers/. 
 
81 CMS, 2020 Estimated Improper Payment Rates for Centers for Medicare & Medicaid Services (CMS) Programs.  Available at 
https://www.cms.gov/newsroom/fact-sheets/2020-estimated-improper-payment-rates-centers-medicare-medicaid-services-cms-programs.  
 
82 CMS, Fiscal Year (FY) 2019 Medicare Fee-For-Service Improper Payment Rate is Lowest Since 2010 while data points to concerns with Medicaid 
eligibility, press release, November 19, 2019.  Available at https://www.cms.gov/newsroom/press-releases/fiscal-year-fy-2019-medicare-fee-
service-improper-payment-rate-lowest-2010-while-data-points. 
 
83 OIG, The Centers for Medicare & Medicaid Services Had Not Recovered More Than a Billion Dollars in Medicaid Overpayments Identified by OIG 
Audits, A-05-17-00013, December 2018.  Available at https://oig.hhs.gov/oas/reports/region5/51700013.asp. 
 
84 OIG, Unaccompanied Children, June 2022.  Available at https://oig.hhs.gov/reports-and-publications/featured-topics/uac/. 
 
85 OIG, The Office of Refugee Resettlement Did Not Award and Manage the Homestead Influx Care Facility Contracts in Accordance With Federal 
Requirements, A-12-20-20001, December 2020.  Available at https://oig.hhs.gov/oas/reports/region12/122020001.asp.  
 
86 OIG, Recommendation Followup: Vulnerabilities Continue To Exist in the HHS Small Business Innovation Research Program, OEI-04-18-00230, 
March 2019.  Available at https://oig.hhs.gov/oei/reports/oei-04-18-00230.asp. 
 
87 31 USC  3351-3358. 
 
88 OIG, Department of Health and Human Services Met Many Requirements, but It Did Not Fully Comply With the Payment Integrity Act of 2019 and 
Applicable Improper Payment Guidance for Fiscal Year 2021, A-17-22-52000, May 2022.  Available at 
https://oig.hhs.gov/oas/reports/region17/172252000.pdf. 
 
89 OIG, The Food and Drug Administration Needs To Improve Its Contract Closeout Processes To Identify Contracts Eligible for Closeout and Close 
Contracts Timely, A-03-20-03004, December 2021.  Available at https://oig.hhs.gov/oas/reports/region3/32003004.asp.  
 
90 OIG, The National Heart, Lung, and Blood Institute Did Not Fully Comply With Federal Requirements for Other Transactions, A-04-20-04078, 
April 2021.  Available at https://www.oig.hhs.gov/oas/reports/region4/42004078.asp.  
 
91 USASpending.gov, The Federal Response to COVID-19.  Available at https://www.usaspending.gov/disaster/covid-19?publicLaw=all. 
 
92 HRSA, COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the 
Uninsured.  Available at https://www.hrsa.gov/coviduninsuredclaim. 
 
 
43 
   
 
93 HRSA, COVID-19 Coverage Assistance Fund.  Available at https://www.hrsa.gov/covid19-coverage-assistance. 
 
94 OIG, HHSs and HRSAs Controls Related to Selected Provider Relief Fund Program Requirements Could Be Improved, A-09-21-06001, 
September 2022.  Available at https://oig.hhs.gov/oas/reports/region9/92106001.asp. 
 
95 OIG, Active Work Plan Items, including ongoing PRF-related reviews.  Available at https://oig.hhs.gov/reports-and-publications/workplan/active-
item-table.asp?search.search=PRF. 
 
96 OIG has found that some Tribes and Tribal organizations have not adequately protected funds under the Indian Self-Determination and Education 
Assistance Act and other programs, resulting in embezzlement and theft of Federal funds. 
 
97 HHS codified the Uniform Guidance at 45 CFR part 75, which prescribes instructions and other pre-award matters for the granting agency to use 
in the announcement and application process for awards made on or after December 26, 2014.  The Uniform Guidance stipulates that the use of 
certain sections is required only for competitive Federal awards but may also be used by the HHS awarding agency for noncompetitive awards 
when appropriate or required by Federal statute.   
 
98 OIG, HHS's Suspension and Debarment Program Helped Safeguard Federal Funding, But Opportunities for Improvement Exist, OEI-04-19-00570, 
January 2022.  Available at https://oig.hhs.gov/oei/reports/OEI-04-19-00570.asp.  
 
99 OIG, States Could Do More To Prevent Terminated Providers From Serving Medicaid Beneficiaries, OEI-03-19-00070, March 2020.  Available at 
https://oig.hhs.gov/oei/reports/oei-03-19-00070.asp. 
 
100 OIG, Problems Remain for Ensuring That All High Risk Medicaid Providers Undergo Criminal Background Checks, OEI-05-00070, July 2019.  
Available at https://oig.hhs.gov/oei/reports/oei-05-18-00070.asp. 
 
101 OIG, Twenty-Three States Reported Allowing Unenrolled Providers To Serve Medicaid Beneficiaries, OEI-05-19-00060, March 2020.  Available at 
https://oig.hhs.gov/oei/reports/oei-05-19-00060.asp. 
 
102 HHS, FY 2019 Agency Financial Report.  Available at https://www.hhs.gov/sites/default/files/fy2019-hhs-agency-financial-report.pdf. 
 
103 Ibid. 
 
104 CMS, CMS Fast Facts.  Available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/CMS-Fast-Facts.  
See also CMS, Financial Report, fiscal year 2021, pp. 1012.  Available at https://www.cms.gov/files/document/cms-financial-report-fiscal-year-
2021.pdf. 
 
105 CMS, Financial Report, fiscal year 2021.  Available at https://www.cms.gov/files/document/cms-financial-report-fiscal-year-2021.pdf.  See 
pp. 4647, Note 10: Net Costs of Operations. 
 
106 This TMC focuses on Medicare and Medicaid, the Departments largest health care programs.  The Department funds other vital health services 
including those through IHS, HRSA, and SAMHSA that are addressed in other TMCs.   
 
