Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
A Message From Christi A. Grimm, 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 September 30, 2022.  
 
As HHSs programs continue to expand, OIG maintains our sharp focus on 
identifying key vulnerabilities.  We use a risk-based approach to provide oversight 
that supports better health, well-being, program integrity, and opportunities for 
savings.   
 
We hold accountable bad actors who hurt people and steal from taxpayer-funded programs.  In 
coordination with our law enforcement partners, we strategically bring to bear every criminal, civil, and 
administrative tool that we have to safeguard the integrity of HHS programs and protect the people they 
serve.  During this reporting period, OIG aggressively pursued entities and individuals committing fraud 
and abuse.  We endeavor to send a strong signal that theft and abuse will not be tolerated in HHS 
programs, including fraud schemes that exacerbate the opioid epidemic, cheat child care programs, and 
endanger patients.  OIGs investigative work led to $1.29 billion in expected investigative recoveries during 
this reporting period.  
 
Findings from our audits and evaluations help to construct actionable strategies that will yield meaningful 
improvements.  Examples from this reporting period include how HHS can reduce patient harm in 
hospitals, better protect children in foster care from sex trafficking, and strengthen its cybersecurity 
posture.  Our work identified suggested ways to better protect Federal funds from misuse, including 
improvements in awarding and monitoring emergency response contracts and implementing the Provider 
Relief Fund Program.  We reported on issues that, if addressed, would better ensure that HHS programs 
run efficiently and effectively, including programs related to confirmatory trials for drugs, prior 
authorization requests for Medicare services, and caring for unaccompanied children served by the Office 
of Refugee Resettlement. 
 
OIG is steadfast in our commitment to drive positive change in HHS programs and in the lives of people 
served by these programs.  My top priority is propelling meaningful improvement in the quality and safety 
of care in the more than 15,000 Medicare- and Medicaid-certified nursing homes nationwide.  During this 
reporting period, we identified deficiencies in compliance with life safety and emergency preparedness 
requirements that put residents at increased risk of injury and death.  We are continuing work on 21 audits 
and evaluations that address a wide range of issues involving nursing homes.  Looking forward, we will 
delve deeply to understand the factors that contribute to poor nursing home performance, what should be 
done to improve residents experience in nursing homes, and how frontline oversight of nursing homes 
can be more effective.   
 
The independent, objective oversight described in this Semiannual Report to Congress reflects the 
excellence and innovation of the OIG workforce as well as the breadth and complexities of work in 
overseeing the more than 100 programs at HHS.  We deploy a multidisciplinary approach and leverage 
data and cutting-edge technology to detect risks and strategically plan the most high-impact oversight 
across HHS programs and services.  The reach, range, and impact of our work are bound only by our 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
constrained resources.  With an eye on problems on the horizon, a focus on equity, and a firm grounding 
in our oversight mission, we will continue to pursue wrongdoers, recover misspent funds, and promote the 
health and well-being of the Nation.      
 
We greatly appreciate the support of Congress and HHS for this important work.  
 
Christi A. Grimm 
Inspector General     
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
 
Table of Contents     
A Message From Christi A. Grimm, Inspector General  2 
OIGs Approach to Driving Positive Change  4 
Highlights of OIG Accomplishments  5 
Selected Acronyms and Abbreviations   15 
Medicare and Medicaid Reports and Reviews  16 
Legal and Investigative Activities Related to Medicare and Medicaid  41 
Public Health and Human Service Agency Reports and Reviews  62 
Legal and Investigative Activities Related to Public Health and Human Service Agencies  76 
Other HHS-Related Reviews and Investigative Activities  77 
Appendix A: Questioned Costs and Funds To Be Put to Better Use  86 
Appendix B: Savings Decisions Supported by OIG Recommendations   97 
Appendix C: Peer Review Results  100 
Appendix D: Summary of Sanction Authorities  103 
Appendix E: Reporting Requirements in the Inspector General Act of 1978  106 
Appendix F: Reporting Requirements in the Inspector General Empowerment Act of 2016  108 
Appendix G: Anti-Kickback StatuteSafe Harbors  115 
   
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 the Office of Audit Services (OAS), Office of Evaluation and Inspections (OEI), 
Office of Investigations (OI), 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 CongressApril 1, 2022, Through September 30, 2022
 
 
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 CongressApril 1, 2022, Through September 30, 2022
 
 
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 enable 
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 CongressApril 1, 2022, Through September 30, 2022
 
 
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 OIGs Top Unimplemented Recommendations: Solutions To Reduce Fraud, 
Waste, and Abuse in HHS Programs (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 to Congress (Semiannual Report) describes 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 April 1, 2022, through 
September 30, 2022.  We also provide data for accomplishments for FY 2022.  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 CongressApril 1, 2022, Through September 30, 2022
 
 
Highlights of OIG Accomplishments 
HHS-OIGs 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 of April 1, 2022, through 
September 30, 2022.  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 2022.  We then highlight significant results from selected audits, 
evaluations, and enforcement activities completed during the reporting period. 
 
At-a-Glance Highlights 
Statistic  FY 2022   
(10/1/20219/30/2022)   
 
Audit Reports Issued  114 
 
Evaluations Issued  43 
 
Expected Audit Recoveries  $1,199,088,845 
 
Questioned Costs  $2,173,082,045 
 
Potential Savings  $279,087,234 
 
New Audit and Evaluation  445 
 
Recommendations 
 
Recommendations Implemented by  424 
 
HHS OpDivs 
 
Expected Investigative Recoveries  $2.73 billion 
 
Criminal Actions  710 
 
Civil Actions  736 
 
Exclusions  2,332 
 
Results for the Semiannual Reporting Period 
During this semiannual reporting period (April 1, 2022, through September 30, 2022), we issued 68 audit 
reports and 29 evaluation reports.  Our audit work identified $62.9 million in expected recoveries as well as 
$612.6 million in questioned costs (costs questioned by OIG because of an alleged violation, costs not 
supported by adequate documentation, or expenditures of funds for which intended purposes were 
unnecessary or unreasonable).  Our audit work also identified $117 million in potential savings for HHS
funds that could be saved if HHS implemented all of OIGs audit recommendations.  During this reporting 
period, OIG made 309 new audit and evaluation recommendations crucial to encouraging positive change 
in HHS programs.  Meanwhile, HHS OpDivs implemented 130 prior recommendations, resulting in positive 
impacts for HHS programs and enrollees. 
 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
OIG also remains at the forefront of the Nations effort to fight fraud in HHS programs and hold 
wrongdoers accountable.  Along with our partners, including DOJ, Medicaid Fraud Control Units (MFCUs 
or Units), and various Federal, State, and local law enforcement agencies, we detect, investigate, and 
prosecute fraud through a coordinated, data-driven approach.  OIGs investigative work led to $1.29 billion 
in expected investigative recoveries and 390 criminal actions during this reporting period.  OIG also took 
civil actions, such as assessing monetary penalties against 416 individuals and entities, and excluded 1,290 
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 this reporting period, organized by subject area.  A 
comprehensive list of OIG work during this reporting period follows, and appendices A through G provide 
data to meet the reporting requirements of the Inspector General Act of 1978. 
 
Responding to the COVID-19 Pandemic and Other Emergencies  
OIG continues 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: (1) protect people; (2) protect funds; 
(3) protect infrastructure; and (4) promote the effectiveness of HHS programs, now and into the future.   
Additional information about the OIG COVID-19 strategic plan, emerging fraud schemes, and work related 
to COVID-19 is available on our website COVID-19 Portal.  
 
Significant OIG oversight work completed during this reporting period related to the COVID-19 pandemic 
includes the following reports: 
 
  FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 
Testing (OEI-01-20-00380), September 2022; 
 
  FDAs Work With the Tri-Agency Task Force for Emergency Diagnostics Helped Labs Implement 
COVID-19 Tests (OEI-01-20-00381), September 2022; 
 
  HHS Did Not Fully Comply With Federal Requirements and HHS Policies and Procedures When 
Awarding and Monitoring Contracts for Ventilators (A-02-20-02002), September 2022; and 
 
  HHSs and HRSAs Controls Related to Selected Provider Relief Fund Program Requirements Could Be 
Improved (A-09-21-06001), September 2022. 
 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
OIG also conducted enforcement activities during this reporting period.  Following are two examples of 
successful outcomes from these cases: 
 
  An individual was sentenced to 37 months in prison, followed by 3 years of supervised release, 
after making threats against Dr. Anthony Fauci.  The individual further admitted to threatening 
other individuals within and outside HHS with the intent of intimidating or interfering with 
performance of their official duties regarding COVID-19 and its testing and prevention. 
 
  A health system agreed to pay $1.75 million in restitution for facilitating COVID-19 vaccinations for 
individuals who were falsely characterized as staff and volunteers and ineligible to participate in 
the CDCs vaccine program specifically designed to vaccinate long-term care facility residents and 
staff during the vaccine rollout, when vaccines were in short supply.  
 
Leveraging Oversight To Better Protect Nursing Home Residents 
Improving nursing home care is a top priority for OIG.  Decades of OIG oversight of nursing homes 
revealed significant challenges and vulnerabilities, and the COVID-19 pandemic brought challenges at 
nursing homes to the forefront.  To better understand contributing factors; identify fraud, inefficiency, and 
substandard care; and aid policymakers, our oversight work is guided by a a three-part strategy: 
 
  Performance.  Understanding what drives nursing home performance, and in particular what 
contributes to poorly performing nursing homes. 
  Residents First.  Ensuring that nursing homes prioritize quality of care and quality of life for 
residents. 
  Oversight.  Ensuring that entities responsible for nursing home oversightCMS and Statesdetect 
problems quickly and insist on rapid remediation.   
 
Currently, OIG has 21 ongoing audits and evaluations of nursing home issues.  We are continuing to 
monitor identified areas of concern, push for implementation of unimplemented recommendations, and 
issue new recommendations as problems and solutions are identified.  Information about ongoing nursing 
home work can be found on OIGs Nursing Homes web page.  Significant OIG work completed during this 
reporting period related to protecting residents in nursing homes includes the following: 
 
  An Estimated 91 Percent of Nursing Home Staff Nationwide Received the Required COVID-19 Vaccine 
Doses, and an Estimated 56 Percent of Staff Nationwide Received a Booster Dose (A-09-22-02003), 
June 2022; and 
 
  Audits of Nursing Home Life Safety and Emergency Preparedness in Eight States Identified 
Noncompliance With Federal Requirements and Opportunities for the Centers for Medicare & 
Medicaid Services To Improve Resident, Visitor, and Staff Safety (A-02-21-01010), July 2022. 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
OIG uses its authorities to exclude entities and individuals engaging in fraud and abuse.  For example, OIG 
excluded an individual who owned seven nursing homes during this reporting period.  OIG had previously 
excluded the individuals seven nursing homes that had been excluded for housing residents during 
Hurricane Ida in an unsanitary warehouse without proper food, water, or waste facilities.   
 
Ensuring Health and Safety of Vulnerable People Served by HHS  
OIG has devoted substantial oversight effort to protect vulnerable peopleincluding the elderly, children, 
and adults with developmental disabilitieswho are served by HHS programs such as Medicare, Medicaid, 
the Unaccompanied Children (UC) Program, and the Child Care and Development Fund (CCDF). 
 
Significant OIG work completed during this reporting period related to ensuring the health and safety of 
vulnerable people served by HHS programs includes the following: 
 
  Adverse Events in Hospitals: A Quarter of Medicare Patients Experienced Harm in October 2018 (OEI-
06-18-00400), May 2022; 
 
  Office of Refugee Resettlements Influx Care Facility and Emergency Intake Sites Did Not Adequately 
Safeguard Unaccompanied Children From COVID-19 (A-06-21-07002), June 2022; 
 
  HHS Should Improve Internal Coordination Regarding Unaccompanied Children, (OEI-BL-20-00670), 
May 2022; 
 
  Operational Challenges Within ORR and the ORR EIS at Fort Bliss Hindered Case Management for 
Children (OEI-07-21-00251), September 2022; 
 
  National Snapshot of State Agency Approaches To Reporting and Locating Children Missing From 
Foster Care (A-07-20-06095), May 2022;  
 
  In Five States, There Was No Evidence That Many Children in Foster Care Had a Screening for Sex 
Trafficking When They Returned After Going Missing (OEI-07-19-00371), July 2022; and 
 
  ACF Should Improve Oversight of Head Start To Better Protect Children's Safety (OEI-BL-19-00560), 
September 2022. 
OIG uses its authorities to suspend or debar individuals or entities engaged in grant or contract fraud.  For 
example, OIG debarred individuals and entities due to criminal convictions during this reporting period.  
Multiple individuals and entities were debarred after being criminally convicted for their role in a scheme 
to defraud child care programs, partially funded by the CCDF, by submitting claims for children who did 
not attend day care programs.  
 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
Preventing and Treating Opioid Misuse  
OIG continued to prioritize oversight and enforcement activities to protect enrollees from prescription 
drug abuse and improve access to medications for opioid use disorder.  
 
Significant OIG work completed during this reporting period related to preventing and treating opioid use 
disorder includes the report Opioid Overdoses and the Limited Treatment of Opioid Use Disorder Continue 
To Be Concerns for Medicare Beneficiaries (OEI-02-22-00390), September 2022. 
 
OIG works with and supports DOJs efforts to identify and criminally prosecute bad actors in Federal health 
care programs.  Following are two examples of successful criminal prosecutions related to improper opioid 
prescriptions and distributions during this reporting period: 
 
  An individual was sentenced to 20 years in prison, followed by 5 years of supervised release, and 
was ordered to pay a $40,000 fine and almost $4 million in restitution for running a prescription 
pill mill and providing unwarranted medications.  
 
  An individual was sentenced to 48 months in Federal prison for conspiring to distribute and 
possess with intent to inappropriately distribute opioid pain medications and other controlled 
substances. 
 
Ensuring Equitable Access to High-Quality Care in Departmental Programs 
OIG works to ensure that people served by HHS programs have equitable access to quality care.  OIG is 
also focused on identifying disparities in access to high-quality care by ensuring that HHS program data 
capture demographic data accurately and through analysis of that program data identify, assess, or 
remediate health disparities when relevant. 
 
Significant OIG work completed during this reporting period related to promoting equitable access to 
high-quality care includes the following: 
 
  Certain Medicare Beneficiaries, Such as Urban and Hispanic Beneficiaries, Were More Likely Than 
Others To Use Telehealth During the First Year of the COVID-19 Pandemic (OEI-02-20-00522), 
September 2022; 
 
  CDC Found Ways To Use Data To Understand and Address COVID-19 Health Disparities, Despite 
Challenges With Existing Data (OEI-05-20-00540), July 2022; and  
 
  Inaccuracies in Medicares Race and Ethnicity Data Hinder the Ability To Assess Health Disparities 
(OEI-02-21-00100), June 2022. 
 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
Reducing Prescription Drug Spending for HHS Programs and Enrollees  
OIG performs work to assess areas in which HHS programs or people enrolled in them may be paying 
more than necessary for vital drugs.   
 
Significant OIG work completed during this reporting period related to prescription drug spending 
includes the following: 
 
  Tennessee Did Not Always Invoice Rebates to Manufacturers for Physician-Administered Drugs 
Dispensed to Enrollees of Medicaid Managed-Care Organizations (A-07-21-06096), September 2022; 
and 
 
  Part D Plan Preference for Higher-Cost Hepatitis C Drugs Led to Higher Medicare and Beneficiary 
Spending (OEI-BL-21-00200), August 2022. 
 
Promoting Program Integrity and Good Financial Stewardship in Traditional Medicare 
The 2022 Medicare Trustees report projected that assets in the Part A trust fund will be depleted by 2028, 
adding urgency to efforts to ensure good stewardship and appropriate use of scarce Medicare funds.  OIG 
recognizes the importance of identifying and mitigating fraud risks in the Medicare program and holding 
accountable those who defraud Medicare, beneficiaries, and taxpayers.  
 
Significant OIG work completed during this reporting period related to Medicare program integrity and 
financial stewardship includes the following: 
 
  Medicare Telehealth Services During the First Year of the Pandemic: Program Integrity Risks (OEI-02-
20-00720), September 2022; and 
 
  Reducing Medicares Payment Rates for Intermittent Urinary Catheters Can Save the Program and 
Beneficiaries Millions of Dollars Each Year (OEI-04-20-00620), September 2022. 
OIG uses its authorities to pursue affirmative administrative action against entities and individuals 
engaging in conduct that violates the Civil Monetary Penalties Law (CMPL).  Following are four examples of 
affirmative administrative litigation in the Medicare program during this reporting period: 
 
  A physician entered into a $1,905,070.74 settlement agreement with OIG to resolve allegations of 
submitting false claims to Medicare for the application, monitoring, and removal of medical devices 
as well as improper claims for reimbursement of devices not covered by the Medicare program. 
 
  An ambulance company entered into a $1,578,412 settlement agreement to resolve allegations that 
claims submitted to Medicare Part B for ambulance transportation to and from skilled nursing 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
facilities were already covered under Part A. 
 
  A physician entered into a $919,644.34 settlement agreement with OIG to resolve allegations of 
presenting to Medicare claims for items or services that were not provided as claimed and were 
false or fraudulent. 
 
  An individual and associated clinics entered into a $409,809.88 settlement agreement with OIG to 
resolve allegations that procedure claims submitted to Medicare for facet joint injections and 
denervations exceeded the coverage limitation of sessions in a rolling, 12-month period.  
 
Promoting Integrity and Effectiveness in Medicare Advantage and Medicaid Managed Care 
Almost half of people with Medicare are currently enrolled in Medicare Advantage Organizations.  
Enrollment is expected to continue to grow to cover 53 percenta majority of Medicare enrolleesby 
2031. 
 
Managed care is now the predominant payment model in Medicaid.  State and Federal expenditures on 
Medicaid managed care are growing.  These expenditures totaled $421 billion and represented 59 percent 
of all Medicaid expenditures in 2021. 
 
Significant OIG work completed during this reporting period related to Medicare Advantage and Medicaid 
managed care includes the following: 
 
  Some Medicare Advantage Organization Denials of Prior Authorization Requests Raise Concerns 
About Beneficiary Access to Medically Necessary Care (OEI-09-18-00260), April 2022;   
 
  Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Cariten Health Plan, Inc., 
(Contract H4461) Submitted to CMS (A-02-20-01009), July 2022; 
 
  CMS Has Opportunities To Strengthen States Oversight of Medicaid Managed Care Medical Loss 
Ratios (OEI-03-20-00231), September 2022; and 
 
  Nearly All States Made Capitation Payments for Beneficiaries Who Were Concurrently Enrolled in a 
Medicaid Managed Care Program in Two States (A-05-20-00025), September 2022. 
 
Ensuring Medicaid Program Integrity  
Medicaid is the largest Federal health care program, with nearly 89 million enrollees as of May 2022.  
Medicaid is administered by States per Federal requirements.  The program is funded jointly by the Federal 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
Government and States.  CMS estimated Federal and State Medicaid expenditures of $671.2 billion in 2020.  
 
Significant OIG work completed during this reporting period related to Medicaid program integrity 
includes the following: 
 
  New York Claimed $196 Million, Over 72 Percent of the Audited Amount, in Federal Reimbursement 
for NEMT Payments to New York City Transportation Providers That Did Not Meet or May Not Have 
Met Medicaid Requirements (A-02-21-01001), September 2022; and 
 
  UPICs Hold Promise To Enhance Program Integrity Across Medicare and Medicaid, But Challenges 
Remain (OEI-03-20-00330), September 2022. 
OIG uses its authorities to exclude entities and individuals engaging in fraud and abuse.  For example, 
during this reporting period, OIG excluded an individual for 30 years who was an owner and operator of a 
billing agency and who was convicted of conspiracy to commit Medicaid fraud.    
 
Promoting Proper Departmental Management and Operations  
OIG reviews programs across the Department to ensure that programs are being administered effectively, 
efficiently, and without waste.   
 
Significant OIG work completed during this reporting period related to proper departmental management 
includes the following: 
 
  FDA: The Food and Drug Administrations Foreign For-Cause Drug Inspection Program Can Be 
Improved To Protect the Nations Drug Supply (A-01-19-01500), June 2022; 
 
  Delays in Confirmatory Trials for Drugs Granted FDAs Accelerated Approval Raise Concerns (OEI-01-
21-00401), September 2022; 
 
  Indian Health Service Capacity To Manage Supplemental $3.5 Billion Allocated to Its Sanitation 
Facilities Construction Program (OEI-06-22-00320), September 2022; and 
 
  Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant 
Financial Interests and Other Support (OEI-03-20-00210), May 2022. 
 
Cybersecurity Protection 
OIG continues to recognize cybersecurity vulnerabilities as major risks to effectively managing and 
safeguarding the Departments programs.  Oversight of the Departments cybersecurity is being 
prioritized.  Repeated cyberattacks focused on accessing critical information in HHS systems added 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
urgency to the task of developing departmental cybersafeguardsin addition to conducting normal 
operationsover the course of the COVID-19 pandemic. 
 
During this reporting period, OIG conducted work examining HHSs cybersecurity controls to strengthen 
HHSs cybersecurity posture including: 
 
  The Centers for Medicare & Medicaid Services Had Policies and Procedures in Place To Mitigate 
Vulnerabilities in a Timely Manner, but Improvements Are Needed (A-18-20-06500), July 2022; 
 
  IHS Telehealth System Was Deployed Without Some Required Cybersecurity Controls (A-18-21-
03100), September 2022; and 
 
  National Institutes of Health Grant Program Cybersecurity Requirements Need Improvement (A-18-
20-06300), September 2022. 
 
 
 
 
 
 
 
 
 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
OIG Participation in Congressional Hearings 
 
6/28/2022  Erin Bliss, Assistant Inspector  Protecting Americas Seniors: Oversight of Private 
General, Office of Evaluation and  Sector Medicare Advantage Plans, U.S. House 
Inspections  Committee on Energy and Commerce.  
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
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 
CMPL  Civil Monetary Penalties Law 
CMS  Centers for Medicare & Medicaid Services 
DEA  Drug Enforcement Administration 
DOJ  Department of Justice 
DME  durable medical equipment 
EMTALA  Emergency Medical Treatment and Labor Act 
FBI  Federal Bureau of Investigation 
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 
MAC  Medicare administrative contractor 
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 
15 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
Medicare and Medicaid Reports and Reviews 
Medicare Program Reports and Reviews 
Financial Management and Improper Payments 
Medicare Improperly Paid Durable Medical Equipment Suppliers an Estimated $8 Million of the 
$40 Million Paid for Power Mobility Device Repairs (A-09-20-03016), May 2022  
 
We found that not all suppliers complied with Medicare requirements when billing for power 
mobility device (PMD) repairs.  For the 922 PMD repairs associated with 100 sampled beneficiaries, 
261 PMD repairs associated with 76 beneficiaries did not comply with those requirements.  
Specifically, documentation did not adequately support the charges for PMD repairs, the labor time 
associated with PMD repairs was not documented, or PMD repair charges were not reasonable and 
necessary.  We also identified questionable charges for 183 PMD repairs associated with 19 
sampled beneficiaries.  Although the billing of these PMD repairs did not reflect noncompliance 
with Medicare requirements, suppliers did not meet documentation standards established by 
guidance or submitted charges that may not have been reasonable and necessary. 
 
On the basis of our sample results, we estimated that $7.9 million of the $40.1 million paid for PMD 
repairs was improperly paid.  We also estimated that Medicare could have saved as much as an 
additional $3.7 million for questionably paid PMD repairs.  In addition, we estimated that Medicare 
beneficiaries could have saved as much as $3 million in coinsurance for the improperly and 
questionably paid PMD repairs. 
 
CMS generally concurred with our recommendations that it instruct the durable medical 
equipment (DME) Medicare contractors to: (1) recover $41,137 in overpayments for PMD repairs; (2) 
notify suppliers to refund $10,494 in coinsurance; and (3) based on the results of this audit, notify 
appropriate suppliers so that they can exercise reasonable diligence to identify, report, and return 
any overpayments.  We also made four procedural recommendations.  
  
Vanderbilt University Medical Center: Audit of Outpatient Outlier Payments (A-06-20-04003), May 
2022  
 
Vanderbilt University Medical Center (VUMC) did not properly bill the claims related to 81 outlier 
payments of 117 sampled claims, resulting in improper outlier payments during our audit period.  
These 81 claims, which had outlier payments totaling $427,644, contained 110 billing errors.  The 
billing errors primarily occurred because VUMC did not have adequately designed controls or 
billing system capabilities to prevent coding errors, charge errors, and billing for services not 
covered by Medicare Part B.   
 
16 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
VUMC concurred with our recommendations that it: (1) refund to the Medicare contractor the 
portion of the $686,500 in estimated outpatient outlier net overpayments for incorrectly billed 
claims that are within the 4-year reopening period and (2) improve procedures, provide education, 
and implement changes to its billing system to ensure that claims billed to Medicare are accurate. 
 
Accuracy of Risk Adjustment and Capitated Payments in Medicare Advantage   
 
To determine the health status of enrollees, CMS relies on MA organizations to collect diagnosis 
codes from their providers and submit these codes to CMS.  Some diagnoses are at higher risk for 
being miscoded, which may result in overpayments from CMS.  During this reporting period, OIG 
conducted seven audits that were designed to assess whether selected diagnosis codes that MA 
organizations submitted to CMS for use in CMSs risk adjustment program complied with Federal 
requirements.  In some cases, we identified underpayments and netted them against 
overpayments.  We conducted two audits that examined all diagnosis codes.  Complete 
recommendations and providers responses can be found in the final reports, which are 
summarized below.  
 
Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Peoples Health Network 
(Contract H1961) Submitted to CMS (A-06-18-05002), May 2022  
 
With respect to the seven high-risk groups covered by our audit, most of the selected diagnosis 
codes that Peoples Health Network (Peoples Health) submitted to CMS for use in CMSs risk 
adjustment program did not comply with Federal requirements.  These errors occurred because 
the policies and procedures that Peoples Health 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 Peoples Health received at least  
$3.3 million in overpayments for these high-risk diagnosis codes for 2015 and 2016.  
 
Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Cariten Health Plan, Inc., 
(Contract H4461) Submitted to CMS (A-02-20-01009), July 2022  
 
With respect to the nine high-risk groups covered by our audit, most of the selected diagnosis 
codes that Cariten Health Plan, Inc. (Cariten) submitted to CMS for use in CMSs risk adjustment 
program did not comply with Federal requirements.  These errors occurred because the policies 
and procedures that Cariten 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 Cariten received at least $9.2 million in net overpayments for 
these high-risk diagnosis codes for 2016 and 2017. 
 
 
 
 
17 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
 
Medicare Advantage Compliance Audit of Specific Diagnosis Codes That WellCare of Florida, Inc., 
(Contract H1032) Submitted to CMS (A-04-19-07084), August 2022 
  
With respect to the seven high-risk groups covered by our audit, most of the selected diagnosis 
codes that WellCare of Florida, Inc. (WellCare) submitted to CMS for use in CMSs risk adjustment 
program did not comply with Federal requirements.  These errors occurred because the policies 
and procedures that WellCare had to prevent, 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 WellCare received at least  
$3.5 million of net overpayments for these high-risk diagnosis codes for 2015 and 2016. 
 
Medicare Advantage Compliance Audit of Diagnosis Codes That Cigna HealthSpring of Florida, Inc. 
(Contract H5410) Submitted to CMS (A-03-18-00002), August 2022  
 
Cigna HealthSpring did not submit some diagnosis codes to CMS for use in the risk adjustment 
program in accordance with Federal requirements.  First, although most of the diagnosis codes 
that Cigna HealthSpring submitted were supported in the medical records and therefore validated 
1,401 of the 1,470 sampled enrollees Hierarchical Condition Categories (HCCs), the remaining 69 
HCCs were not validated and resulted in overpayments.  Second, there were an additional 18 HCCs 
for which the medical records supported diagnosis codes that Cigna HealthSpring should have 
submitted to CMS but did not. 
 
As a result, Cigna HealthSpring received $39,612 of net overpayments for 2015 for the sampled 
enrollees.  As demonstrated by the errors found in our sample, Cigna HealthSprings policies to 
prevent, detect, and correct noncompliance with CMSs program requirements, as mandated by 
Federal regulations, could be improved. 
 
Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Regence BlueCross 
BlueShield of Oregon (Contract H3817) Submitted to CMS (A-09-20-03009), September 2022 
 
With respect to the seven high-risk groups covered by our audit, most of the selected diagnosis 
codes that Regence BlueCross BlueShield of Oregon (Regence) submitted to CMS for use in CMSs 
risk adjustment program did not comply with Federal requirements.  Specifically, for 111 of the 179 
sampled enrollee-years, the diagnosis codes were not supported in the medical records and 
resulted in net overpayments of $248,885.  As demonstrated by the errors in our sample, the 
policies and procedures that Regence had to prevent, detect, and correct noncompliance with 
CMSs program requirements, as mandated by Federal regulations, could be improved.  On the 
basis of our sample results, we estimated that Regence received at least $1.8 million of net 
overpayments for these high-risk diagnosis codes for 2015 and 2016. 
 
