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Active Work Plan Items

Work Plan Home | Recently Added | Work Plan Archive

Active Work Plan Items reflect OIG audits, evaluations, and inspections that are underway or planned. Search the Work Plan using any words or numbers or download the Active Work Plan Items into a spreadsheet.

Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY) Summary Tags
Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY) Summary Tags
December 2021 Centers for Medicare and Medicaid Services Telehealth Services in Select Federal Health Care Programs Office of Evaluation and Inspections OEI-02-22-00150 FY 2023 Throughout the COVID-19 pandemic, the use of telehealth has been critically important. Telehealth has helped ensure access to care while reducing the risk of community spread of the virus. As the effects of the pandemic are still being felt throughout the Nation, there are questions about how telehealth can best be used to meet the needs of beneficiaries in the future. HHS-OIG will work with the other OIG members in and leadership of the Pandemic Response Accountability Committee (PRAC) to produce a report describing the types of telehealth services that are available, including those that were expanded during the pandemic, and key program integrity risks associated with the use of telehealth across six selected Federal health care programs. Medicare is the HHS program included in this evaluation. HHS-OIG will conduct this evaluation with OIGs from the departments of Defense, Justice, Labor, and Veterans Affairs, and the Office of Personnel Management. PRAC will issue the resulting report. It will provide policymakers and stakeholders with foundational information about the nature of telehealth across select Federal health care programs and related program integrity risks in order to inform the use of telehealth in the future. TAGS
November 2021 Centers for Medicare and Medicaid Services National Background Check Program for Long-Term Care Providers: An Interim Assessment of Idaho and Mississippi Office of Evaluation and Inspections OEI-07-20-00181 2022 Section 6201 of the Patient Protection and Affordable Care Act (ACA) established the framework for the National Background Check Program. This program, administered by CMS, provides grants to States to implement background check programs for prospective employees and providers of long-term care services. The ACA requires OIG to evaluate this grant program after its completion (P.L. No. 111-148§6201(a)(7)). For continuing participants Idaho and Mississippi, we will review the implementation of Program requirements for conducting background checks on prospective employees of long-term care facilities and providers who would have direct access to patients. We will determine the costs associated with each State program and determine the checks conducted during the Program. Financial Stewardship, Nursing Homes, Nursing Facilities and Assisted Living Facilities, Elderly, Grants
November 2021 Centers for Medicare and Medicaid Services Identifying Denied Claims in Medicare Advantage Encounter Data Office of Evaluation and Inspections OEI-03-21-00380 2022 CMS requires Medicare Advantage organizations (MAOs) to submit records of all services provided to beneficiaries to CMS's Medicare Advantage (MA) Encounter Data System. These records often (although not always) begin as claims for payments that health care providers submit to MAOs. MAOs must submit all records of services to CMS, including records of denied claims-i.e., claims for which an MAO determines it had no responsibility to pay the health care provider.CMS does not require MAOs to differentiate between paid and denied claims when submitting encounter records.In the absence of requiring a denied claims indicator, CMS requires each MAO to submit claim adjustment reason codes that contain information about how the MAO processed the claim and may be a helpful, but not definitive, method for identifying denied claims. The lack of a definitive method to identify denied claims in the MA encounter data may limit the use of these data to ensure MA program integrity and quality of care. This work will: (1) determine the extent to which the MA encounter data contained potentially denied claims and (2) identify any challenges to MA program oversight that result from the lack of a denied claim indicator on services in the MA encounter data. Managed Care, Elderly, Medicare C
November 2021 Centers for Medicare and Medicaid Services States' Use of Local Provider Participation Funds as the State Share of Medicaid Payments Office of Audit Services W-00-22-31557 2023 Local units or jurisdictions of government have the option to use Local Provider Participation Funds (LPPFs) to generate and collect local funding to finance the State share of Medicaid supplemental and directed payment programs. In the past several years, some States and local units of governments have increasingly used LPPFs to fund the State share of Medicaid payments. As such, we will determine whether the LPPFs the State agency used as the State share of Medicaid payments were permissible and in accordance with applicable Federal and State requirements. Hospitals, Medicaid C
November 2021 Centers for Medicare and Medicaid Services CMS Oversight of Manufacturer-Reported Average Sales Price Data Office of Evaluation and Inspections OEI-03-21-00390 2023 CMS's review of manufacturer-reported average sales price (ASP) data is a vital component of its oversight of Medicare reimbursement for Part B drugs. CMS uses ASPs reported by manufacturers to calculate Medicare Part B drug reimbursement amounts paid to health care providers. Congress has directed the HHS Office of Inspector General to submit a report to Congress-no later than January 1, 2023-that includes an assessment of the accuracy of ASP data submitted by prescription drug manufacturers and recommendations for how to improve the accuracy of that data. This report will identify any potential gaps in CMS oversight and potentially make recommendations to improve the accuracy of: (1) ASP data reporting and (2) Medicare payment amounts calculated from that data. Departmental Operational Issues, Financial Stewardship, Prescription Drug, Medicare B, Elderly
November 2021 Centers for Medicare and Medicaid Services Medicaid Inpatient Hospital Claims With Severe Malnutrition Office of Audit Services W-00-22-31558 2023 Malnutrition can result from treatment of another condition, inadequate treatment or neglect, or general deterioration of a patient's health. Hospitals are allowed to bill for treatment of malnutrition on the basis of the severity of the condition (mild, moderate, or severe) and whether it affects patient care. Severe malnutrition is classified as a major complication or comorbidity (MCC). Adding an MCC to a claim can result in an increased payment by causing the claim to be coded in a higher diagnosis-related group. We will conduct statewide reviews to determine whether hospitals complied with Medicaid billing requirements when assigning severe malnutrition diagnosis codes to inpatient hospital claims. Hospitals, Medicaid
November 2021 Centers for Medicare and Medicaid Services Medicare Payments for Inpatient Claims With Mechanical Ventilation Office of Audit Services W-00-22-35879 2023 We will review Medicare payments for inpatient hospital claims with certain Medicare Severity Diagnosis Related Group (MS-DRG) assignments that require mechanical ventilation to determine whether hospitals' DRG assignments and resultant Medicare payments were appropriate. Mechanical ventilation is the use of a ventilator to take over active breathing for a patient. For certain MS-DRGs to qualify for Medicare coverage, a beneficiary must have received more than 96 hours of mechanical ventilation. Our review will include claims for beneficiaries who received more than 96 hours of mechanical ventilation. Previous OIG reviews identified improper payments made because hospitals inappropriately billed for beneficiaries who did not receive at least 96 hours of mechanical ventilation. Financial Stewardship, Hospitals, Medicare A
November 2021 Administration for Children and Families Audit of Unaccompanied Children Data Cybersecurity Controls Office of Audit Services W-00-22-42038 2023 The Unaccompanied Children (UC) Program, operated by the Office of Refugee Resettlement (ORR) within the Administration for Children and Families (ACF), provides temporary shelter, care, and other related services to UC in its custody. ORR uses the Unaccompanied Children Portal (UC Portal) and other data sources to maintain information on over 100,000 UC. We will determine whether ACF has sufficiently addressed findings identified during a previous UC Portal audit, implemented controls to ensure the cybersecurity of sensitive UC data in accordance with Federal requirements, and incorporated adequate system development life-cycle planning to ensure that the UC Portal aligns with business and performance objectives. Information Technology and Cybersecurity, Children and Families, Other Funding
November 2021 Food and Drug Administration Audit of the Food and Drug Administration's Premarket Tobacco Product Application Process for Electronic Nicotine Delivery System Products Office of Audit Services W-00-22-59465 2023 The Food and Drug Administration (FDA) is responsible for regulating tobacco products. Under section 910 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), manufacturers wanting to market a new tobacco product must first obtain a marketing order. Those seeking a marketing order for a new tobacco product may submit a Premarket Tobacco Product Application (PMTA) to the FDA. FDA has received PMTA submissions from manufacturers of electronic nicotine delivery system (ENDS) products.Section 910(b)(1) of the FD&C Act contains the requirements for a PMTA submission.In FDA's assessment of PMTAs, FDA must determine whether the new tobacco product is appropriate for the protection of public health. Our objectives are to determine: (1) FDA's progress on reviewing applications for ENDS products; (2) whether FDA's policies and procedures ensured that marketing orders were granted or denied for ENDS products in accordance with Federal statutes, regulations, and guidance; and (3) what actions FDA has taken to ensure that ENDS products that are not appropriate for the protection of public health are not marketed. Food, Drug, and Device Safety, Public Health Issues, Children and Families, Other Funding
November 2021 OS OIG CMS FDA CDC Network Cyber Threat Hunting Audit of the HHS Trusted Internet Connection and Select Operating Division Networks Office of Audit Services W-00-22-42039 2023 In recent years, HHS has been the target of numerous cyberattacks, which has affected HHS operations and demanded additional resources to combat the growing cyber threats. The cyberattacks have increased in complexity and frequency and at times evade cybersecurity defense tools. In accordance with the Federal Information Security Modernization Act and the Executive Order on Improving the Nation's Cybersecurity of May 12, 2021, the Federal Government must detect and respond to threats that can potentially affect the confidentiality, availability, and integrity of its services and data. Failure to do so may result in service disruptions and breaches that could potentially affect the security and privacy of public health data or U.S citizens' personally identifiable information. We will perform a series of information technology audits at HHS and selected Operating Divisions to determine whether their network cybersecurity defenses are effective. Information Technology and Cybersecurity, Other Funding
November 2021 Health Resources and Services Administration COVID-19 Pandemic Relief Funding and Its Effects on Nursing Homes: Case Study Office of Evaluation and Inspections OEI-06-22-00040 2023 Congress and HHS used the Provider Relief Fund (PRF) to support nursing homes and other health care providers during the COVID-19 pandemic. Nursing home residents have suffered some of the highest rates of COVID-19 infection and mortality during the pandemic. HHS allocated $10 billion from the PRF directly to nursing homes through two channels: (1) a distribution to skilled nursing facilities for lost revenue and expenses related to preventing, preparing for, and responding to COVID-19; and (2) the Nursing Home Infection Control Distribution, for improving infection control practices and reducing rates of COVID-19 infection. This review will use interviews and other data collected as part of six case studies organized by the Pandemic Response Accountability Committee. We will identify how nursing homes used the funds to support their COVID-19 response, improve infection control practices, and assess selected outcomes from that use of funds. Our work will also evaluate the Health Resources and Services Administration's oversight and efforts to enforce PRF terms, conditions, and reporting requirements. COVID-19, Emergency Preparedness and Response, Nursing Homes, Nursing Facilities, and Assisted Living Facilities, Public Health Issues, Quality of Care, Elderly, Other Funding
November 2021 Centers for Disease Control and Prevention CDC Oversight of the President's Emergency Plan for AIDS Relief Funds Office of Audit Services W-00-22-57301 2022 The Centers for Disease Control and Prevention (CDC) has been working to combat HIV since the start of the HIV epidemic.As an implementing agency of the President's Emergency Plan for AIDS Relief (PEPFAR), CDC works side by side with foreign ministries of health and other partners, leveraging its scientific and technical expertise to help deliver high-impact, sustainable HIV treatment and prevention services to millions of people in the countries most affected by HIV. CDC received more than $5.5 billion in PEPFAR funds during FY 2018 through FY 2020 (an amount equal to about 96 percent of the total PEPFAR funds received by the Department of Health and Human Services (HHS) during these 3 fiscal years) to accelerate HIV treatment and prevention worldwide by using public health, innovation, and data-driven approaches to achieve the global goal of HIV epidemic control. To date, the HHS Office of Inspector General (OIG) has conducted 10 audits of CDC's PEPFAR oversight operations in 5 countries on 3 continents (Africa, Asia, and North America).OIG's PEPFAR oversight has helped CDC and other HHS staff members learn important grant and program integrity lessons that apply to ongoing and future responses to infectious diseases. In previous audits of CDC offices in the United States and foreign countries, OIG identified noncompliance with policies, inadequate monitoring of grantees, and internal control weaknesses in the awarding of PEPFAR funds. We will determine whether CDC: (1) effectively awarded, monitored and accounted for PEPFAR funds in accordance with Federal and departmental requirements, and the Office of the U.S. Global AIDS Coordinator and Global Health Diplomacy guidance; and (2) followed established processes for the reprogramming and/or the redirection of PEPFAR funds used for COVID‑19. The audit of controls over reprogramming and/or redirection of PEPFAR funds for COVID‑19 will be a collaborative audit conducted by HHS-OIG and the U.S. Agency for International Development's OIG. Each OIG will issue a separate report. COVID-19, Public Health Issues, Grants
November 2021 Health Resources and Services Administration Cybersecurity Testing of HHS and Consumer Mobile Applications CDC NIH AHRQ W-00-22-42040 2022 Various HHS OpDivs use mobile applications as alternative ways to reach mobile device users.Cybersecurity researchers have indicated that a large majority of Android and iOS apps across every industry lack the most basic security protections.HHS-OIG will perform a series of penetration test audits of certain mobile applications to determine whether security controls protecting HHS and its OpDivs' mobile applications are effective in preventing certain cyberattacks.Also, as part of this work, we will determine whether HHS and its OpDivs are following required security standards and policies for the development and vetting of mobile apps.HHS-OIG will perform this work because of the steady increase in the use of mobile apps by HHS and its OpDivs to provide access to health services. Departmental Operational Issues, Information Technology and Cybersecurity
October 2021 Centers for Disease Control and Prevention Nursing Home Reporting of COVID-19 Data to the National Healthcare Safety Network Office of Evaluation and Inspections OEI-06-22-00030 2022 Since May 2020, nursing homes nationwide have been required to report COVID-19 data to the National Healthcare Safety Network (NHSN), an infection surveillance system managed by the Centers for Disease Control and Prevention (CDC).This requirement significantly increased nursing home enrollment and reporting, which was formerly voluntary, to NHSN.This study will evaluate CDC processes for nursing home reporting of COVID-19 data to NHSN.We will assess CDC oversight and support of nursing home reporting and identify challenges reporting to NHSN that nursing homes have faced.Our work will inform the Department�s ongoing efforts to support infection surveillance, including the collection of routine infection data and data related to public health emergencies such as COVID-19. COVID-19; Departmental Operational Issues; Nursing Homes; Nursing Facilities, and Assisted Living Facilities; Public Health Issues; Elderly; Other Funding
October 2021 CMS, AHRQ Toolkit for Identifying Adverse Events Through Medical Record Review Office of Evaluation and Inspections OEI-06-21-00030 2022 OIG has found that patient harm is common among Medicare beneficiaries in a range of inpatient health care settings.Federal regulations require that hospitals and other health care facilities identify harm, such as adverse events, and work to reduce these events.We will use guidance materials and tools created for our prior studies of adverse events to develop a web-based toolkit for identifying and measuring adverse events to assist health care facilities, government agencies, and researchers in their efforts to improve care.We will share the resources that we developed and used in our adverse event studies to aid hospitals and other researchers in their own efforts to identify and monitor the incidence of adverse events.The toolkit will provide standard definitions for most event types, lists of triggers to flag patient harm, suggested guidance for reviewers, and considerations for clinical decision making. Hospitals; Quality of Care; Medicare A
October 2021 CMS, AHRQ, OMHA Adverse Events: Disparities Among Hospitalized Medicare Patients Office of Evaluation and Inspections OEI-06-21-00040 2022 Disparities in the delivery of health care and patient outcomes are a significant U.S. public health concern, with communities of color and other disadvantaged groups experiencing poorer health outcomes compared to the U.S. population as a whole.Research on disparities in patient safety and adverse events is limited and this study intends to add to the body of information specific to health outcome disparities.We will identify the extent to which disparities in adverse event rates exist and which patient and hospital characteristics are associated with higher adverse event rates (e.g., race/ethnicity, hospital type, and geographic location).We will use data collected for an ongoing OIG study of adverse events (OEI-06-18-00400), which includes detailed information about adverse events experienced by a random sample of 770 hospitalized Medicare patients.We will analyze these adverse event data in conjunction with demographic information available in the medical record and other information contained in CMS claims data or in publicly available datasets, such as U.S. Census Bureau data.An increased understanding of disparities in patient safety will help medical providers and researchers identify and address the underlying issues that contribute to inequities in the delivery of health care. Hospitals; Quality of Care; Medicare A; Other Minorities
October 2021 Centers for Medicare and Medicaid Services OIG Oversight of State Medicaid Fraud Control Units Office of Evaluation and Inspections OEI-06-21-00270; OEI-07-21-00340; OEI-06-21-00360; OEI-09-22-00020 2022 The 50 State Medicaid Fraud Control Units (MFCUs), located in 49 States and the District of Columbia, investigate and prosecute Medicaid provider fraud as well as complaints of patient abuse or neglect in Medicaid-funded facilities and board and care facilities.OIG provides oversight for the MFCUs and administers a Federal grant award that provides 75 percent of each MFCU's funding.As part of OIG's oversight, we provide guidance to the MFCUs; assess their adherence to Federal regulations, policy, and performance standards; and collect and analyze performance data.We also provide technical assistance and training and identify effective practices in MFCU management and operations.We will perform onsite reviews of a sample of MFCUs. Financial Stewardship; Grants; Medicaid
October 2021 Centers for Medicare and Medicaid Services Comparison of Average Sales Prices and Average Manufacturer Prices Office of Evaluation and Inspections OEI-03-22-00060; OEI-03-22-00070; OEI-03-22-00080; OEI-03-22-00090 2022 When Congress established average sales price (ASP) as the basis for Medicare Part B drug reimbursement, it also provided a mechanism for monitoring market prices and limiting potentially excessive Medicare payment amounts.The Social Security Act mandates that the OIG compare ASPs with average manufacturer prices (AMPs).If OIG finds that the ASP for a drug exceeds the AMP by 5 percent in the two previous quarters or three of the previous four quarters, the Secretary of HHS may substitute the reimbursement amount with a lower calculated rate.These quarterly memos summarize the results of OIG's comparison analysis based on ASP and AMP data.The memo specifically reports the number of drugs OIG identified that met the criteria for substitution of a lower reimbursement amount. OIG Statutory Authority and Regulatory Matters; Prescription Drug; Elderly; Medicare B
October 2021 Indian Health Service Audit of IHS Telehealth Technologies' Cybersecurity Controls Office of Audit Services W-00-21-42037 2022 The COVID-19 pandemic response has included a significant increase in the use of telehealth technologies to provide access to health care.The dramatic growth in telehealth utilization has introduced new cybersecurity risks to medical facilities, including Indian Health Service (IHS) facilities, that use these technologies.We will perform an audit to determine whether IHS has implemented select cybersecurity controls to protect its telehealth technologies from these emerging cybersecurity risks.
September 2021 Administration for Children and Families Efforts To Improve Response to Reports of Abuse and Neglect of Children Living in Congregate Care Facilities in Six States Office of Evaluation and Inspections OEI-07-21-00300 2023 In 2019, there were 9,744 reports of abuse and neglect in congregate care settings, raising concerns about abuse and neglect of children in congregate care facilities (e.g., group homes, residential facilities, institutional settings).For six selected States, this evaluation will analyze a sample of reports of abuse and neglect to determine how States monitor for and respond to these reports.We will also analyze how States respond to multiple reports from the same facility, and how States monitor for and respond to reports from multiple facilities that are owned by the same entity.Additionally, we will use structured interviews with staff from State child welfare agencies to determine how States oversee reports of abuse and neglect in congregate care facilities.Finally, we will analyze how the Administration for Children and Families supports States' efforts to monitor for and respond to reports of abuse and neglect, including responses to multiple reports from the same facility and reports from multiple facilities that are owned by the same entity. Quality of Care; Children and Families; Grants
September 2021 Centers for Medicare and Medicaid Services Accuracy of Manufacturer-Reported Average Sales Pricing Office of Evaluation and Inspections OEI-BL-21-00330 2022 Effective January 1, 2005, the Medicare Modernization Act of 2003 revised how Medicare Part B reimburses health care providers for physician-administered infused and injected drugs, moving from the average wholesale price to the average sales price (ASP).Congress has directed OIG to assess and submit to Congress a report—no later than January 1, 2023—on the accuracy of ASP information submitted by manufacturers and to include any recommendations on how to improve the accuracy of that information.This study will compare the ASPs for the top 25 highest-expenditure drugs in Medicare Part B to other benchmark prices and explore possible reasons for any potential pricing anomalies we identify. Prescription Drug; Medicare B
August 2021 Centers for Medicare and Medicaid Services COVID-19 Increased FMAP State Eligibility Audit Office of Audit Services W-00-21-31556 2022 The Federal Government pays its share of a State's Medicaid expenditures based on the Federal Medical Assistance Percentages (FMAPs), which vary depending on the State's per capita income.Although FMAPs are adjusted annually for economic changes in the States, Congress may increase FMAPs at any time.On March 18, 2020, the then President signed into law the Families First Coronavirus Response Act (FFCRA), which provided a temporary 6.2-percentage-point increase to each qualifying State's and territory's FMAP under section 1905(b) of the Act effective January 1, 2020.States must meet the requirements of section 6008(b) and (c) of the FFCRA to qualify to receive the temporary 6.2-percentage-point increase.We plan to perform audit work at selected States to determine whether those States met the requirements to receive the temporary COVID-19 FMAP increase. COVID-19; Medicaid
August 2021 Centers for Medicare and Medicaid Services Audit of Medicare Part B Opioid-Use-Disorder Treatment Services Provided by Opioid Treatment Programs Office of Audit Services W-00-21-35876 2023 Substance use disorders involving drugs or alcohol can cause serious health problems and even death.Medication-assisted treatment is used to treat substance use disorders, including opioid use disorders (OUDs); sustain recovery; and prevent overdoses.There are three medications to treat OUDs: buprenorphine, methadone, and naltrexone, which are approved by the Food and Drug Administration (FDA).Treatment for OUDs is provided in several settings, including freestanding opioid treatment programs (OTPs). Historically, OTPs could not enroll as providers in Medicare or be paid for services provided to Medicare beneficiaries.Section 2005 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) established a new Medicare Part B benefit for OUD treatment services furnished by OTPs.CMS implemented this benefit beginning January 1, 2020, as required by the SUPPORT Act.OUD treatment services include FDA-approved treatment medication, dispensing and administration of treatment medication, substance use counseling, individual and group therapy, and toxicology testing. In this audit, we will focus on claims for OUD treatment services provided by nonresidential (i.e., freestanding) OTPs, which are identified with the place-of-service code 58.We will review OUD treatment services for Medicare beneficiaries in nonresidential OTPs to determine whether the services were allowable in accordance with Medicare requirements. Financial Stewardship; Non-institutional care; Physician and Healthcare Practitioners; Public Health Issues; Quality of Care; Substance Abuse Disorders; Medicare B
August 2021 Substance Abuse and Mental Health Services Administration Audits of SAMHSA's Certified Community Behavioral Health Clinic Expansion Grants Office of Audit Services W-00-21-59463 2023 Certified Community Behavioral Health Clinics (CCBHCs) are designed to provide comprehensive 24/7 access to:­­ (1) community-based mental health and substance use disorder services, (2) treatment of co-occurring disorders, and (3) physical health care in one location.In Federal fiscal year 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA) awarded CCBHC expansion grants totaling approximately $450 million to increase access to and improve the quality of community mental health and substance use disorder treatment services through direct services.This included $250 million appropriated by the Coronavirus Aid, Relief and Economic Security Act.We will determine whether SAMHSA followed its policies and procedures for awarding and monitoring CCBHC expansion grants.In a separate audit, we will determine whether CCBHCs used expansion grant funds in accordance with Federal requirements and applicable grant terms. Contracts; COVID-19; Departmental Operational Issues; Financial Stewardship; Mental Health; Non-institutional care; Public Health Issues; Quality of Care; Substance Abuse Disorders; Grants
August 2021 Centers for Medicare and Medicaid Services Intimate Partner Violence Screening and Referral by Primary Care Providers for Patients Enrolled in Medicaid Office of Evaluation and Inspections OEI-03-21-00310 2023 Intimate partner violence—which includes physical, sexual, and psychological abuse—is a serious, preventable public health problem that affects millions of Americans.Primary care providers play a critical role in screening patients for intimate partner violence and referring patients who screen positive to support services.The U.S. Preventive Services Task Force (USPSTF) has a recommendation that clinicians screen for intimate partner violence in women of reproductive age and provide or refer women who screen positive to ongoing support services.Despite this recommendation, primary care providers may encounter barriers to screening—including lack of knowledge, time constraints, and lack of adequate compensation.Medicaid expansion programs must provide coverage of certain preventive services recommended by USPSTF including screening for intimate partner violence, and States may opt to cover this preventive service in their traditional Medicaid programs.However, there are no specific procedure codes for providers to bill for time spent screening for intimate partner violence and making referrals to support services.This evaluation will determine whether and how primary care providers who serve Medicaid enrollees screen for intimate partner violence and make referrals to support services.We also expect this work to identify opportunities to improve these screening and referral practices. Non-institutional care; Physician and Healthcare Practitioners; Public Health Issues; Quality of Care; Children and Families; Other Minorities; Medicaid
August 2021 National Institutes of Health Superfund Financial Activities at the National Institute of Environmental Health Sciences Office of Audit Services W-00-21-59050 2022 National Institutes of Health's National Institute of Environmental Health Sciences (NIEHS) provides Superfund Research Program funds for university-based multidisciplinary research on human health and environmental issues related to hazardous substances. Federal law and regulations require that OIG conduct an annual audit of the Institute's Superfund activities (Comprehensive Environmental Response, Compensation, and Liability Act of 1980, 42 U.S.C. § 9611(k)). We will review payments, obligations, reimbursements, and other uses of Superfund money by NIEHS. Departmental Operational Issues​; Other Funding
Revised Centers for Medicare and Medicaid Services Audit of Medicare Emergency Department Evaluation and Management Services Office of Audit Services W-00-21-35877; W-00-22-35877 2022 An emergency department is defined as an organized, hospital-based facility for providing unscheduled or episodic services to patients who present for immediate medical attention.Certain Current Procedural Terminology (CPT) codes should only be used when a beneficiary is seen in an emergency department and the services described by the health care CPT coding system code definition are provided.Medicare reimburses physicians based on a patient's documented needs at the time of a visit.All evaluation and management (E/M) services reported to Medicare must be adequately documented so that medical necessity is clearly evident.This review will determine whether Medicare payments to providers for emergency department E/M services were appropriate, medically necessary, and paid in accordance with Medicare requirements. Departmental Operational Issues​; Emergency Preparedness and Response; Hospitals; Physician and Healthcare Practitioners; Public Health Issues; Quality of Care; Medicare B
Completed Centers for Medicare and Medicaid Services Data Snapshot: Review of Beneficiaries Relationships With Providers for Telehealth Services Office of Evaluation and Inspections OEI-02-20-00521 10/18/2021 In response to the COVID-19 pandemic, both Congress and the Department of Health and Human Services (HHS) expanded access to telehealth for a wide range of services.This expansion enhanced the ability of health care providers to offer care to Medicare beneficiaries remotely during the COVID-19 pandemic.During the expansion, HHS used its enforcement discretion to relax the requirement that a beneficiary must have an established relationship with a provider to receive certain telehealth services.This data snapshot will describe the extent to which Medicare beneficiaries had established relationships with providers from whom they received telehealth services.We will also look for any differences in these relationships between traditional Medicare and Medicare Advantage and among the different types of telehealth services. COVID-19; Managed Care; Physician and Healthcare Practitioners; Medicare B; Medicare C
August 2021 Food and Drug Administration Review of the FDA's Accelerated Approval Pathway Office of Evaluation and Inspections OEI-01-21-00400 2023 The FDA recently approved Aduhelm (aducanumab) to treat patients with Alzheimer's disease using the accelerated approval pathway.The accelerated approval pathway allows the FDA to approve drugs that treat serious conditions and that fill an unmet medical need based on a surrogate endpoint, which is a marker that is thought to predict a clinical benefit.The FDA's approval of Aduhelm raised concerns due to alleged scientific disputes within the FDA, the advisory committee's vote against approval, allegations of an inappropriately close relationship between the FDA and the industry, and the FDA's use of the accelerated approval pathway.In response to these concerns, we will assess how the FDA implements the accelerated approval pathway.This will include reviewing interactions between the FDA and outside parties as well as other aspects of the process, such as deciding on this pathway and scientific disputes.We will review the FDA's relevant policies and procedures, determine compliance with them, and make appropriate findings and recommendations based on a sample of drugs approved using the accelerated approval pathway, which will include Aduhelm.We will not assess the scientific appropriateness of the FDA's approval of any of the drugs under review.This work may result in multiple reports. Food, Drug, and Device Safety; Prescription Drug; Other Funding
Revised Administration for Children and Families Reported Experiences of Staff at Fort Bliss Emergency Intake Site Office of Evaluation and Inspections OEI-07-21-00251 2022 A surge in arrivals of unaccompanied children in spring of 2021 resulted in a dramatic rise in referrals to the Office of Refugee Resettlement (ORR), a program office in the Administration for Children and Families.To accommodate these children, ORR established Emergency Intake Sites (EISs)-temporary, unlicensed mass care provider facilities designed to meet basic standards of care for children on a short-term basis when ORR's permanent, licensed facilities and Influx Care Facilities are unable to accommodate new arrivals.ORR opened its largest EIS at Fort Bliss in El Paso, Texas, on March 30, 2021, to care for up to 10,000 children.In the months since Fort Bliss EIS (Fort Bliss) opened, several individuals have raised concerns about the quality of case management provided there, and its negative impact on children's safety and well-being.This review will analyze interviews and on-site observations regarding case management challenges at Fort Bliss that may have impeded the safe and timely release of children to sponsors.This oversight will help ensure that Fort Bliss and other EISs provide adequate case management services. Contracts; Departmental Operational Issues​; Mental Health; Quality of Care; Children and Families; Other Minorities; Grants
July 2021 Substance Abuse and Mental Health Services Administration Audit of States' Administration of SAMHSA's Substance Abuse Prevention and Treatment Block Grant Funding Office of Audit Services W-00-21-59462 2022 The Substance Abuse and Mental Health Services Administration's (SAMHSA's) Substance Abuse Prevention and Treatment Block Grant (SABG) program is the largest Federal program dedicated to improving publicly funded substance abuse prevention and treatment systems.The program provides funds to all 50 States, the District of Columbia, and U.S. Territories to prevent and treat substance abuse.Federal requirements for the SABG program state that fiscal control and accounting procedures must permit the tracing of funds to a level of expenditure adequate to establish that such funds were not used in violation of block-grant restrictions and statutory prohibitions (45 CFR § 96.30).We will determine whether the States' SABG expenditures for subrecipients, including expenditures for contracted transitional housing providers, complied with Federal and State requirements. Financial Stewardship; Physician and Healthcare Practitioners; Public Health Issues; Substance Abuse Disorders; Grants
July 2021 Centers for Medicare and Medicaid Services States' Oversight of Medicaid Managed Care Medical Loss Ratios Office of Evaluation and Inspections OEI-03-20-00231 2022 Medical loss ratio (MLR) requirements in Medicaid managed care provide a method for addressing State and Federal concerns about growth in Medicaid spending.Federal MLR requirements are intended to ensure that Medicaid managed care plans spend most of the Medicaid capitation payments received from States on beneficiaries' medical care, which limits the amount plans can spend on administration and keep as profit.Pursuant to the May 2016 Medicaid managed care final rule, States must include requirements in managed care plan contracts for plans to calculate MLR percentages and report percentages and related, underlying data to the States.States' collections of complete and accurate MLR data from their managed care plans provide a critical first step for determining Medicaid managed care MLR performance nationwide.Complete and accurate MLR data also enable States to set appropriate managed care payment rates to control Medicaid costs.This work will: (1) determine whether States receive all required MLR data from their plans and (2) examine States' oversight of Medicaid managed care plans' compliance with MLR requirements. Financial Stewardship; Medicaid
July 2021 Centers for Disease Control and Prevention Audit of Centers for Disease Control and Prevention Racial and Ethnic Approaches to Community Health (REACH) Program Office of Audit Services W-00-21-59460 2023 The Racial and Ethnic Approaches to Community Health (REACH) program, administered by the Centers for Disease Control and Prevention (CDC), awards funds to State and local health departments, tribes, universities, and community-based organizations to improve health, prevent chronic diseases, and reduce health disparities among racial and ethnic populations with the highest risk of chronic disease.In FY 2018, CDC awarded $125.5 million in REACH funds to 31 recipients for a 5-year project period beginning September 30, 2018, with 1-year awards averaging $780,000 per recipient.Grant recipients work with communities to reduce health disparities among racial and ethnic populations with the highest burden of chronic disease (e.g., heart disease, type 2 diabetes, and obesity).The program provides culturally tailored interventions to address preventable risk behaviors, including tobacco use, poor nutrition, and physical inactivity.REACH grant recipients are required to work with one or two of the following priority populations: African Americans, Hispanic Americans, Asian Americans, Native Hawaiians/Other Pacific Islanders, and American Indians/Alaska Natives.Recipients are also required to work in three of the following four strategy areas-tobacco, nutrition, physical activity, and community-clinical linkages-and their accompanying activities to improve social and environmental conditions for better health in the community.We will determine whether selected REACH grant recipients used their funding in accordance with Federal requirements and grant terms.Specifically, OIG plans to audit REACH program funds awarded to the selected recipients to ensure that REACH program funds were used for their intended purposes and met the needs of priority populations. Financial stewardship; Public Health Issues; Quality of Care; Native Americans; Other Minorities; Grants