107 CMS, 2020 Report to Congress, Center for Medicare and Medicaid Innovation.  Available at https://innovation.cms.gov/data-and-
reports/2021/rtc-2020. 
 
108 CMS, Meaningful Measures 2.0: Moving from Measure Reduction to Modernization.  Available at https://www.cms.gov/meaningful-measures-
20-moving-measure-reduction-modernization. 
 
109 CMS, Measuring and Improving Quality in Home and Community-Based Services (HCBS).  Available at 
https://www.medicaid.gov/medicaid/quality-of-care/quality-improvement-initiatives/measuring-and-improving-quality-home-and-community-
based-services-hcbs/index.html#:~:text=On%20July%2021st%2C%202022%2C%20CMS,measures%20for%20Medicaid%2Dfunded%20HCBS. 
 
110 CMS, Report to Congress, Annual Update: Identification of Quality Measurement Priorities and Associated Funding for the Consensus-Based 
Entity (currently the National Quality Forum) and Other Entities.  Available at https://www.cms.gov/files/document/2021-report-congress-
identification-quality-measurement-priorities-strategic-plan-initiatives.pdf.  
 
 
44 
   
 
111 OIG, Medicare Could Have Saved Approximately $993 Million in 2017 and 2018 if It Had Implemented an Inpatient Rehabilitation Facility 
Transfer Payment Policy for Early Discharges to Home Health Agencies, A-01-20-00501, December 2021.  Available at 
https://oig.hhs.gov/oas/reports/region1/12000501.asp.  
 
112 OIG, Medicare and Beneficiaries Pay More for Preadmission Services at Affiliated Hospitals Than at Wholly Owned Settings, OEI-05-19-00380, 
December 2021.  Available at https://oig.hhs.gov/oei/reports/OEI-05-19-00380.asp.  
 
113 OIG, Adverse Events in Hospitals: A Quarter of Medicare Patients Experienced Harm in October 2018, OEI-06-18-00400, May 2022.  Available at 
https://oig.hhs.gov/oei/reports/OEI-06-18-00400.asp.  
 
114 CMS, Synthesis of Evaluation Results across 21 Medicare Models, 20122020.  Available at https://innovation.cms.gov/data-and-
reports/2022/wp-eval-synthesis-21models.  
 
115 OIG, Provider Shortages and Limited Availability of Behavioral Health Services in New Mexicos Medicaid Managed Care, OEI-02-17-00490, 
September 2019.  Available at https://oig.hhs.gov/oei/reports/oei-02-17-00490.asp. 
 
116 OIG, COVID-19 Had a Devastating Impact on Medicare Beneficiaries in Nursing Homes During 2020, OEI-02-20-00490, June 2021.  Available at 
https://oig.hhs.gov/oei/reports/OEI-02-20-00490.asp. 
 
117 OIG, Inaccuracies in Medicare's Race and Ethnicity Data Hinder the Ability To Assess Health Disparities, OEI-02-21-00100, June 2022.  Available at 
https://oig.hhs.gov/oei/reports/OEI-02-21-00100.asp.  
 
118 CMS, Medicaid Managed Care Enrollment and Program Characteristics, 2020.  Available at https://www.medicaid.gov/medicaid/managed-
care/downloads/2020-medicaid-managed-care-enrollment-report.pdf. 
 
119 OIG, Medicare Advantage Compliance Audit of Diagnosis Codes That Humana, Inc., (Contract H1036) Submitted to CMS, A-07-16-01165, 
April 2021.  Available at https://oig.hhs.gov/oas/reports/region7/71601165.asp.  See also OIG, Medicare Advantage Compliance Audit of Specific 
Diagnosis Codes That Anthem Community Insurance Company, Inc. (Contract H3655) Submitted to CMS, A-07-19-01187, May 2021.  Available at 
https://oig.hhs.gov/oas/reports/region7/71901187.asp.  See also OIG, Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Blue 
Cross Blue Shield of Michigan (Contract H9572) Submitted to CMS, A-02-18-01028, February 2021.  Available at 
https://oig.hhs.gov/oas/reports/region2/21801028.asp. 
 
120 OIG, Billions in Estimated Medicare Advantage Payments From Chart Reviews Raise Concerns, OEI-03-17-00470, December 2019.  Available at 
https://oig.hhs.gov/oei/reports/oei-03-17-00470.asp. 
 
121 OIG, Billions in Estimated Medicare Advantage Payments From Diagnoses Reported Only on Health Risk Assessments Raise Concerns, 
OEI-03-17-00471, September 2020.  Available at https://oig.hhs.gov/oei/reports/oei-03-17-00471.asp. 
 
122 OIG, Some Medicare Advantage Organization Denials of Prior Authorization Requests Raise Concerns About Beneficiary Access to Medically 
Necessary Care, OEI-09-18-00260, April 2022.  Available at https://oig.hhs.gov/oei/reports/OEI-09-18-00260.asp.  
 
123 OIG, Medicare Advantage Appeal Outcomes and Audit Findings Raise Concerns About Service and Payment Denials, OEI-09-1600410, 
September 2018.  Available at https://oig.hhs.gov/oei/reports/oei-09-16-00410.asp. 
 
124 KFF, authored by Matthew Rae, et al., How the American Rescue Plan Act Affects Subsidies for Marketplace Shoppers and People Who Are 
Uninsured.  Available at https://www.kff.org/health-reform/issue-brief/how-the-american-rescue-plan-act-affects-subsidies-for-marketplace-
shoppers-and-people-who-are-uninsured.  See also Congressional Budget Office, Reconciliation Recommendations of the House Committee on 
Ways and Means.  Available at https://www.cbo.gov/system/files/2021-02/hwaysandmeansreconciliation.pdf.  
 