18 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
Medicare Advantage Compliance Audit of Diagnosis Codes That Inter Valley Health Plan, Inc. 
(Contract H0545), Submitted to CMS (A-05-18-00020), September 2022  
 
Inter Valley Health Plan, Inc. (Inter Valley) did not submit some diagnosis codes to CMS for use in 
the risk adjustment program in accordance with Federal requirements. First, although most of the 
diagnosis codes that Inter Valley submitted were supported in the medical records and therefore 
validated 1,411 of the 1,553 sampled enrollees HCCs, the remaining 142 HCCs were not validated 
and resulted in overpayments.  These 142 unvalidated HCCs included 23 HCCs for which we 
identified 23 other, replacement HCCs for more and less severe manifestations of the diseases.  
Second, there were an additional 12 HCCs for which the medical records supported diagnosis 
codes that Inter Valley should have submitted to CMS but did not. 
 
Thus, the risk scores for the 200 sampled enrollees should not have been based on the 1,553 HCCs.  
Rather, the risk scores should have been based on 1,446 HCCs (1,411 validated HCCs + 23 other 
HCCs + 12 additional HCCs).  As a result, we estimated that Inter Valley received at least $5.3 million 
in net overpayments for 2015.  These errors occurred because Inter Valleys policies and procedures 
to prevent, detect, and correct noncompliance with CMSs program requirements, as mandated by 
Federal regulations, could be improved.  
 
Medicare Advantage Compliance Audit of Specific Diagnosis Codes That BlueCross BlueShield of 
Tennessee, Inc. (Contract H7917) Submitted to CMS (A-07-19-01195), September 2022  
 
With respect to the nine high-risk groups covered by our audit, most of the selected diagnosis 
codes that BlueCross BlueShield of Tennessee, Inc. (BCBST), submitted to CMS for use in CMSs risk 
adjustment program did not comply with Federal requirements.  For 210 of the 270 sampled 
enrollee-years, the medical records that BCBST provided did not support the diagnosis codes and 
resulted in $491,269 in overpayments. 
 
As demonstrated by the errors found in our sample, BCBSTs policies and procedures to prevent, 
detect, and correct noncompliance with CMSs program requirements, as mandated by Federal 
regulations, could be improved.  On the basis of our sample results, we estimated that BCBST 
received approximately $7.8 million in overpayments for 2016 and 2017. 
 
Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Highmark Senior Health 
Company (Contact H3916) Submitted to CMS (A-03-19-00001), September 2022  
 
With respect to the six high-risk groups covered by our audit, most of the selected diagnosis codes 
that Highmark Senior Health Company (Highmark) submitted to CMS for use in CMSs risk 
adjustment program did not comply with Federal requirements.  For 160 of the 226 sampled 
enrollee-years, the diagnosis codes were not supported in the medical records. 
 
19 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
The errors occurred because the policies and procedures that Highmark had to prevent, detect, 
and correct noncompliance with CMSs program requirements, as mandated by Federal 
regulations, could be improved.  As a result, the HCCs (diagnosis code groupings based on 
similarity of clinical characteristics, severity, and cost implications) for these high-risk diagnosis 
codes were not validated.  On the basis of our sample results, we estimated that Highmark received 
at least $6.2 million of net overpayments for 2015 and 2016. 
 
Medicare Advantage Compliance Audit of Specific Diagnosis Codes That HumanaChoice (Contract 
R5826) Submitted to CMS (A-05-19-00039), September 2022  
 
With respect to the nine high-risk groups covered by our audit, most of the selected diagnosis 
codes that HumanaChoice submitted to CMS for use in CMSs risk adjustment program did not 
comply with Federal requirements.  For 207 of the 270 sampled enrollee-years, the diagnosis codes 
that HumanaChoice submitted to CMS were not supported in the medical records and resulted in 
$574,430 of overpayments for the 270 enrollee-years. 
 
These errors occurred because the policies and procedures that HumanaChoice had to prevent, 
detect, and correct noncompliance with CMSs program requirements as mandated by Federal 
regulations could be improved.  On the basis of our sample results, we estimated that 
HumanaChoice received at least $34.4 million of overpayments for these high-risk diagnosis codes 
in 2016 and 2017. 
 
Medicare and Beneficiaries Paid Substantially More to Provider-Based Facilities in Eight Selected 
States in Calendar Years 2010 Through 2017 Than They Paid to Freestanding Facilities in the Same 
States for the Same Type of Services (A-07-18-02815), June 2022  
 
Both the Medicare program and its beneficiaries could have realized significant savings for 
evaluation and management (E&M) services if those services had been paid as if provided at 
freestanding facilities.  If the physicians in the selected States had been paid at the freestanding 
Physician Fee Schedule (PFS) nonfacility rate and hospitals paid nothing under the Outpatient 
Prospective Payment System for our audit period, the Medicare program and its beneficiaries could 
have realized cost savings of more than $1.6 billion.  In addition, beneficiaries would have been 
required to make only one coinsurance payment rather than two (as they are currently required to 
do), and the cost-sharing would generally be lower because it would be based only on the 
freestanding facility rate. 
 
CMS has taken some steps intended to equalize payments.  If these changes had been in effect 
during the period covered by our audit, the potential cost savings of these changes for E&M 
services in the selected States for our audit period could have been a combined $1.4 billion for the 
Medicare program and its beneficiaries.  However, the combined $1.4 billion in potential cost 
savings would still have been less than the $1.6 billion in potential cost savings if E&M services had 
been paid at the freestanding PFS nonfacility rate. 
20 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
 
CMS did not directly agree or disagree with our recommendation that it pursue legislative or 
regulatory changes to lower costs for both the Medicare program and beneficiaries, by equalizing 
payments as appropriate between provider-based facilities and freestanding facilities for E&M 
services. 
 
The Reduced Outlier Threshold Applied to Transfer Claims Did Not Significantly Increase Medicare 
Payments to Hospitals (A-05-19-00019), July 2022  
 
Medicares reduced outlier threshold for transfer claims did not have a significant impact on the 
total Medicare payments to the 30 hospitals we audited.  Of the 5,303 transfer claims, the total 
Medicare payments for 3,668 transfer claims were less than what Medicare would have paid the 
hospitals if they had discharged the beneficiaries.  However, the total Medicare payments for the 
remaining 1,635 transfer claims were $2.9 million more than what Medicare would have paid the 
hospitals if they had discharged the beneficiaries.  Specifically, under the transfer policy, Medicare 
decreased DRG rate payments by $10.8 million, but because of the reduced outlier threshold, 
Medicare increased outlier payments by $13.7 million, resulting in a net increase of $2.9 million in 
total Medicare payments compared to what hospitals would have been paid if they had discharged 
the beneficiaries. 
 
The $2.9 million net increase in total Medicare payments for these 1,635 transfer claims occurred 
because the outlier payment increase using the reduced outlier threshold was greater than the 
DRG payment decrease under the transfer policy.  
 
Medicares reduced outlier threshold for transfer claims does not have a significant enough impact 
for us to recommend a policy change.  Therefore, we do not have any recommendations. 
 
CMS Reported Collecting Just Over Half of the $498 Million in Medicare Overpayments         
Identified by OIG Audits (A-04-18-03085), July 2022  
 
We verified that CMS collected $120 million of the $498 million in sustained Medicare 
overpayments identified in HHS-OIG audit reports issued during our audit period.  Of this 
sustained amount, CMS reported that it had collected $272 million (55 percent) and that it had not 
collected $226 million (45 percent).  CMS provided documentation to support that it had collected 
$120 million of the $272 million.  However, CMS did not provide adequate documentation to 
support that it had collected the remaining $152 million.  In addition, CMS did not take corrective 
action in response to all of the recommendations made in our prior audit report, Obstacles to 
Collection of Millions in Medicare Overpayments.  In that audit report, issued on May 18, 2012, we 
made six recommendations, and CMS agreed to implement four of them.  Of those four 
recommendations, CMS implemented two, partially implemented one, and did not implement one. 
 
21 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
We recommended that CMS: (1) continue its efforts to recover any collectible portion of the 
$226 million in uncollected overpayments, (2) determine what portion of the $152 million was 
collected and recorded in its accounting system, (3) revise 42 CFR section 405.980 and 
corresponding manual instructions related to the reopening period for claims to be consistent with 
statutory provisions contained in section 1870 of the Social Security Act, and (4) develop a plan for 
resolving cost reports applicable to the nine audit reports discussed in this report.  We also made 
other procedural recommendations.  CMS generally did not concur with our findings or 
recommendations.  
 
Medicare Critical Care Services Provider Compliance Audit: Lahey Clinic, Inc. (A-03-20-00002), July 
2022  
 
Lahey Clinic, Inc. (Lahey) complied with Medicare billing requirements for 36 of the 92 critical care 
services that we reviewed.  However, Lahey did not comply with Medicare billing requirements for 
the remaining 56 critical care services.  All 10 of the inpatient admissions reviewed included at least 
1 critical care service that did not comply with Medicare billing requirements.  Specifically, Lahey 
billed for 54 critical care services for patients whose conditions did not indicate that the critical care 
services were medically necessary or for which the physician did not directly provide services that 
were at the level of care required for critical care services.  In addition, Lahey billed for two critical 
care services that were billed using an incorrect Current Procedural Terminology (CPT) code for the 
critical care service provided.  
 
These billing errors resulted in Lahey receiving $6,015 in unallowable Medicare payments.  These 
errors occurred because Lahey did not have adequate policies and procedures to ensure that: (1) 
physicians correctly documented in the patients medical record and identified critical care services 
that met Medicare requirements and (2) coders made correct determinations for critical care 
services that met Medicare requirements. 
 
We recommended that Lahey refund to the MAC $6,015 in overpayments for critical care services, 
and we also made procedural recommendations for Lahey to strengthen its policies and 
procedures.  Lahey partially agreed with our recommendations. 
 
Medicare Hospice Provider Compliance 
 
The Medicare hospice benefit allows providers to claim Medicare reimbursement for hospice 
services provided to individuals with a life expectancy of 6 months or less and who have elected 
hospice care.  Previous OIG reviews found that Medicare inappropriately paid for hospice services 
that did not meet certain Medicare requirements.  Complete recommendations and providers 
responses can be found in the final reports, which are summarized below. 
 
22 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
Medicare Hospice Provider Compliance Audit: Vitas Healthcare Corporation of Florida (A-02-19-
01018), July 2022  
 
Vitas Healthcare Corporation of Florida (Vitas) did not comply with Medicare requirements for 89 
of the 100 claims in our sample.  These improper payments occurred because Vitas policies and 
procedures were not effective to ensure that it maintained documentation to support the level of 
care and hospice services claimed for Medicare reimbursement.  On the basis of our sample 
results, we estimated that Vitas received at least $140 million in improper Medicare reimbursement 
for hospice services that did not comply with Medicare requirements.  
 
Medicare Hospice Provider Compliance Audit: Hospice of Palm Beach County, Inc. (A-02-20-01001), 
September 2022  
 
Hospice of Palm Beach County, Inc. (HPBC) received Medicare reimbursement for hospice services 
that did not comply with Medicare requirements.  Improper payment of these claims occurred 
because HPBCs policies and procedures were not effective in ensuring that the clinical 
documentation it maintained supported the terminal illness prognosis, that the appropriate level of 
care was provided, and that services were supported.  On the basis of our sample results, we 
estimated that HPBC received at least $42.3 million in improper Medicare reimbursement for 
hospice services.  
We made a series of recommendations to Vitas, including that it refund to the Federal Government 
the portion of the estimated $140 million in Medicare overpayments that are within the 4-year 
claims reopening period; identify, report, and return any overpayments in accordance with the 60-
day rule; and strengthen its policies and procedures to ensure that hospice services comply with 
Medicare requirements.  Vitas disagreed with some of our recommendations and partially agreed 
with our findings. 
 
Reducing Medicares Payment Rates for Intermittent Urinary Catheters Can Save the Program and 
Beneficiaries Millions of Dollars Each Year (OEI-04-20-00620), September 2022 
 
In Medicare Part B, suppliers of intermittent urinary catheters received $407 million in FY 2020, 
more than three times the suppliers estimated acquisition costs of $121 million.  Our findings 
demonstrate that Medicare and its beneficiaries have the opportunity to achieve substantial 
savings while allowing suppliers adequate payments for the items and services they provide.  CMS 
did not explicitly indicate whether it concurred with our recommendation; instead, CMS stated that 
it will take our recommendation under consideration as it determines appropriate next steps.  Our 
recommendation was for CMS to lower Medicares payment rates for intermittent urinary catheters. 
 
CMSs System Edits Significantly Reduced Improper Payments to Acute-Care Hospitals After May 
2019 for Outpatient Services Provided to Beneficiaries Who Were Inpatients of Other Facilities (A-09-
22-03007), September 2022 
  
23 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
During our audit period, Medicare inappropriately paid acute-care hospitals $39.3 million for 
outpatient services they provided to beneficiaries who were inpatients of other facilities (i.e., long-
term care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, and critical 
access hospitals).  None of the $39.3 million should have been paid because the inpatient facilities 
were responsible for payment.  Each type of inpatient facility covered by our audit must: (1) provide 
directly all services furnished during an inpatient stay or (2) arrange for services to be provided on 
an outpatient basis by an acute-care hospital and include those outpatient services on its inpatient 
claims submitted to Medicare. 
  
CMS generally concurred with our recommendations that it: (1) direct the Medicare contractors to 
recover the portion of the $39.3 million in improper payments for our audit period that are within 
the 4-year reopening period, (2) instruct acute-care hospitals to refund beneficiaries up to 
$9.8 million in deductible and coinsurance amounts that may have been incorrectly collected from 
them or from someone on their behalf, (3) direct the Medicare contractors to recover any improper 
payments after our audit period, and (4) continue to review the system edits to determine whether 
any refinements are necessary to prevent overpayments to acute-care hospitals for outpatient 
services provided to beneficiaries who are inpatients of other facilities.  The report includes one 
other recommendation. 
 
Medicare Part B Overpaid and Beneficiaries Incurred Cost-Share Overcharges of Over  
$1 Million for the Same Professional Services (A-06-21-05003), September 2022 
 
Not all Medicare Part B payments made to Critical Access Hospitals (CAHs) for professional services 
and payments made to health care practitioners complied with Federal requirements.  For the 
40,026 claims we audited, CAHs and health care practitioners each submitted an equal number of 
claims.  However, for each date of service, only one of the claims complied with Federal 
requirements.  As a result, Medicare administrative contractors (MACs) paid providers $907,438 
more than they should have been paid, and beneficiaries were held responsible for $281,321 more 
than they should have been.  
 
These overpayments occurred because CMS did not have claim system edits to prevent and detect 
duplicate professional services claims for the same date of service, beneficiary, and procedure.  
 
CMS generally concurred with our recommendations that it: (1) direct the MACs to recover the 
$331,448 from the CAHs for 12,156 claims for which the health care practitioners had not 
reassigned their billing rights to the CAHs and $83,412 in cost-sharing overcharges to Medicare 
beneficiaries that are within the 4-year reopening period and (2) direct the MACs to recover the 
$575,990 from health care practitioners for 7,857 claims for which the health care practitioners had 
reassigned their billing rights to the CAHs and $197,909 in cost-sharing overcharges to beneficiaries 
that are within the 4-year reopening period. 
 
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  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
CMSs System Edits Significantly Reduced Improper Payments to Acute-Care Hospitals After May 
2019 for Outpatient Services Provided to Beneficiaries Who Were Inpatients of Other Facilities (A-09-
22-03007), September 2022  
 
During our audit period, Medicare inappropriately paid acute-care hospitals $39.3 million for 
outpatient services they provided to beneficiaries who were inpatients of other facilities.  None of 
the $39.3 million should have been paid because the inpatient facilities were responsible for 
payment.  Each type of inpatient facility covered by our audit must: (1) provide directly all services 
furnished during an inpatient stay or (2) arrange for services to be provided on an outpatient basis 
by an acute-care hospital and include those outpatient services on its inpatient claims submitted to 
Medicare. 
 
Before May 2019, the system edits were not working properly.  However, after CMS modified the 
edits in May 2019, only $3.4 million (less than 9 percent of the $39.3 million in improper payments 
for the entire audit period) was inappropriately paid to acute-care hospitals from  
June 2019 through December 2021.  
  
CMS generally concurred with our recommendations that it: (1) direct the Medicare contractors to 
recover the portion of the $39.3 million in improper payments for our audit period that are within 
the reopening period, (2) instruct acute-care hospitals to refund beneficiaries up to  
$9.8 million in deductible and coinsurance amounts that may have been incorrectly collected from 
them or from someone on their behalf, (3) direct the Medicare contractors to recover any improper 
payments after our audit period, and (4) continue to review the system edits to determine whether 
any refinements are necessary to prevent overpayments to acute-care hospitals for outpatient 
services provided to beneficiaries who are inpatients of other facilities. 
 
Medicare Dialysis Services Provider Compliance AuditDialysis Clinic, Inc. (A-05-20-00010), 
September 2022  
 
Dialysis Clinic, Inc. (DCI) claimed reimbursement for dialysis services that did not comply with 
Medicare requirements for 70 of the 100 sampled claims.  Specifically, DCI submitted claims for 
which: (1) comprehensive assessments or plans of care did not meet Medicare requirements, (2) 
dialysis treatments were not completed, (3) dialysis services were not documented, (4) 
beneficiaries height or weight measurements did not comply with Medicare requirements, and (5) 
the medical record did not have a monthly progress note by a physician or other qualified 
professional. 
 
Although DCI had established corporatewide internal controls to monitor and maintain complete, 
accurate, and accessible medical records at all its facilities, these controls were not always effective 
in ensuring that DCIs claims for dialysis services complied with Medicare requirements.  
 
We estimated that DCI received unallowable Medicare payments of at least $14,193,677 for dialysis 
services that did not comply with Medicare requirements.  Many of the errors we identified did not 
25 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
affect DCIs Medicare reimbursement for the services because they were reimbursed on a bundled, 
per-treatment basis or related to Medicare conditions for coverage.  However, the deficiencies 
could have a significant impact on the quality of care provided to Medicare beneficiaries and could 
result in the provision of inappropriate or unnecessary dialysis services. 
 
DCI did not concur with our recommendations that it refund an estimated $14,193,677 to the 
Medicare program.  We also made a series of recommendations to strengthen DCIs internal 
controls to ensure that dialysis services comply with Medicare requirements. 
 
 
Quality of Care, Safety, and Access 
Some Medicare Advantage Organization Denials of Prior Authorization Requests Raise Concerns 
About Beneficiary Access to Medically Necessary Care (OEI-09-18-00260), April 2022   
Medicare Advantage Organizations (MAOs) sometimes denied prior authorization and payment 
requests that met Medicare coverage rules; we found that 13 percent of prior authorization 
requests that MAOs denied, and 18 percent of payment requests that MAOs denied, met Medicare 
coverage rules and/or MAO billing rules.  When MAOs deny requests for Medicare-covered 
services, they may prevent or delay beneficiaries from accessing needed care and create 
administrative burden for both beneficiaries and providers.   
CMS concurred with our recommendations that: (1) CMS should issue new guidance on the 
appropriate use of MAO clinical criteria in medical necessity reviews; (2) CMS should update its 
audit protocols to address the issues identified in this report, such as MAO use of clinical criteria 
and/or examining particular service types; and (3) CMS should direct MAOs to take additional steps 
to identify and address vulnerabilities that can lead to manual review errors and system errors.  
Posthospital Skilled Nursing Facility Care Provided to Dually Eligible Beneficiaries in Indiana 
Generally Met Medicare Level-of-Care Requirements (A-05-20-00005), April 2022  
 
Posthospital skilled nursing facility (SNF) care provided to 98 of the 100 dually eligible beneficiaries 
in Indiana was not associated with potentially avoidable hospitalizations.  For the remaining two 
beneficiaries, our independent medical review contractor found that because the nursing facilities 
did not have effective prevention strategies, the beneficiaries were hospitalized and later 
discharged to SNF care at the same facility. 
 
Posthospital SNF care provided to 98 of the 100 beneficiaries met the Medicare SNF level-of-care 
requirements.  The remaining two beneficiaries did not meet the Medicare SNF level-of-care 
requirements because the SNF physicians incorrectly determined that the beneficiaries required 
either skilled nursing or skilled rehabilitation services, or both, on a daily basis. 
 
26 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
For all 100 beneficiaries, physicians ordered SNF services.  We noted that records from the hospitals 
where 33 beneficiaries had a qualifying inpatient stay did not contain a clear and definitive hospital 
physician discharge order for SNF care.  Hospital physicians mainly discharged beneficiaries "back 
to nursing facility" without specifying the level of care.  In these cases, SNF physicians certified the 
SNF level of care.  The physician order not only affects level-of-care determination but also has a 
financial impact on the nursing facilities.  
 
Our independent medical review contractor found that SNF care provided to dually eligible 
beneficiaries in Indiana during our audit period generally: (1) was not associated with potentially 
avoidable hospitalizations and (2) met the Medicare level-of-care requirements.  As a result, we do 
not have any recommendations.  However, the quality of care in nursing facilities remains a 
concern for OIG.   
 
Adverse Events in Hospitals: A Quarter of Medicare Patients Experienced Harm in October 2018 (OEI-
06-18-00400), May 2022 
 
One in four Medicare patients experienced patient harm events during their hospital stays in 
October 2018.  Patient harm events indicate that a patients care resulted in an undesirable clinical 
outcome not caused by underlying disease.  Forty-three percent of these harm events could have 
been prevented.  Our findings will help CMS and the Agency for Healthcare Research and Quality 
(AHRQ) track and reduce patient harm in hospitals and improve patient safety.   
 
CMS and AHRQ concurred with all seven of our recommendations.  We recommended to CMS 
that: (1) CMS should update and broaden its lists of hospital-acquired conditions to capture 
common, preventable, and high-cost harm events; (2) CMS should explore expanding the use of 
patient safety metrics in pilots and demonstrations for health care payment and service delivery, as 
appropriate; and (3) CMS, as OIG previously recommended, should develop and release 
interpretive guidance to surveyors for assessing hospital compliance with requirements to track 
and monitor patient harm.  We recommended to AHRQ that: (4) AHRQ should with support from 
HHS leadership coordinate agency efforts to update agency-specific Quality Strategic Plans; (5) 
AHRQ should optimize use of the Quality and Safety Review System (QSRS), including assessing 
the feasibility of automating data capture for national measurement and to facilitate local use; (6) 
AHRQ should develop an effective model to disseminate information on national clinical practice 
guidelines or best practices to improve patient safety; and (7) AHRQ should continue efforts to 
identify and develop new strategies to prevent common patient harm events in hospitals. 
 
Certain Medicare Beneficiaries, Such as Urban and Hispanic Beneficiaries, Were More Likely Than 
Others To Use Telehealth During the First Year of the COVID-19 Pandemic (OEI-02-20-00522), 
September 2022 
 
Beneficiaries in urban areas were more likely than those in rural areas to use telehealth during the 
first year of the pandemic.  Beneficiaries in Massachusetts, Delaware, and California were more 
27 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
likely than beneficiaries in some other States to use telehealth.  Dually eligible beneficiaries (i.e., 
those eligible for both Medicare and Medicaid), Hispanic beneficiaries, younger beneficiaries, and 
female beneficiaries were also more likely than others to use telehealth.  In addition, beneficiaries 
almost always used telehealth from home or other non-health-care settings.  Furthermore, almost 
one-fifth of beneficiaries used certain audio-only telehealth services, with the vast majority of these 
beneficiaries using these audio-only services exclusively.  Older beneficiaries were more likely to 
use these audio-only services, as were dually eligible and Hispanic beneficiaries.  As CMS, HHS, 
Congress, and other stakeholders consider permanent changes to Medicare telehealth services, it is 
important that they balance concerns about issues such as access, quality of care, health equity, 
and program integrity.   
 
CMS did not explicitly indicate whether it concurred with our four recommendations.  Our 
recommendations were that: (1) CMS should take appropriate steps to enable a successful 
transition from current pandemic-related flexibilities to well-considered long-term policies for the 
use of telehealth for beneficiaries in urban areas and from the beneficiarys home, (2) CMS should 
temporarily extend the use of audio-only telehealth services and evaluate their impact, (3) CMS 
should require a modifier to identify all audio-only telehealth services provided in Medicare, and 
(4) CMS should use telehealth to advance health care equity.  
 
Opioid Overdoses and the Limited Treatment of Opioid Use Disorder Continue To Be Concerns for 
Medicare Beneficiaries (OEI-02-22-00390), September 2022 
 
In 2021, almost a quarter of Part D beneficiaries received opioids, about 50,400 Medicare Part D 
beneficiaries experienced an opioid overdose, and more than 1 million Medicare beneficiaries had 
a diagnosis of opioid use disorder during 2021.  However, fewer than one in five Medicare 
beneficiaries with opioid use disorder received medication to treat their opioid use disorder.  At the 
same time, the number of beneficiaries receiving prescriptions for naloxonea drug that reverses 
opioid overdosesthrough Part D grew.  Monitoring opioid use and access to medications for the 
treatment of opioid use disorder as well as to naloxone are critical to addressing the opioid crisis.  
We did not make any recommendations in this report, however, a December 2021 OIG report 
recommended that CMS take steps to improve access to medications for the treatment of opioid 
use disorder and other support services.  We continue to call attention to the importance of 
implementing these recommendations and to ensuring access to treatment for opioid use 
disorder. 
 
Certain Life Care Nursing Homes May Not Have Complied With Federal Requirements for Infection 
Prevention and Control and Emergency Preparedness (A-01-20-00004), September 2022  
 
Selected Life Care nursing homes may not have complied with Federal requirements for infection 
prevention and control and emergency preparedness.  Life Care officials attributed the possible 
noncompliance to: (1) leadership turnover, (2) staff turnover, (3) documentation issues (i.e., 
28 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
information was not documented or documentation was either lost or misplaced), (4) staff 
members who were unfamiliar with requirements (i.e., requirements stipulating that there is no 
grace period for infection preventionists to complete specialized training and that emergency 
preparedness plans needed to be reviewed annually), (5) qualified personnel shortage, and (6) 
challenges related to the COVID-19 public health emergency.  We also believe that many of the 
conditions noted in our report occurred because CMS did not provide nursing homes with 
communication and training related to complying with the new, phase 3 infection control 
requirements, or clarification about the essential components to be integrated in the nursing 
homes emergency plans. 
 
CMS concurred with our recommendation that it instruct State survey agencies SSAs to follow up 
with the 23 nursing homes that we have identified with possible infection prevention and control 
and emergency preparedness deficiencies to verify that they have taken corrective actions. 
 
End-Stage Renal Disease Network Organizations Reported Actions Taken in Response to the COVID-
19 Pandemic (A-05-20-00051), September 2022  
 
The 18 end-stage renal disease (ESRD) Network Organizations that we surveyed provided 
information about the actions they took to aid dialysis clinics and patients and keep CMS informed 
about quality-of-care issues that arose during the COVID-19 pandemic.  Network Organizations 
also reported to us challenges they encountered in taking those actions during the pandemic. 
 
Despite the unprecedented challenges faced by the Network Organizations during the pandemic, 
they took actions to ensure continuity of services in a safe manner for high-risk ESRD beneficiaries.  
Network Organizations served a key role in addressing the additional demands on dialysis clinics 
during the pandemic through actions such as: (1) disseminating changing guidance, (2) aiding 
dialysis clinics to address the increased concerns and grievances related to the pandemic, and (3) 
promoting safe alternative treatment options.  Network Organizations also kept CMS informed of 
quality-of-care issues by communicating through established communication processes and 
processes modified for better use during the pandemic.  This report does not contain any 
recommendations. 
 
Program Integrity 
2021 Performance Data for the Senior Medicare Patrol Projects (OEI-02-22-00310), June 2022 
 
The Senior Medicare Patrol (SMP) projects receive grants from the Administration for Community 
Living to recruit and train retired professionals and other older adults and community members to 
prevent, detect, and report health care fraud, errors, and abuse.  In 2021, the 54 SMP projects had 
a total of 5,346 active team members who conducted a total of 12,660 group outreach and 
education events, reaching an estimated 556,980 people.  In addition, the projects had 239,625 
individual interactions with, or on behalf of, a Medicare beneficiary.  The projects reported 
29 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
$2.5 million in expected Medicare recoveries.  Cost avoidance totaled $41,498, while savings to 
beneficiaries totaled $40,798.     
 
Inaccuracies in Medicares Race and Ethnicity Data Hinder the Ability To Assess Health Disparities 
(OEI-02-21-00100), June 2022 
 
We found that Medicares enrollment race and ethnicity data are less accurate for some groups, 
particularly for beneficiaries identified as American Indian/Alaska Native, Asian/Pacific Islander, and 
Hispanic.  Data that are not accurate limit the ability to assess health disparities.  Limited race and 
ethnicity categories and missing information contribute to inaccuracies in the enrollment data.  
Although the use of an algorithm improves the existing data to some extent, it falls short of self-
reported data.  Finally, Medicares enrollment data on race and ethnicity are inconsistent with 
Federal data collection standards, which inhibits the work of identifying and improving health 
disparities within the Medicare population.  Advancing health equity is a priority for CMS and the 
Department.  Race and ethnicity data are foundational to identifying and understanding health 
disparities among Medicare beneficiaries and to assessing the effectiveness of efforts to reduce 
such disparities.  It is critical that these data are accurate, complete, and comprehensive.  
Therefore, CMS must improve its race and ethnicity data; though a significant undertaking, the 
need for better data is pressing.   
 