July 2021 National Institutes of Health NIH's Oversight Processes To Ensure Diversity Among Human Subjects Enrolled in Clinical Trials Office of Evaluation and Inspections OEI-01-21-00320 2022 Underrepresentation of racial and ethnic minorities, women, and individuals of all ages in clinical trials has been a longstanding concern and has garnered increased attention due to the COVID-19 pandemic's disproportionate impact on minority populations.The National Institutes of Health (NIH) is the largest funder of biomedical and public health research, supporting over $31 billion of research across the agency.NIH's responsibilities include reviewing annual progress reports that document grantees' progress toward NIH-approved enrollment plans, which may include a diversity and inclusion component.This study will assess and describe how NIH monitors and ensures enrollment of racial and ethnic minorities, women, and individuals of all ages within the clinical trials it funds and the actions it takes in response to clinical trials that are not meeting approved enrollment plans.This study will also identify NIH's challenges and the steps it takes to address these challenges while monitoring and ensuring that its grantees meet their commitments to inclusive enrollment in their clinical trials. Financial Stewardship; Public Health Issues; Elderly; Other Minorities; Grants
July 2021 Centers for Medicare and Medicaid Services Home Health Agencies' Emergency Communication Plans: Strengths and Challenges Ensuring Continuity of Care During Disasters Office of Evaluation and Inspections OEI-04-21-00280 2023 The COVID-19 pandemic highlighted the importance of emerging infectious disease (EID) preparedness in health care facilities, including home health agencies (HHAs).OIG has ongoing work reviewing HHA preparedness for EIDs.However, HHAs also must prepare for other types of emergencies.Natural disasters such as hurricanes, floods, and fires continue to threaten operations, even as HHAs continue to address the impact of COVID-19.In 2020, the United States experienced a record number of natural disasters, and Federal scientists predict a greater number of hurricanes and storms in 2021.Previous natural disasters highlighted vulnerabilities in HHAs' preparedness for disasters, specifically with regards to communication and continuity of care.Since November 2017, HHAs have had to comply with CMS Emergency Preparedness Conditions of Participation (EP CoPs).As part of these EP CoPs, CMS requires HHAs to develop communication plans that must include information necessary to ensure continuity of care during any emergency.This evaluation will determine selected HHAs' compliance with EP CoPs and will report factors these HHAs identify as hindering and/or supporting continuity of care during a disaster. Emergency Preparedness and Response; Medicare A
June 2021 National Institutes of Health National Institutes of Health and Grantee Compliance With Federal Requirements To Ensure Proper Monitoring and Use of Grant Funds by Selected Grantees and Subgrantees Office of Audit Services W-00-21-59461 2022 The National Institutes of Health (NIH) is the primary Federal agency that conducts and supports medical research.NIH funds grants, cooperative agreements, and contracts that support the advancement of fundamental knowledge about the nature and behavior of living systems.Approximately 80 percent of NIH funding goes to support research grants, including grants and subawards to support research conducted outside the United States.OIG has previously identified NIH's oversight of grants to foreign applicants as a potential risk to the Department meeting program goals and the appropriate use of Federal funds.NIH must manage and administer Federal awards to ensure that Federal funding is expended and associated programs are implemented in full accordance with statutory and public policy requirements.To do so, NIH must monitor grantee performance and grantee use of NIH funds.Grantees are responsible for complying with all requirements of the Federal award, including maintaining effective internal controls over the Federal award (45 CFR § 75.300 and § 75.305).Grantees that function as pass-through entities must monitor the activities of subrecipients, including foreign subrecipients, to ensure that subawards are used for authorized purposes in compliance with relevant laws and the terms and conditions of the subaward (45 CFR § 75.352). We will review NIH's monitoring of selected grants, and grantee use and management of NIH grant funds in accordance with Federal requirements. COVID-19; Departmental OperationalIssues; Financial Stewardship; Grants
June 2021 Centers for Medicare and Medicaid Services Medicare Payments for Clinical Diagnostic Laboratory Tests in 2020 Office of Evaluation and Inspections OEI-09-21-00240 2022 Medicare is the largest payer of clinical laboratory services in the Nation.Medicare Part B covers most laboratory tests and pays 100 percent of allowable charges.Beneficiaries do not have a copay.The Protecting Access to Medicare Act of 2014 (PAMA) requires CMS to set payment rates for laboratory tests using current charges in the private health care market, under Title XVIII of the Social Security Act.(Pub. L. No. 113-93 § 216(c)(2)(A)).On January 1, 2018, CMS began paying for laboratory tests under the new system mandated by PAMA.PAMA requires OIG to publicly release an annual analysis of the top 25 laboratory tests by expenditures.In accordance with the Act, we will publicly release an analysis of the top 25 laboratory tests by expenditures for 2020. Laboratories; Elderly; Medicare B
Revised Centers for Medicare and Medicaid Services Audit of CMS Clinical Laboratory Fee Schedule Rate-Setting Process for Public Health Emergencies Office of Audit Services W-00-21-35875; W-00-22-35875 2022 Medicare Part B pays for most clinical diagnostic laboratory tests (CDLTs) under the Clinical Laboratory Fee Schedule (CLFS).As a result of the Protecting Access to Medicare Act of 2014 (PAMA), beginning in 2018, CMS sets CLFS reimbursement rates based on the weighted median of private payer rates reported to CMS.A rate is set for each CDLT's Healthcare Common Procedure Coding System (HCPCS) code.The data are reported every 3 years, beginning January 1, 2017.(Reporting was postponed from January 1, 2020, to January 1, 2022, because of the pandemic.) For new CDLTs, CMS or its Medicare administrative contractors set reimbursement rates using "cross-walking" or "gap-filling" methodologies.CMS determines the basis (i.e., cross-walking or gap-filling) after it solicits and receives public comments, announces and holds its CLFS annual public meeting regarding new CDLTs, and considers comments and recommendations (and accompanying data) received, including recommendations from an outside advisory panel.The objective of this audit is to determine whether CMS's procedures for clinical diagnostic laboratory test rate-setting could be improved for future public health emergencies. Departmental Operational Issues; Emergency Preparedness and Response; Quality of Care; Public Health Issues; Laboratories; Medicare B
June 2021 Centers for Medicare and Medicaid Services Audit of Independent Organ Procurement Organizations' Organ Acquisition Overhead Costs Office of Audit Services W-00-21-35874 2022 We will review Medicare payments made to independent organ procurement organizations (OPOs).An OPO is an organization that performs or coordinates the procurement, preservation, and transport of organs and maintains a system for locating prospective beneficiaries for available organs.Medicare reimburses OPOs under 42 CFR § 413.200 according to a cost basis method set out at 42 CFR § 413.24.Prior OIG audits determined that OPOs did not comply with Medicare requirements for reporting overhead costs and administrative and general costs and for reporting organ statistics.We will determine whether payments to OPOs for selected overhead costs complied with Medicare requirements and guidance. Financial Stewardship; Medicare A
June 2021 Health Resources and Services Administration Audit of HRSA's Cybersecurity Controls over the Organ Procurement and Transplantation Network Office of Audit Services W-00-21-42036 2022 The National Organ Procurement and Transplantation Network (OPTN) is used to assist medical professionals involved in U.S. organ donation and transplantation.OPTN is operated under contract with the Health Resources and Services Administration (HRSA).The OPTN operates a transplant information database containing national data on the candidate waiting list, organ donation and matching, and transplantation. This system is critical in helping organ transplant institutions match waiting candidates with donated organs.If appropriate cybersecurity controls are not implemented, there may be a significant impact to patients and health care providers should there be a cybersecurity incident.We will conduct a penetration test and determine whether HRSA has ensured there are adequate cybersecurity controls over OPTN. Departmental Operational Issues​; Information Technology and Cybersecurity; Other Funding
June 2021 National Institutes of Health National Institutes of Health's Use of Single Audit Requirements To Enhance Program Integrity Office of Evaluation and Inspections OEI-04-21-00160 2023 HHS is the largest grant-making agency in the United States.As part of HHS, the National Institutes of Health (NIH) awarded $33.4 billion in grants to over 2,500 external organizations (i.e., universities, medical schools, hospitals, and other research facilities) in FY 2020.External NIH grantees expending $750,000 or more in Federal funds per year must conduct an annual audit in accordance with the Single Audit Act and 45 CFR part 75.These audits provide assurances to NIH that its grantees have adequate internal controls and comply with certain program requirements.NIH must use its grantees' audits to follow up on findings and improve Federal program outcomes.Such action will work to protect the integrity of its awards from fraud, waste, and abuse.We will determine the extent to which NIH monitors and uses grantees' audit findings to improve program integrity at both the individual grantee level and across grantees. Financial Stewardship; Grants
Revised Centers for Medicare and Medicaid Services Accuracy of Place-of-Service Codes on Claims for Medicare Part B Physician Services When Beneficiaries Are Inpatients Under Part A Office of Audit Services W-00-21-35872; �W-00-22-35872 2022 Generally, Medicare makes payments under Part B for physician services and payments under Part A for the costs of inpatient stays at inpatient facilities such as skilled nursing facilities (SNFs) and hospitals.While Medicare pays both SNFs and hospitals through prospective payment systems for the costs of inpatient stays, physician services provided to SNF and hospital inpatients are paid according to the Medicare Physician Fee Schedule.The amount Medicare pays physician service providers (such as physicians, podiatrists, and nurse practitioners, referred to collectively as "physicians") can vary based on where the service is provided (such as a SNF, hospital, or physician's office).Physician services can include medical and surgical procedures, office visits, and medical consultations.Fee schedule payments for physician services are based on three major categories of physician costs: practice expense, physician work, and malpractice insurance.The practice expense is intended to cover overhead costs involved in providing a service.To account for different practice expenses that physicians incur at different settings, Medicare designates a nonfacility rate and a facility rate for each service within the fee schedule.Because physicians generally incur higher practice expenses by performing services in their offices and other nonfacility settings such as independent clinics and urgent care facilities, Medicare generally reimburses physicians at a higher nonfacility rate for services performed in these settings.For services performed at a facility setting such as a SNF or hospital, Medicare generally reimburses physicians for services at a lower facility rate, and the prospective payment system payment to the facility covers the overhead expense.Physicians indicate the applicable place of service on a Medicare claim using a two-digit place-of-service code to ensure that Medicare properly reimburses the physician at either the nonfacility rate or the facility rate.The physical setting where a physician performs a service does not always determine the appropriate place-of-service code.For example, when a beneficiary is a registered inpatient at a hospital or SNF, physician services should always be coded with a facility place-of-service code and paid at the facility rate.This is irrespective of the setting where the patient actually receives the facetoface encounter.Our preliminary data analysis indicates that during 2018 and 2019, Medicare may have paid a significant number of Part B physician service claim lines at the nonfacility rate when the beneficiary was a Part A inpatient at either a hospital or SNF.We will determine whether Medicare appropriately paid claims for Part B physician services based on the correct place-of-service code when a beneficiary was an inpatient at a SNF or hospital. Financial Stewardship; Hospitals; Nursing Homes, Nursing Facilities, and Assisted Living Facilities; Physician and Healthcare Practitioners; Elderly; Medicare B
June 2021 Centers for Medicare and Medicaid Services Audit of Medicaid Applied Behavior Analysis for Children Diagnosed With Autism Office of Audit Services W-00-21-31555 2022 Autism spectrum disorder (autism) is a developmental disability that can cause significant social, communication, and behavioral challenges for children.According to the Centers for Disease Control and Prevention, there is currently no cure for autism; however, research has shown that early intervention and treatment can improve a child's development.A common treatment for autism is Applied Behavior Analysis (ABA).ABA can help an autistic child improve social interaction, learn new skills, maintain positive behaviors, and minimize negative behaviors.In the past few years, some Federal and State agencies have identified questionable billing patterns by some ABA providers as well as Federal and State payments to providers for unallowable services.We will audit Medicaid claims for ABA services provided to children diagnosed with autism to determine whether a State Medicaid agency's ABA payments complied with Federal and State requirements. Financial Stewardship; Non-institutional care; Children and Families; People with Disabilities; Medicaid
June 2021 Administration for Children and Families Safe and Efficient Release of Unaccompanied Children to Sponsors Office of Evaluation and Inspections OEI-07-21-00250 2022 The Office of Refugee Resettlement (ORR), a program office of HHS's Administration for Children and Families, experienced a surge of unaccompanied children in spring 2021.As a result of this surge, ORR experienced difficulties in increasing its capacity to care for unaccompanied children; ORR-funded facilities also faced challenges in recruiting and retaining staff.The need to release unaccompanied children to fully vetted sponsors during a surge may have created vulnerabilities that could have put the children's safety at risk.To address this concern, we will conduct an evaluation of the implementation and efficiency of ORR's sponsor screening and followup processes at facilities during this surge, including the newly established intake and influx centers.This evaluation will determine to what extent: (1) proper steps were taken to safely release unaccompanied children to sponsors and (2) these processes were completed in an efficient manner.
June 2021 Administration for Children and Families Office of Refugee Resettlement Influx Care Facilities and Emergency Intake Sites: Employee/Staff Background Screening Office of Audit Services W-00-21-59459 2022 To address the number of unaccompanied children arriving at the southern border and being referred into the Administration for Children and Families, Office of Refugee Resettlement's (ORR) custody and care, ORR has opened temporary Influx Care Facilities (ICF) and Emergency Intake Sites (EIS) that are not State-licensed.In March 2021, ORR issued waivers for certain background checks for employees, staff, and volunteers at some of its ICF and EIS due to the impossibility or impracticability of obtaining the background check results in a timely manner.Our audit will determine whether these facilities are conducting the background checks that are still required before employees are hired and are implementing mitigation strategies to ensure the safety and well-being of children if ORR permitted employees to have direct access to children before background checks were completed. COVID-19; Public Health Issues; Quality of Care; Children and Families; Grants
June 2021 Administration for Children and Families Office of Refugee Resettlement Influx Care Facilities and Emergency Intake Sites: COVID-19 Protocol and Reporting Office of Audit Services W-00-21-59458 2022 In response to the increase in the number of unaccompanied children transferred into the custody of the Office of Refugee Resettlement (ORR), ORR opened temporary facilities known as Influx Care Facilities (ICF) and Emergency Intake Sites (EIS).In March 2021, ORR issued new guidelines, in consultation with the Centers for Disease Control and Prevention (CDC), for safeguarding against COVID-19 in ORR facilities, including guidance for shortening COVID-19 quarantine duration and increasing testing.Our audit will determine whether the ICF and EIS, which are not State-licensed, have procedures in place to promptly identify and treat children coming into care who have COVID-19 and mitigate the spread of the disease in their facilities.Additionally, we will assess the completeness of ICF and EIS facilities' COVID-19 testing data and results reported to ORR and State/local health entities, as appropriate. COVID-19; Public Health Issues; Quality of Care; Children and Families; Grants
May 2021 HHS, OCR, CMS Audit of the Effectiveness of HHS's Governance To Ensure Hospitals Implement Measures To Prevent, Detect, and Recover From Cyberattacks Office of Audit Services W-00-21-42035 2022 Ransomware, destructive malware, insider threats, and even honest mistakes present an ongoing threat to U.S. hospital operations and the security of electronic protected health information (ePHI).The more quickly and effectively hospitals detect and respond to attacks that may affect the availability and integrity of their data, the more likely they may avoid service disruptions that could potentially affect patient data or lives and save time and money that would be required to recover from such attacks.In recent years, multiple hospitals have fallen prey to significant cyberattacks, including ransomware attacks during the COVID-19 pandemic that have impacted hospital operations and patient care.In October 2020, the Cybersecurity and Infrastructure Security Agency, Federal Bureau of Investigation, and Department of Health and Human Services (HHS) issued a joint cybersecurity advisory regarding ransomware activity targeting the health care and public health sector.The advisory stated that threat actors have continued to develop new functionality and tools, thereby increasing the ease, speed, and profitability of ransomware attacks.HHS-OIG will audit HHS's governance over its programs to determine whether HHS's Office of Civil Rights (OCR) has performed periodic audits of hospitals to assess compliance with Health Insurance Portability and Accountability Act (HIPAA) Security, Privacy, and Breach Notification rules and determine whether these audits effectively assessed ePHI protections.In addition, we will determine whether CMS's certification process for participation in the Medicare program requires hospitals participating in the Medicare program to implement minimum security safeguards to prevent and detect cyberattacks, ensure continuity of patient care, and protect beneficiary data.We will also conduct security assessments at 10 U.S. hospitals to determine whether they have adequately implemented HIPAA security requirements or effective cybersecurity measures to prevent, detect, and recover from cyberattacks. Departmental Operational Issues; Emergency Preparedness and Response; Hospitals; Information Technology and Cybersecurity; Medicare A
May 2021 Centers for Medicare and Medicaid Services Medicare-Related Capital Costs Reported by New Hospitals Office of Audit Services W-00-21-35870 2022 Hospitals are paid through Medicare Part A for Medicare-related capital costs (such as depreciation, interest, rent, and property-related insurance and tax costs).Most hospitals receive payment for capital costs through the Medicare Inpatient Prospective Payment System (IPPS) whereby a portion of their payment for each patient discharge is intended to cover capital costs.New hospitals can be exempted from the IPPS and be paid on a cost basis for their first 2 years of operation.We will determine whether new hospitals claimed Medicare-related capital costs in accordance with Federal regulations. Financial Stewardship; Hospitals; Medicare A
Revised Centers for Medicare and Medicaid Services Audits of Medicare Payments for Spinal Pain Management Services Office of Audit Services W-00-21-35825; W-00-22-35825 2022 Medicare Part B covers various spinal pain management services including facet joint injections, facet joint denervation sessions, lumbar epidural injections, and trigger point injections.Medicare Part B also covers sedation administered during these pain management services.We will audit whether Medicare payments for spinal pain management services billed by physicians complied with Federal requirements. Medical Supplies and Equipment;Physician and Healthcare Practitioners; Elderly; Medicare B
May 2021 Centers for Medicare and Medicaid Services Impact of Expanding the Hospital Transfer Payment Policy for Early Discharges to Postacute Care Office of Audit Services W-00-21-35871 2022 We will determine how the hospital transfer policy for early discharges to postacute care (PAC) would financially affect Medicare and hospitals if it were expanded to include all Medicare Severity Diagnosis-Related Groups (MS-DRGs).The transfer payment policy for discharges from hospitals to PAC facilities, such as a skilled nursing facility, applies to certain specified MS-DRGs.Analysis of Medicare claims data demonstrates significant occurrences of early discharges from hospitals to PAC facilities for MS-DRGs that are not currently subject to the PAC transfer payment policy.Medicare pays a full prospective payment system (PPS) rate to hospitals for these early discharges.In contrast, Medicare pays hospitals a reduced payment for shorter lengths of stay for certain MS-DRGs when beneficiaries are transferred to PAC settings (42 CFR § 412.4(f)).Our proposed audit would provide CMS with a more updated analysis of the financial impact that an expanded hospital-to-PAC transfer payment policy (i.e., all MS-DRGs) would have on Medicare and hospitals. Financial Stewardship; Hospitals; Medicare A
May 2021 Administration for Children and Families Impact of the COVID-19 Pandemic on State Child Support Enforcement Programs Office of Evaluation and Inspections OEI-06-21-00150 2022 The Office of Child Support Enforcement (OCSE) within the Administration for Children and Families funds and oversees State child support enforcement (CSE) agencies, which establish child support orders and collect support.CSE agencies have faced challenges in maintaining their operations and providing essential services during the COVID-19 pandemic.Such challenges include limited access to State courts for child support hearings.Nationally, child support programs are an important source of funds for families, and high unemployment resulting from the COVID-19 pandemic makes these services even more critical.Using a survey of State CSE agencies, interviews, and document reviews, our study will assess the impact of the COVID-19 pandemic on State CSE operations.In addition, we will evaluate the support and oversight of States by the Federal OCSE.We will also identify strategies and promising approaches used by State CSE agencies in managing these critical services during a national emergency. Covid-19; Emergency Preparedness and Response; Children and Families; Other Funding
Revised Health Resources and Services Administration Audit of CARES Act Provider Relief Funds—Payments to Health Care Providers That Applied for General Distribution Under Phases 1, 2, and 3 Office of Audit Services W-00-21-35873; �W-00-22-35873 2022 The Provider Relief Fund (PRF), a $178 billion program, provides relief funds to hospitals and other health care providers for health-care-related expenses or lost revenue attributable to COVID-19 and to ensure that uninsured Americans can get testing and treatment for COVID-19.For the General Distribution of the PRF, HHS allocated funds in three phases: $50 billion during Phase 1 for Medicare providers; $18 billion during Phase 2 for Medicaid and Children's Health Insurance Program providers, dental providers, certain Medicare providers, and assisted living facilities; and $24 billion during Phase 3 for certain behavioral health providers and newly practicing providers, as well as providers that received a payment under a previous phase. Providers applying for General Distribution funds must meet certain requirements, such as submitting revenue information and supporting documentation to the Health Resources and Services Administration, which uses this information to determine eligibility and payments.We will perform a series of audits of funds related to the three phases of the General Distribution to determine whether payments were: (1) correctly calculated for providers that applied for these payments, (2)  supported by appropriate and reasonable documentation, and (3) made to eligible providers. COVID-19; Financial Stewardship; Other Funding
April 2021 National Institutes of Health NIH Oversight of Foreign Grant Recipients' Compliance With Audit Requirements Office of Audit Services W-00-21-59457 2022 The National Institutes of Health (NIH) is the primary Federal agency for conducting and supporting medical research.To realize its mission of extending healthy lifespans and reducing the burdens of illness and disability, NIH funds grants, cooperative agreements, and contracts that support the advancement of fundamental knowledge about the nature and behavior of living systems.The 27 Institutes and Centers of NIH provide leadership and financial support to researchers both inside and outside the United States.Approximately 80 percent of NIH funding goes to support research grants, including grants to foreign organizations.Foreign grant recipients that spend $750,000 or more in HHS funds within one year are subject to certain audit requirements intended to provide assurance to the Federal Government that the recipient has in place adequate internal controls and is generally in compliance with program requirements.We will review NIH funding to foreign grant recipients to determine whether: (1) NIH foreign grant recipients submit required audit reports and (2) NIH appropriately maintains and uses the audit reports. Departmental Operational Issues; Financial Stewardship; Grants
Completed (partial) Centers for Medicare and Medicaid Services Meeting the Challenges Presented by COVID-19: Nursing Homes Office of Evaluation and Inspections OEI-02-20-00490;
OEI-02-20-00491;
OEI-02-20-00492
2022 Nursing homes have been at the epicenter of the COVID-19 pandemic.Residents in these homes have been particularly affected by the disease, as they are predominantly elderly individuals who have underlying medical conditions and live in close quarters.To prevent and mitigate future outbreaks, it is important that we understand how nursing homes experienced the COVID-19 pandemic.This nationwide, three-part study will examine how the pandemic affected nursing homes.The first part will analyze the extent to which Medicare beneficiaries residing in nursing homes were diagnosed with COVID-19 and describe the characteristics of those who were at greater risk.The second part will describe the characteristics of the nursing homes that were hardest hit by the pandemic (i.e., homes with high numbers of beneficiaries who had COVID-19).The third part will describe the strategies nursing homes used to mitigate the unprecedented challenges of COVID-19.These challenges include procuring critical supplies, testing residents and staff, isolating high numbers of contagious residents, caring for those afflicted, and protecting residents and staff on a scale never before experienced in this country. COVID-19; Emergency Preparedness and Response; Nursing Homes, Nursing Facilities, and Assisted Living Facilities; Quality of Care; Elderly; Medicare A; Medicare B; Medicare C; Other Funding
April 2021 Centers for Disease Control and Prevention Use of States' Immunization Information Systems To Monitor COVID-19 Vaccinations Office of Evaluation and Inspections OEI-05-22-00010 2022 Immunization Information Systems (IISs) play an integral role in monitoring vaccine uptake in the population and meeting vaccination goals.While the Centers for Disease Control and Prevention (CDC) and other stakeholders have long invested significant efforts to establish plans and standards to guide improvements in IISs, State, and local jurisdictions have often struggled to make these improvements.CDC's work to collect and share data on COVID-19 vaccinations relies heavily on State and local IISs working with Federal systems, but the preexisting limitations of these systems pose challenges for CDC's goal of comprehensive immunization data being made available for clinical and public health uses.This study will examine State and Federal experiences using these systems to collect, share, and monitor data on COVID-19 vaccinations, and identify lessons learned that can improve vaccination data and monitoring for future mass vaccination campaigns as well as routine vaccination programs. COVID-19; Emergency Preparedness and Response; Information Technology and Cybersecurity; Public Health Issues; Other Funding
April 2021 Indian Health Service Audit of Background Verification Process at IHS-Operated Health Facilities Office of Audit Services W-00-21-59454 2022 The Indian Child Protection and Family Violence Prevention Act (P.L. No. 101-630) requires background checks, including Federal Bureau of Investigation fingerprinting, for individuals whose duties involve contact with children.Furthermore, Indian Health Service (IHS) appropriated funds may not be used to pay for services provided by individuals excluded from federally funded health care programs.Prior OIG audit work identified IHS and Tribal health facilities that did not meet Federal requirements for background verifications of employees in contact with children.We will determine whether IHS-operated health facilities met Federal requirements for background verifications of employees, contractors, and volunteers in contact with Indian children served by the facilities, and whether health care providers treating these children were appropriately licensed. Departmental Operational Issues; Hospitals; Quality of Care; Children and Families; Native Americans; Grants; Medicaid; Medicare A; Medicare B
April 2021 Centers for Medicare & Medicaid Services Duplicate Medicare Professional Fee Billing by Both the Critical Access Hospital and the Health Care Practitioner to Medicare Part B Office of Audit Services W-00-21-35869 2022 Under Section 1834(g)(1) of the Social Security Act and Federal regulations (42 CFR §§ 410.152(k) and 413.70(b)), Critical Access Hospitals (CAHs) are paid under the Standard Payment Method unless they elect to be paid under the Optional (Elective) Payment Method.Under Section 1834(g)(2) of the Social Security Act and Federal regulation (42 CFR § 413.70(b)(3)(i)), a CAH may elect the Optional (Elective) Payment Method, under which it bills the Part B Medicare Administrative Contractor (MAC) for both Medicare Part B facility services and Medicare Part B professional services for its outpatients.If a physician or other practitioner reassigns his or her Medicare Part B billing rights pursuant to 42 CFR part 424, subpart F, and agrees to be included under a CAH's Optional (Elective) Payment Method, he or she must not bill the MAC for any outpatient professional services furnished at the CAH once the reassignment becomes effective.The CAH must forward a copy of the completed assignment form (Form CMS 855R) to the MAC and keep the original form on file.Each practitioner must sign an attestation that clearly states that he or she will not bill Medicare Part B for any services furnished in the CAH outpatient department once the reassignment has been given to the CAH (Medicare Claims Processing Manual, Chapter 4, Section 250.2).We will determine whether CAHs forwarded a completed Form CMS 855R to the MAC.We will determine whether both the CAH and physician billed and were paid by the MAC for the same outpatient professional services.We will determine whether the beneficiary paid coinsurance amounts to both the CAH and physician or other practitioner.We will also determine whether CMS has an edit in place to ensure that duplicate payments for beneficiary outpatient professional services are not made. Hospitals; Medicare A; Medicare B
April 2021 Centers for Medicare & Medicaid Services Skilled Nursing Facility Reimbursement Office of Audit Services W-00-21-35784 2022 A skilled nursing facility (SNF) is a nursing home that provides skilled nursing care and rehabilitation services such as physical, speech, and occupational therapy to beneficiaries who need assistance after hospitalization.  In October 2019, the Centers for Medicare & Medicaid Services (CMS) implemented a new payment system for determining Medicare Part A payments to SNFs.  Specifically, CMS implemented the Patient Driven Payment Model (PDPM), a new case-mix classification system for classifying SNF patients in a Medicare Part A covered stay into payments groups under the SNF Prospective Payment System.  Under PDPM, payment is determined by factoring in a combination of six payment components.  Five of the components are case-mix adjusted and include a physical therapy component, an occupational therapy component, a speech-language pathology component, a nontherapy ancillary services component, and a nursing component.  Additionally, there is a non-case-mix adjusted component to cover utilization of SNF resources that do not vary according to patient characteristics.  We will determine whether Medicare payments to SNFs under PDPM complied with Medicare requirements. Nursing Homes, Nursing Facilities, and Assisted Living Facilities; Elderly; Medicare A
April 2021 Health Resources and Services Administration Audit of Health Resources and Services Administration's COVID-19 Supplemental Grant Funding for Health Centers Office of Audit Services W-00-21-59456 2022 The Health Resources and Services Administration (HRSA) awarded nearly $2 billion in supplemental grant funding to 1,387 health centers nationwide in fiscal year (FY) 2020 to respond to the COVID-19 public health emergency.The funding was intended to support the health centers' activities related to the detection, prevention, diagnosis, and treatment of COVID-19, including maintaining or increasing health center capacity and staffing levels during the pandemic, and expanding COVID-19 testing.The performance period for each of these one-time supplemental grant awards, which HRSA began awarding in March 2020, is 12 months.  Health centers were permitted to charge to their awards pre-award costs in order to support expenses related to the COVID-19 public health emergency dating back to January 20, 2020.We will determine whether health centers used their HRSA COVID-19 supplemental grant funding in accordance with Federal requirements and grant terms. COVID-19; Emergency Preparedness and Response; Financial Stewardship; Public Health Issues; Grants
Revised Centers for Medicare & Medicaid Services Dermatologist Claims for Evaluation and Management Services on the Same Day as Minor Surgical Procedures Office of Audit Services W-00-21-35868 2022 Medicare covers an Evaluation and Management (E/M) service when the service is reasonable and necessary for the diagnosis or treatment of illness or injury, or to improve the functioning of a malformed body member.Generally, Medicare payments for global surgery procedures include payments for necessary preoperative and postoperative services related to surgery when furnished by a surgeon.Medicare global surgery rules define the rules for reporting E/M services with minor surgery and other procedures covered by these rules.In general, E/M services provided on the same day of service as a minor surgical procedure are included in the payment for the procedure.The decision to perform a minor surgical procedure is included in the payment for a minor surgical procedure and must not be reported separately as an E/M service.An E/M service should be billed only on the same day if a surgeon performs a significant and separately identifiable E/M service that is unrelated to the decision to perform a minor surgical procedure.In this instance, the provider should append a modifier 25 to the appropriate E/M code.In 2019, about 56 percent of dermatologists' claims with an E/M service also included minor surgical procedures (such as lesion removals, destructions, and biopsies) on the same day.This may indicate abuse whereby the provider used modifier 25 to bill Medicare for a significant and separately identifiable E/M service when only a minor surgical procedure and related preoperative and postoperative services are supported by the beneficiary's medical record.We will determine whether dermatologists' claims for E/M services on the same day of service as a minor surgical procedure complied with Medicare requirements. Physician and Healthcare Practitioners; Elderly; Medicare B
April 2021 Centers for Medicare & Medicaid Services How Part D Plans' Preference for Higher Cost Hepatitis C Drugs Affects Medicare Beneficiaries Office of Evaluation and Inspections OEI-BL-21-00200 2022 In 2019, Medicare Part D spent approximately $2.5 billion for hepatitis C drugs to treat 50,000 beneficiaries with the disease.Three drugs-Harvoni, Epclusa, and Mavyret—accounted for 93 percent of expenditures, with annual Medicare costs ranging from $28,000 to $77,000 per beneficiary.A portion of these totals was shared by Medicare beneficiaries who faced thousands of dollars in out-of-pocket costs for hepatitis C drugs under Part D.In early 2019, Gilead—the manufacturer of Harvoni and Epclusa—launched authorized generic versions of both drugs with the expressed goal of reducing patients' outofpocket costs.The retail price of authorized generic versions is $24,000, which is significantly less than the prices of Harvoni and Epclusa, and even less than Mavyret.These lower list prices should in turn lead to lower out-of-pocket costs, as authorized generics are as effective as branded versions but sell for only a fraction of the cost.However, a preliminary analysis indicates that Medicare utilization has not shifted from brandname versions of Harvoni and Epclusa to their significantly cheaper, authorized generic versions or to Mavyret.This study will examine the utilization of hepatitis C drugs under Part D and the financial impact on Medicare Part D and beneficiaries. Prescription Drug; Elderly; Medicare D
Revised Indian Health Service Audit of Indian Health Service's COVID-19 Vaccine Policies and Procedures for COVID-19 Vaccines Distributed to Tribal Health Programs Office of Audit Services W-00-21-59455 2022 The COVID-19 pandemic has disproportionately affected American Indian and Alaska Native (AI/AN) populations nationwide.The Centers for Disease Control and Prevention (CDC) reported that the age-adjusted AI/AN population's mortality rate from COVID-19 was 1.8 times higher than that among non-Hispanic whites as of December 2020.The Indian Health Service (IHS) has issued its COVID-19 Pandemic Vaccine Plan detailing how the IHS health care system will distribute, allocate, and administer the COVID-19 vaccine.The CDC recommended that all jurisdictions be prepared to immediately vaccinate identified critical populations as the earliest COVID-19 vaccine doses became available and were granted emergency use authorization.IHS is recognized as a "coordinator," similar to a State or other jurisdiction, for vaccine distribution.Tribal Health Programs and Urban Indian Organizations had the option to receive vaccines through either the IHS or their State.IHS direct facilities receive the vaccine through IHS.Approximately 338 facilities elected to receive vaccines through the IHS (including IHS direct facilities, Tribal Health Programs, and Urban Indian Organizations).We will focus on IHS's coordination of the distribution, allocation, and administration of the vaccine to Tribal Health Programs.The objective of this audit is to determine whether IHS followed the Memorandum of Agreement for the CDC COVID-19 Federal Agency Vaccination Program and the IHS COVID-19 Pandemic Vaccine Plan to coordinate the distribution, allocation, and administration of the vaccines to Tribal Health Programs to protect AI/AN beneficiaries.This objective will allow us to review the OIG priority area of promoting public health and safety with respect to services provided to the vulnerable population served by IHS.It will also allow us to address particularly critical goals that bear directly upon OIG's mission and that are identified in the OIG Strategic Plan: Oversight of COVID-19 Response and Recovery.These goals include protecting the health and safety of the AI/AN population that receives health care services through IHS programs and identifying opportunities to increase the effectiveness of IHS's COVID-19 response.We will review the policies and procedures that IHS had in place during our audit period and evaluate the measures implemented by Tribal Health Programs during Phases 1a and 1b of their vaccination programs—specifically, the measures to distribute, allocate, and administer the COVID-19 vaccines developed by Pfizer-BioNTech and the Moderna—for the period of December 11, 2020, through February 28, 2021.We will select a sample of Tribal Health Programs to review and will identify best practices as well as challenges that Tribal Health Programs have faced when coordinating the distribution, allocation, and administration of COVID-19 vaccinations.