125 OIG, CMS Authorized Hundreds of Millions of Dollars in Advanced Premium Tax Credits on Behalf of Enrollees Who Did Not Make Their Required 
Premium Payments, A-02-19-02005, March 2021.  Available at  https://oig.hhs.gov/oas/reports/region2/21902005.asp.  
 
126 CMS, May 2022 Medicaid and CHIP Enrollment Trends Snapshot.  Available at https://www.medicaid.gov/medicaid/national-medicaid-chip-
program-information/downloads/may-2022-medicaid-chip-enrollment-trend-snapshot.pdf/.  
 
127 KFF, Medicaid and CHIP Eligibility and Enrollment Policies as of January 2022: Findings from a 50-State Survey.  Available at 
https://www.kff.org/medicaid/report/medicaid-and-chip-eligibility-and-enrollment-policies-as-of-january-2022-findings-from-a-50-state-survey/.  
 
 
45 
   
 
128 Some CMS resources for States include: Medicaid and CHIP Unwinding Planning Efforts, April 2022, available at 
https://www.medicaid.gov/resources-for-states/downloads/state-unwinding-best-practices.pdf; Updated Guidance, addressed to State health 
officials, March 2022, available at https://www.medicaid.gov/federal-policy-guidance/downloads/sho-21-002.pdf; Medicaid and Childrens Health 
Insurance Program Return to Normal Operations, Eligibility and Enrollment Pending Actions Resolution Planning Tool  Version 2.0, March 2022, 
available at https://www.medicaid.gov/resources-for-states/downloads/medicaid-chip-covid19-health-emergency-eligibility-enrollment-pending-
actions-resolution-planning-tool.docx; Top 10 Fundamental Actions to Prepare for Unwinding, June 2022, available at 
https://www.medicaid.gov/resources-for-states/downloads/top-10-fundamental-actions-to-prepare-for-unwinding-and-resources-to-support-
state-efforts.pdf.  
 
129 Mostly Medicaid, Brooks-LaSure: ACA marketplace key to Medicaid redeterminations after COVID-19 PHE ends.  Available at 
https://www.mostlymedicaid.com/brooks-lasure-aca-marketplace-key-to-medicaid-redeterminations-after-covid-19-phe-ends/.  
 
130 OIG, Certain Medicare Beneficiaries, Such as Urban and Hispanic Beneficiaries, Were More Likely Than Others To Use Telehealth During the First 
Year of the COVID-19 Pandemic, OEI-02-20-00522, September 2022.  Available at https://oig.hhs.gov/oei/reports/OEI-02-20-00522.asp. 
 
131 The White House, Fact Sheet: Protecting Seniors by Improving Safety and Quality of Care in the Nations Nursing Homes, February 2022.  
Available at https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/28/fact-sheet-protecting-seniors-and-people-with-
disabilities-by-improving-safety-and-quality-of-care-in-the-nations-nursing-homes/.  
 
132 CMS, Updated Guidance for Nursing Home Resident Health and Safety, June 2022.  Available at https://www.cms.gov/newsroom/fact-
sheets/updated-guidance-nursing-home-resident-health-and-safety.  
 
133 OIG, COVID-19 Had a Devastating Impact on Medicare Beneficiaries in Nursing Homes During 2020, OEI-02-20-00490, June 2021.  Available at 
https://www.oig.hhs.gov/oei/reports/OEI-02-20-00490.asp.  
 
134 OIG, An Estimated 91 Percent of Nursing Home Staff Nationwide Received the Required COVID-19 Vaccine Doses, and an Estimated 56 Percent of 
Staff Nationwide Received a Booster Dose, A-09-22-02003, June 2022.  Available at  https://oig.hhs.gov/oas/reports/region9/92202003.asp. 
 
135 CMS, Centers for Medicare & Medicaid Services Staffing Study to Inform Minimum Staffing Requirements for Nursing Homes, August 2022.  
Available at https://www.cms.gov/blog/centers-medicare-medicaid-services-staffing-study-inform-minimum-staffing-requirements-nursing-homes. 
 
136 CMS, Revised Long-Term Care Surveyor Guidance: Revisions to Surveyor Guidance for Phases 2 & 3, Arbitration Agreement Requirements, 
Investigating Complaints & Facility Reported Incidents, and the Psychosocial Outcome Severity Guide, June 2022.  Available at 
https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and-memos-states-and/revised-long-term-
care-surveyor-guidance-revisions-surveyor-guidance-phases-2-3-arbitration.  
 
137 OIG, Audits of Nursing Home Life Safety and Emergency Preparedness in Eight States Identified Noncompliance With Federal Requirements and 
Opportunities for the Centers for Medicare & Medicaid Services to Improve Resident, Visitor, and Staff Safety, OAS-02-21-01010, July 2022.  
Available at https://oig.hhs.gov/oas/reports/region2/22101010.asp. 
 
138 OIG, Onsite Surveys of Nursing Homes During the COVID-19 Pandemic: March 23-May 30, 2020, OEI-01-20-00430, December 2020.  Available at 
https://oig.hhs.gov/oei/reports/OEI-01-20-00430.asp.  
 
139 OIG, States' Backlogs of Standard Surveys of Nursing Homes Grew Substantially During the COVID-19 Pandemic, OEI-01-20-00431, July 2021.  
Available at https://oig.hhs.gov/oei/reports/OEI-01-20-00431.asp.  
 
140 OIG, States Continued To Fall Short in Meeting Required Timeframes for Investigating Nursing Home Complaints: 2016-2018, September 2020.  
Available at https://oig.hhs.gov/oei/reports/OEI-01-19-00421.asp. 
 
141 OIG, CMS Should Take Further Action To Address States With Poor Performance in Conducting Nursing Home Surveys, OEI-06-19-00460, 
January 2022.  Available at https://oig.hhs.gov/oei/reports/OEI-06-19-00460.asp.  
 
142 OIG, CMS Guidance to State Survey Agencies on Verifying Correction of Deficiencies Needs To Be Improved To Help Ensure the Health and Safety 
of Nursing Home Residents, A-09-18-02000, February 2019.  Available at https://oig.hhs.gov/oas/reports/region9/91802000.asp.  
 