Accordingly, we recommended that: (1) CMS should develop its own source of race and ethnicity 
data, (2) CMS should use self-reported race and ethnicity information to improve data for current 
beneficiaries, (3) CMS should develop a process to ensure that the data are as standardized as 
possible, and (4) CMS should educate beneficiaries about CMSs efforts to improve the race and 
ethnicity information.  CMS did not explicitly concur with the first recommendation and concurred 
with the other three recommendations. 
 
 
Review of Medicare Administrative Contractor Information Security Program Evaluations for Fiscal 
Year 2021 (A-18-22-11300), July 2022  
 
The Social Security Act requires that each MAC have its information security program evaluated 
annually by an independent entity.  CMS contracted with Guidehouse, LLP (Guidehouse), to 
evaluate information security programs at the MACs.  
 
Guidehouses evaluations of the contractor information security programs were adequate in scope 
and sufficiency.  Guidehouse identified a total of 95 gaps at the 7 MACs in FY 2021, which was 4 
percent less than the number of gaps for the same 7 MACs in FY 2020.  The number of high- and 
moderate-risk gaps decreased by 39 percent from FY 2020.  Deficiencies remained in eight of the 
nine Federal Information Security Modernization Act of 2014 (FISMA) control areas that were 
tested.  The results warrant CMS continuing its oversight visits to ensure that the MACs remediate 
all gaps to improve the MACs IT security, especially those with increased gaps from the previous 
30 
 
 
  Department of Health and Human Services, Office of Inspector General 
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year.  Gaps that were similar to those from prior years should be considered repeat findings to 
highlight systemic problems and the existence of continued exposure to known weaknesses.  This 
report contains no recommendations. 
 
Medicare Telehealth Services During the First Year of the Pandemic: Program Integrity Risks (OEI-02-
20-00720), September 2022 
 
We identified 1,714 providers out of approximately 742,000 whose billing for telehealth services 
during the first year of the pandemic poses a high risk to Medicare.  Each of these 1,714 providers 
had concerning billing on at least 1 of 7 measures we developed that may indicate fraud, waste, or 
abuse of telehealth services.  In addition, more than half of the high-risk providers we identified are 
a part of a medical practice with at least one other provider whose billing poses a high risk to 
Medicare.  Further, 41 providers whose billing poses a high risk appear to be associated with 
telehealth companies.  Although these high-risk providers represent a small proportion of all 
providers who billed for a telehealth service, these findings demonstrate the importance of strong, 
targeted oversight of telehealth services.   
 
CMS concurred with our recommendation to follow up on the providers identified in this report, 
but CMS did not explicitly indicate whether it concurred with the other four recommendations.  
Our recommendations were that: (1) CMS should strengthen monitoring and targeted oversight of 
telehealth services, (2) CMS should provide additional education to providers on appropriate billing 
for telehealth services, (3) CMS should improve the transparency of incident to services when 
clinical staff primarily delivered the telehealth service, (4) CMS should identify telehealth companies 
that bill Medicare, and (5) CMS should follow up on the providers identified in this report. 
 
Drug Spending and Reimbursement 
Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Fourth Quarter 
of 2021 (OEI-03-22-00200), May 2022, and Comparison of Average Sales Prices and Average 
Manufacturer Prices: Results for the First Quarter of 2022 (OEI-03-22-00210), August 2022 
OIG identified eight drug codes in the fourth quarter of 2021 and eight drug codes in the first 
quarter of 2022 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 substituted rate 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. 
31 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
Part D Plans Generally Include Drugs Commonly Used by Dual Eligibles: 2022 (OEI-05-22-00230), 
June 2022 
 
We found that dual eligiblesthat is, beneficiaries who are covered by both Medicare and 
Medicaidhave access to the majority of commonly used prescription drugs in 2022 via Part D 
plans, as we also found in previous years.  A majority of the 449 Part D plan formularies covered 
almost all (at least 97 percent) of the 200 drugs most commonly used by dual eligibles.  Similarly, 
among Part D plans with premiums below the regional benchmark, a majority of formularies (95 of 
132) covered at least 97 percent of the drugs commonly used by dual eligibles.  This is important 
because when dual eligibles do not select their own Part D plans, CMS randomly assigns them to 
plans with premiums below the regional benchmark without considering their specific prescription 
drug needs.  If dual eligibles plans do not cover specific drugs, they have several options 
(switching plans, using an exceptions and appeals process, finding an alternative drug, or paying 
out of pocket), but these options require beneficiaries to take administrative actions and do not 
guarantee access to the drugs.  
This report did not make recommendations. 
Part D Plan Preference for Higher-Cost Hepatitis C Drugs Led to Higher Medicare and Beneficiary 
Spending (OEI-BL-21-00200), August 2022 
Medicare Part D beneficiaries are much less likely than Medicaid beneficiaries to receive lower-cost 
versions of the same drugs (i.e., authorized generics)as well as other widely used lower-cost 
brand name drugsto treat hepatitis C.  Part Ds programmatic structure may lead plan sponsors 
to prefer higher-cost versions of hepatitis C drugs, which resulted in beneficiaries paying thousands 
more out-of-pocket and nearly double Medicare reinsurance in 2020.  Increasing the use of lower-
cost hepatitis C drugs could generate significant savings for Medicare and its beneficiaries.  CMS 
concurred with OIGs recommendations that CMS: (1) encourage Part D plans to increase access to 
and use of the authorized generic versions of Epclusa and Harvoni, within the authorities granted 
under statute and (2) pursue additional strategiessuch as educating providers and pharmacies
to increase access to and use of lower-cost hepatitis C drugs in Part D. 
Medicare Part B Drug Payments: Impact of Price Substitutions Based on 2020 Average Sales Prices 
(OEI-03-22-00170), September 2022 
 
Because CMS did not implement all eligible drug price reductions based on 2020 ASPs for Part B 
drugs, savings that could have totaled $2.8 million over 1 year amounted to only $8,158.  
(Generally, Part B-covered drugs are those that are injected or infused in physicians offices or 
outpatient settings.  ASPs generally serve as the basis for reimbursement for Part B drugs.  CMS 
has a price-substitution policy under which OIGs comparisons of ASPs with AMPs candepending 
on the differenceresult in the substitution of a lower calculated rate.  The use of this policy serves 
as a mechanism for monitoring market prices and limiting potentially excessive payment amounts.)  
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  Department of Health and Human Services, Office of Inspector General 
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Although the $8,158 amount is small, Medicare and its beneficiaries have saved $73.1 million for 
Part B-covered drugs since the price-substitution policy went into effect in 2013.  These total 
savings highlight the impact of OIGs mandated quarterly ASP-AMP comparisons and the 
implementation of CMSs current price-substitution policy.  This data snapshot contains no 
recommendations.  However, OIG continues to support a previous recommendation that CMS 
expand the price-substitution criteria.   
 
 
Medicaid Program Reports and Reviews 
Financial Management and Improper Payments 
California Improperly Claimed at Least $23 Million of $260 Million in Total Medicaid Reimbursement 
for Opioid Treatment Program Services (A-09-20-02009), April 2022  
 
California claimed Medicaid reimbursement for some opioid treatment program (OTP) services that 
did not meet Federal and State requirements.  Of the 130 sample items, 88 had services that were 
all allowable, but 42 had services that were unallowable.  
 
On the basis of our sample results, we estimated that California claimed at least $23.1 million in 
unallowable Federal Medicaid reimbursement for OTP services during our audit period.  In 
addition, we identified deficiencies in three areas that that did not result in unallowable services but 
could impact the quality of care provided to beneficiaries receiving OTP services.  
 
California agreed with our recommendations that it refund $23.1 million to the Federal Government 
and take specific actions to address the deficiencies that we identified.  In addition, we recommend 
that California take actions to ensure that OTPs comply with Federal and State requirements for 
providing and claiming reimbursement for OTP services.  
 
Washington State Did Not Comply With Federal and State Requirements for Claiming Enhanced 
Federal Reimbursement for Medicaid Managed-Care Health Home Service Expenditures (A-09-20-
02008), May 2022  
 
Washington State did not comply with Federal and State requirements for claiming health home 
service expenditures under Medicaid managed care at the enhanced Federal medical assistance 
percentage.  Specifically, Washington State improperly calculated and claimed enhanced Federal 
reimbursement for its managed-care health home expenditures, totaling $1,770,860.  In addition, of 
the $1,770,860 that Washington State claimed, $374,579 was not supported by encounter data, and 
$29,161 was claimed for unallowable encounters.  These issues occurred because Washington State 
did not follow its State plan or Federal guidance and lacked adequate procedures and Medicaid 
Management Information System (MMIS) edits. 
 
33 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
Washington concurred with our recommendations that it: (1) refund to the Federal Government 
$374,579 for the encounters that were no longer supported and the $29,161 that exceeded the 
number of allowable encounters; (2) determine the portion of the remaining $1,367,120 that should 
have been claimed based on the portion of the managed-care capitation rate attributable to health 
home services and refund any unallowable amounts; (3) review all managed-care health home 
encounters from July 1, 2013, through March 31, 2017, to determine the amount that should have 
been claimed based on the portion of the managed-care capitation rate attributable to health 
home services; (4) implement a procedure to identify whether encounters used to support journal 
vouchers have been removed from the encounter data; and (5) strengthen its MMIS edits to ensure 
that encounters comply with State reporting requirements.  
 
Texas Did Not Report and Return All Medicaid Overpayments for the States Medicaid Fraud Control 
Units Cases (A-06-20-04004), May 2022 
 
Texas did not correctly report and return the Federal share of all MFCU-determined Medicaid 
overpayments identified for the period October 1, 2016, through September 30, 2018.  We 
determined that Texas should have reported MFCU-determined Medicaid overpayments totaling 
$24.3 million (at least $13.9 million Federal share) for the 65 cases with Medicaid restitution during 
the period that we reviewed.  In addition, Texas did not report $5.2 million (at least $2.7 million 
Federal share) for 37 cases within the required timeframe.  These issues occurred because Texas did 
not have adequate internal controls to ensure that it always reported MFCU-determined Medicaid 
overpayments in accordance with Federal requirements. 
 
Texas agreed with our recommendations that it: (1) report and return the Federal share for the 26 
cases, totaling $19 million ($11.1 million Federal share); (2) strengthen internal controls by 
developing written policies and procedures, including procedures for recording MFCU-determined 
Medicaid overpayments, and reconciling case files received from the MFCU with the overpayments 
recorded in the State agencys accounting system; (3) ensure that it reports all MFCU-determined 
Medicaid overpayments in accordance with Federal regulations and within regulatory timeframes; 
and (4) review the MFCU-determined Medicaid overpayments for cases after our audit period to 
ensure that all overpayments were reported on the Form CMS-64. 
 
More Than 90 Percent of the New Hampshire Managed Care Organization and Fee-for-Service 
Claims for Opioid Treatment Program Services Did Not Comply With Medicaid Requirements (A-01-
20-00006), June 2022  
 
New Hampshire claimed Medicaid reimbursement for OTP services that did not comply with 
Federal and State requirements.  Of the 100 OTP services we sampled, 6 complied with Federal and 
State requirements, but 94 did not meet applicable Federal and State requirements.  These 
deficiencies occurred because New Hampshire did not have the resources to oversee providers and 
enforce the OTP requirements.  Providers said high personnel turnover, difficulty attracting and 
retaining personnel, and difficulty keeping patients engaged in counseling services contributed to 
34 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
the lack of adherence to State requirements.  Furthermore, New Hampshire did not always provide 
guidance regarding State OTP requirements. 
 
On the basis of our sample results, we estimated that New Hampshire improperly claimed at least 
$7.9 million in Federal Medicaid reimbursement for OTP services during our audit period. 
 
New Hampshire agreed with our recommendations that it: (1) refund $7.9 million to the Federal 
Government, (2) take steps to ensure that providers comply with Federal and State requirements 
for providing and claiming Medicaid reimbursement for OTP services, and (3) improve 
communication with providers regarding the State requirements for opioid use disorder treatment 
and provide written confirmation about whether offsite counseling may be included as a required 
counseling service. 
 
Montana Claimed Federal Medicaid Reimbursement for More Than $5 Million in Targeted Case 
Management Services That Did Not Comply With Federal and State Requirements (A-07-21-03246), 
August 2022 
  
Montana did not always claim Federal Medicaid reimbursement for targeted case management 
(TCM) services during FYs 2018 through 2020 in accordance with Federal and State requirements.  
Of the 150 randomly sampled grouped line items, 43 sample items were at least partially 
unallowable because they had at least 1 error related to case managers lacking required experience 
or qualifications, unsupported services, unallowable services, or an ineligible recipient.  
  
Montana had policies and procedures in place for the administration of TCM services that, if 
followed, would have ensured compliance with Federal and State requirements.  Based on our 
sample results, we estimated that Montana claimed at least $7.7 million (more than $5 million 
Federal share) in unallowable Medicaid reimbursement for these services. 
  
We recommended that Montana refund to the Federal Government the more than $5 million 
(Federal share) in overpayments.  We also made procedural recommendations that Montana 
always follow its established policies and procedures regarding: (1) TCM providers case manager 
hiring practices, (2) verification that billed services were allowable and properly documented, and 
(3) verification that all individuals receiving services were eligible.  Furthermore, we made 
procedural recommendations that Montana require TCM providers to comply with established 
policies and procedures.  Montana neither concurred nor nonconcurred with our 
recommendations. 
  
New York Claimed $196 Million, Over 72 Percent of the Audited Amount, in Federal Reimbursement 
for NEMT Payments to New York City Transportation Providers That Did Not Meet or May Not Have 
Met Medicaid Requirements (A-02-21-01001), September 2022  
  
35 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
Of the 100 sampled non-emergency medical transportation (NEMT) payments, 17 complied with 
Federal and State requirements.  However, for 41 sampled payments, NEMT payments did not 
comply with Federal and State requirements and were therefore unallowable.  For the remaining 42 
sampled payments, we could not determine whether the services complied with Federal and State 
requirements.  We estimated that New York improperly claimed at least $84,329,893 in Federal 
Medicaid reimbursement for payments to NEMT providers that did not comply with certain Federal 
and State requirements.  In addition, we estimated that New York claimed $112,028,279 in Federal 
Medicaid reimbursement for payments to NEMT providers that may not have complied with certain 
Federal and State requirements.     
 
New York did not indicate concurrence or nonconcurrence with our recommendations that it 
refund $84,329,893 to the Federal Government for the payments that did not comply with certain 
Federal and State requirements and work with the transportation manager to review the 
$112,028,279 in Federal Medicaid reimbursement for payments to NEMT providers that may not 
have complied with certain Federal and State requirements and refund to the Federal Government 
any unallowable amounts.  We also made recommendations for New York to improve its 
monitoring of its NEMT program. 
  
Nearly All States Made Capitation Payments for Beneficiaries Who Were Concurrently Enrolled in a 
Medicaid Managed Care Program in Two States (A-05-20-00025), September 2022  
  
All 47 States reviewed made capitation payments on behalf of Medicaid beneficiaries who were 
concurrently enrolled in two States.  The significant increase in these payments from August 2019 
to August 2020 coincided with an overall increase in Medicaid enrollment during that time, and 
new Federal requirements and flexibilities that were available to States during the COVID-19 public 
health emergency.    
  
CMS does not actively monitor beneficiaries concurrent Medicaid managed care enrollment; 
instead, it relies on the individual States to identify concurrent enrollments and potential erroneous 
payments.  CMS does not provide States with Transformed Medicaid Statistical Information System 
(T-MSIS) national enrollment data that would assist them in identifying beneficiaries who were 
concurrently enrolled in a Medicaid managed care program in two States.  Two States often made 
capitation payments for the same Medicaid beneficiary in part because States did not have full 
access to data they needed to identify beneficiaries who were concurrently enrolled in another 
State.  Therefore, CMS does not take all available steps, either directly or through the States, to 
identify and prevent State capitation payments for non-resident beneficiaries. 
  
CMS did not concur with our recommendations that it provide States with matched T-MSIS 
enrollment data that identify Medicaid beneficiaries who were concurrently enrolled in a Medicaid 
managed care program in two States, and assist States with utilizing the data as needed to reduce 
future capitation payments made on behalf of beneficiaries concurrently enrolled in two States.    
 
36 
 
 
  Department of Health and Human Services, Office of Inspector General 
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CMS Has Opportunities To Strengthen States Oversight of Medicaid Managed Care Medical Loss 
Ratios (OEI-03-20-00231), September 2022 
 
States oversight of Medicaid managed care plans annual reporting of medical loss ratios (MLRs) is 
critical to improve fiscal transparency, monitor costs, and promote high-quality care in Medicaid 
managed care.  (The Federal MLR is the percentage of premium revenue that a managed care plan 
spent on covered health care services and quality-improvement activities in a 12-month period.)  
Although States reported that most of their plans submitted MLR reports, we found that nearly half 
of plans MLR reports were incomplete.  The data element for non-claims costs, generally defined 
as plans expenses for administrative services, accounted for the majority of incomplete MLR 
reports.  In addition, some States did not review selected MLR data elements for accuracy.  We 
made four recommendations to strengthen States oversight of MLR reporting and better ensure 
that plans are using Federal dollars for patient care.   
 
CMS concurred with all four recommendations, which were that: (1) CMS should design an annual 
MLR reporting template for States to provide to their Medicaid managed care plans, (2) CMS 
should clarify that States should verify the completeness of their plans MLR reports, (3) CMS 
should clarify that States should review their plans MLR reports to verify the accuracy of reported 
data elements, and (4) CMS should provide additional guidance to States regarding plans 
reporting of non-claims costs in MLR reports. 
 
Tennessee Did Not Always Invoice Rebates to Manufacturers for Physician-Administered Drugs 
Dispensed to Enrollees of Medicaid Managed-Care Organizations (A-07-21-06096), September 2022 
  
Tennessee did not always comply with Federal Medicaid requirements for invoicing manufacturers 
for rebates for physician-administered drugs dispensed to managed care organization (MCO) 
enrollees.  Tennessee did not invoice for, and collect from manufacturers, rebates totaling $18.4 
million ($12 million Federal share) for physician-administered drugs dispensed to MCO 
enrollees.  In addition, Tennessee did not invoice for, and collect from manufacturers, $43.3 million 
($28.4 million Federal share) in rebates for physician-administered drugs invoiced on crossover 
claims, for which beneficiaries are eligible for both Medicare and Medicaid services. 
 
Although its policies required the collection of drug utilization data necessary to invoice for rebates 
on all claims, Tennessees internal controls did not always ensure that the data were used to invoice 
manufacturers and collect rebates for physician-administered drugs dispensed to enrollees of 
MCOs. 
 
Tennessee generally concurred with our recommendations that it: (1) invoice for and collect 
manufacturers rebates and refund to the Federal Government $11 million (Federal share) for single-
source and top-20 multiple-source drugs; (2) work with the CMS to determine the portion of the $1 
million (Federal share) for other multiple-source drugs that were eligible for rebate, invoice 
manufacturers, and refund the Federal share; and (3) strengthen internal controls for non-crossover 
37 
 
 
  Department of Health and Human Services, Office of Inspector General 
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claims to ensure that all eligible physician-administered drugs are invoiced for rebate.  Tennessee 
did not concur with our recommendation that it consider revising its methodology going forward 
regarding payments for crossover claims. 
 
New York Generally Determined Eligibility for Its Basic Health Program Enrollees in Accordance With 
Program Requirements (A-02-20-01028), September 2022  
 
New York generally determined eligibility for its Basic Health Program (BHP) enrollees in 
accordance with Federal and State requirements.  For five sampled policies, New York enrolled 
individuals who were ineligible or potentially ineligible for the program and received improper 
monthly payments totaling $8,615.  According to New York, system defects prevented controls that 
were in place from working as intended. 
 
On the basis of our sample results, we estimated that the financial impact of the incorrect or 
potentially incorrect eligibility determinations made by New York for its BHP during the audit 
period totaled $69.9 million. 
 
New York did not indicate concurrence or nonconcurrence with our recommendations that it:  
(1) reimburse its BHP Trust Fund $8,615 associated with the improper monthly payments identified 
in our sample and (2) identify and reimburse the BHP Trust Fund all improper payments, which we 
estimate to total $69.9 million, resulting from system defects identified in our report.  We also 
made recommendations for New York to improve its system for enrolling individuals in its BHP. 
 
Texas Claimed or May Have Claimed More Than $30 Million of $9.89 Billion in Federal Funds for 
Medicaid Uncompensated Care Payments That Did Not Meet Federal and State Requirements (A-06-
19-09002), September 2022 
 
Texas claimed $16.90 billion ($9.86 billion Federal share) in uncompensated care payments in 
accordance with applicable Federal and State requirements.  However, Texas incorrectly claimed 
$18.90 million ($11.05 million Federal share).  Specifically, Texas claimed: (1) $12.91 million ($7.51 
million Federal share) because it did not refund the full Federal share of overpayments and (2) 
$5.99 million ($3.54 million Federal share) because it did not collect overpayments it identified.  
Additionally, the State agency may have incorrectly claimed $33.78 million ($19.66 million Federal 
share) because it did not reduce hospitals actual uncompensated care costs by Medicare 
payments the hospitals received. 
 
Texas did not concur with our recommendation that it work with CMS to determine whether the 
$33.78 million in uncompensated care payments hospitals retained should be recouped and refund 
the related Federal share or redistribute the recouped funds to hospitals that had unmet 
uncompensated care costs.  Texas concurred with our recommendations that it: (1) refund 
$11.05 million to the Federal Government for the underreported uncompensated care 
overpayments; (2) follow the CMS-approved methodology for calculating actual uncompensated 
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care costs when reconciling initial uncompensated care payments with providers actual 
uncompensated care costs, including reducing uncompensated care costs by Medicare payments 
providers receive; and (3) establish review procedures for overpayments to ensure that they are 
accurately entered into the State agencys accounting system and returned to the Federal 
Government. 
 
Quality of Care, Safety, and Access 
South Carolina Did Not Fully Comply With Requirements for Reporting and Monitoring Critical 
Events Involving Medicaid Beneficiaries With Developmental Disabilities (A-04-18-07078), April 2022  
 
South Carolina did not fully comply with requirements for reporting and monitoring critical events 
involving Medicaid beneficiaries with developmental disabilities residing in community-based 
settings.  Specifically, South Carolina did not ensure that providers: (1) reported all critical incidents, 
(2) reported within 24 hours or the next business day all critical events, or (3) always submitted the 
results of their internal reviews within 10 working days.  
 
South Carolina concurred with our recommendations that it work with the Department of 
Disabilities and Special Needs (DDSN) to: (1) ensure that providers follow the reporting 
requirements for critical events, (2) provide training to providers on recognizing and reporting 
critical incidents according to reporting requirements, (3) perform analytical procedures such as 
data matches on Medicaid claims data to identify any unreported critical incidents and investigate 
as needed, and (4) ensure that providers submit all incident reports to DDSN through the Incident 
Management System within 24 hours of an incident or the next business day.   
 
Massachusetts Implemented Our Prior Audit Recommendations and Generally Complied With 
Federal and State Requirements for Reporting and Monitoring Critical Incidents (A-01-20-00003), 
April 2022; and Maine Implemented Our Prior Audit Recommendations and Generally Complied 
With Federal and State Requirements for Reporting and Monitoring Critical Incidents (A-01-20-
00007), June 2022  
 
Massachusetts implemented the five recommendations from our prior audit and generally 
complied with Federal and State requirements for reporting and monitoring critical incidents 
involving Medicaid beneficiaries with developmental disabilities residing in group homes.  
However, the corrective actions for one recommendation in our prior audit were not effective in 
addressing one of our previous findings.   
 
Maine implemented the seven recommendations from our prior audit and generally complied with 
Federal and State requirements for reporting and monitoring critical incidents involving Medicaid 
beneficiaries with developmental disabilities.  However, Maines corrective actions for two 
recommendations were not fully implemented by the conclusion of our current audit period and, 
therefore, were only partially effective in addressing two of our previous findings.   
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Massachusetts agreed with our recommendations that it: (1) continue to coordinate with 
Department of Developmental Services and the Disabled Persons Protection Commission to ensure 
that all reasonable suspicions of abuse and neglect are properly identified, reported, and 
investigated as needed; and (2) require periodic training for DDS and group home staff on 
reporting reasonable suspicions of abuse and neglect.  
 
Maine concurred with our recommendations that it: (1) continue to work with CMS to fully 
implement the prior recommendation to ensure that followup reports are submitted by 
community-based providers appropriately and (2) ensure that the Mortality Review Committee 
reviews Mortality Review Form aggregate data to identify patterns and trends and to make 
recommendations to improve care. 
 
National Background Check Program for Long-Term Care Providers: An Interim Assessment (OEI-07-
20-00181), May 2022 
The National Background Check Program (Program) provides grants to States to develop 
programs for conducting background checks of prospective long-term care employees via State 
and Federal criminal history records.  In our interim assessment of Idaho and Mississippi, OIG 
found that during the first years of Program participation, both States were unable to implement 
some requirements and did not consistently report Federal and State funds.  Additionally, one 
State did not report data to accurately assess Program outcomes.  We recommended that CMS 
continue to implement OIGs prior recommendations for it to take appropriate actions to: 
(1) encourage States to obtain the necessary legislative authority from the State to fully implement 
Program requirements and (2) require participating States to consistently submit data that allow 
CMS and each State to calculate determinations of ineligibility.  CMS concurred with our new 
recommendation to ensure that participating States submit accurate quarterly reports. 
 
Drug Spending and Reimbursement 
South Carolina Did Not Always Invoice Rebates to Manufacturers for Physician-Administered Drugs 
(A-07-21-07003), August 2022  
 
South Carolina did not always comply with Federal Medicaid requirements for invoicing 
manufacturers for rebates for physician-administered drugs.  South Carolina did not invoice for, 
and collect from manufacturers, rebates associated with $14.5 million (Federal share) in physician-
administered drugs.  Of this amount, $14.3 million (Federal share) was for single-source drugs and 
$242,000 (Federal share) was for top-20 multiple-source drugs.  Further, we were unable to 
determine whether, in some cases, South Carolina was required to invoice for rebates for other 
multiple-source physician-administered drug claims.  South Carolina did not invoice the 
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manufacturers for rebates associated with claims totaling $1.3 million (Federal share) for these 
multiple-source drugs. 
 
We recommended that South Carolina refund to the Federal Government $14.3 million (Federal 
share) for claims for single-source physician-administered drugs and $242,000 (Federal share) for 
claims for top-20 multiple-source physician-administered drugs.  We also recommended that 
South Carolina work with CMS to determine the unallowable portion of $1.3 million (Federal share) 
for other claims for multiple-source, physician-administered drugs that may have been ineligible 
for Federal reimbursement, refund that amount, and consider invoicing drug manufacturers for 
rebates for these drugs if CMS determines that the drug claims are allowable.  In addition, we 
recommend that South Carolina work with CMS to determine and refund the unallowable portion 
of Federal reimbursement for physician-administered drugs that were not invoiced for rebates after 
December 31, 2019, and continue to review and strengthen its internal controls to ensure that all 
physician-administered drugs eligible for rebates are invoiced.  South Carolina generally concurred 
with our recommendations. 
 
 
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, 
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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 354 criminal and 413 civil actions against individuals 
or entities that engaged in offenses related to health care.  We also reported more than $929.1 million in 
investigative receivables due to HHS and more than $357.5 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. 
 
