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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 2024 Centers for Medicare and Medicaid Services Status of State Medicaid Provider Enrollment and Screening Activities Centers for Medicare and Medicaid Services OEI-05-24-00400 2026 Provider enrollment screening is a key program integrity tool for protecting Medicaid against fraudulent and abusive providers. Federal law requires State Medicaid agencies to screen providers as part of the Medicaid enrollment process. For high-risk provider types, including durable medical equipment, prosthetics, and orthotics suppliers and home health agencies, required screening activities include site visits and fingerprint-based criminal background checks. Prior OIG work has identified issues with States' implementation of provider enrollment and screening requirements for both fee-for-service Medicaid and Medicaid managed care. During the COVID-19 public health emergency, CMS suspended certain screening requirements, which may have exacerbated the issues previously identified and presented new challenges. This study will determine the status of States' required Medicaid provider enrollment and screening and will assess States' standards and processes for screening. Financial Stewardship, Managed Care, Physician and Healthcare Practitioners, Medicaid
December 2024 Centers for Medicare and Medicaid Services Audit of Medicare Part B Remote Patient Monitoring Services Office of Audit ServicesCenters for Medicare and Medicaid Services OAS-25-05-008 2026 Medicare Part B remote patient monitoring (RPM) services have the potential to significantly improve health outcomes, but the services warrant additional oversight. RPM services involve the collection of patient physiologic data used to develop and manage a care plan related to a chronic and/or acute health illness or condition. For example, sensors that monitor temperature in a patient’s extremities may help prevent diabetic ulcers that can lead to amputations. However, since 2018, the way that providers bill for certain Medicare Part B RPM services has changed significantly, and Medicare payments for those services have increased dramatically. RPM services are also susceptible to fraud, waste, and abuse (e.g., unsolicited device shipments, inadequate monitoring, and inappropriate billing). In November 2023, OIG issued a Consumer Alert about a fraud scheme for RPM services. We will determine whether providers furnished and billed for RPM services in accordance with Medicare requirements. Physician and Healthcare Practitioners, Financial Stewardship, Elderly, Medicare B
December 2024 Food and Drug Administration The Food and Drug Administration's Efforts To Oversee and Prevent Employee Conflicts of Interest Office of Audit Services OAS-25-01-010 2026 The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, and by ensuring the safety of our Nation's food supply, cosmetics, and products that emit radiation. As Federal employees, FDA workers are subject to the Standards of Ethical Conduct for Employees of the Executive Branch. FDA employees are also subject to additional requirements to assure that FDA's business is conducted effectively, objectively, and without improper influence or the appearance of improper influence. Employees must be persons of integrity and must observe high standards of honesty, impartiality, and behavior. Employees must not engage in any conduct prejudicial to the Government and must avoid personal conflicts of interest with their public duties and responsibilities. Our objective is to determine whether FDA's ethics program complied with Federal requirements to prevent, identify, and resolve potential conflicts of interest. Departmental Operational Issues, Food, Drug, and Device Safety, Other Funding
November 2024 Administration for Children and Families State Agencies' Compliance With Requirements for Children in Foster Care Placed in Qualified Residential Treatment Programs Office of Audit Services OAS-24-05-010 2026 Title IV-E of the Social Security Act established the Federal Foster Care Program, which provides funding to States for safe and stable out-of-home care for children who meet certain eligibility requirements. The Family First Prevention Services Act of 2018 created a new category of child care institutions, called qualified residential treatment programs, designed to address the needs of children with serious emotional or behavioral disorders or disturbances. We plan to perform audits of selected States to determine compliance with Federal and State requirements related to children in foster care who were eligible for assistance under Title IV-E of the Social Security Act and resided in qualified residential treatment programs. Dependent Care, Quality of Care, Children and Families, Grants