143 OIG, Corporate Integrity Agreement.  Available at 
https://oig.hhs.gov/fraud/cia/agreements/Vanguard_Healthcare_LLC_Vanguard_Healthcare_Services_LLC_Boulevard_Terrace_LLC_Glen_Oaks_LL
C_Imperial_Gardens_Health_and_Rehabilitation_Vanguard_of_Manchester_%20LLC_Vanguard_Financial_Svcs_LLC_etal_01092019.asp. 
 
46 
   
 
 
144 OIG, CMS Could Improve the Data It Uses To Monitor Antipsychotic Drugs in Nursing Homes, OEI-07-19-00490, May 2021.  Available at 
https://oig.hhs.gov/oei/reports/OEI-07-19-00490.pdf. 
 
145 OIG, Facility-Initiated Discharges in Nursing Homes Require Further Attention, OEI-01-18-00250, November 2021.  Available at 
https://oig.hhs.gov/oei/reports/OEI-01-18-00250.pdf. 
 
146 CMS, Updated Guidance for Nursing Home Resident Health and Safety, June 2022.  Available at https://www.cms.gov/newsroom/fact-
sheets/updated-guidance-nursing-home-resident-health-and-safety. 
 
147 OIG, Many Medicaid-Enrolled Children Treated for ADHD Did Not Receive Recommended Followup Care, OEI-07-17-00170, August 2019.  
Available at https://oig.hhs.gov/oei/reports/oei-07-17-00170.asp. 
 
148 OIG, 2019: Vulnerabilities in Hospice Care.  Available at https://oig.hhs.gov/newsroom/media-materials/2019/hospice/.   
 
149 HHS, Featured Priority: Vaccine Confidence.  Available at https://www.hhs.gov/vaccines/featured-priorities/vaccine-confidence/index.html. 
 
150 OIG, Adverse Events in Hospitals: A Quarter of Medicare Patients Experienced Harm in October 2018, OEI-06-18-00400, May 2022.  Available at 
https://oig.hhs.gov/oei/reports/OEI-06-18-00400.asp.  See also: 
 
  OIG, Adverse Events in Skilled Nursing Facilities: National Incidence Among Medicare Beneficiaries, OEI-06-11-00370, February 2014.  
Available at https://oig.hhs.gov/oei/reports/oei-06-11-00370.asp;  
 
  OIG, Adverse Events in Rehabilitation Facilities: National Incidence Among Medicare Beneficiaries, OEI-06-14-00110, July 2016.  Available 
at https://oig.hhs.gov/oei/reports/oei-06-14-00110.asp; and  
 
  OIG, Adverse Events in Long-Term-Care Hospitals: National Incidence Among Medicare Beneficiaries, OEI-06-14-00530, November 2018.  
Available at https://www.oig.hhs.gov/oei/reports/oei-06-14-00530.asp. 
 
151 OIG, Hospital Incident Reporting Systems Do Not Capture Most Patient Harm, OEI-06-09-00091, January 2012.  Available at 
https://oig.hhs.gov/oei/reports/oei-06-09-00091.asp. 
 
152 OIG, Adverse Events In Hospitals: One Quarter of Medicare Patients Experienced Harm in October 2018, OEI-06-18-00400, May 2022.  Available 
at https://oig.hhs.gov/oei/reports/oei-06-18-00400.asp.     
 
153 OIG, Indian Health Service Hospitals: More Monitoring Needed to Ensure Quality Care, OEI-06-14-00010, October 2016.  Available at 
https://oig.hhs.gov/oei/reports/oei-06-14-00010.asp.  See also OIG, Indian Health Service Hospitals: Longstanding Challenges Warrant Focused 
Attention to Support Quality Care, OEI-06-14-00011, October 2016.  Available at https://oig.hhs.gov/oei/reports/oei-06-14-00011.asp. 
 
154 IHS, Quality at IHS.  Available at https://www.ihs.gov/quality/. 
 
155 OIG, IHS Needs To Improve Oversight of Its Hospitals' Opioid Prescribing and Dispensing Practices and Consider Centralizing Its Information 
Technology Functions, A-18-17-11400, July 2019.  Available at https://oig.hhs.gov/oas/reports/region18/181711400.asp. 
 
156 OIG, Indian Health Service Hospitals: More Monitoring Needed to Ensure Quality Care, OEI-06-14-00010, October 2016.  Available at 
https://oig.hhs.gov/oei/reports/oei-06-14-00010.asp.  See also OIG, Longstanding Challenges Warrant Focused Attention to Support Quality Care, 
OEI-06-14-00011, October 2016.  Available at https://oig.hhs.gov/oei/reports/oei-06-14-00011.asp.  See also OIG, Case Study: Indian Health Service 
Management of Rosebud Hospital Emergency Department Closure and Reopening, OEI-06-17-00270, July 2019.  Available at 
https://oig.hhs.gov/oei/reports/oei-06-17-00270.asp.  
 
157 ACF, Office of Head Start, Head Start Services.  Available at  https://www.acf.hhs.gov/ohs/about/head-start. 
 
158 ACF, Office of Child Care, Characteristics of Families Served by the Child Care and Development Fund (CCDF) Based on Preliminary FY2019 Data.  
Available at https://www.acf.hhs.gov/occ/fact-sheet/characteristics-families-served-child-care-and-development-fund-ccdf-based. 
 
159 HHS, Fact Sheet: Unaccompanied Children (UC) Program, August 2022.  Available at https://www.hhs.gov/sites/default/files/uac-program-fact-
sheet.pdf. 
 
 
47 
   
 
160 HHS, Latest UC DataFY 2022.  Available at https://www.hhs.gov/programs/social-services/unaccompanied-children/latest-uc-data-
fy2022/index.html. 
 