COVID-19 Enforcement Activities 
The following case examples involve COVID-19 Enforcement activities:  
MarylandOn August 4, 2022, Thomas Connally was sentenced to 37 months in Federal 
prison, followed by 3 years of supervised release, for making threats against a Federal 
official, specifically for sending emails threatening harm to Dr. Anthony Fauci, the Director 
of the National Institute of Allergy and Infectious Diseases (NIAID) at NIH.  Connally further 
admitted to threatening Dr. Francis Collins, the former Director of the NIH; Dr. Rachel 
Levine, currently the Assistant Secretary for Health at HHS; a Massachusetts public health 
official; and a religious leader.  According to Connallys plea agreement, from December 28, 
2020, to July 25, 2021, Connally used an anonymous email account from a provider of 
secure, encrypted email services based in Switzerland to send a series of emails to Dr. 
Anthony Fauci threatening to harm and/or kill Dr. Fauci and members of his family.  One 
email threatened that Dr. Fauci and his family would be dragged into the street, beaten to 
death, and set on fire.  On April 24, 2021, Connally sent Dr. Collins a series of four emails 
threatening Dr. Collins and his family with physical assault and death if Dr. Collins did not 
stop speaking about the need for mandatory COVID-19 vaccinations.  Connally admitted 
that he sent the threats to Dr. Fauci and Dr. Collins with the intent of intimidating or 
interfering with the performance of their official duties and with the intent to retaliate 
against Dr. Fauci and Dr. Collins for performing their official duties, including discussing 
COVID-19 and its testing and prevention. 
Connally also admitted sending emails threatening harm to three other individuals.  
Specifically, on November 24, 2020, Connally sent a series of six threatening emails to Dr. 
Rachel Levine, then Secretary of Health for the State of Pennsylvania, at Dr. Levines email 
account at the Pennsylvania Department of Health.  The subject lines and body of the 
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emails threatened Dr. Levine with physical violence and death.  Similarly, on August 31, 
2020, Connally sent an email threatening physical violence and death to a Massachusetts 
public health official.  Finally, on April 21, 2021, Connally sent a series of four threatening 
emails to four individuals who work for a religious institution in Newark, New Jersey.  The 
four emails threatened physical violence and death to a religious leader at the institution. 
FloridaOn June 30, 2022, MorseLife Health System Inc. (MorseLife) agreed to pay the 
United States $1.75 million to resolve its potential liability under the False Claims Act for 
facilitating COVID-19 vaccinations for hundreds of individuals ineligible to participate in the 
CDC Pharmacy Partnership for Long-Term Care Program (LTC PPP), a program specifically 
designed to vaccinate long-term care facility (LTCF) residents and staff when doses of 
COVID-19 vaccine were in limited supply at the beginning of the CDC COVID-19 
Vaccination Program.  MorseLife is a not-for-profit corporation located in West Palm 
Beach, Florida, that oversees health care facilities on its campus, including a nursing home 
and an assisted living facility.  
The CDC announced the launch of the LTC PPP in October 2020.  Because the LTCF 
population was at the highest risk of COVID-19 infections, the CDC created the LTC PPP to 
prioritize vaccinations for that population as quickly as possible and while vaccine 
availability was limited.  Under this program, the CDC engaged with pharmacy partners to 
provide end to end management of the COVID-19 vaccination process, including 
conducting on-site vaccination clinics at the nursing homes and other LTCFs.  More than 8 
million vaccine doses were administered to LTCF residents and staff through this program.  
MorseLife enrolled in the LTC PPP and scheduled its first vaccination clinic at MorseLife on 
Dec. 31, 2020 (the vaccination clinic) for residents and staff of the Joseph L. Morse Health 
Center, a skilled nursing facility on MorseLifes campus.  The settlement resolves allegations 
that MorseLife knew that the LTC PPP covered only LTCF residents and staff but 
nevertheless invited and facilitated the vaccination of hundreds of ineligible persons at the 
clinic by characterizing them as staff and volunteers, many of whom MorseLife targeted 
for donations.  Specifically, the United States alleged that MorseLife: (1) characterized board 
members as staff, (2) directed the organizations fundraising arm to invite donors and 
potential donors to the vaccination clinic, and (3) allowed the Vice Chairman of the 
MorseLife Health Systems Inc. Board and his brother to invite close to 300 ineligible 
individuals to receive the vaccine at MorseLife.  
MorseLifes chief executive officer (CEO) allegedly directed the MorseLife Foundation, the 
organizations fundraising arm, to invite donors and potential donors to the vaccination 
clinic, encouraging Foundation employees to take advantage of the vaccination 
opportunity to target billionaires and millionaires for donations.  For example, in one text 
message MorseLifes CEO stated: Im a little disappointed in the foundations mentality; I 
have delivered you 350 of the richest people in the country and youre still thinking $25,000 
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gift....  MorseLifes CEO added: Do not be weak be strong you have the opportunity to 
take advantage of everyone who needs the shot...  Ultimately, the United States alleged 
that, of 976 persons vaccinated at the December 31, 2020, clinic, 567or more than half
were ineligible to participate in the LTC PPP. 
UtahOn July 6, 2022, Dino Rende and Francis Rende II were both sentenced to 36 
months of probation and ordered to pay $500 in restitution after pleading guilty to 
misdemeanor conspiracy to steal or convert Government property charges stemming from 
the theft of CDC COVID-19 Vaccination Record Cards.  In the plea agreement, both 
defendants admitted that between March 2021 and August 2021, they conspired to defraud 
CDC by agreeing to sell stolen CDC COVID-19 Vaccination Record Cards to others for $50 
each.  Both defendants also admitted that defendant Francis Rende II stole at least 20 CDC 
Vaccination Record Cards in March 2021; that he sent his brother, Dino Rende, some of the 
stolen vaccination record cards; and that they agreed to use them and sell them to others 
for $50 each. 
 
Home Health 
The following case examples involve home health fraud:  
  
KentuckyOn May 5, 2022, SHC Home Health Services of Florida, LLC and its related 
entities (collectively, Signature HomeNow) paid $2.1 million to the United States 
Government to settle claims of improperly billing the Medicare Program for home health 
services provided to beneficiaries living in Florida.  Signature HomeNow, whose corporate 
headquarters is located in Louisville, Kentucky, operated home health care services in 
Florida.  According to a complaint filed in the U.S. District Court for the Southern District of 
Florida against Signature HomeNow and the subsequent settlement agreement, it was 
alleged that between 2013 and 2017 Signature HomeNow knowingly submitted false or 
fraudulent claims seeking payment from the Medicare Program for home health services to 
Medicare beneficiaries who: (1) were not homebound, (2) did not require certain skilled 
care, (3) did not have a valid or otherwise appropriate plans of care in place, and/or (4) did 
not have appropriate face-to-face encounters needed to be appropriately certified to 
receive home health services. 
Oklahoma and FloridaOn September 27, 2022, the United States entered into two 
settlements with Carter Healthcare, LLC, an Oklahoma-based for-profit home health 
provider, and its affiliates.  Carter Healthcare agreed to pay $7,175,000 to resolve 
allegations that it violated the False Claims Act by submitting claims to Medicare for 
medically unnecessary home health therapy services to Medicare beneficiaries in Florida, 
and it also agreed to pay $22,948,004 to resolve allegations that it submitted claims to 
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Medicare in violation of the anti-kickback statute by paying physicians remuneration under 
the guise of medical directorships in order to induce referrals of home health patients in 
Oklahoma.  Carter Healthcare and its affiliates (CHC Holdings and CHC-FLA) entered into a 
5-year CIA with OIG as part of the resolution of the matter.  OIG excluded CEO Stanley 
Carter and Chief Operating Officer Brad Carter from participation in Federal health care 
programs for 5 years. 
 
Hospital 
The following case example involves a hospital:  
WashingtonOn April 12, 2022, Providence Health & Services Washington (Providence) 
agreed to pay $22,690,458 to resolve allegations that it fraudulently billed Medicare, 
Medicaid, and other Federal health care programs for medically unnecessary neurosurgery 
procedures.  Providence is a large health care and hospital system that operates 51 
hospitals in 7 western U.S. States, including Providence St. Marys Medical Center 
(Providence St. Marys) in Walla Walla, Washington.  Between 2013 and 2018, Providence St. 
Marys employed neurosurgeons identified in the Settlement Agreement as Dr. A and Dr. B.  
Providence St. Marys paid neurosurgeons based on a productivity metric that provided 
them a financial incentive to perform more surgical procedures of greater complexity.  
Between 2014 and 2018, Dr. A was one of the highest producing neurosurgeons in the 
entire Providence system.  Between 2014 and 2017, based on the productivity metric, 
Providence paid Dr. A between $2.5 million and $2.9 million per year.  This settlement 
resolves allegations that Providence falsely billed Medicare, Washington State Medicaid, 
and other Federal health care programs for deficient and medically unnecessary 
neurosurgery procedures performed by Dr. A and Dr. B. 
As part of the Settlement Agreement, Providence admitted that during the time period in 
which Dr. A and Dr. B were employed at Providence St. Marys as neurosurgeons, 
Providence medical personnel articulated concerns that Dr. A and Dr. B: (1) were 
endangering the safety of patients, (2) created through their surgeries an excessive level of 
complications and negative outcomes, (3) performed surgery on candidates who were not 
appropriate for surgery, and (4) failed to properly document their procedures and 
outcomes.  Providence further admitted that Providence medical personnel articulated 
additional concerns that Dr. A: (1) completed medical documentation with falsified and 
exaggerated diagnoses to obtain reimbursement from insurance providers, (2) performed 
surgical procedures that did not meet the medical necessity requirements set by Medicare 
and other insurance programs, (3) over-operated (i.e., performed surgeries of greater 
complexity and scope than were medically appropriate), and (4) jeopardized patient safety 
by attempting to perform an excessive number of overly complex surgeries.  Finally, 
Providence admitted that, while it eventually placed both Dr. B and Dr. A on administrative 
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leave in February 2017 and May 2018, respectively, it allowed both doctors to resign while 
on leave, and did not take any action to report Dr. A or Dr. B to the National Practitioner 
Data Bank or the Washington State Department of Health. 
 
Pharmacies 
The following case example involves a pharmacy: 
  
New YorkOn April 13, 2022, Aleah Mohammed was sentenced to 6.5 years in prison for 
carrying out multiple schemes to defraud health care programs, including obtaining more 
than $6.5 million from Medicare Part D plans and Medicaid drug plans.  According to court 
documents, Mohammed was the owner and operator of five pharmacies: Superdrugs Inc., 
Superdrugs I Inc., Superdrugs II Inc., S&A Superdrugs II Inc., and Village Stardrugs Inc.  
Between 2015 and2020, Mohammed utilized these pharmacies to engage in schemes that 
defrauded health care programs, including Medicare and Medicaid, by submitting claims 
for prescription drugs that were not dispensed, not prescribed as claimed, not medically 
necessary, or dispensed during a time when the pharmacy was no longer registered with 
the State of New York.  The fraudulent claims included claims for expensive prescription 
drugs for the treatment of human immunodeficiency virus (HIV).  Mohammed and her 
family used proceeds of the scheme to purchase luxury items such as a Cadillac Escalade 
SUV, a Mercedes Benz sedan, a Porsche Turbo coupe, as well as jewelry and real property 
in Queens, New York, and Pocono Pines, Pennsylvania. 
 
 
Prescription Drugs 
The following case examples involve prescription drugs: 
PennsylvaniaOn May 10, 2022, Andrew Berkowitz was sentenced to 20 years in prison, 
followed by 5 years of supervised release, and was ordered to pay a $40,000 fine and 
almost $4 million in restitution for running a prescription pill mill from his medical 
practice, which he operated in Philadelphia under the name A+ Pain Management.  In 
January 2020, Berkowitz pleaded guilty to 19 counts of health care fraud and 23 counts of 
distributing oxycodone outside the course of professional practice and without a legitimate 
medical purpose.  The defendant fraudulently billed insurers for medically unnecessary 
physical therapy, acupuncture, chiropractic adjustments, and prescription drugs.  In 
addition, the defendant fraudulently billed for treatments that were not provided at all.  
Regardless of their medical complaint, at every visit patients received a goodie bag, which 
was a tote bag filled with prescription drugs for which Berkowitz submitted pharmacy 
claims through his company, Bucks Philadelphia Medical Care Group.  The goodie bags 
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typically included a combination of drugs, including topical analgesics such as Relyyt 
and/or lidocaine, muscle relaxers such as chloroxazon and/or cyclobenzaprine, anti-
inflammatories such as celecoxib and/or nalfon, Schedule IV controlled substances such as 
tramadol for pain, and/or eszopiclone and quazepam for insomnia and anxiety.  The 
defendant obtained payments from insurers of more than $4,000 for each bag by falsely 
asserting that the drugs were for the benefit of the patient. 
As part of the fraud scheme, Berkowitz also prescribed oxycodone to pill-seeking patients 
in exchange for their tacit approval that he would submit excessive claims to the patients 
insurer for the goodie bag and other medically unnecessary services.  From 2015 through 
2018, Berkowitz obtained more than $4 million in fraudulent proceeds from his scheme.  
The defendant is also subject to a civil judgement under which he is obligated to pay 
approximately $1.8 million as a result of civil False Claims Act liability for false claims 
submitted to Medicare, and is subject to a permanent prohibition on prescribing, 
distributing, or dispensing controlled substances. 
Washington StateOn April 27, 2022, Janet Sue Arnold was sentenced to 48 months in 
Federal prison for conspiring to distribute and possess with intent to distribute opioid pain 
medications and other controlled substances without a legitimate medical purpose and 
outside the usual course of professional practice.  According to court documents, Arnold 
abused her position of trust as a medical doctor by participating in a prescription drug 
conspiracy with Danielle Corine Mata, David Barnes Nay, Lisa Marie Cooper, and Jennifer 
Cheri Prichard.  As part of their conspiracy, Dr. Arnold and her conspirators pushed 
thousands of pills on the street that were abused by addicts, and potentially caused others 
to become addicted to controlled substances.  Mata and Prichard, who were both addicts, 
started out as patients but eventually started working at Dr. Arnolds clinic, Desert Wind 
Family Practice, in Richland, Washington.  In approximately March 2016, Mata became the 
practices office manager and one of Arnolds most trusted associates.  During the 
conspiracy, Nay and Cooper also provided Mata with the names of fictitious patients for 
her to use on several of the blank, pre-signed prescriptions to obtain opioids. 
The conspiracy operated primarily out of Dr. Arnolds clinic in Richland, Washington.  On a 
regular basis, the conspirators distributed highly addictive and dangerous controlled 
substances, including fentanyl, oxycodone, methadone, hydromorphone, methylphenidate, 
an amphetamine mixture, as well as carisoprodol and alprazolam.  Dr. Arnold had a pattern 
and practice of providing office staff and patients with hundreds of blank, pre-signed 
prescriptions that, after logging into the clinic computer, allowed the conspirators to 
complete and print prescriptions for opioids and other controlled substances.  Text 
messages recovered by investigators from Arnolds and Matas phones showed that Dr. 
Arnold had texted Mata asking whether she needed more signed paper.  
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South DakotaOn July 12, 2022, Donna Garnette was convicted of conspiracy to distribute 
a controlled substance.  Garnette, age 29, was sentenced to 9 years in Federal prison, 
followed by 3 years of supervised release, and was ordered to pay a $100 special 
assessment to the Federal Crime Victims Fund.  Garnette was indicted for the charge by a 
Federal grand jury in May 2021 and pleaded guilty in December 2021.  The conviction 
stemmed from Garnette obtaining and distributing fentanyl (4-ANPP) and hydrocodone 
pills with her conspirators on the Pine Ridge Reservation.  
The case was investigated by the Badlands Safe Trails Task Force, which includes the 
Federal Bureau of Investigation (FBI), Bureau of Indian Affairs, Oglala Sioux Tribe 
Department of Public Safety, South Dakota Department of Criminal Investigation, and HHS-
OIG. 
 
Kickbacks 
The following case example involves kickbacks: 
 
Washington StateOn May 27, 2022, Jae Lee, the CEO of Northwest Physicians Laboratory 
(NWPL), was sentenced to serve 24 months in prison and ordered to pay $7.6 million in 
restitution for conspiracy to solicit kickbacks from medical testing laboratories in exchange 
for referring Government testing business to the laboratories.  CEO Lee helped NWPL 
obtain more than $3.7 million in kickback payments by steering urine drug test specimens 
to two laboratories that billed the Government for testing, resulting in Government 
payments to those two laboratories of more than $6.5 million. 
According to records filed in the case between January 2013 and July 2015, those two 
laboratories, which were not physician owned, made payments to NWPL in exchange for 
referrals of Medicare and TRICARE program business, in violation of the anti-kickback 
statute.  Paying remuneration to medical providers or provider-owned laboratories in 
exchange for referrals encourages providers to order medically unnecessary services.  The 
anti-kickback statute functions, in part, to discourage such behavior.  NWPL was physician-
owned, and for that reason could not test urine samples for patients covered by 
Government health programs such as Medicare, Medicaid, and TRICARE.  To conceal the 
payment of the kickbacks, Lee and other co-conspirators described the fees as being for 
marketing services; however, no marketing services were performed. 
NWPL pleaded guilty in February 2021 and was sentenced to pay $8,114,417 in restitution 
joint and several with the other criminal defendants.  NWPL has been dissolved.  To date, 
the laboratories and individuals involved in this investigation have agreed to pay more than 
$14 million to settle related civil allegations. 
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Nursing Homes 
The following case example involves a nursing home: 
New YorkOn June 29, 2022, the United States settled a civil False Claims Act lawsuit 
against TCPRNC, LLC d/b/a Plaza Rehab and Nursing Center (Plaza Rehab Center) and 
Citadel Consulting Group LLC d/b/a Citadel Care Centers (Citadel).  The settlement resolved 
allegations that Plaza Rehab Center, acting at the direction of Citadel, fraudulently switched 
the type of Medicare coverage in which elderly residents were enrolled to maximize the 
Medicare payments that Plaza Rehab Center would receive.   
Under the settlement, Plaza Rehab Center and Citadel agreed to pay a total of $7.85 million 
and made extensive factual admissions regarding their conduct.  Specifically, Plaza Rehab 
Center and Citadel admitted that their staff often did not obtain the consent of residents or 
authorized representatives before disenrolling the residents from their Medicare Advantage 
Plan.  From September 2016 to February 2019, Citadel exerted pressure on Plaza Rehab 
Center staff to increase the number of residents enrolled in fee-for-service Medicare to 
increase Medicare reimbursements.  Plaza Rehab Center and Citadel also entered into a 
CIA with HHS-OIG, which requires that they maintain a compliance program designed to 
foster adherence to Federal health care program requirements. 
Telemarketing 
The following case example involves telemarketing 
FloridaOn June 16, 2022, Marc Sporn was sentenced to 14 years in prison for health care 
and wire fraud resulting in a loss of more than $20 million to Medicare, and for evading 
taxes.  According to court documents, Marc Sporn owned and operated several 
telemarketing and telemedicine companies, including CPL Media Group Inc. Medipak, LLC; 
Real Time Physicians LLC; 24 HR Virtual MD LLC; Medtech Worldwide Inc.; New World 
Holdings Inc.; and Ins Cov LLC.  Sporn used these companies to market medically 
unnecessary genetic tests to Medicare beneficiaries, and to sell prescriptions (i.e., doctors 
orders) for medically unnecessary genetic tests to laboratories in exchange for kickbacks 
and bribes.  Sporn knew these laboratories would use these doctors orders to bill Medicare 
for medically unnecessary goods and services.  
Through nominee owners, Sporn also operated and controlled Palm Beach companies 
Medi Biotech LLC and Walmol Holdings LLC.  Sporn used Medi Biotech to market 
compounded prescription creams to customers with certain health conditions.  Pharmacies 
and laboratories associated with Medi Biotech filled the prescriptions, billed the customers 
insurance companies, and paid Sporn kickbacks.  In addition to opening bank accounts for 
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Medi Biotech in nominee names, Sporn opened accounts in the name of Walmol Holdings, 
a shell corporation, and in 2014 and 2015, avoided paying more than $1.6 million in 
personal income taxes by diverting millions through the companys accounts.  Sporn used 
these company accounts to purchase luxury items such as high-end watches and diamond 
jewelry, classic and exotic cars, two yachts, and other items.  Sporn also evaded paying 
more than $2.5 million in personal income taxes for other years dating back to 2000.  When 
the IRS attempted to collect back taxes from Sporn, he tried to conceal assets by 
transferring property to trusts and individuals and by repeatedly opening and closing 
companies, among other things.  In addition to the prison term and Medicare restitution, 
Sporn was ordered to pay more than $4 million in restitution to the IRS. 
Affordable Care Act 
The following case example involves the Affordable Care Act (ACA): 
CaliforniaOn August 18, 2022, Ventura Countys organized health system and three 
medical care providers agreed to pay a total of $70.7 million to settle allegations that they 
broke Federal and State laws by submitting or causing the submission of false claims to 
Californias Medicaid program (Medi-Cal) related to Medicaid Adult Expansion under the 
ACA.  The parties that entered into the three separate settlement agreements are: 
  Ventura County Medi-Cal Managed Care Commission, which does business as Gold 
Coast HealthPlan, a county-organized health system (COHS) that contracts to 
arrange for the provision of health care services under Medi-Cal in Ventura County;  
  Ventura County, which owns and operates Ventura County Medical Center, an 
integrated health care system that provides hospital, clinic, and specialty services;  
  Dignity Health, a San Francisco-based not-for-profit hospital system that operates 
two acute-care hospitals in Ventura County; and  
  Clinicas del Camino Real, Inc. (Clinicas), a non-profit health care organization 
headquartered in Camarillo.  
Pursuant to the ACA, beginning in January 2014, Medi-Cal was expanded to cover the 
previously uninsured Adult Expansion populationadults between the ages of 19 and 64, 
without dependent children, and with annual incomes up to 133 percent of the Federal 
poverty level.  The Federal Government fully funded the expansion coverage for the first 
three years of the program.  
Pursuant to contracts with Californias Department of Health Care Services (DHCS), if a 
California COHS did not spend at least 85 percent of the funds it received for the Adult 
Expansion population on allowed medical expenses, the COHS was required to pay back 
to the State the difference between 85 percent and what it actually spent.  California, in 
turn, was required to return that amount to the Federal Government.  
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The three settlements resolve allegations that Gold Coast, Ventura County, Dignity, and 
Clinicas knowingly submitted or caused the submission of false claims to Medi-Cal for 
Additional Services provided to Adult Expansion Medi-Cal members between January 1, 
2014, and May 31, 2015.  The United States and California alleged that the payments were 
not allowed medical expenses under Gold Coasts contract with DHCS, were pre-
determined amounts that did not reflect the fair market value of any Additional Services 
provided, and/or the additional services were duplicative of services already required to be 
rendered.  The United States and California further alleged that the payments were 
unlawful gifts of public funds in violation of Article IV, Section 17, of the Constitution of 
California.  
As a result of the settlements, Gold Coast agreed to pay $17.2 million to the United States; 
Ventura County agreed to pay $29 million to the United States; Dignity agreed to pay 
$10.8 million to the United States and $1.2 million to the State of California; and Clinicas 
agreed to pay $11.25 million to the United States and $1.25 million to the State of California.  
Contemporaneous with the False Claims Act settlement, HHS agreed to release its right to 
exclude Gold Coast and Ventura County from federally funded health care programs in 
exchange for their agreements to enter into 5-year CIAs.  The CIAs require, among other 
things, that Gold Coast and Ventura County each implement centralized risk assessment 
programs as part of their compliance programs, and that each hire an independent review 
organization to complete annual reviews.  Gold Coasts annual reviews will focus on its 
calculation and reporting of MLR data under Medi-Cal, while Ventura Countys annual 
reviews will target hospital claims submitted to Medicare and Medicaid, including claims 
submitted to Medicaid managed care organizations. 
 
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 11 areas: Miami and Tampa/Orlando, Florida; 
Dallas and Houston, Texas; Los Angeles, California; Detroit, Michigan; Brooklyn, New York; Baton Rouge 
and New Orleans, Louisiana; Chicago, Illinois; and Newark, New Jersey/Philadelphia, Pennsylvania; along 
with a Corporate Strike Force located in Washington, DC.  During this semiannual reporting period, Strike 
Force efforts resulted in the filing of charges against 100 individuals or entities, 98 criminal actions, and 
more than $248.2 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 
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in Alabama, Kentucky, Ohio, Tennessee, Virginia, and West Virginia.  OIGs Office of Investigations is 
working closely with its law enforcement partners at the Drug Enforcement Administration (DEA), FBI, 
and the MFCUs to provide investigative 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 example involves a Strike Force case: 
 
FloridaOn July 7, 2022, Jose Santeiro was sentenced to 54 months in prison for engaging in a 
scheme that fraudulently billed approximately $112 million for substance use disorder services that 
were never provided or were medically unnecessary.  According to court documents, Jose Santeiro 
worked with others to unlawfully bill for approximately $112 million of addiction treatment services 
that were never rendered and/or were medically unnecessary at two addiction treatment facilities 
where Santeiro was the medical director.  The facilities were Second Chance Detox LLC, d/b/a 
Compass Detox (Compass Detox), an inpatient detox and residential facility, and WAR Network LLC 
(WAR), a related outpatient treatment program.  
 
According to court documents and evidence presented at trial, Santeiro and others admitted 
patients for medically unnecessary detox services, the most expensive kind of treatment the 
facilities offered.  Patient recruiters offered kickbacks to induce patients to attend the programs 
and then gave them illegal drugs to ensure admittance for detox at Compass Detox.  Evidence at 
trial also showed that Santeiro submitted false and fraudulent claims for excessive, medically 
unnecessary urinalysis drug tests that were never used in treatment.  Santeiro and others then 
authorized the re-admission of a core group of patients who were shuffled between Compass 
Detox and WAR to fraudulently bill for as much as possible, even though the patients did not need 
the expensive treatments for which they were repeatedly admitted.  Santeiro also prescribed 
Compass Detox patients a so-called comfort drink to sedate them, ensure they stayed at the 
facility, and keep them coming back.  The evidence further showed that Santeiros log-in 
information was used by others, with his knowledge, to sign electronic medical files to make it 
appear as if Santeiro had provided treatment himself when he had not. 
 
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. 
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American Indian/Alaska Native Compliance Trainings 
OIG provides a free online training series, Improving Health and Well-Being in American Indian and 
Alaska Native Communities Through Compliance, for grantees and health care providers who serve 
American Indian/Alaska Native (AI/AN) communities.  The training series covers topics such as 
compliance; fraud, waste, and abuse; and health care quality, including how OIG works with the 
AI/AN community to combat the opioid epidemic and to protect patients from sexual abuse.  The 
training series includes web-based trainings, job aids, and videos which are available at 
https://oig.hhs.gov/reports-and-publications/featured-topics/ihs/training.asp.  
 
Whistleblower Protection Training  
In addition to training for health care providers, OIG provides training to HHS employees, 
contractors, and award recipients on Federal whistleblower protections and prohibitions against 
retaliation.  This training is provided by the HHS Whistleblower Protection Coordinator within the 
OIG Office of Counsel to the Inspector General and is conducted in coordination with HHS OpDivs 
and Staff Divisions (StaffDivs).  OIG also provides training videos, materials, and FAQs about 
whistleblower protections on its website at https://oig.hhs.gov/fraud/whistleblower/.  
 
 
Most Wanted Fugitives List 
OIGs Most Wanted Fugitives website continues to garner national and international attention and has 
greatly assisted in helping to capture fugitives charged with defrauding Federal health care programs and 
stealing millions of taxpayer dollars.  The Most Wanted Fugitives website is continually updated and 
features a profile for each fugitive 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 
Most Wanted 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 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 OIG 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 
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HHS-OIG website.  During this semiannual reporting period, the OIG Hotline reported expected recoveries 
of $40,229,634 as a direct result of cases originating from hotline complaints. 
 
OIG Hotline Activity (4/1/20229/30/2022) 
Contacts to 1-800-HHS-TIPS phone line, including  60,880 
callers seeking information 
Total tips evaluated  19,450 
Tips referred for action  10,547 
Closed; no basis provided for further action  1,343 
Closed; no HHS violation1  770 
Closed; other administrative reason  6,790 
 
Sources of tips referred for action 
Phone  2,930 
OIG website  6,112 
Letters or faxes  515 
Other  990 
 
 
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 abuse or neglect of residents in 
health care facilities and board and care facilities and of Medicaid beneficiaries in noninstitutional 
or other settings. 
 
In addition to an annual recertification review of each MFCU, OIG conducts reviews 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: 
 
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  Iowa Medicaid Fraud Control Unit: 2021 Inspection (OEI-07-21-00340), June 2022;  
  Connecticut Medicaid Fraud Control Unit: 2021 Inspection (OEI-06-21-00360), September 
2022; and  
  Michigan Medicaid Fraud Control Unit: 2021 Review (OEI-06-21-00270), September 2022. 
 
 
OIG Joint Casework With MFCUs 
The following case example involves OIGs joint efforts with MFCUs: 
 
LouisianaOn April 19, 2022, Marty Johnson was sentenced to 60 months in prison, 
followed by 1 year of supervised release, and Keesha Dinkins was sentenced to 24 months 
in prison, followed by 1 year of supervised release, in connection with a health care fraud 
and wire fraud scheme.  In addition, Marty Johnson and Keesha Dinkins were ordered to 
jointly pay restitution in the amount of $3.5 million.  According to information presented to 
the court, Marty Johnson owned and operated Positive Change Counseling Agency 
(Positive Change) located in Shreveport, Louisiana, from January 2013 to January 2018. 
Keesha Dinkins was a manager and supervisor at Positive Change, which provided mental 
health rehabilitation and related services to Medicaid beneficiaries in the Caddo and 
Bossier Parish areas.  From 2014 to January 2018, Johnson submitted and caused to be 
submitted fraudulent claims for mental health rehabilitation and non-emergency 
transportation services on behalf of Positive Change.  Keesha Dinkins knew that Marty 
Johnson submitted these fraudulent claims that she and Johnson both knew were not 
performed or rendered.  These fraudulent claims resulted in Positive Change receiving 
payments from Medicaid to which it was not entitled.  Johnson admitted to paying 
individuals money to enroll with Positive Change, increasing the capacity for Positive 
Change to bill Medicaid for services that were not rendered.  Johnson instructed employees 
at Positive Change, and Dinkins advised those employees, to create false client files to 
conceal from Medicaid and insurance company auditors and inspectors that it had not 
performed the services related to its previously submitted claims which had already been 
reimbursed by Medicaid.  To create these false client files, sections from different client 
documents were physically cut to form inserts that were glued into blank client log 
templates.  These templates with the glued inserts were then photocopied to create the 
appearance of legitimate documents.  Johnson and Dinkins supervised and knowingly and 
willfully instructed the employees creating these false client files to place the false and 
fictitious photocopied, cut-and-pasted documents into the client files.  Johnson and Dinkins 
knew that these false client files were used to conceal from Medicaid officials that Positive 
Change did not render the services in the claims submitted by it and paid by Medicaid.  
The case was investigated by HHS-OIG, the Louisiana State Attorney Generals Office MFCU, 
and the FBI. 
 