Completed Centers for Medicare & Medicaid Services Yearend Review of Opioid Use in Medicare Part D in 2020 Office of Evaluation and Inspections OEI-02-20-00401 2022 The opioid crisis remains a public health emergency.In 2018, there were nearly 47,000 opioid-related overdose deaths in the United States.Identifying patients who are at-risk of overdose or abuse is key to addressing this crisis.The COVID-19 pandemic has made this need even more pressing.The National Institutes of Health recently warned that individuals with opioiduse disorder could be particularly hard hit by COVID-19, which is a respiratory virus that attacks the lungs.Respiratory disease is known to increase mortality risks among people taking opioids.This data brief would provide information on opioid utilization among beneficiaries enrolled in Medicare Part D in 2020.It would build on our series of reports, including the recent data snapshot Opioid Use in Medicare Part D During the Onset of the COVID-19 Pandemic (OEI-02-20-00400), which reviewed opioid use in Part D during the first 8 months of 2020.It would provide 2020 data on Part D spending for opioids, and the numbers of beneficiaries who received extreme amounts of opioids through Part D as well as those who appeared to be doctor shopping.It would also identify prescribers who ordered opioids for large numbers of these beneficiaries. COVID-19; Substance Abuse Disorders; People with Disabilities; Medicare D
Revised OS Audit of FY 2021 HHS Consolidated Financial Statements Office of Audit Services W-00-21-40009 2022 The HHS financial statement audit determines whether the financial statements present fairly, in all material respects, the financial position of the audited entity for the specified time period. We will retain an independent external auditor and review the independent auditor's work papers to determine whether financial statement audits of HHS and its components were conducted in accordance with Federal requirements. The financial statement audit is required by Chief Financial Officers Act of 1990, as amended by the Government Management Reform Act of 1994, and performed in accordance with Generally Accepted Government Auditing Standards and Office of Management and Budget (OMB) Bulletin 19-03, "Audit Requirements for Federal Financial Statements." The audited consolidated FYs 2021 and 2022 financial statements for HHS are due to OMB by November 15, 2021 and 2022, respectively. We plan to perform a number of ancillary financial-related reviews pertaining to the audits of the FYs 2021 and 2022 financial statements. The purpose of the ancillary financial-related reviews is to fulfill requirements in OMB Bulletin 21-04, §§ 6.1 through 12. Financial Stewardship; Other Funding
March 2021 OS Audit of FY 2021 CMS Financial Statements Office of Audit Services W-00-21-40008 2022 The CMS financial statement audit determines whether the financial statements present fairly, in all material respects, the financial position of the audited entity for the specified time period (Chief Financial Officers Act of 1990, as amended; Government Management Reform Act of 1994; Federal Financial Management Improvement Act of 1996; Generally Accepted Government Auditing Standards; and Office of Management and Budget Bulletin 19-01, "Audit Requirements for Federal Financial Statements"). We will retain an independent external auditor and review the independent auditor's work papers to determine whether the financial statement audit of CMS was conducted in accordance with Federal requirements. Financial Stewardship; Other Funding
March 2021 OS OIG DATA Act Audit and Data Completeness & Accuracy (2021) Office of Audit Services W-00-21-41021 2022 On May 9, 2014, the President signed the DATA Act of 2014, which mandated the establishment of Government-wide data standards for financial and payment data by May 2015, and agency reporting of consistent, reliable, and searchable financial and payment data by May 2017, to be displayed for taxpayers and policymakers on USASpending.gov. The DATA Act also requires OIG to review a statistically valid sampling of the spending data submitted under this Act by HHS and submit to Congress and make publicly available a report assessing the completeness, timeliness, quality, and accuracy of the data sampled and the implementation and use of data standards by HHS. We will use the independent external auditor contracted to audit the annual CMS and HHS Financial Statement Audits to perform this work. Financial Stewardship; Other Funding
Revised OS, CDC, ASPR Awardee Challenges in Implementing COVID-19 Vaccination Program Office of Evaluation and Inspections OEI-04-21-00190 2022 Dispensing vaccines effectively and efficiently is a critical step in fighting the COVID‑19 pandemic.CDC Immunization and Vaccines for Children Cooperative Agreement awardees, which are typically State and large metropolitan area public health departments, plan for and oversee the vaccine distribution and administration process.Stakeholders have acknowledged challenges early in Phase 1 distribution and dispensing, and note that these challenges will likely span all three phases identified in the CDC's COVID-19 Vaccine Playbook.We will interview all awardees to identify the reported challenges they are facing while distributing and dispensing vaccines.We will also ask awardees about effective strategies to mitigate those challenges, new challenges they anticipate, and how HHS can best support them in distributing and dispensing COVID-19 vaccines.In doing so, this review will provide HHS with timely and actionable information to address challenges associated with the COVID-19 vaccination efforts. Covid-19; Emergency Preparedness and Response; Other Funding
Revised FDA, NIH, CMS Audit of HHS's Contracting Compliance for the Acquisition of Information Technology Office of Audit Services W-00-21-42033; W-00-21-42034 2022 HHS is one of the largest contracting agencies in the Federal Government.In FY 2020, HHS obligated $3.4 billion to the acquisition of information technology (IT).HHS has one of the largest dollar investments in major IT systems and the second-largest number of IT investments in the Federal Government.The Federal Acquisition Regulation guides the acquisition process by which executive agencies of the Federal Government acquire goods and services by contract.We will perform a series of audits (three OpDivs).At each OpDiv, we will examine one vendor with contracts awarded for the acquisition of IT exceeding $10 million during FYs 2018 through 2020.We will determine whether HHS OpDivs are administering certain IT contracts in accordance with Federal statutes, regulations, and HHS policies and procedures. Contracts; Information Technology and cybersecurity; Other Funding
Revised Centers for Medicare and Medicaid Services Audits of Medicare Part B Laboratory Services During the COVID-19 Pandemic Office of Audit Services W-00-21-35867 2022 Laboratory tests are critically important because they are used for early detection, diagnosis, monitoring, and treatment of disease.COVID-19, the disease caused by a new strain of coronavirus that had not been previously identified in humans, first emerged in China in December 2019, and the first reported U.S. case occurred in January 2020.Because of the rapid worldwide spread of the virus, the World Health Organization declared COVID‑19 a global pandemic in March 2020.To protect the health and safety of the American people and to assist the Department of Health and Human Services and its Federal partners, laboratories began to provide COVID-19 testing to identify individuals who had contracted the coronavirus that causes COVID-19.Laboratory testing for both COVID-19 tests and non‑COVID‑19 tests (i.e., laboratory tests that are not for COVID-19) is important for all Medicare beneficiaries, but may be especially important for beneficiaries with certain medical conditions who are identified to be at increased risk for severe illness from COVID-19.Ensuring individuals receive necessary laboratory tests is critical to improving health care quality and containing long-term health costs. Our preliminary analysis has shown that the number of non-COVID-19 tests billed for Medicare Part B beneficiaries during the COVID-19 pandemic has decreased compared with the 6-month period before the pandemic, and many independent laboratories have encountered challenges in providing COVID‑19 testing.We will conduct a series of audits on Medicare Part B laboratory services during the pandemic that will initially focus on the effect of the pandemic on non-COVID-19 testing.The series of audits will also focus on aberrant billing of COVID-19 testing during the pandemic. COVID-19; Laboratories; Medicare B
February 2021 Centers for Medicare and Medicaid Services Audit of Home Health Services Provided as Telehealth During the COVID-19 Public Health Emergency Office of Audit Services W-00-21-35864 2022 On March 13, 2020, President Trump declared a national emergency in response to the COVID‑19 pandemic, which allowed the Centers for Medicare & Medicaid Services (CMS) to take proactive steps to support the response to COVID-19 through the use of section 1135 waivers.By means of this authority, CMS waived certain requirements in order to expand Medicare telehealth benefits to health care professionals who were previously ineligible, including physical therapists, occupational therapists, speech language pathologists, and others.However, the waiver does not allow for payment of telehealth services on home health claims.In the COVID‑19 Public Health Emergency Interim Final Rule With Comment, CMS amended regulations on an interim basis to allow home health agencies to use telecommunications systems in conjunction with in-person visits.In the CY 2021 Home Health PPS Final Rule, CMS permanently finalized these changes.The final amended regulations state that the plan of care must include any provision of remote patient monitoring or other services furnished via telecommunications technology or audio-only technology, and that such services must be tied to patient-specific needs as identified in the comprehensive assessment.They further state that telehealth services cannot substitute for a home visit ordered as part of the plan of care, and cannot be considered a home visit for the purposes of patient eligibility or payment.We will evaluate home health services provided by agencies during the COVID-19 public health emergency to determine which types of skilled services were furnished via telehealth, and whether those services were administered and billed in accordance with Medicare requirements.We will report as overpayments any services that were improperly billed.We will make appropriate recommendations to CMS based on the results of our review. Covid-19; Non-institutional care; OIG Statutory Authority; Elderly Medicare A
Revised ASA Audit of HHS Sole Source Contracts Awarded for COVID-19 Testing Office of Audit Services W-00-21-59453 2022 HHS established contracts under the Public Health and Social Services Emergency Fund to prevent, prepare for, and respond to the COVID- 19 pandemic.The contracts cover more than 600 COVID-19 testing sites in 48 states and the District of Columbia.The contracts utilize a Federal bundled payment program paid directly to retailers that receive a flat fee for each test administered, with participating retailers responsible for coordinating the full, end-to-end testing.The Federal Acquisition Regulation (FAR) guides the acquisition process by which executive agencies of the Federal Government acquire goods and services by contract with appropriated funds.The Health and Human Services Acquisition Regulation establishes uniform HHS acquisition policies and procedures that implement and supplement FAR.The contracts that HHS awarded to contractors were sole source contracts totaling approximately $1 billion for COVID-19 testing.We will review the awarding and management of contracts for COVID-19 testing to determine compliance with applicable Federal statutes, regulations, HHS policies and procedures, contract terms and conditions, and the allowability of claimed costs. Contracts; COVID-19; Other Funding
January 2021 Health Resources and Services Administration Health Resources and Services Administration's Monitoring of High-Risk COVID-19 Grantees Office of Audit Services W-00-21-59452 2022 The Health Resources and Services Administration (HRSA) is the primary Federal agency for improving health care to people who are geographically isolated and economically or medically vulnerable.HRSA funds nearly 1,400 health centers that deliver care to the most vulnerable individuals and families, regardless of ability to pay.HRSA should identify and mitigate risks related to awarding grants to health centers in order to minimize the potential misuse or loss of Federal funds, as required by the HHS Grants Policy Administration Manual, Part F, Chapter 4.a.1.In spring 2020, HRSA awarded through three programs nearly $2 billion to approximately 1,380 health centers in response to the COVID-19 pandemic.To expedite distribution of this funding, HRSA did not require that health centers apply for grants.Instead, it made funds immediately available to health centers.Health centers had 30 days from the award release date to submit the information that is usually submitted, reviewed, and approved during the grant application process prior to a grantee receiving funding.The information that each of the health centers provided included a program narrative, a budget and budget narrative, and a list of equipment to be purchased, if applicable.We will determine whether HRSA had an effective process for identifying and monitoring high-risk health centers that received COVID-19 grant funds. COVID-19; Financial Stewardship; Grants
Revised Centers for Medicare and Medicaid Services Medicare Needs Better Controls To Prevent Fraud, Waste, and Abuse Related to Orthotic Braces Office of Audit Services W-00-21-35863 2022 Prior OIG work identified inappropriate payments for orthotic braces that were not medically necessary, not documented in accordance with Medicare requirements, or fraudulent.We will compile the results of prior OIG audits, evaluations, and investigations of orthotic braces that were paid for by Medicare.We will also analyze data to identify trends in payment, compliance, and fraud vulnerabilities, and offer recommendations for improving detected vulnerabilities. Medical Supplies and equipment; Elderly; Medicare B
January 2021 Centers for Medicare and Medicaid Services Medicare Part D Payments During Covered Part A SNF Stay Office of Audit Services W-00-21-35866 2022 Medicare Part A prospective payments to skilled nursing facilities (SNFs) cover most services, including drugs and biologicals furnished by the SNF for use in the facility for the care and treatment of beneficiaries.Accordingly, Medicare Part D drug plans should not pay for prescription drugs related to posthospital SNF care because these drugs are already included in the consolidated payment for Part A SNF stays.We will determine whether Medicare Part D paid for drugs that should have been paid under Part A SNF stays. Nursing Homes, Nursing Facilities, etc.; Prescription Drug; Elderly Medicare D
January 2021 Centers for Medicare and Medicaid Services Background Checks for Nursing Home Employees Office of Audit Services W-00-21-31553 2022 Federal regulation 42 CFR 483.12(a)(3) provides beneficiaries who rely on long-term care services with protection from abuse, neglect, and theft by preventing prospective employees with disqualifying offenses from being employed by these care providers and facilities.The National Background Check Program was enacted by legislation in 2010 to assist States in developing and improving systems for conducting Federal and State background checks.Prior OIG work has shown that not all States complied with the National Background Check Program for Long-Term Care Providers.We will determine whether Medicaid beneficiaries in nursing homes in selected States were adequately safeguarded from caregivers with a criminal history of abuse, neglect, exploitation, mistreatment of residents, or misappropriation of resident property, according to Federal requirements. Nursing Homes, Nuring Facilties, etc.; Elderly; Medicaid
January 2021 Administration for Children and Families Audit of Delinquent Noncustodial Parents' Tax Refund and Economic Impact Payment Intercepts Office of Audit Services W-00-21-20030 2022 The Child Support Enforcement Program (the program) is a Federal, State, and local partnership, established in 1975 under Title IV-D of the Social Security Act, to collect child support payments from noncustodial parents for distribution to custodial parents.The Coronavirus Aid, Relief, and Economic Security (CARES) Act, signed into law on March 27, 2020, provides qualifying individuals with a recovery rebate (economic impact payment) of up to $1,200 (or $2,400 if married and filing jointly), plus up to $500 for each qualifying child.Congress added a number of exemptions concerning the economic impact payments within the CARES Act; however, it did not exempt child support debt.According to estimates, up to 10.5 million noncustodial parents are delinquent in their payment of child support and could have their economic impact payments intercepted.Based on the significant impact that the CARES Act will have on the collection of delinquent child support due to the intercept of economic impact payments, we determined that the focus of our audit would be to determine whether selected State(s) have policies and procedures in place to ensure that State child support programs collected and distributed delinquent child support under the Federal Tax Refund Offset program.The failure to have effective procedures in place to ensure the collection and distribution of delinquent child support can result in essential child support funds not being provided to custodial parents during the COVID-19 pandemic. COVID-19; Financial Stewardship; Children and Families; Other Funding
January 2021 Centers for Medicare and Medicaid Services Duplicate Payments Made by Medicare and the Department of Veterans Affairs' Veterans Community Care Program Office of Audit Services W-00-21-35865 2022 The Veterans Community Care Program (VCCP) authorizes the Department of Veterans Affairs (VA) to furnish hospital care and medical services to eligible veterans through agreements with non-VA providers.Duplicate claims may be improperly paid by both Medicare and the VCCP if claims for services are billed to both programs.Because Medicare regulations prohibit payment for services that are paid for either directly or indirectly by another Government entity, subject to a few exceptions, Medicare is not responsible for payment of claims for services in which the VCCP has paid for those services.The payments associated with these claims are considered overpayments.This audit is a collaborative effort with VA-OIG to determine whether the VCCP and Medicare paid duplicate claims for the same medical services. Hospitals; Laboratories; Medical Supplies and Equipment; OIG Statutory Authority; Physician and Healthcare Practiioners; Medicare A; Medicare B
Revised Centers for Medicare and Medicaid Services Medicaid Claims for Federal Reimbursement Using Managed-Care Proxy Methodology Office of Audit Services W-00-21-31554 2023 Federal health care benefits are generally allowable when provided to a beneficiary who is a U.S. citizen, U.S. national, or qualified alien.Generally, a qualified alien is ineligible for full-scope Medicaid services before 5 years have passed from the date he or she enters the United States with qualifying status (5-year bar).Medicaid eligibility for most qualified aliens who are subject to the 5-year bar is generally limited to emergency services (restricted-scope services).States may choose to provide full-scope services to qualified aliens who are subject to the 5-year bar using their own State funds.Furthermore, States may choose to cover full-scope services to aliens permanently residing in the United States under color of law and to children under the age of 19 regardless of immigration status.However, the costs related to nonemergency services provided to non-citizens in these groups without satisfactory immigration status are not eligible for Federal reimbursement.We will review whether States properly claimed Federal Medicaid reimbursement related to services provided to non-citizens who lacked satisfactory immigration status. Managed care; Medicaid
Revised Centers for Medicare and Medicaid Services Audits of Medicare Part B Telehealth Services During the COVID-19 Public Health Emergency Office of Audit Services W-00-21-35862 2022 Telehealth is playing an important role during the public health emergency (PHE), and CMS is exploring how telehealth services can be expanded beyond the PHE to provide care for Medicare beneficiaries.Because of telehealth's changing role, we will conduct a series of audits of Medicare Part B telehealth services in two phases.Phase one audits will focus on making an early assessment of whether services such as evaluation and management, opioid use disorder, end-stage renal disease, and psychotherapy (Work Plan number W-00-21-35801) meet Medicare requirements.Phase two audits will include additional audits of Medicare Part B telehealth services related to distant and originating site locations, virtual check-in services, electronic visits, remote patient monitoring, use of telehealth technology, and annual wellness visits to determine whether Medicare requirements are met. COVID-19; Elderly; Medicare Part B
January 2021 Centers for Medicare and Medicaid Services Home Health Agencies' Challenges and Strategies in Responding to the COVID-19 Pandemic Office of Evaluation and Inspections OEI-01-21-00110 2022 Home health agencies (HHAs) have faced unprecedented challenges to providing care during the COVID-19 pandemic.Reported challenges include, but are not limited to, procuring necessary equipment and supplies, implementing telehealth to treat patients remotely, and addressing staffing shortages.However, the full spectrum of these challenges, including how challenges have evolved over time, is unknown.HHAs have used strategies to address these challenges, but the array of strategies and the extent to which HHAs found them helpful are also unknown.This nationwide study will provide insights into the strategies HHAs have used to address the challenges presented by COVID-19, including how well their emergency preparedness plans served them during the COVID-19 pandemic. Covid-19; Non-instituional care; Physicians and Healthcare providers; Public health issues; Medicare A
Completed (partial) Administration for Children and Families States' Use of the Child Welfare Information Systems To Monitor Medication Prescribed to Children in Foster Care Office of Audit Services A-05-18-00007;
W-00-18-59434;
W-00-21-59434
2022 Psychotropic and opioid drugs are among those that may be prescribed to children in foster care.Psychotropic medications treat mental health disorders such as schizophrenia, depression, bipolar disorder, anxiety disorders, and attention deficit/hyperactivity disorder.Prescription opioids include narcotics to manage pain from surgery, injury, or illness, and have a high risk for abuse and misuse.To receive certain Federal funding for child welfare services, States are required to have a plan for overseeing and coordinating health care services for any child in foster care placement, including protocols for the appropriate use and monitoring of medications (the Social Security Act § 422(b)(15)(A)).The Comprehensive Child Welfare Information System (CCWIS) is a federally funded information system for State child welfare agencies to support case management for children and families receiving child welfare services.We will review States' use of the CCWIS for monitoring psychotropic and opioid medications prescribed to children in foster care.Because the Administration for Children and Families (ACF) oversees States' foster care programs, we will also determine the extent to which ACF ensures that children in foster care receive medications in accordance with State requirements.
December 2020 Centers for Medicare and Medicaid Services Risk Assessment at a State Medicaid Agency Office of Audit Services W-00-21-31552 2022 One goal of the President's Management Agenda is to maximize grant funding by applying a risk-based, data-driven framework that balances compliance requirements with demonstrating successful results to the American taxpayer.Enterprise Risk Management-based risk assessments can help organizations quickly understand and prioritize critical, enterprisewide risks, and develop plans to maximize as well as mitigate and manage risk.We will perform an Enterprise Risk Management-based risk assessment at one State Medicaid agency to identify internal control weaknesses and process risks. Departmental Operational Issues; Medicaid
Revised Centers for Medicare and Medicaid Services Followup Review on Medicare Claims for Outpatient Services Provided During Inpatient Stays Office of Audit Services W-00-21-35861 2022 A prior OIG review (A-09-16-02026) identified that Medicare inappropriately paid acute-care hospitals for outpatient services they provided to beneficiaries who were inpatients of other facilities (i.e., long-term care hospitals (LTCHs), inpatient rehabilitation facilities (IRFs), inpatient psychiatric facilities (IPFs), and critical-access hospitals).It was found that none of the $51.6 million we reviewed, representing 129,792 claims, should have been paid because the inpatient facilities were responsible for payments.In addition, beneficiaries were held responsible for unnecessary deductibles and coinsurance totaling $14.3 million paid to acute-care hospitals for those outpatient services.In addition, it was found that Medicare overpaid acute-care hospitals because the common working file (CWF) edits that should have prevented or detected the overpayments were not working properly. Federal regulations state that the inpatient hospital services provided to Medicare beneficiaries are paid under Medicare Part A.These include inpatient stays at LTCHs, IRFs, and IPFs.Federal regulations also state that Medicare does not pay any provider other than the inpatient hospital for services provided to the beneficiary while the beneficiary is an inpatient of the hospital.The hospital must furnish all necessary covered services to the beneficiary either directly or under arrangements.This provision also applies to LTCHs, IRFs, and IPFs.This audit is a followup to determine whether CMS corrected the CWF edits and ensured that the edits were working properly. OIG Statutory Authority...; Medicare A; Medicare B
December 2020 Centers for Medicare and Medicaid Services Comparison of T-MSIS Prescription Drug Payment Data to Actual Pharmacy Reimbursements for Medicaid Managed Care Office of Evaluation and Inspections OEI-03-20-00560 2022 Effective oversight of growing prescription drug costs in Medicaid requires accurate and consistent data.Managed-care organizations (MCOs) are responsible for the majority of Medicaid enrollment and prescription drug reimbursements.The Centers for Medicare and Medicaid Services (CMS) established the Transformed Medicaid Statistical Information System (T-MSIS) to provide CMS, States, and other stakeholders with accurate and reliable Medicaid claims and encounter data to safeguard the Medicaid program.However, States' managed‑care drug claims data reported in T-MSIS may not uniformly represent drug payments across the Medicaid program.The data may contain the amounts MCOs or their pharmacy benefit managers (PBMs) paid to pharmacies or the amounts MCOs paid to their PBMs, which could include certain PBM fees known as "spread." CMS and States have expressed concerns that the use of spread pricing by PBMs lacks transparency and may inflate Medicaid drug costs.This evaluation will identify how States report managed-care drug payment data to T‑MSIS and determine the extent to which these data represent pharmacy reimbursements.Furthermore, we will identify how States ensure the accuracy of their T-MSIS managed-care drug claims data and use these data to oversee managed-care prescription drug expenditures and the PBMs' spread‑pricing practices. Financial Stewardship; Managed Care; Prescription Drug; Medicaid
December 2020 Centers for Medicare and Medicaid Services Supplier Acquisition Costs for Urinary Supplies Office of Evaluation and Inspections OEI-04-20-00620 2022 We will compare current Medicare reimbursement rates to supplier acquisition costs for selected urinary supplies to determine whether Medicare may be paying too much for these items.Medicare Part B payments for urinary supplies, including intermittent urinary catheter tips and intermittent urinary catheters with insertion supplies, has increased from $125 million in 2010 to $298 million in 2019.CMS could reduce payment rates for urinary supplies through two methods: CMS can adjust the fee schedule price, or it may introduce an item into the Competitive Bidding Program (CBP).To facilitate CMS decision making, we will provide cost information and additional context regarding the extent that urinary supplies are a good fit for potential introduction into the CBP. Financial Stewardship; Medical Supplies and Equipment; Elderly; Medicare B
December 2020 Assistant Secretary for Preparedness and Response Audit of the Assistant Secretary for Preparedness and Response Oversight of the Hospital Preparedness Program With Respect to Crisis Standards of Care Office of Audit Services W-00-21-59451 2022 The HHS Assistant Secretary for Preparedness and Response (ASPR) administers the Hospital Preparedness Program (HPP), which awards grants to State, territorial, and major metropolitan public health agencies to advance preparedness in health care systems for emergencies and disasters.Crisis standards of care are guidelines for how providers ration resources, such as ventilators, during mass casualty events, such as pandemics.State public health agencies receiving HPP funds must issue these guidelines, and providers can choose to adopt them.An HHS awarding agency must administer Federal awards in a manner that ensures that programs are implemented in full accordance with U.S. statutory and public policy requirements, including the prohibition of discrimination.Recipients of Federal funds are required to comply with an award's terms and conditions as well as Federal civil rights laws.The objective of our audit is to conduct a grant performance review of ASPR's oversight of the HPP program with respect to awardees' adopting crisis standards of care that comply with Federal nondiscrimination laws. COVID-19; Emergency Preparedness; Public Health Issues; Quality of Care; People with Disabilities; Other minorities; Native American; Elderly; Grants
December 2020 Centers for Medicare and Medicaid Services Race and Ethnicity Data for Medicare Beneficiaries Office of Evaluation and Inspections OEI-02-21-00100 2022 Accurate, complete, and appropriately detailed race and ethnicity data for Medicare beneficiaries are critical to identifying and mitigating health disparities.As racial and ethnic disparities have emerged among those impacted by COVID-19, the availability and quality of data on race and ethnicity has garnered greater attention and scrutiny.This study will describe the extent to which Medicare's race and ethnicity data for beneficiaries are complete and accurate.We will compare these data to data from other sources.We will also determine the extent to which the Medicare beneficiary race and ethnicity data align with Federal data standards. Public Health Issues; Other Minorities; Native Americans; Medicare A; Medicare B; Medicare C
Revised Centers for Medicare & Medicaid Services Medicare Part B Payments for Psychotherapy Services Office of Audit Services W-00-17-35801; A-09-17-xxxxx 2022 Medicare Part B covers psychotherapy services. Psychotherapy is the treatment of mental illness and behavioral disturbances in which a physician or other qualified health care professional establishes professional contact with a patient and, through therapeutic communication and techniques, attempts to alleviate emotional disturbances, reverse or change maladaptive patterns of behavior, and encourage personality growth and development. In calendar year 2016, Part B allowed approximately $1.2 billion for psychotherapy services, including individual and group therapy. A prior OIG review found that Medicare allowed $185 million in inappropriate outpatient mental health services, including psychotherapy services. The review found that psychotherapy services were particularly problematic, noting that almost half of the psychotherapy services reviewed were inappropriate. Specifically, Medicare paid for services that were not covered, inadequately documented, or medically unnecessary. We will review Part B payments for psychotherapy services to determine whether they were allowable in accord with Medicare documentation requirements. COVID-19; Phyisicians and Healthcare Practitioners; Elderly Medicare B
Revised Centers for Medicare and Medicaid Services CMS Oversight of the Two-Midnight Rule for Inpatient Admissions Office of Audit Services W-00-20-35857 2022 Prior OIG audits identified millions of dollars in overpayments for inpatient claims with short lengths of stay.Instead of billing the stays as inpatient claims, they should have been billed as outpatient claims, which usually results in a lower payment.To reduce inpatient admission errors, CMS implemented the Two-Midnight Rule in fiscal year 2014.Under the Two-Midnight Rule, CMS generally considered it inappropriate to receive payment under the inpatient prospective payment system for stays not expected to span at least two midnights.The only procedures excluded from the rule were newly initiated mechanical ventilation and any procedures appearing on the Inpatient Only List.Revisions were made to the Two-Midnight Rule after its implementation.We plan to audit hospital inpatient claims after the implementation of and revisions to the Two-Midnight Rule to determine whether inpatient claims with short lengths of stay were incorrectly billed as inpatient and should have been billed as outpatient or outpatient with observation.We also plan to review policies and procedures for enforcing the Two-Midnight Rule at the administrative level and contractor level.While OIG previously stated that it would not audit short stays after October 1, 2013, this serves as notification that the OIG will begin auditing short stay claims again, and when appropriate, recommend overpayment collections. tags
November 2020 Centers for Medicare and Medicaid Services Medicare Part D Compounded Drugs Office of Audit Services W-00-21-35415 2022 In 2016, OIG called attention to significant growth in spending for compounded drugs.Specifically, OIG found that Medicare Part D spending for compounded topical drugs grew by 625 percent during 2006—2015.OIG has been involved in an increasing number of fraud investigations related to compounded drugs.We will conduct a risk assessment of CMS's oversight of pharmacies compounding drugs for beneficiaries to determine whether systemic vulnerabilities affecting the integrity of Medicare Part D; specifically, we will assess the risk that pharmacies did not meet Federal and State requirements. Prescription Drug; Elderly; Medicare D
November 2020 Centers for Medicare and Medicaid Services Medicaid and ACA Enrollment Processes During the COVID-19 Pandemic Office of Evaluation and Inspections OEI-09-20-00590 2022 Economic and health impacts caused by the COVID-19 pandemic have left States facing increases in new applications for health insurance through the Medicaid and ACA Marketplace programs.Responding to the pandemic, including meeting the new enrollment and oversight demands, has taxed State health care systems.This evaluation will assess efforts by the States and CMS to effectively enroll residents impacted by the COVID-19 pandemic in Medicaid and ACA Marketplace plans.By identifying effective practices or any breakdowns in enrollment and oversight systems, this review would help improve the efficiency of State health insurance enrollment processes under both emergency and more typical conditions. tags
November 2020 Centers for Medicare and Medicaid Services Nursing Homes' Compliance With Facility-Initiated Discharge Requirements Office of Evaluation and Inspections OEI-01-18-00251 2022 A facility-initiated transfer or discharge of a resident from a nursing home can be an unsafe and traumatic experience for the resident and his or her family.To address these concerns, Congress passed the Nursing Home Reform Act of 1987 to protect residents against inappropriate facility-initiated transfer and discharge.However, data from the National Ombudsman Reporting System show that from 2011 through 2016, the Long-Term Care Ombudsman Program, established to advocate for older Americans by the Older Americans Act of 1965, cited complaints related to "discharge/eviction" more frequently than any other concern.In addition, the media has highlighted the rise in nursing home evictions.We have ongoing work determining the extent to which State long-term care ombudsmen, State survey agencies, and CMS address facility-initiated discharges from nursing homes.To complement this ongoing work, we will examine the extent to which nursing homes meet CMS requirements for facility-initiated discharges. tags
Completed (partial) Centers for Disease Control and Prevention Grantees' Use of President's Emergency Plan for AIDS Relief Funds Office of Audit Services A-04-19-01015;
A-04-20-01017
W-00-19-57300;
W-00-20-57300;
W-00-21-57300
2022 Through the President's Emergency Plan for AIDS Relief (PEPFAR), the Centers for Disease Control and Prevention (CDC) has altered the course of the global acquired immunodeficiency syndrome (AIDS) epidemic, saving millions of lives, improving the lives of countless others, and preventing millions of infections around the world.CDC received more than $1.9 billion in FY 2019 PEPFAR funds (about 95 percent of all PEPFAR funds received by HHS) to accelerate progress toward achieving an AIDS‑free generation and to create a lasting infrastructure that allows partner countries to respond to a range of health challenges and threats.To date, OIG has conducted a series of PEPFAR audits at CDC offices in five countries on three continents (Africa, North America, and Asia).OIG's PEPFAR oversight has helped CDC and other HHS staff learn important grant and program integrity lessons that apply to ongoing and future responses to infectious diseases.In previous audits of CDC offices in the United States and foreign countries, OIG identified noncompliance with policies, inadequate monitoring of grantees, and internal control weaknesses in the awarding of PEPFAR funds.We will determine whether CDC has: (1) effectively awarded, monitored and accounted for PEPFAR funds in accordance with Federal regulations, HHS Departmental regulations, and the Office of the U.S. Global AIDS Coordinator and Global Health Diplomacy guidance; and (2) taken corrective action to implement internal controls, including adhering to policies and procedures for awarding and monitoring PEPFAR funds. Public Health Issues; Grants
November 2020 Centers for Medicare & Medicaid Services Facility-Initiated Discharge in Nursing Homes Office of Evaluation and Inspections OEI-01-18-00250 2022 The transfer or discharge of a resident initiated by a nursing home can be an unsafe and traumatic experience for the resident and his or her family.To address these concerns, Congress passed the Nursing Home Reform Act of 1987 to protect residents against inappropriate facility-initiated discharges.However, data from the National Ombudsman Reporting System show that from 2011 through 2016, the Long-Term Care Ombudsman Program, established to advocate for older Americans by the Older Americans Act of 1965, cited complaints related to "discharge/eviction" more frequently than any other concern.In addition, the media has recently highlighted the rise in nursing home evictions.CMS estimates that as many as one-third of all residents in long-term care facilities may experience a facility-initiated transfer or discharge.In other work, we are examining the extent to which nursing homes meet CMS requirements for facility-initiated discharges.In this work, we will determine the extent to which State long-term care ombudsmen, State survey agencies, and CMS address facility-initiated discharges from nursing homes. tags
Revised Centers for Medicare & Medicaid Services Audit of Medicaid Components for States in Cycle 1 of CMS's PERM Review Office of Audit Services W-00-20-31540 2022 The Improper Payments Information Act of 2002 requires the heads of Federal agencies to annually review programs they administer in order to identify programs that may be susceptible to significant improper payments and estimate the amount of improper payments.The Medicaid program has been identified as a program at risk for significant improper payments.CMS developed the Payment Error Rate Measurement (PERM) program to measure improper payments in the Medicaid program.PERM produces an improper payment rate based on reviews of the fee-for-service, managed care, and eligibility components of Medicaid.In 2017, CMS published a new, final rule implementing substantive changes to the PERM program that, among other things, were aimed at improving program integrity and promoting State accountability through policy and operational improvements.We will assess the adequacy of the PERM program by determining the accuracy of determinations for the eligibility, fee-for-service, and managed care components of the PERM error rate. Departmental Operational Issues; Medicaid
Revised Health Resources and Services Administration Audit of HRSA's Controls Over Medicare Providers' Compliance with the Attestation, Submitted-Revenue-Information, and Quarterly Use-of-Funds Reporting Requirements Related to the $50 Billion General Distribution of the Provider Relief Fund Office of Audit Services W-00-21-59060 2022 A combined $175 billion in funding from the Coronavirus Aid, Relief, and Economic Security (CARES) Act and the Paycheck Protection Program and Health Care Enhancement Act constitutes the Provider Relief Fund (PRF), which provides relief funds to hospitals and other health care providers for health-care-related expenses or lost revenue attributable to COVID-19 and to ensure that uninsured Americans can get testing and treatment for COVID-19.HHS allocated $50 billion for a General Distribution to Medicare providers.