161 OIG, Separated Children Placed in Office of Refugee Resettlement Care, OEI-BL-18-00511, January 2019.  Available at 
https://www.oig.hhs.gov/oei/reports/oei-BL-18-00511.asp. 
 
162 OIG, The Tornillo Influx Care Facility: Concerns About Staff Background Checks and Number of Clinicians on Staff, A-12-19-20000, 
November 2018.  Available at https://oig.hhs.gov/oas/reports/region12/121920000.asp.  
 
163 OIG, Unaccompanied Alien Children Program Care Provider Facilities Do Not Include All Required Security Measures in Their Checklists, 
OEI-05-19-00210, June 2020.  Available at  https://oig.hhs.gov/oei/reports/oei-05-19-00210.asp.  
 
164 OIG, The Office of Refugee Resettlements Incident Reporting System Is Not Effectively Capturing Data To Assist Its Efforts To Ensure the Safety of 
Minors in HHS Custody, OEI-09-19-00430, June 2020.  Available at https://oig.hhs.gov/oei/reports/oei-09-18-00430.asp. 
 
165 OIG, HHS Should Improve Internal Coordination Regarding Unaccompanied Children, OEI-BL-20-00670, May 2022.  Available at 
https://oig.hhs.gov/oei/reports/OEI-BL-20-00670.asp. 
 
166 OIG, Operational Challenges Within ORR and the ORR Emergency Intake Site at Fort Bliss Hindered Case Management for Children, 
September 2022.  Available at https://oig.hhs.gov/oei/reports/OEI-07-21-00251.asp. 
 
167 The United States Attorneys Office, District of Montana, White House Announces Presidential Task Force on Protecting Native American Children 
in the Indian Health Service System, press release, March 26, 2019.  Available at https://www.justice.gov/usao-mt/pr/white-house-announces-
presidential-task-force-protecting-native-american-children-indian. 
 
167 OIG, Unaccompanied Alien Children Care Provider Facilities Generally Conducted Required Background Checks but Faces Challenges in Hiring, 
Screening, and Retaining Employees, A-12-19-20001, September 2019.  Available at https://oig.hhs.gov/oas/reports/region12/121920001.asp.  
 
168 DOJ, Presidential Task Force on Protecting Native American Children in the Indian Health Service System Presents Findings to First Lady Melania 
Trump, press release, July 24, 2020.  Available at https://www.justice.gov/usao-ndok/pr/presidential-task-force-protecting-native-american-
children-indian-health-service.  
 
169 OIG, The Tornillo Influx Care Facility: Concerns About Staff Background Checks and Number of Clinicians on Staff, A-12-19-20000, 
November 2018.  Available at https://oig.hhs.gov/oas/reports/region12/121920000.asp.  
 
170 OIG, Work Plan, Office of Refugee Resettlement Influx Care Facilities and Emergency Intake Sites: Employee/Staff Background Screening, 
W-00-21-59459.  Report scheduled for release in 2023.  Available at https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-
summary-0000590.asp. 
 
171 OIG, All Six States Reviewed Had Partially Implemented New Criminal Background Check Requirements for Childcare Providers, and Five of the 
States Anticipate Full Implementation by Fiscal Year 2020, A-05-19-00015, August 2019.  Available at 
https://oig.hhs.gov/oas/reports/region5/51900015.asp.  See also: 
 
  OIG, Colorado's Monitoring Did Not Ensure Child Care Provider Compliance With State Criminal Background Check Requirements at 18 of 
30 Providers Reviewed, A-07-19-06084, April 2021.  Available at https://oig.hhs.gov/oas/reports/region7/71906084.asp; 
 
  OIG, Virginia's Monitoring Did Not Ensure Child Care Provider Compliance With State Criminal Background Check Requirements at 8 of 30 
Providers Reviewed, A-03-19-00253, February 2021.  Available at https://oig.hhs.gov/oas/reports/region3/31900253.asp; 
 
  OIG, Indiana's Monitoring Did Not Ensure Child Care Provider Compliance With State Criminal Background Check Requirements at 17 of 30 
Providers Reviewed, A-05-19-00012, August 2020.  Available at https://oig.hhs.gov/oas/reports/region5/51900012.asp; 
 
  OIG, Rhode Island's Monitoring Did Not Ensure Child Care Provider Compliance With State Criminal Background Check Requirements at 18 
of 30 Providers Reviewed, A-01-18-02505, August 2020.  Available at https://oig.hhs.gov/oas/reports/region1/11802505.asp; 
 
  OIG, New Jersey's Monitoring Did Not Ensure Child Care Provider Compliance With State Criminal Background Check Requirements at 9 of 
30 Providers Reviewed, A-02-19-02004, July 2020.  Available at https://oig.hhs.gov/oas/reports/region2/21902004.asp; 
 
 
48 
   
 
  OIG, Illinois' Monitoring Did Not Ensure Childcare Provider Compliance With State Criminal Background Check Requirements at 12 of 30 
Providers Reviewed, A-05-19-00016, April 2020.  Available at https://oig.hhs.gov/oas/reports/region5/51900016.asp; and 
 
  OIG, New Hampshire's Monitoring Did Not Ensure Childcare Provider Compliance With State Criminal Background Check Requirements at 
21 of 30 Providers Reviewed, A-01-18-02504, April 2020.  Available at https://oig.hhs.gov/oas/reports/region1/11802504.asp. 
 
172 OIG, Tribal Health Programs: Concerns About Background Verifications for Staff Working With Indian Children, A-01-20-01500, August 2020.  
Available at https://oig.hhs.gov/oas/reports/region1/12001500.asp. 
 
173 OIG, National Background Check Program for Long-Term-Care Providers: An Interim Assessment, OEI-07-20-00181, May 2022.  Available at 
https://oig.hhs.gov/oei/reports/oei-07-20-00181.asp.   
 
174 Federal Register, HHS-ACF final rule for Child Care and Development Fund Program, September 30, 2016.  Available at 
https://www.govinfo.gov/content/pkg/FR-2016-09-30/pdf/2016-22986.pdf.  
 
