Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
 
A Message From Christi A. Grimm, Principal Deputy Inspector General 
I am pleased to submit this Semiannual Report to Congress summarizing 
the activities of the Department of Health and Human Services (HHS), 
Office of Inspector General (OIG), for the 6-month period ending on 
March 31, 2021. 
 
As COVID-19 relief and recovery efforts continue, oversight is imperative 
so that Americans can know whether these programs are working as 
intended and where improvements should be made.  OIG has 67 ongoing 
or completed reviews of COVID-19 related programs.  Completed work 
during this period detailed how the pandemic challenged the countrys 
health system.  This work included a review of infection control and 
complaint surveys at nursing homes during the early months of the 
pandemic, a second pulse survey of hospitals challenges in responding 
to COVID-19, and a survey of opioid treatment programs challenges and 
actions taken to provide services during the pandemic.  OIG partnered with the Pandemic Response 
Accountability Committee and other Offices of Inspector General on a report examining COVID-19 testing 
efforts across six Federal health care programs.  The report offers insights that policymakers should 
consider regarding availability, accessibility, and cost-effectiveness of COVID-19 testing.  
 
OIG is aggressively investigating pandemic-related fraud that harms individuals and jeopardizes public 
health efforts.  We are using every tool in our arsenal to bring criminals to justice, recover ill-gotten gains, 
and alert the public to emerging fraud schemes.  OIG is partnering on this effort with law enforcement and 
oversight agencies across Government, including through the recently announced COVID-19 Fraud 
Enforcement Task Force.  In addition, OIG is engaged in extensive oversight of the $463 billion in COVID 
relief and recovery funding provided to or flowing through HHS.  During this reporting period, OIG 
initiated additional audits of billions of dollars of funding from the Provider Relief Fund, and an OIG 
investigation led to the first criminal charge in the Nation related to misappropriating money received 
through the Provider Relief Fund.   
 
As the COVID-19 pandemic response and recovery evolves in the United States, OIGs oversight will evolve 
as well.  Although there has been progress on many fronts, much remains to be done, studied, and 
remedied going forward.  It will be critical to understand the efficacy of pandemic response efforts over 
time and the lessons learned for future pandemics and broader emergency preparedness.  For example, 
patient health and safety in nursing facilities will be an area of particular importance.  Moreover, the 
pandemic has more sharply focused health care providers and policymakers on broader changes to 
delivery of health care, such as expanding use of telehealth and shifting to value-based care.  Transparency 
and program integrity will be core to ensuring that these changes produce the intended benefits for 
patients, providers, and programs.  
 
Beyond COVID-19, OIG conducted substantial oversight of HHSs $2.2 trillion in spending in fiscal year 
2020.  During this reporting period, for example, investigative work led to 221 criminal actions and $1.37 
billion in expected investigative recoveries.  OIG audits identified $566 million in expected recoveries and 
$920 million in potential savings for HHS programs.  OIG reports addressed Medicare and Medicaid  
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
 
program integrity and improper payments, grant funding, the Indian Health Service, cybersecurity, and 
more.  Our mission is both broad and deep, touching at the heart of some of the most pressing challenges 
facing the Nation.  One such challenge is the care of unaccompanied children crossing the U.S. southern 
border.  OIG has continued its work overseeing HHSs Unaccompanied Children Program, including 
reviews of the contracting for, and safety and security of, HHS facilities for unaccompanied children.  
Another pressing challenge is health disparities.  OIG oversees many HHS programs that are intended to 
reach underserved populations and reduce health disparities.  OIG will continue to apply an equity lens to 
our work to identify opportunities for HHS programs to advance equity in areas such as access to care, 
quality of care, and health outcomes.   
 
Through the talents of 1,600 dedicated, mission-driven professionals, OIG provides objective, independent 
oversight to protect HHS programs and the health and well-being of the people they serve.  OIG pursues 
excellence and innovation in oversight and enforcement, supporting our reviews and investigations with 
modern data analytics techniques and cutting-edge technologies.  We marshal our resources to foster 
transparency, hold wrongdoers accountable, and deliver actionable recommendations and insights to 
policymakers in HHS, Congress, and the public.  To enhance our impact, OIG is assessing how to 
modernize the transparency and usability of our data, including information provided to the public and 
other stakeholders, to promote compliance with program requirements and reduce fraud, waste, and 
abuse.  Across our work, we strive to ensure that HHS programs operate as intended to deliver positive 
outcomes for beneficiaries and taxpayers alike.   
 
OIG appreciates the ongoing support of Congress and HHS for our important work.   
 
 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
 
Table of Contents 
 
OIGs Approach to Driving Positive Change  4 
Highlights of OIG Accomplishments  5 
OIG Participation in Congressional Hearings  13 
Selected Acronyms and Abbreviations  14 
Medicare and Medicaid Reports and Reviews  15 
Legal and Investigative Activities Related to Medicare and Medicaid  41 
Public Health and Human Service Agency Reports and Reviews   58 
Legal and Investigative Activities Related to Public Health and Human Service Agencies  68 
Other HHS-Related Reviews and Investigative Activities  69 
Appendix A: Questioned Costs and Funds To Be Put to Better Use  74 
Appendix B: Peer-Review Results  79 
Appendix C: Summary of Sanction Authorities  82 
Appendix D: Reporting Requirements in the Inspector General Act of 1978  85 
Appendix E: Reporting Requirements in the Inspector General Empowerment Act of 2016  88 
Appendix F: Anti-Kickback StatuteSafe Harbors  98 
 
OIGs Approach to Driving Positive Change 
THE DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS), Office of Inspector General (OIG), provides 
independent and objective oversight that promotes economy, efficiency, and effectiveness in HHS 
programs and operations.  OIGs program integrity and oversight activities are shaped by legislative and 
budgetary requirements and adhere to professional standards established by the 
Government Accountability Office (GAO), Department of Justice (DOJ), and Inspector General community.  
Through a nationwide network of audits, investigations, and evaluations, OIG carries out its mission to 
protect the integrity of HHS programs and the health and welfare of the people served by those programs.  
OIGs work is conducted by three operating componentsthe Office of Audit Services (OAS), Office of 
Evaluation and Inspections (OEI), and Office of Investigations (OI)with assistance from the Office of 
Counsel to the Inspector General (OCIG) and Mission Support and Infrastructure (MSI).  
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
OIG Organization 
Office of Audit Services 
OAS conducts audits of HHS programs and operations either through its own resources or by 
overseeing audit work done by others.  Audits examine the performance of HHS programs and/or 
of HHSs grantees and contractors in carrying out their respective responsibilities and provide 
independent assessments of HHS programs and operations.  These audits help reduce waste, 
abuse, and mismanagement and promote the economy, efficiency, and effectiveness of programs 
and operations throughout HHS. 
 
Office of Evaluation and Inspections 
OEI conducts national evaluations to provide HHS, Congress, and the public with timely, useful, 
and reliable information on significant issues.  These evaluations focus on preventing fraud, waste, 
and abuse and promoting economy, efficiency, and effectiveness in HHS programs.  OEI reports 
also present practical recommendations for improving program operations. 
 
Office of Investigations 
OI conducts criminal, civil, and administrative investigations of fraud and misconduct related to 
HHS programs, operations, and beneficiaries.  With investigators working in almost every State, the 
District of Columbia, and Puerto Rico, OI coordinates with DOJ and other Federal, State, and local 
law enforcement authorities.  OI also coordinates with OAS and OEI when audits and evaluations 
uncover potential fraud.  OIs investigative efforts often lead to criminal convictions, administrative 
sanctions, or civil monetary penalties (CMPs). 
 
Office of Counsel to the Inspector General 
OCIG provides legal services to OIG, rendering advice and opinions on HHS programs and 
operations and providing all legal support for OIGs internal operations.  OCIG represents OIG in all 
civil and administrative fraud and abuse cases involving HHS programs, including the False Claims 
Act, program exclusion, self-disclosure, and CMP cases.  In connection with these cases, OCIG also 
negotiates and monitors corporate integrity agreements (CIAs).  OCIG renders advisory opinions, 
issues compliance program guidance, publishes fraud alerts, and provides other guidance to the 
health care industry about the anti-kickback statute and other OIG enforcement authorities.   
 
Mission Support and Infrastructure 
MSI is composed of the Immediate Office of the Inspector General and the Office of Management 
and Policy.  MSI is responsible for coordinating OIG activities and providing mission support, 
including setting vision and direction for OIGs priorities and strategic planning; ensuring effective 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
management of budget, finance, human resource management, and other operations; and serving 
as a liaison with HHS, Congress, and other stakeholders.  MSI plans, conducts, and participates in a 
variety of cooperative projects within HHS and with other Government agencies.  MSI provides 
critical data analytics, data management, and information technology (IT) infrastructure that 
enables OIG components to conduct their work efficiently and effectively.  
 
OIG Strategic Publications
 
 
HHS-OIG Strategic Plan 
OIGs Strategic Plan outlines the approach to protecting the integrity of HHS programs.  The plan 
has three key goals: (1) to fight fraud, waste, and abuse; (2) to promote quality, safety, and value in 
HHS programs and for HHS beneficiaries; and (3) to advance excellence and innovation.  These 
goals drive OIGs work planning for audits and evaluations as well as OIGs approach to 
enforcement.  These goals also serve as a starting point for OIGs assessment of its own 
effectiveness. 
 
OIG Work Plan 
OIGs Work Plan sets forth projects that OIG plans to undertake during the fiscal year (FY) and 
beyond.  Projects listed in the Work Plan span HHSs operating divisions (OpDivs), which include 
the Centers for Medicare & Medicaid Services (CMS), public health agencies such as the Centers for 
Disease Control and Prevention (CDC) and the National Institutes of Health (NIH), and human 
services agencies such as the Administration for Children and Families (ACF) and the 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
Administration for Community Living (ACL).  The Work Plan also includes oversight of State and 
local governments use of Federal funds as well as the administration of HHS.  Some of the projects 
described in the Work Plan are statutorily required. 
 
OIGs Top Recommendations 
OIG drives positive change by not only identifying risks, problems, abuses, and deficiencies, but 
also recommending solutions to address them.  OIG maintains a list of recommendations it has 
made to address vulnerabilities detected in its reviews, and it keeps track of whether these 
recommendations have been implemented.  OIG systematically follows up on its recommendations 
with the relevant HHS programs.  From among the recommendations that have not been 
implemented, OIG identifies the top recommendations that, if implemented, are likely to garner 
significant savings and improvements in quality, efficiency, and effectiveness.  OIG compiles these 
recommendations in the Solutions To Reduce Fraud, Waste, and Abuse in HHS Programs: OIGs Top 
Recommendations (previously known as the Compendium of Unimplemented Recommendations). 
 
Top Management and Performance Challenges Facing HHS 
To focus HHSs attention on the most pressing issues, each year OIG identifies the Top 
Management and Performance Challenges facing HHS.  These top challenges arise across HHS 
programs and cover critical HHS responsibilities, including delivering quality services and benefits, 
exercising sound fiscal management, safeguarding public health and safety, and enhancing 
cybersecurity. 
 
OIGs Semiannual Report to Congress  
OIGs Semiannual Report(s) to Congress (Semiannual Reports) describe OIGs work on identifying 
significant problems, abuses, deficiencies, remedies, and investigative outcomes relating to the 
administration of HHS programs and operations that were disclosed during the reporting period.  
In the report below, we present OIG expected recoveries, criminal and civil actions, and other 
statistics as a result of our work for the semiannual reporting period of October 1, 2020, through 
March 31, 2021.  We also highlight some of our work completed during this semiannual reporting 
period. 
 
 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
Highlights of OIG Accomplishments 
HHS-OIGS SEMIANNUAL REPORT TO CONGRESS (Semiannual Report) describes OIGs work identifying 
significant risks, problems, abuses, deficiencies, remedies, and investigative outcomes relating to the 
administration of HHS programs and operations that were disclosed during the semiannual reporting 
period October 1, 2020, through March 31, 2021.  In this highlights section, we present data on OIG reports 
issued, expected recoveries, criminal and civil actions, and other statistics resulting from our work for both 
the semiannual reporting period and the entirety of FY 2021.  We then highlight significant results from 
selected audits, evaluations, and enforcement activities completed during the reporting period. 
 
At-a-Glance Highlights 
Statistic  Semiannual Reporting Period 
 (10/1/20203/31/2021)  
Audit Reports Issued  75 
Evaluations Issued  20 
Expected Audit Recoveries  $566.46 million 
Potential Savings  $919.97 million 
New Audit and Evaluation  228 
Recommendations 
Recommendations Implemented by  181 
HHS OpDivs 
Expected Investigative Recoveries  $1.37 billion 
Criminal Actions  221 
Civil Actions  272 
Exclusions  1,036 
 
Results for the Semiannual Reporting Period 
During this semiannual reporting period (October 1, 2020, through March 31, 2021), we issued 75 audit 
reports and 20 evaluation reports.  Our audit work identified $566.46 million in expected recoveries (costs 
questioned by OIG because of an alleged violation, costs not supported by adequate documentation, or 
the expenditure of funds where the intended purpose is unnecessary or unreasonable).  Our audit work 
also identified $919.97 million in potential savings for HHSfunds that could be saved if HHS implemented 
all of OIGs audit recommendations.  During this reporting period, OIG made 228 new audit and evaluation 
recommendations to encourage positive change in HHS programs.  Meanwhile, HHS OpDivs implemented 
181 prior recommendations to drive positive impact for HHS programs and beneficiaries. 
 
OIG also remains at the forefront of the Nations efforts to fight fraud in HHS programs and hold 
wrongdoers accountable for their actions.  Along with our partners DOJ, Medicaid Fraud Control Units 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
(MFCUs or Units), and other Federal, State, and local law enforcement agencies, we detect, investigate, and 
prosecute fraud through a coordinated and data-driven approach.  OIGs investigative work led to 
$1.37 billion in expected investigative recoveries and 221 criminal actions during this reporting period.  OIG 
also took civil actions, such as assessing monetary penalties, against 272 individuals and entities, and 
excluded 1,036 individuals and entities from Federal health care programs. 
 
OIG continues to focus on the most significant and high-risk issues in health care and human services.  Our 
mission is to provide objective oversight to promote the economy, efficiency, effectiveness, and integrity of 
HHS programs, as well as the health and welfare of the people they serve.  Below we highlight results from 
selected OIG oversight and enforcement activities from the semiannual reporting period of October 1, 
2020, through March 31, 2021, organized by subject area.  A comprehensive list of OIG work during the 
reporting period follows, and Appendices AF provide data to meet the reporting requirements in the 
Inspector General Act of 1978. 
 
Responding to the COVID-19 Pandemic 
OIG is conducting and continues to plan innovative work to advance the four goals that drive OIGs 
strategic planning and mission execution with respect to HHSs COVID-19 response and recovery.  These 
goals are to: (1) protect people, (2) protect funds, (3) protect infrastructure, and (4) promote effectiveness 
of HHS programs.   
OIG is using risk assessment and data analytics to identify, monitor, and target potential fraud, waste, and 
abuse affecting HHS programs and beneficiaries and to promote the effectiveness of HHSs COVID-19 
response and recovery programs.  OIG is coordinating our COVID-19 work with key oversight and law 
enforcement partners, including the Pandemic Response Accountability Committee; Federal, State, local, 
and Tribal entities; and GAO, among others, to ensure adequate oversight, avoid duplication, and share 
insights.  OIG created a COVID-19 web page that alerts the public about emerging fraud schemes related 
to COVID-19.  Additional information about the OIG COVID-19 strategic plan and work related to COVID-
19 is available on our website, COVID-19 Portal.   
Significant OIG work during this semiannual reporting period related to COVID-19 includes the following: 
OIG analyzed onsite surveys of nursing homes during the COVID-19 pandemic and identified opportunities 
for improvement.  Nursing home residents are particularly vulnerable to infectious diseases such as 
COVID-19, and infection control has been a persistent problem for most nursing homes.  In a review of 
infection control and complaint surveys conducted during March 23May 30, 2020, OIG found that some 
efforts instituted by CMS have resulted in less comprehensive oversight of nursing homes and residents.  
OIG recommended that CMS assess the results of the infection control survey and revise the survey as 
appropriate.  (See report OEI-01-20-00430.)   
 
 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
OIG conducted a nationwide pulse survey of hospitals responding to the COVID-19 pandemic.  Hospitals 
reported that COVID-19 has significantly strained health care delivery.  In February 2021, hospitals reported 
that operating in survival mode for an extended period of time has created new and different problems 
than experienced earlier in the pandemic and exacerbated longstanding challenges in health care delivery, 
access, and health outcomes.  (See report OEI-09-21-00140.)  
OIG engaged with nursing homes and emergency medical services (EMS) providers throughout the 
country to help providers report allegations of unsafe practices.  OIG identified nursing homes as having a 
significant number of COVID-19-related deaths and provided these nursing homes and EMS providers in 
close proximity to these facilities with information on how to report allegations of unsafe practices 
resulting in COVID-19 exposure, overall quality of care concerns, patient abuse and neglect, and fraud and 
misconduct.  OIG also maintains a web page to provide additional elder care and safety awareness 
resources and support information for seniors, their families, and caregivers.  (See Operation Care Web 
Page.) 
OIG co-led the first report by the Pandemic Response Accountability Committee (PRAC) Health 
Subcommittee focused on COVID-19 testing data across six Federal programs.  We partnered with six 
Federal OIGs to analyze COVID testing in selected programs in each of our Departments.  In HHS, OIG 
found that Medicare Part B paid for nearly 8 million COVID-19 tests from February through August 2020, 
with 13 percent of beneficiaries receiving at least one test.  The proportion of Part B beneficiaries tested 
largely matched the distributions across overall Medicare Part B enrollment when compared by age, 
gender, and race/ethnicity.  Medicare Part B paid more than $551 million for COVID-19 tests during that 
time, with an average of $69 per test.  (See report Federal COVID-19 Testing Report: Data Insights from Six 
Federal Health Care Programs.)  
OIG alerted the public about fraud schemes related to COVID-19.  Scammers are using telemarketing calls, 
text messages, social media platforms, and door-to-door visits to perpetrate COVID-19-related scams.  
Fraudsters are offering COVID-19 tests, COVID-19 vaccine appointments, HHS grants, and Medicare 
prescription cards in exchange for personal details, including Medicare information.  However, these 
services are unapproved and illegitimate.  The personal information collected can be used to fraudulently 
bill Federal health care programs and commit medical identity theft.  (See Fraud Alert.)  
Ensuring Health and Safety of Children Served by HHS 
OIG has devoted substantial oversight efforts to protect children served by HHS programs such as the 
Unaccompanied Children (UC) Program and the Child Abuse Prevention and Treatment Act (CAPTA).   
The Office of Refugee Resettlement (ORR) did not award and manage the Homestead influx care facility 
contracts in accordance with Federal statutes, regulations, and HHS policies and procedures.  ORR did not 
award a $341 million sole source contract to Comprehensive Health Service, LLC, in accordance with 
Federal regulations and did not effectively manage its HHS contracts for services provided at Homestead 
in accordance with Federal statutes, regulations, and HHS policies and procedures.  (See report A-12-20-
20001.) 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
OIG found that ACF does little to oversee States compliance with CAPTAs requirement for court 
representation, relying instead on States self-certification.  OIG has found that ACF is neither supporting 
States in implementing the CAPTAs requirement for court representatives for child victims of abuse and 
neglect, nor is ACF monitoring States compliance with the requirement.  As a result, ACF cannot ensure 
that all such victims have court representation to protect their best interests.  (See report OEI-09-18-
00430.) 
Preventing and Treating Opioid Misuse 
OIG continues to prioritize oversight activities to protect beneficiaries from prescription drug abuse and to 
provide insight into the challenges the COVID-19 pandemic is having on opioid users.  
OIG found that the COVID-19 pandemic may be putting Medicaid beneficiaries at greater risk of opioid 
misuse or overdose in 2020 and beyond.  OIG found that across 6 Appalachian States in 2018, nearly 6,000 
Medicaid beneficiaries received potentially harmful amounts of opioids; more than 450 of these 
beneficiaries were at serious risk of opioid misuse or overdose; and 19 prescribers stood out in their 
prescribing of opioids to beneficiaries at serious risk.  (See report OEI-05-19-00410.) 
OIG found that during the first 8 months of 2020and the onset of the COVID-19 pandemicat least 
5,000 Medicare Part D beneficiaries per month suffered opioid overdoses and almost a quarter of a million 
received high amounts of opioids.  At the same time, the number of beneficiaries receiving drugs for 
medication-assisted treatment (MAT) increased slightly and the number receiving naloxone declined 
through April 2020 but increased in the following months.  (See report OEI-02-20-00400.) 
OIG found that few patients received high amounts of opioids from Indian Health Service (IHS)-run 
pharmacies, and IHS reported positive outcomes from opioid-related initiatives.  However, IHS has 
opportunities to improve the efficiency of its opioid monitoring systems and IHS staff reported challenges 
in using State-run prescription drug monitoring programs (PDMPs) and in tracking care outside of IHS.  
(See report OEI-05-18-00470.) 
OIG surveyed opioid treatment programs (OTPs) to quantify the impact that the COVID-19 pandemic has 
had on OTPs.  OIG found that OTPs reported a variety of challenges they have encountered during the 
COVID-19 pandemic and actions they have taken to address those challenges while ensuring the continuity 
of needed services and protecting the health and safety of their patients and staff.  The information 
provides Substance Abuse and Mental Health Services Administration and other decisionmakers with a 
national snapshot of OTPs challenges and the actions they have taken to continue providing services 
during the pandemic.  (See report A-09-20-01001.)  
Ensuring Medicare Program Integrity 
A key component of OIGs mission is to promote integrity and efficiency in Medicare through a nationwide 
program of audits, evaluations, inspections, investigations, and enforcement actions. 
OIG found that hospitals did not comply with Medicare requirements for reporting cardiac device credits, 
resulting in potential Medicare overpayments.  OIG found that hospitals likely did not comply with 
Medicare requirements associated with reporting manufacturer credits for recalled or prematurely failed 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
cardiac medical devices.  As a result, 911 hospitals received payments of $76 million rather than the $43 
million they should have received, resulting in $33 million in potential overpayments.  It was determined 
that Medicare contractors made these overpayments because they do not have a post payment review 
process to ensure that hospitals reported manufacturer credits for cardiac medical devices.  (See report A-
01-18-00502.) 
OIG found that CMS and its contractors did not use Comprehensive Error Rate Testing (CERT) data to 
identify and focus on error-prone providers for review and corrective action.  Using CERT data, OIG 
identified 100 error-prone providers from 2014 through 2017.  Of the $5.8 million reviewed by CERT for 
these providers, $3.5 million was incorrect, which is an improper payment rate of 60.7 percent.  We 
determined that during the same period, Medicare made $19.1 billion in fee-for-service (FFS) payments to 
these 100 error-prone providers.  (See report A-05-17-00023.) 
OIG found that inpatient hospital billing in the years leading up to the COVID-19 pandemic indicates that 
some stays billed at the highest severity level in the diagnosis-related group (DRG) could be susceptible to 
inappropriate billing.  OIG found that the number of inpatient stays billed at the highest severity level in 
the DRG increased by almost 20 percent from FY 2014 through FY 2019, ultimately accounting for nearly 
half of all Medicare spending on inpatient hospital stays.  (See report OEI-02-18-00380.) 
OIG found that Medicare made payments that were not in accordance with Federal requirements to 
physicians for selected facet-joint injection sessions, and Noridian Healthcare Solutions made improper 
Medicare payments of $4 million to physicians in Jurisdiction E for spinal facet-joint injections.  The 
Medicare administrative contractors (MACs) in 11 jurisdictions with a coverage limitation made improper 
payments of $748,555 for selected facet-joint injection sessions.  OIG also estimated that Noridian 
improperly paid physicians $4.2 million for spinal facet-joint injections in Jurisdiction E, which covers 
California, Hawaii, Nevada, and the U.S. territories of American Samoa, Guam, and Northern Mariana 
Islands.  (See reports A-09-20-03003 and A-09-20-03010.) 
OIG found that most of the selected diagnosis codes that Blue Cross Blue Shield of Michigan (BCBSM) 
submitted to CMS for use in its risk adjustment program did not comply with Federal requirements.  OIG 
found that the diagnosis codes that BCBSM submitted to CMS were not supported in the medical records 
and resulted in net overpayments of $668,264.  On the basis of our sample results, we estimated that 
BCBSM received at least $14.5 million of net overpayments for these high-risk diagnosis codes in 2015 and 
2016.  (See report A-02-18-01028.) 
Protecting Beneficiaries  
A top priority for OIG is protecting the health and well-being of HHS beneficiaries, including residents in 
nursing homes and beneficiaries receiving hospice care.  
OIG found that CMS can better leverage staffing data to provide consumers with required information and 
to help State survey agencies protect nursing home residents.  CMS has taken important steps to build a 
new source for data on nursing home staffing on the Care Compare website and to use these data to 
better inform consumers and improve nursing home oversight.  However, OIG found that the staffing 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
information that CMS provides on Care Compare could be more useful to consumers if it included data on 
nurse staff turnover and tenure, as required by Federal law.  (See report OEI-04-18-00451.) 
The chief executive officer (CEO) of a Texas-based group of hospice and home health entities was 
sentenced to 15 years in prison for falsely enrolling patients in hospice programs.  On February 3, 2021, 
Henry McInnis was sentenced to 15 years in prison for falsely telling thousands of patients with long-term 
incurable diseases they had less than 6 months to live, to enroll the patients in hospice programs for which 
they were otherwise unqualified, thereby increasing revenue to the company.  OIG partnered with 
investigators from the Texas Medicaid Fraud Control Unit and the Federal Bureau of Investigation (FBI) to 
investigate the case.  Between 2009 and 2018, over $150 million in false and fraudulent claims for hospice 
and other health care services were submitted by McInnis and his co-conspirators.  
Fighting Fraud To Protect the Medicare and Medicaid Programs 
OIG remains at the forefront of the Nations efforts to fight fraud in HHS programs and hold wrongdoers 
accountable for their actions.  
An individual was sentenced to 70 months in prison and ordered to pay restitution for health care fraud 
and conspiring to unlawfully distribute controlled substances.  Dr. Eugene Gosy was sentenced to 70 
months in prison plus 3 years of supervised release and ordered to pay $344,562 in restitution to his 
victims, including Medicare.  OIG partnered on this investigation with investigators from the FBI and the 
Drug Enforcement Administration (DEA).  Dr. Gosy and his employees issued more prescriptions for 
controlled substances annually than any other prescriber or prescribing entity in New York State, including 
hospitals.  
Ensuring Medicaid Program Integrity 
Medicaid is the largest Federal health care program, with over 70 million individuals enrolled, and 
represents over one-sixth of the national health economy.  Medicaid is administered by States in 
accordance with Federal requirements.  The program is funded jointly by the Federal Government and 
States.  For FY 2019, CMS estimated Federal and State Medicaid expenditures of $614 billion. 
OIG found that most States did not provide complete or accurate payment data in the Transformed 
Medicaid Statistical Information System (T-MSIS) on managed care payments to providers.  In addition, 
two States failed to provide any data for January 2020.  Effective oversight of Medicaid requires a national 
system with complete and accurate data.  CMS established the T-MSIS for this purpose.  Payment data are 
a critical component of T-MSIS.  These data include the amounts paid, billed, and allowed for every service 
provided to Medicaid enrollees, including those services provided through managed care.  (See report 
OEI-02-19-00180.) 
OIG conducted high-level risk assessment of Puerto Ricos Medicaid program and identified key programs 
areas at high risk for improper Medicaid program payments.  Specifically, we identified program integrity, 
beneficiary eligibility, provider enrollment, overpayment reporting, and contracting as key areas at high 
risk for improper Medicaid program payments.  We used the results of this assessment to set priorities for 
future audits in Puerto Ricos program.  (See report A-02-20-01011.) 
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  Department of Health and Human Services, Office of Inspector General 
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OIG found that New York claimed Federal reimbursement for personal care services that did not comply 
with certain Federal and State requirements.  Specifically, New York received reimbursement for personal 
care services for which there was no valid nursing or social assessment, no independent medical review, no 
valid physicians order or the order was not timely, no documentation of services provided, and no plan of 
care.  Moreover, the health and safety of some Medicaid beneficiaries may have been put at risk because 
their personal care aides had not undergone a criminal history check or did not meet training 
requirements.  (See report A-02-19-01016.) 
Ensuring the Financial Integrity of HHS Programs 
To protect financial integrity, OIG continues to examine how HHS may improve controls to prevent and 
detect improper and unauthorized payments, strengthen oversight of external funding recipients use of 
Federal funds, and implement a robust program integrity strategy to protect current and future HHS 
programs. 
OIG found that CMS authorized hundreds of millions of dollars in advanced premium tax credits (APTCs) 
on behalf of enrollees who did not make their required premium payments.  We estimated that 
$950 million of $42.5 billion in authorized APTCs during 2018 were unallowable because they were made 
on behalf of enrollees who did not make their required premium payments.  (See report A-02-19-02005.) 
OIG found that although CDC implemented corrective actions to improve oversight of the Presidents 
Emergency Plan for AIDS Relief (PEPFAR) recipients, some internal control weaknesses remained.  OIG 
identified six trends in which recipients: (1) had either inadequate or no policies and procedures related to 
management of PEPFAR funds, (2) did not comply or may not have complied with HHS regulations 
regarding value added tax, (3) had transactions that were either not supported or unallowable, (4) did not 
accurately report PEPFAR expenditures on the financial reports or did not file reports on time, (5) did not 
have annual audits performed or submitted on time, and (6) could not reconcile PEPFAR expenditures to 
amounts reported on their financial reports.  (See report A-04-18-01010.) 
OIG found that in selected states, 67 of 100 health centers did not use their Health Resources and Services 
Administration (HRSA) Access Increases in Mental Health and Substance Abuse Services (AIMS) grant 
funding in accordance with Federal requirements.  OIG found that HRSA did not effectively monitor health 
centers progress toward meeting service expansion requirements and did not ensure that health centers 
spent their AIMS grant funds in accordance with grant requirements.  (See report A-02-19-02001.) 
Promoting High Quality and Safe Care in IHS  
IHS is the principal Federal health care provider for American Indians and Alaska Natives.  HHS must 
ensure adequate access to quality care and safety for IHS beneficiaries.   
OIG found that an estimated 13 percent of patients in IHS hospitals experienced patient harm events, with 
higher rates of harm in smaller hospitals.  Harm events were more prevalent among older adults and labor 
and delivery patients, and about half of events were preventable (i.e., they could have been avoided if 
patients had been given better care).  (See report OEI-06-17-00530.) 
11 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
OIG found instances of IHS labor and delivery care not following national clinical guidelines or best 
practices.  Through medical review of 48 IHS labor and delivery patients, OIG found that 27 of the patients 
in our sample received care at IHS hospitals that did not follow national clinical guidelines or best 
practices.  Of these 27 patients, 6 patients received care that did not follow one or more national clinical 
guidelines and did not use the best practice of quantitative estimation of blood loss associated with a 
postpartum hemorrhage.  Of the remaining 21 patients, 13 received care that did not meet one or more 
national clinical guidelines and 8 received care that did not use the best practice of quantitative estimation 
of blood loss.  (See report OEI-06-19-00190.) 
OIG found that IHS facilities made progress incorporating patient protection policies, but challenges 
remain.  In recent years, IHS had cases of health care providers abusing patients under facility care, 
including a pediatrician who was convicted of multiple counts of child sexual abuse.  Although OIG found 
that IHS facilities made strides to incorporate the agencys updated policies to prevent and address child 
sexual abuse by health care providers, OIG recommended that IHS should work to resolve the challenges 
that its facilities report in carrying out the policies and their concerns that staff and patients may not feel 
safe reporting abuse.  (See report OEI-06-19-00331.) 
Ensure Implementation of Geospatial-Related Requirements Across HHS  
The Geospatial Data Act of 2018 (GDA) mandates that OIG conduct an audit of HHSs collection, 
production, acquisition, maintenance, distribution, use, and preservation of geospatial data. 
OIG found that HHS made some progress to comply with GDA, but we identified certain covered agency 
responsibilities that HHS had yet to meet.  OIG also found that HHS had not maintained a departmentwide 
inventory of all geospatial data assets, as required by GDA and had not designated a senior agency official 
in accordance with OMB guidance to Federal agencies.  (See report A-18-20-11500.) 
Combating Cybersecurity Threats Within HHS  
OIG continues to make strides at protecting the cybersecurity of HHS agencies and programs.  
OIG identified cybersecurity vulnerabilities and possible compromise of HHSs systems and networks.  
Because of the current public health emergency and increased cyberactivity, we only posted the title of our 
 