November 2024 Centers for Medicare and Medicaid Services Access to Hepatitis C Treatment in Medicaid Office of Evaluation and Inspections OEI-BL-24-00450 2026 Hepatitis C is a liver disease caused by the highly infectious hepatitis C virus. If untreated, hepatitis C can result in serious liver disease. In the past decade, direct-acting antiviral drugs that can cure hepatitis C within 12 weeks have revolutionized treatment. Despite their improved tolerability over previous treatments and recommended use by prominent medical associations, these hepatitis C drugs are underutilized, and the virus continues to spread. In recent years, Federal and State policymakers have attempted to improve access to hepatitis C treatment while simultaneously addressing its high cost. In Medicaid-which serves a high proportion of people with hepatitis C-some States have arranged alternative payment structures for hepatitis C drugs and removed related coverage restrictions. This study will examine the extent to which Medicaid enrollees diagnosed with chronic hepatitis C receive drug treatment in Medicaid and identify potential disparities in treatment rates. Prescription Drug, Medicaid
November 2024 Centers for Medicare and Medicaid Services Medicare Advantage Health Risk Assessments - Continuity of Care Office of Audit Services OAS-24-07-015 2026 CMS makes monthly risk-adjusted payments to Medicare Advantage (MA) organizations based in part on the health characteristics of the enrollees being covered (Social Security Act § 1853(a)). Federal regulations at 42 CFR § 422.310(b) require that MA organizations submit risk adjustment data, which includes diagnosis codes, to CMS in accordance with CMS instructions. Inaccurate diagnoses may cause CMS to pay MA organizations improper amounts. MA organizations use health risk assessments (HRAs) to gather information, including diagnoses, about enrollees. MA organizations can use HRAs for early identification of health risks to improve enrollees' care and health outcomes. However, prior OIG work found that MA organizations may have inappropriately leveraged HRAs to maximize risk-adjusted payments. These audits focused on enrollees whose diagnoses, reported first on HRAs, mapped to hierarchical condition categories and resulted in increased risk-adjusted payments from CMS to MA organizations. We will determine whether MA organizations complied with Federal requirements when: (1) submitting diagnoses reported on HRAs to CMS for use in CMS's risk-adjustment program and (2) taking any needed steps to ensure continuity of care and integration of services for enrollees who had received HRAs. Managed Care, Quality of Care, Elderly, People with Disabilities, Medicare C
November 2024 Centers for Medicare and Medicaid Services Medicare Part B Drug Payments: Impact of Price Substitutions Based on 2023 Average Sales Prices Office of Evaluation and Inspections OEI-03-25-00050 2025 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. Section 1847A(d)(1)-(3) of the Social Security Act mandates that OIG compare ASPs with average manufacturer prices (AMPs) and the widely available market price, if any. If OIG finds that the ASP for a drug exceeded the AMP by 5 percent in the two previous quarters or in three of the previous four quarters, the Secretary of Health and Human Services may substitute the reimbursement amount with a lower calculated rate. Over the past decade, OIG has produced annual reports aggregating the results of our mandated quarterly ASP-to-AMP comparisons. This annual report will quantify the savings to Medicare and its beneficiaries that are a direct result of CMS's price substitution policy based on 2023 ASPs, and it may offer recommendations for Medicare to achieve additional savings. Prescription Drug, Elderly, Medicare B
November 2024 Centers for Medicare and Medicaid Services Medicare Part B Payments for Skin Substitutes Office of Audit Services OAS-25-09-005 2026 Skin substitutes help aid in wound healing and redevelopment of skin. Medicare covers skin substitutes that are reasonable and necessary for the treatment of an enrollee's condition. Local coverage determinations state that Medicare Part B generally covers skin substitutes for treatment of diabetic foot ulcers and venous leg ulcers that have failed to respond to at least 4 weeks of standard wound care. However, no national or local coverage requirements apply for other wound types (e.g., pressure ulcers or trauma wounds), and coverage of skin substitutes for these wounds is determined on a case-by-case basis. Medicare Part B pays for skin substitutes based on the number of service units billed at prices ranging from approximately $100 to more than $1,000 per square centimeter. From calendar years 2020 through 2023, Medicare Part B payments for skin substitutes have increased substantially. We will review Medicare Part B claims for skin substitutes to identify payments that were at risk for noncompliance with Medicare requirements. Medical Supplies and Equipment, Elderly, Medicare B