175 OIG, et al., Ensuring Beneficiary Health and Safety in Group Homes Through State Implementation of Comprehensive Compliance Oversight, 
January 2018.  Available at https://oig.hhs.gov/reports-and-publications/featured-topics/group-homes/group-homes-joint-report.asp.   
 
176 CMS, CMCS Informational Bulletin: Health and Welfare of Home and Community Based Services (HCBS) Waiver Recipients.  Available at 
https://www.medicaid.gov/federal-policy-guidance/downloads/cib062818.pdf.  
 
177 See Medicaid.gov, Home & Community Based Services Training Series.  Available at https://www.medicaid.gov/medicaid/home-community-
based-services/home-community-based-services-training-series/index.html#health.  See also CMS, Home and Community-Based Services Quality 
Measure Set, letter to State Medicaid directors, July 2022.  Available at https://www.medicaid.gov/federal-policy-
guidance/downloads/smd22003.pdf.   
 
178 CMS, CMS Fast Facts.  Available at https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/cms-fast-
facts/index.html.  
 
179 OIG, Incidents of Potential Abuse and Neglect at Skilled Nursing Facilities Were Not Always Reported and Investigated, A-01-16-00509, 
June 2019.  Available at https://oig.hhs.gov/oas/reports/region1/11600509.asp.  
 
180 CMS, Updated Guidance for Nursing Home Resident Health and Safety.  Available at https://www.cms.gov/newsroom/fact-sheets/updated-
guidance-nursing-home-resident-health-and-safety. 
 
181 OIG, Safeguards Must Be Strengthened To Protect Medicare Hospice Beneficiaries From Harm, OEI-02-17-00021, July 2019.  Available at 
https://oig.hhs.gov/oei/reports/oei-02-17-00021.asp. 
 
182 OIG, CMS Could Use Medicare Data To Identify Instances of Potential Abuse or Neglect, A-01-17-00513, June 2019.  Available at 
https://oig.hhs.gov/oas/reports/region1/11700513.asp.  
 
183 OIG, In Five States There Was No Evidence That Many Children in Foster Care Had a Screening for Sex Trafficking When They Returned After 
Going Missing, OEI-07-19-00371, July 2022.  Available at https://oig.hhs.gov/oei/reports/OEI-07-19-00371.asp. 
 
184 OIG, A Resource Guide for Using Diagnosis Codes in Health Insurance Claims To Help Identify Unreported Abuse or Neglect, A-01-19-00502, 
July 2019.  Available at https://oig.hhs.gov/oas/reports/region1/11900502.asp?utm_source=website&utm_medium=asp&utm_campaign=abuse-
neglect-guide.  
 
185 OIG, Medicaid Data Can Be Used To Identify Instances of Potential Child Abuse or Neglect, A-01-19-00001, July 2020.  Available at 
https://oig.hhs.gov/oas/reports/region1/11900001.asp.  
 
186 Foundations for Evidence-Based Policymaking Act of 2018, P.L. 111-435 (January 14, 2019).  Enterprise data governance is one of the four areas 
of the Federal Data Strategy.  Available at https://strategy.data.gov/.  The Federal Data Strategy Action Plan requires all Federal agencies to make 
several data governance improvements including establishing a data governance body.  The plan includes Action 2: Constitute a Diverse Data 
Governance Body.  Available at https://strategy.data.gov/action-plan/#action-2-constitute-a-diverse-data-governance-body.  The HHS Data 
Governance Board serves as the principal data governance forum and decision-making body for managing HHSs data as a strategic asset and 
 
49 
   
 
supporting HHS in meeting its mission and agency priorities, including implementation of the Evidence Act.  See 
https://beta.healthdata.gov/dataset/HHS-Data-Governance-Board-Membership/w3i2-jayx/data. 
 
187 HHS, Office of the Chief Technology Officer, The State of Data Sharing at the U.S. Department of Health and Human Services.  Available at 
https://www.hhs.gov/sites/default/files/HHS_StateofDataSharing_0915.pdf. 
 
188 CDC, CDC Moving Forward, August 2022.  Available at https://www.cdc.gov/about/organization/cdc-moving-forward.html.  CDC, Data 
Modernization Initiative, May 2022.  Available at https://www.cdc.gov/surveillance/data-modernization/index.html.  
 
189 GAO, Agencies Need to Develop Modernization Plans for Critical Legacy Systems, GAO-19-471, June 2019.  Available at 
https://www.gao.gov/assets/gao-19-471.pdf.   
 
190 OIG, Operational Challenges Within ORR and the ORR Emergency Intake Site at Fort Bliss Hindered Case Management for Children, 
OEI-07-21-00251, September 2022.  Available at https://oig.hhs.gov/oei/reports/OEI-07-21-00251.asp. 
 
191 OIG, Communication and Management Challenges Impeded HHSs Response to the Zero-Tolerance Policy, OEI-BL-18-00510, March 2020.  
Available at https://oig.hhs.gov/oei/reports/oei-BL-18-00510.asp. 
 
192 HHS, Office of the Chief Technology Officer, The State of Data Sharing at the U.S. Department of Health and Human Services, September 2018.  
Available at https://www.hhs.gov/sites/default/files/HHS_StateofDataSharing_0915.pdf.  
 
193 T-MSIS is a joint effort by the States and CMS to build a national Medicaid data set that addresses identified problems with prior Medicaid data 
sets.  CMS intends for T-MSIS to provide States and the Federal Government with a national Medicaid data repository that would, among other 
functions, support program management, financial management, and program integrity.  See CMS, letter to State health officials, SHO #18-008, 
August 10, 2018.  Available at https://www.medicaid.gov/federal-policy-guidance/downloads/sho18008.pdf. 
 