cybersecurity audits.  (See reports A-18-19-06002, A-18-20-06001, and A-18-20-08012.)  
12 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
OIG Participation in Congressional Hearings 
 
OIG did not participate in any congerssional hearings during the semiannnual reporting period.  
 
 
 
 
13 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
Selected Acronyms and Abbreviations  
 
ACA  Patient Protection and Affordable Care Act 
ACF  Administration for Children and Families 
ACL  Administration for Community Living 
CDC  Centers for Disease Control and Prevention 
CIA  corporate integrity agreement 
CMP  civil monetary penalty 
CMS  Centers for Medicare & Medicaid Services 
DOJ  Department of Justice 
DME  durable medical equipment 
EMTALA  Emergency Medical Treatment and Labor Act 
FDA  Food and Drug Administration 
GAO  Government Accountability Office 
HHS  Department of Health and Human Services 
HIPAA  Health Insurance Portability and Accountability Act of 1996 
HRSA  Health Resources and Services Administration 
IHS  Indian Health Service 
MCO  managed care organization 
MFCU  Medicaid Fraud Control Unit 
NIH  National Institutes of Health 
OAS  Office of Audit Services 
OASH  Office of Safety and Health 
OCIG  Office of Counsel to the Inspector General 
OEI  Office of Evaluation and Inspections 
OI  Office of Investigations 
OIG  Office of Inspector General 
OMB  Office of Management and Budget 
OS  Office of the Secretary 
SAMHSA   Substance Abuse and Mental Health Services Administration 
14 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
Medicare and Medicaid Reports and Reviews 
Medicare Program Reports and Reviews 
Financial Management and Improper Payments 
 
Cedars-Sinai Medical Center: Audit of Medicare Payments for Bariatric Surgeries 
(A-09-18-03010), October 2020  
 
Cedars-Sinai Medical Center (Cedars-Sinai) did not fully comply with Medicare requirements and 
the Medicare contractors local coverage determinations (LCDs) and local coverage article (LCA) 
when billing for bariatric surgeries.  For 37 of the 62 claims we reviewed, Cedars-Sinai complied 
with Medicare requirements and the specifications in Noridians LCDs and LCA for documenting 
previously unsuccessful medical treatment for obesity.  However, Cedars-Sinai did not comply with 
the specifications in the LCDs for 12 claims, with payments totaling $154,074, and did not comply 
with the specifications in the LCA for 13 claims, with payments totaling $175,199.   
 
Cedars-Sinai partially agreed with our recommendations that it: (1) refund to Medicare the portion 
of the $154,074 in overpayments for bariatric surgery claims that did not comply with the 
specifications in the LCDs and that are within the 4-year reopening period; (2) exercise reasonable 
diligence to identify, report, and return any overpayments in accordance with the 60-day rule; (3) 
work with Noridian to take action deemed necessary regarding $175,199 in payments for bariatric 
surgery claims with dates of service on or after the effective date of the LCA; (4) update its patient 
checklist to include all of Noridians specifications for billing bariatric surgeries; and (5) obtain 
supporting medical record documentation from other providers before performing any future 
bariatric surgeries. 
   
Medicare Improperly Paid Physicians for More Than Five Spinal Facet-Joint Injection Sessions During 
 
a Rolling 12-Month Period (A-09-20-03003), October 2020, and 
Noridian Healthcare Solutions, LLC, Made Improper Medicare Payments of $4 Million to Physicians in 
 
Jurisdiction E for Spinal Facet-Joint Injections (A-09-20-03010), February 2021 
 
Medicare did not pay physicians for selected facet-joint injection sessions in accordance with 
Federal requirements, and Noridian Healthcare Solutions, LLC (Noridian), did not pay physicians in 
Jurisdiction E for spinal facet-joint injections in accordance with Medicare requirements.  
Specifically, the MACs in the 11 jurisdictions with a coverage limitation made improper payments of 
$748,555.  If the remaining MAC jurisdiction had kept the coverage limitation in place during our 
audit period, Medicare could have saved $513,328.  
 
15 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
CMS concurred with our recommendations that, for the 11 MAC jurisdictions with a coverage 
limitation for the number of facet-joint injection sessions during a rolling 12-month period, it: (1) 
direct the MACs that oversee the 11 jurisdictions to recover $748,555 in improper payments made 
to physicians; (2) instruct the MACs to notify physicians so that they can exercise reasonable 
diligence to identify, report, and return any overpayments in accordance with the 60-day rule and 
identify any returned overpayments as having been made; (3) develop oversight mechanisms for 
the MACs to implement to prevent or detect payments to physicians for more than 5 facet-joint 
injection sessions received by beneficiaries during a rolling 12-month period; and (4) direct the 
MACs that oversee the 11 jurisdictions to review claims for facet-joint injections after our audit 
period to identify instances in which Medicare inappropriately paid physicians and recover any 
improper payments identified.  CMS concurred with our recommendation that, for the remaining 
MAC jurisdiction, which did not have a coverage limitation, it consider working with the MAC to 
determine whether it should re-implement this coverage limitation, which could have saved 
$513,328 during our audit period. 
 
Of Noridians sampled 100 beneficiary days, 49 complied with the requirements; however, the 
remaining 51 beneficiary days did not comply with 1 or more of the requirements.  As a result, 
Noridian improperly paid physicians $12,546.  On the basis of our sample results, we estimated that 
Noridian improperly paid physicians $4.2 million for facet-joint injections for our audit period.  
 
Noridian concurred with our recommendations that it: (1) recover $12,546 in improper payments 
made to physicians; (2) based on the results of this audit, notify appropriate physicians (i.e., those 
for whom Noridian determines this audit constitutes credible information of potential 
overpayments) so that the physicians can exercise reasonable diligence to identify, report, and 
return any overpayments in accordance with the 60-day rule and identify any of those returned 
overpayments as having been made in accordance with this recommendation; and (3) provide 
annual training to physicians and their billing staff in Jurisdiction E specific to Medicare 
requirements for billing of facet-joint injections, which could have saved an estimated $4.2 million 
for our audit period. 
 
CMS Did Not Ensure That Medicare Hospital Payments for Claims That Included Medical Device 
Credits Were Reduced in Accordance With Federal Regulations, Resulting in as Much as $35 Million in 
 
Overpayments (A-07-19-00560), November 2020 
CMS did not ensure that Outpatient Prospective Payment System (OPPS) payments for claims that 
included medical device credits were reduced in accordance with Federal regulations.  These 
regulations require the use of the device offset amount100 percent of the device offset amount 
for each without cost or full credit replacement device and 50 percent of the device offset amount 
for each partial credit replacement devicewhen calculating the reduced OPPS payment amount.  
By following the Medicare Claims Processing Manual (the Manual) instructions, MACs did not 
comply with these regulations when calculating the claims that we reviewed.  As a result, Medicare 
made estimated overpayments of as much as $35.4 million to hospitals for our audit period.  This 
16 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
error occurred because as part of Federal rulemaking in calendar year (CY) 2014, CMS announced 
its intention to update Federal regulations to reduce OPPS payments for replaced medical devices.  
This intended update was not finalized in the text of the Federal regulations.  However, CMS 
revised the relevant language in its guidancethe Manual. 
 
CMS did not concur with our recommendations that it: (1) work with the MACs to recover from 
hospitals Medicare OPPS overpayments, which total as much as an estimated $35.4 million; (2) 
work with the MACs to recover Medicare OPPS overpayments from hospitals for any additional 
claims that included medical device credits and that were outside of our audit period; and (3) revise 
the OPPS regulations or the Manual instructions to resolve the conflict between these 
requirements for OPPS claims with medical device credits. 
 
Despite Savings on Many Lab Tests in 2019, Total Medicare Spending Increased Slightly Because of 
Increased Utilization in Certain High-Priced Tests (OEI-09-20-00450), December 2020    
 
In the second year of the new Medicare Part B clinical laboratory payment system that is required 
by the Protecting Access to Medicare Act of 2014, reduced payment rates on many lab tests 
resulted in savings for Medicare.  However, total Medicare Part B spending on lab tests increased 
slightly because of increased utilization and spending on certain high-priced tests, such as genetic 
tests.  Our data brief contains no recommendations.    
 
The Centers for Medicare & Medicaid Services Could Improve Its Wage Index Adjustment for 
 
 
Hospitals in Areas With the Lowest Wages (A-01-20-00502), December 2020 
When postpandemic conditions allow for new initiatives, CMS could consider focusing the bottom 
quartile wage index adjustment more precisely toward the hospitals that are the least able to raise 
wages without that adjustment.  Those hospitals are the ones with low or negative profit margins 
rather than higher, positive profit margins.  CMS could also consider studying the question of why 
some hospitals in a particular area were able to pay higher wages than other hospitals in the same 
area prior to the implementation of the bottom quartile wage index adjustment.  More information 
might enable CMS to focus the adjustment even more precisely. 
 
Trend Toward More Expensive Inpatient Hospital Stays in Medicare Emerged Before COVID-19 and 
Warrants Further Scrutiny (OEI-02-18-00380), January 2021 
 
Hospitals play an essential role in our health care system; nearly one-fifth of all Medicare payments 
are for inpatient hospitalizations.  Inpatient hospital billing in the years leading up to the pandemic 
indicates that some stays at the highest severity level could be susceptible to inappropriate billing.  
Our findings can help CMS gain a better understanding of how hospitals bill Medicare and improve 
its oversight of hospital billing.  Our recommendation was for it to conduct targeted reviews of 
Medicare Severity Diagnosis Related Groups (MS-DRGs) and stays that are vulnerable to upcoding, 
as well as the hospitals that frequently bill them.  CMS did not concur. 
17 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
 
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 
 
Most of the selected diagnosis codes that BCBSM submitted to CMS for use in CMSs risk 
adjustment program did not comply with Federal requirements.   
For 188 of the 248 enrollee-years, the diagnosis codes that BCBSM submitted to CMS were not 
supported in the medical records and resulted in net overpayments of $668,264. 
  
These errors occurred because the policies and procedures that BCBSM had to detect and correct 
noncompliance with CMSs program requirements, as mandated by Federal regulations, were not 
always effective.  On the basis of our sample results, we estimated that BCBSM received at least 
$14.5 million of net overpayments for these high-risk diagnosis codes in 2015 and 2016. 
                              
BCBSM concurred with our recommendations that it: (1) refund to the Federal Government the  
$14.5 million of net overpayments; (2) identify, for the high-risk diagnoses included in this report, 
similar instances of noncompliance that occurred before or after our audit period and refund any 
resulting overpayments to the Federal Government; and (3) examine its existing compliance 
procedures to identify areas where improvements can be made to ensure that diagnosis codes at 
high risk for being miscoded comply with Federal requirements, and take the necessary steps to 
enhance those procedures.   
  
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 
For 13 of the 155 sampled policies, APTCs totaling $43,455 authorized by CMS were unallowable 
because they were made on behalf of enrollees who did not make their required premium 
payments.  Specifically, for seven sampled policies enrollees were improperly confirmed (i.e., 
treated as if they had made their first premium payments) or provided coverage by their qualified 
health plan (QHP) issuers when their policies should have been terminated for nonpayment of 
premiums.  In addition, for nine sampled policies, CMS reported inaccurate enrollment data to the 
Internal Revenue Service (IRS), thereby preventing the IRS from recouping APTCs paid on behalf of 
enrollees who did not make their required premium payments.  Three sampled policies contained 
both deficiencies. 
  
On the basis of our sample results, we estimated that $950 million of $42.5 billion in authorized 
APTCs during 2018 for 659,143 of 5.3 million policies were unallowable because they were made on 
behalf of enrollees who did not make their required premium payments. 
  
CMS did not concur with our recommendation that it work with the Department of the Treasury 
and QHP issuers to recover or take other remedial action for: (1) the $43,455 in improper APTCs 
identified in our sample; and (2) the remaining improper APTCs, which we estimate to be 
18 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
$950 million, for policies for which the payments were not allowable.  CMS concurred with our 
recommendation that it develop a process to collect additional information from QHP issuers. 
   
Peninsula Regional Medical Center: Audit of Medicare Payments for Polysomnography Services 
(A-04-19-07087), March 2021, and  
 
North Mississippi Medical Center: Audit of Medicare Payments for Polysomnography Services  
(A-04-19-07086), March 2021  
 
Peninsula Regional Medical Center (Peninsula) submitted Medicare claims for some 
polysomnography services that did not comply with Medicare billing requirements.  On the basis of 
our sample results, we estimated that Peninsula received overpayments of at least $66,647 for 
polysomnography services provided during the audit period.  The errors occurred because 
Peninsula's policies and procedures did not address the processing of Medicare claims for 
polysomnography services to ensure that services billed to Medicare were adequately documented 
and coded correctly. 
 
North Mississippi Medical Center (North Mississippi) submitted Medicare claims for some 
polysomnography services that did not comply with Medicare billing requirements.  On the basis of 
our sample results, we estimated that North Mississippi received overpayments of at least $67,038 
for polysomnography services provided during the audit period.  North Mississippi stated that the 
errors occurred because of a misunderstanding of the Medicare policy.  Although North Mississippi 
had some policies and procedures in place, they did not adequately explain how to process 
Medicare claims for polysomnography services and ensure that services billed to Medicare were 
coded correctly or that technicians attending a polysomnography service had the required 
credentials. 
 
Peninsula concurred with our findings and recommendations that it: (1) refund to the Medicare 
program the estimated $66,647 overpayment for claims that it incorrectly billed; (2) based on the 
results of this audit, exercise reasonable diligence to identify, report, and return any overpayments 
in accordance with the 60-day rule; and (3) implement policies and procedures to ensure that 
Medicare claims for polysomnography services comply with Medicare requirements. 
 
North Mississippi concurred with our recommendations that it: (1) refund to the Medicare program 
the estimated $67,038 overpayment for claims that it incorrectly billed; (2) based on the results of 
this audit, exercise reasonable diligence to identify, report, and return any overpayments in 
accordance with the 60-day rule; (3) educate its staff on properly billing for polysomnography 
services; and (4) revise policies and procedures to ensure that claims are coded correctly and that 
sleep technicians have the required credentials before billing claims for polysomnography services 
to ensure full compliance with Medicare requirements. 
 
 
19 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
An Ophthalmology Clinic in California: Audit of Medicare Payments for Eye Injections of Eylea and 
   
Lucentis (A-09-19-03022), March 2021 
An ophthalmology clinic in California (the Clinic) generally complied with Medicare requirements 
when billing for intravitreal injections of Eylea and Lucentis, which accounted for 88 percent of the 
total payments in our sample.  However, the Clinic did not always comply with Medicare 
requirements when billing for other services provided on the same day as the intravitreal injections 
(e.g., injections of an anesthesia drug).  For 301 services and drugs, the Clinic did not comply with 
the requirements: 195 services were not separately payable, and 106 services and drugs were not 
reasonable and necessary.  
 
Because the Clinic's medical director was unfamiliar with Medicare's billing requirements, the Clinic 
did not have policies and procedures to ensure that services and drugs billed to Medicare were 
correctly billed or reasonable and necessary.  On the basis of our sample results, we estimated that 
at least $398,625 of the $4.3 million paid to the Clinic was unallowable for Medicare 
reimbursement.  
 
The Clinic concurred in part with our recommendation that it refund to the Medicare contractor 
$398,625 in estimated overpayments for intravitreal injections of Eylea and for other services 
provided on the same day as intravitreal injections of Eylea and Lucentis.  The Clinic concurred with 
our recommendation that, based on the results of this audit, it exercise reasonable diligence to 
identify, report, and return any overpayments in accordance with the 60-day rule.  We also made 
two procedural recommendations to ensure that the Clinic complies with Medicare requirements. 
 
Quality of Care, Safety, and Access 
 
Update on Oversight of Opioid Prescribing and Monitoring of Opioid Use: States Have Taken Action 
 
To Address the Opioid Epidemic (A-09-20-01000), October 2020 
We identified actions that selected States took related to their oversight of opioid prescribing and 
their monitoring of opioid use.  In July 2019, we issued a report summarizing and comparing 
information provided by eight selected States: Nebraska, Nevada, New Hampshire, Tennessee, 
Texas, Utah, Washington, and West Virginia.  For this update to our original audit, we selected an 
additional three States in the Appalachian region, an area with high rates of opioid overdose 
deaths: Alabama, Kentucky, and Ohio.  This report summarizes and compares information provided 
by all 11 States as of various dates between October 2018 and May 2020. 
 
The selected States have created policies and procedures and passed laws and regulations related 
to opioids.  The States are using opioid-related data to perform both data analytics and outreach 
to providers and patients.  The States have implemented a number of opioid-related prevention, 
detection, and treatment programs.  Finally, the States have taken many other actions to address 
the opioid epidemic.  This report contains no recommendations. 
20 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
 
Onsite Surveys of Nursing Homes During the COVID-19 National Emergency: March 23May 30, 
2020, (OEI-01-20-00430), December 2020 
 
In response to the COVID-19 pandemic, CMS adjusted its oversight approach to suspend standard 
surveys, prioritize the most serious complaints, elevate attention on infection control, and develop 
a new survey tool to ensure that nursing homes implement actions to prevent the spread of 
COVID-19.  However, these changes have resulted in less comprehensive oversight of nursing 
homes and residents.  Our findings can help CMS enhance its approach to nursing home oversight.  
CMS did not explicitly concur with our first and third recommendations but stated that it has 
already taken steps to implement those recommendations.  CMS did not concur with our second 
recommendation.  We recommended that CMS:     
 
  assess the results of infection control surveys and revise the survey as appropriate, 
  work with States to help overcome challenges with PPE and staffing, and 
  clarify expectations for States to complete backlogs of standard surveys and high-priority 
complaint surveys. 
 
Federal COVID-19 Testing Report: Data Insights From Six Federal Health Care Programs (Federal 
COVID-19 Testing Report: Data Insights From Six Federal Health Care Programs ), January 2021 
 
COVID-19 testing trends in six Federal health care programs largely followed the same pattern as 
national testing from February 2020 through August 2020, the first 7 months of the pandemic.   
This report, conducted in partnership with the Council of the Inspectors General on Integrity and 
Efficiencys (CIGIEs) Pandemic Response Accountability Committee, provides policymakers with key 
insights on COVID-19 testing as the Federal Government continues to respond to the pandemic.  
These insightspresented at an aggregated level and individual program levelinform 
policymakers on the following: number of COVID-19 tests administered; populations that received 
COVID-19 tests, types of COVID-19 tests administered; costs of testing, places where COVID-19 
tests were administered, and amount of time it took to return test results. 
 
Program Integrity 
 
Medicare Critical Care Services Provider Compliance Audit: Clinical Practices of the University of   
 
Pennsylvania (A-03-18-00003), October 2020 
Clinical Practices of the University of Pennsylvania (Clinical Practices) complied with Medicare billing 
requirements for 136 of the 150 critical care services that we reviewed.  However, Clinical Practices 
did not comply with Medicare billing requirements for the remaining 14 critical care services, and 
these errors resulted in Clinical Practices receiving $1,399 in unallowable Medicare payments.  
These errors occurred because Clinical Practices incorrectly identified and billed critical care 
services for physician services that did not meet Medicare requirements.  
21 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
 
On the basis of our sample results, we estimated that Clinical Practices received overpayments of at 
least $151,588 for the audit period. 
 
Clinical Practices did not indicate concurrence or nonconcurrence with our recommendations that 
it: (1) refund to the MAC a total of $151,588 in estimated overpayments for critical care services; (2) 
based on the results of this audit, exercise reasonable diligence to identify, report, and return any 
overpayments in accordance with the 60-day rule and identify any of those returned overpayments 
as having been made in accordance with this recommendation; and (3) strengthen policies and 
procedures to ensure that critical care services billed to Medicare are adequately documented and 
correctly billed. 
   
Medicare Home Health Agency Provider Compliance Audit: Gem City Home Care, LLC 
(A-05-18-00011), October 2020; 
 
Medicare Home Health Agency Provider Compliance Audit: Visiting Nurse Association of Central 
 
Jersey Home Care and Hospice, Inc. (A-02-17-01025), October 2020; 
 
Medicare Home Health Agency Provider Compliance Audit: The Palace at Home
(A-04-17-07067), November 2020; 
   
Medicare Home Health Agency Provider Compliance Audit: Total Patient Care Home Health, LLC  
 
(A-06-16-05005), December 2020; 
Medicare Home Health Agency Provider Compliance Audit: Tender Touch Health Care Services
   
(A-04-18-07077), December 2020;
   
Medicare Home Health Agency Provider Compliance Audit: Southeastern Home Health 
 
 
Services (A-03-17-00004), January 2021; and 
 
Medicare Home Health Agency Provider Compliance Audit: Brookdale Home Health, LLC 
(A-04-18-06221), February 2021 
 
Gem City Home Care, LLC (Gem City), did not comply with Medicare billing requirements for 25 of 
the 100 home health claims that we reviewed.  On the basis of our sample results, we estimated 
 
that Gem City received overpayments of at least $2.67 million during this period.
Visiting Nurse Association of Central Jersey Home Care and Hospice, Inc. (VNA of Central Jersey), 
did not comply with Medicare billing requirements for 14 of the 100 home health claims that we 
reviewed.  On the basis of our sample results, we estimated that VNA of Central Jersey received 
overpayments of at least $2 million for the audit period. 
 
22 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
The Palace at Home (The Palace) did not comply with Medicare billing requirements for 20 of the 
100 home health claims that we audited.  On the basis of our sample results, we estimated that The 
Palace received overpayments of at least $731,304 for our audit period.  All of the incorrectly billed 
claims are outside of the 4-year reopening period. 
 
Total Patient Care Home Health, LLC (TPC), did not comply with Medicare billing requirements for 
32 of the 100 home health claims that we reviewed.  On the basis of our sample results, we 
estimated that TPC received overpayments of at least $1.7 million for our audit period.  As of the 
publication of this report, all 100 claims within our sample are outside of the Medicare 4-year 
claim-reopening period. 
 
Tender Touch Health Care Services (Tender Touch) did not comply with Medicare billing 
requirements for 21 of the 100 home health claims that we reviewed.  On the basis of our sample 
results, we estimated that Tender Touch received overpayments of at least $478,780 for the audit 
period. 
 
Southeastern Home Health Services (Southeastern) did not comply with Medicare billing 
requirements for 18 of the 100 home health claims that we reviewed.  On the basis of our sample 
results, we estimated that Southeastern received overpayments of at least $1.8 million for our audit 
period.  All 100 claims within our sample are outside of the Medicare 4-year claim-reopening 
period. 
 
Brookdale Home Health, LLC (Brookdale), did not comply with Medicare billing requirements for 46 
of the 100 home health claims that we reviewed.  On the basis of our sample results, we estimated 
that Brookdale received overpayments of approximately $3.3 million for the audit period. 
 
Gem City did not concur with our recommendations that it: (1) refund to the Medicare program the 
portion of the estimated $2.67 million in overpayments for incorrectly billed claims that are within 
the 4-year reopening period; (2) for the remaining portion of the estimated $2.67 million 
overpayment for claims that are outside of the reopening period, exercise reasonable diligence to 
identify and return overpayments in accordance with the 60-day rule, and identify any returned 
overpayments as having been made in accordance with this recommendation; (3) exercise 
reasonable diligence to identify and return any additional similar overpayments outside of our 
audit period; and (4) strengthen its procedures to ensure that the homebound statuses of 
Medicare beneficiaries are verified and continually monitored, that the specific factors qualifying 
beneficiaries as homebound are documented, and that beneficiaries receive only reasonable and 
necessary skilled services. 
 
VNA of Central Jersey disagreed with our recommendations that it: (1) refund to the Medicare 
program the portion of the estimated $2 million overpayment for claims incorrectly billed that are 
within the reopening period; (2) exercise reasonable diligence to identify and return overpayments, 
in accordance with the 60-day rule, for claims that are outside the reopening period; (3) exercise 
23 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
reasonable diligence to identify and return any additional similar overpayments outside of our 
audit period; and (4) strengthen its procedures for billing home health services.  
 