November 2024 Centers for Medicare and Medicaid Services Medications for Opioid Use Disorder in Medicare in 2023: Annual Review Office of Evaluation and Inspections OEI-02-24-00430 2025 The opioid crisis remains a public health emergency. In 2023, an estimated 81,842 opioid-related overdose deaths occurred in the United States. Ensuring both that patients who would benefit from treatment for opioid use disorder have access to this treatment and that people have opioid overdose-reversal drugs on hand are key to addressing this crisis. This data brief, Medications for Opioid Use Disorder in Medicare in 2023: Annual Review, builds on our series of annual reports on opioid utilization in Medicare Part D and the treatment of opioid use disorder among people enrolled in Medicare. It provides 2023 data on the number of enrollees who received medications to treat opioid use disorder, the number of enrollees who experienced an opioid overdose, and the number of enrollees who received opioid overdose reversal drugs. Prescription Drug, Substance Abuse Disorders, Elderly, Medicare B, Medicare C, Medicare D
November 2024 Centers for Medicare and Medicaid Services Update: Average Sales Price Reporting for Skin Substitutes Office of Evaluation and Inspections OEI-BL-24-00420 2025 In March 2023, OIG issued a report that found that manufacturer noncompliance with new average sales price (ASP) reporting requirements for skin substitutes led to millions in excessive Part B payments. ASP is used to set Medicare payment amounts. Since that report was issued, Part B expenditures for skin substitutes have risen significantly, exceeding $1.6 billion in the fourth quarter of 2023 alone. Despite efforts by CMS to address the accuracy and completeness of ASP reporting, the sharp increase in expenditures raises concerns that poor ASP reporting continues to result in excess Medicare payments. Given this rapid increase in Part B expenditures and a recent history of fraud in the area, this study will provide an update on reporting issues as well as highlight billing trends and identify potential solutions to any challenges in using the ASP methodology for skin substitutes. Financial Stewardship, Prescription Drug, Elderly, Medicare B
November 2024 Centers for Medicare and Medicaid Services Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Fourth Quarter of 2024 Office of Evaluation and Inspections OEI-03-25-00030 2025 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. Section 1847A(d)(1)-(3) of the Social Security Act mandates that OIG compare ASPs with average manufacturer prices (AMPs) and widely available market price (if any). 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 Health and Human Services may substitute the reimbursement amount with a lower calculated rate. This quarterly memo summarizes the results of OIG's comparison analysis based on ASP and AMP data reported for the fourth quarter of 2024. 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
November 2024 Centers for Medicare and Medicaid Services Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the First Quarter of 2025 Office of Evaluation and Inspections OEI-03-25-00040 2025 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. Section 1847A(d)(1)-(3) of the Social Security Act mandates that OIG compare ASPs with average manufacturer prices (AMPs) and widely available market price (if any). 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 Health and Human Services may substitute the reimbursement amount with a lower calculated rate. This quarterly memo summarizes the results of OIG's comparison analysis based on ASP and AMP data reported for the first quarter of 2025. 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
November 2024 Centers for Medicare and Medicaid Services Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Third Quarter of 2024 Office of Evaluation and Inspections OEI-03-25-00020 2025 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. Section 1847A(d)(1)-(3) of the Social Security Act mandates that OIG compare ASPs with average manufacturer prices (AMPs) and widely available market price (if any). 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 Health and Human Services may substitute the reimbursement amount with a lower calculated rate. This quarterly memo summarizes the results of OIG's comparison analysis based on ASP and AMP data reported for the third quarter of 2024. 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