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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 opinions 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 
14 requests for advisory opinions, issued 11 advisory opinions, and modified 2 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 (also known 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 1,290 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 1,290 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:  
 
North CarolinaOn May 19, 2022, OIG excluded the owner and operator of a billing 
agency for a minimum period of 30 years based on her conviction for health care fraud 
conspiracy.  Specifically, the individual engaged in a scheme to defraud Medicaid by 
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submitting claims for fictitious services or services that were never provided.  The court 
ordered her to pay approximately $6,121,600 in restitution, and she was sentenced to 84 
months of incarceration.      
 
GeorgiaOn May 19, 2022, a dietary supplements company and its owner were excluded 
for a minimum period of 3 years based on their convictions for introducing a misbranded 
drug into interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act.  
Specifically, the individual and company pled guilty to selling and distributing a vitamin D 
product with false and misleading marketing claims that their product would lower 
consumers risks of contracting COVID-19.  
 
LouisianaOn May 22, 2022, OIG excluded the owner of seven nursing homes in the State 
of Louisiana for an indefinite period of time based on his ownership of excluded entities.  
As background, OIG had previously excluded the seven nursing homes owned by this 
individual after the State of Louisiana revoked their licenses to operate as nursing homes 
following a series of documented violations identified in the aftermath of Hurricane Ida.  
Specifically, the nursing homes evacuated more than 800 residents of the facilities to a 
single warehouse where subsequent State inspectors observed residents living in inhumane 
conditions (e.g., some residents were sleeping on mattresses near standing water, some 
residents were undressed or naked, other residents were calling for help but being left 
alone with full diapers).  During these onsite visits, the owner attempted to threaten, 
intimidate, and interfere with the assessment of the site, where seven residents eventually 
died. 
 
WashingtonOn July 20, 2022, a physician in Seattle was excluded for a minimum period 
of 18 years based on his conviction by jury verdict of multiple counts of wire fraud, bank 
fraud, and money laundering.  Specifically, the physician submitted false and misleading 
loan applications as part of a fraud scheme to obtain funding from the Paycheck Protection 
Program and Economic Injury Disaster Loan Program, authorized by the Coronavirus Aid, 
Relief, and Economic Security (CARES) Act designed to offset economic hardships caused 
by the COVID-19 pandemic.  In addition, the court ordered him to pay $1,438,000 in 
restitution and sentenced him to 48 months of incarceration.  The Washington Department 
of Health Medical Commission also suspended his license to practice.  
 
TexasOn August 18, 2022, OIG excluded a physician for a minimum period of 25 years 
based on his convictions for conspiracy to distribute a controlled substance and commit 
mail fraud.  In addition to illegally dispensing controlled substances (e.g., hydrocodone), 
this physician conspired with others to unlawfully enrich themselves by submitting 
fraudulent claims to workers compensation programs as well as other health insurers for 
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medical services that were not rendered.  The court ordered the physician to pay 
approximately $376,300 in restitution and serve 144 months of incarceration.  
 
MaineOn September 20, 2022, OIG excluded a physicians assistant for a minimum 
period of 23 years based on his conviction of unlawful sexual contact with a minor patient.  
The court also sentenced the physicians assistant to 7 years of incarceration, and the Maine 
State Board of Medical Licensure revoked his license. 
 
Suspensions and Debarments  
Suspensions and debarments are administrative tools used by HHS and other Federal agencies to 
protect the Government from individuals and entities that 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 that 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 examples involve debarment:  
  
NebraskaMubanga Chongo-Ofafa, Little Blessings Learning Center, Seth Mock, Mocks 
Loving Life Learning Center, and Aileen Kogera Njoroge were each debarred for a period of 
3 years.  The debarment was imposed by the HHS Suspension and Debarment Official 
based on a referral from OIG.  Chongo-Ofafa, Little Blessings, Mock, Mocks Loving Life 
Learning Center, and Njoroge were criminally convicted for their role in a scheme to 
defraud child care programs by submitting claims for children who did not attend the child 
care program.  The child care program is funded in part by HHS's Administration for 
Children and Families' Child Care Development Fund (CCDF).  The CCDF provides child care 
subsidies to low-income families where the parents are employed or engaged in approved 
job training.  A review of timesheets reflected that the State was falsely billed for families 
whose children did not attend day care on the days and times claimed. 
 
WashingtonSami Anwar and his companies Mid Columbia Research LLC and Zain 
Research LLC were each debarred for a period of 3 years.  The debarment was imposed by 
the HHS Suspension and Debarment Official based on a referral from OIG.  Sami Anwar, 
through his clinical research companies Mid Columbia and Zain Research, was paid by drug 
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sponsors and clinical research organizations to conduct clinical research and drug trials.  
Between 2013 and 2018 Sami Anwar directed a scheme to have his companies pose as 
legitimate human clinical research sites and provide false clinical research trial data 
regarding drug safety and efficacy to dozens of drug companies, and through them, to the 
Food and Drug Administration (FDA). By engaging in this fraud, Sami Anwar bilked millions 
from drug sponsors, endangered study participants, and provided false data to the FDA 
and DEA regulators. 
 
Civil Monetary Penalties Law 
The 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 $27.7 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:  
  
 
GeorgiaMichael Dalton Hanowell, M.D.; Hanowell Spine Clinic, LLC; and Hanowell Pain 
Management, LLC (collectively, Dr. Hanowell) entered into a $409,809.88 settlement 
agreement with OIG.  The settlement agreement resolves allegations that Dr. Hanowell 
submitted claims to Medicare for facet joint injections and denervations that exceeded the 
allowable number of sessions in a rolling 12-month period. 
 
New YorkRichmond County Ambulance, Inc. (RCA) entered into a $1,578,412 settlement 
agreement with OIG.  The settlement agreement resolves allegations that RCA presented 
claims to Medicare Part B for ambulance transportation to and from skilled nursing facilities 
(SNFs) where such transportation was already covered by the SNF consolidated billing 
payment under Medicare Part A. 
 
MinnesotaDr. Kenneth P. Martinez and his professional corporation (Kenneth P. Martinez, 
M.D., a Medical Corporation d/b/a Neurology and Pain Specialty Center) (collectively, Dr. 
Martinez), entered into a $919,644.34 settlement agreement with OIG.  The settlement 
agreement resolves allegations that Dr. Martinez knowingly presented to Medicare claims 
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for items or services that Dr. Martinez knew or should have known were not provided as 
claimed and were false or fraudulent.  Specifically, Dr. Martinez submitted claims: (1) using 
CPT code 95937 (neuromuscular junction testing) under the National Provider Identifier 
(NPI) number of Kenneth P. Martinez, M.D., when the neuromuscular junction testing was 
either not medically necessary or was not performed at the applicable standard of care; 
and (2) using CPT Code 95913 (for 13 or more nerve conduction studies) under Kenneth P. 
Martinez, M.D.s NPI number when Kenneth P. Martinez, M.D., performed only 12 or fewer 
nerve conduction studies. 
 
ArizonaJustin Thompson, DC; Physical Medicine of Scottsdale, LLC d/b/a Arizona Pain 
Relief; Anthem Physical Medicine; and Biltmore Physical Medicine (collectively, Arizona 
Pain Relief") entered into a $1,905,070.74 settlement agreement with OIG.  The settlement 
agreement resolves allegations that Arizona Pain Relief submitted false claims to Medicare 
for: (1) implantable neurostimulator devices using HCPCS Code L8679 when they instead 
provided auricular peripheral nerve stimulation devices that are not covered by Medicare; 
(2) CPT Codes 95970, 64555, and 64999 that were associated with the application, 
monitoring, and removal of the device; and (3) CPT Codes 99211, 99212, and 99213 for 
evaluation and management (E&M) services billed on the same date of service as HCPCS 
Code L8679 that were billed for time spent providing and removing the device when no 
separate and identifiable E&M service was provided. 
 
 
Self-Disclosure Programs  
Health care providers, suppliers, or other individuals or entities subject to CMPs can apply for 
acceptance into the Health Care Fraud Self-Disclosure Protocol, a program created in 1998 for 
voluntary disclosure of self-discovered evidence of potential fraud.  The Health Care Fraud Self-
Disclosure Protocol may give individuals and entities 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 FAR-based contract with HHS.  The OIG 
Grant Self-Disclosure Program is available for application by HHS 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 $18.8 million in 
HHS receivables. 
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The following case examples pertain to provider self-disclosure settlements:  
  
IllinoisAfter they self-disclosed conduct to OIG, Presence Central and Suburban Hospitals 
Network d/b/a AMITA Health Mercy Medical Center and Presence Chicago Hospitals 
Network d/b/a AMITA Health Saints Mary and Elizabeth Medical Center (collectively, 
AMITA) agreed to pay $6,232,195.50 for allegedly violating the CMPL.  OIG alleged that 
AMITA submitted claims to Medicare Part A for inpatient psychiatric admissions that were 
not medically necessary. 
 
MarylandAfter it self-disclosed conduct to OIG, Corridor Anesthesia, LLC (Corridor) 
agreed to pay $1,117,684.50 for allegedly violating the CMPL.  OIG alleged that Corridor 
submitted claims to Federal health care programs for services provided by certified 
registered nurse anesthetists (CRNAs) who were not authorized to bill for their services on 
behalf of Corridor.  Therefore, Corridor billed for these services under the name of another 
CRNA who was authorized to bill on behalf of Corridor. 
 
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 
compliance 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 parties that 
fail to comply with the requirements of their CIAs. 
 
The following case examples involve CIA enforcement: 
 
OklahomaAfter it disclosed conduct to OIG pursuant to its CIA, Oklahoma Heart Hospital 
South, LLC entered into a $1,151,770.50 False Claims Act settlement agreement with DOJ 
and OIG.  The United States alleged that the hospital billed Medicare for intensive cardiac 
rehabilitation that was not provided under a plan established, reviewed, and signed by a 
physician, or not updated, reviewed, and signed by a physician every 30 days.    
 
MichiganAfter it disclosed conduct to OIG pursuant to its CIA, William Beaumont 
Hospital (WBH) agreed to pay $1,732,548 for allegedly violating the CMPL by paying 
kickbacks.  OIG alleged that WBH: (1) paid remuneration to cardiologists in the form of 
excess compensation and (2) paid remuneration to a medical practice in the form of free 
use of medical equipment and personnel. 
 
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Public Health and Human Service Agency 
Reports and Reviews  
Public Health Agency Reports and Reviews 
 
Office of the Assistant Secretary for Preparedness and Response 
HHS Did Not Fully Comply With Federal Requirements and HHS Policies and Procedures When 
Awarding and Monitoring Contracts for Ventilators (A-02-20-02002), September 2022  
  
HHSs Administration for Strategic Preparedness and Response (ASPR) did not consistently award 
and monitor contracts for ventilators for use in responding to the COVID-19 pandemic in 
accordance with Federal requirements and HHS policies and procedures.  Specifically, ASPR did not 
establish roles and responsibilities for communication with other emergency response teams, did 
not always accurately report contract data, and did not always properly monitor contractor 
performance. 
  
As a result, ASPR could not ensure compliance with applicable Federal requirements or that each 
contracts terms were economically and efficiently achieved; therefore, ASPR could not determine 
whether the use of taxpayer funds was reasonable.  In addition, the Federal Government may have 
used inaccurate contract data supplied by ASPR to measure and assess the impact of Federal 
procurements on Coronavirus Aid, Relief, and Economic Security (CARES) Act spending.  Finally, 
ASPR potentially hindered the Strategic National Stockpiles ability to meet anticipated ventilator 
demand in support of the Federal Governments COVID-19 pandemic response. 
  
ASPR did not indicate concurrence or nonconcurrence with our recommendations, including that it 
establish written policies and procedures for communicating with federally established emergency 
response team lead agencies, accurately report contract data, and strengthen its policies and 
procedures to ensure proper monitoring of contractor performance. 
 
Food and Drug Administration 
The Food and Drug Administrations Foreign For-Cause Drug Inspection Program Can Be Improved 
To Protect the Nations Drug Supply (A-01-19-01500), June 2022  
 
FDAs timeframes for completing the steps in the foreign for-cause drug inspection process 
generally improved after it implemented programmatic changes in 2017.  However, we found that: 
(1) FDA did not always follow its policies and procedures for foreign for-cause drug inspections and 
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(2) FDA could not provide documentation to support that all lead investigators completed the 
required training before they conducted inspections. 
 
According to FDA, it had limited resources and faced unexpected events and complex 
circumstances.  FDA did not ensure that it recorded certain information in the Establishment 
Inspection Report (EIR), such as whether an inspection was announced.  If FDA does not follow its 
policies and procedures related to timeliness, regulatory deficiencies may not be corrected in an 
efficient manner.  FDA did not ensure that lead investigators completed required training before 
they conducted inspections because FDA did not have policies and procedures that required 
investigators supervisors to verify that lead investigators completed the required training prior to 
being assigned to an inspection.  FDA officials told us that because of multiple location moves, FDA 
misplaced records indicating that lead investigators completed training requirements.  It is a 
vulnerability to have lead investigators conduct inspections before ensuring that they are qualified. 
 
FDA concurred with our recommendations that it identify and implement additional ways to 
improve the timeliness of its foreign for-cause drug inspection process.  We also made other 
procedural recommendations that are listed in the report. 
 
Delays in Confirmatory Trials for Drugs Granted FDAs Accelerated Approval Raise Concerns (OEI-01-
21-00401), September 2022 
 
More than one-third of accelerated approval drug applications with incomplete confirmatory trials 
are past their trials original planned completion dates, including four drug applications that are 
more than 5 years past those dates.  Additionally, we found that Medicare and Medicaid spent 
more than $18 billion from 2018 to 2021 for accelerated approval drugs with incomplete 
confirmatory trials past their trials original planned completion dates.   
 
FDA Repeatedly Adapted Emergency Use Authorization Policies to Address the Need for COVID-19 
Testing (OEI-01-20-00380), September 2022 
 
From January through May 2020, FDA repeatedly adapted its approach to how it used Emergency 
Use Authorizations (EUAs) to address COVID-19 testing challenges; however, efforts to increase test 
availability sometimes came at a cost to test quality.  Our findings underscore the need to apply 
insights from FDAs early experiences with the COVID-19 pandemic toward current and future 
infectious disease emergencies to better balance test availability and quality.   
 
FDA concurred with all six of our recommendations, which were that: (1) FDA should assess and, as 
appropriate, revise guidance for test EUA submissions; (2) FDA should develop a suite of EUA 
templates for future emergencies involving novel pathogens; (3) FDA should expand the FDA 
Center for Devices and Radiological Healths existing device-tracking platform to facilitate EUA 
submission and monitoring; (4) FDA should expand and improve resources for test developers on 
the EUA process; (5) FDA should establish formal communication channels between FDA and the 
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lab community, to be used in emergency testing; and (6) FDA should work with Federal partners to 
implement lessons learned about a national testing strategy that go beyond the EUA process 
 
FDAs Work With the Tri-Agency Task Force for Emergency Diagnostics Helped Labs Implement 
COVID-19 Tests (OEI-01-20-00381), September 2022 
 
FDAs engagement with the Tri-Agency Task Force for Emergency Diagnostics demonstrates the 
value of interagency coordination and collaboration to facilitate emergency test implementation in 
laboratories.  This task forcea joint effort of FDA, CDC, and CMSwas established in 2019 to 
enhance the effectiveness of the Federal response to emergencies that require laboratories to 
implement tests.  Prior to the COVID-19 pandemic, the task force identified gaps to prepare for 
future emergencies.  During the pandemic, it provided a venue for member agencies to coordinate 
their responses to pandemic-related challenges.  FDAs continued coordination with the task force 
holds potential for further improvements in emergency test implementation in laboratories. 
 
 
Indian Health Service 
Indian Health Service Capacity To Manage Supplemental $3.5 Billion Allocated to Its Sanitation 
Facilities Construction Program (OEI-06-22-00320), September 2022 
 
Congress appropriated $3.5 billion to the Indian Health Service (IHS) for Sanitation Facilities 
Construction projects under the Infrastructure Investment and Jobs Act (IIJA), and allocated 0.5 
percent of the supplemental funding to OIG for oversight.  As part of a more comprehensive 
evaluation, OIG conducted preliminary research of IHSs capacity to administer and oversee the 
$3.5 billion.  Through this research, we identified three initial observations about IHS capacity, 
which we shared with IHS to assist the agency as it continues its planning for how to use and 
oversee the funds.  These observations were that: (1) IHS quickly began preparations to increase 
capacity and administer the funds using existing, generally supported methods; (2) to administer 
the IIJA-funded projects and meet sanitation needs, IHS faces financial, capacity, and other 
challenges that warrant continued attention; and (3) plans are still unclear for IHS assessment of 
the use of IIJA funds, strategies for future spending, and assisting Tribes with long-term operation 
of IIJA-funded facilities. 
 
IHSs National Supply Service Center Was Generally Effective in Providing Supplies to Facilities During 
the COVID-19 Pandemic, but Its Internal Controls Could Be Improved (A-07-20-04124), September 
2022  
 
IHSs National Supply Service Center (NSSC) was generally effective in facilitating the distribution of 
medical supplies and equipment during the COVID-19 pandemic.  However, we noted that NSSCs 
internal controls could be improved.  In lieu of written policies and procedures, NSSC relied on the 
institutional knowledge of key employees in implementing a new medical supply distribution 
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method as the pandemic developed.  NSSC also did not have sufficient warehouse facilities.  
Finally, NSSCs inventory management system was outdated and could not track the routing of a 
product that had been shipped or provide necessary information about the shipment to the 
customer. 
 
Because NSSC did not have written policies and procedures in place that would provide a 
framework to guide decision making for emergency situations, its current process is not optimal or 
sustainable, particularly when institutional knowledge is subsequently lost or diminished.  As a 
result, there is an increased risk that NSSC will not be able to respond effectively to future 
emergencies.  NSSCs outdated inventory management system also poses an increased risk to the 
effectiveness and efficiency of NSSC operations in the future. 
 
IHS concurred with our recommendations that NSSC strengthen internal controls by developing 
and implementing written policies and procedures for emergency situations; identify feasibly viable 
options, including seeking additional funding, to prepare for future emergency situations that 
address additional storage capacity and inventory distribution; and upgrade its inventory 
management system software to improve its ability to interface with customers and vendors. 
 
IHS Telehealth System Was Deployed Without Some Required Cybersecurity Controls (A-18-21-
03100), September 2022  
  
IHS deployed a national telehealth system, which increased the availability of health care services 
during the pandemic, but it did not complete select IT controls as required prior to deploying its 
telehealth system nationally.  Specifically, IHS did not complete the contingency plan, risk 
assessment, finalized authorization to operate, and system security plan.  Additionally, after 
deployment of the telehealth system, IHS did not remediate known vulnerabilities on some 
telehealth system devices in a timely manner.  IHS has since completed the controls covered by this 
audit, and no major incidents or breaches have been reported to HHS. 
  
IHS concurred with our recommendations that it develop a strategy for identifying, implementing, 
and testing cybersecurity controls for new information systems that are deployed in an expedited 
fashion to meet an urgent, mission-critical need.   
 
 
Centers for Disease Control and Prevention 
CDC Found Ways To Use Data To Understand and Address COVID-19 Health Disparities, Despite 
Challenges With Existing Data (OEI-05-20-00540), July 2022 
 
Although CDCs racial, ethnic, and socioeconomic data associated with COVID-19 testing, cases, 
hospitalizations, and deaths have limitations, CDC found ways to use these and other data to 
understand and address COVID-19 health disparities.  These findings illuminate challenges that 
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jurisdictions and CDC face in collecting and using public health data and help CDC prioritize efforts 
to improve the data collected.   
 
CDC concurred with both of our recommendations, which were that: (1) CDC should expand efforts 
both to improve racial and ethnic data associated with COVID-19 and to supplement them with 
additional data sources and (2) CDC should ensure that Tribal Epidemiology Centers have timely 
access to all public health data to which they are entitled.  
 
HHS Should Improve Internal Coordination Regarding Unaccompanied Children, (OEI-BL-20-00670) 
May 2022 
 
OIG identified a lack of internal coordination during the development and early implementation of 
a CDC public health order (Title 42 order) that significantly affected Office of Refugee 
Resettlement (ORR) programs to serve unaccompanied children.  (ORR is a program office within 
the HHSs Administration for Children and Families.)  Effective coordination is critical, because in 
order to effectively predict programmatic and capacity needs, ORR must have timely access to all 
relevant information about HHS decision making that affects unaccompanied children.   
 
CDC and ACF concurred with both of our recommendations, which were that: (1) HHS should take 
steps to improve internal coordination and communication about unaccompanied children; and (2) 
HHS should ensure that CDC coordinates with ORR when making future decisions that could affect 
the number of unaccompanied children placed in ORRs care, including any Title 42 order. 
 
 
CDCs Corrective Actions Improved Program Operations at the National Institute of Health in 
Mozambique and Facilitated the Institutes Implementation of Prior OIG Audit Recommendations (A-
04-20-01019), September 2022  
 
CDCs corrective actions, in response to our November 2016 memorandum, improved program 
operations at the National Institute of Health in Mozambique (the Institute).  Specifically, CDC took 
the following eight corrective actions, which we confirmed through our current audit:  
(1) designated the Institute a high-risk organization, (2) added special award conditions,  
(3) conducted a site visit in December 2016, (4) delayed new funding to the Institute,  
(5) conducted a risk and business system assessment in March 2018, (6) hired a project officer to 
manage the Government-to-Government portfolio in Mozambique, (7) worked with the Institute to 
ensure proper systems and practices are in place, and (8) employed a fiscal agent.  
 
Of our 10 prior audit recommendations, 2 remained unimplemented when the current audit began: 
(1) refund to CDC $431,458 of unallowable expenditures and (2) work with CDC to obtain value-
added tax (VAT) reimbursement from the Government of Mozambique.  
 
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The Institute implemented the first recommendation by refunding $5,287 per CDCs instruction.  To 
implement the second, the Institute is seeking a refund from the Government of Mozambique of 
$546,543 for the VAT it paid with U.S. Presidents Emergency Plan for AIDS Relief (PEPFAR) funds 
from September 2012 through December 2015, when a new agreement was reached providing a 
framework for VAT reimbursement.  During our audit period, the Institute tracked VAT payments 
and reported them to CDC quarterly for reimbursement requests.  This report includes no 
recommendations. 
 
 
National Institutes of Health 
Opportunities Exist To Strengthen NIH Grantees Oversight of Investigators Foreign Significant 
Financial Interests and Other Support (OEI-03-20-00210), May 2022 
 
The integrity and security of research funded by NIH relies, in part, on grantee institutions 
(hereafter grantees) oversight of their investigators significant financial interests and other 
support.  We found that most grantees failed to meet at least one Federal requirement related to 
investigators foreign significant financial interests and other support.  In addition, many grantees 
lacked oversight practices that would help ensure that all materials submitted to NIH are complete 
and accurate.  At the same time, grantees reported promising practices that, if more widely 
adopted, present additional opportunities to strengthen oversight of investigators foreign 
significant financial interests and other support.   
 
NIH concurred with all seven of our recommendations, which were that: (1) NIH should ensure that 
grantees comply with Federal requirements to train investigators regarding disclosure of significant 
financial interests, (2) NIH should ensure that grantees conduct the required review of 
investigators significant financial interests to determine whether conflicts exist, (3) NIH should 
specifically require grantees to provide trainings and maintain a written policy regarding 
investigators disclosure of other support, (4) NIH should modify reporting mechanisms to require 
grantees to report whether investigators significant financial interests and other support involve 
foreign entities, (5) NIH should conduct outreach to grantees with R13 conference grants to clarify 
requirements regarding the disclosure and review of investigators significant financial interests and 
other support, (6) NIH should clarify whether and how grantees should verify investigators 
significant financial interests and other support prior to submitting information to NIH, and (7) NIH 
should establish a method for grantees to share their best practices for identifying and reviewing 
investigators foreign significant financial interests and other support. 
 
The National Institutes of Health Administered Superfund Appropriations During Fiscal Year 2021 in 
Accordance With Federal Requirements (A-04-22-04088), August 2022  
 
During FY 2021, NIH administered Superfund appropriations in accordance with applicable Federal 
requirements.  Specifically, NIH obligated and disbursed Superfund appropriations in accordance 
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with Federal laws and in similar proportions to prior years.  In addition, NIHs monitoring of 
Superfund grants generally ensured that grantees met requirements for financial, performance, 
and audit reporting.  This report contains no recommendations. 
 
The National Institutes of Health Did Not Ensure That All Clinical Trial Results Were Reported in 
Accordance With Federal Requirements (A-06-21-07000), August 2022  
 
NIH did not ensure that all NIH-funded intramural and extramural clinical trials complied with 
Federal reporting requirements for responsible parties to submit the results of clinical trials to 
ClinicalTrials.gov.  The noncompliance with Federal reporting requirements occurred because NIH 
did not have adequate procedures for ensuring that responsible parties submitted the results of 
clinical trials, took limited enforcement action when there was noncompliance, and continued to 
fund new research of responsible parties that had not submitted the results of their completed 
clinical trials.  For the 47 NIH-funded clinical trials in which the responsible party submitted their 
results (35 submitted on time and 12 submitted late), NIH complied with the Federal reporting 
requirements to post the results to ClinicalTrials.gov. 
 
NIH concurred with our recommendations that it: (1) improve its procedures to ensure that 
responsible parties of NIH-funded clinical trials comply with requirements to submit results to 
ClinicalTrials.gov in a timely manner, (2) take enforcement actions against responsible parties that 
are late in submitting trial results or do not submit results, and (3) work with the responsible parties 
to understand their challenges related to ClinicalTrials.gov and implement procedures to address 
these challenges. 
 
National Institutes of Health Grant Program Cybersecurity Requirements Need Improvement (A-18-
20-06300), September 2022  
 
CliftonLarsonAllen (CLA) completed this audit on behalf of OIG and found that NIH did not have: 
(1) an adequate pre-award risk assessment process because it does not consider cybersecurity and 
does not include a special term and condition addressing cybersecurity risk in the Notice of Award; 
(2) adequate policies because the NIH Grants Policy Statement (NIHGPS) does not include specific, 
risk-based provisions on cybersecurity; and (3) adequate post-award monitoring to ensure that 
grantees maintain effective cybersecurity to protect sensitive and confidential data and NIHs 
intellectual property.   
 
NIH did not concur with CLAs recommendations that NIH: (1) assess its grant award programs to 
determine which grants should require additional cybersecurity protections; (2) based on results of 
NIHs risk assessment of grant awards, include cybersecurity controls that should be implemented; 
(3) strengthen the NIHGPS to establish clear and measurable standards for cybersecurity 
protections; (4) strengthen the pre-award process to identify and address how cybersecurity risk 
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will be assessed; and (5) strengthen the NIH post-award process to confirm that cybersecurity 
protections to adequately safeguard sensitive and confidential data have been implemented.   
 
Human Services Agency Reports and Reviews 
Administration for Children and Families 
National Snapshot of Trends in the National Domestic Violence Hotlines Contact Data Before and 
During the COVID-19 Pandemic (A-09-21-06000), April 2022  
 
Although our analysis showed little change in total contact volume for the National Domestic 
Violence Hotline from the period before to the period during the pandemic, we identified notable 
changes in the contact data for some subcategories of data that we analyzed.  Furthermore, our 
analysis showed notable fluctuations in the number of contacts for some subcategories of data in 
certain months during the pandemic.  Although the Hotline provided explanations for what could 
have contributed to these fluctuations, it could not determine whether they were a result of the 
pandemic.  The Hotline believed that the full impact of the pandemic may not be reflected in the 
contact data until more time has passed.  
 
The Hotline identified four challenges that it faced during the pandemic: (1) connecting victims to 
providers and resources that were operating at a limited capacity because of the pandemic, (2) 
tracking the unique impact of the pandemic on victims to better serve contacts needs,  
(3) addressing a decrease in contact volume from victims who may have needed help but did not 
contact the Hotline because they were in closer proximity to their abusers as a result of shelter-in-
place orders, and (4) fostering meaningful connections among Hotline staff to carry its mission 
forward.  To address these challenges, the Hotline took actions to help ensure that it continued to 
support those affected by domestic violence.  This report includes no recommendations.  
 
National Snapshot of State Agency Approaches to Reporting and Locating Children Missing From 
Foster Care (A-07-20-06095), May 2022  
 
There were 110,446 missing children episodes during our audit period, from July 1, 2018, through 
December 31, 2020.  The average number of days that the children were missing ranged from 7 to 
96 days; the number of children who were still missing as of December 31, 2020, was 6,619; and the 
majority (65 percent) of missing children were between 15 and 17 years old.  The data also showed 
that among the missing children, 51 percent were females, 48 percent were males, and 1 percent 
were reported without gender data, or reported as transgender or undecided. 
 
All 50 State agencies said that they had implemented policies and procedures regarding measures 
to report and locate missing children.  Some State agencies reported enhanced procedures when a 
high-risk child went missing, or created special units or had specifically designated staff to help 
locate missing children.  
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We identified several barriers and other deficiencies in State agencies policies and procedures.  
These barriers included limitations in State agencies data systems, lack of oversight to ensure 
timeliness when reporting missing children, and issues involving the collaboration and exchange of 
information with Federal agencies and law enforcement. 
 
The most frequently identified challenges were: (1) locating children who repeatedly go missing 
from foster care, (2) obtaining cooperation from missing childrens families and friends and from 
law enforcement, (3) finding correct placements for children to prevent them from running away, 
and (4) lack of awareness of the support and technical assistance that ACF provides.  This report 
makes no recommendations. 
 