We recommend that The Palace, based on the results of this audit, exercise reasonable diligence to 
identify, report, and return any overpayments in accordance with the 60-day rule and identify any 
of those returned overpayments as having been made in accordance with this recommendation.  
We also recommend that The Palace strengthen its procedures to ensure full compliance with 
requirements for billing home health services.  The Palace stated that it plans to appeal our 
findings.  
 
TPC disagreed with our recommendations that it: (1) exercise reasonable diligence to identify, 
report, and return any overpayments in accordance with the 60-day rule; (2) identify any of those 
returned overpayments as having been made in accordance with this recommendation; and (3) 
strengthen its procedures to ensure that the homebound statuses of Medicare beneficiaries are 
verified and continually monitored, that the specific factors qualifying beneficiaries as homebound 
are documented, and that beneficiaries receive only reasonable and necessary skilled services. 
 
Tender Touch did not address our recommendations that it: (1) refund to the Medicare program 
the portion of the estimated $478,780 overpayment for claims incorrectly billed that are within the 
4-year reopening period; (2) based on the results of this audit, exercise reasonable diligence to 
identify, report, and return any overpayments in accordance with the 60-day rule and identify any 
of those returned overpayments as having been made in accordance with this recommendation; 
and (3) strengthen its procedures.  
 
Southeastern did not agree with our recommendations that it: (1) exercise reasonable diligence to 
identify, report, and return any overpayments in accordance with the 60-day rule and identify any 
of those returned overpayments as having been made in accordance with this recommendation 
and (2) strengthen its procedures to ensure that the homebound statuses of Medicare beneficiaries 
are verified and continually monitored, that the specific factors qualifying beneficiaries as 
homebound are documented, that beneficiaries receive only reasonable and necessary skilled 
services, and that the correct Health Insurance Prospective Payment System payment codes are 
billed. 
 
Brookdale generally agreed with our recommendations that it: (1) refund to the Medicare program 
the portion of the estimated $3.3 million overpayment for claims incorrectly billed that are within 
the reopening period; (2) exercise reasonable diligence to identify, report, and return any 
overpayments in accordance with the 60-day rule and identify any of those returned overpayments 
as having been made in accordance with this recommendation; and (3) strengthen some of its 
procedures. 
 
24 
 
 
  Department of Health and Human Services, Office of Inspector General 
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Medicare Hospital Provider Compliance Audit: St. Francis Hospital (A-05-18-00048),
October 2020; 
 
Medicare Hospital Provider Compliance Audit: Edward W. Sparrow Hospital (A-05-18-00045), 
   
November 2020; 
 
Medicare Hospital Provider Compliance Audit: Providence Medical Center (A-07-18-05113), 
   
December 2020; and 
Medicare Hospital Provider Compliance Audit: Sunrise Hospital & Medical Center (A-04-19-08075), 
   
March 2021 
St. Francis Hospital complied with Medicare billing requirements for 86 of the 100 inpatient and 
outpatient claims we reviewed.  On the basis of our sample results, we estimated that St. Francis 
Hospital received overpayments of at least $1.6 million for the audit period.  
 
Edward W. Sparrow Hospital complied with Medicare billing requirements for 91 of the 100 
inpatient and outpatient claims we reviewed.  However, Edward W. Sparrow Hospital did not fully 
comply with Medicare billing requirements for the remaining nine claims, resulting in 
overpayments of $47,317 for the audit period.  On the basis of our sample results, we estimated 
that Edward W. Sparrow Hospital received overpayments of at least $550,917 for the audit period. 
 
Providence Medical Center complied with Medicare billing requirements for 87 of the 100 inpatient 
and outpatient claims we reviewed.  However, Providence Medical Center did not fully comply with 
Medicare billing requirements for the remaining 13 claims, resulting in overpayments of $57,800 for 
calendar years 2016 and 2017.  On the basis of our sample results, we estimated that Providence 
Medical Center received overpayments of at least $325,241 for the audit period. 
 
Sunrise Hospital & Medical Center complied with Medicare billing requirements for 46 of the 100 
inpatient and outpatient claims we reviewed.  However, Sunrise Hospital & Medical Center did not 
fully comply with Medicare billing requirements for the remaining 54 claims, resulting in net 
overpayments of $999,950 for the audit period.  On the basis of our sample results, we estimated 
that Sunrise Hospital & Medical Center received overpayments of at least $23.6 million for the 
audit period.  During the course of our audit, Sunrise Hospital & Medical Center submitted five of 
these claims for reprocessing, and we verified those claims as correctly reprocessed.  Accordingly, 
we have reduced the recommended refund by $8,914. 
 
 
St. Francis Hospital generally disagreed with our recommendations that it: (1) refund to the 
Medicare contractor $1.6 million in estimated overpayments for the audit period for incorrectly 
billed claims that are within the reopening period; (2) based on the results of this audit, exercise 
reasonable diligence to identify, report, and return any overpayments in accordance with the 60-
day rule and identify any returned overpayments as having been made in accordance with this 
25 
 
 
  Department of Health and Human Services, Office of Inspector General 
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recommendation; and (3) strengthen its controls to ensure full compliance with Medicare 
requirements; specifically ensure that all inpatient rehabilitation facility beneficiaries meet Medicare 
criteria for acute inpatient rehabilitation, that all inpatient beneficiaries meet Medicare 
requirements for inpatient hospital services, that procedure and diagnosis codes are supported in 
the medical records and staff are properly trained, and that medical records accurately document 
distinct procedural services and staff are properly trained. 
 
Edward W. Sparrow Hospital partly concurred with our recommendations that it exercise 
reasonable diligence to identify, report, and return any overpayments in accordance with the 60-
day rule and identify any of those returned overpayments as having been made in accordance with 
this recommendation and strengthen its controls to ensure full compliance with Medicare 
requirements.   
 
Providence Medical Center disagreed with our recommendations that it: (1) refund to the Medicare 
contractor the portion of the $325,241 in estimated overpayments for the audit period for claims 
that it incorrectly billed that are within the reopening period and (2) based on the results of this 
audit, exercise reasonable diligence to identify, report, and return any overpayments in accordance 
with the 60-day rule, and identify any of those returned overpayments as having been made in 
accordance with this recommendation.  Regarding our recommendation to strengthen controls to 
ensure full compliance with Medicare requirements, Providence Medical Center described 
corrective actions that it had taken or planned to take. 
 
Sunrise Hospital & Medical Center generally disagreed with our recommendations that it: (1) refund 
to the Medicare contractor $23.6 million in net estimated overpayments for the audit period for 
claims that it incorrectly billed that are within the reopening period; (2) based on the results of this 
audit, exercise reasonable diligence to identify, report, and return any overpayments in accordance 
with the 60-day rule and identify any of those returned overpayments as having been made in 
accordance with this recommendation; and (3) strengthen controls to ensure full compliance with 
Medicare requirements. 
 
   
Medicare Hospice Provider Compliance Audit: Hospice Compassus, Inc., of Payson, Arizona 
(A-02-16-01023), November 2020;  
   
Medicare Hospice Provider Compliance Audit: Hospice Compassus, Inc., of Tullahoma, 
 
 
Tennessee (A-02-16-01024), December 2020; and
 
Medicare Hospice Provider Compliance Audit: Tidewell Hospice, Inc. (A-02-18-01024), 
February 2021 
 
Hospice Compassus, Inc., of Payson, Arizona (Payson), did not comply with Medicare requirements 
for 39 of the 100 claims in our sample.  For these claims, Payson claimed Medicare reimbursement 
26 
 
 
  Department of Health and Human Services, Office of Inspector General 
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for hospice services: (1) for which the associated beneficiary did not meet eligibility requirements, 
(2) that were not documented, and (3) at a reimbursement rate associated with a level of care 
higher than what the associated beneficiary required. 
 
Hospice Compassus, Inc., of Tullahoma, Tennessee (Tullahoma), did not comply with Medicare 
requirements for 35 of the 100 claims in our sample.  For these claims, Tullahoma claimed Medicare 
reimbursement for hospice services (1) for which the clinical record did not support the 
beneficiarys terminal prognosis, (2) that were not documented, and (3) for which the notice of 
election was not filed timely with the MAC.  
 
Tidewell Hospice, Inc. (Tidewell), did not comply with Medicare requirements for 18 of the 100 
claims in our sample.  For these claims, Tidewell claimed Medicare reimbursement for hospice 
services for which the clinical record did not support the beneficiarys terminal illness prognosis or 
 
the level of care claimed and for services that were not eligible for Medicare reimbursement. 
Payson generally disagreed with our recommendations that it: (1) exercise reasonable diligence to 
identify, report, and return overpayments in accordance with the 60-day rule; (2) based on the 
results of our audit, identify, report, and return any additional overpayments as having been made 
in accordance with our recommendations; and (3) strengthen its procedures to ensure that hospice 
services comply with Medicare requirements.  
 
Tullahoma generally disagreed with our recommendations that it: (1) exercise reasonable diligence 
to identify, report, and return overpayments in accordance with the 60-day rule; (2) based on the 
results of our audit, identify, report, and return any additional overpayments as having been made 
in accordance with our recommendations; and (3) strengthen its procedures to ensure that hospice 
services comply with Medicare requirements. 
 
Tidewell partly agreed and partly disagreed with our recommendations that it: (1) refund to the 
Federal Government the portion of the estimated $8.3 million in Medicare overpayments that are 
within the 4-year claims reopening period; (2) exercise reasonable diligence to identify, report, and 
return overpayments, in accordance with the 60-day rule; and (3) strengthen its policies and 
procedures to ensure that hospice services comply with Medicare requirements. 
 
CMS and Its Contractors Did Not Use Comprehensive Error Rate Testing Program Data To Identify 
 
and Focus on Error-Prone Providers (A-05-17-00023), January 2021 
CMS and its contractors did not use CERT data to identify and focus on error-prone providers for 
review and corrective action.  Using CERT data, we identified 100 error-prone providers from 2014 
through 2017.  Of the $5.8 million reviewed by CERT, $3.5 million was incorrect, which is an 
improper payment rate of 60.7 percent.  We determined that during the same period, Medicare 
made $19.1 billion in FFS payments to these 100 error-prone providers. 
 
27 
 
 
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The term "error-prone provider" is an OIG-created term to refer to a list of providers identified as 
having higher rate of errors in the CERT sample data.  When used to describe OIG analysis of CERT 
data from 2014 through 2017, the term refers to providers that had at least one error in each of the 
4 CERT years analyzed, an error rate of higher than 25 percent in each of the 4 CERT years 
analyzed, and a total error amount of at least $2,500.  An error-prone provider is statistically more 
likely to submit an improper claim than the average provider.  
 
CMS did not concur with our recommendations that it: (1) review the list of 100 error-prone 
providers identified in this audit and take specific action as appropriate, such as prior authorization, 
prepayment reviews, and postpayment reviews, and (2) use annual CERT data to identify individual 
providers that have an increased risk of receiving improper payments and apply additional 
program integrity tools to these providers. 
 
Drug Pricing and Reimbursement 
Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Second 
Quarter of 2020 (OEI-03-21-00050), November 2020, and 
 
Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Third Quarter 
of 2020 (OEI-03-21-00060), February 2021 
 
OIG identified seven drug codes in the second quarter of 2020 and seven drug codes in the third 
quarter of 2020 that met CMSs criteria for price substitution.  OIG compares average sales prices 
(ASPs) to average manufacturer prices (AMPs) every quarter and identifies Part B-covered drug 
codes eligible for price substitutions.  If OIG finds that the ASP for a drug exceeds the AMP by a 
certain percentagecurrently, 5 percentthe ASP-based payment amount is substituted with a 
lower calculated rate.  This serves as a mechanism for monitoring market prices and limiting 
potentially excessive payment amounts.  OIG provides these drug codes to CMS for its review.  
CMS reviews this information and determines whether to implement price substitutions that would 
limit excessive payments for Part B drugs. 
 
Opioid Use in Medicare Part D During the Onset of the COVID-19 Pandemic (OEI-02-20-00400), 
February 2021 
 
During the first 8 months of 2020and the onset of the COVID-19 pandemicat least 5,000 Part 
D beneficiaries per month suffered opioid overdoses and almost a quarter of a million received 
high amounts of opioids.  At the same time, the number of beneficiaries receiving drugs for MAT 
increased slightly and the number receiving naloxone declined through April but increased in the 
following months.  As the COVID-19 pandemic continues to affect millions of Americans, vigilance 
remains important.  It is essential that CMSand HHSmonitor trends in prescriptions for drugs 
for MAT and naloxone and take appropriate action if the number of prescriptions begins to fall off.   
 
28 
 
 
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Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
Medicaid Program Reports and Reviews 
Financial Management and Improper Payments 
Colorado Improperly Claimed Millions in Enhanced Federal Medicaid Reimbursement for New 
  Adult Group Beneficiaries Because of a Data Processing Error (A-07-17-02807), October 2020  
 
Colorado claimed reimbursement for Medicaid services provided from January 1, 2014, through 
September 30, 2015, to some beneficiaries who were enrolled in the new adult group but who later 
became ineligible for Medicaid coverage.  As a result, Colorado improperly claimed and received 
over $1.9 million in Federal reimbursement for these beneficiaries past the termination dates of 
their Medicaid eligibility. 
 
Colorado properly terminated 1,543 beneficiaries eligibility in the Colorado Benefits Management 
System (CBMS), which determines Medicaid eligibility and interfaces with other automated systems, 
but erroneously kept them as eligible in the Medicaid Management Information System (MMIS).  
The beneficiaries eligibility was not terminated in the MMIS because of a data processing error.  
Although the CBMS interfaced with the MMIS, for some beneficiaries a change in eligibility 
determination from eligible to ineligible that occurred in the CBMS did not transfer correctly to the 
MMIS.  
 
Colorado disagreed with our recommendations that it: (1) refund to the Federal Government the 
over $1.9 million in improperly claimed Medicaid reimbursement and (2) identify and refund to the 
Federal Government any payments made on behalf of ineligible beneficiaries for whom services 
after our audit period were claimed and reimbursed past the termination dates of their eligibility.  
Colorado did not comment on our recommendation that it establish adequate system controls that 
ensure that eligibility determinations transfer correctly from the CBMS to the MMIS to prevent 
payments from being made on behalf of ineligible beneficiaries. 
 
Hospitals Did Not Comply With Medicare Requirements for Reporting Cardiac Device Credits (A-01-
 
18-00502), November 2020 
For 3,233 of the 6,558 Medicare claims that we reviewed, hospitals likely did not comply with 
Medicare requirements associated with reporting manufacturer credits for recalled or prematurely 
failed cardiac medical devices.  As a result, 911 hospitals received payments of $76 million rather 
than the $43 million they should have received, resulting in $33 million in potential overpayments.  
MACs made these overpayments because they do not have a postpayment review process that 
would ensure that hospitals reported manufacturer credits for cardiac medical devices. 
 
CMS partly concurred with our recommendations that it: (1) instruct MACs to recover the portion of 
the $33 million in identified Medicare overpayments that are within the reopening period; (2) notify 
hospitals associated with potential overpayments outside the reopening period so that they can 
29 
 
 
  Department of Health and Human Services, Office of Inspector General 
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return any overpayments in accordance with the 60-day rule; (3) require hospitals to use condition 
codes 49 and 50 on claims; (4) instruct MACs to implement a postpayment review process; (5) 
obtain device credit listings from manufacturers and determine whether providers reported credits 
as required; (6) direct MACs to determine whether hospitals have engaged in a pattern of incorrect 
billing after our audit period and, if so, take appropriate action in accordance with CMS policies 
and procedures; and (7) consider eliminating the current Medicare requirements for reporting 
device credits by reducing the payments for cardiac device replacement procedures. 
   
Ohio Did Not Correctly Determine Medicaid Eligibility for Some Newly Enrolled Beneficiaries 
(A-05-18-00027), November 2020, and  
 
Louisiana Did Not Correctly Determine Medicaid Eligibility for Some Newly Enrolled Beneficiaries 
 
(A-06-18-02000), January 2021 
For our sample of 150 beneficiaries, Ohio did not determine eligibility for 18 beneficiaries in 
accordance with Federal and State requirements and did not provide supporting documentation to 
verify that the remaining 66 potentially ineligible beneficiaries were newly eligible.  (The total 
exceeds 150 because 3 beneficiaries were found to be ineligible for 1 determination period and 
found to be potentially ineligible for another period.)   
 
For our sample of 120 Medicaid beneficiaries, Louisiana made Medicaid payments on behalf of 4 
beneficiaries who did not meet requirements and 1 beneficiary who may not have met 
requirements.  Based on our sample results, we estimated that Louisiana made Medicaid payments 
of $20.1 million (100-percent Federal share) on behalf of 16,358 beneficiaries who did not meet 
requirements.   
 
On the basis of our sample results, we estimated that Ohio made Medicaid payments of 
$77.5 million (Federal share) on behalf of 51,219 ineligible beneficiaries and $746.4 million (Federal 
share) on behalf of 241,998 potentially ineligible beneficiaries.  Based on our sample results, we 
estimated that Louisiana made Medicaid payments of $20.1 million (100-percent Federal share) on 
behalf of 16,358 beneficiaries who did not meet requirements.   
 
Ohio did not indicate concurrence or nonconcurrence with our recommendations that it: (1) 
redetermine, if necessary, the current Medicaid eligibility of the sampled beneficiaries; (2) ensure 
that its eligibility determination system has the functionality to verify eligibility requirements and 
perform eligibility determinations in accordance with Federal and State requirements; (3) educate 
eligibility caseworkers about relevant Federal and State eligibility requirements; and (4) ensure that 
documentation supporting eligibility determinations is maintained in beneficiaries records.  
 
Louisiana agreed with our recommendations that it: (1) promptly provide notice and cancel the 
eligibility of beneficiaries identified with income over the allowable limit; (2) educate State analysts 
on established policies and procedures regarding requirements to promptly provide notice and 
30 
 
 
  Department of Health and Human Services, Office of Inspector General 
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cancel eligibility, verify income, and provide retroactive eligibility; and (3) redetermine, if necessary, 
the current Medicaid eligibility status of the sampled beneficiaries for whom income or dependent 
verifications did not meet Federal and State requirements. 
   
Ohio Made Capitation Payments to Managed Care Organizations for Medicaid Beneficiaries  With 
 
Concurrent Eligibility in Another State (A-05-19-00023), November 2020, and 
Illinois Made Capitation Payments to Managed Care Organizations for Medicaid Beneficiaries 
 
 
With Concurrent Eligibility in Another State (A-05-19-00031), February 2021  
Ohio made an estimated $5.9 million in August 2018 capitation payments on behalf of beneficiaries 
who were concurrently eligible and residing in another State.  On the basis of our sample results, 
we estimated that Ohio could have saved $5.9 million ($4.2 million Federal share) for August 2018 
capitation payments made to managed care organizations on behalf of beneficiaries with 
concurrent eligibility. 
 
Illinois made an estimated $3.8 million in August 2018 capitation payments on behalf of 
beneficiaries who were concurrently eligible and residing in another State.  On the basis of our 
sample results, we estimated that Illinois could have saved $3.8 million ($2.1 million Federal share) 
for August 2018 capitation payments made to managed care organizations on behalf of 
beneficiaries with concurrent eligibility.  
 
Ohio did not indicate concurrence or nonconcurrence with our recommendations that it: (1) 
develop or enhance current procedures to identify beneficiaries with concurrent eligibility in 
another State, which could have saved Ohio an estimated $5.9 million ($4.2 million Federal share) 
in capitation payments for August 2018, and (2) ensure that procedures are in place for county 
caseworkers to timely review and terminate eligibility for beneficiaries who were identified as 
concurrently eligible in another State. 
 
Illinois concurred with our recommendations that it: (1) develop or enhance current procedures to 
identify beneficiaries with concurrent eligibility in another State, which could have saved Illinois an 
estimated $3.8 million ($2.1 million Federal share) in capitation payments for the month of August 
2018, and (2) ensure that procedures are in place for caseworkers to timely review and terminate 
eligibility for beneficiaries who were identified as concurrently eligible in another State. 
 
Florida Received Unallowable Medicaid Reimbursement for School-Based Services (A-04-18-07075), 
November 2020  
 
Florida did not always claim Federal Medicaid reimbursement for school-based services in 
accordance with Federal and State requirements.  Of the 200 school-based services in our sample, 
168 met Federal and State requirements.  However, Florida incorrectly claimed reimbursement for 
the remaining 32 sampled services totaling $644 because they did not meet 1 or more Federal 
31 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
requirements as follows: individual education plans or plans of care without the required signature, 
not enough supporting documentation to substantiate services, and provider qualification 
requirements such as licenses and training courses missing.  
 
These deficiencies occurred because Florida did not have formal policies and procedures to ensure 
that the claims school districts submitted were adequately documented.  In addition, Florida did 
not adequately monitor for compliance with Federal and State requirements school-based services 
claims that the school districts submitted. 
 
On the basis of our sample results, we estimated that Florida claimed at least $1.4 million in 
unallowable costs during our audit period. 
 
Florida did not concur with our recommendations that it: (1) refund $1.4 million to the Federal 
Government, (2) work with CMS to review Medicaid claims for school-based services after our audit 
period and refund any overpayments, and (3) improve its policies and procedures to ensure that it 
is adequately monitoring school-based service claims to ensure compliance with Federal and State 
requirements.  
 
Nebraska Claimed Almost All Medicaid Payments for Targeted Case Management Services in 
   
Accordance With Federal Requirements but Claimed Some Unallowable Duplicate Payments 
(A-07-19-03239), December 2020  
 
Nebraska claimed almost all Federal Medicaid reimbursement for targeted case management 
services during FY 2016 through FY 2018 in accordance with Federal and State requirements.  The 
150 claims we sampled had no errors with respect to services provided, recipient eligibility, or 
provider qualifications.  
 
However, 6 of the 150 sampled claims were not allowable because the claims had duplicate 
monthly payments.  In these instances, a provider received two or more monthly payments on 
behalf of a single recipient in a single month, which resulted in a total payment amount that 
exceeded the approved monthly rate.  Nebraska made 164 duplicate monthly payments during our 
audit period, which resulted in overpayments of $22,484 (Federal share).  Nebraska made these 
duplicate payments because its system edits did not always prevent it from paying total monthly 
amounts that exceeded the approved monthly rates to providers on behalf of these recipients. 
 
Nebraska agreed with our recommendations that it refund $22,484 (Federal share) in 
overpayments to the Federal Government and implement the necessary MMIS edits to prevent and 
detect duplicate payments. 
 
32 
 
 
  Department of Health and Human Services, Office of Inspector General 
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New York Improved Its Monitoring of Its Personal Care Services Program But Still Made 
 
 
Improper Medicaid Payments of More Than $54 Million (A-02-19-01016), December 2020 
New York claimed Federal reimbursement for personal care services that did not comply with 
certain Federal and State requirements for 28 of the 100 sampled claims.  Specifically, New York 
received reimbursement for personal care services for which there was: (1) no valid nursing or social 
assessment, (2) no independent medical review, (3) no valid physicians order or the order was not 
timely, (4) no documentation of services provided, and (5) no plan of care.  Additionally, for some 
claims, the personal care aide who provided the associated services had not undergone a timely 
criminal history check or did not meet training requirements. 
 
The unallowable claims occurred because New Yorks monitoring of the personal care services 
program was not adequate to ensure that services complied with Federal and State requirements.  
However, we noted that in 2017, New York made some improvements to its monitoring of the 
program. 
 
On the basis of our sample results, we estimated that New York improperly claimed at least 
$54.5 million in Federal Medicaid reimbursement for personal care services during our audit 
period.  In addition, the health and safety of some Medicaid beneficiaries may have been put at 
risk because their personal care aides had not undergone a criminal history check or did not meet 
training requirements. 
 
New York did not specifically indicate concurrence or nonconcurrence with our recommendations 
that it refund $54.5 million to the Federal Government, continue to improve its monitoring of local 
districts, and reinforce Medicaid requirements related to personal care services. 
 
California Claimed at Least $2 Million in Unallowable Medicaid Reimbursement for a Selected 
 
 
Providers Opioid Treatment Program Services (A-09-20-02001), January 2021 
California did not claim Medicaid reimbursement for the selected providers OTP services in 
accordance with Federal and State requirements.  Of the 100 sample items, 1 sample item was 
allowable, but 99 sample items had services that were unallowable.  On the basis of our sample 
results, we estimated that California claimed at least $2.4 million in unallowable Federal Medicaid 
reimbursement for OTP services during our audit period.  
 
These deficiencies occurred because Californias oversight activities did not ensure that OTP 
services met Federal and State requirements.  We also identified deficiencies in two areas in which 
California could improve the quality of care provided to beneficiaries receiving OTP services. 
 
California agreed with our recommendations that it: (1) refund $2.4 million to the Federal 
Government for unallowable OTP services furnished by the selected provider, (2) ensure that the 
selected provider complies with Federal and State requirements for providing and claiming 
33 
 
 
  Department of Health and Human Services, Office of Inspector General 
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reimbursement for OTP services, (3) verify that the selected provider implements corrective action 
plans that were approved by California, (4) perform postpayment reviews to identify disallowances 
for OTP services that did not comply with State requirements, and (5) work with the selected 
provider to improve the quality of care provided to beneficiaries by correcting deficiencies. 
 
Massachusetts Made at Least $14 Million in Improper Medicaid Payments for the Nonemergency 
 
Medical Transportation Program (A-01-19-00004), January 2021 
Massachusetts claimed Federal Medicaid reimbursement for 86 of 100 sampled lines of service 
submitted by transportation providers that did not comply with certain Federal and State 
requirements.  The improper claims for unallowable services were made because the States 
monitoring and oversight of the nonemergency medical transportation (NEMT) program did not 
ensure that NEMT services were for qualifying medical services and were adequately documented. 
In addition, for all 100 sample items, driver qualifications and vehicle inspection, registration, and 
maintenance policies or schedules were not adequately documented.  On the basis of our sample 
results, we estimated that at least 758,847 Medicaid claims totaling $14,142,730 ($7,071,365 Federal 
share) did not comply with certain Federal and State regulations.   
 
Massachusetts generally concurred with our recommendations, including that it: (1) refund 
$7,071,365 to the Federal Government, (2) perform data matches to all claims billed on the day of 
an NEMT service to ensure that only NEMT claims are paid when there is a corresponding 
qualifying medical service, (3) work with its brokers to ensure that documentation contains all 
necessary elements to support the NEMT service, (4) evaluate opportunities to better monitor 
transportation services, and (5) work with its brokers to implement controls that ensure drivers and 
vehicles used to provide NEMT services can be directly and clearly traced to the correct driver 
qualifications and vehicle records. 
 
Quality of Care, Safety, and Access 
Aspects of Texas Quality Incentive Payment Program Raise Questions About Its Ability To 
 
 
Promote Economy and Efficiency in the Medicaid Program (A-06-18-07001), December 2020 
Certain aspects of Texas Quality Incentive Payment Program (QIPP) raise questions about its ability 
to promote economy and efficiency in Medicaid.  Specifically: (1) nursing facilities received less than 
half of the earned incentive payments, (2) nursing facilities participating in QIPP generally rated 
below average in overall quality, (3) nursing facilities that declined in performance continued to 
receive quality improvement incentive payments, and (4) two local government entities 
participating in QIPP funded $1.3 million ($737,944 Federal share) of the non-Federal share of QIPP 
payments through intergovernmental transfers (IGTs) financed by means of debt instruments. 
 
QIPP provides some incentives for nursing facilities to improve the quality of resident care. 
However, the results of our audit suggest that further analysis of the program is warranted. 
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  Department of Health and Human Services, Office of Inspector General 
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We recommended that CMS: (1) work with Texas to determine whether the source of IGTs and the 
practice of using debt instruments to fund the non-Federal share of QIPP payments meets 
program objectives and promotes economy and efficiency in Medicaid and (2) reevaluate Texas 
QIPP to ensure that it operates in a manner that meets program objectives while promoting 
economy and efficiency in Medicaid.  Texas did not concur with our first recommendation but did 
concur with our second recommendation. 
 