Completed Centers for Medicare and Medicaid Services Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Second Quarter of 2024 Office of Evaluation and Inspections OEI-03-25-00010 2025 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. Section 1847A(d)(1)-(3) of the Social Security Act mandates that OIG compare ASPs with average manufacturer prices (AMPs) and widely available market price (if any). 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 Health and Human Services may substitute the reimbursement amount with a lower calculated rate. This quarterly memo summarizes the results of OIG's comparison analysis based on ASP and AMP data reported for the second quarter of 2024. 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
November 2024 Centers for Medicare and Medicaid Services Medicare Part B Payments for Incident-To Services Office of Audit Services OAS-25-01-003 2026 Medicare Part B pays for physicians' services and services and supplies “incident to” a physician's services that are furnished by the physician's staff, including non-physician practitioners. Incident to services must be an integral part of the physician's services during diagnosis or treatment of an injury or illness, and, in general, must be furnished under the physician's direct supervision. Incident-to services are billed under the physician's National Provider Identifier number as if the physician personally provided the services. Medicare reimburses the incident to service at the full rate of the Medicare Physician Fee Schedule. Prior OIG work found that improving the transparency of incident-to services is critical to program integrity efforts. Our objective is to determine whether Medicare Part B payments for services performed incident to physicians' services complied with Medicare requirements. Physician and Healthcare Practitioners, Medicare B
November 2024 Centers for Medicare and Medicaid Services Medicaid Personal Care Services Office of Audit Services W-00-19-31536 2025 Personal care services (PCS) are categorized as a range of human assistance provided to persons with disabilities and chronic conditions to enable them to accomplish activities of daily living or instrumental activities of daily living. PCS assists people enrolled in Medicaid 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 PCS claims complied with Federal and State requirements. Physician and Healthcare Practitioners, Medicare B
October 2024 Centers for Medicare and Medicaid Services Wheelchair Repair Services for Medicare Enrollees Office of Evaluation and Inspections OEI-07-24-00380 2026 Wheelchair malfunctions and subsequent repairs are disruptive to users' mobility, and media sources have raised concerns about the timeliness and quality of wheelchair repair services. Wheelchair suppliers must adhere to quality standards set by legislation and by CMS. This evaluation will examine durable medical equipment suppliers who provide wheelchair repair services and will consider the duration of repairs, suppliers' implementation of selected quality standards, and accreditors' identification of deficiencies related to wheelchair repairs. We will review documentation from wheelchair suppliers and accreditation organizations and conduct interviews with CMS, accreditation organizations, and Medicare enrollees. Medical Supplies and Equipment, Quality of Care, People with Disabilities, Elderly, Medicare Part B, Medicare Part C
October 2024 Centers for Medicare and Medicaid Services Audit of Medicare Part D Over-the-Counter Drugs Office of Audit Services< OAS-24-02-004 2026 Over-the-counter (OTC) drugs may be purchased without a prescription. Medicare Part D does not cover OTC drugs under their basic prescription drug benefit or as a supplemental benefit under enhanced alternative coverage. Subject to approval by the Food and Drug Administration (FDA), companies may convert a brand-name prescription-only (Rx-only) drug to an OTC drug. After FDA approves a brand-name drug's conversion to OTC status, which includes requiring changes to its labeling, the drug is no longer considered an Rx-only drug. Because the labeling of brand-name drugs and generic equivalents must be identical, makers of the generic equivalents must make corresponding revisions to their labeling or cease marketing their generic equivalents. We will conduct a nationwide audit of Medicare Part D prescription drug event data to identify payments for OTC drugs sold under obsolete Rx-only labeling. We will determine whether CMS oversight of Medicare Part D sponsors ensured compliance with Federal requirements for preventing payments for OTC drugs. Managed Care, Medicaid