California Collected and Disbursed Stimulus Payments and Income Tax Refunds Under the Federal 
Tax Refund Offset Program in Accordance With Federal and State Requirements (A-01-21-01501), 
June 2022  
 
California collected and disbursed stimulus payments and income tax refunds under the Federal 
Tax Refund Offset (FTR Offset) program in accordance with Federal and State requirements during 
our audit period.  For all 115 noncustodial parents sampled, we found that California collected and 
disbursed $144,262 in FTR Offset payments. 
 
Specifically, California complied with Federal and State requirements by having in its records a 
copy of the support order and modifications that specifies the date of issuance and amount of 
support.  California maintained a copy of the payment record and provided written notices of the 
FTR Offset to noncustodial parents.  In addition, California accurately and timely disbursed FTR 
Offset payments to custodial parents and updated the noncustodial parents arrears balances.  This 
report contains no recommendations. 
 
Office of Refugee Resettlements Influx Care Facility and Emergency Intake Sites Did Not Adequately 
Safeguard Unaccompanied Children From COVID-19 (A-06-21-07002), June 2022 
 
During our site visits, we found that most facilities could have done more to meet CDC and HHS 
recommendations and requirements designed to keep children safe and protect against the spread 
of COVID-19.  We found that these facilities lacked: (1) procedures for COVID-19 testing of children, 
employees, and volunteers; (2) measures to protect against the spread of COVID-19; and (3) 
procedures to report required testing and results to ORR and State and local health entities. 
 
These issues occurred, in part, because ORR was rapidly expanding capacity, setting up emergency 
intake sites (EISs), and developing COVID-19 protocols and guidance for their use.  However, ORR 
did not have a process in place for widely disseminating the guidance and frequent updates to 
appropriate staff at the EISs.  Moreover, ORR did not effectively monitor facilities to ensure 
compliance with guidance on COVID-19 testing, mitigation, and reporting requirements.  As a 
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result, facilities did not fully implement procedures related to COVID-19, thereby potentially placing 
the health and safety of children, employees, and volunteers at risk. 
 
ACF concurred with our recommendations that ORR: (1) develop a process to clearly communicate 
COVID-19 guidance and updates to the appropriate staff at the EISs, (2) reiterate to facilities that 
they must comply with ORRs COVID-19 testing and reporting requirements and with State 
reporting requirements, (3) improve and increase training provided to facilities regarding COVID-19 
mitigation strategies, and (4) perform routine oversight of facilities to reinforce implementation 
and compliance with all requirements related to COVID-19. 
 
Nevadas Monitoring Did Not Ensure Child Care Provider Compliance With State Criminal 
Background Check Requirements at 9 of 30 Providers Reviewed (A-09-21-01000), August 2022  
 
Nevadas monitoring of child care providers did not ensure provider compliance with State 
requirements related to criminal background checks for 9 of the 30 child care providers we 
reviewed.  These deficiencies occurred because providers did not notify Nevada of a new 
household member or newly hired staff, and Nevada officials stated that they misinterpreted the 
State regulations on completing criminal background checks for minors.  Additionally, Nevada did 
not have an explicit requirement or policy to conduct an in-State sex offender registry check for all 
child care staff members. 
 
We recommended that Nevada: (1) ensure that child care providers notify Nevada when a new 
household member is added or a new employee is hired so that the State may conduct the 
required criminal background checks; (2) ensure that all required criminal background checks are 
conducted for the 21 individuals we identified who did not have all of the required checks at the 
time of our audit; (3) ensure that all required criminal background checks are conducted for all 
employees who are under the age of 18; (4) revise its policies and procedures to ensure that all 
child care staff members, regardless of age, are fingerprinted and have background checks 
completed immediately after being hired; and (5) add a written requirement and policy to conduct 
the in-State sex offender registry check for all child care staff members.  Nevada agreed with our 
findings and provided information on actions that it had taken or planned to take to address our 
recommendations. 
 
The Municipality of Barceloneta Did Not Always Manage Its Head Start Disaster Assistance Awards in 
Accordance With Federal and Commonwealth Requirements (A-02-20-02003), August 2022 
  
The Municipality of Barceloneta (the Municipality) did not always manage Head Start disaster 
assistance awards in accordance with Federal and Commonwealth requirements.  Specifically, the 
Municipalitys financial management system did not always ensure compliance with requirements 
for: (1) submitting timely and accurate Federal financial reports, (2) maintaining support for award 
drawdowns, and (3) timely completing bank reconciliations.  Additionally, the Municipality did not 
conduct timely criminal background checks for nine individuals associated with our sampled 
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expenditure transactions.  These deficiencies occurred because the Municipality did not have 
adequate controls in place to ensure proper financial management and compliance with criminal 
background checks.  As a result, the Municipality did not minimize the risk of fraud, waste, and 
abuse of Federal funds, and potentially jeopardized the safety of children. 
  
The Municipality did not indicate concurrence or nonconcurrence with our recommendations, 
including that it reinforce existing financial management policies and procedures and ensure that 
criminal background checks are completed within required timeframes. 
 
Operational Challenges Within ORR and the ORR EIS at Fort Bliss Hindered Case Management for 
Children (OEI-07-21-00251), September 2022 
 
We found that operational challenges within the Office of Refugee Resettlement (ORR)which is 
part of ACFand at the ORR EIS at Fort Bliss, Texas, hindered case management from the facilitys 
opening in March 2021 through June 2021.  (This EIS is one of 14 that ORR opened in 2021 to 
handle the substantial increase in unaccompanied children arriving at the U.S. southern border.)  
These challenges may have adversely affected childrens well-being while in ORR care and their 
safety following their release to sponsors (i.e., parents, guardians, or relatives or other parent-
designated individuals).   
 
ACF concurred with all five of our recommendations, which were that: (1) ACF should develop and 
issue a plan that supports ORR and its contractors in securing qualified case managers during an 
influx to help ensure childrens safe and timely release to sponsors, (2) ACF should provide case 
managers with timely and comprehensive training and support to help ensure childrens safe and 
timely release to sponsors, (3) ACF should create an emergency policy development protocol that 
ensures that ORR field guidance developed during an influx receives adequate input from career 
staff with expertise in child welfare, (4) ACF should ensure that ORRs case management system 
addresses challenges regarding usability and search capabilities, and (5) ACF should ensure that 
ORRs employees and employees of ORRs contractors and recipients are informed about Federal 
whistleblower protections. 
 
ACF Should Improve Oversight of Head Start To Better Protect Childrens Safety (OEI-BL-19-00560), 
September 2022 
 
ACF is not aware of all incidents in which children in the care of a Head Start center are abused, left 
unsupervised, or released to an unauthorized person, impeding ACFs efforts to protect childrens 
safety.  Head Start grant recipients did not always comply with Federal requirements to self-report 
all incidents of child abuse, lack of supervision, or unauthorized release.  Furthermore, using data 
from 2 States, OIG identified 130 such incidents that occurred in Head Start centers but of which 
ACF was not aware.  Our findings can help ACF ensure that it is aware of all significant incidents 
and can take appropriate action to protect childrens safety.  
 
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ACF concurred with all four of our recommendations, which were that: (1) ACF should improve 
Head Start grant recipients self-reporting of incidents of child abuse, lack of supervision, and 
unauthorized release through better guidance and stronger consequences for failure to report; (2) 
ACF should extend the reporting requirement to include incidents of child abuse, lack of 
supervision, and unauthorized release in blended classrooms in which the victim is not a Head 
Start-funded child; (3) ACF should improve data-sharing with States about incidents of child abuse, 
lack of supervision, and unauthorized release in Head Start centers; and (4) ACF should disseminate 
information about innovative practices that Office of Head Start regional offices have developed to 
better identify and prevent incidents that threaten childrens safety. 
 
Indiana Did Not Comply With Requirements for Documenting Psychotropic and Opioid Medications 
Prescribed for Children in Foster Care (A-05-21-00020), September 2022  
 
Indiana did not always comply with State requirements related to the psychotropic and opioid 
medications prescribed for children in foster care who were eligible for assistance under Title IV-E 
of the Act.  Specifically, we found that: (1) the health care records for 109 of the 115 children in the 
sample did not contain medical passports, (2) the psychotropic or opioid medications prescribed 
for 76 of the 115 children were not recorded in the Management Gateway for Indianas Kids system, 
(3) the health care records for 49 of the 85 children in the sample who were prescribed 
psychotropic medications did not include authorizations for those medications, and (4) the health 
care records for 13 of the 21 children residing in residential facilities and prescribed psychotropic 
medications did not contain the required written reports and medical reviews from the prescribing 
health care providers. 
 
Indiana concurred with our recommendations, including that it: (1) ensure that health care records 
for the children under its care and supervision are maintained in accordance with State 
requirements by providing training, technical assistance, and implementing additional controls and 
procedures; (2) obtain the psychotropic medication authorizations for the children in the sample 
who are currently in foster care and did not have the authorizations documented; and (3) continue 
efforts with the Indiana Family and Social Services Administration to obtain access to Medicaid 
claim history. 
 
 
Safety of Children in Foster Care 
In Five States, There Was No Evidence That Many Children in Foster Care Had a Screening for Sex 
Trafficking When They Returned After Going Missing (OEI-07-19-00371), July 2022 
 
In five States, we found that the case file documentation for two-thirds of children lacked evidence 
that they were screened to identify whether they were victims of sex trafficking when they returned 
to foster care after going missing, as required by Federal law.  For some of the children who were 
screened, their case file documentation lacked information to ensure that the children were 
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accurately identified as possible victims of sex trafficking.  As a result, many childrens risks and 
potential needs may have gone unidentified and unaddressed, and ACF cannot be assured that 
children in foster care are protected from the dangers of sex trafficking, or that victims of sex 
trafficking are identified and are provided with needed support services.   
 
ACF concurred with all recommendations, which were that: (1) ACF should work with States to 
improve compliance with requirements to screen children who return to foster care after going 
missing to identify whether they are victims of sex trafficking, (2) ACF should encourage all States 
to evaluate the value of adding an assessment of risk for sex trafficking when children return to 
foster care after going missing, and (3) ACF should conduct oversight activities to identify States 
that may not screen all children for sex trafficking when they return to foster care after going 
missing. 
 
Health Resources and Services Administration 
The Health Resources and Services Administration Should Improve Its Oversight of the Cybersecurity 
of the Organ Procurement and Transplantation Network (A-18-21-11400), August 2022 
  
The Health Resources and Services Administration (HRSA) had ensured that most of the general IT 
controls that we selected to test were implemented for the Organ Procurement and 
Transplantation Network (OPTN) by the United Network for Organ Sharing (UNOS) to protect the 
confidentiality, integrity, and availability of transplant data in accordance with Federal 
requirements.  However, we identified areas for which HRSA could improve its oversight of UNOS 
to ensure that all Federal cybersecurity requirements are being met in a timely manner.  We noted 
that HRSA could improve its oversight of UNOS to ensure that UNOS performs adequate reviews 
of local user access of the OPTN, and that certain key cybersecurity policies and procedures were 
finalized and in place. 
  
We recommend that HRSA develop additional oversight controls and procedures (e.g., deliverable 
schedules, compliance assessments, and monitoring) to ensure that the OPTN contractor complies 
with all Federal cybersecurity requirements and implements security controls over the OPTN in an 
effective and timely manner.  HRSA stated that it has made efforts to continuously strengthen its 
oversight and controls over OPTN. 
 
HHSs and HRSAs Controls Related to Selected Provider Relief Fund Program Requirements Could Be 
Improved (A-09-21-06001), September 2022 
In the context of unprecedented challenges from the COVID-19 national emergency, HHS and 
HRSA developed controls related to selected Provider Relief Fund (PRF) program requirements 
designed to ensure that providers received the correct PRF payments from the Phase 1 General 
Distribution in a fast, fair, and transparent manner.  However, we determined that some of these 
controls could be improved.  
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Because of statutory requirements, HHS and HRSA prioritized rapid disbursement of payments 
over the risk of making improper payments, because HHS and HRSA determined that activities to 
lower the risk would have delayed the payments.  As HRSA fully implements postpayment quality 
control review processes, it should consider the information and recommendations in this 
report.  In addition, HHS should use the information and recommendations when determining 
lessons learned and look for additional ways to safeguard taxpayers money when rapidly 
disbursing assistance payments to health care providers in response to future national 
emergencies. 
HRSA concurred with all of our recommendations, including that it continue to perform 
postpayment quality control reviews of selected providers, consider reviewing 189 providers that 
were identified for manual review, and seek repayment of any overpayments from providers.  We 
also recommended that HRSA ensure that the HHS Program Support Center collects payments 
made to selected providers that did not return their rejected payments as of March 9, 2022.  
Furthermore, we recommended that HRSA could conduct a cost-benefit analysis for manual review 
of additional providers and, if the benefit outweighs the cost, it could select additional providers 
for review.  
 
Substance Abuse and Mental Health Services Administration 
Louisiana Faced Compliance and Contracting Challenges in Implementing Opioid Response Grant 
Programs (A-06-20-07003), April 2022  
 
Louisiana implemented State Targeted Response (STR) grant programs by expanding prevention, 
treatment, and recovery services for opioid use disorder.  However, we found that Louisiana faced 
challenges in complying with Federal regulations related to reporting and oversight.  Additionally, 
Louisiana met program goals of the STR grant for prevention, treatment, and recovery services, but 
did not adequately address challenges it faced meeting grant terms.  
 
During the first year of the State Opioid Response (SOR) grant, Louisiana implemented a 
collaborative approach to enhance and expand the capacity of treatment providers.  Louisiana 
created crisis mobile teams to increase outreach to community programs by partnering with the 
local governing entities (LGEs) and expanded access to recovery support services by increasing safe 
recovery housing.  Louisiana complied with Federal regulations related to the SOR grant.  However, 
we found that Louisiana did not meet treatment services and naloxone distribution goals during 
the first year of its SOR grant. 
 
Louisiana concurred with our recommendations that it: (1) develop a process to ensure accurate 
reporting on the Annual Progress Reports, (2) improve monitoring of subrecipients to ensure that 
distribution of naloxone kits are tracked and distribution requirements are met, (3) work with the 
LGEs and OTPs to identify ways to support clients access to transportation to obtain treatment and 
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determine how transportation could be addressed in each specific region of the State, and (4) 
review the contracting process to determine whether there are ways to expedite the process to 
provide funds to subrecipients and outside organizations in a timely manner. 
 
 
 
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, 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.  Accordingly, PSC is not referring any individuals in 
default 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 zero criminal actions and no court-ordered restitution or settlements.   
 
 
Engaging the Public in Capturing Deadbeat Parents 
Because of the success of OIGs Most Wanted Fugitives website, 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 
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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. 
 
 
Other HHS-Related Reviews and Investigative 
Activities 
Cross-Cutting Medicare and Medicaid 
Selected Dialysis Companies Implemented Additional Infection Control Policies and Procedures To 
Protect Beneficiaries and Employees During the COVID-19 Pandemic (A-05-20-00052), May 2022  
 
The nine selected dialysis companies surveyed (representing 83 percent of the ESRD facilities that 
had a Medicare or Medicaid certification at any point during 2020) implemented additional 
infection control policies and procedures in accordance with CMS and CDC recommendations to 
protect high-risk ESRD beneficiaries and employees during the COVID-19 pandemic.  We found 
that all nine companies had infection control policies and procedures in place to protect 
beneficiaries and employees, and when recommended by CMS and CDC, the companies 
implemented additional policies and procedures.  However, although two companies provided 
education about the importance of hand hygiene, they did not emphasize the importance of hand 
hygiene immediately before and after any contact with a face mask or cloth face covering, as 
recommended by CDC.  
 
Because the nine selected companies implemented additional infection control policies and 
procedures as recommended by CMS and CDC, this report contains no recommendations. 
 
An Estimated 91 Percent of Nursing Home Staff Nationwide Received the Required COVID-19 Vaccine 
Doses, and an Estimated 56 Percent of Staff Nationwide Received a Booster Dose (A-09-22-02003), 
June 2022  
 
On the basis of our sample results, as of the week ended March 27, 2022, we estimated that 91 
percent of staff nationwide had received the required vaccine doses, 56 percent of staff nationwide 
had received a booster dose, and 6 percent of staff nationwide had been granted a religious 
exemption.  We did not estimate the percentages among the small number of staff members (i.e., 
38) in our nationwide sample results who were partially vaccinated, who were granted a medical 
exemption, who applied for an exemption that was being reviewed, or for whom the vaccination 
status could not be determined.  
 
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In addition, the estimated percentages of staff who received the required vaccine doses, staff who 
received a booster dose, and staff who were granted a religious exemption varied depending on 
the locations (i.e., HHS regions) of the nursing homes in which they worked.  This report includes 
no recommendations. 
 
The Centers for Medicare & Medicaid Services Had Policies and Procedures in Place To Mitigate 
Vulnerabilities in a Timely Manner, but Improvements Are Needed (A-18-20-06500), June 2022  
 
CMS had cybersecurity controls in place to remediate known vulnerabilities in accordance with 
Federal regulations and standards; however, it did not consistently apply security updates to 
systems with known vulnerabilities and did not consistently upgrade or patch operating systems 
that had reached the end-of-life period and were no longer supported by the vendor.  This 
occurred because CMS did not have effective management oversight to ensure that CMS mitigated 
vulnerabilities in a timely manner.  As a result, some CMS systems had open vulnerabilities that 
were vulnerable to exploitation by malicious actors beyond the acceptable limits defined in Binding 
Operational Directive (BOD) 19-02. 
 
CMS concurred with our recommendations that it: (1) remediate the vulnerabilities identified on 
internet-facing systems and implement procedures to ensure compliance with BOD 19-02 
requirements; (2) implement procedures to ensure that unsupported software that no longer 
receives security updates, repairs, bug fixes, and threat mitigation is replaced prior to the known 
end of support or implement compensating controls (if possible) and accept risk in accordance 
with existing CMS policies and procedures; (3) implement oversight to ensure that corrective 
actions are performed in accordance with Federal requirements and in the timeframe set forth in 
CMS policy; and (4) implement a process to centralize the monitoring and reporting of 
vulnerabilities identified in all CMS systems across all CMS data centers. 
 
Certain Nursing Homes May Not Have Complied With Federal Requirements for Infection Prevention 
and Control and Emergency Preparedness (A-01-20-00005), July 2022  
 
Selected nursing homes may not have complied with Federal requirements for infection prevention 
and control and emergency preparedness.  Specifically, 28 of the 39 nursing homes had possible 
deficiencies.  We found 48 instances at 25 nursing homes of possible noncompliance with infection 
prevention and control requirements and 18 instances at 18 nursing homes of possible 
noncompliance with emergency preparedness requirements related to all-hazards risk assessments 
and strategies to address emerging infectious diseases.  The nursing homes attributed the possible 
noncompliance to: (1) nursing home inadequate internal controls, (2) nursing home inadequate 
management oversight, (3) nursing home administrative and leadership changes, (4) inadequate 
communication and training from CMS, and (5) inconsistent and confusing regulations. 
 
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CMS generally agreed with our recommendations that it: (1) instruct SSAs to follow up with the 28 
nursing homes that we have identified with potential infection prevention and control and 
emergency preparedness deficiencies to ensure that they have taken corrective actions,  
(2) issue updated phase 3 interpretive guidance as soon as feasible, (3) provide training to SSAs on 
the updated phase 3 interpretive guidance as soon as feasible, and (4) consider updating the 
regulation to make clear that nursing homes must include emerging infectious diseases as a risk on 
their facility- and community-based all-hazards risk assessments. 
 
Audits of Nursing Home Life Safety and Emergency Preparedness in Eight States Identified 
Noncompliance With Federal Requirements and Opportunities for the Centers for Medicare  
& Medicaid Services To Improve Resident, Visitor, and Staff Safety (A-02-21-01010), July 2022  
 
We identified a total of 2,233 areas of noncompliance with life safety and emergency preparedness 
requirements at 150 of the 154 nursing homes we visited.  As a result, residents, visitors, and staff at 
the nursing homes were at increased risk of injury or death during a fire or other emergency.  CMS 
subsequently followed up with State survey agencies to determine whether they had addressed the 
recommendations included in our prior audits.  According to CMS, the States had already taken 
acceptable actions to address our recommendations.  
 
We identified several opportunities for CMS to expand on its life safety requirements for nursing 
homes to improve the safety of residents, visitors, and staff.  Among other findings, CMS could 
propose regulations requiring nursing homes to install carbon monoxide detectors according to 
national standards.  We also noted areas in which CMS could improve its support for State survey 
operations and nursing home training.  CMS could work with State survey agencies to address 
issues preventing more frequent surveys of high-risk facilities and require mandatory participation 
in standardized nursing home staff training.  
 
We made a series of recommendations to CMS to address our findings, including that it propose 
regulations requiring nursing homes to install carbon monoxide detectors and work with States to 
encourage mandatory participation in standardized training for nursing home staff.  CMS generally 
agreed with our recommendations and described steps it has taken or plans to take to address 
them. 
 
UPICs Hold Promise To Enhance Program Integrity Across Medicare and Medicaid, but Challenges 
Remain (OEI-03-20-00330), September 2022 
 
Although Unified Program Integrity Contractors (UPICs) hold promise for leveraging cross-program 
consolidation to strengthen oversight across Medicare and Medicaid, improvements are needed to 
better combat fraud, waste, and abuseparticularly in Medicaid.  The UPICs conducted only 
minimal activities related to Medicaid managed care, even though most Medicaid enrollees receive 
services through managed care.  We also found wide unexplained disparities in program integrity 
activities across UPICs, even after adjusting for the size of their respective oversight responsibilities.  
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However, the development of collaborative processes, analytical tools, and new technologies 
across the UPICsincluding the Unified Case Management System and Major Case Coordination 
initiativehelps to achieve the benefits of unifying program integrity activities.  Our findings can 
help CMS identify ways to strengthen UPICs abilities to detect and deter fraud, waste, and abuse in 
both Medicare and Medicaid.   
 
CMS concurred with all of our recommendations, which were that: (1) CMS should implement a 
plan to increase UPICs Medicaid program integrity activities, particularly related to managed care; 
(2) CMS should make improvements to the Unified Case Management System; (3) CMS should 
implement a plan to help ensure the success of the Major Case Coordination initiative for Medicaid 
referrals; and (4) CMS should identify the reasons for the unexplained variation in program integrity 
activities across UPICs. 
 
 
General Departmental 
Review of the Department of Health and Human Services Compliance With the Federal Information 
Security Modernization Act of 2014 for Fiscal Year 2021 (A-18-21-11200), April 2022  
 
Overall, through the evaluation of FISMA metrics, it was determined that HHSs information 
security program was Not Effective.  This determination was made based on HHS not meeting the 
Managed and Measurable maturity level for the Identify, Protect, Detect, and Recover function 
areas as required by DHS guidance and the FY 2021 Inspector General FISMA Reporting Metrics.  
However, HHS continues to implement changes to strengthen the maturity of its enterprisewide 
cybersecurity program.  We identified opportunities where HHS can strengthen its overall 
information security program. 
 
We made recommendations to the Office of the Chief Information Officer that should further 
strengthen HHSs cybersecurity program and enhance information security controls at HHS.  
Recommendations specific to deficiencies found at the reviewed HHS OpDivs were provided 
separately.  
 
Department of Health and Human Services Met Many Requirements, but It Did Not Fully Comply 
With the Payment Integrity Information Act of 2019 and Applicable Improper Payment Guidance for 
the Fiscal Year 2021 (A-17-22-52000), May 2022  
 
Ernst & Young (EY), LLP, determined that HHS met many requirements but did not fully comply 
with the Payment Integrity Information Act of 2019 (PIIA).  Among the items required for 
compliance with PIIA that HHS complied with, EY determined that HHS: (1) published the Agency 
Financial Report for FY 2021; (2) conducted risk assessments for 38 programs not susceptible to 
improper payments and determined that the programs were not at risk for improper payments; 
and (3) published corrective action plans for 8 of the 11 programs that are susceptible to significant 
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improper payments as determined by HHS management, OMB, or through legislation.  EY also 
determined that HHS developed a plan to meet improper payment and unknown payment 
reduction targets for 7 of 11 programs, and also reported an improper and unknown payment rate 
of less than 10 percent for 5 of the 11 programs.  
 
EY concluded that HHS did not comply with several other PIIA requirements.  EY found HHS: (1) did 
not report an improper and unknown payment estimate for the Temporary Assistance for Needy 
Families program, advanced premium tax credit, and foster care; (2) reported improper and 
unknown payment rates in excess of 10 percent for Medicaid, the Childrens Health Insurance 
Program, and Medicare Advantage; and (3) had completed minimal recovery audit activities for the 
identified improper payments for the Medicare Advantage and Medicare Prescription Drug Benefit 
programs.  
 
Cost Allocation Services Needs To Update Its Indirect Cost Rate-Setting Guidance (A-06-20-01000), 
June 2022  
 
We found that Cost Allocation Services (CASs) indirect cost rate-setting process for nonprofit 
organizations did not always comply with Federal regulations and its own policies.  Specifically, we 
found that: (1) CAS did not ensure compliance with Federal regulations when negotiating indirect 
cost rates, (2) CAS did not always follow its Review Guide, (3) CAS did not always follow its internal 
guidance or negotiate rates in a timely manner, and (4) indirect cost rate proposals included 
potentially unallowable compensation costs.  These errors occurred because CAS had not updated 
the Review Guide since 2003 to ensure that it reflected Federal requirements and its internal 
guidance.  According to CAS officials, CAS also faced issues with the heavy workload associated 
with negotiating indirect cost rates and has been unable to fill positions for negotiators and branch 
chiefs lost through attrition.  
 
CAS generally concurred with our recommendation that it: (1) update its Review Guide to include 
applicable Federal regulations and CAS internal policies and procedures and (2) provide training to 
its branch chiefs and negotiators to ensure that its indirect cost rate-setting process conforms with 
Federal regulations.  Additionally, CAS should review its staffing levels and determine whether they 
are sufficient to meet the agencys objectives and seek clarification on whether the executive 
compensation policy complies with Federal law and Governmentwide policy. 
 
HHS Made Some Progress Toward Compliance With the Geospatial Data Act (A-18-22-11400), 
September 2022  
 
HHS made some progress toward compliance with the Geospatial Data Act (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, or accurately reported its 
achievements in implementing the GDA requirements, as required by GDA section 759(b). 
 
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These conditions occurred because there was limited Departmentwide oversight and coordination 
in HHSs implementation of geospatial-related responsibilities, requirements, policies, and activities.  
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.  
 
HHS concurred with our recommendations that it: (1) ensure that HHS and its components fully 
implement the covered agency responsibilities found in GDA section 759(a); (2) ensure that the 
HHS Senior Agency Official for Geospatial Information or designated official oversee, coordinate, 
and facilitate HHSs implementation of the geospatial-related requirements, policies, and activities; 
(3) maintain an inventory of all geospatial data assets, per section 759(b) of the GDA; and (4) 
prepare the required annual reports or self-assessments based on the status of all of HHSs 
components. 
 
 
Grants and Contracts 
HHS is the largest grantmaking organization and one of the largest contracting agencies in the Federal 
Government.  In FY 2022, HHS awarded more than $792 billion in grants and more than $33 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 80,000 employees worldwide.  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 example relates to misuse of grant funds:  
  
TennesseeOn August 22, 2022, Patrick Martin was sentenced to 15 months in prison for 
embezzling approximately $211,000 from the Community Prevention Coalition of Jackson 
County while serving as the Coalitions Executive Director.  Martin was initially charged in 
May 2019 and pleaded guilty in August 2021 to wire fraud, failure to pay overemployment 
taxes, and filing a false income tax return.  According to court documents, beginning in 
2014, Martin submitted applications to an agency of the Department of Health and Human 
Services for Drug Free Communities program grants and received awards for the Coalition 
totaling $375,000 over 3 years.  Martin was supposed to use the grant funds on behalf of 
the Coalition, but instead used the money for his own personal benefit, including to make 
an automobile purchase, pay personal bills, make home renovations, and provide financial 
support to someone outside of his family.  As the Executive Director of the Coalition, Martin 
also was responsible for paying over certain employment taxes withheld from employees 
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paychecks to the IRS.  Martin failed to do so and used this money for his own personal 
benefit as well.  Martin also filed false income tax returns with the IRS for tax years 2014 and 
2015, failing to report the income from his embezzlement scheme. 
 
Martin was also ordered to pay restitution in the amount of $507,373.76, with $375,000 to 
be paid to HHSs Substance Abuse and Mental Health Services Administration, the agency 
that awarded the grant; and $132,373.76 to be paid to the IRS.  Martin was also ordered to 
forfeit $211,795.84. 
 
Small Business Innovative Research Program  
The National Defense Authorization Act for Fiscal Year 2012,  5143, requires OIG to report annually 
on the number of cases referred to OIG to fraud, waste, or abuse in the Small Business Innovation 
Research/Small Business Technology Transfer (SBIR/STTR) program.  OIG must also report on the 
actions taken in each case; justification for not taking action on a case; and an accounting of funds 
used to address waste, fraud, and abuse in this program.  From October 1, 2022, through 
September 30, 2022, OIG received zero referrals related to potential fraud, waste, or abuse with 
respect to HHS SBIR/STTR programs, and no cases were opened.  For FY 2022, there was 
approximately one civil action with total money associated at $541,531.  The total number of case 
hours worked was 654.25 for a total cost of case time of $129,214.38.  At the end of FY 2022, OIG 
was working on one SBIR/STTR investigation.  
 