 
Risk Assessment Puerto Rico Medicaid Program (A-02-20-01011), December 2020 
 
To fulfill OIG's responsibilities under P.L. No. 116-94, we conducted a high-level risk assessment of 
Puerto Rico Medicaid program controls and processes.  Our approach included interviewing 
program officials from the various units that administer the Puerto Rico Medicaid program and 
reviewing documents that they provided.  
 
We identified program integrity, beneficiary eligibility, provider enrollment, overpayment reporting, 
and contracting as key areas at high risk for improper Medicaid program payments.  In addition, 
we determined that the risk of improper Medicaid program payments in Puerto Rico could be 
increased because there have been no recent reviews of Puerto Rico Medicaid program payments 
performed by CMS, and because Puerto Rico's MMIS has not been fully implemented.  Finally, we 
identified one area (program management) at moderate risk for improper Medicaid program 
payments due to limitations in staff hiring and training.  
 
Based on the results of our high-level risk assessment, we determined that to protect Federal funds 
by identifying inaccurate program payments, audits of Puerto Rico's Medicaid program are 
warranted.  We have used the results of this assessment to set priorities for performing these 
audits.  We plan to initiate two audits in FY 2021 related to potentially improper payments.  
Specifically, we will determine whether Puerto Rico improperly claimed Medicaid reimbursement 
for payments on behalf of deceased beneficiaries and beneficiaries assigned multiple Medicaid 
identification numbers. 
   
Iowa Should Improve Its Oversight of Selected Nursing Homes Compliance With Federal
Requirements for Life Safety and Emergency Preparedness (A-07-19-03238), February 2021  
 
Iowa did not ensure that selected nursing homes in the State that participated in the Medicare or 
Medicaid programs complied with CMS requirements for life safety and emergency preparedness. 
During our onsite inspections, we identified deficiencies in areas related to life safety and 
emergency preparedness at all 20 nursing homes we reviewed.  We found 122 instances of 
noncompliance with life safety requirements and 133 instances of noncompliance with emergency 
preparedness requirements.  As a result, residents at the 20 nursing homes were at increased risk 
of injury or death during a fire or other emergency. 
 
35 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
The identified areas of noncompliance occurred because Iowa did not have a standardized life 
safety training program for all staff (not currently required by CMS).  In addition, Iowa did not 
adequately follow up on deficiencies previously cited or require nursing homes or inspection 
contractors to: (1) tag systems that are critical to the health and safety of nursing home residents 
when these systems may not work as required and (2) notify the State. 
 
Iowa agreed with our recommendations that it: (1) follow up with the 20 nursing homes to ensure 
that corrective actions have been taken regarding the deficiencies identified in this report, (2) work 
with CMS to develop standardized life safety training for nursing home staff, and (3) conduct more 
frequent surveys and followup at nursing homes with a history of multiple high-risk deficiencies.  
Iowa disagreed with our recommendation that it require nursing homes to tag deficient critical 
systems. 
 
New York Did Not Fully Comply With Federal and State Requirements for Reporting and Monitoring 
Critical Incidents Involving Medicaid Beneficiaries With Developmental Disabilities (A-02-17-01026), 
February 2021  
 
New York did not ensure that providers fully complied with Federal waiver and State requirements 
for reporting and monitoring critical incidents involving Medicaid beneficiaries with developmental 
disabilities residing in community-based settings.  Of the 30 incidents of potential abuse and 
neglect in our sample, 23 incidents were properly reported and investigated; however, 7 incidents 
were not.  Because incidents of potential abuse and neglect were not properly reported or 
investigated, beneficiaries were put at an increased risk of harm.  
 
Of the 48 reported and substantiated incidents of abuse and neglect in our judgmental sample, we 
found that the associated providers complied with the critical incident reporting and monitoring 
requirements. 
 
New York agreed with our recommendations that it: (1) reinforce guidance to the provider 
community on various specific requirements related to the reporting and investigating of critical 
incidents; (2) issue guidance and/or provide training to the provider community on the importance 
of identifying the root cause of an incident, and identifying trends in incidents; and (3) review the 
three internal occurrence investigations identified in our report for compliance with investigative 
requirements, and make any necessary changes to the incident classifications in accordance with 
Part 624. 
 
CMS Use of Data on Nursing Home Staffing: Progress and Opportunities To Do More                   
(OEI-04-18-00451), March 2021 
 
CMS has taken important steps to build and use a new data source for information on nursing 
home staffing, but CMS has opportunities to better leverage this information.  Our findings can 
help CMS identify ways to better inform consumers and improve oversight of staffing in nursing 
36 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
homes.  CMS concurred with all four of our recommendations.  Our recommendations were for 
CMS to:  
 
  provide data to consumers on nurse staff turnover and tenure, as required by Federal law;  
  ensure the accuracy of non-nurse staffing data used on Care Compare; 
  consider residents level of need when identifying nursing homes for weekend inspections; 
and 
  take additional steps to strengthen oversight of nursing home staffing. 
 
Data on Medicaid Managed Care Payments to Providers Are Incomplete and Inaccurate,  
(OEI-02-19-00180), March 2021 
 
Effective oversight of Medicaid requires a national system with complete and accurate data.  CMS 
established the T-MSIS for this purpose.  Payment data are a critical component of T-MSIS.  These 
data include the amounts paid, billed, and allowed for every service provided to Medicaid 
enrollees, including those services provided through managed care.  CMS did not concur with any 
of our recommendations, which were to: 
 
  review States managed care payment data in T-MSIS and ensure that States have 
corrective action plans to improve data completeness and quality, as appropriate; 
  make public its reviews of States managed care data; and 
  clarify and expand its initiative on payment data.   
 
Florida Did Not Ensure That Nursing Facilities Always Reported Allegations of Potential Abuse 
 
or Neglect of Medicaid Beneficiaries and Did Not Always Assess, Prioritize, or Investigate 
 
 
Reported Incidents (A-04-17-08058), March 2021 
Florida did not ensure that nursing facilities always reported potential abuse or neglect of Medicaid 
beneficiaries transferred from nursing facilities to hospital emergency departments.  Additionally, 
we could not determine whether Florida complied with Federal requirements for assigning a 
priority level, initiating onsite surveys, and recording allegations of potential abuse or neglect.  
Lastly, Florida's incident report program may not have been effective in accomplishing the 
program's goal and objectives.  Certain internal control deficiencies and practices could limit the 
effectiveness of Florida's complaint and incident program.  Specifically, Florida: lacked written 
policies and procedures for processing incident reports, had inadequate intake staffing, had 
inadequate incident report processing, lacked written policies and procedures for managing late 
incident report filings, and lacked written policies and procedures for managing APS abuse and 
neglect investigation notifications. 
 
Florida generally concurred with our recommendations that it: (1) work with CMS to provide clear 
guidance to nursing facilities regarding what constitutes a reportable incident, (2) establish 
procedures to require assessment start and end dates and priority level assignments, and (3) 
37 
 
 
  Department of Health and Human Services, Office of Inspector General 
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establish and implement written policies and procedures for incident report processing.  We made 
further recommendations to improve the effectiveness of the complaint and incident report 
process.  
 
Drug Pricing and Reimbursement 
 
Massachusetts Claimed Unallowable Federal Reimbursement for Some Medicaid 
Physician-Administered Drugs (A-06-18-04001), October 2020  
 
Massachusetts did not always comply with Federal Medicaid requirements for invoicing 
manufacturers for rebates for physician-administered drugs.  Massachusetts did not invoice 
manufacturers for rebates associated with $11.4 million (Federal share) in physician-administered 
drugs.  Of this amount, $10.5 million was for single-source drugs, and $883,000 was for top-20 
multiple-source drugs.  Of the $11.4 million, $9.7 million was related to claims identified as hospital 
outpatient.  Massachusetts did not invoice for rebates for any physician-administered drug claims 
identified as hospital outpatient claims.  In addition, some claims identified as physician claims 
were not invoiced for rebates.  Because Massachusetts internal controls did not always ensure that 
it invoiced manufacturers to secure rebates, Massachusetts improperly claimed Federal 
reimbursement for these single-source drugs and top-20 multiple-source drugs. 
 
Further, Massachusetts did not submit the utilization data necessary to secure rebates for all other 
physician-administered drugs.  Providers submitted claims totaling $4.2 million (Federal share) that 
did not have National Drug Codes (NDCs) or had invalid NDCs.  Furthermore, under the Medicaid 
drug rebate program, claims totaling $782,917 (Federal share), which contained NDCs, could have 
been eligible for rebates.  
 
Massachusetts partly agreed with our recommendations that it: (1) refund to the Federal 
Government $10.5 million (Federal share) for claims for single-source physician-administered drugs 
that were ineligible for Federal reimbursement; (2) refund to the Federal Government $882,892 
(Federal share) for claims for top-20 multiple-source physician-administered drugs that were 
ineligible for Federal reimbursement; and (3) work with CMS to determine the proper resolution of 
the other claims in question, $4.9 million Federal share.  We also made procedural 
recommendations. 
 
Minnesota Did Not Bill Manufacturers for Some Rebates for Drugs Dispensed to Enrollees of 
 
 
Medicaid Managed-Care Organizations (A-05-17-00018), October 2020
Minnesota did not fully comply with Federal Medicaid requirements for billing manufacturers for 
rebates for drugs dispensed to managed care organization (MCO) enrollees.  Minnesota did not 
bill for and collect manufacturers rebates that we calculated to be $6.1 million (Federal share).  
Specifically, it did not bill for and collect manufacturers rebates that we calculated to be (1) 
$5.9 million (Federal share) for pharmacy drugs and for single-source and top-20 multiple-source 
38 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
physician-administered drugs that were eligible for rebates and (2) $173,780 (Federal share) for 
physician-administered drugs that may have been eligible for rebates.  Minnesota did not always 
bill for and collect manufacturers rebates because Minnesota and its contractor did not identify all 
of the rebate-eligible drugs in the utilization data submitted by the MCOs. 
 
Minnesota agreed with our recommendations that it: (1) bill for and collect manufacturers rebates 
for pharmacy drugs and for single-source and top-20 multiple-source physician-administered 
drugs that we calculated to be $5.9 million (Federal share) and refund the Federal Government and 
(2) work with CMS to determine whether the non-top-20 multiple-source physician-administered 
drugs were eligible for rebates that we calculated to be $173,780 (Federal share) and, if so, upon 
receipt of the rebates, refund the Federal share.  We also made a recommendation related to 
pharmacy and physician-administered drugs that were not billed for rebates after our audit period 
and a procedural recommendation to ensure that all rebate-eligible drugs are properly identified 
and billed for rebate. 
 
Opioids in Medicaid: Concerns About Opioid Use Among Beneficiaries in Six Appalachian States in 
2018 (OEI-05-19-00410), December 2020  
 
We found that across 6 Appalachian States in 2018, nearly 6,000 Medicaid beneficiaries received 
potentially harmful amounts of opioids; more than 450 of these beneficiaries were at serious risk of 
opioid misuse or overdose; and 19 prescribers stood out in their prescribing of opioids to  
beneficiaries at serious risk.  The COVID-19 pandemic may be putting beneficiaries at greater risk of 
opioid misuse or overdose in 2020 and beyond.  OIG is committed to fighting the opioid crisis and 
protecting beneficiaries from prescription drug abuse and misuse.  As part of this commitment, 
OIG is working with our law enforcement partners to bring resources and expertise to these six 
States through the Appalachian Regional Prescription Opioid Strike Force. 
 
States Could Do More To Oversee Spending and Contain Medicaid Costs for Specialty Drugs,           
(OEI-03-17-00430), December 2020 
 
Overall, State Medicaid programsFFS programs and Medicaid MCOsused over 100 distinct 
criteria to categorize thousands of drugs as specialty drugs.  Further, States reported limited 
oversight of their Medicaid MCOs management of specialty drug categorization and spending.  
These findings indicate that as more expensive specialty drugs enter the market, CMS and States 
may not be using all available tools to contain rising expenditures for specialty drugs in their 
Medicaid programs.  CMS concurred with our first and third recommendations and did not concur 
with our second recommendation.  Our recommendations were for it to:  
 
  work with States to expand alternative reimbursement models to address the rising costs 
for drugs often categorized as specialty drugs;  
  provide States with acquisition cost data for a wider range of specialty drugs; and 
39 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
  collaborate with States to conduct greater oversight of Medicaid MCOs management of 
specialty drugs; this oversight could include a review of contract language that allows 
States to obtain requested information on specialty drug categorizations, specialty drug 
reimbursement methodologies, and cost management strategies from the MCOs. 
   
40 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
Legal and Investigative Activities Related to 
Medicare and Medicaid  
OIG investigates allegations of fraud, waste, and abuse in all HHS programs.  Our largest body of work 
involves investigating matters related to the Medicare and Medicaid programs, such as patient harm; 
billing for services not rendered, medically unnecessary services, or upcoded services (i.e., services billed 
for at a level higher than warranted); illegal billing, sale, and diversion of prescription drugs; the marketing 
of off-label uses for prescription drugs; and solicitation and receipt of kickbacks, including illegal payments 
to patients for involvement in fraud schemes and illegal referral arrangements between physicians and 
medical companies. 
 
OIG also conducts investigations regarding organized criminal activity, including medical identity theft and 
fraudulent medical schemes established for the sole purpose of stealing Medicare dollars.  Investigators 
are opening an increasing number of cases against health care providers who engage in these health care 
fraud schemes.  Those who participate in the schemes may face heavy fines, jail time, and exclusion from 
participation in Federal health care programs. 
 
One of the most common types of fraud perpetrated against Medicare, Medicaid, and other Federal health 
care programs involves filing false claims for reimbursement.  False claims may be pursued under Federal 
and State criminal statutes and, when appropriate, under the False Claims Act.  Depending on the types of 
fraud or other violations involved, OIG investigations may culminate in criminal or civil court judgments 
and decisions, administrative sanctions and decisions, and/or negotiated settlement agreements.  
Investigative outcomes take many forms, including incarceration, restitution, fines, penalties, forfeitures, 
assessments, and exclusion of individuals or entities from participation in all Federal health care programs.  
Frequently used exclusion and penalty authorities are described on our website at 
http://oig.hhs.gov/fraud/enforcement/cmp/. 
 
During this semiannual reporting period, we reported 213 criminal and 261 civil actions against individuals 
or entities who engaged in offenses related to health care.  We also reported over $799.4 million in 
investigative receivables due to HHS and more than $568.2 million in non-HHS investigative receivables, 
including civil and administrative settlements or civil judgments related to Medicare, Medicaid, and other 
Federal, State, and private health care programs.   
 
Criminal and Civil Enforcement Activities Related to Medicare and Medicaid 
The following recently completed actions and settlements are organized by the type of provider or entity 
involved.  Additional cases appear in the Medicare Fraud Strike Force Activities section below. 
 
41 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
 Ambulance Transportation Company 
The following case example involves an ambulance transportation company:  
  
New YorkOn December 16, 2020, Aleksandr Radinovskiy was sentenced to 24 months in 
prison, followed by 24 months of probation, and ordered to pay $10,650,670 in restitution.  
Radinovskiy pleaded guilty to one count of conspiracy to offer and pay health care 
kickbacks, and one count of conspiracy to defraud the lawful functions of the IRS.  
Radinovskiy and his father, Igor Radinovskiy, participated in a conspiracy in which they paid 
more than $8.6 million in kickbacks to co-conspirator companies not enrolled in the 
Medicaid program for the referral of beneficiaries recruited by those co-conspirators, so 
that Sabe Ambulette Services (Sabe) could falsely bill Medicaid as if Sabe had transported 
those beneficiaries to various clinics in Brooklyn and Queens.  The defendants then falsely 
reported to the IRS that the illegal kickback payments were legitimate business expenses, 
which caused relevant tax forms to falsely under-report business income and claim 
deductions. 
 
Physical Therapy 
The following case example involves physical therapy:  
  
GeorgiaOn December 15, 2020, physical therapy provider McLeod-Hughes and 
Associates, LLC, and its owner Barry McLeod-Hughes, agreed to pay $506,811 to resolve 
allegations that it violated the False Claims Act by submitting bills to the Medicare and 
TRICARE programs for physical therapy services provided by unlicensed, uncredentialed or 
otherwise unapproved individuals.  Additionally, McLeod-Hughes has voluntarily agreed to 
be excluded as a provider from Medicare and other Federal health care programs.  Federal 
health care programs, such as Medicare and TRICARE, allow services to be provided and 
billed only by certain licensed and approved providers and only under certain 
circumstances.  
 
The alleged scheme resolved by the settlement concerned McLeod-Hughess submission of 
claims to Medicare and TRICARE for physical therapy services purportedly provided by 
approved providers when, in fact, athletic trainers and other unlicensed, uncredentialed, or 
otherwise unapproved individuals furnished the physical therapy services.  
 
Pharmaceutical Companies 
The following case example involves pharmaceutical companies:  
  
MassachusettsOn December 17, 2020, Cambridge-based pharmaceutical company, 
Biogen Inc. agreed to pay $22 million to resolve allegations that it violated the False Claims 
42 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
Act by illegally using two foundations, the Chronic Disease Fund (CDF) and the Assistance 
Fund (TAF), as conduits to pay the Medicare copayments for patients taking Biogens 
multiple sclerosis drugs, Avonex and Tysabri.  Advanced Care Scripts (ACS), a specialty 
pharmacy that performed services for Biogen, has also agreed to pay $1.4 million to resolve 
allegations that it conspired with Biogen to enable Biogen to use CDF and TAF as conduits 
for Biogen to pay Medicare copayments for Avonex and Tysabri patients.  In separate 
settlements in late 2019, CDF paid $2 million and TAF paid $4 million to resolve allegations 
concerning their respective roles in enabling certain pharmaceutical companies to pay 
kickbacks to Medicare patients.  
 
As part of the settlements, the Government alleged that Biogen, acting with ACSs help, 
used CDF and TAF, each of which claimed status as nonprofit organizations for tax 
purposes, as conduits to pay the copayment obligations of thousands of Medicare patients 
taking Avonex and Tysabri.  The Government specifically alleged that in 2011, Biogen 
identified Medicare-eligible Avonex patients in Biogens free drug program, and arranged 
for ACS to transfer those patients from the Biogen free drug program to CDF, so that CDF 
could cover those patients Medicare copayments and the patients purchase of Avonex 
would generate Medicare revenue for Biogen.  Biogen then paid CDF, and ACS promptly 
sent CDF batch files of copayment assistance applications for Medicare-eligible Avonex 
patients who had been receiving the free drug from Biogen.  CDF subsequently approved 
most of those applications and covered the costs of those patients Medicare copayments 
for Avonex. 
 
Durable Medical Equipment Companies 
The following case examples involve durable medical equipment (DME) companies:  
  
New YorkOn December 21, 2020, Apria Healthcare Group, Inc., and its affiliate, Apria 
Healthcare LLC (Apria), entered into a settlement agreement under which it agreed to pay 
$40.5 million to resolve allegations that Apria submitted false claims to Federal health 
programs, including Medicare and Medicaid, seeking reimbursement for the rental of costly 
non-invasive ventilators (NIVs) to program beneficiaries who were not using the NIVs, 
making them not medically necessary, in addition to the improper waiver of patient co-
insurance payments.  
 
According to court documents, Apria decided in 2014 to prioritize the expansion of its NIV 
rental business because health care programs like Medicare paid as much as $1,400 per 
month to cover NIVs, a type of complex respiratory equipment that can dynamically adjust 
the pressure level of air delivery.  That expansion, however, came at the cost of Aprias 
compliance with the basic medical necessity requirement of Federal health programs.  
Specifically, while Apria knew that it was responsible for monitoring patients utilization of 
their NIVs and to stop billing when NIVs were no longer being used, it did not have enough 
43 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
respiratory therapy staff to conduct such monitoring.  As a result, Apria routinely billed 
Medicare and other programs when it did not know whether NIVs were still being used by 
patients, which would have made their use medically necessary.  Further, even when Apria 
had information indicating that patients were no longer using their NIVs, it often continued 
to bill the Federal health programs.  
 
In connection with this settlement, Apria also entered into a CIA with HHS-OIG, which 
requires Apria to implement board oversight, a claims review process by an Independent 
Review Organization, and other compliance steps designed to foster adherence to Federal 
health care program requirements and thereby protect the programs. 
 
New YorkOn November 23, 2020, Etienne Allonce, the former co-owner of Medical 
Solutions Management, Inc. (MSM), a DME supplier in Hicksville, New York, was sentenced 
to 36 months in prison for health care fraud and ordered to pay $4,444,468 in restitution.  
Between April 2003 and March 2007, Allonce, along with his wife and MSM co-owner 
Michel Allonce, submitted approximately $10 million in false claims to Medicare and 
Medicaid, seeking payment for medical supplies never ordered by MSM and never 
delivered to patients at nursing homes.  Etienne Allonce fled the United States just hours 
before Federal agents arrested his wife in 2007.  In September 2018, Allonce was expelled 
from Haiti where he had fled shortly before his indictment in the Eastern District of New 
York 11 years earlier.  Prior to his return to the United States, Allonce was placed on HHS-
OIGs Most Wanted List.  
   
Pharmacies 
The following case examples involve pharmacies: 
  
New YorkOn October 23, 2020, Sajid Javed, an owner and operator of a number of 
pharmacies in the New York City area, was sentenced to 30 months in prison for using his 
pharmacies to submit more than $7.1 million in fraudulent claims to Medicare and 
Medicaid.  Javed was ordered to pay restitution in the amounts of $6,040,451.32 to 
Medicare and $1,150,562.16 to Medicaid.  While owning and operating pharmacies located 
in Brooklyn and Queens, Javid conducted a multimillion-dollar scheme to defraud Medicare 
and Medicaid programs by seeking reimbursement for prescription drugs that were not 
distributed to customers.  Specifically, from January 2013 through December 2014, Javed 
obtained more than $7.1 million in reimbursements from Medicare and Medicaid for 
prescription drugs that his pharmacies never actually dispensed to customers.  Javed 
defrauded Medicare and Medicaid into providing him with these reimbursements by 
obtaining prescriptions from other individuals who were willing to forego delivery of the 
medications in exchange for a share of the reimbursed proceeds, in the form of kickbacks.  
Javed offered to pay, and did actually pay, kickbacks in furtherance of this scheme. 
 
44 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
 
Prescription Drugs 
The following case example involves prescription drugs: 
 
New YorkOn October 15, 2020, Dr. Eugene Gosy was sentenced to 70 months in prison 
and 3 years of supervised release, and ordered to pay $344,562.65 in restitution to his 
victims, including Medicare.  The sentence was the result of Dr. Gosy's guilty plea, entered 
on January 7, 2020, in which he pleaded guilty to one count of conspiracy to unlawfully 
distribute controlled substances and one count of health care fraud.  
 
In carrying out the conspiracy, Dr. Gosy and his employees issued more prescriptions for 
controlled substances annually than any other prescriber or prescribing entity in New York 
State, including hospitals.  Specifically, Dr. Gosy and his employees carried out their 
conspiracy by: (1) prescribing controlled substances without conducting a physical 
examination and/or after conducting only a limited and inadequate physical examination; 
(2) prescribing controlled substances in ways that were likely to cause, and did cause, 
dependence and addiction, and that contributed to existing addictions; (3) issuing 
prescriptions for controlled substances in dosages and/or in combinations dangerous to 
the health and safety of the patient; (4) issuing prescriptions for controlled substances 
despite indications that patients were abusing and misusing the prescribed controlled 
substances; (5) issuing prescriptions for controlled substances to patients despite knowing 
that such patients had overdosed or had otherwise been hospitalized for conditions 
relating to misuse of controlled substances; (6) continuing to prescribe controlled 
substances in the same manner, and failing to adapt practices to prevent additional deaths 
and overdoses, despite having notice that the treatment they were following had resulted 
in obvious drug-seeking behavior and addiction, numerous patient overdoses, and patient 
deaths; (7) signing death certificates in the absence of an autopsy or medical examination 
for deceased patients to whom Gosy and/or his employees had prescribed controlled 
substances despite aberrant behaviors; and (8) recommending a course of treatment, 
including the prescribing of controlled substances, which caused the death of at least six 
individuals, and contributed to the deaths of others. 
 
Kickbacks 
The following case example involves kickbacks: 
 
WisconsinOn January 11, 2021, AutoGenomics, Inc., entered into a settlement agreement 
under which it agreed to pay $2,538,000 to resolve allegations that it violated the False 
Claims Act and anti-kickback statute by engaging in a scheme to bill Medicare for 
molecular genetic testing performed for nursing home patients that were induced by the 
payment of remuneration, or kickbacks, for the referral of those genetic tests.  
45 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
 
AutoGenomics, located in Carlsbad, California, formerly owned and operated a laboratory 
doing business as PersonalizeDx Labs (collectively AutoGenomics).  In April 2013 and 
March 2015, AutoGenomics entered into agreements with a California-based health care 
marketing company to utilize AutoGenomics laboratory services for tests ordered by the 
health care marketing companys clients.  Pursuant to these agreements, AutoGenomics 
paid the health care marketing company a specified monetary kickback for each test that 
was reimbursed by Medicare, but only if Medicare paid the claim.  Under these agreements, 
the amount of the kickback was based on either a percentage or fixed amount of 
Medicares reimbursement for each test.  
 
Electronic Health Records 
The following case example involves electronic health records (EHRs): 
 
MassachusettsOn January 28, 2021, athenahealth, Inc. (Athena), a developer of EHR 
services, agreed to pay $18.25 million to resolve allegations that it violated the False Claims 
Act (by paying illegal kickbacks to generate sales of its EHR product, athenaClinicals.  The 
United States alleged that Athena violated the False Claims Act and the anti-kickback 
statute through three marketing programs.  First, Athena allegedly invited prospects and 
customers to all-expenses-paid sporting, entertainment, and recreational events.  The most 
lavish of these events, such as bucket list trips to the Masters Tournament and the 
Kentucky Derby, included complimentary travel along with luxury accommodations, meals, 
and alcohol.  Second, Athena allegedly paid illegal fees to its customers through its Lead 
Generation program designed to identify new prospective customers.  Under this 
program, Athena paid up to $3,000 per physician who signed up for Athena services, 
regardless of how much time (if any) the client spent speaking or meeting with the lead.  
Finally, it is alleged that Athena entered into deals with competing companies that had 
decided to discontinue their health IT products.  Pursuant to those agreements, known as 
Conversion Deals, the other companies agreed to refer their clients to Athena, and 
Athena paid competitors based on the value and volume of practices that were successfully 
converted into Athena customers.  As a result of these kickbacks, it is alleged that Athena 
improperly generated sales for itself while causing health care providers to submit false 
claims to the Federal Government related to incentive payments for adoption and 
meaningful use of Athenas EHR technology. 
 
Hospice 
The following case example involves a hospice: 
 
TexasOn February 3, 2021, Henry McInnis, the CEO of a Texas-based group of hospice 
and home health entities, was sentenced to 15 years in prison for falsely telling thousands 
46 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
of patients with long-term incurable diseases that they had less than 6 months to live, in 
order to enroll the patients in hospice programs for which they were otherwise unqualified, 
thereby increasing revenue to the company.  In November 2019, McInnis was convicted by 
a Federal jury in Brownsville, Texas, of one count each of conspiracy to commit health care 
fraud, conspiracy to commit money laundering, and obstruction of justice; as well as six 
counts of health care fraud.  McInniss co-conspirator, Rodney Mesquias, 50, the owner of 
the hospice and home health entities, was also convicted following the November 2019 
trial.  Mesquias was sentenced to 20 years in prison in December 2020.  Two other co-
conspirators have pleaded guilty and are awaiting sentencing.  
 
From 2009 to 2018, McInnis, Mesquias and others orchestrated a scheme that involved the 
submission of over $150 million in false and fraudulent claims for hospice and other health 
care services.  McInnis served as the top corporate officer and administrator and oversaw 
the day-to-day operations of the Merida Group, a large health care company that operated 
dozens of locations throughout Texas.  McInnis also oversaw and enforced a companywide 
practice of falsifying medical records to conceal the scheme.  Multiple witnesses testified 
that McInnis ordered employees to alter medical records to make it appear that patients 
were terminally ill, while in reality some patients were employed or even participating in 
sporting events.  As CEO, McInnis also adopted a policy that paid illegal kickbacks.  They 
directed bribes to physicians under the guise of medical director fees to certify unqualified 
patients for hospice and home health.  In some cases, they improperly offered payoffs to 
marketers in exchange for recruitment of patients who could be placed on extremely 
expensive hospice services.  
 