October 2024 Centers for Medicare and Medicaid Services Medicare Payments to Suppliers for Oxygen and Oxygen Equipment Office of Audit Services OAS-24-09-012 2026 Medicare covers reasonable and necessary durable medical equipment, prosthetics, and orthotics supplies, such as oxygen and oxygen equipment (Social Security Act §§ 1861(n), (s)(6), (8), and (9) and § 1862 (a)(1)(A)). For calendar year 2023, Medicare paid more than $674 million for oxygen and oxygen equipment. CMS has consistently identified high rates of improper payment for oxygen and oxygen equipment through its Comprehensive Error Rate Testing program. Upon request, a supplier must provide documentation, including records from the treating practitioner, indicating that oxygen and oxygen equipment were reasonable and necessary for an enrollee's condition (42 CFR § 410.38(d)(3)). We will determine whether Medicare paid suppliers for oxygen and oxygen equipment according to Medicare requirements. Medical Supplies and Equipment, Elderly, Medicare Part B
October 2024 Centers for Medicare and Medicaid Services Audit of Medicaid Reimbursement for Clinical Laboratory Services Office of Audit Services OAS-25-01-004 2026 Outpatient clinical diagnostic laboratory tests encompass tests performed in a physician's office, by an independent laboratory, or by a hospital laboratory, and provide information for the diagnosis, prevention, or treatment of disease or for the assessment of a medical condition. Medicaid reimbursement for outpatient clinical diagnostic laboratory services performed in a physician's office, by an independent laboratory, or by a hospital laboratory, generally may not exceed the amount set in the Medicare clinical laboratory fee schedule. Our objective is to determine whether selected States claimed Federal Medicaid reimbursement for outpatient clinical diagnostic laboratory services in accordance with the payment limits set in Federal and State requirements. Laboratories, Medicaid
September 2024 Food and Drug Administration FDA's Postmarket Evaluations of Drugs That May Pose Safety Risks Office of Evaluation and Inspections OEI-06-24-00020 2025 The Food and Drug Administration (FDA) is responsible for ensuring the safety of drugs. Once drugs are on the market, the agency reviews reports of adverse drug events and other data to identify what it calls "potential signals of serious risk," or safety signals. Safety signals suggest there may be a risk to the public associated with use of the drug. FDA evaluates each safety signal to determine the degree of risk and takes regulatory or compliance action when warranted, such as requesting an update to the drug's safety label or issuing safety alerts to the public. This study will examine FDA's postmarket evaluations of safety signals, including timeliness and actions taken to protect the public from harm. We will review case files and summary data for safety signal evaluations over a 10-year period and will interview FDA leadership and staff about their decision-making process. Food, Drug, and Device Safety; Prescription Drug; Other Funding
September 2024 Centers for Medicare and Medicaid Services Medicaid Managed Care Organizations in States With Remittance Requirements Office of Audit Services OEI-06-24-00020 2025 CMS established medical loss ratios (MLRs) in Medicaid managed care as a tool to ensure that managed care plans spend most of their revenue on services related to the health of their enrollees, thereby limiting the amount that plans can spend on administration and keep as profit. As part of the capitation rate setting process, Federal regulations require States to set their plans' capitation rates so that plans will reasonably achieve MLRs of at least 85 percent. Further, States also have the option to require their managed care plans to pay remittances if the plan fails to meet the minimum MLR set by the State. We will review States and managed care plans with contract provisions that require remittances from managed care plans if a minimum MLR is not met. We will determine whether the remittances the MCOs reported to States were correctly calculated and whether the Federal share of remittances that States received was returned to the Federal Government. Managed Care, Medicaid
September 2024 Centers for Medicare and Medicaid Services Comparative Analysis Between Medicare Payments and Hospital's Published Prices Office of Audit Services OAS-24-07-001 2026 CMS issued a final rule (effective January 1, 2021), to improve transparency in health care costs by requiring hospitals to make their prices readily available for consumers (the Hospital Price Transparency (HPT) rule). CMS believes that the Hospital Price Transparency (HPT rule) will increase market competition and drive down the cost of health care services. One of the requirements of the HPT rule is for hospitals to make public all negotiated charges with third-party payers. We will examine and conduct an analysis to compare the pricing information published by the hospitals to the amounts that Medicare paid. Specifically, we will evaluate how much Medicare pays in comparison to the third-party payer negotiated charges and the minimum negotiated charges. Financial Stewardship, Hospitals, Physician and Healthcare Practitioners, Elderly, Medicare A