Providers that receive PRF funds are subject to certain requirements for attestation, submission of revenue information, and reporting of quarterly use-of-funds to HHS.A provider that received a PRF payment and retained it for at least 90 days without contacting HHS regarding the payment is deemed to have accepted its terms and conditions.Further, a provider must submit general revenue data after receiving or when applying to receive a payment.Finally, according to the CARES Act, Division B, Title V, Section 15011(b)(2), no later than 10 days after the end of each calendar quarter, a provider that received more than $150,000 in total funds for the coronavirus response and related activities shall submit a report to HHS regarding the use of those funds.
As part of the OIG's oversight of the $50 billion General Distribution of the PRF, we will provide a snapshot of the effectiveness of the Health Resources and Services Administration's (HRSA's) controls over Medicare providers' compliance with the attestation, submitted-revenue-information, and quarterly use-of-funds reporting requirements.Specifically, we will review HRSA's internal controls and assess its policies and procedures related to these areas.
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October 2020 Centers for Medicare and Medicaid Services Medicare Telehealth Services During the COVID-19 Pandemic: Program Integrity Risks Office of Evaluation and Inspections OEI-02-20-00720 2022 In response to the COVID-19 pandemic, CMS implemented a number of waivers and flexibilities that allowed Medicare beneficiaries to access a wider range of telehealth services without having to travel to a health care facility.This review will be based on Medicare Parts B and C data and will identify program integrity risks associated with Medicare telehealth services during the pandemic.We will analyze providers' billing patterns for telehealth services.We will also describe key characteristics of providers that may pose a program integrity risk to the Medicare program. tags
Revised Administration for Children and Families Audit of National Domestic Violence Hotline and Shelter-in-Place Orders During the COVID-19 Pandemic Office of Audit Services W-00-20-20028 2022 The COVID-19 pandemic poses special challenges for victims of domestic violence.Because of economic and other uncertainties surrounding the pandemic and the shelter-in-place orders in effect for most States, abusers may exert further power and control over their partners.Victims in these States are more socially isolated and have fewer opportunities to connect with others who may be able to assist them.Isolated victims may be less likely to use crisis hotlines because their abusers are close by, and victims may face repercussions if they reach out for help.For fiscal year 2020, the Administration for Children and Families allocated $12 million for the National Domestic Violence Hotline (the Hotline).The Hotline operates a 24-hour, national, toll-free, and confidential telephone hotline for victims of domestic violence.It maintains a comprehensive resource database on services for these victims and is the only 24/7 center in the Nation that has access to service providers and shelters across the United States.The Coronavirus Aid, Relief, and Economic Security Act provided additional funding of $2 million for the Hotline, including hotline services provided remotely.Our objectives are to identify: (1) trends with the Hotline data that occurred during nationwide shelter-in-place orders and (2) whether the Hotline faced challenges that occurred during States' shelter-in-place orders and actions it has taken to address these challenges while continuing to support those affected by domestic violence. COVID-19; Public Health Issues; Children & Families Grants
Revised Centers for Medicare and Medicaid Services Ineligible Providers in Medicare Part C and Part D Office of Audit Services W-00-20-35859 2022 CMS contracts with Medicare Advantage plans and private prescription drug plans (collectively known as "sponsors") to offer Part C and Part D managed care benefits to eligible beneficiaries.Federal law prohibits Medicare payments for services provided or prescriptions written by individuals or entities who are excluded from Federal health care programs (excluded providers) when the sponsor knows or has reason to know of the exclusion.Federal regulations also prohibit Medicare payments to ineligible providers whose billing privileges have been deactivated, denied, or revoked.We will conduct a nationwide audit of Medicare Part C and Part D managed care data for calendar years 2018 and 2019 to identify ineligible providers that had been excluded, precluded, or deactivated as Medicare providers but provided services through Part C and D sponsors.Our audit will determine whether Part C and Part D sponsors complied with Federal requirements on preventing ineligible providers from rendering services to Medicare beneficiaries. tags
Revised Centers for Medicare and Medicaid Services Nationwide Review of the Administration and Oversight of Physician-Administered Drugs Office of Audit Services W-00-20-35860 2022 States are required to collect rebates on covered outpatient drugs administered by physicians in order to be eligible for Federal matching funds (SSA § 1927(a)).Previous OIG work identified significant concerns with States' efforts in obtaining rebates for these physician-administered drugs.We will summarize the results and issues identified in these audits and examine CMS's policies and procedures to ensure States appropriately collect Medicaid rebates on physician-administered drugs. tags
Revised Centers for Medicare and Medicaid Services Joint Work With State Agencies Office of Audit Services W-00-21-40002 2022 To strengthen program integrity and efficiently use audit resources, we will enhance our efforts to provide broader oversight of the Medicaid program by partnering with State auditors, State comptrollers general, and State inspectors general.Federal-State partnerships will provide effective methods that address improper payments in fee-for-service programs such as home health, hospice, and durable medical equipment, and in managed care.OIG will partner with States to: (1) address known vulnerabilities that it has identified in both Medicare and Medicaid to curb such vulnerabilities in Medicaid nationwide; and (2) identify new areas that put the integrity of the Medicaid program at risk. tags
Revised Centers for Medicare and Medicaid Services Risk Assessment of Puerto Rico Medicaid Program Office of Audit Services W-00-20-31544 2022 The Puerto Rico Medicaid program is a 100-percent managed care program that provides health services to more than 1 million beneficiaries.In December 2019, Congress provided Puerto Rico additional funding under the Further Consolidated Appropriations Act of 2020 (P.L. 116‑94).P.L. 116‑94 also contains anticorruption measures including requirements for OIG to develop and submit to Congress a report identifying payments made under Puerto Rico's Medicaid program to managed care organizations that are at high risk for waste, fraud, or abuse, and a plan for auditing such payments. tags
Revised Administration for Children and Families Audit of States' Efforts To Locate IV-E Eligible Children Missing From Foster Care Office of Audit Services W-00-20-20027;
W-00-21-20027;
W-00-22-20027
2022 Title IV-E of the Social Security Act established the Federal Foster Care Program, which helps States provide safe and stable out-of-home care for children who meet certain eligibility requirements until they are safely returned home, placed permanently with adoptive families, or placed in other planned arrangements.� We will conduct a survey examining the policies and procedures that State agencies adopted pertaining to reporting and locating children missing from foster care placements during the period July�1,�2019, through September 30, 2020.� We will use the responses obtained from State agencies to provide Federal, State and local decisionmakers insight into the issues surrounding children missing from foster care and share approaches for addressing those issues in order to reduce the number of and improve outcomes for children missing from foster care.� We will also examine whether State agencies are reporting children missing from foster care to the National Center for Missing and Exploited Children and to the National Crime Information Center as required by Federal law. Public Health Issues, Children and Families, TGrants
Revised CDC, ACF Public Health Actions Affecting Unaccompanied Children: Coordination Between CDC and the Office of Refugee Resettlement Office of Evaluation and Inspections OEI-BL-20-00670 2022 The Unaccompanied Alien Children (UAC) Program, operated by the Office of Refugee Resettlement (ORR), provides care and placement for children without lawful immigration status who do not have a parent or guardian in the United States available to take custody.In March 2020, the Centers for Disease Control and Prevention (CDC) issued a public health order intended to reduce the spread of COVID-19.Pursuant to the CDC order, the Department of Homeland Security has substantially reduced the number of children referred to the UAC Program, instead expelling such children immediately or detaining them in hotels until they are repatriated.Effective coordination between CDC and ORR is critical to ensure that HHS fulfills its responsibilities toward vulnerable children.We will assess the extent to which CDC has coordinated with ORR to ensure that the UAC Program has sufficient and timely information for effective capacity planning.We will also assess CDC's actions to determine and carry out its responsibilities toward children detained pursuant to the public health order and the extent to which CDC has consulted with ORR on issues pertaining to children's welfare. tags
Revised Administration for Children and Families Separated Children Placed in Office of Refugee Resettlement Care: Update Office of Evaluation and Inspections OEI-BL-20-00680 2022 The Unaccompanied Alien Children (UAC) Program, operated by the Office of Refugee Resettlement (ORR), provides care and placement for children without lawful immigration status who do not have a parent or guardian in the United States available to take custody.The UAC Program serves children who arrive in the United States unaccompanied, as well as children who are separated from their parents or legal guardians by immigration authorities after entering the country (i.e., separated children).Under a June 26, 2018, Federal court order, families entering the United States without authorization cannot be separated at the border by immigration authorities unless the parent meets certain criteria, such as having a criminal history.We will determine the total number of separated children referred to ORR after June 26, 2018.We will also determine key characteristics of this population, identify the reasons for their separation, and compare their outcomes (e.g., length of time in care) to the UAC Program child population overall. tags
Revised Health Resources and Services Administration Audit of Health Resources and Services Administration's COVID-19 Uninsured Program Office of Audit Services W-00-20-30053 2022 To address the COVID-19 pandemic, the Families First Coronavirus Response Act (FFCRA) and the Paycheck Protection Program and Health Care Enhancement Act (PPP) together appropriated $2 billion to reimburse providers for costs associated with conducting COVID-19 testing and testing-related items and services for the uninsured.Additionally, a portion of the $175 billion appropriated to the Provider Relief Fund by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) and PPP will be used for treating uninsured individuals with a confirmed COVID-19 diagnosis.HHS, through the Health Resources and Services Administration (HRSA), launched the COVID-19 Uninsured Program Portal, a single electronic claims processing system for health care providers for submitting claims for reimbursements for diagnostic testing and treating uninsured individuals.We will determine whether claims for COVID-19 diagnostic testing and treatment services reimbursed by HHS through HRSA's COVID-19 Uninsured Program complied with Federal requirements. tags
Revised Centers for Medicare and Medicaid Services Use of Medicare Telehealth Services During the COVID-19 Pandemic Office of Evaluation and Inspections OEI-02-20-00520 2022 In response to the coronavirus disease 2019 (COVID-19) pandemic, CMS made a number of changes that allowed Medicare beneficiaries to access a wider range of telehealth services without having to travel to a health care facility.Although these changes are currently temporary, CMS is exploring whether telehealth flexibilities should be extended.These two concurrent reviews will be based on Medicare Parts B and C data and will examine the use of telehealth services in Medicare during the COVID-19 pandemic.The first review will examine the extent to which telehealth services are being used by Medicare beneficiaries, how the use of these services compares to the use of the same services delivered face-to-face, and the different types of providers and beneficiaries using telehealth services.The second review will identify program integrity risks with Medicare telehealth services to ensure their appropriate use and reimbursement during the COVID-19 pandemic. tags
Revised ASPR, CDC, FDA, NIH, CMS HHS and ASPR Actions Related to Resources, Supplies, and Treatments Needed to Address COVID-19 Office of Evaluation and Inspections OEI-09-20-00570 2022 HHS may take a variety of actions in response to an emerging infectious disease, including, but not limited to, actions related to resources, supplies, and treatments needed to address COVID-19.This study will examine actions taken by HHS, including the Office of Assistant Secretary for Preparedness and Response, to protect public health in response to the COVID-19 pandemic. tags
Completed (partial) Centers for Medicare and Medicaid Services Infection Control at Home Health Agencies During the COVID-19 Pandemic Office of Audit Services A-01-20-00508;
W-00-20-35858
2022 The coronavirus that causes the respiratory disease COVID-19 is especially dangerous for adults aged 65 years and older and those with underlying medical conditions.Medicare beneficiaries receiving home health services may be at a high risk of developing severe illness from COVID-19.Home health services are covered for the elderly and disabled under the Medicare program.Home health services may include skilled nursing care, physical therapy, speech-language pathology, occupational therapy, and medical supplies.Home health agencies (HHAs) must meet certain requirements to participate in the Medicare and Medicaid programs, including meeting infection prevention and control standards.On March 10, 2020, CMS issued a State Survey Directors Letter, "Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) in Home Health Agencies (HHAs)," to provide HHAs with guidance on addressing the outbreak and minimizing transmission.Home health workers often travel to several homes on a weekly basis, which increases their risk of exposure to the COVID-19 and increases the risk of infection among Medicare beneficiaries.HHAs must maintain a coordinated agencywide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases.We will interview corporate officers from the three HHA providers with the largest market share in 2019 as well as HHAs that have recently been cited by CMS for infection control and prevention deficiencies to determine the extent to which their infection control and prevention policy and procedures comply with CMS guidance regarding COVID-19. tags
September 2020 Food and Drug Administration Review of the Food and Drug Administration's Contract Closeout Actions Office of Audit Services W-00-20-59423 2021 As one of the largest contracting agencies in the Federal Government, HHS performed contracting actions (awards and modifications) totaling almost $26.5 billion in fiscal year 2019.Prior OIG work identified issues regarding contract closeout, which is required once a contracting officer receives evidence of receipt of property and final payment, or evidence of physical completion of a contract.The closeout process generally provides a last chance to detect and recover improper contract payments, and delayed closeout poses a financial risk to agency funds.Also, the closeout process: (1) ensures that goods and services were provided as intended; (2) validates final costs and payments; and (3) frees excess funds for possible use elsewhere.We will determine whether FDA closed contracts in accordance with the Federal Acquisition Regulation and departmental guidance.We will also determine whether the FDA identified contracts when they became eligible for closeout. tags
Revised National Institutes of Health NIH-Funded Clinical Trials Reported to ClinicalTrials.gov Office of Audit Services W-00-21-51020 2022 The National Institutes of Health (NIH) provides funds to awardees to conduct clinical trials involving human subjects.These trials are intended to evaluate the effects of drugs or medical devices regulated by the FDA, as well as other interventions that are not regulated by the FDA.Clinical trials are vital to medical advances because they test new and existing health-related interventions, helping us understand whether they are safe and effective for humans when used as intended.Having information about the results of clinical trials fosters improved patient safety by giving doctors, researchers, and the public at large access to information that may inform medical decisions, help focus on areas in need of study, and maximize the public's investment—and trust—in research.Federal law, regulations, and NIH award terms and conditions generally require NIH awardees to submit the results of certain clinical trials to NIH within 1 year after the earlier of the estimated or the completion date of the applicable clinical trial.NIH has extended this requirement to all clinical trials that receive NIH funding.NIH is required to post the results of these trials on Clinical Trials.gov within 30 days of receiving them.We will conduct an audit at NIH to determine whether NIH ensured that NIH-funded intramural and extramural clinical trials complied with Federal reporting requirements. tags
August 2020 Centers for Medicare and Medicaid Services Audit of Medicare Payments for Inpatient Discharges Billed by Hospitals for Beneficiaries Diagnosed With COVID-19 Office of Audit Services W-00-20-35856 2022 Section 3710 of the Coronavirus Aid, Relief, and Economic Security Act directs the Secretary to increase the weighting factor that would otherwise apply to the assigned diagnosis-related group by 20 percent for an individual who is diagnosed with COVID-19 and discharged during the COVID-19 public health emergency period.We will audit whether payments made by Medicare for COVID-19 inpatient discharges billed by hospitals complied with Federal requirements. tags
Revised Centers for Medicare and Medicaid Services Audit of CARES Act Provider Relief Funds: General and Targeted Distributions to Providers Office of Audit Services W-00-20-35855 2022 The Coronavirus Aid, Relief, and Economic Security (CARES) Act and the Paycheck Protection Program and Health Care Enhancement Act appropriated $175 billion for the Provider Relief Fund (PRF) to support health care providers affected by the COVID-19 pandemic.� In April 2020, the Health Resources and Services Administration began distributing the funds through general distributions to Medicare providers based on 2018 net patient revenue and targeted distributions for certain provider types (e.g., providers in areas particularly impacted by COVID-19, skilled nursing providers, and providers in rural areas).� Providers such as hospitals may be eligible for PRF payments from the general and targeted distributions.� We will select for audit a statistical sample of providers that received general and/or targeted distributions.� Our objective is to determine whether providers that received PRF payments complied with certain Federal requirements, and the terms and conditions for reporting and expending PRF funds. tags
Revised Centers for Medicare and Medicaid Services Infection Control and Emergency Preparedness at Dialysis Centers During the COVID-19 Pandemic Office of Audit Services W-00-20-35852 2022 CDC has stated that beneficiaries with serious underlying medical conditions, such as end-stage renal disease (ESRD), are at higher risk for severe illness from COVID-19.Regardless of the current pandemic, dialysis patients are at high risk of infection because of weakened immune systems, coexisting conditions such as diabetes, and treatments requiring frequent use of catheters or insertions of needles to access the bloodstream.ESRD facility conditions for coverage regarding infection control and emergency preparedness are defined in 42 CFR 494 Subpart B.On March 30, 2020, CMS issued a revised memorandum providing guidance for infection control and prevention of COVID-19 in dialysis facilities.We will interview corporate officers from the three ESRD service companies covering more than 75 percent of CY 2018 Medicare reimbursements and 71 percent of dialysis clinics.Our objective is to determine whether ESRD facilities implemented additional infection control and emergency preparedness procedures in accordance with CMS and CDC guidance to safeguard high risk ESRD beneficiaries during the COVID-19 pandemic. tags
Revised HHS Audit of Foundational Cybersecurity Controls for the U.S. Healthcare COVID-19 Portal and Protect.HHS.gov Office of Audit Services W-00-20-42031 2022 The Protect.HHS.gov ecosystem and the U.S. Healthcare COVID-19 portal are both critically important systems contributing to the Federal pandemic response.The data collected by these systems are utilized in the response to COVID-19 by, for example, tracking the movement of the virus, identifying potential stresses in the health care delivery system, and provide information about the distribution of supplies.Without proper cybersecurity, the integrity and availability of the data are at risk and the impact to public health efforts could be significant if decisionmakers cannot rely on COVID-19 data from States, communities, and hospitals.We will determine whether HHS has implemented foundational cybersecurity controls to ensure the integrity and availability of Protect.HHS.gov and the U.S. Healthcare COVID-19 portal. tags
Revised Indian Health Service Audit of the Distribution of Supplies From Indian Health Service's National Supply Service Center in Response to COVID-19 Office of Audit Services W-00-20-20026 2022 COVID-19 has created unprecedented challenges for the U.S. hospital system, including Indian Health Service (IHS), Tribal, and Urban Indian Health Program (UIHP) facilities.American Indians and Alaska Natives (AI/AN) are particularly vulnerable to COVID-19 due to the relatively high rates of diabetes, cancer, heart disease, and asthma among these populations.These vulnerabilities can be heightened by the strong familial structures in AI/AN communities, in which families commonly live in multigenerational homes.Such socially cohesive communities provide a broad range of benefits to their members, but paradoxically these strong structures make it all the more difficult to maintain physical distancing during a pandemic. IHS has received funding for medical supplies and equipment through the COVID-19 relief bills allocated to IHS, Tribal, and UIHP facilities.The objective of this audit is to determine whether IHS had adequate internal controls to ensure that medical supplies and equipment were effectively distributed to the National Supply Service Center's customers in response to the COVID-19 pandemic. tags
Revised Centers for Medicare and Medicaid Services Accuracy of Nursing Home Compare Website's Reported Health, Fire Safety, and Emergency Preparedness Deficiencies Office of Audit Services W-00-20-31551 2022 CMS's Nursing Home Compare website provides information on nursing homes that participate in the Medicare or Medicaid programs.CMS reports the information for consumers to research and make decisions when selecting a nursing home.Included in the information are a nursing home's quality ratings; the results of recent health, fire safety, and emergency preparedness inspections; staffing levels; quality-of-care measures; and penalties assessed by CMS.We will review the information reported on Nursing Home Compare and determine whether the information is accurate and can be relied upon by consumers to compare and select nursing homes. tags
Revised Assistant Secretary for Preparedness and Response Audit of the Assistant Secretary for Preparedness and Response Biomedical Advanced Research and Development Authority's Awarding of Research and Development Contracts for FY 2017 through FY 2020 Office of Audit Services W-00-20-59448 2022 The Office of the Assistant Secretary for Preparedness and Response (ASPR) leads the Nation's medical and public health preparedness for, response to, and recovery from disasters and public health emergencies.The Biomedical Advanced Research and Development Authority (BARDA), a part of ASPR, aids in safeguarding our Nation from pandemic influenza and emerging infectious diseases, and supports the transition of medical countermeasures, such as vaccines, from research through advanced development.Congressional FY appropriations for BARDA are made available to support advanced research and development pursuant to section 319L of the Public Health Service Act and other administrative expenses.We will review contracts awarded through the ASPR Next and BARDA Division of Research, Innovation, and Ventures (DRIVe) programs which were created by ASPR to spur innovation in either the development of certain new lifesaving technologies and products or medical countermeasure efforts.We will determine whether ASPR complied with Federal requirements when awarding contracts with BARDA FY 2017 through FY 2020 appropriations.Furthermore, we will determine whether ASPR appropriately used the ASPR Next and DRIVe programs when awarding contracts. tags
Revised Centers for Medicare and Medicaid Services Swing-Bed Services at Nationwide Critical Access Hospitals Office of Audit Services W-00-20-35853 2022 In 2015, the Office of Inspector General reported that swing-bed usage at Critical Access Hospitals (CAHs) significantly increased from CY 2005 through CY 2010.Medicare spending for swing-bed services at CAHs steadily increased to, on average, almost four times the cost of similar services at alternative facilities.We estimated that Medicare could have saved $4.1 billion over the CY 2005 through CY 2010 period if payments for swing-bed services at CAHs had been made using Skilled Nursing Facility Prospective Payment System rates.We will review swing-bed data for CY 2015 through CY 2019 to determine whether: (1) any actions were taken to reduce swing-bed usage at CAHs; (2) Medicare payment amounts were updated for swing-bed services to CAHs; and (3) alternative care was available to Medicare beneficiaries at a potentially lower rate. tags
Revised Assistant Secretary for Preparedness and Response Audit of Obligations and Expenditures Made From Biomedical Advanced Research and Development Authority FY 2018 and FY 2019 Appropriations Office of Audit Services W-00-20-59449 2022 The Office of the Assistant Secretary for Preparedness and Response (ASPR) leads the Nation's medical and public health preparedness for, response to, and recovery from disasters and public health emergencies.The Biomedical Advanced Research and Development Authority (BARDA), part of ASPR, aids in safeguarding our nation from pandemic influenza and emerging infectious diseases, and supports the transition of medical countermeasures, such as vaccines, from research through advanced development.Congressional FY 2018 and FY 2019 appropriations for BARDA were made available to support advanced research and development pursuant to section 319L of the Public Health Service Act and other administrative expenses of BARDA.We intend to audit the obligations and expenditures made from these appropriations to determine whether they were used for their intended purpose in accordance with Federal requirements. tags
Revised Centers for Medicare and Medicaid Services End Stage Renal Disease Networks' Responsibilities During COVID-19 Office of Audit Services W-00-20-35851; W-00-22-35851 2022 CDC has stated that beneficiaries with serious underlying medical conditions, such as end stage renal Disease (ESRD), are at higher risk for severe illness from COVID-19.As per the CDC, prompt detection, triage, and isolation of potentially infectious patients are essential to prevent unnecessary exposures among patients and health care personnel at dialysis facilities.ESRD treatment facilities are organized into groups called Networks.Network Organizations under CMS contracts develop relationships with dialysis professionals, providers, and patients, and create a collaborative environment to improve patient care.The Network Organizations' contracts include statutory responsibilities and quality improvement activities that could be important in protecting ESRD beneficiaries during the COVID-19 pandemic.In addition to Network Organizations, the ESRD National Coordinating Center (NCC) supports and coordinates activities for the ESRD program on a national level.We will interview Network Organizations, NCC, and CMS officials to identify the actions Network Organizations are taking to aid dialysis clinics and patients in response to COVID-19 and keep CMS abreast of quality-of-care issues resulting from COVID-19. tags
Revised Indian Health Service Audit of Indian Health Service's Coverage of COVID-19 Testing Office of Audit Services W-00-20-20025 2022 The Families First Coronavirus Response Act provided $64 million in additional resources for COVID-19 response activities through the Indian Health Service (IHS) and requires coverage, without cost-sharing, for COVID-19 testing for American Indians/Alaska Natives, who receive health services.The Paycheck Protection Program and Health Care Enhancement Act provided $750 million for COVID-19 testing and testing-related services through IHS.From these two Acts, funding for COVID-19 testing to urban Indian organizations total $53 million and funding to IHS Federal health programs and Tribal health programs total $611 million.We will audit IHS's allocation and utilization of funding to urban Indian organizations, IHS Federal health programs and Tribal health programs.Specifically, our objectives will be to determine whether: (1) IHS allocated the COVID-19 funds to ensure that testing supplies were available to meet community needs, and (2) COVID-19 funds were used by IHS and grantees for testing, including other testing-related services, in accordance with Federal requirements. tags
Revised Assistant Secretary for Preparedness and Response Audit of HHS's Awarding of Ventilator Production Contracts Under the Defense Production Act in Response to COVID-19 Office of Audit Services W-00-20-59450 2022 To address the COVID-19 pandemic, the President used his authority under the Defense Production Act of 1950 to direct the Department of Health and Human Services to facilitate the supply of materials for the production of ventilators.In response, the Office of the Assistant Secretary for Preparedness and Response (ASPR) awarded 10 contracts totaling more than $2.9 billion to supply more than 187,000 ventilators for the Strategic National Stockpile by the end of 2020.This work will focus on the top five highest dollar value contracts awarded by ASPR for supplying these ventilators.We plan to determine whether ASPR's awarding and monitoring of these contracts complied with Federal requirements and HHS policies and procedures. tags
Revised Centers for Disease Control and Prevention CDC's Collection and Use of Data on Disparities in COVID-19 Cases and Outcomes Office of Evaluation and Inspections OEI-05-20-00540 2022 With emerging information on rates of infection and outcomes for the ongoing coronavirus disease 2019 (COVID-19), numerous reports document a disproportionate burden of infection and deaths among communities of color and economically disadvantaged communities.This study will examine data that the Centers for Disease Control and Prevention (CDC) collects and maintains that can be used to assess racial, ethnic, and socioeconomic disparities in COVID-19 cases and outcomes, as well as how CDC uses those data as part of its activities to address the COVID-19 pandemic.We will also examine CDC's lessons learned about how to best protect communities of color and economically disadvantaged communities in future public health emergencies. tags
Revised OS, HRSA, CDC Geographic Distribution of Provider Relief Funds to Communities Disproportionately Impacted by Adverse COVID-19 Outcomes Office of Evaluation and Inspections OEI-05-20-00580 2022 As information on rates of infection and outcomes for the ongoing COVID-19 pandemic emerges, numerous reports document racial, ethnic, and socioeconomic disparities in rates of adverse outcomes from COVID-19, including death.This study will review the locations of hospitals that received Provider Relief Funds, with particular attention to hospitals located in communities of color and economically disadvantaged communities that were disproportionately impacted by adverse COVID-19 outcomes (i.e., hospitalization or death). tags
Revised Centers for Medicare and Medicaid Services Audit of CMS's Controls Over the Expanded Accelerated and Advance Payment Program Payments and Recovery Office of Audit Services W-00-20-35854 2022 This work will provide details of the effectiveness of CMS controls over its Accelerated and Advance Payment Program (AAP) payments to providers and payment recovery.We will obtain data and meet with program officials to understand CMS's eligibility determination process for AAP payments and the steps CMS will have taken to recover such funds in compliance with the CARES Act and other Federal requirements.The objectives of our work will be to determine whether CMS made AAP payments to eligible providers and implemented controls to recover the AAP payments in compliance with the CARES Act and other Federal requirements.We will also evaluate a select group of providers to determine whether they were eligible for AAP payments, and their efforts to repay CMS in compliance with the CARES Act and other Federal requirements. tags
Revised Centers for Medicare and Medicaid Services Medicaid: Expedited Provider Enrollment During COVID-19 Emergency Office of Audit Services W-00-20-31547 2022 As a result of the coronavirus disease 2019 (COVID-19) pandemic, Medicaid provider enrollment through State Medicaid agencies has been expedited under the SSA §1135 Authority to Waive Requirements during National Emergencies.Rapid loosening of established provider screening and background check requirements may limit a State's ability to identify providers who are not eligible to participate in Medicaid.Our objective is to determine whether the State agency and providers complied with Federal and State requirements for newly enrolled providers under the national emergency declaration and if the State established tracking controls for these providers as well as giving providers adequate guidance on waived enrollment requirements. tags
Revised Centers for Medicare and Medicaid Services Assessing Trends Related to the Use of Psychotropic Drugs in Nursing Homes Office of Evaluation and Inspections OEI-07-20-00500 2022 Previous OIG work found that elderly nursing home residents who were prescribed antipsychotic drugs—a type of psychotropic drug—were at risk for harm.CMS concurred with some OIG recommendations and developed new initiatives.However, policymakers continue to raise concerns about whether CMS has made sufficient progress in reducing the use of antipsychotic drugs to care for the elderly.We will report the changes over time for the following: (1) the use of psychotropic drugs for elderly nursing home residents; (2) citations and civil monetary penalties assessed to nursing homes regarding psychotropic drugs; and (3) the presence of diagnoses that exclude nursing home residents from CMS's measure of the use of antipsychotic drugs. tags
Revised Centers for Medicare and Medicaid Services Hospital Collection Effort for Medicare Bad Debt Basic Health Program Eligibility Determinations Office of Audit Services W-00-20-35849 2022 Medicare allows providers to claim reimbursement for a portion of these uncollectible deductibles and coinsurance (known as “bad debt”) once the provider establishes that reasonable collection efforts were made, that the debt was uncollectible, and that there was no likelihood of future recovery based on sound business judgment.Reasonable collection efforts can include billings, followup letters, phone calls, and personal contact.We plan to select a random sample of hospitals and review the policies and procedures in place related to collecting deductibles and coinsurance, offering financial assistance, identifying bad debt, and accounting for the receipt of previously reimbursed bad debt.In addition, we will select a judgmental sample of claims with high-dollar bad-debt amounts (coinsurance or deductible) and determine how the hospitals adhered to Federal criteria in treating these bad debts.Our audit will determine whether hospitals' policies and procedures for collecting Medicare deductible and coinsurance amounts from beneficiaries are in compliance with Federal regulations for the reimbursement of bad debt. tags