Medicare Fraud Strike Force Activities 
In 2007, Medicare Fraud Strike Force teams began an effort to combine resources of Federal, State, and 
local law enforcement entities to prevent and combat health care fraud, waste, and abuse.  These 
partnerships among OIG and HHS, DOJ, U.S. Attorneys Offices, FBI, and State and local law enforcement 
have a common goal: to analyze health care fraud data and investigative intelligence to quickly identify 
fraud and bring prosecutions.  Strike Force teams operate in the following areas: Miami and 
Tampa/Orlando, Florida; Dallas and Houston, Texas; McAllen/Rio Grande, Texas; Los Angeles, California; 
Detroit, Michigan; Brooklyn, New York; The Gulf Coast (Baton Rouge and New Orleans, Louisiana; Southern 
Mississippi); Chicago, Illinois; and Newark, New Jersey/Philadelphia, Pennsylvania; along with National 
Rapid Response Strike Force located in Washington, DC.  During this semiannual reporting period, Strike 
Force efforts resulted in the filing of charges against 72 individuals or entities, 54 criminal actions, and 
more than $207.0 million in investigative receivables. 
In October 2018, DOJ announced the creation of a new initiative to combat the Nations opioid 
epidemic.  The Appalachian Regional Prescription Opioid Strike Force covers 10 Federal judicial districts 
in Alabama, Kentucky, Ohio, Tennessee, Virginia, and West Virginia.  OIGs Office of Investigations is 
working closely with its law enforcement partners at DEA, FBI, and the MFCUs to provide investigative 
47 
 
 
  Department of Health and Human Services, Office of Inspector General 
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support.  Cases involve physicians and pharmacies that are responsible for medically unnecessary 
opioid prescriptions and dangerous drug combinations that are being paid for by Medicare and 
Medicaid.  In many instances, there are other allegations of wrongdoing relating to kickbacks, health 
care fraud, and quality of care, including patient overdoses and deaths. 
 
The following case examples involve Strike Force cases: 
 
FloridaOn November 13, 2020, Tania Rodriguez was sentenced to 30 months in prison and 24 
months of supervised release and Rafael Vidal was sentenced to 18 months in prison and 24 
months of supervised release for their roles in submitting false and fraudulent claims to Medicare.  
Rodriguez, the owner and operator of American United Pharmacy, and co-defendant Vidal were 
ordered to pay $1,450,000 in restitution. 
 
Rodriguez and Vidal participated in a conspiracy to use their company, American United Pharmacy 
Corp. of Miami, to offer and pay kickbacks for the referral of Medicare beneficiaries to their 
pharmacy, and to submit false and fraudulent claims to Medicare for prescription drugs that were 
not provided to Medicare beneficiaries.  As a result, Medicare paid American United Pharmacy 
approximately $1,450,000 that it was not entitled to receive.  
 
FloridaOn October 30, 2020, Sebastian Ahmed was sentenced to 210 months in prison and 
ordered to pay $4,231,288 in restitution following his conviction, after a 6-week jury trial, of 
conspiracy to commit health care fraud and wire fraud, 5 counts of health care fraud, conspiracy to 
commit money laundering, and 11 counts of money laundering.  As part of the scheme, the 
conspirators exploited vulnerable drug addicts; falsified paperwork; and entered into various 
kickback arrangements, all to receive millions of dollars of falsely and fraudulently obtained funds 
for their own personal use and benefit.   
 
Ahmed was the CEO, president and CFO of the two substance abuse treatment centers: Jacobs 
Well and Medi MD; as well as a medical health clinic, Arnica Health, all of which he operated under 
the umbrella of Serenity Treatment Center, Serenity Living, and Serenity Ranch Recovery in Davie, 
Florida.  Ahmed operated the three clinics from in or around June 2016 through May 2019.  The 
Government emphasized at trial that defendant (1) engaged in illegal billing to private insurance 
plans through Jacobs Well prior to the clinic being certified by the Department of Children and 
Families (DCF) in February 9, 2017; (2) provided unlawful inducements to the approximately 500 
patients consisting of free airline travel, housing, vapes, manicures, cash, and failure to collect 
patient responsibilities for copayments and deductibles; and (3) billed for medically unnecessary 
therapeutic services consisting of therapy and urine analyses, the former having not been provided 
but billed by defendants substance abuse clinics.  The patients were also permitted to reside in co-
ed housing in which destructive sexual relationships, not conducive to real addiction treatment, 
formedsometimes between the staff and patients, according to the testimony and evidence.  
From June 2016 through May 2019, the Government attributed approximately $38 million in 
48 
 
 
  Department of Health and Human Services, Office of Inspector General 
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fraudulent billing submitted by Ahmeds clinics, which resulted in the reimbursement of over 
$6 million in payments. 
 
Compliance Trainings 
Health Care Provider Compliance Training  
OIG provides free training on our website for health care providers, compliance professionals, and 
attorneys.  OIGs Provider Compliance Training was an initiative developed in 2011 that continues to 
reach the health care community with OIGs message of compliance and prevention via free 
downloadable comprehensive training materials and podcasts.  OIGs provider compliance training 
resources are available at https://oig.hhs.gov/compliance/compliance-guidance/index.asp. 
 
Fugitives List 
The OIG Fugitives website has greatly assisted in helping to capture fugitives charged with defrauding 
Federal health care programs and stealing millions of taxpayer dollars.  The Fugitives website is continually 
updated and features a profile for each fugitive, a Most Wanted List, as well as an online tip form and a 
hotline number for individuals to report fugitive-related information to OIG, in English or Spanish, 24 hours 
a day, 365 days a year.  The Fugitives list is available at https://oig.hhs.gov/fraud/fugitives/.  During this 
semiannual reporting period, no fugitives were captured. 
 
HHS-OIG Hotline 
As part of OIGs Office of Investigations, the hotline is the public-facing division for OIGs intake and 
evaluation of fraud tips.  The mission of the HHS-OIG Hotline is to support OIGs oversight responsibilities 
in safeguarding the integrity of all programs and personnel under HHSs purview and protecting them 
from fraud, waste, and abuse.  The hotline achieves its mission through its staffs dedication to timely 
intake and analysis of information received from various sources, such as the Submit a Complaint link on 
the HHS-OIG website.  During this semiannual reporting period, the OIG Hotline reported expected 
recoveries of $19,292,750 as a direct result of cases originating from hotline complaints. 
 
OIG Hotline Activity (10/1/203/31/21) 
Contacts to 1-800-HHS-TIPS phone line, including  55,541 
callers seeking information 
Total tips evaluated  18,262 
Tips referred for action  9,732 
Closed; no basis provided for further action  3,699 
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  Department of Health and Human Services, Office of Inspector General 
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Closed; no HHS violation1  790 
 
Sources of tips referred for action 
Phone  3,553 
OIG website  4,676 
Letters or faxes  556 
Other  947 
 
Medicaid Fraud Control Units 
OIG Oversight of Medicaid Fraud Control Units 
MFCUs are key partners with OIG in the fight against fraud, waste, and abuse in State Medicaid 
programs.  OIG has oversight responsibility for MFCUs and administers grants that provide Federal 
funding for their operations.  Currently, all 50 States, the District of Columbia, Puerto Rico, and the 
U.S. Virgin Islands operate MFCUs.  The Federal Government reimburses 90 percent of a MFCUs 
total expenditures during the first 3 years of operation and 75 percent thereafter.  MFCUs 
investigate and prosecute Medicaid provider fraud as well as patient abuse and neglect in health 
care facilities and board and care facilities. 
 
 
 
1 Some of the closed complaints in this reporting period may have been evaluated or referred for action in a previous reporting 
period. 
50 
 
 
  Department of Health and Human Services, Office of Inspector General 
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Medicaid Fraud Control Units Fiscal Year 2020 Annual Report (OEI-09-21-00120), March 2021 
This annual report provides statistics that highlight the accomplishments of the 53 MFCUs during 
FY 2020.  MFCUs reported that the COVID-19 pandemic created significant challenges for MFCU 
staff, operations, and court proceedings.  However, MFCUs reported taking steps to mitigate the 
effects of the pandemic and, despite challenges, continued to carry out their Medicaid program 
integrity functions in FY 2020.  MFCUs reported 1,017 convictions in FY 2020.  Fraud cases 
accounted for 76 percent of the MFCU convictions, while 24 percent involved patient abuse or 
neglect.  Approximately 47 percent of the 774 MFCU fraud convictions involved personal care 
services attendants and agencies.  MFCUs were responsible for 786 civil settlements and 
judgments, 33 percent of which involved pharmaceutical manufacturers.  MFCUs reported $1 billion 
in criminal and civil recoveries.  In an appendix to the report, OIG summarizes beneficial practices 
identified by OIG in its reviews or inspections that may be useful to other MFCUs. 
OIG Reviews and Inspections of MFCUs 
In addition to an annual recertification review of each MFCU, OIG conducts reviews and inspections 
of a sample of MFCUs.  OIG evaluates MFCU operations based on 12 performance standards and 
assesses compliance with laws, regulations, and OIG policy guidance.  During the reporting period, 
OIG issued reports of onsite reviews of the following MFCUs: 
 
Illinois Medicaid Fraud Control Unit: 2019 Onsite Inspection (OEI-06-19-00510), March 2021 
 
OIG Joint Casework With MFCUs 
The following case example involves OIGs joint efforts with MFCUs: 
 
MissouriOn February 5, 2021, Denis Mikhlin was sentenced in Federal court to 108 months in 
prison and was ordered to pay $181,665 in restitution.  In August 2020, the 41-year-old resident of 
St. Louis County, Missouri, pleaded guilty to four felony counts of conspiracy, obtaining oxycodone 
and other opioid drugs by fraud and deceit, receiving illegal kickbacks in return for sending urine 
specimens to Central Diagnostic Laboratory for medically unnecessary testing, and causing the 
Medicare and Medicaid programs to pay $4,704,568 for medically unnecessary services.  Mikhlin 
conspired with Dr. Jerry Leech and others to issue and distribute illegal prescriptions for opioids 
and other controlled substances to patients.  Mikhlin and his co-conspirators knew the patients did 
not have a legitimate medical need for drugs and instead were abusing the drugs or selling them.  
Additionally, Mikhlin recruited individuals and paid them for the use of their names on the 
fraudulent prescriptions.  Once the prescriptions were filled, some of the drugs were returned to 
Mikhlin and the rest were kept by the individuals or sold to others.  To conceal this illegal activity, 
Mikhlin and others created patient files, falsely indicating the patients had been examined by the 
prescribing doctors and were regularly monitored and tested.  OIG investigated this case with the 
51 
 
 
  Department of Health and Human Services, Office of Inspector General 
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FBI, Missouri Medicaid Fraud Control Unit, Missouri Attorneys General Office, and the Department 
of Defense. 
 
Advisory Opinions and Other Industry Guidance  
Advisory opinions, which are developed in consultation with DOJ, are issued to requesting parties 
regarding the interpretation and applicability of certain statutes relating to Federal health care programs.  
The Health Insurance Portability and Accountability Act of 1996 (HIPAA),  205, allows OIG to provide case-
specific formal guidance on the application of the anti-kickback statute and safe harbor provisions and 
other OIG health care fraud and abuse sanctions.  During this semiannual reporting period, OIG received 
19 requests for advisory opinions and issued 5 advisory opinions. 
 
Sanction Authorities and Other Administrative Actions  
Various Federal laws provide authorities the ability to impose administrative sanctions for fraud and abuse 
as well as other activities that pose a risk to Federal health care programs and their beneficiaries.  
Sanctions include the exclusion of individuals and entities from Federal health care programs and the 
imposition of CMPs for submitting false and fraudulent claims to a Federal health care program or for 
violating the anti-kickback statute, the physician self-referral law (commonly referred to as the Stark Law), 
or the Emergency Medical Treatment and Labor Act (EMTALA), also known as the patient dumping 
statute.  Sanctions also include referrals for suspension and debarment in cases of grant and contract 
fraud. 
 
During this semiannual reporting period, OIG imposed 1,086 administrative sanctions in the form of 
program exclusions or administrative actions for alleged fraud or abuse or other activities that posed a risk 
to Federal health care programs and their beneficiaries.  
 
Exclusion and penalty authorities are described in Appendix C and on our website at 
http://oig.hhs.gov/fraud/enforcement/cmp/index.asp. 
 
Program Exclusions 
During this semiannual reporting period, OIG excluded 1,036 individuals and entities from 
Medicare, Medicaid, and other Federal health care programs.  Most of the exclusions resulted from 
convictions for crimes relating to Medicare or Medicaid, patient abuse or neglect, financial 
misconduct, controlled substances, or as a result of license revocation.  OIG completed the 
deployment of a new service for MFCUs to report convictions through a central web-based portal 
for exclusions.  OIG is also responsible for reinstating providers who apply and have met the 
requirements of their exclusions.  For a list of excluded individuals and entities, see 
https://exclusions.oig.hhs.gov/. 
 
The following are case examples of program exclusions: 
52 
 
 
  Department of Health and Human Services, Office of Inspector General 
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TexasAnthony Mamboleo Nyakeo (Nyakeo), a certified nurse aide (CNA), was excluded 
under Section 1128(a)(4) for a minimum period of 75 years based on his conviction of two 
counts of aggravated sexual assault of an elderly or disabled person.  While employed as a 
CNA of a licensed nursing home facility, Nyakeo sexually assaulted one of his patients.  The 
victim suffered from dementia, was disabled, nonverbal, incontinent, and unable to feed 
herself, move on her own, or vocalize.  The victim suffered significant injuries from the 
assault that required medical intervention and surgical repair.  The Court sentenced Nyakeo 
to life imprisonment and ordered him to register as a sex offender.   
 
MassachusettsInsys Pharma, Inc. (Insys Pharma) is a pharmaceutical company that 
developed and owns a liquid formulation of fentanyl called Subsys.  HHS-OIG excluded 
Insys Pharma for a minimum period of 5 years due to its conviction of five counts of Mail 
Fraud in the United States District Court for the District of Massachusetts.  Beginning in 
August 2012 and continuing until June 2015, Insys paid bribes and kickbacks to certain 
practitioners as part of a scheme to defraud patients and insurers, including Medicare.  
Insys disguised the bribes and kickbacks as honoraria purportedly given for the 
practitioners participation in the Insys Speaker Program (ISP).  Participants in the ISP were 
rewarded with lucrative speaking opportunities based on the volume of Subsys 
prescriptions that they wrote and were removed from the program if they failed to 
prescribe a sufficient volume of Subsys.  ISP events were often social gatherings at high-
priced restaurants that involved no education or presentation about the drug.  Often the 
events had no attendees at all, and Insys sales representatives were instructed by 
management to falsify the names of ISP attendees on sign-in sheets.  The Court sentenced 
Insys to pay a criminal monetary penalty of $2 million and to surrender $28 million in 
forfeiture.  
 
The following subjects were also excluded for convictions related to the Insys Pharma 
scheme:   
 
MassachusettsJohn N. Kapoor (Kapoor) was excluded for a minimum period of 58 years 
based on his conviction of Racketeering Conspiracy by the United States District Court for 
the District of Massachusetts.  Kapoor was the founder, owner, and sole investor of the 
parent company of Insys Pharma, Insys Therapeutics, Inc. (Insys).  Kapoor also held 
executive management positions at Insys, including executive chairman of the board of 
directors and chief executive officer.  From approximately May 2012 to December 2015, 
Kapoor directed, approved, and participated in the scheme to bribe and pay kickbacks to 
targeted medical practitioners and increase Subsys sales through fraud.  Kapoor directed 
his co-conspirators to closely monitor ISP participating practitioners for return on 
investment by comparing the amount of speaker honoraria paid to each individual 
speaker versus the net revenue generated by the speaker.  Kapoor also pressured Insys 
employees to mislead insurers to obtain payment authorization for illegal Subsys 
53 
 
 
  Department of Health and Human Services, Office of Inspector General 
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prescriptions.  The Court sentenced Kapoor to 66 months of incarceration and ordered him 
to pay $59,755,362.45 in restitution.   
 
MassachusettsMichael L. Babich (Babich), who held executive management positions 
including vice president and CEO of Insys, was excluded for a minimum period of 50 years 
due to his conviction for conspiracy and wire fraud.  From approximately May 2012 to 
December 2015, Babich conspired with other high-level officials at Insys to increase profits 
in connection with the sale of Subsys by providing kickbacks and bribes to medical 
practitioners.  By paying and concealing the kickbacks and bribes, Babich fraudulently 
caused insurers, including Medicare and Medicaid, to pay for prescriptions and dosage 
increases that the insurers otherwise would not have agreed to pay.  The Court sentenced 
Babich to 30 months of incarceration and ordered him to pay $59,755,362.45 in restitution.  
 
MassachusettsAlec Burlakoff (Burlakoff) held executive management positions including 
regional sales manager for the Southeast Region and Vice President of Sales for Insys 
Therapeutics, Inc. (Insys).  OIG excluded Burlakoff for a minimum period of 50 years due to 
his conviction of racketeering conspiracy.  From approximately May 2012 to December 
2015, Burlakoff played a key role in implementing the scheme whereby Insys would pay 
bribes and kickbacks to increase sales of Subsys.  Burlakoff closely monitored the amount 
of Subsys being prescribed by each practitioner, and intentionally chose to bribe 
practitioners known to abusively prescribe opioid medication.  Burlakoff also pressured his 
sales staff to advocate for higher doses of Subsys.  The Court sentenced Burlakoff to 26 
months of imprisonment and ordered him to pay $59,755,362.45 in restitution. 
 
Suspensions and Debarments  
Suspensions and debarments are administrative tools used by HHS and other Federal agencies to 
protect the Government from individuals and entities who have engaged in contract fraud, have 
misused grant funds, or are otherwise not presently responsible.  Because these are 
Governmentwide sanctions, an individual or entity that has been suspended or debarred by HHS or 
any other agency is ineligible to participate in any future funding opportunities across the Federal 
Government for a specified period of time. 
 
OIG refers individuals and entities who have potentially engaged in grant or contract fraud or 
misconduct to the HHS Suspension and Debarment Official, who is responsible for determining 
whether to impose a suspension or debarment.  OIG continues to develop a robust Suspension 
and Debarment program and uses this tool to protect Government programs against fraud, waste, 
poor performance, and noncompliance with contract provisions or applicable law.  
 
The following case example involves debarment:  
 
54 
 
 
  Department of Health and Human Services, Office of Inspector General 
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NebraskaTillie Aldrich, a general member of the Tribal Council of the Omaha Tribe of 
Nebraska, directly and indirectly misrepresented the level of her involvement in the 
preparation of the claims submitted to IHS for unpaid contract support.  Aldrich made a 
proposal to the Tribal Council for authorization of unreasonable bonus or incentive 
payments in which the proposal also include unreasonable bonus or incentive payment 
amounts to be paid to members of the Tribal Council and others to induce the Tribal 
Council to approve the proposal.  Aldrich also caused checks to be prepared and issued in-
house from the Carl T. Curtis Health Education Center account without going through the 
normal review and issuance procedure the Omaha Tribe had established with Bland and 
Associates.  As a result, Aldrich pleaded guilty and received 5 years of probation and was 
ordered to pay $13,404.44 in restitution.  
  
Civil Monetary Penalties Law 
The Civil Monetary Penalties Law (CMPL) authorizes OIG to impose administrative penalties, 
assessments, and exclusions against a person who, among other things, submits, or causes to be 
submitted, claims to a Federal health care program that the person knows, or should know, are 
false or fraudulent.  The exclusions statute also authorizes OIG to exclude a person who violates 
the CMPL.  During this semiannual reporting period, OIG concluded cases involving more than 
$32 million in CMPs and assessments. 
 
Affirmative Litigation 
The CMPL authorizes OIG to use its administrative remedies to affirmatively pursue cases.  OIG 
may also exclude under the exclusions statute for engaging in conduct that violates the CMPL.  
When OIG excludes under the exclusions statute for engaging in conduct that violates the CMPL, it 
is known as an affirmative exclusion. 
 
The following case examples involve affirmative litigation under the CMPL:  
  
TexasWilliam Rosellini, Nexeon Medsystems, Inc., Pulsus Medical, LLC, and Nexeon 
Medsystems Puerto Rico Operating Company, Inc. (collectively, Nexeon), entered into a 
settlement agreement with OIG in which they agreed to pay $50,000 and be excluded from 
participation in all Federal health care programs for 5 years under 42 U.S.C. 1320a-7a and 
42 U.S.C. 1320a-7(b)(7). The settlement agreement resolves allegations that Nexeon drew 
down funds from the HHS Payment Management System from NIH Small Business 
Innovation Research (SBIR) awards that were: (1) sent to an overseas affiliate without NIH 
approval, in violation of NIH SBIR requirements; (2) based on quotes and other potential 
costs that were never incurred; (3) commingled among various affiliates and used for 
unallowable costs unrelated to the NIH SBIR awards; and (4) not supported by adequate 
documentation to ensure that the funds were used for allowable costs in accordance with 
the terms and conditions of the awards.  Simultaneous to the execution of the settlement 
55 
 
 
  Department of Health and Human Services, Office of Inspector General 
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agreement, Nexeon entered into a Voluntary Debarment Agreement with the HHS 
Suspension and Debarment Official in which they agreed to accept 5-year debarments 
from participation in covered transactions. 
 
TexasMiguel Angel Molinas, M.D., and Miguel Angel Molinas, M.D., P.A (collectively, 
Molinas), entered into a settlement agreement with OIG in which they paid $185,410.68 to 
resolve allegations that Molinas billed Medicare for specified Current Procedural 
Terminology (CPT) codes while Dr. Molinas neither performed nor supervised the services 
himself. 
 
Patient Dumping  
Some of the CMPL cases that OIG resolved during this semiannual reporting period were pursued 
under EMTALA, a statute designed to prevent hospitals from denying emergency care to patients 
and to ensure patient access to appropriate emergency medical services. 
 
The following case example involves EMTALA:  
  
North CarolinaFrye Regional Medical Center (FRMC) entered into a $100,000 settlement 
agreement with OIG.  The settlement resolved allegations based on the following facts: on 
January 10, 2016, B.R. came to FRMCs emergency department complaining of chest pain, 
nausea, vomiting, and diarrhea.  FRMC failed to perform an adequate screening exam, and 
B.R. waited 3 hours and 44 minutes in the waiting room while his symptoms worsened, with 
no treatment.  B.R. left FRMC and went to another hospital.  The second hospital diagnosed 
him with triple vessel disease, performed an emergency heart catheterization, and sent him 
back to FRMC for an urgent triple coronary bypass surgery.  FRMC paid $100,000, the 
maximum penalty, to resolve these allegations.  
 
Self-Disclosure Programs  
Health care providers, suppliers, or other individuals or entities subject to CMPs can apply for 
acceptance into the Provider Self-Disclosure Protocol, a program created in 1998 for voluntary 
disclosure of self-discovered evidence of potential fraud.  The self-disclosure program may give 
providers the opportunity to avoid costs or disruptions associated with Government-directed 
investigations and civil or administrative litigation.  
 
Application processes for two additional self-disclosure programs were recently added to the OIG 
website for HHS contractors and grantees.  The OIG contractor self-disclosure program provides 
contractors the opportunity to self-disclose when they have potentially violated the False Claims 
Act or other Federal criminal laws prohibiting fraud, conflict of interest, bribery, or gratuity.  This 
self-disclosure process is only available to those with a Federal Acquisition Regulations (FAR)-based 
contract with HHS.  The OIG Grant Self-Disclosure Program is available for application by HHS 
56 
 
 
  Department of Health and Human Services, Office of Inspector General 
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grantees or HHS grant subrecipients and provides the opportunity for voluntary disclosure to OIG 
of potential fraud.  OIG evaluates the reported results of each internal investigation under the 
provider self-disclosure protocol to determine the appropriate course of action.  The self-disclosure 
guidelines are available on the OIG website at https://oig.hhs.gov/compliance/self-disclosure-
info/index.asp.  During this semiannual reporting period, provider self-disclosure cases resulted in 
more than $59.3 million in HHS receivables. 
 
The following case examples pertain to provider self-disclosure settlements:  
  
MassachusettsAfter it self-disclosed conduct to OIG, Steward Holy Family Hospital, Inc. 
(Steward) paid $6,952,847 for allegedly violating the CMPL.  OIG alleged that Steward failed 
to maintain physician certifications, recertifications, and treatment plans for inpatient 
psychiatry services in violation of Medicare billing requirements.  Steward retained a third-
party contractor who was responsible for managing Stewards inpatient psychiatric unit 
including maintaining proper medical records for the patients in the unit. 
 
VirginiaAfter it self-disclosed conduct to OIG, Virginia Hospital Center Arlington Health 
System d/b/a Virginia Hospital Center (VHC), Virginia, paid $6,050,628 for allegedly 
violating the CMPL, specifically, provisions of the CMPL applicable to physician self-referrals 
and kickbacks.  OIG alleged that VHC paid remuneration to two medical groups in the form 
of office space, office staff, and services rendered under call coverage arrangements. 
 
 
Corporate Integrity Agreements  
Many health care providers elect to settle their cases before litigation.  As part of the settlements, 
providers often agree to enter into CIAs with OIG to avoid exclusions from Medicare, Medicaid, 
and other Federal health care programs.  Under a CIA, a provider commits to establishing a 
program and taking other specified steps to ensure future compliance with Medicare and Medicaid 
rules.  The compliance programs are designed, in part, to prevent future fraud.  OIG monitors 
providers compliance with these agreements and may impose penalties on entities that fail to 
comply with the requirements of their CIAs. 
 
The following case example involves CIA enforcement: 
 
TennesseeEffective January 20, 2021, OIG excluded Grace and Theophilus Egbujor 
(collectively, the Egbujors), for a period of 5 years based on a material breach of their CIA.  
On August 4, 2020, OIG issued a Notice of Material Breach and Intent to Exclude letter to 
the Egbujors after their failure to abide by a Departmental Appeals Board decision 
affirming the Administrative Law Judges order that they pay $1,322,500 in stipulated 
penalties assessed under their CIA.  The stipulated penalties were assessed as a result of 
their failure to repay overpayments identified by the independent review organization in 
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the second and third CIA annual reports.  The Egbujors failed to respond to OIGs Notice of 
Material Breach and Intent to Exclude and did not appeal the subsequent OIG Notice of 
Exclusion.  The exclusions went into effect on January 20, 2021. 
 
 
Public Health and Human Service Agency 
Reports and Reviews  
Public Health Agency Reports and Reviews 
Hospitals Reported That the COVID-19 Pandemic Has Significantly Strained Health Care Delivery: 
Results of a National Pulse Survey February 2226, 2021 (OEI-09-21-00410), March 2021 
 
In February 2021, hospitals reported that operating in survival mode for an extended period of 
time has created new and different problems than experienced earlier in the pandemic and 
exacerbated longstanding challenges in health care delivery, access, and health outcomes.  
Hospital administrators described difficulty balancing the complex and resource-intensive care 
needed for COVID-19 patients with efforts to resume routine hospital care.  They reported that 
staffing shortages have affected patient care, and that exhaustion and trauma have taken a toll on 
staffs mental health.  Administrators detailed challenges associated with vaccine distribution efforts 
and concerns about vaccine hesitancy among staff and members of their communities.  
Additionally, many hospitals reported experiencing financial instability because of increased 
expenses associated with responding to a pandemic and lower revenues from decreased use of 
other hospital services.  Hospitals indicated that many of the challenges were more severe for rural 
hospitals.  Hospitals reported a range of strategies to address their challenges, and identified areas 
in which further government support could help as they continue responding to the pandemic.  
Beyond the immediate needs in responding to COVID-19, the pulse survey reveals longer-term 
opportunities for improvement to address challenges that existed before, and were exacerbated 
by, the pandemic.   
 