August 2024 Administration for Children and Families Review of the Office of Refugee Resettlement's National Call Center Response to Incoming Calls Office of Evaluation and Inspections OEI-07-24-00370 2025 The Office of Refugee Resettlement's (ORR) National Call Center (NCC) is a helpline available to unaccompanied children, parents, and sponsors, among others. Children who were released to sponsors may contact the helpline if they feel unsafe or are not receiving adequate care, and sponsors may contact the helpline to report a child as missing or to request additional community resources. We will examine the steps that ORR's NCC took in responding to calls related to children's safety after release to a sponsor. We will consider whether there are opportunities for ORR's NCC, within the scope of its authority, to strengthen its response to incoming calls, which could result in better protecting children. Contracts; Departmental Operational Issues; Public Health Issues; Children and Families; Grants
August 2024 CMS, ASPR Health Care Facilities and Geographic Areas With Potentially Limited Response Capabilities During the 2024 Hurricane Season Office of Evaluation and Inspections OEI-04-24-00390 2025 Hurricane season spans June 1 through November 30 each year, and the 2024 hurricane season was forecast to have above-normal storm activity. To strengthen preparedness and response capabilities—and ultimately improve continuity of care—we will synthesize program and performance data to provide new insights about health care facilities and geographic areas that may be at risk and potentially less prepared for a hurricane or similar storm event. This information could be used by HHS to minimize the potential effects of these risks before, during, or following a hurricane event. Emergency Preparedness and Response; Nursing Homes, Nursing Facilities, and Assisted Living Facilities; Public Health Issues; Elderly; Medicaid; Medicare A
August 2024 Centers for Medicare and Medicaid Services Audit of Medicare Claim Lines for Which Payments Exceeded Charges Office of Audit Services WA-24-0061 (W-00-24-35920) 2026 CMS contracts with Medicare Administrative Contractors to, among other things, process and pay claims for items and services covered under Medicare Part B, including, but not limited, to physicians' services; outpatient hospital services; drugs and biologicals that are usually not self-administered; durable medical equipment; and outpatient physical therapy, occupational therapy, and speech-language pathology services. Generally, Medicare Part B payments are based on a fee schedule, prospective payments system, or some other method (e.g., a percentage of the average sales price for Part B drugs and biologicals), instead of a cost or charge basis. In most cases, a health care provider's billed charges exceed the amount that Medicare pays for Part B items and services. Therefore, a Medicare payment that significantly exceeds the billed charges can be an overpayment. Previous OIG audits found that when a health care provider was paid more than it charged for a claim line, that claim line was often incorrect, which resulted in overpayment to the health care provider. Our objective will be to determine whether certain Medicare payments that exceeded charges for Medicare Part B items and services were correct. Physician and Healthcare Practitioners; Prescription Drug; Elderly; Medicare B
August 2024 Centers for Medicare and Medicaid Services Joint Pain Management Therapies: Hyaluronic Acid Knee Injections Office of Audit Services WA-24-0063 (W-00-24-35921) 2025 Hyaluronic acid, also known as hyaluronan or hyaluronate, is a naturally occurring substance found in the fluid surrounding knee joints. Joints with degenerative joint disease are found to have lower concentrations of hyaluronic acid, resulting in pain, immobility, and reduction of function and the ability to complete activities of daily living. Hyaluronic acid knee injections are used to treat individuals with degenerative joint disease(s) such as knee osteoarthritis. We will determine whether Medicare paid physicians for hyaluronic acid injections in accordance with Medicare requirements. Food, Drug, and Device Safety; Physician and Healthcare Practitioners; People with Disabilities; Elderly; Medicare B