Revised Centers for Medicare and Medicaid Services Basic Health Program Eligibility Determinations Office of Audit Services W-00-20-31549 2022 We will determine whether States made Basic Health Program (BHP) payments on behalf of beneficiaries who did not meet Federal and State eligibility requirements.Section 1331 of the Affordable Care Act (ACA) gives States the option to create a BHP that provides health benefits coverage for low-income residents, citizens or lawfully present non-citizens, who would otherwise be eligible to purchase coverage through the Health Insurance Marketplace.The option also gives States the ability to provide more affordable coverage for these low-income residents and improve continuity of care for people whose income fluctuates above and below Medicaid and Children's Health Insurance Program levels.The BHP is funded primarily by Federal funds and must include 10 essential health benefits specified by the ACA. tags
July 2020 Centers for Medicare and Medicaid Services Biosimilar Trends in Medicare Part D Office of Evaluation and Inspections OEI-05-20-00480 2022 Biologic drugs—generally large, complex molecules produced in a living system—are among the most expensive drugs on the U.S. market.Biosimilar drugs are highly similar and have no clinically meaningful difference from their reference biologics; they also tend to be less expensive than their reference biologics.Medicare Part D and beneficiaries have the potential to spend less on prescription drugs with the increased use of biosimilars rather than their reference biologics, but use of biosimilars remains low.Limited coverage of biosimilars by Part D plans and formulary tier placement may discourage the use of less expensive biosimilars.Our study will describe utilization and cost trends of biosimilars and reference biologics covered by Part D over time.In addition, we will determine how much Medicare and beneficiaries paid for biosimilars and reference biologics covered by Part D in 2019, and then compare those costs to determine how much Part D and beneficiaries would have spent with increased use of biosimilars. tags
Revised Centers for Medicare and Medicaid Services Beneficiary Cost-Sharing in Part D Office of Evaluation and Inspections OEI-02-20-00460 2022 A priority of OIG and HHS is to lower drug spending for people and programs.In Medicare Part D, as drug costs rise, the amount that beneficiaries pay out-of-pocket also increases.This amount—known as beneficiary cost-sharing—is not capped in Part D.As a result, some beneficiaries may have high out-of-pocket costs for their prescriptions.If beneficiaries' costs become unaffordable, they may skip doses of medication or forgo purchasing it altogether.This data brief will provide in-depth data on the amount beneficiaries pay out-of-pocket for Part D drugs.It will also determine the proportion of beneficiaries who have high cost-sharing and describe these beneficiaries and the drugs they commonly receive, including the proportion of drugs that are high cost. tags
Revised Centers for Medicare and Medicaid Services Analysis of New Rural Add-On Payment Methodology Office of Audit Services W-00-20-35850 2022 Section 50208 of the Bipartisan Budget Act of 2018 (the BBA) extended rural add-on payments for home health episodes and visits ending during calendar years (CYs) 2019 through 2022, and mandated implementation of a new methodology for applying those payments.Beginning in CY 2019, rural add-on payments were provided in varying amounts according to classification in one of three rural categories: (1) high utilization, (2) low population density, and (3) all other.The BBA requires home health claims to indicate the code for the county in which the home health service is provided.CMS has instructed providers to use value code 85 to report the county code and will return claims for correction when the code is missing or invalid.The BBA also mandated that, no later than January 1, 2023, HHS-OIG submit to Congress an analysis of Medicare home health claims and utilization of home health services by county (or equivalent area) and recommendations, as appropriate, based on such analysis.To meet that mandate, we will perform an analysis of Medicare home health claims for CYs 2019 through 2021.We will trend the claim data and cost reports to determine what impact, if any, the new rural add-on methodology has had on home health agency providers and the utilization of home health services in rural areas. tags
Revised Centers for Medicare and Medicaid Services Centers for Medicare & Medicaid Services and States Implement Policy Modifications To Ensure That Medicaid Beneficiaries Continue To Receive Prescriptions Office of Audit Services W-00-20-31550 2022 Medicaid is a joint Federal-State program that pays for medical assistance for individuals and families with low incomes.All States currently provide coverage for outpatient prescription drugs within their State Medicaid programs.Under section 1135 of the Act, CMS may temporarily waive or modify certain Medicaid requirements to ensure that sufficient health care items and services are available to meet the needs of beneficiaries in times of an emergency.The coronavirus disease 2019 (COVID-19) pandemic highlights the need for States to efficiently and effectively respond to protect the needs of Medicaid beneficiaries.This audit will provide insights from State officials on action taken by States and DC to ensure Medicaid beneficiaries continue to receive prescriptions during the COVID-19 pandemic.We will interview State officials from several States and DC to determine actions taken or planned.Our objective is to review actions taken or planned by States and DC to ensure Medicaid beneficiaries continue to receive prescriptions during the COVID-19 pandemic. tags
Revised Centers for Medicare and Medicaid Services Trend Analysis of Medicare Laboratory Billing for Potential Fraud and Abuse With COVID-19 Add-on Testing Office of Evaluation and Inspections OEI-09-20-00510 2022 The coronavirus disease 2019 (COVID-19) pandemic has led to an unprecedented demand for diagnostic laboratory testing to determine whether an individual has the virus. Beyond the COVID-19 tests, laboratories can also perform add-on tests, for example to confirm or rule out diagnosis other than COVID-19. However, OIG has program integrity concerns related to add-on tests in conjuction with COVID-19 testing, particularly related to potentially fraudulent billing for associated respiratory pathogen panel (RPP) tests, allergy tests, or genetic tests. The Centers for Medicare & Medicaid Services has relaxed rules related to COVID-19 testing and other associated diagnostic laboratory testing to no longer require an order from the treating physician or nonphysician practitioner (NPP) during the COVID-19 public health emergency. Relaxation of the physician ordering/NPP rules could allow unscrupulous actors more leeway for fraudulent billing of unnecessary add-on testing. This study will examine Medicare claims data for laboratory testing to identify trends in the use of RPP, allergy, and genetic testing and identify patterns of billing by laboratories that may indicate fraud and abuse. tags
Revised Centers for Medicare and Medicaid Services Medicaid—Telehealth Expansion During COVID-19 Emergency Office of Audit Services W-00-20-31548 2022 As a result of the coronavirus disease 2019 (COVID-19) pandemic, State Medicaid programs have expanded options for telehealth services.Rapid expansion of telehealth may pose challenges for State agencies and providers, including State oversight of these services.Our objective is to determine whether State agencies and providers complied with Federal and State requirements for telehealth services under the national emergency declaration, and whether the States gave providers adequate guidance on telehealth requirements. tags
Revised Administration for Children and Families Audit of Foster Care Services During Coronavirus Disease 2019 (COVID-19) Office of Audit Services W-00-20-20024 2022 Title IV-E of the Social Security Act (the Act), as amended, authorizes the Federal Foster Care Program, which helps provide safe and stable out-of-home care for children until the children are safely returned home, placed permanently with adoptive families, or placed in other planned arrangements for permanency.Title IV-B of the Act authorizes Federal funding to States to promote flexibility in the development and expansion of coordinated child and family services programs.In response to COVID-19, on April 15, 2020, the Children's Bureau—the operating division of the Administration for Children and Families (ACF) that administers the Title IV-B and Title IV-E programs at the Federal level—provided flexibility to State Title IV-E agencies related to (1) fingerprint-based criminal record checks requirements for prospective foster parents (allowing for name-based checks until fingerprint-based checks can safely be done), and (2) caseworker visit requirements (allowing videoconferencing visits to count toward the requirement that 50 percent of visits must occur in the child's home).On April 27, 2020, the Children's Bureau reminded States of additional flexibilities afforded by the Statute, including the authority to modify foster family licensing standards as long as the standards are applied to all of these placements in accordance with the requirements of the Statute.Additionally, States have the authority to set their own foster care maintenance payment rates including, at their own discretion, enhancing those rates for children who test positive for COVID-19.
We intend to survey all States and identify the States that adopted any new licensing regulations or policies and procedures as a result of the existing flexibilities in the Statute and the waivers provided by ACF.Based on the information gathered, we plan to identify three States and conduct separate audits to ensure foster care providers are safeguarding the health and safety of children during the COVID-19 pandemic and identify any vulnerabilities or gaps in policies or procedures that could place these children at risk.As part of these audits, we would ensure that criminal record checks for foster parents conducted via name-based checks were ultimately conducted through fingerprints whenever determined safe to do so.
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Revised Office of the Secretary Audit of Cost Allocation Services' Negotiation and Approval of Indirect Cost Rates for Nonprofit Organizations Office of Audit Services W-00-20-51003 2022 Cost Allocation Services (CAS), which is within the Department of Health and Human Services (HHS) Program Support Center, is designated as the Agency to negotiate facility and administrative indirect cost rate agreements for nonprofit organizations receiving the largest dollar value of Federal funds from HHS grant or contract funds.The indirect cost rate agreements are used by grantee institutions to charge Federal programs for administrative and facility costs associated with conducting Federal programs.Previous OIG audits of nonprofit organizations have raised concerns about the indirect cost rate negotiations and subsequent agreements.Our objective will be to assess CAS's indirect rate setting process and determine its compliance with Federal regulations when negotiating and approving indirect cost rates for nonprofit organizations. tags
Revised Centers for Medicare and Medicaid Services Advanced Care Planning Services: Compliance With Medicare Requirements Office of Audit Services W-00-20-35848 2022 In 2016, Medicare began paying for Advanced Care Planning (ACP), which is a face-to-face service through which a Medicare physician (or other qualified health care professional) and a patient discuss the patient's wishes for health care if he or she becomes unable to make decisions about care.It allows Medicare beneficiaries to make important decisions, giving them control over the type of care they receive and when they receive it.Previous reviews have shown improper payments due to a lack of clinical documentation to support face-to-face services, clinical documentation of the time spent discussing ACP, or both.We plan to perform a nationwide audit to determine whether Medicare providers for ACP services complied with Federal regulations. tags
Revised Centers for Medicare and Medicaid Services Utilization of Medication-Assisted Treatment in Medicare Office of Evaluation and Inspections OEI-02-20-00390 2022 The opioid crisis remains a public health emergency.The current coronavirus disease 2019 (COVID-19) pandemic makes the need to focus on the opioid crisis even more pressing.The National Institutes of Health recently issued a warning that individuals with opioid use disorder could be particularly hard hit by COVID-19.An important step in addressing the crisis is to focus on concerns about access to treatment.Recent OIG studies have found that the utilization of drugs for medication-assisted treatment (MAT) is low and that concerns exist related to access.The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act requires Medicare to cover certain treatment services provided by opioid treatment programs, including methadone.This study will assess the extent to which Medicare beneficiaries with opioid use disorder are receiving MAT drugs through Medicare and the extent to which they are receiving counseling or behavioral therapies.It will also determine whether Medicare beneficiaries with opioid use disorder who are not receiving MAT drugs have certain characteristics in common. tags
June 2020 Centers for Medicare and Medicaid Services Results of UPICs' Benefit Integrity Activities Office of Evaluation and Inspections OEI-03-20-00330 2022 The Unified Program Integrity Contractors (UPICs) are the only benefit integrity contractors that safeguard both the Medicare and Medicaid programs from fraud, waste, and abuse.The Medicare and Medicaid programs provide health coverage to more than 100 million Americans.UPICs must effectively detect and deter fraud, waste, and abuse.This study will continue OIG's work examining the results from benefit integrity contractors' identification and investigation of fraud, waste, and abuse.It also will identify any barriers and challenges UPICs have experienced while conducting unified benefit integrity activities across Medicare and Medicaid. tags
Revised Administration for Children and Families Audit of Grantee's Expenditures Under the Additional Supplemental Appropriations for Disaster Relief Requirement Act, 2018 Office of Audit Services W-00-20-20023 2022 On February 9, 2018, the Bipartisan Budget Act of 2018 (P.L. 115-123) included division B, subdivision 1, the Further Additional Supplemental Appropriations for Disaster Relief Requirement Act, 2018, which provided disaster relief totaling approximately $89.3 billion.Of this, HHS was allocated $5.97 billion ($1.07 billion for discretionary programs and $4.9 billion for Medicaid).OIG received $2 million to provide oversight of HHS's activities and to ensure that program activities and funds expended for recovery and response efforts related to hurricanes Harvey, Irma, and Maria achieved their intended purposes to help individuals and communities in need.For this series of reviews, we will determine whether Further Additional Supplemental Appropriations for Disaster Relief Requirement Act, 2018, recipients claimed allowable costs in accordance with Federal requirements. tags
Revised Centers for Medicare and Medicaid Services Penetration Tests of State Medicaid Management Information Systems and Eligibility & Enrollment Systems Office of Audit Services W-00-20-42028; W-00-21-42028 2022 State Medicaid agencies use the Medicaid Management Information System (MMIS) for administrating the Medicaid program; processing beneficiary and provider inquiries and services; operating claims control and computer capabilities; and managing reporting for planning and control.State Medicaid Eligibility & Enrollment (E&E) systems support processes related to a determination of Medicaid coverage and required procedures necessary for registration.State agencies are responsible for the security of MMIS and E&E systems.HHS OIG will perform a series of penetration tests in select State MMIS or Medicaid E&E environments to identify cybersecurity vulnerabilities on high-risk information systems and networks. tags
Revised Centers for Medicare and Medicaid Services Audit of Nursing Home Infection Prevention and Control Program Deficiencies Office of Audit Services W-00-20-31545 2022 The Centers for Disease Control and Prevention has indicated that individuals at high risk for severe illness from coronavirus disease 2019 (COVID-19) are people aged 65 years and older and those who live in a nursing home.Currently, more than 1.3 million residents live in approximately 15,450 Medicare- and Medicaid-certified nursing homes in the United States.As of February 2020, State Survey Agencies have cited more than 6,600 of these nursing homes (nearly 43 percent) for infection prevention and control program deficiencies, including lack of a correction plan in place for these deficiencies.To reduce the likelihood of contracting and spreading COVID-19 at these nursing homes, effective internal controls must be in place.Our objective is to determine whether selected nursing homes have programs for infection prevention and control and emergency preparedness in accordance with Federal requirements. tags
Revised OS Audit of CARES Act Provider Relief Funds—Distribution of $50 Billion to Health Care Providers Office of Audit Services W-00-20-35847; W-00-22-35847 2022 This work will examine the effectiveness of HHS controls over the awarding and disbursement of $50 billion in Provider Relief Fund (PRF) payments to hospitals and other providers.We will obtain data and interview program officials to gain an understanding of how PRF payments were calculated and review PRF payments for compliance with Coronavirus Aid, Relief, and Economic Security (CARES) Act requirements.Among other things, we will seek to determine whether HHS controls over PRF payments ensured that payments were correctly calculated and disbursed to eligible providers. tags
Completed Centers for Medicare and Medicaid Services Blood Lead Screening Tests for Medicaid-Enrolled Children Office of Evaluation and Inspections OEI-07-18-00371 2022 Under the Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) benefit, Medicaid-enrolled children are required to receive blood lead screenings, followup services, and treatment for conditions identified through screenings.This work expands on previous OIG work in EPSDT screenings and will incorporate State health department data to supplement screening rates for Medicaid-enrolled children who may receive lead screenings in other settings.Additionally, this work will identify barriers to and opportunities for improving required lead screenings and boosting education and outreach for practitioners, parents, and caregivers. tags
Revised National Institutes of Health Review of Institutions of Higher Education Grantees Receiving National Institutes of Health Awards Office of Audit Services W-00-20-59445 2022 More than 80 percent of National Institutes of Health (NIH) funding is awarded through almost 50,000 competitive grants to more than 300,000 researchers at more than 2,500 universities, medical schools, and other research institutions located in every State and around the world.OIG has identified areas of potential risk at institutions of higher education receiving NIH awards such as inappropriate or unsupported charges to Federal awards, lack of financial conflict-of-interest polices, and deficiencies in internal control related to the financial management system.In addition, Congress, NIH, and Federal intelligence agencies have raised concerns about foreign threats to the integrity of U.S. medical research and intellectual property at institutions of higher education.Our objective will be to determine whether institutions of higher education (1) managed NIH awards to ensure allowability of costs in accordance with Federal and award requirements, and (2) met Federal conflict-of-interest requirements. tags
Revised Centers for Medicare and Medicaid Services Medicare Part D Payments for Transmucosal Immediate-Release Fentanyl Drugs Office of Audit Services W-00-20-35846 2022 Transmucosal Immediate-Release Fentanyl (TIRF) drugs are a Schedule II controlled substance.Medicare Part D covers TIRF drugs only for managing breakthrough pain in adult cancer patients who are already receiving and are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.We will determine whether TIRF drugs were appropriately dispensed in Medicare Part D in accordance with Medicare requirements. tags
Revised National Institutes of Health Audit of National Institutes of Health's Cybersecurity Provisions and Related Efforts to the Grant Program Office of Audit Services W-00-20-42027 2022 The purpose of this audit is to determine if NIH has controls in place to ensure grants have appropriate cybersecurity provisions.The National Institutes of Health (NIH) is comprised of 27 separate components called Institutes and Centers and is the primary Federal agency responsible for conducting and supporting biomedical research for the purpose of enhancing health, lengthening life, and reducing illness and disability.Annually, NIH invests nearly $39.2 billion in medical research projects on a number of common and rare diseases, including cancer, Alzheimer's, diabetes, arthritis, heart ailments, and AIDS.More than 80 percent of the NIH's funding is awarded through approximately 50,000 competitive grants to more than 300,000 researchers at more than 2,500 universities, medical schools, and other research institutions in every State and around the world.

Specifically, the audit will review NIH's policies and procedures to determine if NIH has controls or requirements in place to ensure grants have appropriate cybersecurity provisions, and review NIH's policies and procedures to test and verify that adequate cybersecurity is in place over the grantee research data.
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Revised Centers for Medicare & Medicaid Services Blood Lead Screening Tests, Followup Services, and Treatment for Medicaid-Enrolled Children Office of Evaluation and Inspections OEI-07-18-00370 2022 There is no safe level of lead exposure for children. In the absence of timely screening, followup services, and treatment, children remain vulnerable to cognitive deficiencies associated with lead exposure. Medicaid-enrolled children are required to receive blood lead screenings. Under the Early and Periodic Screening, Diagnostic, and Treatment program, children are also entitled to receive followup services and treatment for conditions identified through screenings (e.g., elevated blood lead levels (EBLLs). Although previous OIG reports identified low rates of lead screenings, an evaluation of followup services for Medicaid-enrolled children with EBLLs has not been done. We will identify the percentage of children under 26 months of age who (1) received required blood lead screenings, (2) had EBLLs, and (3) received needed followup services and treatment. Additionally, we will determine why children with EBLLs did not receive screening, followup services, and treatment and the extent to which the Centers for Medicare & Medicaid Services provided guidance and technical assistance to States. tags
May 2020 Centers for Medicare & Medicaid Services Nursing Homes: CMS Oversight of State Survey Agencies Office of Evaluation and Inspections OEI-06-19-00460 2022 CMS enters into agreements with State survey agencies (SAs) to conduct surveys to determine whether nursing homes are compliant with Medicare requirements. Recent reports by OIG found problems in SA performance, including not verifying whether nursing homes corrected deficiencies and not investigating complaints in a timely manner. CMS evaluates SA performance in fulfilling their surveying responsibilities, including through Federal monitoring surveys and performance thresholds described in the State Performance Standards System. When there is inadequate SA performance, CMS may impose a sanction or remedy, such as providing for training of survey teams, requiring the SA to submit a corrective action plan, or reducing the State's allotment of Federal financial participation. We will describe CMS's efforts to work with SAs to improve performance by conducting interviews and reviewing supporting documentation about CMS's monitoring efforts. We will also identify any challenges or barriers that may impede CMS's ability to help SAs improve performance. tags
Revised Centers for Medicare & Medicaid Services Review of the Medicare DRG Window Policy Office of Evaluation and Inspections OEI-05-19-00380 2022 Outpatient services directly related to an inpatient admission are considered part of the inpatient payment and are not separately payable by Medicare. The diagnosis-related group (DRG) window policy defines when CMS considers outpatient services to be an extension of inpatient admissions, and generally includes services that are (1) provided within the 3 days immediately preceding an inpatient admission to an acute-care hospital, (2) diagnostic services or admission-related nondiagnostic services, and (3) provided by the admitting hospital or by an entity wholly owned or operated by the admitting hospital. Building on previous OIG work, we will determine the number of admission-related outpatient services that were not covered by the DRG window policy in 2018, including services that were provided prior to the start of the DRG window and services that were provided at hospitals that shared a common owner. We will also determine the amounts that Medicare and beneficiaries would have saved in 2018 if the DRG window policy had been updated to include more days and other hospital ownership structures. In addition, we will interview CMS staff to identify other payment models that CMS could use to pay for outpatient services related to inpatient admissions. tags
Revised Centers for Medicare & Medicaid Services Medicare Payments for Stelara Office of Evaluation and Inspections OEI-BL-19-00500 2022 Since 2016, total Medicare Part B payments to physicians for Stelara-an expensive drug used to treat certain autoimmune diseases that is often self-injected by patients in their home-have increased substantially. Such a large increase in payments for a drug that would not typically be covered under Part B raises questions about what is driving the growth, including the possibility of improper billing. In this study, OIG will (1) determine whether versions of Stelara that are typically self-injected meet the criteria for Medicare Part B coverage, (2) identify factors that may be causing the substantial growth in payments, and (3) determine whether claims for Stelara show evidence of improper billing by physicians. tags
Revised Food and Drug Administration FDA's Tobacco Retailer Compliance Check Inspection Program Office of Evaluation and Inspections OEI-01-20-00240; OEI-01-20-00241 2022 Youth tobacco use, specifically e-cigarette use, continues to grow at an alarming rate. The Centers for Disease Control and Prevention (CDC) found that e-cigarette use among youth increased by more than 1.5 million users (38 percent) between 2017 and 2018. FDA's Retailer Compliance Check Inspection program plays a key role in its Youth Tobacco Prevention Plan. Under the program, FDA contractors, generally States, carry out undercover buy inspections of tobacco retailers to ensure that they comply with restrictions on sales to minors. They also conduct advertising and labeling inspections to ensure that retailers comply with limitations on marketing of tobacco products. Since the program began in 2010, contractors have carried out over 1 million inspections. The first time FDA finds violations during a tobacco retailer inspection, FDA generally issues a warning letter. When followup inspections reveal subsequent violations, FDA may seek to impose civil monetary penalties and no-tobacco-sale orders that prevent retailers with repeated violations from selling tobacco products indefinitely or for a specified period of time. We will determine the extent and nature of inspections, violations, and enforcement actions by inspection type, on a State-by-State basis, and over time. We will also assess FDA's direction and oversight of the program, including how it targets inspection priorities and holds contractors responsible for their performance. tags
May 2020 HHS Assessing HHS Agencies' Adherence to Health, Safety, and Operational Protocols During Repatriation and Quarantine Efforts for the COVID-19 Outbreak Office of Evaluation and Inspections OEI-04-20-00360 2022 The U.S. Department of Health and Human Services (HHS) plays a lead role in preparing for and responding to public health emergencies. The current novel coronavirus (COVID-19) pandemic highlights the need for HHS to efficiently and effectively respond to protect the nation. OIG will evaluate how HHS staff were deployed, trained, and protected when assigned tasks that could entail potential exposure to COVID-19, such as work at quarantine sites and at ports of entry. We will analyze steps taken to protect HHS staff and, in turn, the public, during pre-deployment, deployment, and post-deployment. We will also review the extent to which HHS has established mechanisms to identify and correct any vulnerabilities in deployment protocols. We plan to issue multiple work products reporting findings for the Administration for Children and Families (ACF), Centers for Disease Control and Prevention (CDC), and the Department overall. tags
Revised Food and Drug Administration The Food and Drug Administration's Role in Facilitating Testing for COVID-19 Office of Evaluation and Inspections OEI-01-20-00380 2022 When the Secretary of the Department of Health and Human Services determines that there is a public health emergency and declares that circumstances exist justifying an Emergency Use Authorization (EUA), the Food and Drug Administration (FDA) can issue an EUA under section 564 of the Federal Food, Drug, and Cosmetic Act.An EUA allows for the use of certain unapproved medical products, or unapproved uses of certain approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when there are no adequate, approved, and available alternatives.FDA issued the first COVID-19 EUA for a diagnostic test to the Centers for Disease Control and Prevention and issued subsequent EUAs to other laboratories.This work will examine FDA's EUA processes and any challenges it may have faced regarding EUAs for COVID-19 diagnostic tests and serological tests for antibodies developed in response to the viral infection. tags
Revised Assistant Secretary for Preparedness and Response Audit of ASPR's Operation of the Strategic National Stockpile in Response to the COVID-19 Disease Pandemic Office of Audit Services W-00-20-59446 2022 The Strategic National Stockpile (Stockpile) is a repository of supplies for use in the event of a national emergency in the United States or its territories.Originally funded by Congress in Fiscal Year 1999 and operated by the Centers for Disease Control and Prevention, the Assistant Secretary for Preparedness and Response (ASPR) at the Department of Health and Human Services has been responsible since 2018 for the operation of the Stockpile.OIG has historically reviewed various aspects of the Department's emergency preparedness and response.We plan to determine whether ASPR's operation of the Stockpile was effective in response to the coronavirus disease 2019 (COVID-19) pandemic. tags
Revised Centers for Disease Control and Prevention Audit of HHS's Production and Distribution of COVID-19 Lab Test Kits Office of Audit Services W-00-20-57303 2022 When a new viral disease emerges, CDC uses its expertise and biosafety laboratories to develop and distribute tests to state public health laboratories.CDC uses confirmed viral samples from initial patients to develop these tests.To ensure that it has a functioning test, CDC conducts quality assurance reviews.After validating that it has a functioning test, CDC sends the tests to state public health labs for their use.During the early phases of identification and spread of the novel coronavirus in the United States in 2020, CDC developed testing kits, called the CDC 2019-Novel Coronavirus Real-Time Reverse Transcriptase-PCR Diagnostic Panel (CDC 2019-nCoV Real Time RT-PCR), and sent the kits to qualified laboratories to identify COVID-19 cases.We plan to review the controls that HHS has in place to produce and distribute the COVID-19 test kits and whether CDC has designed and implemented controls to mitigate any potential risks.The objective of our audit will be to review CDC's process of producing and distributing the COVID-19 test kits. tags
Revised Administration for Children and Families Health and Safety Monitoring in Head Start Office of Evaluation and Inspections OEI-BL-19-00560 2022 Head Start serves roughly 1 million vulnerable children and their families annually at a cost of $10.06 billion as of fiscal year 2020. Prior OIG work identified significant health and safety violations at some Head Start facilities. We will examine how the Office of Head Start (OHS) monitors and enforces Federal health and safety standards in Head Start facilities. Additionally, we will describe recent trends in health and safety violations and assess whether OHS consistently and effectively monitors grantees to ensure children's safety. tags
Revised ASFR A Review of HHS's Suspension and Debarment in Protecting the Integrity of Federal Awards Office of Evaluation and Inspections OEI-04-19-00570 2022 HHS is the largest grant-making agency and third largest contracting agency in the Federal Government. Thus, it is important for HHS to have an effective suspension and debarment program. An effective suspension and debarment program protects the integrity of Government grants, contracts, loans, and other assistance programs by preventing awardees who demonstrate a lack of honesty, integrity, or performance from receiving additional Federal awards (i.e., grants, contracts, loans, and other forms of assistance). This study will describe the actions that HHS is taking to protect its awards and will determine the effective and potentially ineffective characteristics of the Department's suspension and debarment program. tags
Completed (partial) Centers for Medicare and Medicaid Services CMS's Internal Controls Over Hospital Preparedness for Emerging Infectious Disease Epidemics Such as Coronavirus Disease 2019 Office of Audit Services A-02-21-01003;
W-00-20-35845;
W-00-21-35845
2022 Hospitals that participate in the Medicare program must comply with Federal participation requirements, including requirements that hospitals engage in all-hazards emergency preparedness planning. On February 1, 2019, CMS added planning for emerging infectious diseases to its emergency preparedness guidance. We will audit CMS's internal controls over hospital preparedness for an emerging infectious disease epidemic, such as coronavirus disease 2019 (COVID-19). We will also audit hospital compliance with CMS's emergency preparedness requirements. tags
Revised Centers for Medicare & Medicaid Services Medicaid—Audit of Health and Safety Standards at Individual Supported Living Facilities Office of Audit Services W-00-20-31543 2022 State agencies operate home and community-based services programs under a 1915(c) waiver to their respective Medicaid State plans. Some of these waivers allow for providing services to individuals with developmental disabilities. Such waivers include individualized supported living habilitation services, which provide assistance and necessary support to achieve personal outcomes that enhance individuals' ability to live in and participate in their communities. To receive approval for a waiver, State agencies must ensure the health and welfare of the beneficiaries of the service. Recent media coverage throughout the United States of deaths of people with developmental disabilities involving abuse, neglect, or medical errors has led to OIG audits in several States. Our objective is to determine whether State agencies and providers complied with Federal and State health and safety requirements involving Medicaid beneficiaries with developmental disabilities residing in individualized supported living settings, including infection control for conditions such as coronavirus disease 2019 (COVID-19) and other infectious diseases. tags
Completed (partial) Centers for Medicare & Medicaid Services Health and Safety Standards in Social Services for Adults Office of Audit Services A-05-16-00044;
A-05-17-00030;
A-05-17-00009;
A-05-17-00028;
W-00-20-31503
2022 State agencies operate elderly waiver programs under a 1915(c) waiver to their Medicaid State plan. Adult day centers are center-based facilities directly licensed by the State agency. They provide adult day services to functionally impaired adults on a regular basis for periods of fewer than 24 hours during the day in a nonresidential setting. As the licensing agency for adult day care centers, the State agency must ensure that adult day centers follow applicable licensing standards to protect the health and safety of adults receiving services at these facilities. Recent OIG reports have identified numerous instances of noncompliance in regulated child care facilities and family adult foster care homes. We will determine whether regulated adult day centers comply with applicable Federal, State, and local regulations and standards on ensuring the health and safety of adults in their care, including infection control for conditions such as coronavirus disease 2019 (COVID-19) and other coronaviruses. tags