Centers for Disease Control and Prevention 
Although CDC Implemented Corrective Actions To Improve Oversight of the Presidents Emergency 
Plan for AIDS Relief Recipients, Some Internal Control Weaknesses Remained (A-04-18-01010), 
December 2020  
 
Our analysis of 21 prior audit reports on PEPFAR recipients identified the following trends in which 
recipients: (1) had either inadequate or no policies and procedures related to management of 
PEPFAR funds (19 of 21 reports), (2) did not comply or may not have complied with HHS 
regulations regarding value-added tax (18 of 21 reports), (3) had transactions that were either not 
58 
 
 
  Department of Health and Human Services, Office of Inspector General 
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supported (16 of 21 reports) or unallowable (15 of 21 reports), (4) did not accurately report PEPFAR 
expenditures on the financial reports or did not file reports on time (11 of 21 reports), (5) did not 
have annual audits performed or submitted on time (9 of 21 reports), and (6) could not reconcile 
PEPFAR expenditures to amounts reported on their financial reports (7 of 21 reports). 
 
In response to the six trends identified in our prior audits, CDC took action to improve its oversight 
of PEPFAR recipients.  Finally, CDC had two internal control weaknesses in its post-award oversight 
that it did not adequately address in its in-country office Standard Operating Procedures (SOPs).  
 
CDC officials concurred with our recommendations that CDC implement requirements for CDC in-
country offices to have SOPs for Cooperative Agreement (CoAg) management and periodically 
review and update CDC in-country office SOPs for CoAg management.  
 
Independent Attestation Review: Centers for Disease Control and Prevention Fiscal Year 2020 
Detailed Accounting Report, Performance Summary Report for National Drug Control Activities, 
Budget Formulation Compliance Report, and Accompanying Required Assertions (A-03-21-00355), 
 
January 2021
Based on our review, we are not aware of any material modifications that should be made to CDCs 
Detailed Accounting Report and Performance Summary Report for FY 2020 and CDCs Budget 
Formulation Compliance Report for FY 2022 for them to be in accordance with the Office of 
National Drug Control Policy (ONDCP) Compliance Reviews Circular. 
 
Indian Health Service 
Few Patients Received High Amounts of Opioids from IHS-Run Pharmacies (OEI-05-18-00470), 
December 2020 
 
Data show that few patients received high amounts of opioids from IHS-run pharmacies, and that 
IHS reported positive outcomes from opioid-related initiatives.  However, IHS has opportunities to 
improve the efficiency of its opioid monitoring systems and IHS staff reported challenges in using 
State-run PDMPs and in tracking care outside of IHS.  Our findings recognize IHSs efforts to 
address the opioid crisis.  Our recommendations aim to enhance the efficiency of IHSs monitoring 
and reducing the challenges that staff reported in using State-run PDMPs effectively.  IHS 
concurred with our recommendations, which included:  
 
  Assess the costs and benefits of updating its EHR system with tools to support more 
automated monitoring. 
  Request support from States and Federal partners to address challenges with State-run 
PDMPs. 
 
Incidence of Adverse Events in Indian Health Service Hospitals (OEI-06-17-00530), December 2020 
59 
 
 
  Department of Health and Human Services, Office of Inspector General 
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An estimated 13 percent of patients in IHS hospitals experienced adverse events and temporary 
harm events during stays in FY 2017, with higher rates of harm in smaller hospitals.  Adverse events 
and temporary harm events indicate that a patients care resulted in an undesirable clinical 
outcome not caused by underlying disease.  Within our sample, harm events were more prevalent 
among older adults and labor and delivery patients, and about half of events were preventable.  
IHS concurred with all three of our recommendations, which are: 
 
  Establish patient harm monitoring and reduction as a key priority of the Office of Quality. 
  Effectively track and monitor patient harm events using an improved incident reporting 
system. 
  Implement quality improvement plans to improve patient safety across IHS, including plans 
that focus specifically on smaller hospitals and patient groups at higher risk of harm. 
 
Indian Health Service Facilities Made Progress Incorporating Patient Protection Policies, but 
Challenges Remain (OEI-06-19-00331), December 2020 
 
In recent years, IHS had cases of health care providers abusing patients under facility care, 
including a pediatrician who was convicted of multiple counts of child sexual abuse.  In early 2019, 
IHS updated its policies to prevent and address child sexual abuse by providers.  In December 
2019, OIG issued its first report in a two-part series examining IHS patient protection policies.  The 
first report found that IHS had strengthened its patient protection policies, but there were gaps in 
coverage and IHS facilities were still early in implementation.  This is the second report in that 
series, which found that most facilities had fully incorporated the agencywide requirements into 
their local policies but faced challenges in carrying out the policies and reported remaining barriers 
that may deter staff and patients from reporting patient abuse.  IHS concurred with our 
recommendations, which are:  
 
  Provide additional guidance and training to facilities on patient protection policies, 
including the role of law enforcement and the reporting process related to patient abuse.  
  Improve the process and timeliness for conducting staff background investigations and 
notifying facilities when staff are approved. 
  Examine and revise, as needed, the reporting structure in the policies and the incident 
reporting system to ensure that staff and patients can report abuse anonymously. 
  Establish and enforce a deadline by which all facilities must fully incorporate the new 
requirements into their policies and procedures, and actively monitor facility adherence. 
 
Instances of IHS Labor and Delivery Care Not Following National Clinical Guidelines or Best Practices 
(OEI-06-19-00190), December 2020 
 
About half of the labor and delivery patients (27 of 48) included in our review of maternal care 
provided in IHS hospitals received care that did not follow national clinical guidelines (13 patients), 
60 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
did not use best practices for blood loss estimation (8 patients), or included both concerns 
(6 patients) during their stays at IHS hospitals.  IHS is taking steps to further improve the care 
provided to labor and delivery patients, and we believe this report provides the agency with 
information that will assist in this effort.  IHS concurred with all three of our recommendations, 
which are: 
 
  Assess IHSs labor and delivery practices and consider practice improvements based on the 
findings of this assessment. 
  Take steps to ensure that IHS providers employ best practices in diagnosing and treating 
postpartum hemorrhage. 
  Encourage and support greater adoption of the Alliance for Innovation on Maternal 
Healths bundles of maternal-safety best practices.  
 
Independent Attestation Review: Indian Health Service Fiscal Year 2020 Detailed Accounting Report, 
 
Performance Summary Report for National Drug Control Activities, Budget Formulation   
 
Compliance Report, and Accompanying Required Assertions (A-03-21-00351), January 2021 
Based on our review, we are not aware of any material modifications that should be made to IHSs 
Detailed Accounting Report and Performance Summary Report for FY 2020 and IHSs Budget 
Formulation Compliance Report for FY 2022 for them to be in accordance with the ONDCP 
Compliance Reviews Circular. 
 
Although the Bemidji Area Office Had Adequate Procedures To Disburse Indian Health Service 
   
Funds, It Needs To Strengthen Its Procedures for Monitoring the Use of the Funds 
(A-05-18-00019), February 2021  
 
IHSs Bemidji Area Office (BAO) generally had adequate procedures to disburse IHS funds to 
programs.  However, BAOs procedures for monitoring the use of funds did not include: (1) routine 
reconciliations of amounts reported in the Uniform Financial Management System (UFMS) with 
amounts recorded in supporting documents, (2) monitoring and evaluating IHS Direct programs 
use of no-year Health Service funds carried forward by appropriation year and budget activity 
programs, and (3) evaluating IHS Direct programs use of current no-year Health Service funds. 
 
IHS concurred with our recommendations that BAO establish procedures to: (1) reconcile IHS funds 
recorded in the UFMS on a regular schedule with amounts reported in supporting documents, such 
as worksheets and funding agreements; (2) monitor and evaluate IHS Direct programs use of no-
year Health Services funds carried forward by appropriation year and budget activity program; and 
(3) evaluate IHS Direct programs use of current no-year Health Services funds. 
 
61 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
National Institutes of Health 
The National Institutes of Health Administered Superfund Appropriations During Fiscal Year 2019 in 
 
Accordance With Federal Requirements (A-04-20-04077), December 2020 
During FY 2019, NIH administered Superfund appropriations in accordance with applicable Federal 
requirements.  Specifically, NIH obligated and disbursed Superfund appropriations in accordance 
with Federal requirements and in similar proportions to prior years.  In addition, the Institutes 
monitoring of Superfund grants generally ensured that grantees met requirements for financial, 
performance, and audit reporting.  This report contains no recommendations. 
 
Independent Attestation Review: National Institutes of Health Fiscal Year 2020 Detailed Accounting 
Report, Performance Summary Report for National Drug Control Activities, Budget Formulation 
 
Compliance Report, and Accompanying Required Assertions (A-03-21-00352), January 2021 
Based on our review, we are not aware of any material modifications that should be made to NIHs 
Detailed Accounting Reports and Performance Summary Report for FY 2020 and NIHs Budget 
Formulation Compliance Reports for FY 2022 for them to be in accordance with the ONDCP 
Circular. 
Human Services Agency Reports and Reviews 
Administration for Children and Families 
Office of Refugee Resettlement Ensured That Selected Care Providers Were Prepared To 
 
 
Respond to the COVID-19 Pandemic (A-04-20-02031), November 2020 
The Office of Refugee Resettlement (ORR) ensured that the 11 facilities we selected for review 
followed ORR requirements in preparing for and responding to communicable diseases and were 
prepared to respond to the COVID-19 pandemic.  Specifically, ORR provided detailed COVID-19-
response guidance, encouraged telehealth visits, and updated the Unaccompanied Alien Children 
(UAC) Portal. 
 
The 11 selected facilities that we reviewed were generally prepared to respond to an emergency 
event, such as the COVID-19 pandemic, in accordance with Federal guidance.  Specifically, they had 
policies and procedures, the capability to quarantine COVID-19 cases in their facilities, and 
adequate personal protective equipment.  
 
ORR officials stated that, since 2006, ORR has had a policy in place that required its facilities to 
prepare for and respond to a communicable disease outbreak; therefore, the facilities were 
generally able to quickly pivot to respond to the COVID-19 pandemic.  This report contains no 
recommendations. 
 
62 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
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  
 
ORR did not award a $341 million sole source contract to Comprehensive Health Service, LLC 
(CHS), in accordance with Federal regulations and did not effectively manage its HHS contracts for 
services provided at Homestead in accordance with Federal statutes, regulations, and HHS policies 
and procedures.  Because ORR did not follow Federal regulations or effectively manage its 
contracts for services provided at Homestead, it: (1) did not receive the benefit of a full and open 
competition, such as potentially receiving higher quality services or services at a lower cost when it 
awarded a sole-source letter contract to CHS; (2) paid approximately $67 million to operate 
Homestead fully staffed and equipped for nearly 3 months after the last child left Homestead; (3) 
increased the risk of approving invoices that were incorrect or for services not performed; and (4) 
made approximately $2.6 million in overpayments to CHS. 
 
ACF, commenting on behalf of ORR, generally agreed with our recommendations that it: (1) 
develop plans for upcoming service needs by using all available data and indicators to ensure that 
it adheres to Federal requirements and (2) recoup the $2,581,157 overpayment of fixed fees from 
CHS.  We also made several other recommendations related to establishing policies and 
procedures to better protect Federal funds and manage its contracts in accordance with Federal 
statutes, regulations, and HHS policies and procedures.  
 
Virginias 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 
Virginias monitoring process ensured provider compliance with State requirements related to 
criminal background checks at 22 of the 30 child care provider locations we reviewed but did not 
ensure provider compliance at the remaining 8 locations.  In total, we found that 15 of the 377 
household members and employees reviewed did not have a current and completed background 
check.  By not ensuring that all child care staff members who supervised or had routine 
unsupervised contact with children had complete criminal background checks, Virginia potentially 
jeopardized the safety of children in its care. 
 
Virginia concurred with our recommendations that it: (1) conduct all required criminal background 
checks for the 15 individuals in our sample who did not have the required checks at the time of our 
review; (2) revise State guidelines to specify that inspectors should use verified information, such as 
payroll data, from each child day center to determine which employees criminal background 
checks must be reviewed; (3) revise State guidelines to increase the number of current employees 
that inspectors review at all child day centers to ensure provider compliance with criminal 
background check requirements; and (4) provide periodic training to providers to ensure they 
request required background checks. 
 
63 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
ACF Cannot Ensure That All Child Victims of Abuse and Neglect Have Court Representation         
(OEI-12-16-00120), March 2021 
 
Our findings demonstrate that ACF is neither supporting States in implementing CAPTAs 
requirement for court representatives for child victims of abuse and neglect, nor is ACF monitoring 
States compliance with the requirement.  As a result, ACF cannot ensure that all such victims have 
court representation to protect their best interests.   
 
We recommend that ACF conduct oversight activitiesseeking statutory authority as necessary
to identify, and proactively provide technical assistance to, States that may not appoint a court 
representative to every child victim.  We also recommend that ACF proactively identify and address 
obstacles that States face in reporting complete and accurate data on court representatives.  ACF 
did not explicitly concur or nonconcur with our recommendations.  However, ACF asserted a lack 
of statutory authority to implement our recommendations and stated that our recommended 
approach is inconsistent with the structure of the CAPTA State grant program.   
 
Health Resources and Services Administration 
In Selected States, 67 of 100 Health Centers Did Not Use Their HRSA Access Increases in Mental 
Health and Substance Abuse Services Grant Funding in Accordance With Federal Requirements      
 
(A-02-19-02001), November 2020 
Most health centers in the 30 States did not use their AIMS grant funding in accordance with 
Federal requirements and grant terms.  In addition, HRSA did not effectively monitor health 
centers progress toward meeting service expansion requirements and did not ensure that health 
centers spent their AIMS grant funds in accordance with grant requirements. 
 
On the basis of our sample results, we estimated that 454 of 665 health centers did not use their 
AIMS grant funding in accordance with Federal requirements and grant terms.  We also estimated 
that 125 health centers did not increase the total number of mental health and substance use 
disorder services patients, and that 99 health centers did not hire new staff or increase hours of 
existing staff within 120 days of their AIMS grant award.  As a result, patients may not have received 
the services.  In addition, we estimated that the health centers charged unallowable costs totaling 
nearly $6 million and improperly allocated costs totaling $10.9 million to their AIMS grants that 
could have been spent on AIMS-related purposes.  
 
We made a series of recommendations to HRSA, including that it improve its monitoring of how 
health centers meet targets for future grant funding opportunities and charge expenditures to their 
HRSA grants.  We also recommended that HRSA require the health centers to refund unallowable 
and improperly allocated costs to the Federal Government.  HRSA generally concurred with our 
recommendations.  
 
64 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
Drug Control Activities, Budget Formulation Compliance Report, and Accompanying Required 
 
 
Assertions (A-03-21-00354), January 2021 
Our review identified that HRSA incorrectly asserted that its reported drug obligations were only 
actual obligations.  This resulted in a deviation from the ONDCP Compliance Reviews Circular.  
Based on our review, except for this matter, we are not aware of any other material modifications 
that should be made to HRSAs Detailed Accounting Report and Performance Summary Report for 
FY 2020 and HRSAs Budget Formulation Compliance Report for FY 2022 for them to be in 
accordance with the ONDCP Compliance Reviews Circular. 
 
Substance Abuse and Mental Health Services Administration 
Opioid Treatment Programs Reported Challenges Encountered During the COVID-19 Pandemic and 
Actions Taken To Address Them (A-09-20-01001), November 2020  
 
OTPs reported a variety of: (1) challenges they have encountered during the COVID-19 pandemic 
and (2) actions they have taken to address those challenges while ensuring the continuity of 
needed services and protecting the health and safety of their patients and staff. 
 
The information in this report was gathered to support HHSs goal of reducing opioid morbidity 
and mortality and to help the Substance Abuse and Mental Health Services Administration 
(SAMHSA) by providing information on the impact that the COVID-19 pandemic has had on OTPs.  
This information was current when we conducted our interviews but may not represent all the 
challenges that OTPs have faced or the actions they have taken to address those challenges.  We 
recognize that SAMHSA has taken actions to support OTPs as they work on the front lines to treat 
people diagnosed with opioid use disorders and to ensure the safety of the health care workforce.  
The information in this report provides SAMHSA and other decisionmakers (e.g., State and Tribal 
officials and other Federal agencies) with a national snapshot of OTPs challenges and the actions 
they have taken to continue providing services during the pandemic. 
 
SAMHSA described actions that it had taken after becoming aware of COVID-19s impact on 
operations for its behavioral health stakeholders, such as providing technical assistance and 
training during the pandemic. 
 
New York Provided Projects for Assistance in Transition From Homelessness Grant Services to 
 
Ineligible Individuals and Did Not Contribute Any Required Non-Federal Funds (A-02-19-02006),   
 
December 2020 
New York did not always comply with Projects for Assistance in Transition From Homelessness 
(PATH) program requirements.  Specifically, 7 of the 50 consumers we sampled lived in permanent 
housing settings, and documentation in their case files did not indicate that they continued to need 
PATH services to prevent a recurrence of homelessness.  In addition, New York did not meet its 
65 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
funding obligation for non-Federal contributions to its PATH program and did not have written 
agreements with PATH providers, as required.  Also, New York inaccurately reported the number of 
consumers enrolled in its PATH program and did not timely file its financial report to SAMHSA. 
Finally, New York had not performed the financial closeout of its PATH program and did not verify 
that funds were appropriately used by providers or that unused funds were returned to the Federal 
Government. 
 
On the basis of our sample results, we estimated that 578 consumers (14 percent) were ineligible to 
receive PATH program services.  Also, New York did not meet its funding obligation for non-
Federal contributions, which resulted in the entire grant amount of $4.2 million being unallowable. 
 
New York disagreed with our recommendation that it refund the entire grant amount, totaling $4.2 
million, to the Federal Government.  New York agreed with our procedural recommendations, 
including that New York ensure that PATH program services are only provided to eligible 
consumers.  
 
Ohio Made Progress Toward Achieving Program Goals for Enhancing Its Prescription Drug 
 
 
Monitoring Program (A-05-18-00004), December 2020 
We identified actions that Ohio has taken, using Federal funds for improving PDMPs, to achieve 
program goals of improving safe prescribing practices and preventing prescription drug abuse and 
misuse as of August 2019.  Ohio also complied with Federal requirements for submitting its Federal 
Financial Report and Annual Performance Report and publicly reported the five CDC-directed 
indicators.  
 
The Ohio Department of Health made improvements in its PDMP related to two required strategies 
of CDCs "Prescription Drug Overdose: Prevention for States" (PfS) program: (1) enhance and 
maximize a State PDMP and (2) implement community or insurer health system interventions 
aimed at preventing prescription drug overdose and abuse.  It also made improvements in its 
PDMP related to the two optional PfS program strategies: (1) conduct policy evaluations to reduce 
prescription drug overdose morbidity and mortality and (2) develop and implement Rapid 
Response Projects. 
 
Further, Ohio improved access and strengthened the States PDMP using Substance Abuse and 
Mental Health Services Administration grant funding.  Ohios Board of Pharmacy (BoP) improved 
real-time access to PDMP data by integrating Ohios PDMP with existing technologies such as 
EHRs to improve the ability of Ohios PDMP to reduce the nature, scope, and extent of prescription 
drug abuse.  BoP also strengthened Ohios PDMP by providing resources to make the changes 
necessary to increase interoperability with other States PDMPs.  
 
Additionally, Ohio used the grant funds that we reviewed in accordance with Federal regulations. 
Therefore, we are making no recommendations.   
66 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
 
Choctaw Nation of Oklahoma Made Progress Toward Meeting Program Goals During the First 
 
 
Year of Its Tribal Opioid Response Grant (A-07-20-04121), January 2021 
The Choctaw Nation met some program goals for its Tribal Opioid Response (TOR) grant during 
the first grant year.  Specifically, the Choctaw Nation met program goals in the areas of prevention 
and recovery.  The Choctaw Nation also made progress toward meeting treatment program goals 
but encountered some challenges that prevented it from increasing the availability of MAT services 
for Tribal members within its health care system.  The Choctaw Nation was unable to achieve one 
of its goals during the first grant year: to send a provider to a 12-month addiction and pain 
management fellowship to obtain credentialing as an Addiction Medicine Specialist.  Although the 
Choctaw Nation was unable to establish MAT services by enrolling a provider in this addiction and 
pain management fellowship, the Tribe instead sent some of its current providers to become MAT 
waiver trained. 
 
The Choctaw Nation generally complied with Federal cost principles when administering its TOR 
grant.  However, during the first grant year the Choctaw Nation claimed a cost of $2,405 to the 
TOR grant that was unallowable.  
 
The Choctaw Nation did not directly agree or disagree with our recommendations, including that it 
refund unallowable costs of $2,405 to the TOR grant.  We also made procedural recommendations 
to the Choctaw Nation to train staff to identify contract costs that are allowable under Federal 
regulations and strengthen or establish policies and procedures regarding Tribal departmental 
responsibilities and staff access to contractual agreements.  
 
Independent Attestation Review: Substance Abuse and Mental Health Services Administration 
 
Fiscal Year 2020 Detailed Accounting Report, Performance Summary Report for National Drug 
 
Control Activities, Budget Formulation Compliance Report, and Accompanying Required 
 
 
Assertions (A-03-21-00353), January 2021 
 
Based on our review, we are not aware of any material modifications that should be made to 
SAMHSAs Detailed Accounting Report and Performance Summary Report for FY 2020 and 
SAMHSAs Budget Formulation Compliance Report for FY 2022 for them to be in accordance with 
the ONDCP Compliance Review Circular. 
 
 
   
67 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
Legal and Investigative Activities Related to 
Public Health and Human Service Agencies 
Health Education Assistance Loan Program Exclusions 
OIG excludes from Federal health care programs individuals who have defaulted on Health Education 
Assistance Loan (HEAL) loans.  Under the HEAL program, which stopped making loans in 1998, the HRSA 
guaranteed commercial loans to students seeking education in health-related fields.  The students can 
defer repayment of the loans until after they graduate and begin to earn income.  Although HHSs 
Program Support Center (PSC) takes steps to ensure repayment, some loan recipients do not resolve their 
debt.  After PSC has exhausted efforts to secure repayment of a debt, it declares an individual in default.  
The Social Security Act permits that thereafter, such individuals may not receive reimbursement under 
Medicare, Medicaid, and all other Federal health care programs for nonpayment of the loans. 
 
Currently, there is a moratorium on collection activities and PSC is not pursuing any settlement 
agreements at this time.  Therefore, OIG has no figures to report for this semiannual reporting period.  
 
Child Support Enforcement Activities 
OIG Investigations 
OIG investigates noncustodial parents who violate 18 U.S.C.  228 by failing to pay court-ordered 
child support.  OIG works with ACFs Office of Child Support Enforcement; DOJ; U.S. Attorneys 
Offices; the U.S. Marshals Service; and Federal, State, and local partners to address egregious child 
support enforcement cases with appropriate law enforcement and prosecutorial action.  During this 
semiannual reporting period, OIG investigations of child support enforcement cases nationwide 
resulted in no criminal actions and court-ordered restitution and settlements.   
 
Engaging the Public in Capturing Deadbeat Parents 
Because of the success of OIGs Most Wanted Fugitives List, OIG launched its Most Wanted 
Deadbeat Parents website.  The site identifies parents who fail to pay court-ordered child support 
for their children and thereby put an unnecessary strain on the custodial parents and the children 
as well as on agencies that enforce these matters.  The site, which is updated frequently, includes 
information on OIGs role in pursuing parents who fail to pay court-ordered child support.  OIGs 
Most Wanted Deadbeat Parents website can be found at https://oig.hhs.gov/fraud/child-support-
enforcement/index.asp. 
   
68 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
Other HHS-Related Reviews and Investigative 
Activities 
General Departmental 
HHS Made Some Progress Toward Compliance With the Geospatial Data Act (A-18-20-11500), 
 
October 2020 
HHS made some progress to comply with the GDA, but we identified certain covered agency 
responsibilities that HHS had yet to meet.  Additionally, HHS had not maintained a 
departmentwide inventory of all geospatial data assets, as required by GDA section 759(b), and 
had not designated a senior agency official for geospatial information (SAOGI) in accordance with 
OMB guidance to Federal agencies. 
 
These conditions occurred because of the lack of departmentwide oversight and coordination in 
HHSs implementation of geospatial-related responsibilities, requirements, policies, and activities. 
Additionally, the Departments senior agency officials were not aware of the GDA and HHSs 
responsibilities mandated by the GDA.  These conditions contributed to HHSs noncompliance with 
the covered agency responsibilities established in the GDA.  
 
As a result, HHS is susceptible to inefficient and ineffective management of geospatial assets, which 
increases the risk of inconsistent efforts or inability to minimize the costs to acquire, manage, 
share, and use geospatial data, expertise, technology, and services. 
 
We recommended that HHS ensure that HHS and its components fully implement the covered 
agencys responsibilities found in GDA section 759(a), maintain an inventory of all geospatial data 
assets, and appoint an SAOGI.  HHS did not concur or nonconcur with our recommendations.  
However, HHS indicated that it will take action to ensure compliance with the covered agency 
responsibilities established by the GDA.  
 
Financial Statement Audit of the Department of Health and Human Services for Fiscal Year 2020 
(A-17-20-00001), November 2020 
 
Based on its audit, Ernst & Young found that the FY 2020 HHS consolidated balance sheets and the 
related consolidated statements of net cost and changes in net position and combined statements 
of budgetary resources were presented fairly, in all material respects, in conformity with U.S. 
generally accepted accounting principles.  Ernst & Young was unable to obtain sufficient audit 
evidence for the amounts presented in the statements of social insurance as of January 1, 2020, 
2019, 2018, 2017, and 2016, and the related statements of changes in social insurance amounts for 
the periods ended January 1, 2020, and 2019.  As a result, Ernst & Young was not able to, and did 
69 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
not, express an opinion on the financial condition of the HHS social insurance program and related 
changes in the social insurance program for the specified periods.  
 
Ernst & Young also noted two matters involving internal controls with respect to financial 
reporting.  Under the standards established by the American Institute of Certified Public 
Accountants and Government Auditing Standards, issued by the Comptroller General of the United 
States, Ernst & Young did not identify any deficiencies in internal control that it considered a 
material weakness.  Ernst & Young noted improvements over internal controls but continued to 
identify two significant deficiencies related to HHSs Financial Information Systems and HHSs 
Financial Reporting Systems, Analyses, and Oversight. 
 
Report on the Financial Statement Audit of the Centers for Medicare & Medicaid Services for Fiscal 
Year 2020 (A-17-20-53000), November 2020 
 
Based on its audit, Ernst & Young found that the FY 2020 CMS consolidated balance sheets and the 
related consolidated statements of net cost and changes in net position and combined statement 
of budgetary resources were presented fairly, in all material respects, in conformity with U.S. 
generally accepted accounting principles.  Ernst & Young was unable to obtain sufficient audit 
evidence for the amounts presented in the statements of social insurance as of January 1, 2020, 
2019, 2018, 2017, and 2016, and the related statements of changes in social insurance amounts for 
the periods ended January 1, 2020, and 2019.  As a result, Ernst & Young was not able to, and did 
not, express an opinion on the financial condition of the CMS social insurance program and related 
changes in the social insurance program for the specified periods. 
 
Ernst & Young also noted two matters involving internal controls with respect to the financial 
reporting: financial reporting processes and information systems controls.  Also, during FY 2020, 
CMS was not in full compliance with the requirements of the Payment Integrity Information Act of 
2019 or section 6411 of the Affordable Care Act.    
   
U.S. Department of Health and Human Services Met the Requirements of the Digital  Accountability 
and Transparency Act of 2014, With Areas That Require Improvement (A-17-20-54000), November 
 
2020
Our performance audit determined that HHS complied with the reporting requirements of the 
Digital Accountability and Transparency Act of 2014 (DATA Act) as stipulated by OMB, the Council 
of the Inspectors General on Integrity and Efficiency, and Treasury.  Although HHS met the 
reporting requirements, our performance audit determined that: 
 
Although improvements with respect to the controls within HHSs IT infrastructure and financial 
systems have been made, we observed deficiencies related to access controls, configuration 
management, segregation of duties, and interface controls. 
 
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  Department of Health and Human Services, Office of Inspector General 
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For the period of performance dates, we found discrepancies between File D2 and the supporting 
documents.  HHS management indicated that a gap existed between the operating divisions 
understanding of the standard interface file (SIF) creation process for these fields.  Multiple date 
fields are collected through the SIF file process, and operating divisions misinterpreted the different 
definitions for these date fields including, specifically, the period of performance data element.  
 