August 2024 National Institutes of Health Audit of NIH Other Transactions Award Recipients' Costs Office of Audit Services WA-24-0058 (W-00-24-59491) 2025 The National Institutes of Health (NIH) is one of a small number of Federal agencies with authority to fund programs through instruments known as other transactions (OTs). Between 2016 and 2023, NIH awarded more than $5.3 billion in OTs to fund public health initiatives and biomedical research programs. OTs are a more flexible type of award instrument because, among other things, they are not subject to the Federal Acquisition Regulation, the Uniform Guidance, or other regulations. OTs are intentionally flexible to allow for negotiation of terms and conditions for the program being funded. As such, OTs are considered to be higher risk than traditional awards, such as a contract or grant, and should generally only be used when the objectives of a Federally funded project cannot be accomplished under a traditional award. Prior OIG work identified weaknesses in NIH's processes for determining that costs incurred under OT awards were allowable. This audit is part of a series of audits of selected OT recipients. Our objective is to determine whether the NIH OT award recipient claimed costs that were allowable in accordance with the terms and conditions of its NIH OT award. Departmental Operational Issues Financial Stewardship
July 2024 Centers for Medicare and Medicaid Services Medicare Payments for Clinical Diagnostic Laboratory Tests in 2023 Office of Evaluation and Inspections OEI-09-24-00350 2025 Medicare is the largest payer of clinical diagnostic laboratory services in the United States. Medicare Part B covers most lab tests and pays 100 percent of allowable charges without patient cost-sharing obligation. The Protecting Access to Medicare Act of 2014 (PAMA), Pub. L. No. 113-93, requires CMS to set payment rates for lab tests using current charges in the private health care market under Title XVIII of the Social Security Act (PAMA, § 216(a)). On January 1, 2018, CMS began paying for lab tests under a new system mandated by PAMA. PAMA also requires OIG to publicly release an annual analysis of the top 25 laboratory tests by expenditure. (Pub. L. No. 113-93 § 216(c)(2)(A)). In accordance with PAMA, we will publicly release an analysis of the top 25 laboratory tests by expenditure for 2023. COVID-19; Laboratories; Medicare B
July 2024 Centers for Medicare and Medicaid Services State Directed Payments in Medicaid Managed Care Office of Audit Services WA-24-0056 (W-00-24-31580) 2025 As the HHS agency overseeing Medicaid, CMS issued regulations establishing certain circumstances under which States may direct managed-care payments to providers. These payments are referred to as State directed payments. While working within Federal parameters, States determine criteria for providers to receive these directed payments. For selected State directed payments in Medicaid managed care, our objective is to determine whether the State: (1) obtained CMS approval for the directed payment proposal, (2) complied with CMS-approved requirements and outcomes in the approved proposal, and (3) ensured that directed payments were made according to the approved proposal. Managed Care; Medicaid
July 2024 Centers for Medicare and Medicaid Services Medicaid Managed Care Capitation Payments on Behalf of Incarcerated Enrollees Office of Audit Services WA-24-0057 (W-00-24-31581) 2025 States contract with Medicaid managed care organizations to provide specific services to Medicaid enrollees, 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 § 435.1009, and guidance from CMS state that Federal financial participation is generally not available for services provided to adult inmates of public institutions except when the individual 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 incarcerated in State prisons. Managed care; Medicaid
July 2024 Centers for Medicare and Medicaid Services Followup Review of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Provided by Suppliers During Inpatient Stays Office of Audit Services WA-24-0059 (W-00-24-35919) 2025 Overlapping claims can happen when an enrollee receives a durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) item during an inpatient stay at an acute-care hospital. In general, certain items, supplies, and services furnished to inpatients are covered under Medicare Part A and should not be billed separately to Medicare Part B (42 CFR §§§ 409.10; Medicare Claims Processing Manual, Chapter 3 §10.4). Therefore, DMEPOS claims for enrollees who received DMEPOS items during an inpatient stay (excluding admission and discharge dates) in a hospital should not be billed to Medicare Part B, and any Medicare payments made on those claims would be considered overpayments. Prior OIG reviews and investigations have identified this area as at risk for noncompliance with Medicare billing requirements. For this followup audit, we will review Medicare payments to certain types of inpatient hospitals to determine whether claims billed to Part B for certain DMEPOS items provided during inpatient stays were made in accordance with Federal requirements. Additionally, we will review the CMS Common Working File system edits that should deny claims for DMEPOS items furnished during an inpatient stay. Hospitals; Medical Supplies and Equipment; Medicare A