Recovery Act Retaliation Complaint Investigations  
The Recovery Act,  1553, prohibits non-Federal employers that have received Recovery Act 
funding from retaliating against employees who disclose evidence of mismanagement of Recovery 
Act funds or any violation of law related to Recovery Act funds.  OIGs are required to include in 
their Semiannual Report the retaliation complaint investigations that they decided not to conduct 
or continue during the reporting period.  During this semiannual reporting period, OIG did not 
close, decline, or give extensions on Recovery Act Retaliation Complaint investigations of 
whistleblower retaliation. 
 
Contract Audits 
Pursuant to the National Defense Authorization Act for FY 2008,  845, OIGs appointed under the 
Inspector General Act of 1978 are required to submit information on final completed contract audit 
reports issued during the period to the contracting activity as part of their semiannual report, 
pursuant to section 5 of the Inspector General Act.  This information must contain significant audit 
findings.  OIG issued no final reports meeting  845 criteria during this semiannual reporting 
period. 
 
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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 Single Audit Division reviewed 261 reports covering 
$2.1 trillion in audited costs.  Federal dollars covered by these audits totaled $994.6 billion, of which 
about $374.9 billion were HHS funds. 
Uniform guidance at 2 CFR 200 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 organizationwide 
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 
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, April 1, 2022, Through September 30, 2022 
 
Not requiring changes or having minor changes   209 
Requiring major changes  5 
Having significant technical inadequacies  47 
Total Number of Non-Federal Audits  261 
 
Other Reporting Requirements and Reviews  
Legislative and Regulatory Reviews  
Pursuant to the Inspector General Act,  4(a)(2), OIG is required to review existing and proposed 
legislation and regulations relating to HHSs programs and operations and make recommendations 
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concerning their impact on economy and efficiency or the prevention and detection of fraud and 
abuse.  Most audits and other reviews that we conduct are designed to test compliance with 
and/or assess the administration and oversight of existing laws and regulations.  Our reports of 
such reviews describe findings, which include questioned costs, inefficiencies, vulnerabilities to 
fraud, inconsistencies, errors in application, or weaknesses in oversight or supporting systems.  Our 
corresponding recommendations tell HHS and its OpDivs or StaffDivs what administrative, 
regulatory, or legislative actions we believe are needed to effectively respond to the findings.  Our 
regularly published core publications reflect the relationship between our work and laws and 
regulations. 
 
  This report, like our previous Semiannual Reports, describes findings and recommendations 
from recently completed reviews, many of which focus on existing laws and regulations.   
  OIGs Top Unimplemented Recommendations: Solutions To Reduce Fraud, Waste, and Abuse in 
HHS Programs describes priority findings and recommendations from past periods that remain 
to be implemented.   
  Our Work Plan provides citations to laws and regulations that are the subject of ongoing or 
future reviews. 
 
We also review proposed legislation and regulations related to HHS programs and operations.  In 
addition, we provide independent, objective technical assistance on a bipartisan, bicameral basis to 
congressional committees and members who request it. 
   
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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. 
  
The lists of issued reports includes all reports and is provided in accordance with the Inspector General Act, 
 5(a)(6). 
 
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  42  $1,688,550,000  $1,060,782,000 
Issued during the reporting period2  27  $612,549,000  $115,075,000 
Total Section 1  69  $2,301,099,000  $1,175,857,000 
Section 2        
Reports for which management decisions were made 
during the reporting period3        
Disallowed costs  17  *$62,898,000  $687,000 
Costs not disallowed  2  $637,950,000  $636,621,000 
Total Section 2  19  $700,848,000  $637,308,000 
* Audit receivables (expected recoveries).       
Section 3       
Reports for which no management decisions had been 
made by the end of the reporting period 
(Section 1Section 2)4  50  $1,600,251,000  $538,549,000 
86 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
Section 4       
Reports for which no management decisions were made   
within 6 months of issuance5  24  $594,970,000  $0 
 
Table 1 End Notes 
1 The opening balance was adjusted upward by $6.5 million because of a reevaluation of previously issued 
recommendations.  
 
2 An issued report containing recommendations for both questioned costs and funds put to better use will 
be counted in Table 1 and Table 2. 
3 Revisions to previously reported management decisions: 
A-05-17-00038, Indiana Claimed Unallowable Federal Reimbursement for Some Medicaid Physician-
Administered Drugs.  CMS subsequent review determined that disallowed cost should be reduced by 
$431,000. 
 
4 Included are management decisions submitted during the period on $428,126,000 which are under 
management review. 
5 Because of administrative delays, some of which were beyond management control, resolution of the 
following 24 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. 
 
Audits for Which No Management Decision Was Received Within 6 Months of Issuance 
Audit CIN  Audit Title 
A-07-16-01165  Medicare Advantage Compliance Audit of Diagnosis Codes That Humana, Inc. 
(Contract H1036), Submitted to CMS, APR 2021, $197,720,651 
A-02-14-02017  New York Misallocated Costs to Establishment Grants for a Health Insurance 
Marketplace, NOV 2016, $149,654,512 
A-07-17-01169  Medicare Advantage Compliance Audit of Diagnosis Codes That SCAN Health Plan 
(Contract H5425), Submitted to CMS, FEB 2022, $54,318,154 
A-01-14-02503  Maryland Misallocated Millions to Establishment Grants for a Health Insurance 
Marketplace, MAR 2015, $28,400,000 
A-04-14-07050  Kentucky Misallocated Millions to Establishment Grants for a Health Insurance 
Marketplace, FEB 2017, $25,530,429 
A-07-18-04111  Mississippi Needs To Improve Oversight of Its Child Care Payment Program, APR 
2020, $22,284,900 
A-02-15-02008  New York Did Not Comply With Federal Grant Requirements for Allocating and 
Claiming Marketplace Contract Costs, DEC 2017, $20,415,344 
87 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
A-07-15-04226  Not All of Missouri's Child Care Subsidy Program Payments Complied With Federal 
and State Requirements, NOV 2017, $19,076,167 
A-07-19-01188  Medicare Advantage Compliance Audit of Specific Diagnosis Codes That UPMC 
Health Plan, Inc. (Contract H3907) Submitted to CMS, NOV 2021, $6,401,297 
A-02-18-01028  Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Blue Cross 
Blue Shield of Michigan (Contract H9572) Submitted to CMS, FEB 2021, $14,534,375 
A-06-17-07004  Southwest Key Programs Failed To Protect Federal Funds Intended for the Care and 
Placement of Unaccompanied Alien Children, SEP 2020, $13,130,848 
A-01-15-02500  Vermont Did Not Properly Allocate Millions to Establishment Grants for a Health 
Insurance Marketplace, SEP 2016, $11,243,006 
A-09-21-03002  Medicare Improperly Paid Physicians for Spinal Facet-Joint Denervation Sessions, DEC 
2021, $9,528,296 
A-02-18-01029  Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Healthfirst 
Health Plan, Inc., (Contract H3359) Submitted to CMS, JAN 2022, $5,221,901 
A-01-19-00500  Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Tufts Health 
Plan (Contract H2256) Submitted to CMS, FEB 2022, $3,758,335 
A-07-19-01187  Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Anthem 
Community Insurance Company, Inc. (Contract H3655) Submitted to CMS, MAY 2021, 
$3,468,954 
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, 
APR 2019, $2,623,785 
A-07-17-02808  The Colorado Health Insurance Marketplaces Financial Management System Did Not 
Always Comply With Federal Requirements, JUL 2018, $2,567,604 
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, JUN 2013, $1,419,524 
A-05-14-00045  The Minnesota Marketplace Misallocated Federal Funds and Claimed Unallowable 
Costs, NOV 2016, $1,279,677 
A-02-18-02011  Gateway Community Action Partnership Claimed Unallowable Costs, Did Not 
Comply With Federal Regulations on Construction and Major Renovations, and Did 
Not Accurately Account for Grant Funds, MAY 2021, $932,907 
A-09-14-01007  Nevada Misallocated Costs for Establishing a Health Insurance Marketplace to Its 
Establishment Grants, FEB 2016, $893,464 
A-07-17-01173  Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Coventry 
Health Care of Missouri, Inc. (Contract H2663) Submitted to CMS, OCT 2021, 
$548,852 
A-03-16-00250  Youth for TomorrowNew Life Center, Inc., an Administration for Children and 
Families Grantee, Did Not Comply With All Applicable Federal Policies and 
Requirements, SEP 2020, $16,851 
 
TOTAL CINS: 24 
TOTAL AMOUNT: $594,970,000 
 
 
88 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
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, de-obligation of funds, and/or avoidance of unnecessary expenditures.  Table 2 reports HHS 
program officials decisions to take action on these audit recommendations.   
 
Table 2: Audit Reports With Funds Put to Better Use 
Number of 
Description  Reports  Dollar Value 
 
Section 1   
Reports for which no management decisions had been made by the 
beginning of the reporting period  9  $17,247,368,000 
Reports issued during the reporting period1  2  $40,039,000 
Total Section 1  11  $17,287,407,000 
Section 2     
Reports for which management decisions were made during the 
reporting period     
Value of recommendations agreed to by management     
Based on proposed management action  2  $116,992,000 
Based on proposed legislative action  0  $0 
Value of recommendations not agreed to by management  2  $48,756,000 
Total Section 2  4  $165,748,000 
Section 3     
Reports for which no management decisions had been made by the 
end of the reporting period1 (Section 1Section 2)2,3  9  $17,121,659,000 
 
 
Table 2 End Notes 
1 An issued report containing recommendations for both questioned costs and funds put to better use will be 
counted in Table 1 and Table 2. 
2 Included is a management decision submitted during the period on $15 billion which is under management review. 
3 Because of administrative delays, some of which were beyond management control, three of the seven audits open 
at end of the period were not resolved within 6 months of report issuance.  OIG is working with management to 
reach resolution on these recommendations before the end of the next semiannual reporting period. 
 
 
 
89 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
Audits for Which No Management Decision Was Received Within 6 Months of Issuance 
Audit CIN  Audit Title 
A-03-17- Hospitals Overbilled Medicare $1 Billion by Incorrectly Assigning Severe Malnutrition Diagnosis Codes to 
00010  Inpatient Hospital Claims, JUL 2020, $1,024,623,449 
A-03-13- HHS Did Not Identify and Report Antideficiency Act Violations, MAY 2017, $49,445,025 
03002 
A-07-17- Incorrect Acute Stroke Diagnosis Codes Submitted by Traditional Medicare Providers Resulted in Millions of 
01176  Dollars in Increased Payments to Medicare Advantage Organizations, SEP 2020, $14,417,533 
TOTAL CINS: 3 
TOTAL AMOUNT: $1,088,486,000 
Audit Reports by Issue Date  
 
Report Number  Title  Issued  Questioned  Funds Put to 
Costs  Better Use 
A-04-18-07078  South Carolina Did Not Fully Comply With  4/1/2022  -  - 
Requirements for Reporting and Monitoring Critical 
Events Involving Medicaid Beneficiaries With 
Developmental Disabilities 
A-05-20-00005  Posthospital Skilled Nursing Facility Care Provided to  4/7/2022  -  - 
Dually Eligible Beneficiaries in Indiana Generally Met 
Medicare Level-of-Care Requirements 
A-06-20-07003  Louisiana Faced Compliance and Contracting  4/8/2022  -  - 
Challenges in Implementing Opioid Response Grant 
Programs 
A-09-20-02009  California Improperly Claimed at Least $23 Million of  4/20/2022  $23,139,767   - 
$260 Million in Total Medicaid Reimbursement for 
Opioid Treatment Program Services 
A-01-20-00003  Massachusetts Implemented Our Prior Audit  4/25/2022  -  - 
Recommendations and Generally Complied With 
Federal and State Requirements for Reporting and 
Monitoring Critical Incidents 
A-18-21-11200  Review of the Department of Health and Human  4/25/2022  -  - 
Services Compliance with the Federal Information 
Security Modernization Act of 2014 for Fiscal Year 
2021 
A-09-21-06000  National Snapshot of Trends in the National Domestic  4/27/2022  -  - 
Violence Hotline's Contact Data Before and During 
the COVID-19 Pandemic 
A-17-22-52000  Department of Health and Human Services Met Many  5/9/2022  -  - 
Requirements, but It Did Not Fully Comply With the 
Payment Integrity Information Act of 2019 and 
Applicable Improper Payment Guidance for Fiscal 
Year 2021 
A-09-20-02008  Washington State Did Not Comply With Federal and  5/13/2022  $403,740   - 
State Requirements for Claiming Enhanced Federal 
Reimbursement for Medicaid Managed-Care Health 
Home  
90 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
A-07-20-06095  National Snapshot of State Agency Approaches to  5/19/2022  -  - 
Reporting and Locating Children Missing From Foster 
Care 
A-05-20-00052  Selected Dialysis Companies Implemented Additional  5/24/2022  -  - 
Infection Control Policies and Procedures To Protect 
Beneficiaries and Employees During the COVID-19 
Pandemic 
A-06-18-05002  Medicare Advantage Compliance Audit of Specific  5/25/2022  $3,312,219   - 
Diagnosis Codes That Peoples Health Network 
(Contract H1961) Submitted to CMS 
A-06-20-04003  Vanderbilt University Medical Center: Audit of  5/25/2022  $686,500   - 
Outpatient Outlier Payments 
A-06-20-04004  Texas Did Not Report and Return All Medicaid  5/25/2022  $11,122,401   - 
Overpayments for the State's Medicaid Fraud Control 
Unit Cases 
A-09-20-03016  Medicare Improperly Paid Durable Medical  5/31/2022  $41,137   $11,687,528  
Equipment Suppliers an Estimated $8 Million of the 
$40 Million Paid for Power Mobility Device Repairs 
A-01-21-01501  California Collected and Disbursed Stimulus  6/1/2022  -  - 
Payments and Income Tax Refunds Under the Federal 
Tax Refund Offset Program in Accordance with 
Federal and State Requirements 
A-06-20-01000  Cost Allocation Services Needs To Update Its Indirect  6/1/2022  -  - 
Cost Rate-Setting Guidance 
A-01-20-00007  Maine Implemented Our Prior Audit  6/6/2022  -  - 
Recommendations and Generally Complied With 
Federal and State Requirements for Reporting and 
Monitoring Critical Incidents 
A-07-18-02815  Medicare and Beneficiaries Paid Substantially More to  6/10/2022  -  - 
Provider-Based Facilities in Eight Selected States in 
Calendar Years 2010 Through 2017 Than They Paid to 
Freestanding Facilities in the Same States for the 
Same Types of Services 
A-06-21-07002  Office of Refugee Resettlements Influx Care Facility  6/22/2022  -  - 
and Emergency Intake Sites Did Not Adequately 
Safeguard Unaccompanied Children From COVID-19 
A-01-20-00006  More Than 90 Percent of the New Hampshire  6/23/2022  $7,943,271   - 
Managed Care Organization and Fee-for-Service 
Claims for Opioid Treatment Program Services Did 
Not Comply With Medicaid Requirements 
A-09-22-02003  An Estimated 91 Percent of Nursing Home Staff  6/23/2022  -  - 
Nationwide Received the Required COVID-19 Vaccine 
Doses, and an Estimated 56 Percent of Staff 
Nationwide Received a Booster Dose 
A-01-19-01500  The Food and Drug Administration's Foreign For- 6/24/2022  -  - 
Cause Drug Inspection Program Can Be Improved To 
Protect the Nation's Drug Supply 
A-18-20-06500  The Centers for Medicare & Medicaid Services Had  6/29/2022  -  - 
Policies and Procedures in Place To Mitigate 
Vulnerabilities in a Timely Manner, but Improvements 
Are Needed 
91 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
A-05-19-00019  The Reduced Outlier Threshold Applied to Transfer  7/5/2022  -  - 
Claims Did Not Significantly Increase Medicare 
Payments to Hospitals 
A-02-19-01018  Medicare Hospice Provider Compliance Audit: Vitas  7/14/2022  $140,370,745   - 
Healthcare Corporation of Florida 
A-02-21-01010  Audits of Nursing Home Life Safety and Emergency  7/15/2022  -  - 
Preparedness in Eight States Identified 
Noncompliance With Federal Requirements and 
Opportunities for the Centers for Medicare & 
Medicaid Services to Improve Resident, Visitor, and 
Staff Safety 
A-02-20-01009  Medicare Advantage Compliance Audit of Specific  7/18/2022  $9,212,531   - 
Diagnosis Codes That Cariten Health Plan, Inc., 
(Contract H4461) Submitted to CMS 
A-03-20-00002  Medicare Critical Care Services Provider Compliance  7/19/2022  $6,015   - 
Audit: Lahey Clinic Inc. 
A-04-18-03085  CMS Reported Collecting Just Over Half of the  7/25/2022  -  - 
$498 Million in Medicare Overpayments Identified by 
OIG Audits 
A-01-20-00005  Certain Nursing Homes May Not Have Complied  7/26/2022  -  - 
With Federal Requirements for Infection Prevention 
and Control and Emergency Preparedness 
A-18-22-11300  Review of Medicare Administrative Contractor  7/27/2022  -  - 
Information Security Program Evaluations for Fiscal 
Year 2021 
A-04-22-04088  The National Institutes of Health Administered  8/10/2022  -  - 
Superfund Appropriations During Fiscal Year 2021 in 
Accordance With Federal Requirements 
A-07-21-07003  South Carolina Did Not Always Invoice Rebates to  8/10/2022  $15,851,354   - 
Manufacturers for Physician-Administered Drugs 
A-06-21-07000  The National Institutes of Health Did Not Ensure That  8/12/2022  -  - 
All Clinical Trial Results Were Reported in Accordance 
With Federal Requirements 
A-17-22-00009  Independent Service Auditors Report on the  8/15/2022  -  - 
Department of Health & Human Services Program 
Support Center, Grants Finance and Administrative 
Services, Payment Management System for the 
Period October 1, 2021June 30, 2022 
A-17-22-00010  Independent Service Auditors Report on the  8/15/2022  -  - 
Department of Health & Human Services, Center for 
Information Technology at the National Institutes of 
Health, Information Technology General Controls 
System for the UNIX and Windows Environments 
A-03-18-00002  Medicare Advantage Compliance Audit of Diagnosis  8/19/2022  $39,612   - 
Codes That Cigna HealthSpring of Florida, Inc. 
(Contract H5410) Submitted to CMS 
A-09-21-01000  Nevadas Monitoring Did Not Ensure Child Care  8/23/2022  -  - 
Provider Compliance With State Criminal Background 
Check Requirements at 9 of 30 Providers Reviewed 
92 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
A-07-21-03246  Montana Claimed Federal Medicaid Reimbursement  8/26/2022  $5,065,966   - 
for More Than $5 Million in Targeted Case 
Management Services That Did Not Comply With 
Federal and State Requirements 
A-04-19-07084  Medicare Advantage Compliance Audit of Specific  8/29/2022  $3,518,465   - 
Diagnosis Codes That WellCare of Florida, Inc., 
(Contract H1032) Submitted to CMS 
A-18-21-11400  The Health Resources and Services Administration  8/29/2022  -  - 
Should Improve Its Oversight of the Cybersecurity of 
the Organ Procurement and Transplantation Network 
A-02-20-02003  The Municipality of Barceloneta Did Not Always  8/30/2022  -  - 
Manage Its Head Start Disaster Assistance Awards in 
Accordance With Federal and Commonwealth 
Requirements 
A-02-20-02002  HHS Did Not Fully Comply With Federal  9/1/2022  -  - 
Requirements and HHS Policies and Procedures 
When Awarding and Monitoring Contracts for 
Ventilators 
A-18-21-03100  IHS Telehealth System Was Deployed Without Some  9/7/2022  -  - 
Required Cybersecurity Controls 
A-02-21-01001  New York Claimed $196 Million, Over 72 Percent of  9/12/2022  $196,358,172   - 
the Audited Amount, in Federal Reimbursement for 
NEMT Payments to New York City Transportation 
Providers That Did Not Meet or May Not Have Met 
Medicaid Requirements 
A-09-20-03009  Medicare Advantage Compliance Audit of Specific  9/13/2022  $1,890,855   - 
Diagnosis Codes That Regence BlueCross BlueShield 
of Oregon (Contract H3817) Submitted to CMS 
A-07-21-06096  Tennessee Did Not Always Invoice Rebates to  9/14/2022  $12,028,934   $28,351,111  
Manufacturers for Physician-Administered Drugs 
Dispensed to Enrollees of Medicaid Managed-Care 
Organizations 
A-01-20-00004  Certain Nursing Homes May Not Have Complied  9/15/2022  -  - 
With Federal Requirements for Infection Prevention 
and Control and Emergency Preparedness 
A-07-21-07004  System Review Report: External Quality Control  9/15/2022  -  - 
Review of the Audit Organization of the U.S. 
Department of Labor, Office of Inspector General 
A-07-20-04124  IHS's National Supply Service Center Was Generally  9/16/2022  -  - 
Effective in Providing Supplies to Facilities During the 
COVID-19 Pandemic, but Its Internal Controls Could 
Be Improved 
A-05-20-00025  Nearly All States Made Capitation Payments for  9/19/2022  -  - 
Beneficiaries Who Were Concurrently Enrolled in a 
Medicaid Managed Care Program in Two States 
93 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
A-06-21-05003  Medicare Part B Overpaid and Beneficiaries Incurred   9/19/2022  $1,188,759   - 
Cost-Share Overcharges of Over $1 Million for the 
Same Professional Services 
A-18-20-06300  National Institutes of Health Grant Program  9/19/2022  -  - 
Cybersecurity Requirements Need Improvement 
A-02-20-01028  New York Generally Determined Eligibility for Its Basic  9/20/2022  $8,615   - 
Health Program Enrollees in Accordance With 
Program Requirements 
A-05-20-00051  End-Stage Renal Disease Network Organizations'  9/21/2022  -  - 
Reported Actions Taken in Response to the COVID-19 
Pandemic 
A-09-22-03007  CMS's System Edits Significantly Reduced Improper  9/22/2022  $39,310,499   - 
Payments to Acute-Care Hospitals After May 2019 for 
Outpatient Services Provided to Beneficiaries Who 
Were Inpatients of Other Facilities 
A-02-20-01001  Medicare Hospital Provider Compliance Audit:  9/23/2022  $42,336,162   - 
Hospice of Palm Beach County, Inc. 
A-05-18-00020  Medicare Advantage Compliance Audit of Diagnosis  9/26/2022  $5,372,998   - 
Codes that Inter Valley Health Plan, Inc. (Contract 
H0545), Submitted to CMS 
A-09-21-06001  HHS's and HRSA's Controls Related to Selected  9/26/2022  -  - 
Provider Relief Fund Program Requirements Could Be 
Improved 
A-18-22-11400  HHS Made Some Progress Toward Compliance With  9/26/2022  -  - 
the Geospatial Data Act 
A-04-20-01019  CDC's Corrective Actions Improved Program  9/27/2022  -  - 
Operations at the National Institute of Health in 
Mozambique and Facilitated the Institute's 
Implementation of Prior OIG Audit Recommendations  
A-05-21-00020  Indiana Did Not Comply With Requirements for  9/27/2022  -  - 
Documenting Psychotropic and Opioid Medications 
Prescribed for Children in Foster Care 
A-05-20-00010  Medicare Dialysis Services Provider Compliance Audit:  9/28/2022  $14,193,677   - 
Dialysis Clinic, Inc. 
A-03-19-00001  Medicare Advantage Compliance Audit of Specific  9/29/2022  $6,227,005   - 
Diagnosis Codes That Highmark Senior Health 
Company (H3916) Submitted to CMS 
A-06-19-09002  Texas Claimed or May Have Claimed More Than $30  9/29/2022  $30,719,788   - 
Million of $9.89 Billion in Federal Funds for Medicaid 
Uncompensated Care Payments That Did Not Meet 
Federal and State Requirements 
A-07-19-01195  Medicare Advantage Compliance Audit of Specific  9/29/2022  $7,784,540   - 
Diagnosis Codes That BlueCross BlueShield of 
Tennessee, Inc. (Contract H7917) Submitted to CMS 
A-05-19-00039  Medicare Advantage Compliance Audit of Specific  9/30/2022  $34,414,828   - 
Diagnosis Codes That HumanaChoice (Contract 
R5826) Submitted to CMS 
  Total Reports:  68    $612,548,555   $40,038,639  
 
94 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
Evaluation Reports by Operating Division  
 
Report Number  Title  Operating  Issue Date 
Division 
OEI-07-19-00371   In Five States, There Was No Evidence That Many Children in Foster Care  ACF  7/05/2022 
Had a Screening for Sex Trafficking When They Returned After Going 
Missing 
OEI-07-21-00251   Operational Challenges Within ORR and the ORR EIS at Fort Bliss  ACF  9/22/2022 
Hindered Case Management for Children 
OEI-BL-20-00670   HHS Should Improve Internal Coordination and Better Protect the  ACF  5/02/2022 
Wellbeing of Unaccompanied Children 
OEI-BL-19-00560   ACF Should Improve Oversight of Head Start To Better Protect Children's  ACF  9/26/2022 
Safety 
OEI-05-20-00540   CDC Found Ways To Use Data To Understand and Address COVID-19  CDC  7/13/2022 
Health Disparities, Despite Challenges With Existing Data 
OEI-02-22-00310   2021 Performance Data for the Senior Medicare Patrol Projects  CMS  6/08/2022 
OEI-02-21-00100   Inaccuracies in Medicare's Race and Ethnicity Data Hinder the Ability to  CMS  6/13/2022 
Assess Health Disparities 
OEI-02-20-00522   Certain Medicare Beneficiaries, Such as Urban and Hispanic Beneficiaries,  CMS  8/29/2022 
Were More Likely Than Others to Use Telehealth During the First Year of 
the COVID-19 Pandemic 
OEI-02-20-00720   Medicare Telehealth Services During the First Year of the Pandemic:  CMS  9/02/2022 
Program Integrity Risks 
OEI-02-22-00390   Opioid Overdoses and the Limited Treatment of Opioid Use Disorder  CMS  9/13/2022 
Continue To Be Concerns for Medicare Beneficiaries 
OEI-03-22-00200   Comparison of Average Sales Prices and Average Manufacturer Prices:  CMS  5/12/2022 
Results for the Fourth Quarter of 2021 
OEI-03-22-00210   Comparison of Average Sales Prices and Average Manufacturer Prices:  CMS  8/11/2022 
Results for the First Quarter of 2022 
OEI-03-20-00231   CMS Has Opportunities to Strengthen States' Oversight of Medicaid  CMS  9/19/2022 
Managed Care Medical Loss Ratios 
OEI-03-22-00170   Medicare Part B Drug Payments: Impact of Price Substitutions Based on  CMS  9/23/2022 
2020 Average Sales Prices 
OEI-03-20-00330   UPICs Hold Promise to Enhance Program Integrity Across Medicare and  CMS  9/29/2022 
Medicaid, But Challenges Remain 
OEI-04-20-00620   Reducing Medicares Payment Rates for Intermittent Urinary Catheters  CMS  8/31/2022 
Can Save the Program and Beneficiaries Millions of Dollars Each Year 
OEI-05-22-00230   Part D Plans Generally Include Drugs Commonly used by Dual Eligibles:  CMS  6/21/2022 
2022 
OEI-06-18-00400   Adverse Events in Hospitals: A Quarter of Medicare Patients Experienced  CMS  5/09/2022 
Harm in October 2018 
95 
 
 
  Department of Health and Human Services, Office of Inspector General 
Semiannual Report to CongressApril 1, 2022, Through September 30, 2022
 
 
OEI-07-20-00181   National Background Check Program for Long-Term Care Providers: An  CMS  5/09/2022 
Interim Assessment 
OEI-09-18-00260   Some Medicare Advantage Organization Denials of Prior Authorization  CMS  4/27/2022 
Requests Raise Concerns About Beneficiary Access to Medically Necessary 
Care 
OEI-BL-21-00200   Part D Plan Preference for Higher-Cost Hepatitis C Drugs Led to Higher  CMS  8/09/2022 
Medicare and Beneficiary Spending 
OEI-01-20-00381   FDAs Work With the Tri-Agency Task Force for Emergency Diagnostics  FDA  9/16/2022 
Helped Labs Implement COVID-19 Tests 
OEI-01-20-00380   FDA Repeatedly Adapted Emergency Use Authorization Policies To  FDA  9/16/2022 
Address the Need for COVID-19 Testing 
OEI-01-21-00401   Delays in Confirmatory Trials for Drugs Granted FDAs Accelerated  FDA  9/26/2022 
Approval Raise Concerns 
OEI-06-22-00320   Initial Observations of IHS Capacity To Manage Supplemental $3.5 Billion  IHS  9/28/2022 
Appropriated to Sanitation Facilities Construction Projects 
OEI-06-21-00360   Connecticut Medicaid Fraud Control Unit: 2021 Inspection  MFCU  9/01/2022 
OEI-06-21-00270   Michigan Medicaid Fraud Control Unit: 2021 Review  MFCU  9/26/2022 
OEI-07-21-00340   Iowa Medicaid Fraud Control Unit: 2021 Inspection  MFCU  6/15/2022 
OEI-03-20-00210   Opportunities Exist To Strengthen NIH Grantees Oversight of  NIH  6/02/2022 
Investigators Foreign Significant Financial Interests and Other Support 
  Total Reports  29   
 
 
 
 
 
 
 
   
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Appendix B: Savings Decisions Supported by 
OIG Recommendations 
 
The table below lists policy decisions reflected in legislation, regulations, or other directives from prior 
years that are supported by OIG recommendations and for which cost savings were estimated, usually by 
third parties, such as the Congressional Budget Office (CBO) or HHS actuaries.  Of the $23.9 billion in 
savings estimated for the decisions below, $2.9 billion was attributed to FY 2022.  This figure reflects the 
most recent available savings estimates issued by the third-party appraiser; actual savings may be higher 
or lower.    
  