We recommend that HHS continue to focus its efforts on resolving issues related to its IT system 
controls, fully implementing interface controls by updating the governance for different 
environments to be compliant.  We also recommend that HHS continue to progress toward 
producing high-quality data; remediating deficiencies in financial, procurement and grant-related 
systems; and better automating DATA Act data collection and submission processes.  Finally, we 
recommend that HHS focus on refreshing operating divisions understanding of Departmental 
guidance and identifying any potential need for operating division training to prevent and detect 
future accuracy issues.  
 
 
Grants and Contracts 
HHS is the largest grant-making organization and one of the largest contracting agencies in the Federal 
Government.  In FY 2019, HHS awarded more than $559 billion in grants and over $26 billion in contracts 
across all program areas.  OIGs direct annual discretionary appropriation funding is used to conduct 
program integrity and enforcement activities with regard to the more than 100 public health and human 
services programs carried out by more than 80,00 employees around the world.  The size and scope of 
departmental awards make their operating effectiveness crucial to the success of programs designed to 
improve the health and well-being of the public.  
 
  Grant Fraud Investigations 
 
  The following case examples relate to misuse of grant funds: 
 
KansasOn November 23, 2021, KalScott Engineering, Inc. (KalScott) and its president, Thomas 
Sherwood, and Vice President Suman Saripalli, entered into a settlement agreement under which 
they agreed to pay $672,352 to resolve allegations that the company submitted false claims to 
obtain grant funds from the SBIR and Small Business Technology Transfer (STTR) programs, which 
are competitive programs that encourage American small businesses to engage in research, on 
behalf of the Federal Government, that has the potential for commercialization.  Grant recipients 
must designate a principal investigator and key personnel who will work on the grant-funded 
project.  Small businesses may subcontract a portion of the work to other entities, but the small 
business itself must perform a majority of the grant-funded work.  Between April 2012 and July 
2015, KalScott received SBIR grants from NIH, the National Aeronautics and Space Administration 
(NASA), and the Air Force; as well as an STTR grant from the Navy.  The United States contends 
that the company wrongfully obtained grant funds from NASA and the Navy because KalScott 
71 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
designated Mr. Saripalli as a principal investigator when he was not eligible to serve in that role.  In 
addition, it is alleged that KalScott did not perform a majority of work under the Air Force grant, 
and that KalScott used different key personnel than it listed in its proposal to obtain the NIH grant. 
 
New YorkOn October 6, 2020, Geoffrey Girnun, a former associate professor and cancer 
researcher at Stony Brook Universitys Department of Pathology of Medicine, was sentenced to 1 
year and 1 day in prison for theft of Government funds related to a grant he received to research 
the effect of certain molecules on cancer.  Girnun pleaded guilty in January 2020 and pursuant to 
his plea agreement, he agreed to forfeit $225,000 and resign from his position at Stony Brook 
University.  The court also ordered Girnun to pay $225,000 in restitution to NIH and Stony Brook 
University.   
 
In approximately 2013 and 2017, Girnun formed two sham companies, Atlas Metabolomics, LLC 
(Atlas) and Empyrean Biosciences, LLC (Empyrean) that purportedly provided research items and 
equipment for the defendants cancer-related research projects.  From approximately December 
2013 through September 2019, Girnun submitted fraudulent electronic invoices to Stony Brook 
University for payment to the sham companies for equipment, goods and services that were never 
received or provided.  Stony Brook University then used NIH and the universitys grant and 
foundation funds to pay the sham companies over $200,000.  Girnun withdrew the fraudulently 
obtained grant funds from Atlas and Empyreans bank accounts and used the money for personal 
expenses, including payments toward the mortgage on his residence and tuition for his children. 
 
OIG Reviews of Non-Federal Audits 
OIG reviews audits conducted by non-Federal auditors of entities receiving Federal awards.  During 
this semiannual reporting period, OIGs National External Audit Review Center reviewed 388 
reports covering $930.2 billion in audited costs.  Federal dollars covered by these audits totaled 
$204.9 billion, of which about $115.6 billion were HHS funds. 
Uniform guidance at 2CFR200 Subpart F establishes audit requirements for State and local 
governments, colleges and universities, and nonprofit organizations receiving Federal 
awards.  Under the uniform guidance, covered entities must conduct annual organization-wide 
single audits of all Federal money they receive.  These audits are conducted by non-Federal 
auditors, such as public accounting firms and State auditors.  OIG reviews the quality of these 
audits and assesses the adequacy of the entities management of Federal funds. 
OIGs oversight of non-Federal audit activity informs Federal managers about the soundness of 
management of Federal programs and identifies any significant areas of internal control weakness, 
noncompliance, and questioned costs for resolution or followup.  We identify entities for high-risk 
monitoring, alert program officials to any trends that could indicate problems in HHS programs, 
and profile non-Federal audit findings of a particular program or activity over time to identify 
systemic problems.  We also provide training and technical assistance to grantees and members of 
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  Department of Health and Human Services, Office of Inspector General 
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the auditing profession.  OIG maintains a process to assess the quality of the non-Federal reports 
received and the audit work that supports the selected reports. 
OIGs reports on non-Federal audits reviewed during this reporting period are categorized in the 
following table. 
 
Non-Federal Audits, October 1, 2020, Through March 31, 2021 
 
Not requiring changes or having minor changes   365 
Requiring major changes  22 
Having significant technical inadequacies  1 
Total Number of Non-Federal Audits  388 
 
 
   
73 
 
 
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Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
Appendix A: Questioned Costs and Funds To 
Be Put to Better Use 
The following tables summarize OIGs monetary recommendations and HHS responses to them.  This 
information is provided in accordance with the Inspector General Act,  5(a)(8) and (a)(9) (5 U.S.C. App.  
5(a)(8) and (a)(9)), and the Supplemental Appropriations and Rescissions Act of 1980.  
 
Audit Reports With Questioned Costs 
As defined by the Inspector General Act, the term questioned cost means a cost that is questioned by 
OIG because of: (1) an alleged violation of a provision of law, regulation, contract, grant, cooperative 
agreement, or other agreement or document governing the expenditure of funds; (2) a cost that is not 
supported by adequate documentation at the time of the audit; or (3) the expenditure of funds for the 
intended purpose is unnecessary or unreasonable.  Questioned costs that HHS program officials have, in a 
management decision, sustained or agreed, should not be charged to the Government are disallowed 
costs.  Superscripts indicate end notes that follow the tables below. 
 
Table 1: Audit Reports With Questioned Costs 
Number of  Dollar Value  Dollar Value 
Description  Reports  Questioned  Unsupported 
Section 1          
Reports for which no management decisions had been 
made by the beginning of the reporting period1  76  $1,850,465,000  $505,797,000 
Issued during the reporting period  34  $241,954,000  $2,581,000 
Total Section 1  110  $2,092,419,000  $508,378,000 
Section 2       
Reports for which management decisions were made 
during the reporting period2, 3       
Disallowed costs  54  *$566,464,000  $0 
Costs not disallowed  7  $19,241,000  $0 
Total Section 2  61  $585,705,000  $0 
* Audit receivables (expected recoveries)       
Section 3       
Reports for which no management decisions had been 
made by the end of the reporting period 
(Section 1 minus Section 2)  49  $1,506,714,000  $508,378,000 
Section 4       
Reports for which no management decisions were made 
within 6 months of issuance4  28  $1,302,503,000  $505,797,000 
74 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
 
Table 1 End Notes 
1 The opening balance was adjusted upward by $18.9 million because of a reevaluation of previously issued 
recommendations.  
2 Revisions to previously reported management decisions: 
  A-07-13-02795, Palmetto Government Benefits Administrator Did Not Always Refer Medicare Cost 
Reports and Reconcile Outlier Payments in Jurisdiction 1.  CMS reduced disallowed costs by 
$12,821,146 as a result of a MAC settlement due to bankruptcy provisions. 
  A-06-16-00018, Arkansas Claimed Unallowable Federal Reimbursement for Some Medicaid 
Physician-Administered Drugs.  CMSs subsequent review of support documentation provided by 
the State of Arkansas, determined that disallowed cost should be reduced by $8,747,496. 
  A-04-13-07043, Medicare Compliance Review of Florida Hospital Orlando for the Period January 1, 
2011, Through June 30, 2012.  Based on redetermination appeals for extrapolated overpayments 
totaling $11,512,530, recoveries were reduced by $7,403,950. 
  Not detailed are reductions to previously disallowed management decisions totaling 
$8.9 million.   
3 Included are management decisions to disallow $10.8 million in questioned costs that were identified by 
non-Federal auditors in audits of State and local governments, colleges and universities, and nonprofit 
organizations receiving Federal awards conducted in accordance with Office of Management and Budget 
Circular A-133.  OIG is currently ensuring that work performed by these non-Federal auditors complies with 
Federal audit standards; accordingly, OIG tracks, resolves, and reports on recommendations in these audits. 
4 Because of administrative delays, some of which were beyond management control, resolution of the 
following 28 audits were not completed within 6 months of issuance of the reports; however, agency 
management has informed us that the agency is working to resolve the outstanding recommendations 
before the end of the next semiannual reporting period. 
 
Audit CIN  Audit Title 
A-02-15-02013  CMS Did Not Always Accurately Authorize Financial Assistance Payments to Qualified Health 
Plan Issuers in Accordance With Federal Requirements During the 2014 Benefit Year, 
August 2018, $939,287,686 
A-02-14-02017  New York Misallocated Costs to Establishment Grants for a Health Insurance Marketplace, 
November 2016, $149,654,512 
A-02-16-02007  Lincoln Hall Boys Haven, an Administration for Children and Families Grantee, Did Not Always 
Comply With Applicable Federal and State Policies and Requirements, February 2019, 
$29,807,160 
A-01-14-02503  Maryland Misallocated Millions to Establishment Grants for a Health Insurance Marketplace, 
March 2015, $28,400,000 
A-04-14-07050  Kentucky Misallocated Millions to Establishment Grants for a Health Insurance Marketplace, 
February 2017, $25,530,429 
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Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
A-07-18-04111  Mississippi Needs To Improve Oversight of Its Child Care Payment Program, April 2020, 
$22,284,900 
A-02-15-02008  New York Did Not Comply With Federal Grant Requirements for Allocating and Claiming 
Marketplace Contract Costs, December 2017, $20,415,344 
A-01-17-00506  Medicare Paid Twice for Ambulance Services Subject to Skilled Nursing Facility Consolidated 
Billing Requirements, February 2019, $19,938,117 
A-07-15-04226  Not All of Missouri's Child Care Subsidy Program Payments Complied With Federal and State 
Requirements, November 2017, $19,076,167 
A-06-17-07004  Southwest Key Programs Failed To Protect Federal Funds Intended for the Care and Placement of 
Unaccompanied Alien Children, September 2020, $13,130,848 
A-01-15-02500  Vermont Did Not Properly Allocate Millions to Establishment Grants for a Health Insurance 
Marketplace, September 2016, $11,243,006 
A-02-14-02024  Newark Preschool Council, Inc., Did Not Always Comply With Head Start Requirements, February 
2017, $9,950,556 
A-02-16-02013  The Children's Village Inc., an Administration for Children and Families Grantee, Did Not Always 
Comply With Applicable Federal and State Policies and Requirements, April 2019, $2,623,785 
A-07-17-02808  The Colorado Health Insurance Marketplaces Financial Management System Did Not Always 
Comply With Federal Requirements, July 2018, $2,567,604 
A-04-16-00112  North Carolina Made Capitation Payments to Managed Care Entities After Beneficiaries' Deaths, 
September 2020, $1,948,657 
A-07-11-06013  The University Of Colorado Denver Did Not Always Claim Selected Costs Charged Directly to 
Department of Health And Human Services Awards in Accordance With Federal Regulations, 
June 2013, $1,419,524 
A-05-14-00045  The Minnesota Marketplace Misallocated Federal Funds and Claimed Unallowable Costs, 
November 2016, $1,279,677 
A-01-19-02500  Cape Cod Child Development Program Did Not Meet Its Head Start Non-Federal Share 
Obligations, April 2020, $1,196,293 
A-01-18-02501  Vermonts Office of Child Support Needs Better Oversight Over Its Administrative Costs Claimed, 
September 2019, $1,058,309 
A-09-14-01007  Nevada Misallocated Costs for Establishing a Health Insurance Marketplace to Its Establishment 
Grants, February 2016, $893,464 
A-12-17-00002  The Office of the Secretary of Health and Human Services Did Not Comply With Federal 
Regulations for Chartered Aircraft and Other Government Travel Related to Former Secretary 
Price, July 2018, $341,616 
A-02-17-02003  Sharon Baptist Head Start Claimed Unallowable Rent and Failed To Return Embezzled Funds, 
July 2020, $207,264 
A-05-18-00008  The Next Door Foundation Claimed Unallowable Indirect Costs and Did Not Document the 
Funding Source of Program Expenditures in Accordance With Federal Requirements, 
September 2019, $142,104 
A-09-18-03031  CMS Could Have Saved $192 Million by Targeting Home Health Claims for Review With Visits 
Slightly Above the Threshold That Triggers a Higher Medicare Payment, July 2020, $41,613 
A-09-18-03018  Medicare Improperly Paid Suppliers an Estimated $92.5 Million for Inhalation Drugs, 
October 2019, $36,825 
A-03-16-00250  Youth For TomorrowNew Life Center, Inc., an Administration for Children and Families Grantee, 
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Did Not Comply With All Applicable Federal Policies and Requirements, September  2020, 
$16,851 
A-04-18-02010  Florida's Refugee Medical Assistance Payments Were Generally Allowable, January 2020, $8,772 
A-05-18-00015  The University of Minnesota Complied With Federal Requirements To Perform Risk Assessments 
and Monitor Subrecipients, November 2019, $1,924 
TOTAL CINS: 28 
TOTAL AMOUNT: $1,302,503,000 
 
 
Audit Reports With Funds Recommended To Be Put to Better Use 
The phrase recommendations that funds be put to better use means that funds could be used more 
efficiently if management took action to implement an OIG recommendation through reductions in 
outlays, deobligation of funds, and/or avoidance of unnecessary expenditures.  Table 2 reports HHS 
program officials decisions to take action on these audit recommendations.   
 
 
Number of 
Description  Reports  Dollar Value 
Section 1     
Reports for which no management decisions had been made by the 
beginning of the reporting period  17  $17,622,190,000 
Reports issued during the reporting period  4  $10,917,000 
Total Section 1  21  $17,633,107,000 
Section 2     
Reports for which management decisions were made during the 
reporting period1     
Value of recommendations agreed to by management     
Based on proposed management action  8  $919,971,000 
Based on proposed legislative action  0  $0 
Value of recommendations not agreed to by management  1  $103,514,000 
Total Section 2  9  $1,023,485,000 
Section 3     
Reports for which no management decisions had been made by the 
end of the reporting period2 (Sec. 1 minus Sec. 2)  12  $16,609,622,000 
 
Table 2 End Notes 
1 Revisions to previously reported management decisions: 
  A-01-15-00515, Wisconsin Physicians Service Paid Providers for Hyperbaric Oxygen Therapy Services That Did 
Not Comply With Medicare Requirements.  CMSs subsequent review of additional documentation realized 
savings totaling $7,069,366, thus reducing the value agreed upon by $35,259,970. 
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2 Because of administrative delays, some of which were beyond management control, 9 of the 12 audits open at end 
of the period were not resolved within 6 months of issuance of reports.  OIG is working with management to reach 
resolution on these recommendations before the end of the next semiannual reporting period. 
Audit CIN  Audit Title 
A-05-12-00020  Medicare And Beneficiaries Could Save Billions If CMS Reduces Hospital Outpatient Department 
Payment Rates for Ambulatory Surgical Center-Approved Procedures to Ambulatory Surgical 
Center Payment Rates, April 2014, $15,000,000,000 
A-03-17-00010  Hospitals Overbilled Medicare $1 Billion by Incorrectly Assigning Severe Malnutrition Diagnosis 
Codes to Inpatient Hospital Claims, July 2020: $1,024,623,449 
A-03-16-03001  The Centers for Medicare & Medicaid Services Did Not Identify and Report Potential 
Antideficiency Act Violations for 12 Contracts Used To Establish the Federal Marketplace Under 
the Affordable Care Act, February 2020, $186,993,209 
A-06-17-08004  Medicare Part D Is Still Paying Millions for Drugs Already Paid for Under the Part A Hospice 
Benefit, August 2019, $160,800,000 
A-05-16-00060  Hospitals Received Millions in Excessive Outlier Payments Because CMS Limits the Reconciliation 
Process, November 2019, $125,000,000 
A-03-13-03002  HHS Did Not Identify and Report Antideficiency Act Violations, May 2017, $49,445,025 
A-04-18-04067  Inadequate Edits and Oversight Caused Medicare To Overpay More Than $267 Million for 
Hospital Inpatient Claims With Post-Acute-Care Transfers to Home Health Services, 
August 2020, $40,610,333 
A-07-17-01176  Incorrect Acute Stroke Diagnosis Codes Submitted by Traditional Medicare Providers Resulted in 
Millions of Dollars in Increased Payments to Medicare Advantage Organizations, 
September 2020, $14,417,533 
A-09-18-03030  Medicare Incorrectly Paid Providers for Emergency Ambulance Transports From Hospitals to 
Skilled Nursing Facilities, September 2019, $968,718 
TOTAL CINS: 9 
TOTAL AMOUNT: $16,602,858,000 
 
 
   
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
Appendix B: Peer-Review Results 
The Inspector General Act of 1978, as amended, requires OIGs to report the results of peer reviews of their 
operations conducted by other OIGs, the date of the last peer review, outstanding recommendations from 
peer reviews, and peer reviews conducted by an OIG of other OIGs in the semiannual period.  Peer reviews 
are conducted by member organizations of CIGIE.   
 
Office of Audit Services  
During this semiannual reporting period, one peer review involving OAS was completed.  Information 
concerning OASs peer-review activity during a prior reporting period is also listed below. 
 
 
OAS  Date  Reviewing Office  Office Reviewed 
March 2021  General Services  HHS-OIG, OAS 
Administration OIG 
 
The system of quality control for the audit organization of HHS-OIG in effect for the year ending 
September 30, 2020, has been suitably designed and complied with to provide HHS-OIG with 
reasonable assurance of performing and reporting in conformity with applicable professional 
standards in all material respects.  Federal audit organizations can receive a rating of pass, pass 
with deficiencies, or fail.  HHS-OIG received a peer-review rating of pass. 
 
 
 
OAS  Date  Reviewing Office  Office Reviewed 
April 2019  HHS-OIG, OAS  Department of Transportation 
(DOT) OIG 
The system of quality control for the audit organization of DOT-OIG in effect for the year ending 
September 30, 2018, has been suitably designed and complied with to provide DOT-OIG with 
reasonable assurance of performing and reporting in conformity with applicable professional 
standards in all material respects.  Federal audit organizations can receive a rating of pass, pass 
with deficiencies, or fail.  DOT-OIG received a peer-review rating of pass. 
 
 
Office of Investigations 
During this semiannual reporting period, no peer reviews involving OI were completed.  Listed below is 
information about OIs peer-review activities during prior reporting periods. 
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OI  Date  Reviewing Office  Office Reviewed 
  October 2018  SSA-OIG  HHS-OIG, OI 
The system of internal safeguards and management procedures for the investigative function of 
HHS-OIG in effect for the year ending September 30, 2018, was in full compliance with the quality 
standards established by CIGIE and the Attorney Generals guidelines. 
 
OI  Date  Reviewing Office  Office Reviewed 
  August 2017  HHS-OIG, OI  U.S. Postal Service (USPS) OIG 
The system of internal safeguards and management procedures for the investigative function of 
the USPS-OIG in effect for the year ending September 30, 2015, was in full compliance with the 
quality standards established by CIGIE and the Attorney Generals guidelines.  
 
Office of Evaluation and Inspections 
During this semiannual reporting period, one peer review involving OEI was completed.  Information 
concerning OEIs peer-review activity during a prior reporting period is also listed below. 
 
OEI  Date  Reviewing Office  Office Reviewed 
November 2020  Department of State,  HHS-OIG, OEI 
OIG 
 
A CIGIE external peer Review Team assessed the extent to which HHS-OIG, OEI met seven Quality 
Standards for Inspection and Evaluation (Blue Book) standards.  The seven covered standards are: 
Quality Control, Planning, Data Collections and Analysis, Evidence, Records Maintenance, 
Reporting, and Followup.  The assessment included a review of OEIs internal policies and 
procedures documented in the OEI procedures manual.  It also included a review of four reports 
issued between June 1, 2019, and June 1, 2020, to determine whether the reports compiled with the 
seven standards and internal policies and procedures.  The Review Team determined that OEIs 
policies and procedures generally met the seven standards.  The four reports reviewed generally 
met the standards and complied with OEIs internal policies and procedures.  
 
 
OEI        Date  Reviewing Office  Office Reviewed 
  June 2020  HHS-OIG, OEI  Department of Veterans Affairs 
(VA) OIG 
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Semiannual Report to CongressOctober 1, 2020, through March 31, 2021
 
 
The Veterans Affairs, Office of Inspector General, Office of Audits and Evaluations and Office of 
Healthcare Inspections (collectively VA-OIG) policies and procedures addressed the Quality 
Standards for Inspection and Evaluation (Blue Book) standards.  The seven covered standards are: 
Quality Control, Planning, Data Collections and Analysis, Evidence, Records Maintenance, 
Reporting, and Followup.  In addition, each of the four reviewed VA-OIG reports complied with 
those standards and the VA-OIGs internal policies and procedures.  As a result of our findings, 
there are no recommendations associated with this external peer review.  The report also noted a 
VA-OIG beneficial practice of using specialized staff to conduct independent referencing reviews of 
its reports to achieve greater consistency in its quality assurance processes. 
 
 
OEI  Date  Reviewing Office  Office Reviewed 
September 2019  HHS-OIG, OEI  Department of Interior (DOI) 
OIG 
The DOI-OIG Inspection and Evaluation components policies and procedures mostly met CIGIEs 
Blue Book standards.  We reviewed four reports: two fully met the applicable Blue Book standards 
and two did not.  DOI-OIG concurred with recommendations related to Evidence, Planning, and 
Data Collection and Analysis but did not concur with recommendations related to Reporting. 
 
 
OEI  Date  Reviewing Office  Office Reviewed 
September 2018  HHS-OIG, OEI  Department of Defense (DoD) 
OIG 
The DoD OIG Inspection and Evaluation components policies and procedures generally met 
CIGIEs Blue Book standards.  In addition, the 10 reports reviewed generally met the applicable Blue 
Book standards.  Onsite visits for these reviews were conducted from October 2, 2017, through 
 
November 17, 2017. 
81 
 
 
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Appendix C: Summary of Sanction Authorities 
The Inspector General Act of 1978, as amended, specifies requirements for semiannual reports to be made 
to the HHS Secretary for transmittal to Congress.  A selection of other authorities appears below.  
 
Program Exclusions 
The Social Security Act,  1128 (42 U.S.C.  1320a-7), provides several grounds for excluding individuals and 
entities from participation in Medicare, Medicaid, and other Federal health care programs.  Exclusions are 
required (mandatory exclusion) for individuals and entities convicted of the following types of criminal 
offenses: (1) Medicare or Medicaid fraud; (2) patient abuse or neglect; (3) felonies for other health care 
fraud; and (4) felonies for illegal manufacture, distribution, prescription, or dispensing of controlled 
substances.   
 
OIG is authorized (permissive exclusion) to exclude individuals and entities on several other grounds, 
including misdemeanors for other health care fraud (other than Medicare or Medicaid); suspension or 
revocation of a license to provide health care for reasons bearing on professional competence, 
professional performance or financial integrity; provision of unnecessary or substandard services; 
submission of false or fraudulent claims to a Federal health care program; or engaging in unlawful kickback 
arrangements.  
 
The ACA added another basis for imposing a permissive exclusion, that is, knowingly making, or causing to 
be made, any false statements or omissions in any application, bid, or contract to participate as a provider 
in a Federal health care program, including managed care programs under Medicare and Medicaid, as well 
as Medicares prescription drug program.  
 
Providers subject to exclusion are granted due process rights.  These include a hearing before an 
administrative law judge and appeals to the HHS Departmental Appeals Board and Federal district and 
appellate courts regarding the basis for and the length of the exclusion.  
 
Civil Monetary Penalties Law 
The CMPL of the Social Security Act, 1128A (42 U.S.C.  1320a 7a), imposes penalties, assessments, and 
exclusion from participation in Federal health care programs for engaging in certain activities.  For 
example, a person who submits, or causes to be submitted, to a Federal health care program a claim for 
items and services that the person knows, or should know, is false or fraudulent is subject to a penalty of 
up to $15,270 for each item or service falsely or fraudulently claimed, an assessment of up to three times 
the amount falsely or fraudulently claimed, and exclusion.  
 
For the purposes of the CMPL, should know is defined to mean that the person acted in reckless 
disregard or deliberate ignorance of the truth or falsity of the claim.  The law and its implementing 
82 
 
 
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regulations also authorize actions for a variety of other violations, including submission of claims for items 
or services furnished by an excluded person; requests for payment in violation of an assignment 
agreement; violations of rules regarding the possession, use, and transfer of biological agents and toxins; 
and payment or receipt of remuneration in violation of the anti-kickback statute (42 U.S.C.  1320a 7b (b)).   
 
The ACA added more grounds for imposing CMPs.  These include, among other types of conduct, 
knowingly making, or causing to be made, any false statements or omissions in any application, bid, or 
contract to participate as a provider in a Federal health care program (including Medicare and Medicaid 
managed care programs and Medicare Part D); the ACA authorizes a penalty of up to $55,262 for each 
false statement, as well as activities relating to fraudulent marketing by MCOs, their employees, or their 
agents.   
 
The 21st Century Cures Act (enacted on December 13, 2016) added more grounds for imposing CMPs, 
assessments, and exclusion from Federal health care programs for fraudulent conduct in an HHS grant, 
contract, or other agreement.  OIG may assess CMPs of up to $10,000 per claim and assessments of up 
to three times the amount claimed for knowingly presenting a false or fraudulent claim.  In addition, OIG 
may impose a penalty of up to $50,000 and assessments of up to three times the amount of funds at issue: 
(1) for each instance of knowingly making a false statement in a document required to be submitted to 
receive funds under an HHS contract, grant, or other agreement; (2) for knowingly making or using a false 
record or statement that is material to a false or fraudulent claim; and (3) for knowingly making or using a 
false record or statement material to an obligation to pay or transmit funds or property owed to HHS.  OIG 
may impose a penalty of up to $10,000 per day and assessments of up to three times the amount at issue 
for knowingly concealing, or knowingly and improperly avoiding or decreasing, an obligation owed to HHS 
with respect to an HHS grant, contract, or other agreement.  Finally, HHS-OIG may impose a penalty of up 
to $15,000 per day for failing to grant timely access to OIG upon reasonable request for audits or to carry 
out other statutory functions in matters involving an HHS grant, contract, or other agreement.   
 
Patient Dumping 
The Social Security Act, 1867 (42 U.S.C.  1395dd), provides that when an individual goes to the ER of a 
Medicare-participating hospital, the hospital must provide an appropriate medical screening examination 
to determine whether that individual has an emergency medical condition.  If an individual has such a 
condition, the hospital must provide either treatment to stabilize the condition or an appropriate transfer 
to another medical facility.  
 
If a transfer is ordered, the transferring hospital must provide stabilizing treatment to minimize the risks of 
transfer and must ensure that the receiving hospital agrees to the transfer and has available space and 
qualified personnel to treat the individual.  In addition, the transferring hospital must effect the transfer 
through qualified personnel and transportation equipment.  Further, a participating hospital with 
specialized capabilities or facilities may not refuse to accept an appropriate transfer of an individual who 
needs services if the hospital has the capacity to treat the individual.  
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OIG is authorized to collect CMPs of up to $53,484 against small hospitals (fewer than 100 beds) and up 
to $106,965 against larger hospitals (100 beds or more) for each instance in which the hospital negligently 
violated any of the section 1867 requirements.  In addition, OIG may collect a penalty of up to 
$106,965 from a responsible physician for each negligent violation of any of the section 1867 requirements 
and, in some circumstances, may exclude a responsible physician.   
 