Revised Centers for Medicare and Medicaid Services Medicaid Nursing Home Life Safety and Emergency Preparedness Reviews Office of Audit Services W-00-20-31525 2022 Previous OIG audits on Medicaid nursing home life safety and emergency preparedness have identified multiple issues that put vulnerable populations at risk and indicated that nursing homes in various States are not complying with these requirements. In 2016, CMS updated its health care facilities' life safety and emergency preparedness requirements to improve protections for all Medicare and Medicaid beneficiaries, including those residing in long-term-care (LTC) facilities. In addition, in 2019 CMS also issued expanded guidance on emerging infectious disease control to ensure that health care facilities are prepared to respond to threats from infectious diseases. OIG is reviewing this area because residents of LTC facilities are particularly vulnerable to risks such as fires, natural disasters, or disease outbreak (such as COVID-19 and other coronaviruses). Our objective is to determine whether LTC facilities that received Medicare or Medicaid funds complied with new Federal requirements for life safety and emergency and infectious disease control preparedness. tags
Completed (Partial) Administration for Children and Families Emergency Preparedness and Response at Care Provider Facilities in the Office of Refugee Resettlement's Unaccompanied Alien Children Program Office of Audit Services A-04-20-02031;
W-00-20-20021
2022 The Emergency Supplemental Appropriations for Humanitarian Assistance and Security at the Southern Border Act, 2019 (P.L. 116-26) appropriated $2.9 billion for the Unaccompanied Alien Children (UAC) Program. Within this $2.9 billion, title IV of P.L. 116-26 provided $5 million for OIG to conduct additional oversight of the UAC Program, which is managed by HHS's Office of Refugee Resettlement (ORR). As part of OIG's oversight of ORR, we plan to review UAC Program emergency preparedness and response plans and procedures. The ORR Guide Children Entering the United States Unaccompanied states that UAC care providers are responsible for safety planning for each facility, including development of a written safety plan for all UAC children in its care and program staff. This written plan should address emergency situations such as evacuations (e.g., due to hurricane, fire, or other emergency), medical and mental health emergencies, and disease outbreaks (such as COVID-19). Each facility must also have policies and procedures for identifying, reporting, and controlling communicable diseases (for example, coronaviruses). In addition, each licensed care provider facility must adhere to State licensing requirements regarding emergency preparedness and response. Our objective will be to determine whether selected care provider facilities followed Federal and State requirements in preparing for and responding to emergency events. tags
Revised Centers for Medicare and Medicaid Services Medicare Part B Payments to Physicians for Co-Surgery Procedures Office of Audit Services W-00-20-35844; W-00-22-35844 2022 Under Medicare Part B, when the individual skills of two surgeons are necessary to perform a specific surgical procedure or distinct parts of a surgical procedure (or procedures) simultaneously on the same patient during the same operative session (co-surgery), each surgeon should report the specific procedure(s) by billing the same procedure code(s) with a modifier "62." By appending modifier "62" to the procedure code(s), the fee schedule amount applicable to the payment for each co-surgeon is 62.5 percent of the global surgery fee schedule amount. We plan to audit a sample of claim line items-specifically where different physicians billed for the same co-surgery procedure code, for the same beneficiary, on the same date of service. Our objective is to determine whether Medicare Part B payments to physicians for co-surgery procedures were properly made. tags
Revised National Institutes of Health Grantee Institutions' Actions To Strengthen Policies in Response to Concerns Regarding Potential Foreign Influence on NIH-Funded Research Office of Evaluation and Inspections OEI-03-20-00210 2022 The National Institutes of Health (NIH) requires grantee institutions to report their researchers' financial interests and affiliations with foreign entities. NIH and Congress have raised concerns that the failure by some NIH-funded researchers to disclose to grantee institutions substantial contributions of resources from other organizations, including foreign governments, threatens to distort decisions about the appropriate use of NIH funds. In response to these concerns, NIH has taken steps to improve the accurate reporting of all sources of research support, financial interests, and affiliations. In July 2019, NIH released a notice to its extramural research community clarifying its policy regarding other support, including foreign affiliations. Given NIH's efforts to increase awareness among its grantee institutions regarding financial interests and foreign influence, this evaluation will focus on grantee institutions' policies and procedures related to (1) ensuring that researchers report all foreign affiliations (including foreign positions and scientific appointments, financial interests in foreign entities, research support from foreign entities, and any other foreign affiliations) and (2) reviewing the foreign affiliations that researchers report. This evaluation will also determine to what extent grantee institutions have updated or revised these policies and procedures to address recent concerns and NIH guidance. tags
Revised Centers for Medicare and Medicaid Services Medicare Hospital Payments for Claims Involving the Acute- and Post-Acute-Care Transfer Policies Office of Audit Services W-00-20-35832 2022 Medicare's acute- and post-acute-care transfer policies designate some discharges as transfers when beneficiaries receive care from certain post-acute-care facilities. The diagnosis-related group (DRG) payment provides payment in full to hospitals for all inpatient services associated with a particular diagnosis. Because of its transfer payment policies, Medicare pays hospitals a per diem rate for early discharges when beneficiaries are transferred to another prospective payment system hospital or to post-acute-care settings, including skilled nursing facilities, inpatient rehabilitation facilities, home health agencies, long-term-care hospitals, psychiatric hospitals, and hospice. This is based on the presumption that hospitals should not receive full payments for beneficiaries discharged early and then admitted for additional care in other clinical settings. Previous Office of Inspector General reviews identified Medicare overpayments to hospitals that did not comply with Medicare's post-acute-care transfer policy. We will review Medicare hospital discharges that were paid a full DRG payment when the patient was transferred to a facility covered by the acute and post-acute transfer policies where Medicaid paid for the service. Under the acute- and post-acute transfer policies, these hospital inpatient stays should have been paid a reduced amount. Additionally, we will assess the transfer policies to determine if they are adequately preventing cost shifting across healthcare settings. tags
Revised Office of the Secretary HHS Compliance with the Improper Payment Elimination and Recovery Act Office of Audit Services W-00-20-40037 2022 The Improper Payments Information Act of 2002 (IPIA), as amended by the Improper Payments Elimination and Recovery Act of 2010 (IPERA) and the Improper Payments Elimination and Recovery Improvement Act of 2012 (IPERIA), requires the head of each Federal agency with programs or activities that may be susceptible to significant improper payments to report certain information to Congress. For any program or activity with estimated improper payments exceeding $10 million and 1.5 percent, or $100 million regardless of the improper payment rate, HHS must report to Congress improper payment estimates, corrective action plans, and reduction targets. Pursuant to IPERA and OMB Circular A-123, Appendix C, Requirements for Payment Integrity Improvement, OIG will review HHS compliance with IPIA, as amended, as well as how HHS assesses the programs it reports and the accuracy and completeness of the reporting in HHS's Agency Financial Report. We will make recommendations as needed. We will use the independent external auditor contracted to audit the annual CMS and HHS Financial Statement Audits to perform this work. tags
February 2020 Centers for Medicare & Medicaid Services Nationwide Audit of Medicare Part D Eligibility Verification Transactions Office of Audit Services W-00-20-35751 2022 An E1 transaction is a Medicare Part D eligibility verification transaction that the pharmacy submits to the Part D transaction facilitator to bill for a prescription or determine drug coverage billing order. The Part D transaction facilitator returns information to the pharmacy that is needed to submit the prescription drug event. E1 transactions are part of the real-time process of the Coordination of Benefits and calculating the true out-of-pocket costs (CMS, Medicare Prescription Drug Benefit Manual, Pub. No. 100-18, chapter 14, 30.4). We will review CMS's oversight of E1 transactions processed by contractors and determine whether the E1 transactions were created and used for intended purposes. tags
February 2020 Centers for Medicare & Medicaid Services Medicaid MCO PBM Pricing Office of Audit Services W-00-20-31542 2022 The State Medicaid agency and the Federal Government are responsible for financial risk for the costs of Medicaid services. Managed care organizations (MCOs) contract with State Medicaid agencies to ensure that beneficiaries receive covered Medicaid services including prescription drugs. MCOs may contract with pharmacy benefit managers (PBMs) to manage or administer the prescription drug benefits on their behalf. Spread pricing is a practice where a PBM charges an MCO more for a drug than the amount a PBM pays a pharmacy. Our audit will determine whether States provide adequate oversight of Medicaid MCOs to ensure accountability over amounts paid for prescription drug benefits to its PBMs. tags
Revised Centers for Medicare & Medicaid Services Early Discharges From Inpatient Rehabilitation Facilities to Home Health Services Office of Audit Services W-00-20-35831 2022 Under the inpatient rehabilitation facility (IRF) prospective payment system (PPS), the Centers for Medicare & Medicaid Services (CMS) established an IRF transfer payment policy based on a per diem amount for each case-mix group (CMG) for which the discharge occurred before the average length of stay for the respective CMG. The IRF transfer payment policy applies to early IRF transfers to another IRF, an inpatient hospital, a nursing home that accepts payments under Medicare or Medicaid, or a long-term-care facility. CMS excluded IRF discharges to home health services from this policy because the home health agency PPS had just been developed and claims data were not available for CMS to analyze. CMS was concerned, however, about IRF incentives to discharge patients prematurely under the IRF PPS to home health services. Our objective is to determine how an IRF transfer payment policy for early discharges to home health services would financially affect Medicare Part A and IRFs. tags
Revised Administration for Children and Families Audit of Office of Refugee Resettlement's Placement and Transfer of Children in the Unaccompanied Alien Children Program Office of Audit Services W-00-20-20002 2022 The Unaccompanied Alien Children Program, managed by the Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), provides temporary shelter, care, and other related services to unaccompanied children. ORR funds a network of approximately 170 state-licensed care provider facilities for children in its custody. The ORR Guide: Children Entering the United States Unaccompanied details the policies for initial placement of children in and transfer between ORR care provider facilities. ORR must make every effort to place and keep each child in the least restrictive setting available that is in the child's best interest. Our objective will be to determine whether ORR followed its policies, procedures, and guidance both when making initial placements in care provider facilities funded by ORR and when transferring children between those facilities. We will also determine how frequently children are transferred between care provider facilities, the reason for transfers and denials of transfers, and any challenges that care provider facilities face when children are identified as requiring a transfer. Departmental Operational Issues; Emergency Preparedness and Response; Hospitals; Information Technology and Cybersecurity; Medicare A
Completed (partial) Centers for Medicare & Medicaid Services Medicare Part B Payments for Laboratory Services Office of Audit Services A-06-16-02002;
A-09-16-02034;
A-06-17-04002;
A-04-18-08063;
A-09-19-03027;
A-06-20-04000;
W-00-17-35726;
W-00-20-35726;
W-00-22-35726;
various reviews
2022 Medicare covers diagnostic clinical laboratory services that are ordered by a physician who is treating a beneficiary and who uses the results in the management of the beneficiary's specific medical problem (42 CFR 410.32(a)). These covered services can be furnished in hospital laboratories (for outpatient or nonhospital patients), physician office laboratories, independent laboratories, dialysis facility laboratories, nursing facility laboratories, and other institutions. Previous OIG audits, investigations, and inspections have identified areas of billing for clinical laboratory services that are at risk for noncompliance with Medicare billing requirements. Payments to service providers are precluded unless the provider furnishes on request the information necessary to determine the amounts due (the Social Security Act § 1833(e)). We will review Medicare payments for clinical laboratory services to determine laboratories' compliance with selected billing requirements. We will focus on claims for clinical laboratory services that may be at risk for overpayments. For example, our reviews will focus on the improper use of claim line modifiers for a code pair, genetic testing, and urine drug testing services. We may use the results of these reviews to identify laboratories or other institutions that routinely submit improper claims. tags
Revised Office of the Assistant Secretary for Preparedness and Response Technology Use in Emergency Response: Experiences From Recent California Wildfires Office of Evaluation and Inspections OEI-09-19-00540 2023 Technology offers the potential for efficient and accurate medical response in the event of an emergency or disaster. In the recent California wildfires, some responders used technology-driven tools such as data analytics to locate vulnerable Medicare beneficiaries in a disaster zone and a network of health information exchanges to access patients' electronic medical records and deliver care away from their typical care setting. This case study will examine two uses of technology that were deployed during the 2017 and 2018 California wildfires, the emPOWER program and PULSE (Patient Unified Lookup System) system, to aid in emergency response. We will interview implementers and users of these tools from the Office of the Assistant Secretary for Preparedness Response, Office of the National Coordinator, State agencies, and local counties on their experiences with the adoption, implementation, and deployment of these tools; the benefits derived from these tools; and any challenges that were overcome. We will use these lessons learned to identify strategies that entities can use to incorporate technology in emergency preparedness and response. To the extent possible, we will also gather data about the reach of these tools, such as how many individuals benefited from using them. tags
December 2019 Administration for Children and Families Emergency Preparedness and Response at Care Provider Facilities in the Office of Refugee Resettlement's Unaccompanied Alien Children Program Office of Audit Services W-00-20-20021 2021 The Emergency Supplemental Appropriations for Humanitarian Assistance and Security at the Southern Border Act, 2019 (P.L. 116 -26) appropriated $2.9 billion for the Unaccompanied Alien Children (UAC) program. Within this $2.9 billion, title IV of P.L. 116-26, provided $5 million for OIG to conduct additional oversight of the UAC program, which is managed by HHS's Office of Refugee Resettlement (ORR). As part of OIG's oversight of ORR, we plan to review UAC Program emergency preparedness and response plans and procedures. The ORR Guide "Children Entering the United States Unaccompanied" states that UAC care providers are responsible for safety planning for each facility, to include a written safety plan for all UAC children in its care and program staff. In addition, each licensed care provider facility must adhere to State licensing requirements in regard to emergency preparedness and response. Our objective will be to determine whether selected care provider facilities followed Federal and State requirements in preparing for and responding to emergency events. tags
Completed (partial) Substance Abuse and Mental Health Services Administration Post-Award State or Tribal Audits of Substance Abuse and Mental Health Services Administration's Opioid Response Grants Office of Audit Services W-00-20-59441;
A-07-20-04121;
W-00-21-59442;
W-00-22-59441�
2022 The Substance Abuse and Mental Health Services Administration (SAMHSA) has awarded a series of grants to combat opioid use disorder. These grants include State Targeted Response to the Opioid Crisis grants (Opioid STR) with approximately half of $970 million awarded in fiscal year (FY) 2017 and the other half awarded in FY 2018. In FY 2018, SAMHSA also awarded more than $930 million in the State Opioid Response grants (SOR) and approximately $50 million in Tribal Opioid Response grants (TOR). The purpose of the Opioid STR, SOR, and TOR grants are to increase access to treatment, reduce unmet treatment need, and reduce opioid overdose related deaths. This post-award audit will determine how select States or Tribal agencies implemented programs under the Opioid STR, SOR, or TOR grants. We will also determine whether the activities of these agencies and subrecipients responsible for implementing the programs complied with Federal regulations and met grant program goals. tags
Completed (partial) Centers for Medicare & Medicaid Services Medicaid Concurrent Eligibility Office of Audit Services A-05-19-00023;
A-05-19-00031;
A-05-19-00032;
W-00-19-31539
2023 State Medicaid agencies contract with managed care organizations (MCOs) to make services available to enrolled Medicaid beneficiaries. The contractual arrangement shifts financial risk for the cost of care to the MCO. State Medicaid agencies pay MCOs on a per-beneficiary per-month basis, and MCOs are at financial risk if the costs of care exceed those payments. If a beneficiary who resides in one State subsequently establishes residency in another State, the beneficiary's Medicaid eligibility in the previous State should end and the MCO should not receive payments for that beneficiary. Our review will determine whether States made capitation payments on behalf of beneficiaries who established residency in another State. tags
Completed OS, ACF, AHRQ, CDC, FDA, HRSA, NIH, OIG Audit of HHS Information Technology Recovery Readiness Office of Audit Services A-18-20-04007 2021 HHS is responsible for administering programs that support the health and welfare of one in four Americans. HHS also leads the nation's medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. To ensure continuity of this extensive mission and in accordance with Federal mandates, HHS must have effective contingency plans in place to ensure that it continues to meet its mission in the event of a disaster or major disruption. We will determine whether HHS has effective contingency planning for its information technology systems tags
Completed (partial) Indian Health Service Review of Background Verification Process at Tribally Operated Health Facilities Office of Audit Services A-01-20-01500; W-00-20-51001 2022 The Indian Health Service's (IHS's) mission is to partner with American Indians and Alaska Natives to elevate their physical, mental, social, and spiritual health to the highest level. The goal of IHS is to ensure that comprehensive, culturally acceptable personal and public health services are available and accessible to all of the approximately 2.6 million members of the 573 federally recognized Tribes. In 1975, Congress recognized the importance of Tribal decision making in Tribal affairs and the nation-to-nation relationship between the United States and Tribes through the passage of the Indian Self-Determination and Education Assistance Act (ISDEAA) (P.L. No. 93-638). Under ISDEAA, federally recognized Tribes administer their own healthcare programs and services that IHS would otherwise provide through P.L. No. 93-638 funding agreements with IHS. In 2019, a pediatrician who worked at several IHS health facilities during a 21-year period was convicted of sexually abusing children served at these facilities. Congressional officials have expressed concerns about safeguards for Indian children and specifically about IHS failing to address this pediatrician's history of offenses at the various IHS health facilities where he was employed. The Indian Child Protection and Family Violence Prevention Act (P. L. No. 101-630), requires background checks, including Federal Bureau of Investigation fingerprinting, for employees whose job duties involve contact with children. Prior OIG audit work identified two Tribal health facilities that did not meet Federal requirements for background verifications for employees in contact with children. We will determine whether the tribally operated health facilities met Federal and Tribal requirements for background verification of employees, contractors, and volunteers in contact with children served by the facilities. tags
Completed (partial) Centers for Medicare & Medicaid Services Medicare Advantage Risk-Adjustment Data - Targeted Review of Documentation Supporting Specific Diagnosis Codes Office of Audit Services A-07-19-01187;
W-00-20-35079
2022 Payments to Medicare Advantage (MA) organizations are risk-adjusted on the basis of the health status of each beneficiary. MA organizations are required to submit risk-adjustment data to CMS in accordance with CMS instructions (42 CFR § 422.310(b)), and inaccurate diagnoses may cause CMS to pay MA organizations improper amounts (SSA §§ 1853(a)(1)(C) and (a)(3)). In general, MA organizations receive higher payments for sicker patients. CMS estimates that 9.5 percent of payments to MA organizations are improper, mainly due to unsupported diagnoses submitted by MA organizations. Prior OIG reviews have shown that some diagnoses are more at risk than others to be unsupported by medical record documentation. We will perform a targeted review of these diagnoses and will review the medical record documentation to ensure that it supports the diagnoses that MA organizations submitted to CMS for use in CMS's risk score calculations and determine whether the diagnoses submitted complied with Federal requirements. tags
Completed (partial) Centers for Medicare & Medicaid Services Review of Hospice Inpatient and Aggregate Cap Calculations Office of Audit Services W-00-19-35826;
W-00-21-35826
2022 Hospice care can provide great comfort to beneficiaries, families, and caregivers at the end of a beneficiary's life. To ensure that hospice care does not exceed the cost of conventional medical care at the end of life, Medicare imposes two annual limits to payments made to hospice providers: the inpatient cap and the aggregate cap. The inpatient cap limits the number of days of inpatient care for which Medicare will pay to 20 percent of a hospice's total Medicare patient care days, and a hospice must refund to Medicare any payment amounts in excess of the inpatient cap. The aggregate cap limits the total aggregate payments that any individual hospice can receive in a cap year to an allowable amount based on an annual per-beneficiary cap amount and the number of beneficiaries served. Any amount paid to a hospice for its claims in excess of the aggregate cap is considered an overpayment and must be repaid to Medicare. Medicare administrative contractors (MACs) oversee the cap process and hospices must file their self-determined aggregate cap determination notice with their MAC no later than 5 months after the end of the cap year and remit any overpayment due at that time. tags
Revised Centers for Medicare & Medicaid Services Medicare Part B Payments for Speech-Language Pathology Office of Audit Services W-00-19-35827; W-00-21-35827 2022 Outpatient speech therapy services are provided by speech-language pathologists and are necessary for the diagnosis and treatment of speech and language disorders that result in communication disabilities and swallowing disorders (dysphagia). When Medicare payments for a beneficiary's combined physical therapy and speech therapy exceed an annual therapy spending threshold (e.g., $2,010 in 2018), the provider must append the KX modifier to the appropriate Healthcare Common Procedure Coding System reported on the claim. The KX modifier denotes that outpatient physical therapy and speech therapy services combined have exceeded the annual spending threshold per beneficiary, and that the services being provided are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. We will determine whether the claims using the KX modifier adhere to Federal requirements. In addition, we will evaluate payment trends to identify Medicare payments for outpatient speech therapy services billed using the KX modifier that are potentially unallowable. tags
Revised Centers for Medicare & Medicaid Services Review of Medicare Payments for Power Mobility Device Repairs Office of Audit Services W-00-19-35828; W-00-22-35828 2022 Medicare Part B covers medically necessary power mobility devices (PMDs), such as power wheelchairs, and PMD repairs that are reasonable and necessary to make the equipment serviceable. For calendar year 2018, Medicare Part B paid approximately $46.7 million for PMD repairs, including replacement parts needed to repair PMDs. Durable medical equipment (DME) suppliers must maintain documentation from the physician or treating practitioner indicating that the PMD being repaired continued to be medically necessary and that the repairs were reasonable and necessary. DME suppliers must also maintain detailed records describing the need for and nature of all repairs, which includes a justification for the replaced parts and the labor time. In addition, if the expense for repairs exceeds the estimated expense of purchasing or renting another PMD for the remaining period of medical need, no payment can be made for the amount of the excess. We will audit Medicare payments for PMD repairs to determine whether suppliers complied with Medicare requirements. tags
Completed (partial) Centers for Medicare & Medicaid Services Review of Medicare Part B Urine Drug Testing Services Office of Audit Services A-09-20-03017;
W-00-20-35829
2022 Medicare covers treatment services for substance use disorders (SUDs), such as inpatient and outpatient services when they are reasonable and necessary. SUDs occur when the recurrent use of alcohol or other drugs causes clinically significant impairment, including health problems, disability, and failure to meet major responsibilities at work, school, or home. Medicare also covers clinical laboratory services, including urine drug testing (UDT), under Part B. Physicians use UDT to detect the presence or absence of drugs or to identify specific drugs in urine samples. A patient in active treatment for an SUD or being monitored during different phases of recovery from an SUD may undergo medical management for a variety of medical conditions. UDT results influence treatment and level-of-care decisions for individuals with SUDs. The 2018 Medicare fee-for-service improper payment data showed that laboratory testing, including UDT, had an improper payment rate of almost 30 percent, and that the overpayment rate for definitive drug testing for 22 or more drug classes was 71.7 percent. We will review UDT services for Medicare beneficiaries with SUD-related diagnoses to determine whether those services were allowable in accordance with Medicare requirements. tags
Revised Centers for Medicare & Medicaid Services Supplier Compliance with Medicare Requirements for Replacement of Positive Airway Pressure Device Supplies Office of Audit Services W-00-20-35830; W-00-22-35830 2022 Beneficiaries receiving continuous positive airway pressure or respiratory assist device (collectively known as positive airway pressure (PAP) devices) therapy require replacement of supplies (e.g., mask, tubing, headgear, and filters) when they wear out or are exhausted. Medicare payments for these replacement supplies in 2017 and 2018 were approximately $945.8 million. Prior OIG work found that most Medicare claims that suppliers submitted for replacement PAP device supplies did not comply with Medicare requirements. For supplies and accessories used periodically, orders must specify the type of supplies needed, the frequency of use, if applicable, and the quantity to be dispensed, and suppliers must not automatically ship refills on a predetermined basis (Centers for Medicare & Medicaid Services Medicare Program Integrity Manual, Pub. 100-08, Ch. 5, §§ 5.2.3 and 5.2.8). We will review claims for frequently replaced PAP device supplies at selected suppliers to determine whether documentation requirements for medical necessity, frequency of replacement and other Medicare requirements are met. tags
Revised Centers for Medicare & Medicaid Services Medicare Payments of Positive Airway Pressure Devices for Obstructive Sleep Apnea Without Conducting a Prior Sleep Study Office of Audit Services W-00-19-35823; W-00-22-35823 2022 An OIG analysis of the 2017 Comprehensive Error Rate Testing (CERT) program for positive airway pressure (PAP) device payments shows potential overpayments of $566 million. Claims for PAP devices used to treat obstructive sleep apnea (OSA) for beneficiaries who have not had a positive diagnosis of OSA based on an appropriate sleep study are not reasonable and necessary (Medicare National Coverage Determination Manual, Chapter 1, Part 4, § 240.4 and Local Coverage Determination (LCD) L33718). Medicare will not pay for items or services that are not "reasonable and necessary" (Social Security Act § 1862(a)(1)(A)). We will examine Medicare payments to durable medical equipment providers for PAP devices used to treat OSA to determine whether an appropriate sleep study was conducted. tags
Revised Centers for Medicare & Medicaid Services States' Medicaid Agency Claims for Indian Health Service Expenditures Office of Audit Services W-00-19-31538 2022 The Federal government pays its share of a State's Medicaid expenditures based on the Federal Medical Assistance Percentage (FMAP), which varies depending on the State's relative per capita income. States' regular FMAPs range from a low of 50 percent to a high of 83 percent; however, States receive a 100-percent FMAP for expenditures related to services received through Indian Health Service (IHS) facilities. In Federal fiscal years 2016 through 2018, States claimed $6.6 billion in expenditures at the IHS services FMAP, all of which was federally funded. We will analyze selected States' methodologies for identifying expenditures claimed at the IHS services FMAP and determine whether the States claimed these expenditures in accordance with Federal requirements. tags
Revised Administration for Children and Families States' Prevention of Child Sex Trafficking in Foster Care Office of Evaluation and Inspections OEI-07-19-00371 2022 In 2013, the Administration for Children and Families reviewed statistics from several studies and found that up to 90 percent of children who were victims of sex trafficking had been involved with child welfare services, which include foster care. States are required by Federal law to develop policies and procedures related to identifying and providing services for children in foster care who are, or are at risk of becoming, a victim of sex trafficking. For select States, we will use foster care case file documentation to evaluate (1) the extent to which children were screened to determine whether they are, or are at risk of becoming, a victim of sex trafficking by using the States' policies and procedures; and (2) the extent to which children in foster care who are, or are at risk of becoming, a victim of sex trafficking were provided needed services. tags
Revised Centers for Medicare & Medicaid Services Medicaid Assisted Living Services Office of Audit Services W-00-19-31541 2022 Medicaid may provide assisted living services to beneficiaries who are medically eligible for placement in a nursing home but opt for a less medically intensive, lower-cost setting. These services may include personal care (e.g., assistance with dressing and bathing), homemaker services (e.g., housecleaning and laundry), personal emergency response services, and therapy services (i.e., physical, speech, and occupational). A 2018 Government Accountability Office report indicated that improved Federal oversight of beneficiary health and welfare is needed in States' administration of Medicaid assisted living services. We will determine whether assisted living providers are meeting quality-of-care requirements for Medicaid beneficiaries residing in assisted living facilities and whether the providers properly claimed Medicaid reimbursement for services in accordance with Federal and State requirements. tags
Revised Centers for Medicare & Medicaid Services Medicare Part B Services to Medicare Beneficiaries Residing in Nursing Homes During Non-Part A Stays Office of Audit Services W-00-19-35824; W-00-22-35824 2022 Medicare pays physicians, non-physician practitioners, and other providers for services rendered to Medicare beneficiaries, including those residing in nursing homes (NHs). Most of these Part B services are not subject to consolidated billing; therefore, each provider submits a claim to Medicare. Since the 1990s, OIG has identified problems with Part B payments for services provided to NH residents. An opportunity for fraudulent, excessive, or unnecessary Part B billing exists because NHs may not be aware of the services that the providers bill directly to Medicare, and because NHs provide access to many beneficiaries and their records. We will determine whether Part B payments to Medicare beneficiaries in NHs are appropriate and whether NHs have effective compliance programs and adequate controls over the care provided to their residents. tags
Revised Centers for Medicare & Medicaid Services Review of Medicare Facet Joint Procedures Office of Audit Services W-00-19-35825; W-00-22-35825� 2022 Facet joint injections are an interventional technique used to diagnose or treat back pain. Several previous reviews found significant billing errors in this area, including a prior OIG review. We will review whether payments made by Medicare for facet joint procedures billed by physicians complied with Federal requirements (Social Security Act, § 1833(e), 42 CFR § 424.32(a)(1), and 42 CFR §414.40). tags
Revised Centers for Medicare & Medicaid Services Overturned Denials in Medicaid Managed Care Office of Evaluation and Inspections OEI-09-19-00350 2022 Managed care organizations (MCOs) contract with State Medicaid agencies to provide beneficiaries with Medicaid services. MCOs must cover services in at least the same amount, duration, and scope that would be covered under Medicaid fee-for-service. However, capitated payment models in managed care may create an incentive for MCOs to inappropriately limit or deny access to covered services to increase profits. We will review the extent to which selected MCOs' denied services and payments were overturned upon appeal. We will also review any concerns about the selected MCOs' performance related to denials and appeals that were identified through State oversight and monitoring efforts. tags
Revised Food and Drug Administration Review of the Food and Drug Administration's Foreign Drug Inspection Process Office of Audit Services W-00-19-50000 2022 The Food and Drug Administration (FDA) is responsible for overseeing the safety and effectiveness of all drugs marketed in the United States. However, FDA's oversight of the nation's drug supply chain has become increasingly complicated because many drugs used in the U.S. are manufactured overseas. FDA estimates that nearly 40 percent of finished drugs and approximately 80 percent of active pharmaceutical ingredients are manufactured in registered establishments in more than 150 countries. To ensure that drugs are manufactured in compliance with current good manufacturing practice regulations, FDA conducts inspections of foreign facilities that manufacture drugs for the U.S. market. At the end of an inspection, observations are made and a determination of whether any condition or practice violates Federal requirements. FDA may take additional actions to ensure that the violations are corrected. In May 2017, FDA began implementing major programmatic changes to enhance its ability to protect public health. FDA's major programmatic changes included a structural realignment of its Office of Regulatory Affairs (ORA) and an agreement between FDA's Center for Drug Evaluation and Research and ORA that aligns and coordinates FDA's field professionals who conduct inspections and its review staff who evaluate drug products. Recently, Congress raised concerns about the safety of certain drugs manufactured overseas and the challenges that FDA faces with its foreign drug inspection process. Our review will determine whether recent programmatic changes have improved FDA's foreign drug inspection process. tags
Completed (partial) Centers for Medicare & Medicaid Services Review of Medicare Part B Claims for Intravitreal Injections of Eylea and Lucentis Office of Audit Services A-09-19-03022;
A-09-19-03025;
W-00-19-30100;
W-00-22-30100