194 CMS, Fact Sheet: Medicaid & CHIP and the COVID-19 Public Health Emergency, May 2021.  Available at https://www.cms.gov/newsroom/fact-
sheets/fact-sheet-medicaid-chip-and-covid-19-public-health-emergency. 
 
195 OIG, Data on Medicaid Managed Care Payments to Providers Are Incomplete and Inaccurate, OEI-02-19-00180, March 2021.  Available at 
https://oig.hhs.gov/oei/reports/OEI-02-19-00180.asp.  
 
196 HHS, HHS Information Technology Strategic Plan.  Available at https://www.hhs.gov/sites/default/files/hhs-it-strategic-plan-final-fy2021-
2023.pdf.  
 
197 As of 2019, 65 percent of physicians electronically exchanged health information through some mechanism (sending, receiving, or querying), 
and of those physicians more than 75 percent experienced improvements in their practice quality, care coordination, patient safety and efficiency.  
Office of the National Coordinator for Health Information Technology, Interoperability Among Office-Based Physicians in 2019, July 2022.  Available 
at https://www.healthit.gov/sites/default/files/2022-07/Interoperability_Among_Office-Based_Physicians_in_2019.pdf.  See also, OIG, Using 
Health IT for Care Coordination: Insights from Six Medicare Accountable Care Organizations, OEI-01-16-00180, May 2019.  Available at 
https://oig.hhs.gov/oei/reports/oei-01-16-00180.asp. 
 
198 National Cybersecurity Center of Excellence and National Institute of Standards and Technology, Implementing a Zero Trust Architecture, 
October 2020.  Available at https://www.nccoe.nist.gov/sites/default/files/legacy-files/zta-project-description-final.pdf.  A zero-trust cybersecurity 
approach removes the assumption of trust typically given to devices, subjects, and networks.  It focuses on accessing resources in a secure manner, 
regardless of network location, subject, and asset, and enforcing risk-based access controls while continually inspecting, monitoring, and logging 
interactions.   
 
199 GAO, NIH Needs to Take Further Actions to Resolve Control Deficiencies and Improve Its Program, GAO-22-104467, December 2021.  Available at 
https://www.gao.gov/assets/gao-22-104467.pdf.  
 
200 OIG, The IHS Telehealth System Was Deployed Without Some Required Cybersecurity Controls, A-18-21-03100, September 2022.  Available at 
https://oig.hhs.gov/oas/reports/region18/182103100.asp.  OIG, IHS Needs To Improve Oversight of Its Hospitals Opioid Prescribing and Dispensing 
Practices and Consider Centralizing Its Information Technology Functions, A-18-17-11400, July 2019.  Available at 
https://oig.hhs.gov/oas/reports/region18/181711400.asp.  
 
201 Fierce Healthcare, Healthcare data breaches hit all-time high in 2021, impacting 45M people, February 1, 2022.  Available at 
https://www.fiercehealthcare.com/health-tech/healthcare-data-breaches-hit-all-time-high-2021-impacting-45m-people. 
 
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202 Healthcare IT News, Healthcare breach costs hit record high, July 27, 2022.  Available at https://www.healthcareitnews.com/news/healthcare-
breach-costs-hit-record-high#:~:text=The%20average%20total%20cost%20of,identify%20and%20contain%20a%20breach. 
 
203 American Hospital Association reposted an FBI report, Unpatched and Outdated Medical Devices Provide Cyber Attack Opportunities, 
September 2022.  Available at https://www.aha.org/cybersecurity-government-intelligence-reports/2022-09-12-fbi-pin-tlp-white-unpatched-and-
outdated. 
 
204 HHS, FDA, Justification of Estimates for Appropriations Committees.  Available at https://www.fda.gov/media/157192/download. 
 
205 OIG, FDA Should Further Integrate Its Review of Cybersecurity Into the Premarket Review Process for Medical Devices, OEI 09 16 00220, 
September 2018.  Available at https://oig.hhs.gov/oei/reports/oei-09-16-00220.asp.  See also OIG, The Food and Drug Administrations Policies and 
Procedures Should Better Address Postmarket Cybersecurity Risk to Medical Devices, A-18-16-30530, October 2018.  Available at 
https://oig.hhs.gov/oas/reports/region18/181630530.asp.  
 
206 OIG, Medicare Lacks Consistent Oversight of Cybersecurity for Networked Medical Devices in Hospitals, OEI-01-20-00220, June 2021.  Available at  
https://oig.hhs.gov/oei/reports/OEI-01-20-00220.asp. 
 
207 ACF, HHS Task Force to Prevent and End Human Trafficking, Fact Sheet.  Available at https://www.acf.hhs.gov/archive/otip/fact-sheet/hhs-task-
force-prevent-and-end-human-trafficking. 
 
208 HHS, HHS Announces $3 Billion in American Rescue Plan Funding for SAMHSA Block Grants to Address Addiction, Mental Health Crisis, May 2021,  
Available at https://www.hhs.gov/about/news/2021/05/18/hhs-announces-3-billion-in-american-rescue-plan-funding-for-samhsa-block-
grants.html.  
 
209 ASPE, U.S. Department of Health and Human Services Overdose Prevention Strategy.  Available at 
https://aspe.hhs.gov/sites/default/files/documents/101936da95b69acb8446a4bad9179cc0/overdose-prevention-strategy.pdf.  
 
210 Executive Office of the President, Office of Management and Budget, memorandum, Promoting Accountability through Cooperation among 
Agencies and Inspectors General, December 3, 2021.  Available at https://www.whitehouse.gov/wp-content/uploads/2021/12/M-22-04-IG-
Cooperation.pdf.  
 
211 Executive Office of the President, Office of Management and Budget, memorandum, Advancing Effective Stewardship of Taxpayer Resources 
and Outcomes in the Implementation of the Infrastructure Investment and Jobs Act.  Available at https://www.whitehouse.gov/wp-
content/uploads/2022/04/M-22-12.pdf. 
 