Anti-Kickback Statute and Civil False Claims Act Enforcement Authorities 
The Anti-Kickback Statute 
The anti-kickback statute authorizes penalties against anyone who knowingly and willfully solicits, 
receives, offers, or pays remuneration, in cash or in kind, to induce or in return for: (1) referring an 
individual to a person or an entity for the furnishing, or arranging for the furnishing, of any item or 
service payable under the Federal health care programs; or (2) purchasing, leasing, or ordering, or 
arranging for or recommending the purchasing, leasing, or ordering, of any good, facility, service, 
or item payable under the Federal health care programs (Social Security Act,  1128B(b) (42 U.S.C.  
1320a-7b(b)).  
 
Individuals and entities who engage in unlawful referral or kickback schemes may be subject to 
criminal penalties under the general criminal anti-kickback statute; a CMP under OIGs authority 
pursuant to the Social Security Act,  1127(a)(7) (42 U.S.C.  1320a-7a); and/or program exclusion 
under OIGs permissive exclusion authority under the Social Security Act,  1128(b)(7) (42 U.S.C.  
1320a-7(b)(7)).  
 
The False Claims Act 
Under the False Claims Act, as amended by the False Claims Amendments Act of 1986 (31 U.S.C.  
37293733), a person or an entity is liable for up to treble damages and a penalty between 
$11,181 and $22,363 for each false claim it knowingly submits, or causes to be submitted, to a 
Federal program.  Similarly, a person or an entity is liable under the False Claims Act if it knowingly 
makes or uses, or causes to be made or used, a false record or statement to have a false claim 
paid.  The False Claims Act defines knowing to include the traditional definition and also 
instances in which the person acted in deliberate ignorance or reckless disregard of the truth or 
falsity of the information.  Under the False Claims Act, no specific intent to defraud is required.  
Further, the False Claims Act contains a qui tam, or whistleblower, provision that allows a private 
individual to file a lawsuit on behalf of the United States and entitles that whistleblower to a 
percentage of any fraud recoveries.  The False Claims Act was amended again in 2009 in response 
to recent Federal court decisions that narrowed the laws applicability.  Among other things, these 
amendments clarify the reach of the False Claims Act to false claims submitted to contractors or 
grantees of the Federal Government.   
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Appendix D: Reporting Requirements in the 
Inspector General Act of 1978 
The reporting requirements of the Inspector General Act of 1978, as amended, are listed in the following 
table along with the location of the required information.  
 
Section  Requirement  Location 
Section 4 
(a)(2)  Review of legislation and regulations  Other HHS-Related 
Reviews and 
Investigations section   
Section 5 
(a)(1)  Significant problems, abuses, and deficiencies  Throughout this report 
(a)(2)  Recommendations with respect to significant problems,  Throughout this report 
abuses, and deficiencies 
(a)(3)  Prior significant recommendations on which corrective  Solutions To Reduce 
action has not been completed  Fraud, Waste, and Abuse 
in HHS Programs: Top 
Unimplemented 
Recommendations 
(previously known as the 
Compendium of 
Unimplemented 
Recommendations) 
(a)(4)  Matters referred to prosecutive authorities  Legal and Investigative 
Activities Related to the 
Medicare and Medicaid 
Programs section 
(a)(5)  Summary of instances in which information requested by  None for this reporting 
OIG was refused  period 
(a)(6)  List of audit reports  Throughout this report  
(a)(7)  Summary of significant reports  Throughout this report 
(a)(8)  Statistical Table 1Reports With Questioned Costs  Appendix A 
(a)(9)  Statistical Table 2Funds Recommended To Be Put to  Appendix A 
Better Use 
(a)(10)  Summary of previous audit reports without management  Appendix A 
decisions, in which no establishment comment was returned 
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Section  Requirement  Location 
within 60 days, and in which there are any outstanding 
unimplemented recommendations 
(a)(11)  Description and explanation of revised management  Appendix A 
decisions 
(a)(12)  Management decisions with which the Inspector General  None for this reporting 
disagrees  period 
(a)(13)  Information required by the Federal Information Security  Other HHS-Related 
Management Act.   Reviews and Investigative 
Activities section 
 
(a)(14)-(16)  Results of peer reviews of HHS-OIG conducted by other  Appendix B 
OIGs or the date of the last peer review, outstanding 
recommendations from peer reviews, and peer reviews 
conducted by HHS-OIG of other OIGs 
(a)(17)  Investigative statistical tables  Appendix E 
(a)(18)  Metrics description for statistical tables  Appendix E 
(a)(19)  Investigations on senior Government employees  Appendix E 
(a)(20)  Description of whistleblower retaliation instances  Appendix E 
(a)(21)  Description of attempts to interfere with OIG independence  Appendix E 
(a)(22)  Description of closed and nondisclosed reports and  Appendix E 
investigations regarding senior Government employees 
 
Other Reporting Requirements 
Section  Requirement  Location 
845  Significant contract audits required to be reported pursuant  Other HHS-Related 
to the National Defense Authorization Act for FY 2008  Reviews and 
(P.L. No. 110-181),  845.  Investigations section 
   205  Pursuant to HIPAA (P.L. No. 104-191),  205, the Inspector  Appendix F 
General is required to solicit proposals annually via a Federal 
Register notice for developing new and modifying existing 
safe harbors to the anti-kickback statute of the Social 
Security Act,  1128(b) and for developing special fraud 
alerts.  The Inspector General is also required to report 
annually to Congress on the status of the proposals received 
related to new or modified safe harbors. 
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Section  Requirement  Location 
1553  Pursuant to the American Recovery and Reinvestment Act of  Other HHS-Related 
2009, P.L. No. 111-5,  1553, OIG reports to Congress the  Reviews and 
retaliation complaint investigations it decided not to 
Investigations section 
conduct or continue during the period. 
 
 
 
 
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Appendix E: Reporting Requirements in the 
Inspector General Empowerment Act of 2016 
The Inspector General Empowerment Act of 2016 establishes new reporting requirements for the 
Semiannual Reports.  These requirements amend portions of section 5 of the Inspector General Act.  The 
requirements are below in italics, followed by OIGs responses.  
 
Each Inspector General shall, not later than April 30 and October 31 of each year, prepare 
semiannual reports summarizing the activities of the Office during the immediately preceding 
6-month periods ending March 31 and September 30.  Such reports shall include, but need not be 
limited to- 
(10) A summary of audit, inspection, and evaluation reports issued before the commencement of the 
reporting period- 
(A) for which no management decision has been made by the end of the reporting period (including 
the date and title of each such report), an explanation of the reasons such management decision has 
not been made, and a statement concerning the desired timetable for achieving a management 
decision on each such report;  
 
For audit and evaluation reports issued from FY 2011 through FY 2021, OIG had a total of 115 
reports with overdue final management decisions (FMDs) as of the end of this reporting period.2  
The breakdown of those 115 reports by HHS OpDiv is as follows: 
 
OpDiv  Overdue FMDs 
    ACF   24 
    ASPR   1 
    CMS   50 
    FDA   1 
    IHS   13 
    NIH   6 
    OASH   1 
    OS   19 
 
 
 
 
2 OIG can track the status of management decisions for all reports back to FY 2011.  OIG can track the status of management 
decisions for audit reports back to FY 1990.  We have identified three additional audit reports (one CMS, one FDA, and one OS) 
with overdue management decisions from FYs 1990 through 2010. 
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OIG is unable to provide reasons and timetables for each of these overdue management decisions 
because of the volume and the fact that OIG did not historically track this information.  
 
(B) for which no establishment comment was returned within 60 days of providing the report to the 
establishment; and  
 
For draft reports that include recommendations, OIG typically requests establishment comments 
within 30 days.  In some instances, OIG grants extensions when requested and appropriate.  When 
OIG does not receive establishment comments or a request for extension within the 30-day 
timeframe, OIG typically issues the report and notes the lack of establishment comments.   
 
For this semiannual reporting period, OIG had none for which no establishment comment was 
returned within 60 days of providing the report to the establishment. 
 
(C) for which there are any outstanding unimplemented recommendations, including the aggregate 
potential cost savings of those recommendations.  
 
OIG is actively tracking 1,424 unimplemented open recommendations made in reports issued since 
FY 2011.  Given the volume of recommendations OIG makes each year, the table below reflects 
summary data by FY: 
 
 
Number of Reports  Number of  Dollar Value of 
FY  
With Unimplemented  Unimplemented  Aggregate Potential 
(20112021) 
Recommendations  Recommendations  Cost Savings 
   2011  12  18  $408,135,515 
   2012  22  25  $397,437,195 
   2013  27  40  $234,261,321 
   2014  28  51  $15,122,628,339 
   2015  27  44  $332,579,636 
   2016  25  58  $187,140,410 
   2017  39  101  $1,116,136,306 
   2018  54  155  $1,900,522,940 
   2019  80  264  $789,241,080 
   2020  123  477  $3,008,481,919 
   2021  58  191  $240,344,137 
Totals  495  1,424  $23,736,908,798 
 
OIG annually produces Solutions To Reduce Fraud, Waste, and Abuse in HHS Programs: OIGs Top 
Recommendations (previously known as the Compendium of Unimplemented Recommendations), 
which constitutes OIGs response to a specific requirement of the Inspector General Act, as 
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amended ( 5(a)(3)).  It identifies significant recommendations with respect to problems, abuses, or 
deficiencies for which corrective actions have not been completed.  It also includes an appendix 
listing OIGs significant unimplemented recommendations, which represent opportunities to 
achieve expected impact through cost savings, improvements in program effectiveness and 
efficiency, or increasing quality of care and safety of beneficiaries.  In OIGs view, these 
recommendations would most positively impact HHS programs in terms of cost savings and/or 
quality improvements and should therefore be prioritized for implementation.   
 
(17) Statistical tables showing- 
(A) the total number of investigative reports issued during the reporting period; 
(B) the total number of persons referred to the DOJ for criminal prosecution during the reporting 
period; 
(C) the total number of persons referred to State and local prosecuting authorities for criminal 
prosecution during the reporting period; and 
(D) the total number of indictments and criminal information during the reporting period that 
resulted from any prior referral to prosecuting authorities; 
 
Total number of investigative reports issued during the reporting period,  None 
including Management Implication Reports and Investigative Advisories 
Total number of persons referred3 to Federal prosecuting authorities for  1,253 
criminal prosecution during the reporting period4 
Total number of persons referred to State and local prosecuting  125 
authorities for criminal prosecutions during the reporting period  
Total number of Federal indictments and criminal information during the  346 
reporting period that resulted from any prior referral to prosecuting 
authorities 
Total number of State and local indictments and criminal information  47 
during the reporting period that resulted from any prior referral to 
prosecuting authorities 
 
(18) A description of the metrics used for developing the data for the statistical tables under 
paragraph (17);  
 
Regarding (17)(A), OIG considers Investigative Reports as Management Implication Reports 
and Investigative Advisories.  A Management Implication Report identifies systemic 
 
 
3 A referral includes OIG presentations to DOJ and/or State/local prosecutorial authorities.   
4 OIG counts persons as both individuals and entities.   
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weaknesses or vulnerabilities within HHS programs, which are generally identified during the 
course of an OIG investigation and could lead to fraud, waste, or abuse.  It provides 
recommendations to correct or minimize the problem.  Corrective actions may require 
administrative, procedural, policy, regulatory, or legislative change.  When a Management 
Implication Report is issued to an HHS OpDiv or StaffDiv, it is generally signed by the Inspector 
General.  Investigative Advisories are similar documents that bring renewed attention to an 
identified HHS issue and are generally signed by the Deputy Inspector General for 
Investigations.  
 
Regarding (17)(B) and (C), OIG defines this measure as the term presentations to both 
Federal and State/local prosecuting jurisdictions as the representation of the work we do.  For 
example, when OIG opens an investigation, it evaluates the complaint and decides whether to 
present the matter for prosecution.  Generally, if the case has prosecutorial merit, and is 
accepted for Federal prosecution, OIG works with DOJ as the primary investigative agency, as 
opposed to referring the matter to DOJ without further involvement on OIG's part.  OIG works 
with State and local prosecutorial authorities in addition to working with DOJ.  
 
Regarding (17)(D), the table above provides the number of indictments/criminal information 
during the semiannual reporting period, including sealed indictments/criminal information.  
However, the information cannot be limited to only those that occurred as a result of a 
presentation in a previous period.  In certain situations, the presentation and charging dates 
are in the same reporting period.  
 
(19) A report on each investigation conducted by the Office involving a senior Government employee 
where allegations of misconduct were substantiated, including a detailed description of- 
(A) the facts and circumstances of the investigation; and 
(B) the status and disposition of the matter, including- 
(i) if the matter was referred to the Department of Justice, the date of the referral; and 
(ii) if the Department of Justice declined the referral, the date of the declination; 
 
To respond fully to this subparagraph, OIG would need to make a finding of misconduct.  However, 
OIG does not make findings regarding its investigations relating to substantiated allegations of 
departmental employee misconduct.  Our reports relay the facts obtained during the investigations 
(e.g., parties involved, dates of events) related to any substantiated allegations.  At the conclusion 
of an OIG investigation related to substantiated allegations concerning possible employee 
misconduct, OIG provides a report to management in the employing agency.  The agency 
management makes determinations of employee misconduct.  The disposition of the matter and 
any resulting administrative actions are taken by the agency.   
 
However, we request from the agency a copy of an SF-50 documenting a personnel action, if one is 
taken.  To the extent that we have information regarding subsequent administrative action, OIG can 
provide that information.  However, because there are sometimes settlement agreements that may 
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impact the final action, OIG may not have a complete record of the disposition of the investigation.  
Accordingly, such information might be more efficiently and effectively provided directly by the 
employing agency.   
 
For this section, OIG describes investigations during this reporting period, both criminal and 
administrative, involving senior Government employees for whom allegations of misconduct were 
substantiated.  The descriptions below include a level of detail appropriate for each investigation, 
depending on whether the case details were available in public documents.  During this reporting 
period, OIG investigated five senior Government employees for misconduct. 
(20) A detailed description of any instance of whistleblower retaliation, including information about 
the official found to have engaged in retaliation and what, if any, consequences the establishment 
imposed to hold that official accountable; 
 
For departmental agencies, OIG conducts investigations and gathers facts related to whistleblower 
complaints.  Before 2015, OIG made no determinations as to whether retaliatory action had been 
taken.  However, to better facilitate the report review process, OIG changed its process in 2015 to 
include findings in its reports as to whether it was more likely than not that whistleblower 
retaliation had occurred.  Although OIG now includes these findings in its reports, it does not make 
recommendations as to what, if any, corrective action(s) should be taken.   
 
During the time period from October 1, 2020, through March 31, 2021, OIG did not issue any 
reports that included findings of retaliation. 
 
When determining the level of detail to provide for a description of any instance of whistleblower 
retaliation, OIG is always mindful of the risk that a detailed description of the allegation could 
inadvertently reveal the whistleblowers identity, thus having a chilling effect on future 
whistleblowers.  
 
(21) A detailed description of any attempt by the establishment to interfere with the independence of 
the Office, including- 
(A) with budget constraints designed to limit the capabilities of the Office; and 
(B) incidents where the establishment has resisted or objected to oversight activities of the Office 
or restricted or significantly delayed access to information, including the justification of the 
establishment for such action; and 
 
Although there have been instances in which HHS agencies have questioned OIG oversight 
activities or have not provided all information in the precise content, format, and timeline as 
requested, OIG has not identified any instances in which HHS interfered with the independence of 
OIG during this reporting period.  OIG would immediately notify Congress if it were unable to 
resolve these issues within HHS.   
 
(22) Detailed descriptions of the particular circumstances of each- 
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(A) inspection, evaluation, and audit conducted by the Office that is closed and was not 
disclosed to the public; and 
 
The table below lists evaluation and audit reports for this semiannual reporting period that did not 
result in public reports.  However, in some circumstances, a public summary of these nonpublic 
reports was published.   
 
Nonpublic Reports by Category, October 1, 2020, Through March 31, 2021 
 
Number of 
Category/Description 
Reports 
IT security reviews (involve IT systems, e.g., penetration test audits)  4 
Homeland security issues (involve particularly sensitive topics, e.g., bioterrorism, 
None 
emergency preparedness, and classified or potentially classified information) 
Recipient Capability Audits (primarily in Head Start/Early Head Start programs)  None 
Reimbursable audits performed for other Federal agencies (primarily contract 
None 
audits) 
Confidential or proprietary information (e.g., Medicare Part B drug 
None 
claims/imaging services, Medicare investment income) 
Medicare Adverse Event Reviews (required by law not to disclose)  None 
Medicare Prescription Drug Event Reviews  None 
Other  None 
HHS technical assistance reports5  None 
Finance-related attestation reviews  1 
   Total  5 
 
(B) Investigation conducted by the Office involving a senior Government employee that is closed and 
was not disclosed to the public.  
 
In section 5(a)(19), we detail investigations of senior Government employees in which allegations 
were substantiated.  Those investigations are all closed and none have been disclosed to the 
public.  OIG interprets section 5(a)(22)(B) as requiring reporting on investigations with either 
substantiated or unsubstantiated allegations.  As such, we refer to our section 5(a)(19) response to 
address investigations of senior Government employees in which allegations were substantiated 
that were closed and not disclosed to the public.  Our section 5(a)(22)(B) response describes 
 
 
5 OIG routinely provides technical assistance to HHS.  Generally, that technical assistance is not part of a formal report and is not 
formally tracked.  However, in some limited circumstances, OIG does provide technical assistance in a formal report, and only that 
category of technical assistance is reflected in this table.   
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investigations during this reporting period, both criminal and administrative, involving a senior 
Government employee in which OIG did not substantiate allegations of misconduct.   
 
When determining the level of detail to provide for the investigations described above, OIG is 
mindful of the risk that a detailed description of the investigation could inadvertently reveal the 
subjects identity.  During this reporting period, OIG investigated five senior Government 
employee(s) for misconduct, but OIG determined the allegations to be unsubstantiated.  
Descriptions of the investigations are below.  
 
Description of  Status  Disposition  DOJ  DOJ  DOJ  DOJ 
Investigation  Referral  Referral  Declinati Declination 
Date  on  Date 
A complaint was  Closed  Unsubstantiated  No  N/A  N/A  N/A 
received that 
alleged a senior 
Government 
employee made an 
unauthorized 
disclosure of 
confidential 
information related 
to the clinical trials 
of a COVID-19 
treatment to a 
politico reporter. 
A complaint was  Closed  Unsubstantiated  No  N/A  N/A  N/A 
received that a 
senior Government 
employee allegedly 
received financial 
benefits from a 
contractor in 
exchange for 
securing a 4-year, 
sole source 
contract with that 
same contractor. 
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A senior  Closed  Insufficient  Yes  8/20/2020  Yes  12/7/2020 
Government  evidence 
employee made 
both verbal and 
written false 
statements to an 
investigator.  The 
senior Government 
employees 
statements 
obstructed a critical 
investigation under 
the President's 
Emergency Plan for 
Aids Relief in five 
Central American 
countries.  The 
senior Government 
employee also 
failed to report a 
grantee employee's 
allegations of grant 
fraud and other 
violations to the 
OIG or other 
qualified 
(investigative) 
agency. 
A complaint was  Closed  Insufficient  No  N/A  N/A  N/A 
received that a  evidence. 
senior Government 
employee provided 
a subcontractor 
strategic advantage 
with information 
that was 
proprietary to itself 
and other 
information that 
was proprietary to 
another contractor.  
There was also an 
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allegation that the 
senior Government 
employee provided 
the subcontractor 
with access to 
agency systems, 
even though this 
subcontractor did 
not have access.  
Additionally, it was 
alleged that there 
was a personal 
relationship 
between the senior 
Government 
employee and one 
of the 
subcontractors 
employees.  
A complaint was  Closed  Insufficient  No  N/A  N/A  N/A 
received that  evidence 
alleged a senior  
Government 
employee owned 
several businesses 
and ran them 
during work 
hours.  The senior 
Government 
employee was 
using government 
computers, phones, 
copy machines, 
and fax machines 
for their personal 
businesses.  It was 
also alleged that 
the senior 
Government 
employee is 
collecting kickbacks 
from the Puerto 
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Rican government 
for work in Puerto 
Rico. 
 
 
 
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Appendix F: Anti-Kickback StatuteSafe 
Harbors 
Pursuant to HIPAA,  205, the Inspector General is required to solicit proposals annually via a Federal 
Register notice for developing new and modifying existing safe harbors to the anti-kickback statute, 
section 1128B(b) of the Social Security Act and for developing special fraud alerts.  The Inspector General is 
also required to report annually to Congress on the status of the proposals received related to new or 
modified safe harbors.   
 
In crafting safe harbors for a criminal statute, it is incumbent upon OIG to engage in a complete and 
careful review of the range of factual circumstances that may fall within the proposed safe harbor subject 
area to uncover all potential opportunities for fraud and abuse by unscrupulous providers.  Having done 
so, OIG must then determine, in consultation with DOJ, whether it can develop effective regulatory 
limitations and controlsto not only foster beneficial or innocuous arrangements but also protect the 
Federal health care programs and their beneficiaries from abusive practices. 
 
Public proposals for new and modified safe harbors  
Annual Solicitation  
 
In December 2019, OIG published its annual solicitation in the Federal Register (Annual Solicitation).6  In 
response to the Annual Solicitation, OIG received the following proposals related to safe harbors:  
 
Proposal   OIG Response  
Modification of the transportation  OIG recently issued a final rule that, among other things, revised 
safe harbor to: (i) permit marketing in  the local transportation safe harbor and finalized a new patient 
defined circumstances; (ii) protect  engagement tools and supports safe harbor.  This new safe 
free or discounted local  harbor may also protect certain arrangements involving the 
transportation services for health- provision of free or discounted local transportation services, 
related, nonmedical purposes; (iii)  provided all safe harbor conditions are met.  See 81 Fed. Reg. 
allow patients to schedule free or  77684 (Dec. 2, 2020) (the Regulatory Sprint Final Rule).  We 
discounted transportation services  believe these regulations and accompanying preamble in the 
and medical appointments online;  Regulatory Sprint Final Rule are sufficiently responsive to these 
and (iv) protect the provision of free  proposals.   
or discounted local transportation   
services between or among 
 
 
6 OIG, Solicitation of New Safe Harbors and Special Fraud Alerts, 84 Fed. Reg. 72,289 (Dec. 31, 2019), available at 
https://www.govinfo.gov/content/pkg/FR-2019-12-31/pdf/2019-27202.pdf.  
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Proposal   OIG Response  
providers, where all such providers  For example, in the Regulatory Sprint Final Rule, we expressly 
are furnishing home care to the same  declined to extend the local transportation safe harbor to 
patient.    protect transportation services for health-related, nonmedical 
purposes.  Id. at 77863.  Similarly, we reiterated our 
longstanding concerns related to the marketing of 
transportation services.  Id. at 77864; see also 81 Fed. Reg. 
88368, 88386 (Dec. 7, 2016).   
 
For questions about the application of certain fraud and abuse 
authorities to particular factual arrangements, the advisory 
opinion process remains available.   
A new safe harbor that would protect  OIG is not adopting this suggestion.  As we noted in the 
value-based contracting and  Regulatory Sprint Final Rule, we may consider this topic for 
outcomes-based contracting for the  future rulemaking. 
purchase of pharmaceutical products.   
A new safe harbor that would protect  In the Regulatory Sprint Final Rule, OIG finalized a new patient 
patient engagement and product  engagement and support safe harbor.  42 CFR  1001.952(hh).  
support activities furnished by  This safe harbor does not protect the provision of patient 
pharmaceutical manufacturers to  engagement tools or supports furnished or funded by a 
patients.   pharmaceutical manufacturer, distributor, or wholesaler due to, 
among other reasons, concerns that such entities would use the 
safe harbor to protect arrangements that are intended to 
market their products or inappropriately tether clinicians to the 
use of a particular product.  81 Fed. Reg. 77709, 77782.  For the 
same reasons, we decline to adopt this suggestion.   
A new safe harbor to protect data  In the Regulatory Sprint Final Rule, OIG finalized a new care 
analytics arrangements between or  coordination arrangements safe harbor, 42 CFR  1001.952(ee), 
among pharmaceutical  that may protect the exchange of data analytic tools between or 
manufacturers, pharmacy benefit  among eligible entities that are party to a value-based 
managers, payors, and providers.   arrangement, provided all safe harbor conditions are met.  81 
Fed. Reg. 77823.  However, in the Regulatory Sprint Final Rule, 
we stated that, among other entities, pharmaceutical 
manufacturers and pharmacy benefit managers are ineligible to 
use this safe harbor.  For the same reasons included in the 
Regulatory Sprint Final Rule, we decline to adopt a new safe 
harbor to protect arrangements involving these entities. 
A new patient medication adherence  As part of the Regulatory Sprint Final Rule, OIG finalized a new 
safe harbor that would protect  patient engagement tools and supports safe harbor that 
remuneration furnished to patients  protects certain eligible entities provision of patient 
intended to support patient  engagement tools or supports, of which, depending on the facts 
adherence to a medication treatment  and circumstances, may include remuneration designed to 
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Proposal   OIG Response  
regimen prescribed by the patients  advance patients medication adherence.  We believe that 
health care provider.   regulation and our discussion related to that safe harbor in the 
Regulatory Sprint Final Rule is sufficiently responsive to this 
request.  
A new safe harbor or modification to  OIG is not adopting these suggestions.  As we recently 
one or more existing safe harbors  articulated in the Regulatory Sprint Final Rule, beneficiary cost-
that would protect patient cost- sharing obligations are a programmatic requirement, and we do 
sharing waivers in the following  not believe it would be appropriate to broadly protect cost-
circumstances: (i) upon a good faith  sharing waivers that could obviate a programmatic requirement 
determination of financial need; (ii)  created by statute.  85 Fed. Reg. 77793.  
by all providers and suppliers, so   
long as certain criteria are met (e.g.,   
providers do not claim the cost-
sharing waiver as bad debt); or (iii) 
applied to those amounts greater 
than a providers good-faith estimate 
of a patients cost-sharing liability.   
 
With certain modifications, finalize  Both safe harbors were finalized in a recent rulemaking entitled 
the pharmacy benefit manager  Fraud and Abuse; Removal of Safe Harbor Protection for 
service fees safe harbor and the  Rebates Involving Prescription Pharmaceuticals and Creation of 
point-of-sale reductions in price for  New Safe Harbor Protection for Certain Point-of-Sale 
prescription pharmaceutical products  Reductions in Price on Prescription Pharmaceuticals and Certain 
safe harbor, as proposed by OIG in a  Pharmacy Benefit Manager Service Fees.  85 Fed. Reg. 76666 
February 2019 rulemaking.    (Nov. 30, 2020).   
 
 
Regulatory Sprint to Coordinated Care  
 
In addition to the Annual Solicitation, in the October 17, 2019, Federal Register, OIG issued a proposed rule 
in connection with HHSs Regulatory Sprint to Coordinated Care, which aimed to reduce regulatory 
barriers and accelerate the transformation of the health care system into one that better pays for value 
and promotes care coordination (OIG NPRM).7  The proposals set forth in the OIG NPRM were, in large 
part, finalized in the Regulatory Sprint Final Rule and, in certain instances, incorporates some of the ideas 
we received in responses to our Annual Solicitation.  The Regulatory Sprint Final Rule adds new safe 
harbors to protect certain arrangements for value-based care, patient engagement tools and support, and 
 
 
7 OIG, Medicare and State Healthcare Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and 
Civil Monetary Penalty Rules Regarding Beneficiary Inducements, 84 Fed. Reg. 55,694 (Oct. 17, 2019), available at 
https://www.govinfo.gov/content/pkg/FR-2019-10-17/pdf/2019-22027.pdf.  
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cybersecurity technology and services; modifies several existing safe harbors; and implements a new 
exception under the CMPL provision prohibiting beneficiary inducements.  The Regulatory Sprint Final Rule 
provides greater certainty for health care providers and others participating in value-based arrangements 
and providing coordinated care for patients.  It is intended to ease compliance with OIGs authorities for 
health care providers and others across the industry, while including strong safeguards to help protect 
patients and Federal health care programs from fraud and abuse. 
 
 
101