2022 Medicare Part B covers ophthalmology services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Ophthalmology services include intravitreal injections of Eylea and Lucentis to treat eye diseases such as wet age-related macular degeneration. Medicare pays for an intravitreal injection (which is considered a minor surgery) as part of a global surgical package that includes the preoperative, intraoperative, and postoperative services routinely performed by the physician. Medicare pays for Eylea and Lucentis separately from the intravitreal injection. Chapter 12, section 40.1 of the Centers for Medicare & Medicaid Services' Medicare Claims Processing Manual states that separate payment can be made for other services provided by the same physician on the same day as the global surgery if the services are significant and separately identifiable or unrelated to the surgery. We will review claims for intravitreal injections of Eylea and/or Lucentis and the other services billed on the same day as the injection, including evaluation and management services, to determine whether the services were reasonable and necessary and met Medicare requirements. tags
Revised OS Review of Office of Intergovernmental and External Affairs Charge Card Programs Office of Audit Services W-00-19-59443 2022 Under the Government Charge Card Abuse Prevention Act of 2012 (Charge Card Act) and Office of Management and Budget Memorandum M-13-21, Implementation of the Government Charge Card Abuse Prevention Act of 2012, agencies must establish and maintain safeguards and internal controls for the charge card program. Offices of Inspectors General (OIGs) are required to conduct annual risk assessments of agency purchase card and travel card programs to analyze the risks of illegal, improper, and erroneous purchases. HHS-OIG's risk assessment of HHS's charge card program for FY 2017, identified Office of Intergovernmental and External Affairs (IEA) as having a high risk of inappropriate travel card and purchase card transactions. Because IEA's charge card program was assessed as high risk, the Charge Card Act requires HHS-OIG to conduct a further review. We will review the IEA's travel card and purchase card programs to determine whether the programs complied with Federal requirements. tags
June 2019 Centers for Medicare & Medicaid Services Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries - 10-Year Update Office of Evaluation and Inspections OEI-06-18-00400 2022 OIG has conducted studies about adverse events (patient harm) in various healthcare settings since 2008, with 15 reports released or in process through 2019. The series includes a congressionally-mandated study released in 2010 that found that 27 percent of Medicare beneficiaries experienced adverse events or temporary harm events while hospitalized in 2008. The current study will replicate the methodology used in the prior work for a sample of Medicare beneficiaries admitted to acute-care hospitals in 2018. We will measure the incidence of adverse events and temporary harm events, the extent to which the harms were preventable given better care, and the associated costs to Medicare. We will compare the 2018 results with the prior study results to assess progress in reducing harm at the 10-year mark, and identify differences in harm rates, types, contributing factors, preventability, and costs. tags
Revised Centers for Medicare & Medicaid Services Inappropriate Denial of Services and Payment in Medicare Advantage Office of Evaluation and Inspections OEI-09-18-00260 2022 Capitated payment models are based on payment per person rather than payment per service provided. A central concern about the capitated payment model used in Medicare Advantage is the incentive to inappropriately deny access to, or reimbursement for, health care services in an attempt to increase profits for managed care plans. We will conduct medical record reviews to determine the extent to which beneficiaries and providers were denied preauthorization or payment for medically necessary services covered by Medicare. To the extent possible, we will determine the reasons for any inappropriate denials and the types of services involved. tags
Revised Centers for Medicare & Medicaid Services Comparison of Provider-Based and Freestanding Clinics Office of Audit Services W-07-18-02815 2022 Provider-based facilities often receive higher payments for some services than freestanding clinics. The requirements that a facility must meet to be treated as provider-based are at 42 CFR § 413.65(d). We will review and compare Medicare payments for physician office visits in provider-based clinics and freestanding clinics to determine the difference in payments made to the clinics for similar procedures. We will also assess the potential impact on Medicare and beneficiaries of hospitals' claiming provider-based status for such facilities. tags
Completed (partial) Centers for Medicare & Medicaid Services Home Health Compliance with Medicare Requirements Office of Audit Services A-06-16-05005;
A-02-17-01025;
A-02-16-01001;
A-05-16-00057;
A-05-16-00055;
A-01-16-00500;
A-07-16-05092;
A-07-16-05093;
A-05-17-00022;
A-02-17-01022;
A-03-17-00004;
A-04-16-06195;
A-03-17-00009;
A-02-19-01013;
W-00-19-35712;
W-00-16-35712;
W-00-16-35501;
W-00-17-35712;
various reviews
2022 The Medicare home health benefit covers intermittent skilled nursing care, physical therapy, speech-language pathology services, continued occupational services, medical social worker services, and home health aide services. For CY 2014, Medicare paid home health agencies (HHAs) about $18 billion for home health services. Centers for Medicare & Medicaid Services's Comprehensive Error Rate Testing (CERT) program determined that the 2014 improper payment error rate for home health claims was 51.4 percent, or about $9.4 billion. Recent OIG reports have similarly disclosed high error rates at individual HHAs. Improper payments identified in these OIG reports consisted primarily of beneficiaries who were not homebound or who did not require skilled services. We will review compliance with various aspects of the home health prospective payment system and include medical review of the documentation required in support of the claims paid by Medicare. We will determine whether home health claims were paid in accordance with Federal requirements. tags
Revised Other OIG Reviews of Non-Federal Audits Office of Audit Services W-00-19-40005 2022 In accordance with the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS awards at 45 CFR Part 75, State, local, and Indian tribal governments; colleges and universities; and nonprofit organizations receiving Federal awards are required to have annual organization-wide audits of all Federal funds that they receive. OIG reviews the audits and reports to ensure they meet applicable standards, identifies any follow-up work needed, and identifies issues that may require management attention. OIG also provides upfront technical assistance to non-Federal auditors to ensure they understand Federal audit requirements and to promote effective audit work. We analyze and record electronically the audit findings reported by non-Federal auditors for use by HHS managers. Our reviews inform HHS managers about the management of Federal programs and identify significant areas of internal control weaknesses, noncompliance with laws and regulations, and questioned costs that require formal resolution by Federal officials. We will continue to review the quality of audits conducted by non-Federal auditors, such as public accounting firms and State auditors, in accordance with the uniform grant guidance. tags
Revised Centers for Medicare & Medicaid Services Review of State Uncompensated Care Pools Office of Audit Services W-00-19-31537 2022 Some State Medicaid agencies operate uncompensated care pools (UCPs) under waivers approved by CMS. Section 1115 of Title XIX of the Social Security Act gives CMS authority to approve experimental, pilot, or demonstration projects that it considers likely to help promote the objectives of the Medicaid program. The purpose of these projects, which give States additional flexibility to design and improve their programs, is to demonstrate and evaluate State-specific policy approaches to better serve Medicaid populations. To implement a State demonstration project, States must comply with the special terms and conditions (STCs) of the agreement between CMS and the State. The purpose of the UCPs is to pay providers for uncompensated cost incurred in caring for low-income (Medicaid and uninsured) patients. Through UCPs, States pay out hundreds of millions of dollars to providers and receive Federal financial participation. However, in some States there has previously been little oversight of the payments. We will determine whether selected States' Medicaid agencies made payments to hospitals under the UCPs that were in accordance with the STCs of the waiver and with applicable Federal regulations. tags
Completed (partial) Substance Abuse and Mental Health Services Administration Projects for Assistance in Transition from Homelessness Program Office of Audit Services A-02-19-02006;
W-00-19-50100; W-00-21-50100
2022 HHS provides Federal funds to various States to administer the Projects for Assistance in Transition from Homelessness (PATH) program. The PATH program supports the delivery of outreach and various services to individuals with serious mental illness and those with co-occurring substance use disorders who are experiencing homelessness or are at imminent risk of becoming homeless. During Federal fiscal year 2018, the Substance Abuse and Mental Health Services Administration (SAMHSA), the HHS agency that administers and oversees the PATH program, awarded approximately $62 million in grant funds to various States to operate the PATH program. We will determine whether some of these grant recipients complied with Federal requirements in providing PATH program services. tags
Revised Centers for Medicare & Medicaid Services Medicaid Managed Care Organization Denials Office of Audit Services W-00-19-31535 2023 The State Medicaid agency and the Federal Government are responsible for financial risk for the costs of Medicaid services. Managed care organizations (MCOs) contract with State Medicaid agencies to ensure that beneficiaries receive covered Medicaid services. The contractual arrangement shifts financial risk for the costs of Medicaid services from the State Medicaid agency and the Federal Government to the MCO, which can create an incentive to deny beneficiaries' access to covered services. Our review will determine whether Medicaid MCOs complied with Federal requirements when denying access to requested medical and dental services and drug prescriptions that required prior authorization. tags
Completed (partial) Centers for Medicare & Medicaid Services Review of Monthly ESRD-Related Visits Billed by Physicians or Other Qualified Healthcare Professionals Office of Audit Services A-07-19-05117;
W-00-19-35822;
W-00-22-35822
2022 Most physicians and other practitioners (e.g., clinical nurse specialists, nurse practitioners, or physician's assistants) who manage the care of patients who receive outpatient dialysis services at end-stage renal disease (ESRD) facilities are paid a monthly capitation payment (MCP) for ESRD-related physician services. The MCP amount is based on the number of visits provided within each month and the age of the ESRD beneficiary. The physician or other practitioner can bill only one of three current procedural terminology (CPT) codes for ESRD-related visits of one per month, two to three per month, or four or more per month (CMS, Medicare Claims Processing Manual, Pub. No. 100-04, chapter 8, § 140.1). The Comprehensive Error Rate Testing program's special study of the Healthcare Common Procedure Coding System codes for ESRD-related services found that for some codes, approximately one-third of the payments for ESRD-related services were improper payments due to insufficient documentation, incorrect coding, or no documentation submitted (CMS, Medicare Quarterly Provider Compliance Newsletter Guidance to Address Billing Errors, volume 5, issue 3, April 2015). We will review whether physicians or other qualified healthcare professionals billed monthly ESRD-related visits in accordance with Federal requirements (Social Security Act, §§ 1815(a) and 1833(e)). tags
Completed (partial) Centers for Medicare & Medicaid Services Medicaid Personal Care Services Office of Audit Services A-02-19-01016;
W-00-19-31536
2022 Personal care services (PCS) is a Medicaid benefit for the elderly, people with disabilities, and people with chronic or temporary conditions. It assists them with activities of daily living and helps them remain in their homes and communities. Examples of PCS include bathing, dressing, light housework, money management, meal preparation, and transportation. Prior OIG reviews identified significant problems with States' compliance with PCS requirements. Some reviews also showed that program safeguards intended to ensure medical necessity, patient safety, and quality, and prevent improper payments were often ineffective. We will determine whether improvements have been made to the oversight and monitoring of PCS and whether those improvements have reduced the number of PCS claims not in compliance with Federal and State requirements. tags
Completed (partial) Centers for Medicare & Medicaid Services MCO Payments for Services After Beneficiaries' Deaths Office of Audit Services A-06-16-05004;
A-05-19-00007;
A-04-19-06223;
A-07-20-05125;
A-04-15-06190;
W-00-20-31497;
W-00-19-31497
2023 Previous OIG reports found that Medicare paid for services that purportedly started or continued after beneficiaries' dates of death. We will identify Medicaid managed care payments made on behalf of deceased beneficiaries. We will also identify trends in Medicaid claims with service dates after beneficiaries' dates of death. tags
Revised Centers for Medicare & Medicaid Services Post-Hospital Skilled Nursing Facility Care Provided to Dually Eligible Beneficiaries Office of Audit Services W-00-20-35821 2022 Skilled nursing facilities (SNFs) are specially qualified facilities that provide extended care services, such as skilled nursing care, rehabilitation services, and other services to Medicare beneficiaries who meet certain conditions. During previous OIG reviews, we noted that some nursing facility residents who were receiving Medicaid-covered nursing home care were admitted to a hospital and returned to the same facility to receive Medicare-covered post-hospital SNF care. In some cases, hospital physicians discharged beneficiaries to "home" rather than "SNF," yet nursing facility physicians certified that skilled care was needed. Because Medicare pays substantially more for SNF care than Medicaid for nursing home care, nursing facilities have financial incentives to increase the level of care to "skilled." We will determine whether the post-hospital SNF care provided to dually eligible beneficiaries met the level of care requirements. Specifically, we will determine whether (1) the SNF level of care was certified by a physician (e.g., a hospital or SNF physician) or a physician extender (i.e., a nurse practitioner, clinical nurse specialist, or physician assistant); (2) the condition treated at the SNF was a condition for which the beneficiary received inpatient hospital services or a condition that arose while the beneficiary was receiving care in a SNF for a condition for which the beneficiary received inpatient hospital services; (3) daily skilled care was required; (4) the services delivered were reasonable and necessary for the treatment of a beneficiary's illness or injury; and (5) improper Medicare payments were made on the claims we review. We will also determine whether any of the hospital admissions we review were potentially avoidable. tags
Completed (partial) OS Review of HHS Government Purchase, Travel, and Integrated Charge Card Programs Office of Audit Services A-04-19-06234;
A-04-19-06235;
W-00-19-59041
2022 The Government Charge Card Abuse Prevention Act of 2012 (Charge Card Act) requires Inspectors General (IGs) to conduct periodic risk assessments of their agencies' charge card programs to analyze the risks of illegal, improper, or erroneous purchases. The Charge Card Act requires IGs to use the risk assessments to determine the necessary scope, frequency, and number of IG audits or reviews of the charge card programs. It requires Federal agencies to establish and maintain safeguards and internal controls for purchase cards, convenience checks, travel cards, and integrated cards. The Office of Management and Budget has instructed IGs to submit annual status reports on purchase and travel card audit recommendations beginning January 31, 2014, for compilation and transmission to Congress and the Government Accountability Office. We will review HHS's charge card programs (i.e., purchase, travel, or integrated cards) to assess the risks of illegal, improper, or erroneous purchases. HHS's charge card programs enable cardholders to pay for commercial goods, services, and travel expenses. tags
Revised OS OIG DATA Act Readiness Review (2016) and Data Completeness and Accuracy (2017, 2019, 2021).(Performing a scaled down version on an interim basis for FY 2018.) Office of Audit Services W-00-19-41021 2022 On May 9, 2014, the President signed the DATA Act of 2014, which mandated the establishment of Government-wide data standards for financial and payment data by May 2015, and agency reporting of consistent, reliable, and searchable financial and payment data by May 2017, to be displayed for taxpayers and policymakers on USASpending.gov. The DATA Act also requires OIG to review a statistically valid sampling of the spending data submitted under this Act by HHS and submit to Congress and make publically available a report assessing the completeness, timeliness, quality, and accuracy of the data sampled and the implementation and use of data standards by HHS. We will use the independent external auditor contracted to audit the annual CMS and HHS Financial Statement Audits to perform this work. tags
Revised Centers for Medicare & Medicaid Services Medicare Part B Payments for Podiatry and Ancillary Services Office of Audit Services W-00-19-35818; W-00-21-35818 2022 Medicare Part B covers podiatry services for medically necessary treatment of foot injuries, diseases, or other medical conditions affecting the foot, ankle, or lower leg. Part B generally does not cover routine foot-care services such as the cutting or removal of corns and calluses or trimming, cutting, clipping, or debridement (i.e., reduction of both nail thickness and length) of toenails. Part B may cover these services, however, if they are performed (1) as a necessary and integral part of otherwise covered services, (2) for the treatment of warts on the foot, (3) in the presence of a systemic condition or conditions, or (4) for the treatment of infected toenails. Medicare generally does not cover evaluation and management (E&M) services when they are provided on the same day as another podiatry service (e.g., nail debridement performed as a covered service). However, an E&M service may be covered if it is a significant separately identifiable service. In addition, podiatrists may order, refer, or prescribe medically necessary ancillary services such as x-rays, laboratory tests, physical therapy, durable medical equipment, or prescription drugs. Prior OIG work identified inappropriate payments for podiatry and ancillary services. We will review Part B payments to determine whether podiatry and ancillary services were medically necessary and supported in accordance with Medicare requirements. tags
Completed (partial) National Institutes of Health NIH's Pre-Award Process for Assessing Risk of Grant Applicants and Post-Award Process for Oversight of Grantees Office of Audit Services W-00-19-51002; A-03-19-03004; A-05-19-00017; A-05-20-0006;
A-05-20-00026;
W-00-20-51002
2022 Extramural research grants accounted for more than 80 percent of the $37 billion that the National Institutes of Health (NIH) received for FY 2018 from Congress. Before making a Federal award, NIH is required to determine whether a party is eligible to receive Federal funds. Even if eligible, a party may be subject to certain conditions because of the risk(s) associated with making the Federal award. The Departments of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (Public Law No. 115-245) and its Accompanying Report directed that OIG examine NIH's oversight of its grantees' compliance with NIH policies, including NIH efforts to ensure the integrity of its grant application and selection processes. We will conduct audits at NIH's Institutes and Centers to review their (i) pre-award process for assessing risk of potential recipients of Federal funds, and (ii) post-award process for overseeing and monitoring of grantees on the basis of risks identified during the pre-award process. tags
Revised Centers for Medicare & Medicaid Services Medicare Outpatient Outlier Payments for Claims With Credits for Replaced Medical Devices Office of Audit Services W-00-19-35819; W-00-21-35819 2022 Item Summary CMS requires hospitals to submit a zero or token charge when they receive a full credit for a replacement device, but CMS does not specify how charges should be reduced for partial credits. CMS makes an additional payment (an outpatient outlier payment) for hospital outpatient services when a hospital's charges, adjusted to cost, exceed a fixed multiple of the normal Medicare payment. 42 CFR § 419.43(d). Prior OIG reviews focused on finding unreported credits for medical devices and recommended that CMS recoup Medicare funds for the overstated ambulatory payment classification payment only. This audit focuses on overstated Medicare charges on outpatient claims that contain both an outlier payment and a reported medical device credit. We will determine whether Medicare payments for replaced medical devices and their respective outlier payments were made in accordance with Medicare requirements. tags
Completed Centers for Medicare & Medicaid Services Duplicate Payments for Home Health Services Covered Under Medicare and Medicaid Office of Audit Services W-00-19-31141 2020 Medicare Home Health Agency (HHA) coverage requirements state that an HHA is responsible for providing all services either directly or under arrangement while a beneficiary is under a home health plan of care authorized by a physician. Consequently, Medicare pays a single HHA overseeing that plan. "Dual eligible beneficiaries" generally describes beneficiaries eligible for both Medicare and Medicaid. Medicare pays covered medical services first for dual eligible beneficiaries because Medicaid is generally the payer of last resort. We will determine whether States made Medicaid payments for home health services for dual eligible beneficiaries who are also covered under Medicare. tags
Completed Centers for Disease Control and Prevention CDC's Oversight of the President's Emergency Plan for AIDS Relief Funds Office of Audit Services W-00-19-57301; W-00-20-57301; W-00-20-57301 2022 Through the President's Emergency Plan for AIDS Relief (PEPFAR), the Centers for Disease Control and Prevention (CDC) has altered the course of the global acquired immunodeficiency syndrome (AIDS) epidemic, saving millions of lives, improving the lives of countless others, and preventing millions of infections around the world. CDC received more than $1.7 billion of fiscal year 2017 PEPFAR funds (about 97 percent of the funds received by HHS) to accelerate progress toward achieving an AIDS-free generation and create a lasting infrastructure that allows partner countries to respond to a range of health challenges and threats. To date, OIG has conducted a series of PEPFAR audits at CDC in five countries in Africa, North America, and Asia. OIG's oversight of PEPFAR has helped CDC and other HHS staff learn important grant and program integrity lessons that apply to ongoing and future responses to infectious diseases. In previous audits of CDC offices in the United States and foreign countries, OIG identified noncompliance with policies, inadequate monitoring of grantees, and internal control weaknesses in the award of PEPFAR funds. We will determine whether CDC has taken corrective action to ensure it has improved and implemented internal controls, including adhering to policies and procedures for awarding and monitoring PEPFAR funds. tags
Completed (partial) Administration for Children and Families Child Care and Development Fund: Provider Compliance with State Criminal Background Check Requirements Office of Audit Services A-07-19-06084;
W-00-18-20020;
W-00-19-20020;
W-00-20-20020;
W-00-21-20020;
A-01-18-02504;
A-01-18-02505;
A-02-19-02004;
A-03-19-00253;
A-04-19-02023;
A-04-19-03580;
A-05-19-00012;
A-05-19-00016;
A-06-19-07001; �
A-07-19-06085;
A-09-19-01000
2022 Reauthorized in the Child Care and Development Block Grant Act of 2014 (CCDBG Act), the Child Care and Development Fund is the primary source of Federal subsidies of childcare costs to low-income families. All licensed, regulated, and registered childcare providers, as well as all childcare providers eligible to deliver childcare services, are subject to the CCDBG Act's requirements for criminal background checks. The CCDBG Act mandates that a State have policies and procedures in place that meet the criminal background check requirements. To determine whether the States' monitoring process has ensured compliance by childcare providers with States' requirements for criminal background checks established under the CCDBG Act, we will assess provider compliance with the criminal background record check requirements that have been established by each State. tags
October 2018 Centers for Medicare & Medicaid Services Medicaid Capitation Payments Made on Behalf of Incarcerated Individuals Office of Audit Services W-00-18-31534; various reviews 2022 States contract with Medicaid managed care organizations to provide specific services to enrolled Medicaid beneficiaries, usually in return for a predetermined periodic payment, known as a capitation payment. Section 1905 of Title XIX of the Social Security Act, 42 CFR § 435, and guidance from the Centers for Medicare & Medicaid Services state that Federal financial participation is not available for services provided to inmates of public institutions, except when the inmate is not in a prison setting and becomes an inpatient in a medical institution. We will determine whether select States made unallowable capitation payments to Medicaid managed care organizations on behalf of individuals who were incarcerated. tags
August 2018 Centers for Medicare & Medicaid Services Potential Abuse and Neglect of Children Receiving Medicaid Benefits Office of Audit Services W-00-18-31533 2022 Medicaid beneficiaries, including children, are treated at inpatient and outpatient medical facilities for conditions that may be the result of abuse or neglect. Although all States have laws mandating reporting of suspected child abuse, these laws vary considerably in their definitions, scope, and procedures. Prior OIG reviews have highlighted problems with the quality of care and the reporting and investigation of potential abuse or neglect of vulnerable beneficiary populations at group homes, nursing homes, and skilled nursing facilities. On the basis of diagnoses from medical facilities treating conditions potentially related to abuse or neglect, we will determine the prevalence of Medicaid claims indicating potential abuse or neglect of children receiving Medicaid benefits. tags
Completed (partial) Centers for Medicare & Medicaid Services Physicians Billing for Critical Care Evaluation and Management Services Office of Audit Services A-03-18-00003;
W-00-18-35816;
W-00-22-35816;
various reviews
2022 Critical care is defined as the direct delivery of medical care by a physician(s) for a critically ill or critically injured patient. Critical care is usually given in a critical care area such as a coronary, respiratory, or intensive care unit, or the emergency department. Payment may be made for critical care services provided in any location as long as the care provided meets the definition of critical care. Critical care is exclusively a time-based code. Medicare pays physicians based on the number of minutes they spend with critical care patients. The physician must spend this time evaluating, providing care and managing the patient's care and must be immediately available to the patient. This review will determine whether Medicare payments for critical care are appropriate and paid in accordance with Medicare requirements. tags
Completed (partial) Substance Abuse and Mental Health Services Administration SAMHSA's Oversight of Accreditation Bodies for Opioid Treatment Programs Office of Audit Services A-09-18-01007; W-00-20-59035 2021 The Substance Abuse and Mental Health Services Administration (SAMHSA) estimates that 2.5 million people have an opioid use disorder related to prescription pain relievers and/or heroin. Medication-Assisted Treatment (MAT), provided by opioid treatment programs (OTPs), is a significant component of the treatment protocols for opioid use disorder and plays a large role in combating the opioid epidemic in the United States. SAMHSA issued final regulations to establish an oversight system for the treatment of substance use disorders with MAT. These regulations (42 CFR Part 8) established procedures for an entity to become an approved accreditation body, which evaluates OTPs and ensures SAMHSA's opioid dependency treatment standards are met. Our objective is to determine whether SAMHSA's oversight of accreditation bodies complied with Federal requirements. This series of audits will include SAMHSA-approved accrediting bodies that have accredited OTPs. tags
Completed Administration for Children and Families ACF Child Care Development Fund: Program Integrity Office of Audit Services A-07-18-04111 2020 The Child Care and Development Fund (CCDF) program provides subsidized childcare to low-income families, families receiving temporary public assistance, and families transitioning from public assistance so family members can work or attend training or education. Each State must develop, and submit to the Administration for Children and Families (ACF) for approval, a plan that identifies the purposes for which CCDF funds will be spent for a 3-year grant period and designates a lead agency responsible for administering childcare programs. States receive block grants and other Federal funds (approximately $5.77 billion annually) to operate their childcare programs. Prior OIG work identified vulnerabilities in States' internal controls for the CCDF program and a national CCDF payment error rate of 5.74 percent. We will determine whether State agencies complied with Federal and State requirements when making payments to licensed providers under these childcare programs for Federal fiscal years 2016 through 2018. tags
Revised All STAFFDIV/
OPDIVs
Identification of HHS Cybersecurity Vulnerabilities Office of Audit Services W-00-18-42021; W-00-18-42022 2022 HHS OIG will perform a series of IT audits at the HHS Office of the Secretary and its Operating Divisions (OPDIVs) in an effort to identify cybersecurity vulnerabilities and possible compromise of the HHS Office of the Secretary and its OPDIVs' systems and networks. tags
Revised Centers for Medicare & Medicaid Services Increased Payments For Transfer Claims With Outliers Office of Audit Services W-00-19-35814 2022 While the transfer rule reduces the Diagnosis Related Group (DRG), Disproportionate Share Hospital (DSH), and Indirect Medical Education (IME) payments on a Medicare beneficiary's claim, the methodology for calculating cost outlier payments can result in such payments being higher than what would have been paid in a nontransfer context. Under the transfer rule, CMS reduces the DRG payment by applying a graduated per diem payment on the Medicare claim of the hospital transferring the patient to another setting early in the patient's hospital stay. Because DSH and IME payments are determined as a percentage of the reduced DRG payment, they are also reduced. By contrast, by reducing the threshold above which a claim qualifies as an outlier, the application of the outlier methodology at 42 CFR Sec. 412.80(b) can result in an increase in the outlier payment in transfer cases. We will produce a report describing the extent to which additional Medicare outlier payments negate the reduction in DRG, DSH, and IME payments of transfer claims. tags
Revised Centers for Medicare & Medicaid Services Review of Post-Operative Services Provided in the Global Surgery Period Office of Audit Services W-00-18-35810; W-00-22-35810 2022 Section 523 of Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) requires CMS to collect data on post-operative services included in global surgeries and requires OIG to audit and verify a sample of the data collected. We will review a sample of global surgeries to determine the number of post-operative services documented in the medical records and compare it to the number of post-operative services reported in the data collected by CMS. We will verify the accuracy of the number of post-operative visits reported to CMS by physicians and determine whether global surgery fees reflected the actual number of post-operative services that physicians provided to beneficiaries during the global surgery period. tags
Revised Centers for Medicare & Medicaid Services Medicare Part B Payments for End-Stage Renal Disease Dialysis Services Office of Audit Services W-00-18-35811 2022 Medicare Part B covers outpatient dialysis services for beneficiaries diagnosed with end-stage renal disease (ESRD). Prior OIG work identified inappropriate Medicare payments for ESRD services. Specifically, OIG identified unallowable Medicare payments for treatments not furnished or documented, services for which there was insufficient documentation to support medical necessity, and services that were not ordered by a physician or ordered by a physician that was not treating the patient. (Social Security Act §§ 1862(a)(l)(A) and 1833(e), 42 CFR §§ 410.32(a) and (d), 42 CFR §§ 410.12(a)(3), 424.5(a)(6), and 424.10). Additionally, prior OIG reviews identified claims that did not comply with Medicare consolidated billing requirements (the Act § 1881(b)(14), Medicare Claims Processing Manual, Pub. No. 100-04, Ch. 8 and Medicare Benefit Policy Manual, Pub. No. 100-02, Ch. 11). We will review claims for Medicare Part B dialysis services provided to beneficiaries with ESRD to determine whether such services complied with Medicare requirements. tags
Revised Centers for Medicare & Medicaid Services Medicare Payments Made Outside of the Hospice Benefit Office of Audit Services W-00-20-35797 2022 According to 42 CFR 418.24(d), in general, a hospice beneficiary waives all rights to Medicare payments for any services that are related to the treatment of the terminal condition for which hospice care was elected. The hospice agency assumes responsibility for medical care related to the beneficiary's terminal illness and related conditions. Medicare continues to pay for covered medical services that are not related to the terminal illness. Prior OIG reviews have identified separate payments that should have been covered under the per diem payments made to hospice organizations. We will produce summary data on all Medicare payments made outside the hospice benefit, without determining the appropriateness of such payments, for beneficiaries who are under hospice care. In addition, we will conduct separate reviews of selected individual categories of services (e.g., durable medical equipment, prosthetics, orthotics and supplies, physician services, outpatient) to determine whether payments made outside of the hospice benefit complied with Federal requirements. tags
Completed (partial) Centers for Medicare & Medicaid Services Noninvasive Home Ventilators - Compliance With Medicare Requirements Office of Audit Services A-04-18-04066;
W-00-18-35809;
W-00-22-35809
2022 For items such as noninvasive home ventilators (NHVs) and respiratory assist devices (RADs) to be covered by Medicare, they must be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Depending on the severity of the beneficiary's condition, an NHV or RAD may be reasonable and necessary. NHVs can operate in several modes, i.e., traditional ventilator mode, RAD mode, and basic continuous positive airway pressure (CPAP) mode. The higher cost of the NHVs' combination of noninvasive interface and multimodal capability creates a greater risk that a beneficiary will be provided an NHV when a less expensive device such as a RAD or CPAP device is warranted for the patient's medical condition. Prior OIG work identified significant growth in Medicare billing for NHVs in the years since they reached the market. We will determine whether claims for NHVs were medically necessary for the treatment of beneficiaries' diagnosed illnesses and whether the claims complied with Medicare payment and documentation requirements. tags
Completed (partial) Centers for Medicare & Medicaid Services States' Procurement of Private Contracting Services for the Medicaid Management Information System Office of Audit Services W-00-18-31532 2022 The Medicaid Management Information System (MMIS) is an integrated group of procedures and computer processing operations designed to meet principal objectives such as processing medical claims. Medicaid reimburses States' MMIS administrative costs at enhanced rates of 90 and 75 percent. Many States use private contractors to design, develop, and operate their MMIS. When procuring MMIS contracting services, States are required to follow the same policies and procedures used for procurements paid with non-Federal funds. Additionally, States must receive CMS's prior approval to receive enhanced Federal matching funds for MMIS administrative costs related to private contractors. States have reportedly had issues with private MMIS contractors, including with initial procurements. We will determine if selected States followed applicable Federal and State requirements related to procuring private MMIS contracting services and claiming Federal Medicaid reimbursement. tags