212 HHS, IEA Mission Statement: Functions of the Office of Intergovernmental and External Affairs (IEA).  Available at 
https://www.hhs.gov/about/agencies/iea/about/index.html.  
 
213 CDC, Opioid Rapid Response Program (ORRP).  Available at https://www.cdc.gov/opioids/opioid-rapid-response-program.html.  
 
214 FDA, FDA Developing New Framework for Continued, Expanded Access to Infant Formula Options for U.S. Parents and Caregivers.  Available at 
https://www.fda.gov/news-events/press-announcements/fda-developing-new-framework-continued-expanded-access-infant-formula-options-us-
parents-and.  
 
215 ASPR, Public Health Supply Chain and Industrial Base One-Year Report.  Available at 
https://aspr.hhs.gov/MCM/IBx/2022Report/Pages/default.aspx. 
  
216 HHS, U.S. Transition to 988 Suicide & Crisis Lifeline Begins Saturday, July 15, 2022.  Available at 
https://www.hhs.gov/about/news/2022/07/15/us-transition-988-suicide-crisis-lifeline-begins-saturday.html. 
 
217 GAO, High Risk List.  Available at https://www.gao.gov/high-risk-list?source=email.  See also https://files.gao.gov/reports/GAO-22-
105291/index.html#appendix18.  
 
218 ASPR, Introducing the Administration for Strategic Preparedness and Response, July 2022.  Available at 
https://aspr.hhs.gov/ASPRBlog/Pages/BlogDetailView.aspx?ItemID=439.  
 
219 ASPR, ASPR's Response to the Monkeypox Outbreak, August 2021.  Available at https://aspr.hhs.gov/monkeypox/Pages/default.aspx.  
 
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220 CDC, Moving Forward, August 2022.  Available at https://www.cdc.gov/about/organization/cdc-moving-forward.html. 
 
221 OIG, OIG Resources for Emergency Preparedness and Response.  Available at https://www.oig.hhs.gov/reports-and-publications/featured-
topics/response/index.asp.  
 
222 OIG, Office of Refugee Resettlement's Influx Care Facility and Emergency Intake Sites Did Not Adequately Safeguard Unaccompanied Children 
From COVID-19, A-06-21-07002, June 2022.  Available at https://www.oig.hhs.gov/oas/reports/region6/62107002.asp.  
 
223 114th Congress (2021-2022), S.1397 - Tribal Health Data Improvement Act of 2021.  Available at https://www.congress.gov/bill/117th-
congress/senate-bill/1397/text.  
 
224 GAO, Tribal Epidemiology Centers: HHS Actions Needed to Enhance Data Access, GAO-22-104698, March 2022.  Available 
https://www.gao.gov/products/gao-22-104698. 
 
225 OIG, CDC Found Ways To Use Data To Understand and Address COVID-19 Health Disparities, Despite Challenges With Existing Data, 
OEI-05-20-00540, July 2022.  Available at https://oig.hhs.gov/oei/reports/OEI-05-20-00540.asp.  
 
226 CDC, CDC data show disproportionate COVID-19 impact in American Indian/Alaska Native populations, press release, August 19, 2020.  Available 
at https://www.cdc.gov/media/releases/2020/p0819-covid-19-impact-american-indian-alaska-native.html.  See also CDC, Morbidity and Mortality 
Weekly Report (MMWR), COVID-19 Among American Indian and Alaska Native Persons23 States, January 31July 3, 2020, August 2020.  
Available at  https://www.cdc.gov/mmwr/volumes/69/wr/mm6934e1.htm?s_cid=mm6934e1_w. 
 
227 CDC, Risk for COVID-19 Infection, Hospitalization, and Death By Race/Ethnicity, September 2022.  Available at 
https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-race-ethnicity.html. 
 
228 CDC, What is Health Equity?  Available at https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html. 
 
229 117th Congress (20212022), H.R.3684  Infrastructure Investment and Jobs Act.  Available at https://www.congress.gov/bill/117th-
congress/house-bill/3684.  
 
230 OIG, In Five States, There Was No Evidence That Many Children in Foster Care Had a Screening for Sex Trafficking When They Returned After 
Going Missing, OEI-07-19-00371, July 2022.  Available at https://oig.hhs.gov/oei/reports/OEI-07-19-00371.asp.  
 
231 OIG, National Snapshot of State Agency Approaches To Reporting and Locating Children Missing From Foster Care, A-07-20-06095, May 2022.  
Available at https://oig.hhs.gov/oas/reports/region7/72006095.asp.  
 
232 OIG, Case Study: Missouri's Efforts To Protect Children Missing From Foster Care, OEI-07-19-00372, September 2021.  Available at 
https://oig.hhs.gov/oei/reports/OEI-07-19-00372.asp.  
 
233 OIG, Communication and Management Challenges Impeded HHS's Response to the Zero-Tolerance Policy, OEI-BL-18-00510, March 2020.  
Available at https://oig.hhs.gov/oei/reports/oei-BL-18-00510.asp. 
 
234 OIG, HHS Should Improve Internal Coordination Regarding Unaccompanied Children, OEI-BL-20-00670, May 2022.  Available at 
https://oig.hhs.gov/oei/reports/OEI-BL-20-00670.asp. 
 
235 OIG, CMS Should Take Further Action To Address States With Poor Performance in Conducting Nursing Home Surveys, OEI-06-19-00460, 
January 2022.  Available at https://oig.hhs.gov/oei/reports/OEI-06-19-00460.asp.  
 
236 OIG, More Than One-Third of Medicaid-Enrolled Children in Five States Did Not Receive Required Blood Lead Screening Tests, OEI-07-18-00371, 
October 2021.  Available at https://oig.hhs.gov/oei/reports/OEI-07-18-00371.asp.  
 
237 OIG, Many Medicare Beneficiaries Are Not Receiving Medication to Treat Their Opioid Use Disorder, OEI-02-20-00390, December 2021.  Available 
at https://oig.hhs.gov/oei/reports/OEI-02-20-00390.asp. 
 
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