After laws involving HHS programs are enacted, OIG analyzes the laws to identify the provisions that 
comport with our prior recommendations, that is, whether our recommendations support the decisions 
that were made.  A similar process occurs with respect to administrative decisions in regulations or other 
directives or agreements (e.g., modifications to Medicaid State Plans).  Most of the decisions reported in 
this appendix reflect ways in which funds could be put to better use, such as reductions in Federal 
spending or the avoidance of unnecessary or inappropriate expenditures, or both.    
  
To quantify the value of administrative decisions, we use estimates developed by, or in consultation with, 
HHS OpDivs or StaffDivs.  To quantify the value of legislative decisions, we generally use estimates 
developed by CBO.  CBO projects the annual increases or reductions in Federal spending that it expects 
would result from enacting the legislation.  The policy decisions shown on the table beginning on the next 
page mirror both OIGs recommendations and the contributions of others, such as HHS staff and OpDivs, 
congressional committees, and the GAO.   
  
Centers for Medicare & Medicaid Services Programs  
OIG Recommendations   Policy Decisions   Estimated Savings  
Calculation of Average Manufacturer  Section 1603 of the Continuing Appropriations  $280 million 
Price (AMP) Under the Medicaid Drug Act, 2020, and Health Extenders Act of 2019 
Rebate Program   amended section 1927(k)(1)(C) of the Social 
Seek legislative change to exclude  Security Act (the Act) to exclude generic drug 
authorized generic drug transactions  transactions to secondary manufacturers in the 
to secondary manufacturers from the brand name drug's AMP calculations.  CBO 
AMP calculation of the brand name  estimated savings of $3.15 billion over 10 years.  
drug.  The recommendation reflected   
findings in OIG report A-06-18-
04002.   
  
Medicaid Rebate for Generic Drugs   Section 602 of the Bipartisan Budget Act of 2015 $134 million  
(P.L. No. 114-74) (See Tab 2) was enacted and 
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Generic drug price increases  included provisions extending the additional 
exceeded the specified statutory  rebate to generic drugs.  The additional rebate 
inflation factor applicable to brand- for generic drugs will apply to rebate periods 
name drugs for 22 percent of the  beginning with the first quarter of 2017.  CBO 
quarterly AMPs that OIG reviewed.  If estimated savings of $1.008 billion over 10 
the provision for brand-name drugs  years.  
were extended to generic drugs, the    
Medicaid program would receive 
additional rebates.  This finding was 
noted in OIG reports A-06-07-00042 
and A-06-15-00030.   
Hospital Transfer Policy for Early  Section 53109 of the Bipartisan Budget Act  $545 million  
Discharges to Hospice Care    of 2018 modified existing law to require that, 
Change regulations or pursue a  beginning in FY 2019, discharges to hospice 
legislative change, if necessary, to  care would also qualify as a post-acute-care 
establish a hospital transfer  transfer and be subject to payment 
payment policy for early discharges adjustments.   
to hospice care.  The    
recommendation reflected findings 
in OIG report A-01-12-00507.   
Reductions in Medicare Bad Debt  Section 3201 of the Middle Class Tax  $1,590 million  
Reimbursement    Extension and Job Creation Act of 2012 
Seek legislative authority to  applied percentage reductions in bad debt 
eliminate (or reduce) Medicare  reimbursement to all providers eligible to 
payments to hospitals for bad debt  receive bad debt reimbursement.  CMS 
associated with beneficiaries failure estimated savings to Medicare of $10.92 
to pay their deductibles and  billion over 10 years with $1.39 billion 
coinsurance.  The recommendations attributed to FY 2020.  (77 Fed. Reg. 67450, 
reflected findings in OIG report A- 67523 (Nov. 9, 2012)).   
14-90-00339 and subsequent    
reviews.   
Payments for Prescription Drugs  CMS issued a final rule about the Contract  $211 million 
Provided to Incarcerated  Year 2015 Policy and Technical Changes to the 
Beneficiaries    Medicare Advantage and the Medicare 
Work with prescription drug plan  Prescription Drug programs.  The eligibility 
sponsors to identify and resolve  requirements to enroll in Medicare Advantage 
improper Medicare Part D  and Part D are outlined in Sections 
payments made for prescription  1851(a)(3)(B) and 1860D-1(a)(3)(A) of the 
drugs provided to incarcerated  Act.  To enroll in Medicare Advantage, a 
beneficiaries.  The recommendation beneficiary must be entitled to Part A and 
reflected findings in OIG report A- enrolled in Part B.  To enroll in Part D, a 
07-12-06035.    beneficiary must be entitled to Part A and/or 
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enrolled in Part B.  An incarcerated beneficiary 
is not precluded from meeting the eligibility 
requirements for Part A and Part B, but in 
general, no Medicare Payment is made for 
these individuals.  CMS promulgated 
regulations to require Part D plans to disenroll 
incarcerated beneficiaries.  CMS estimated 
savings of $1.6 billion over 10 years with 
$172 million attributed to FY 2020.  (79 Fed. 
Reg. 29844, 29953 (May 23, 2014)).   
  
Medicare Payments for Vacuum  Section 203 of the Achieving a Better Life  $44.4 million 
Erection Systems    Experience Act of 2014 implements changes 
Seek legislative authority to include to treat VES prosthetic devices and related 
vacuum erection systems (VES) in  accessories as statutorily noncovered in the 
the Competitive Bidding program  same manner that erectile dysfunction drugs 
and then implement a National  are treated in Medicare Part D.  CBO 
Mail-Order Competitive Bidding  estimated savings of $444 million over 10 
Program for VES.  The  years.   
recommendation reflected findings    
in OIG report A-07-12-05024.   
  
Excessive Medicaid Payments to  Agreement between CMS and the State of  $100 million 
New York State    New York, dated March 20, 2015, to repay 
Ensure that expenditures related to  $1.95 billion over 12 years with $100 million 
developmental centers and other  attributed to FY 2020.   
intermediate care facilities and any    
revised payment methodology be 
consistent with efficiency and 
economy.  The recommendation 
reflected findings in OIG reports A-
02-11-01029, A-02-13-01008, and 
other reviews.   
  
 
 
 
 
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Appendix C: 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 reporting 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 prior reporting periods are listed below. 
 
 
OAS  Date  Reviewing Office  Office Reviewed 
 
September 2022  HHS-OIG, OAS  Department of Labor OIG 
 
The system of quality control for the audit organization of Labor OIG in effect for the year ending 
September 30, 2021, has been suitably designed and complied with to provide Labor 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.  Labor OIG received a peer review rating of Pass. 
 
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. 
 
Office of Investigations 
During this semiannual reporting period, no peer reviews involving OI were completed.  Listed below is 
information concerning OIs peer review activities during prior reporting periods. 
   
 
OI  Date  Reviewing Office  Office Reviewed 
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  October 2018  Social Security  HHS-OIG, OI 
Administration OIG 
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 OIG 
The system of internal safeguards and management procedures for the investigative function of 
the U.S. Postal Service 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, no peer reviews involving OEI were 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 
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 of CIGIE.  The seven covered standards are: Quality 
Control, Planning, Data Collections and Analysis, Evidence, Records Maintenance, Reporting, and 
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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  U.S. 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. 
 
 
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Appendix D: 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 
Section 1128 of the Social Security Act (42 U.S.C.  1320a-7), provides numerous 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 17 other grounds, including 
misdemeanors for health care fraud other than Medicare or Medicaid fraud; 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.  
 
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, found at Section 1128A of the Social Security Act (42 U.S.C.  1320a-7a), authorizes 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 $20,000 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 
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; and payment or receipt of remuneration in violation of the Federal anti-kickback statute (42 
U.S.C.  1320a-7b(b)).   
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The 21st Century Cures Act (enacted on December 13, 2016) added more grounds for imposing CMPs, 
assessments, and exclusions from Federal health care programs for fraudulent and other improper conduct 
related to HHS grants, contracts, and other agreements.  OIG may impose a CMP of up to $10,000 per 
specified claim, an assessment of up to three times the amount claimed, and an exclusion upon any person 
who knowingly presents a specified claim under and HHS grant, contract, or other agreement that they 
know or should know is false or fraudulent.  In addition, OIG may impose a CMP of up to $50,000, an 
assessment of up to three times the amount of funds at issue, and an exclusion upon any person who: (1) 
knowingly makes a false statement in a document required to be submitted to receive funds under an HHS 
contract, grant, or other agreement; (2) knowingly makes or uses a false record or statement that is 
material to a false or fraudulent claim; or (3) knowingly makes or uses a false record or statement material 
to an obligation to pay or transmit funds or property owed to HHS.  OIG may also impose a CMP of up to 
$10,000 per day, an assessment of up to three times the amount at issue, and an exclusion upon any 
person who for knowingly conceals, or knowingly and improperly avoids or decreases, an obligation owed 
to HHS with respect to an HHS grant, contract, or other agreement.  Finally, OIG may impose a penalty of 
up to $15,000 per day and an exclusion upon any person who fails to grant timely access to OIG upon 
reasonable request for the purpose of audits, investigations, evaluations, or other statutory functions of the 
OIG in matters involving HHS grants, contracts, or other agreements.   
 
Patient Dumping 
Section 1867 of the Social Security Act (42 U.S.C.  1395dd), provides that when an individual goes to the 
Emergency Department 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 when the hospital does not have the capabilities to 
stabilize the condition 
 
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.  
 
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.   
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Anti-Kickback Statute and Civil False Claims Act Enforcement Authorities 
The Anti-Kickback Statute 
The Federal anti-kickback statute makes it a criminal offense to knowingly and willfully offer, pay, 
solicit, or receive any remuneration to induce, or in return for, the referral of an individual to a 
person for the furnishing of, or arranging for the furnishing of, any item or service reimbursable 
under a Federal health care program.  The statutes prohibition also extends to remuneration to 
induce, or in return for, the purchasing, leasing, or ordering of, or arranging for or recommending 
the purchasing, leasing, or ordering of, any good, facility, service, or item reimbursable by a Federal 
health care program.  (Social Security Act,  1128B(b) (42 U.S.C.  1320a-7b(b)).  
 
Individuals and entities who engage in conduct prohibited by the anti-kickback statute may be 
subject to criminal penalties and fines under the anti-kickback statute; CMPs under OIGs authority 
pursuant to the Social Security Act,  1128A(a)(7) (42 U.S.C.  1320a-7a(a)(7)-); 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)).  In addition, a conviction under the anti-kickback statute leads to mandatory 
exclusion under the Social Security Act, 1128(a)(1) (42 U.S.C.  1320a-7a(a)(1)).  Finally, a claim that 
includes items or services resulting from a violation of the Federal anti-kickback statute constitutes 
a false or fraudulent claim for purposes of the False Claims Act.  (Social Security Act,  1128B(b)(g) 
(42 U.S.C.  1320a-7b(b)(g)). 
 
The False Claims Act 
OIG investigates alleged violations of the False Claims Act (31 U.S.C.  37293733).  Under the 
False Claims Act, 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.  Similar to the CMPL, the False Claims Act defines knowing to include instances in which the 
person acted in deliberate ignorance or reckless disregard of the truth or falsity of the information.  
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 in 2009.  Among other 
things, the amendments clarified the reach of the False Claims Act to false claims submitted to 
contractors or grantees of the Federal Government.   
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Appendix E: 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  
(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 
and Appendix A 
(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 
within 60 days, and in which there are any outstanding 
unimplemented recommendations 
(a)(11)  Description and explanation of revised management  Appendix A 
decisions 
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Section  Requirement  Location 
(a)(12)  Management decisions with which the Inspector General  None for this reporting 
disagrees  period 
(a)(13)  Information required by the Federal Financial Management  Nothing to report 
Improvement Act of 1996   
 
(a)(14)-(16)  Results of peer reviews of HHS-OIG conducted by other  Appendix C 
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 F 
(a)(18)  Metrics description for statistical tables  Appendix F 
(a)(19)  Investigations on senior Government employees  Appendix F  
(a)(20)  Description of whistleblower retaliation instances  Appendix F 
(a)(21)  Description of attempts to interfere with OIG independence  Appendix F 
(a)(22)  Description of closed and nondisclosed reports and  Appendix F 
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 G  
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. 
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 F: 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 2022 OIG had a total of 86 reports 
with overdue final management decisions (FMDs) as of the end of this reporting period.  The 
breakdown of those 86 reports by HHS OpDiv is as follows: 
 
OpDiv  Overdue FMDs 
ACF   17 
ASPR   4 
CMS  46 
FDA  1 
IHS   10 
NIH   3 
OASH   1 
OS   4 
 
OIG is unable to provide reasons and timetables for each of these overdue management decisions, 
because of the volume and 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  
 
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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 zero reports 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 1,451 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 
FY (2011 With  Dollar Value of Aggregate 
Unimplemented 
2022)  Unimplemented  Potential Cost Savings 
Recommendations 
Recommendations 
2011  12  17  $408,135,515 
2012  18  21  $369,932,148 
2013  24  37  $234,261,321 
2014  22  38  $15,072,080,989 
2015  22  36  $304,720,009 
2016  18  35  $184,156,192 
2017  30  90  $1,100,958,099 
2018  38  119  $525,408,004 
2019  59  175  $728,613,733 
2020  80  249  $2,458,020,804 
2021  98  230  $880,662,095 
2022  106  404  $2,495,003,205 
Totals  527  1,451  $24,761,952,114 
 
 
OIG annually produces OIGs Top Unimplemented Recommendations: Solutions To Reduce Fraud, 
Waste, and Abuse in HHS Programs, which constitutes OIGs response to a specific requirement of 
the Inspector General Act, as 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 
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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  1,041 
criminal prosecution during the reporting period4 
Total number of persons referred to State and local prosecuting authorities  120 
for criminal prosecutions during the reporting period  
Total number of Federal indictments and criminal information during the  314 
reporting period that resulted from any prior referral to prosecuting 
authorities 
Total number of State and local indictments and criminal information during  66 
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 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 
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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 and criminal information 
during the semiannual reporting period, including sealed indictments and 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 DOJ, the date of the referral; and  
(ii) if DOJ declined the referral, the date of the declination;   
 
For this section, OIG describes investigations, both criminal and administrative, involving senior 
Government employees for whom allegations of misconduct were investigated and substantiated.  
For the reporting period, the OIG investigation of one senior Government employee for 
misconduct was substantiated.  
 
Description of  Status  Disposition  DOJ  DOJ  DOJ  DOJ 
Investigation  Referral Referral Declination Declination 
Date  Date 
A senior Government official  Closed  Substantiated  Yes  1/8/2021 Yes  1/8/2021 
allegedly violated conflict of 
interest rules applicable to all 
Executive Branch employees.  
 
OIG provides investigative facts for the purpose of referring a matter or allegation to the 
appropriate deciding authority (Department, OpDiv, DOJ, etc.).  OIG does not make findings 
regarding its investigations of departmental employees.  Our reports relay the facts obtained 
during the investigations (e.g., parties involved, dates of events).  At the conclusion of an OIG 
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investigation related to 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.  Although, we request from the agency a copy of an SF-50 documenting 
a personnel action, if one is taken, there are sometimes settlement agreements that may impact 
the final action.  Therefore, OIG may not have a complete record of the disposition of the 
investigation.  
 
(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; 
 
OIG conducts investigations into whistleblower retaliation against current and former HHS 
employees, applicants for HHS employment, HHS contractors, subcontractors, personal services 
contractors, grantees, and subgrantees who disclose information to OIG, and other protected 
sources, under the authority of the Whistleblower Protection Act of 1989, 41 U.S.C.  4712, the 
Military Whistleblower Protection Act (10 U.S.C. 1034), and Presidential Policy Directive 19.  OIG 
makes a determination as to whether retaliatory action has been taken and includes these findings 
in reports, along with recommendations for corrective action.  OIG provides a summary of any 
substantiated retaliation report on the OIG website to enhance transparency and employer 
accountability.  In the reporting period, OIG submitted one report to the Office of the Secretary of 
HHS 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.   
 
OIG conducted an investigation in response to allegations made by a complainant at the 
Tennessee Coalition to End Domestic and Sexual Violence (Coalition), a CDC grantee.  The 
complainant alleged that, while working for the Coalition, under Domestic Violence Prevention 
Enhancement and Leadership Through Alliances (DELTA) program grants, the complainants 
supervisors and responsible management officials (RMOs), terminated the complainant for making 
allegations that Federal grant laws were being repeatedly violated by the Coalition.  Specifically, 
investigators found that the complainant made written and oral protected disclosures to the RMOs 
and a CDC employee alleging DELTA grant mismanagement.  OIG investigators found that the 
RMOs terminated the complainants employment in retaliation for making protected disclosures.  
The OIG investigative report included recommendations for corrective action and was provided to 
the Office of the Secretary of HHS, which may seek to implement alternative or additional actions 
as deemed appropriate.   
 
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The report included the following recommendations for corrective action: (1) that whistleblower 
protection training be required for the grantee and its employees, as well as for CDC employees 
who work in the DELTA program; and (2) that the complainant be made whole in the form of 
backpay since their constructive discharge. 
 
(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 take appropriate action in accordance 
with the Inspector General Act if it were unable to resolve these issues within HHS.   
 
(22) Detailed descriptions of the particular circumstances of each: 
(A) inspection, evaluation, and audit conducted by the Office that is closed and was not 
disclosed to the public; and 
 
The table below lists inspection, evaluation, and audit reports for this semiannual reporting period 
that did not result in public reports.   
 
 
Number of 
Category/Description 
Reports 
IT security reviews (involve IT systems, e.g., penetration test audits)  0 
Other  0 
HHS technical assistance reports  0 
Finance-related attestation reviews  2 
Total  2 
 
(B) Investigation conducted by the Office involving a senior Government employee that is closed and 
was not 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 four 
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investigations closed during this reporting period involving senior Government employees for 
whom allegations of misconduct were investigated and not substantiated.  
 
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 
 
Description of  Status  Disposition  DOJ  DOJ  DOJ  DOJ 
Investigation  Referral Referral Declination Declination 
Date  Date 
A senior Government  Closed  Unsubstantiated No  N/A  N/A  N/A 
employee allegedly inappropriately 
touched/sexually assaulted another 
Government employee and a 
former patient. 
A senior Government employee  Closed  Unsubstantiated No   N/A  N/A  N/A 
allegedly attempted to pressure 
employees to contract with a 
company for which the senior 
Government employees family 
member has a financial interest.  
A senior Government employee  Closed  Unsubstantiated No   N/A  N/A  N/A 
supervised a contracted employee. 
The contracted employee allegedly 
attempted to pull a patients pants 
down during an examination 
despite the patients objection. 
A senior Government employee  Closed  Unsubstantiated No  N/A  N/A  N/A 
allegedly retaliated against an 
employee for reporting violations 
of law and department policies.  
 
 
 
 
 
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Appendix G: 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 Federal 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 industry 
stakeholders.  Having done so, OIG must then determine, in consultation with DOJ, whether it can develop 
effective regulatory limitations and controlsnot only to foster beneficial or innocuous arrangements
but also to protect the Federal health care programs and their beneficiaries from abusive practices. 
] 
Public proposals for new and modified safe harbors  
Annual Solicitation  
 
In December 2021, OIG published its annual solicitation in the Federal Register (Annual Solicitation).1  In 
response to the Annual Solicitation, OIG received the following proposals related to safe harbors:  
 
Proposal  OIG Response 
Repeal or modification of existing safe harbors  OIG is not adopting commenters suggestions to 
(e.g., the group purchasing organization (GPO)  repeal or modify the GPO safe harbor, among 
safe harbor, 42 C.F.R.  1001.952(f)) to address  others, to address their comments and concerns 
comments and concerns regarding the manner  about the financial arrangements for which GPOs 
in which GPOs and pharmacy benefit managers  and PBMs may be using these safe harbors.  We 
(PBMs) may be using such safe harbors to  may consider this topic in future rulemaking or in 
protect purportedly abusive arrangements.  future guidance.  OIG highlights that there is a 
statutory exception addressing GPOs at section 
1128B(b)(3)(C) of the Social Security Act. 
Modification of the Cooperative Hospital  OIG is not adopting this suggestion. We may 
Services Organization (CHSO) safe harbor, 42  consider this topic in future rulemaking. 
C.F.R.  1001.952(q), to: (i) protect only CHSO 
 
 
1 OIG, Solicitation of New Safe Harbors and Special Fraud Alerts, 86 Fed. Reg. 71,611 (Dec. 17, 2021), 
https://www.govinfo.gov/content/pkg/FR-2021-12-17/pdf/2021-27314.pdf.  
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arrangements that involve the provision of items 
or services that are components of the direct or 
indirect overhead costs associated with the 
inpatient or outpatient hospital services of the 
nonprofit patron-hospitals; and (ii) exclude 
protection for the creation of revenue-producing 
joint venture arrangements for non-hospital, 
post-discharge home care services and the 
distribution of CHSO revenues to patrons based 
on referrals. 
A new safe harbor to protect: (i) value-based  OIG is not adopting this suggestion.  We 
price-adjustment arrangements that are  appreciate learning about ways in which 
dependent on the achievement of a measurable  pharmaceutical manufacturers, medical device 
clinical or cost outcome associated with the  manufacturers, and durable medical equipment, 
value of a sellers reimbursable items or services;  prosthetics, orthotics, and supplies (DMEPOS) 
and (ii) the provision of value-based services,  entities believe that they could contribute to the 
such as services that enable parties to measure  coordination of care and the overall delivery of 
outcome measures associated with value-based  high-value care through, for example, value-
price-adjustment arrangements.   based price-adjustment arrangements or value-
based services arrangements.  However, we 
continue to have concerns about the offer of 
remuneration by these entities that raises many 
of the traditional fraud and abuse risks under the 
Federal anti-kickback statute.  We may consider 
this topic in future rulemaking.  
A new safe harbor to protect drug copayment  OIG is not adopting this suggestion.  The offer of 
assistance in situations where a less expensive  cost-sharing assistance for a drug, particularly by 
and equally effective alternative drug does not  the manufacturer of such drug (either directly or 
exist.  indirectly), presents many of the traditional risks 
of fraud and abuse that the Federal anti-kickback 
statute is designed to prevent. 
New safe harbors to protect: (i) value-based  OIG is not adopting these suggestions.  We 
purchasing arrangements between  continue to evaluate the ways in which 
pharmaceutical manufacturers and payors or  pharmaceutical manufacturers may be able to 
PBMs; and (ii) the provision of data analytics by a  contribute to the coordination of care and the 
drug, biologic, or device manufacturer.  overall delivery of high-value care through, for 
example, value-based purchasing arrangements 
or data sharing arrangements.  However, we 
continue to have concerns about the offer of 
remuneration through these programs, which 
raises many of the traditional fraud and abuse 
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risks under the Federal anti-kickback statute.  We 
may consider this topic in future rulemaking. 
Modifications to the safe harbors for value-based  As explained in the preamble to the final rule at 
arrangements, including the safe harbors for  85 Fed. Reg. 77,684 (Dec. 2, 2020) (referred to in 
arrangements for patient engagement and  this Appendix G as the 2020 final rule), 
support to improve quality, health outcomes,  remuneration exchanged by pharmaceutical 
and efficiency, 42 C.F.R.  1001.952(hh), to protect  manufacturers and, in certain circumstances, 
the exchange of remuneration by certain entities  medical device manufacturers and DMEPOS 
that currently cannot use the safe harbors (e.g.,  entities, are not eligible for protection under the 
pharmaceutical manufacturers, medical device  value-based safe harbors due to (among other 
manufacturers, laboratory companies, and  reasons) concerns that such entities could use 
suppliers of durable medical equipment,  the safe harbor to protect arrangements that are 
prosthetics, orthotics, or supplies).  intended to market their products or 
inappropriately tether clinicians to the use of a 
particular product.2  Consequently, OIG declines 
to adopt this suggestion.     
New safe harbors to implement the Final Rule for  OIG is not adopting this suggestion.  Section 
the Removal of Safe Harbor Protection for  11301 of the Inflation Reduction Act of 2022 
Rebates Involving Prescription Pharmaceuticals  extended the moratorium on the implementation 
and Creation of New Safe Harbor Protection for  of the Final Rule for the Removal of Safe Harbor 
Certain Point-of-Sale Reductions in Price on  Protection for Rebates Involving Prescription 
Prescription Pharmaceuticals and Certain  Pharmaceuticals and Creation of New Safe 
Pharmacy Benefit Manager Service Fees.  Harbor Protection for Certain Point-of-Sale 
Reductions in Price on Prescription 
Pharmaceuticals and Certain Pharmacy Benefit 
Manager Service Fees until January 1, 2032. 
 
New safe harbor for charitable assistance  OIG is not adopting this suggestion.  We may 
programs to protect the provision of medical  consider this topic in future rulemaking. 
products and pharmaceutical products at no 
charge to patients in financial need. 
Modification to existing safe harbor at 42 C.F.R.   OIG is not adopting this suggestion.  A rebate is 
1001.952(h) to define rebate to include any  a type of discount, and a discount is a reduction 
service fee paid as a percent-of-sales.  in price charged for an item or service.  A 
discount, including a rebate, does not include 
payment for a service.  In a final rule issued in 
1991, OIG stated that contracts for personal or 
 
 
2 Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil 
Monetary Penalty Rules Regarding Beneficiary Inducements, 85 Fed. Reg. 77,684, 77,709 (Dec. 2, 2020), 
https://www.govinfo.gov/content/pkg/FR-2020-12-02/pdf/2020-26072.pdf. 
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management services do not fit within the 
statutory discount exception or the definition of 
discount in the regulatory safe harbor.3  We 
decline to revise the definition of rebate to 
include service fees paid as a percent of sales. 
New safe harbor for manufacturer-sponsored  OIG is not adopting this suggestion.  We 
patient engagement and product support  continue to evaluate the ways in which 
programs, including therapy management and  pharmaceutical manufacturers may be able to 
medication adherence support to encourage  contribute to the delivery of quality care for 
patients to manage and follow their treatment  patients through programs such as medication 
plans.  adherence support, but we continue to have 
concerns about the offer of remuneration to 
patients through these programs, which raises 
many of the traditional fraud and abuse risks 
(e.g., patient steering).  We may consider this 
topic in future rulemaking. 
New safe harbor to protect internal cost sharing  OIG is not adopting the suggestion to create a 
(or gainsharing) payments or modification to the  new safe harbor or modify the personal services 
personal services and management contracts  and management contracts and outcomes-
and outcomes-based payment arrangements  based payment arrangements safe harbor.  We 
safe harbor, 42 C.F.R.  1001.952(d), to expand  continue to believe, as stated in the preamble to 
the definition of "outcomes-based payment" to  the 2020 final rule, that payments for 
include internal cost sharing (or gainsharing)  arrangements that reduce internal costs may 
payments.  pose risks to patient care, among other 
concerns.4  At this time, we continue to believe 
that the risks outweigh any potential benefits of 
these arrangements such that safe harbor 
protection is not warranted.   
New safe harbor for payments from hospitals to  OIG is not adopting this suggestion.  We believe 
post-acute-care providers to transition patients  that existing regulations, including new and 
to clinically appropriate, lower-cost care settings.  modified safe harbors that were finalized in the 
2020 final rule, provide sufficient regulatory 
flexibility for financial arrangements between 
referral sources that balance the goals of care 
coordination and delivery of value-based care 
with the need to protect both patients and 
 
 
3 42 C.F.R.  1001.952(h)(5)(vi); OIG, Medicare and State Health Care Programs: Fraud and Abuse; OIG Anti-Kickback Provisions, 56 
Fed. Reg. 35,952 (July 29, 1991), https://oig.hhs.gov/documents/compliance/857/072991.htm. 
4 85 Fed. Reg. at 77,845. 
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Federal health care programs.  We may consider 
this topic in future rulemaking. 
A new safe harbor for the waiver or offset of  OIG has repeatedly expressed concerns 
cost-sharing obligations for items and services  regarding routine waivers of Medicare cost-
provided in connection with: (i) value-based  sharing amounts that do not meet an exception 
arrangements for care management or remote  to the civil monetary penalty provision 
patient monitoring; and (ii) the Acute Care  prohibiting inducements to beneficiaries at 
Hospital at Home program and any follow-on  section 1128A(i)(6)(A) of the Social Security Act.  
model that may be established by CMS following  Accordingly, we decline to adopt these 
the expiration of the Section 1135 public health  suggestions. 
emergency waiver. 
A new safe harbor that would protect  OIG is not adopting this suggestion.  We may 
remuneration between wholly owned  consider this topic in future rulemaking. 
subsidiaries and between a parent company and 
a subsidiary. 
 
 
 
 
 
 
 
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