Revised Centers for Medicare & Medicaid Services CMS Medicare Overpayment Recoveries Related to Recommendations in OIG Audit Reports Office of Audit Services W-00-18-35807 2022 HHS is responsible for resolving Federal audit report recommendations related to its activities, grantees, and contractors within 6 months after formal receipt of the audit reports. From October 1, 2014, to December 31, 2016, OIG issued 153 audit reports that related to the Medicare program and that contained 193 monetary recommendations totaling $648 million. Of the $648 million in recommended overpayment recoveries, CMS agreed to collect $566 million applicable to 190 recommendations. We will determine the extent to which CMS: (1) collected agreed upon Medicare overpayments identified in OIG audit reports and (2) took corrective action in response to the recommendations in our prior audit report examining CMS' overpayment recoveries (A-04-10-03059). In that report, we recommended that CMS enhance its systems and procedures for recording, collecting, and reporting overpayments. We also recommended that CMS provide guidance to its contractors on how to document that overpayments were actually collected. tags
Completed (partial) Office of the Assistant Secretary for Financial Resources Grantee Compliance With Cost Principles for Organizations With Multiple HHS Discretionary Funding Sources Office of Audit Services A-05-18-00008;
A-06-18-02002;
A-02-18-02011;
W-00-18-59433;
W-00-19-59433;
A-01-19-02500;�
A-04-19-08069
2022 Department of Health and Human Services (HHS) grantees must maintain financial management systems that contain written procedures for determining the reasonableness, allocability, and allowability of costs in accordance with applicable Federal cost principles and the terms and conditions of the award (45 CFR § 75.302(b)(7)). Grantees also must maintain accounting records that are supported by source documentation (45 CFR § 75.302(b)(3)) and financial management systems that provide for accurate and complete disclosure of the financial results of each project or program sponsored by HHS (45 CFR § 75.302(b)(2)). We will review select grantees receiving HHS grant funding from multiple sources to determine whether they are allocating and claiming costs in accordance with Federal requirements. We will also review procedures in place for HHS oversight and coordination between the participating grant programs. tags
Completed (partial) Centers for Medicare & Medicaid Services Medicaid School-Based Costs Claimed Based on Contingency Fee Contractor Coding Office of Audit Services A-04-18-07075;
W-00-18-31529
2022 Several State Medicaid agencies retain consultants to assist with preparing Medicaid claims for school-based activities. Consultants often are paid a contingency fee based on the percentage of Federal funds reimbursed to the State. During a prior review, we found that one consultant developed unsupported timestudies that it used to develop payment rates for school-based health services. Based on those rates, the State claimed unallowable Federal funds. Consultants developed timestudies using a similar methodology in many other States. We will initiate a multiple State review with a roll-up report to CMS to determine whether consultants developed school-based Medicaid rates based on unsupported timestudies and unallowable costs in these States tags
Removed Centers for Medicare & Medicaid Services Review of CMS Systems Used to Pay Medicare Advantage Organizations Office of Audit Services W-00-18-35804 2021 Medicare Advantage (MA) organizations submit to CMS diagnoses on their beneficiaries; in turn, CMS categorizes certain diagnoses into groups of clinically related diseases called hierarchical condition categories (HCC). For instances in which a diagnosis maps to a HCC, CMS increases the risk-adjusted payment. CMS has designed its Medicare Part C systems to capture the necessary data in order to make these increased payments to MA organizations. As CMS transitions to a new data system to make these payments, OIG will conduct analysis to inform both use of current systems and the transition to a new system. We will review the continuity of data maintained on current Medicare Part C systems. Specifically, we will review instances in which CMS made an increased payment to an MA organization for a HCC and determine whether CMS's systems properly contained a requisite diagnosis code that mapped to that HCC. tags
Completed (partial) Centers for Medicare & Medicaid Services State Compliance With Requirements for Reporting and Monitoring Critical Incidents Office of Audit Services A-09-17-02006;
A-06-17-04003;
A-04-17-04063;
A-02-17-01026;
A-04-17-08058;
A-04-17-03084;
A-06-17-02005;
A-09-19-02005;
W-00-17-31040;
A-02-17-01026;
A-03-17-00202;
A-06-17-01003;
2022 The Centers for Medicare & Medicaid Services requires States to implement an incident reporting system to protect the health and welfare of the Medicaid beneficiaries who receive services in community-based settings or nursing facilities. During prior audits, OIG found that some States did not always comply with Federal and State requirements for reporting and monitoring critical incidents such as abuse and neglect. We will review additional State Medicaid Agencies to determine whether the selected States are in compliance with the requirements for reporting and monitoring critical incidents. Our work will focus on Medicaid beneficiaries residing in both community-based settings and nursing facilities. tags
Completed (partial) 2017 Centers for Medicare & Medicaid Services Payment Credits for Replaced Medical Devices That Were Implanted Office of Audit Services A-01-18-00502;
A-05-16-00059;
W-00-16-35745;
W-00-18-35745
2022 Certain medical devices are implanted during inpatient or outpatient procedures. Such devices may require replacement because of defects, recalls, mechanical complication, and other factors. Under certain circumstances, Federal regulations require reductions in Medicare payments for inpatient, outpatient, and ambulatory surgical center (ASC) claims for the replacement of implanted devices due to recalls or failures (42 CFR §§ 412.89, 419.45, and 416.179). Prior OIG reviews have determined that Medicare administrative contractors made improper payments to hospitals for inpatient and outpatient claims for replaced medical devices. We will determine whether Medicare payments for replaced medical devices were made in accord with Medicare requirements. tags
Completed (partial) Centers for Medicare & Medicaid Services Use of Funds by Medicaid Managed Care Organizations Office of Audit Services A-05-18-00018;
W-00-18-31526
2022 Managed care is a health care delivery system organized to manage cost, utilization, and quality. In 2015, Federal Medicaid managed care payments were approximately $161.8 billion, which was more than 40 percent of the $349.8 billion in total Federal expenditures for Medicaid. States continue to expand their use of managed care. To deliver services to Medicaid managed care enrollees, States contract with managed care organizations (MCOs) and make monthly payments, called a capitation payment, to those plans to provide enrollees with Medicaid-covered services. Appropriately set capitation rates help to ensure that adequate payments are made to provide services to beneficiaries. We will examine how Medicaid funds received by MCOs are used to provide services to enrollees. tags
Revised Centers for Medicare & Medicaid Services Review of Medicare Payments for Bariatric Surgeries Office of Audit Services W-00-20-35226 2022 Bariatric surgery is performed to treat comorbid conditions associated with morbid obesity. (A comorbid condition exists simultaneously with another medical condition.) Medicare Parts A and B cover certain bariatric procedures if the beneficiary has (1) a body mass index of 35 or higher, (2) at least one comorbidity related to obesity, and (3) been previously unsuccessful with medical treatment for obesity (CMS, Medicare National Coverage Determinations Manual, Pub. No. 100-03, chapter 1, part 2, § 100.1). Treatments for obesity alone are not covered. The Comprehensive Error Rate Testing program's special study of certain Healthcare Common Procedure Coding System codes for bariatric surgical procedures found that approximately 98 percent of improper payments lacked sufficient documentation to support the procedures (CMS, Medicare Quarterly Provider Compliance Newsletter, "Guidance to Address Billing Errors," volume 4, issue 4, July 2014). We will review supporting documentation to determine whether the bariatric services performed met the conditions for coverage and were supported in accordance with Federal requirements (Social Security Act, §§ 1815(a) and 1833(e)). tags
Completed (partial) Centers for Medicare & Medicaid Services States' Collection of Rebates on Physician-Administered Drugs Office of Audit Services A-02-16-01012;
A-06-16-00018;
A-05-16-00013;
A-05-16-00014;
W-00-16-31400;
various reviews
2022 States are required to collect rebates on covered outpatient drugs administered by physicians in order to be eligible for Federal matching funds (SSA § 1927(a)). Previous OIG work identified concerns with States' collection and submission of data to Centers for Medicare & Medicaid Services, including national drug codes that identify drug manufacturers, thus allowing States to invoice the manufacturers responsible for paying rebates (Deficit Reduction Act of 2005). We will determine whether States have established adequate accountability and internal controls for collecting Medicaid rebates on physician-administered drugs. We will assess States' processes for collecting national drug code information on claims for physician-administered drugs and subsequent processes for billing and collecting rebates. tags
Completed (partial) Centers for Medicare & Medicaid Services States' Collection of Rebates for Drugs Dispensed to Medicaid MCO Enrollees Office of Audit Services A-06-16-00004;
A-07-16-06065;
A-09-16-02027;
A-09-16-02028;
A-09-16-02029;
A-02-16-01011;
A-09-16-02031;
A-06-16-00001
W-00-16-31483;
various reviews
2022 Medicaid MCOs are required to report enrollees' drug utilization to the State for the purpose of collecting rebates from manufacturers. Section 2501(c) of the Patient Protection and Affordable Care Act expanded the rebate requirement to include drugs dispensed to MCO enrollees. We will determine whether States are collecting prescription drug rebates from pharmaceutical manufacturers for Medicaid MCOs. Drugs dispensed by Medicaid MCOs were excluded from this requirement until March 23, 2010. tags
Completed (partial) Centers for Medicare & Medicaid Services Selected Inpatient and Outpatient Billing Requirements Office of Audit Services A-04-17-08057;
A-04-17-08055;
A-01-15-00515;
A-05-16-00064;
A-04-16-04049;
A-05-16-00062;
A-05-17-00026;
A-07-17-05102;
A-02-18-01018;
A-02-18-01025;
A-05-19-00024;
W-00-17-35538;
various reviews
2022 This review is part of a series of hospital compliance reviews that focus on hospitals with claims that may be at risk for overpayments. Prior OIG reviews and investigations have identified areas at risk for noncompliance with Medicare billing requirements. We will review Medicare payments to acute care hospitals to determine hospitals' compliance with selected billing requirements and recommend recovery of overpayments. Our review will focus on those hospitals with claims that may be at risk for overpayments. W-00-17-35538 tags
Completed (partial) Centers for Medicare & Medicaid Services Competitive Bidding for Medical Equipment Items and Services - Mandatory Review Office of Audit Services A-05-14-00049;
W-00-14-35241;
various reviews
2022 Federal law requires OIG to conduct postaward audits to assess Centers for Medicare & Medicaid Services's competitive bidding program. (Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), § 154(a)(1)(E)). We will review the process Centers for Medicare & Medicaid Services used to conduct competitive bidding and to make subsequent pricing determinations for certain medical equipment items and services in selected competitive bidding areas under rounds 1 and 2 of the competitive bidding program. tags
Completed (partial) Centers for Medicare & Medicaid Services Contractor Pension Cost Requirements Office of Audit Services A-07-17-00528;
A-07-20-00598;
A-07-21-00607;
W-00-17-35067;
W-00-22-35094;
various reviews
2022 Medicare contractors are eligible to be reimbursed a portion of their pension costs and are required to separately account for the Medicare segment pension plan assets based on the requirements of their Medicare contracts and Cost Accounting Standards. We will determine whether Medicare contractors have calculated and claimed reimbursement for Medicare's share of various employee pension costs in accordance with their Medicare contracts and applicable Federal requirements. We will determine whether contractors have fully implemented contract clauses requiring them to determine and separately account for the employee pension assets and liabilities allocable to their contracts with Medicare. We will also review Medicare contractors whose Medicare contracts have been terminated, assess Medicare's share of future pension costs, and determine the amount of excess pension assets as of the closing dates. Applicable requirements are found in the FAR at 48 CFR Subpart 31.2; Cost Accounting Standards 412 and 413; and the Medicare contract, Appendix B, § XVI. W-00-17-35067 tags
Completed (partial) Centers for Medicare & Medicaid Services Contractor Postretirement Benefits and Supplemental Employee Retirement Plan Costs Office of Audit Services A-07-18-00552;
A-07-17-00501;
A-07-17-00498;
A-07-17-00499;
A-07-17-00500;
A-07-17-00502;
A-07-17-00521;
A-07-20-00591;
A-07-20-00600;
A-07-21-00609;
A-07-21-00611;
A-07-21-00614;
A-07-21-00615;
A-07-21-00613;
W-00-17-35095;
W-00-21-35095; various reviews
2022 Centers for Medicare & Medicaid Services reimburses a portion of its contractors' postretirement health benefits costs and the supplemental employee retirement plans costs. The reimbursement is determined by the cost reimbursement principles contained in the FAR, Cost Accounting Standards as required by the Medicare contracts. We will review the postretirement health benefit costs and the supplemental employee retirement plans of Medicare contractors to determine the allowability, allocability, and reasonableness of the benefits and plans, as well as the costs charged to Medicare contracts. Criteria are in the FAR at 48 CFR §§ 31.201 through 31.205. tags
Completed (partial) Centers for Medicare & Medicaid Services Risk Adjustment Data - Sufficiency of Documentation Supporting Diagnoses Office of Audit Services A-07-16-01165;
W-00-16-35078;
various reviews
2022 Payments to Medicare Advantage organizations are risk adjusted on the basis of the health status of each beneficiary. Medicare Advantage organizations are required to submit risk adjustment data to Centers for Medicare & Medicaid Services in accordance with Centers for Medicare & Medicaid Services instructions (42 CFR § 422.310(b)), and inaccurate diagnoses may cause Centers for Medicare & Medicaid Services to pay Medicare Advantage organizations improper amounts (SSA §§ 1853(a)(1)(C) and (a)(3)). In general, Medicare Advantage organizations receive higher payments for sicker patients. Centers for Medicare & Medicaid Services estimates that 9.5 percent of payments to Medicare Advantage organizations are improper, mainly due to unsupported diagnoses submitted by Medicare Advantage organizations. Prior OIG reviews have shown that medical record documentation does not always support the diagnoses submitted to Centers for Medicare & Medicaid Services by Medicare Advantage organizations. We will review the medical record documentation to ensure that it supports the diagnoses that Medicare Advantage organizations submitted to Centers for Medicare & Medicaid Services for use in Centers for Medicare & Medicaid Services's risk score calculations and determine whether the diagnoses submitted complied with Federal requirements. tags
Completed (partial) Centers for Medicare & Medicaid Services Documentation of Pharmacies' Prescription Drug Event Data Office of Audit Services A-07-16-06068;
W-00-17-35411;
various reviews
2022 Drug plan sponsors must submit prescription drug event records, which is a summary record of individual drug claim transactions at the pharmacy, for the HHS Secretary to determine payments to the plans (SSA § 1860D-15(f)(1)). We will determine whether Medicare Part D prescription drug event records submitted by the selected pharmacies were adequately supported and complied with applicable Federal requirements. We will also conduct additional reviews of selected retail pharmacies identified in a prior OIG report as having questionable Part D billing. tags
Completed (partial) Centers for Medicare & Medicaid Services Medicaid Health Home Services for Beneficiaries with Chronic Conditions Office of Audit Services A-02-17-01004;
A-02-19-01007;
A-07-20-04117;
W-00-17-31524;
W-00-20-31524;
A-02-17-00000
2022 Section 1945 of the Social Security Act created an optional Medicaid State Plan benefit for States to establish "health homes" to coordinate care for people with Medicaid who have chronic medical conditions. States receive a 90-percent enhanced Federal Medical Assistance Percentage (FMAP) for health home services valid through the first eight quarters of the program. The State option to provide health home services to eligible Medicaid beneficiaries became effective on January 1, 2011. As of May 2017, CMS has approved Medicaid State plan amendments for 21 States and the District of Columbia for health home programs. More than 1 million Medicaid beneficiaries have been enrolled in these programs. We will review Medicaid health home programs for compliance with relevant Federal and State requirements. tags
Revised Centers for Medicare & Medicaid Services Medicaid Nursing Home Life Safety Reviews Office of Audit Services A-02-17-01027;
W-00-17-31525;
2022 CMS recently updated its health care facilities' life safety and emergency preparedness requirements to improve protections for all Medicare and Medicaid beneficiaries, including those residing in LTC facilities. These updates include requirements that facilities install expanded sprinkler and smoke detector systems to protect residents from the hazards of fire and develop an emergency preparedness plan that facilities must review, test, update, and train residents on annually. The plan must include provisions for sheltering in place and evacuation. OIG is reviewing this area because residents of LTC facilities are particularly vulnerable to the risk of fires, since many of these residents have limited or no mobility. Our objective is to determine if LTC facilities that received Medicare or Medicaid funds complied with new Federal requirements for life safety and emergency preparedness for the period May 4, 2016, through November 15, 2017. tags
Completed (partial) Centers for Medicare & Medicaid Services Part D Sponsors Reporting of Direct and Indirect Remunerations Office of Audit Services A-03-18-00006;
A-03-18-00007;
W-00-18-35514; A-03-18-xxxxx
2022 Medicare calculates certain payments to sponsors on the basis of amounts actually paid by the Part D sponsors, net of direct and indirect remuneration (DIR). (42 CFR pt. 423, subpart G.) DIR includes all rebates, subsidies, and other price concessions from sources (including, but not limited to, manufacturers and pharmacies) that decrease the costs incurred by Part D sponsors for Part D drugs. CMS requires that Part D sponsors submit DIR reports for use in the payment reconciliation process. We will determine whether Part D sponsors complied with Medicare requirements for reporting DIR. tags
Completed (partial) Centers for Medicare & Medicaid Services Consumer-Directed Personal Assistance Program Office of Audit Services A-02-16-01026;
W-00-16-31035;
2022 Medicaid Consumer-Directed Personal Assistance Programs provide an alternative way of receiving home care services in which consumers have more control over who provides their care and how it is provided. Rather than assigning a home care agency that controls selection, training, and scheduling of aides, the consumer, or the family member, friend, or guardian directing his or her care, performs all these functions usually done by the agency. Eligible individuals include those eligible for services provided by a certified home health agency, a long-term home health care (waiver) program, AIDS home care program, or personal care (home attendant). Prior OIG work has shown vulnerabilities in personal care programs resulting in ineligible beneficiaries and Medicaid payments that do not comply with Federal and State regulations. We will determine whether selected States made Medicaid payments for consumer-directed personal assistance program claims in accordance with applicable Federal and State regulations. tags
Completed (partial) Centers for Medicare & Medicaid Services Recovery of Federal Funds Through Judgments/Settlements Office of Audit Services A-05-17-00041;
A-03-17-00203;
A-07-18-02814;
W-00-17-31522; A-05-17-00000
2022 Any State action taken as a result of harm to a State's Medicaid program must seek to recover damages sustained by the Medicaid program as a whole, including both Federal and State shares. On October 28, 2008, CMS issued a letter (SHO #08-004) to State health officials that clarified language from Section 1903(d) of the Social Security Act, stating that the Federal Government is entitled to the Federal Medical Assistance Percentages (FMAP) proportionate share of a States entire settlement or final judgment amount. We will determine whether selected States reported and returned the applicable FMAP share of the settlement and judgment amounts to the Federal Government. tags
Revised Centers for Medicare & Medicaid Services Nationwide Medicare Electronic Health Record Incentive Payments to Hospitals Office of Audit Services W-00-20-35795 2022 Medicare incentive payments were authorized over a 5-year period to hospitals that adopted electronic health record (EHR) technology (Recovery Act, 4102). From January 1, 2011, through December 31, 2016, the Centers for Medicare & Medicaid Services (CMS) made Medicare EHR incentive payments to hospitals totaling $14.6 billion. The Government Accountability Office identified improper incentive payments as the primary risk to the Medicare EHR incentive program. A Department of Health and Human Services, Office of Inspector General (OIG), report describes the obstacles that CMS faces in overseeing the Medicare EHR incentive program. In addition, previous OIG reviews of Medicaid EHR incentive payments found that State agencies overpaid hospitals by $66.7 million and would in the future overpay these hospitals an additional $13.2 million. These overpayments resulted from inaccuracies in the hospitals calculations of total incentive payments. We will review the hospitals incentive payment calculations to identify potential overpayments that the hospitals would have received as a result of the inaccuracies. tags
Completed (partial) Centers for Medicare & Medicaid Services Medicaid Claims for Opioid Treatment Program Services Office of Audit Services A-02-17-01021;
A-06-20-08000;
A-07-20-04118;
W-00-17-31523;
W-00-20-31523
2022 Medicaid is a significant source of coverage and funding for behavioral health treatment services, including treatment of substance abuse. Some Medicaid State agencies provide payment for Opioid Treatment Program (OTP) services. Services can be provided at freestanding and hospital-based OTPs. We will determine whether selected State agencies complied with certain Federal and State requirements when claiming Medicaid reimbursement for OTP services. tags
Completed (partial) Centers for Medicare & Medicaid Services Medicaid Targeted Case Management Office of Audit Services A-07-16-03215;
A-07-17-03219;
W-00-17-31082;
A-07-17-03219
2022 The Social Security Act, § 1915(g)(2), defines case management services as those assisting individuals eligible under the State plan in gaining access to needed medical, social, educational, and other services. Case management services do not include the direct delivery of an underlying medical, educational, social, or other service for which an eligible individual has been referred. Payments for case management services may not duplicate payments made to public agencies under other program authorities for the same service. Prior OIG work in one State identified 18 percent of such claims as unallowable, with an additional 20 percent as potentially unallowable. We will determine whether Medicaid payments for targeted case management services in selected States were made in accord with Federal requirements. tags
Completed Centers for Medicare & Medicaid Services Treatment of Authorized Generic Drugs Office of Audit Services A-06-18-04002 2019 An authorized generic drug is one that the manufacturer holding the title to the original new drug application permits another manufacturer to sell under a different national drug code.'' Provisions in 42 CFR § 447.506(b) provide that the manufacturer holding title to the original new drug application of the authorized generic drug must include the sales of this drug in its average manufacturer price (AMP) only when such drugs are being sold by the manufacturer directly to a wholesaler. Manufacturers that also include the sales of an authorized generic to a secondary manufacturer could lower the AMP and, consequently, a lower rebate would be paid to the State. We will review drug manufacturers' treatment of sales of authorized generics in their calculation of AMP for the Medicaid drug rebate program. We will determine whether manufacturers included sales of authorized generics to secondary manufacturers in their AMP calculations. tags
Completed (partial) Centers for Medicare & Medicaid Services Oversight and Effectiveness of Medicaid Waivers Office of Audit Services A-03-17-00200;
A-02-17-01005;
A-04-17-04058;
A-05-19-00022;
W-00-17-31513
2022 More States are using waivers to alter their Medicaid program in significant ways. Oversight of State waiver programs present challenges to ensure that payments made under the waivers are consistent with regards to efficiency, economy, and quality of care and do not inflate Federal costs. We will determine the extent to which selected States made use of Medicaid waivers and if costs associated with the waivers are efficient, economic, and do not inflate Federal costs. We will also look at Centers for Medicare & Medicaid Services's oversight of State Medicaid waivers. tags
Completed (partial) Centers for Medicare & Medicaid Services Transportation Services - Compliance with Federal and State Requirements Office of Audit Services A-05-16-00021;
A-07-16-03209;
W-00-16-31121
various reviews
2022 Federal regulationsrequire States to ensure necessary transportation for Medicaid beneficiaries to and from providers (42 CFR § 431.53). Each State may have different Medicaid coverage criteria, reimbursement rates, rules governing covered services, and beneficiary eligibility for services. We will determine the appropriateness of Medicaid payments by States to providers for transportation services. tags
Completed (partial) Centers for Medicare & Medicaid Services Duplicate Payments for Beneficiaries with Multiple Medicaid Identification Numbers Office of Audit Services A-04-16-07061;
A-02-20-01007;
W-00-16-31374;
various reviews
2022 During a preliminary data match, OIG identified a significant number of individuals who were assigned more than one Medicaid identification number and for whom multiple Medicaid payments were made for the same period. We will review duplicate payments made by States on behalf of Medicaid beneficiaries with multiple Medicaid identification numbers and identify States' procedures or other controls for preventing such payments. tags
Completed (partial) Centers for Medicare & Medicaid Services Medical Loss Ratio - Recoveries of MCO Remittances from Profit-Limiting Arrangements Office of Audit Services A-06-18-09001;
W-00-18-31508
2022 When a State recovers a prior expenditure, it must refund the Federal share by reporting the recovery to Centers for Medicare & Medicaid Services at the FMAP used to calculate the amount it had originally received (SSA § 1903(d)(2); Centers for Medicare & Medicaid Services State Medicaid Manual, § 2500.6(B)). In its final rule (81 Fed. Reg. 27498 (May 6, 2016)), Centers for Medicare & Medicaid Services encouraged States to adopt provisions in contracts with managed care plans that would require remittances from the MCOs if a minimum medical loss ratio is not met. A medical loss ratio is a tool that can help ensure that the majority of capitated payments are used to deliver services to beneficiaries. Prior OIG reviews found that some States have adopted such remittance provisions. We will review States and managed care plans with contract provisions that require remittances from managed care plans if a minimum percentage of total costs to be expended for medical services (medical loss ratio) is not met. We will determine whether the Federal share of recoveries of MCO payments that States received through profit-limiting methodologies is returned to the Federal Government. Centers for Medicare & Medicaid Services reimburses each State at the FMAP for the quarter in which the expenditure was made (SSA § 1903(a)(1)). tags
November 2016 Centers for Medicare & Medicaid Services Managed Long-Term-Care Reimbursements Office of Audit Services W-00-17-31510 2022 Medicaid managed care plans are subject to Federal requirements (42 CFR Part 438). Some States contract with MCOs to provide long-term services. We will review States' reimbursements made to managed long-term-care plans to determine whether those reimbursements complied with certain Federal and State requirements. tags
November 2016 Centers for Medicare & Medicaid Services Medicaid Managed Care Reimbursement Office of Audit Services W-00-17-31471; various reviews 2022 States contract with MCOs to provide coverage for specific services to enrolled Medicaid beneficiaries. In return for covering those services, MCOs are paid a set monthly capitation payment. Previous work by GAO found that Centers for Medicare & Medicaid Services's oversight of States' rate-setting required improvement and that States may not audit or independently verify the MCO-reported data used to set rates (GAO-10-810). We will review States' managed care plan reimbursements to determine whether MCOs are appropriately and correctly reimbursed for services provided. We will ensure that the data used to set rates are reliable and include only costs for services covered under the State plan or costs of services authorized by Centers for Medicare & Medicaid Services (42 CFR § 438.6(e)). We will also verify that payments made under a risk-sharing mechanism and incentive payments made to MCOs are within the limits set forth in Federal regulations (42 CFR § 438.6(c)(5)(ii) and 42 CFR § 438.6(c)(5)(iii) and (iv)).mary tags
Completed (partial) Centers for Medicare & Medicaid Services Delivery System Reform Incentive Payments Office of Audit Services A-02-17-01007;
A-06-17-09002;
W-00-17-31516; various reviews
2022 Delivery System Reform Incentive Payments are incentive payments made under Section 1115 waivers to hospitals and other providers that develop programs or strategies to enhance access to health care, increase the quality and cost-effectiveness of care, and increase the health of patients and families served. States must be able to demonstrate outcomes and ensure accountability for allocated funding. These incentive payments have significantly increased funding to providers for their efforts related to the quality of services. For example, one State made incentive payments totaling more than $6 billion in a 5-year period. We will ensure that select States adhered to applicable Federal and State requirements when they made incentive payments to providers. tags
Completed (partial) Centers for Medicare & Medicaid Services Medicaid Eligibility Determinations in Selected States Office of Audit Services A-09-16-02023;
A-04-16-08047;
A-02-16-01005;
A-07-16-04228;
W-00-16-31140;
various reviews
2022 The ACA, § 2001, required significant changes affecting State processes for Medicaid enrollment, modified criteria for Medicaid eligibility, and authorized the use of an enhanced FMAP of 100 percent for newly eligible individuals. We will determine the extent to which selected States made inaccurate Medicaid eligibility determinations. We will examine eligibility inaccuracy for Medicaid beneficiaries in selected States that expanded their Medicaid programs pursuant to the Patient Protection and Affordable Care Act and in States that did not. We will also assess whether and how the selected States addressed issues that contributed to inaccurate determinations. For some States, we will calculate a Medicaid eligibility error rate and determine the amount of payments associated with beneficiaries who received incorrect eligibility determinations. tags
Completed (partial) Centers for Medicare & Medicaid Services Outpatient Outlier Payments for Short-Stay Claims Office of Audit Services A-06-16-01002;
W-00-16-35775
2022 CMS makes an additional payment (an outlier payment) for hospital outpatient services when a hospital's charges, adjusted to cost, exceed a fixed multiple of the normal Medicare payment (Social Security Act (SSA) § 1833(t)(5)). The purpose of the outlier payment is to ensure beneficiary access to services by having Medicare share in the financial loss incurred by a provider associated with extraordinarily expensive individual cases. Prior OIG reports have concluded that hospitals' high charges, unrelated to cost, lead to excessive inpatient outlier payments. We will determine the extent of potential Medicare savings if hospital outpatient short stays (same day or over one midnight) were ineligible for an outlier payments. Prior to a nationwide review, we plan to perform several reviews at one or more hospitals to determine whether outpatient outlier payments to hospitals are associated with extraordinarily expensive individual cases. tags
Completed (partial) Centers for Medicare & Medicaid Services Payments for Medicare Services, Supplies, and DMEPOS Referred or Ordered by Physicians Compliance Office of Audit Services A-09-17-03002;
W-00-17-35748;
W-00-22-35748
2022 Centers for Medicare & Medicaid Services requires that physicians and nonphysician practitioners who order certain services, supplies, and/or DMEPOS be Medicare-enrolled physicians or nonphysician practitioners and be legally eligible to refer and order services, supplies, and DMEPOS (ACA § 6405). If the referring or ordering physician or nonphysician practitioner is not eligible to order or refer, then Medicare claims should not be paid. We will review select Medicare services, supplies, and DMEPOS referred or ordered by physicians and nonphysician practitioners to determine whether the payments were made in accordance with Medicare requirements. tags
Completed (partial) Centers for Medicare & Medicaid Services Ambulance Services - Supplier Compliance with Payment Requirements Office of Audit Services A-02-16-01021;
A-09-17-03018;
W-00-17-35574;
W-00-22-35574;
various reviews
2022 Medicare pays for emergency and nonemergency ambulance services when a beneficiary's medical condition at the time of transport is such that other means of transportation would endanger the beneficiary (SSA § 1861(s)(7)). Medicare pays for different levels of ambulance service, including basic life support, advanced life support, and specialty care transport (42 CFR § 410.40(b)). Prior OIG work found that Medicare made inappropriate payments for advanced life support emergency transports. We will determine whether Medicare payments for ambulance services were made in accordance with Medicare requirements. tags
Completed (partial) Centers for Medicare & Medicaid Services Review of Hospices' Compliance with Medicare Requirements Office of Audit Services A-02-16-01023;
A-02-16-01024;
A-02-18-01001;
A-09-18-03016;
A-09-18-03017;
A-09-18-03028;
A-09-20-03034;
A-09-20-03035;
A-09-18-03024;
A-09-18-03009;
W-00-16-35783;
W-00-18-35783 various reviews
2022 Hospice provides palliative care for terminally ill beneficiaries and supports family and other caregivers. When a beneficiary elects hospice care, the hospice agency assumes the responsibility for medical care related to the beneficiary's terminal illness and related conditions. Federal regulations address Medicare conditions of and limitations on payment for hospice services (42 CFR Part 418, Subpart G). We will review hospice medical records and billing documentation to determine whether Medicare payments for hospice services were made in accordance with Medicare requirements. tags
Completed Centers for Medicare & Medicaid Services Medicare Payments for Transitional Care Management Office of Audit Services W-00-17-35786 7/7/2021 Transitional Care Management (TCM) includes services provided to a patient whose medical and/or psychosocial problems require moderate or high-complexity medical decision-making during transitions in care from an inpatient hospital setting (including acute hospital, rehabilitation hospital, long-term acute care hospital), partial hospital, observation status in a hospital, or skilled nursing facility/nursing facility, to the patient's community setting (home, domicile, rest home, or assisted living). Beginning January 1, 2013, Medicare covered TCM services and paid for them under the Medicare Physician Fee Schedule. Medicare-covered services, including chronic care management, end-stage renal disease, and prolonged services without direct patient contact, cannot be billed during the same service period as TCM. We will determine whether payments for TCM services were in accordance with Medicare requirements. tags