June 2024 Centers for Medicare and Medicaid Services Assessment of the Special Focus Facility Program for Nursing Homes Office of Evaluation and Inspections OEI-01-23-00050;
OEI-01-23-00052
2025 CMS established the Special Focus Facility (SFF) Program to improve care in the poorest performing nursing homes. CMS and State survey agencies conduct increased oversight of nursing homes in the SFF Program by surveying these facilities twice per year, about twice as often as required for other nursing homes. In October 2022, CMS updated the SFF Program to shorten the amount of time that nursing homes spend as an SFF and increase the number of nursing homes that go through the program. This study will evaluate CMS's and State survey agencies' implementation of the SFF Program, including implementation of the October 2022 program updates. In addition, this study will identify factors that have aided graduated SFFs with sustaining quality improvements and will assess the extent to which CMS and States incorporate these factors into the SFF Program. Finally, this study will also provide descriptive information about nursing homes that participated in the SFF Program from 2013 through 2022. Nursing Homes, Nursing Facilities, and Assisted Living Facilities; Elderly; Medicaid; Medicare A
Completed National Institute of Health Review of Institutions of Higher Education Grantees Receiving National Institutes of Health Awards Office of Audit Services W-00-24-59445;
A-04-20-03583
2024 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. Grants; Financial Stewardship
June 2024 Centers for Medicare and Medicaid Services Medicare Payments for Lower Extremity Peripheral Vascular Procedures Office of Audit Services W-00-24-35914 2025 The use of peripheral vascular procedures in an office setting has increased among the Medicare population over the past decade. For CYs 2022 and 2023, Medicare paid approximately $1.16 billion for lower extremity peripheral vascular procedures in office settings. These minimally invasive procedures aim to improve blood flow when arteries narrow or become blocked because of peripheral arterial disease but are generally recommended only after patients have tried medical and exercise therapy and have lifestyle-limiting symptoms. In addition, CMS and whistleblower fraud investigations have identified these procedures as vulnerable to improper payments. We will analyze Medicare fee-for-service for peripheral vascular procedures for questionable characteristics and review the program integrity activities of CMS and its contractors to combat fraud, waste, and abuse specific to these procedures. Additionally, we will assess whether these procedures complied with CMS requirements and met applicable treatment guidelines. Financial Stewardship; Elderly; Medicare B
June 2024 Centers for Medicare and Medicaid Services Medicare Enrollees Leaving Hospitals Against Medical Advice Office of Audit Services W-00-24-35915 2025 Hospitals indicate on a claim that a patient left against medical advice (AMA) with a specific patient discharge status code-"07," which stands for "left against medical advice or discontinued care." According to some academic researchers, the AMA designation indicates a higher risk that a patient experienced poor quality health care. The researchers also note that hospital stays coded with the AMA designation may be associated with increased patient morbidity and mortality percentage rates. In addition, the researchers note that historically medically underserved groups of patients are more likely than other groups to receive the AMA designation. The percentage rates that hospitals have been designating that Medicare enrollees left AMA have increased over the past three decades. This data brief will analyze the percentage rates and outcomes for enrollees that hospitals designate as left AMA as well as provide CMS and other stakeholders with information that can be used to address health disparities and improve enrollee outcomes. Financial Stewardship; Hospitals; Quality of Care; Elderly; Native Americans; Other Minorities; Medicare A
June 2024 Centers for Medicare and Medicaid Services Use of Electronic Visit Verification Data for Medicaid Personal Care Services Office of Evaluation and Inspections OEI-09-24-00290 2026 Section 12006 of the 21st Century Cures Act (Cures Act) requires that States implement and use an Electronic Visit Verification (EVV) system to verify the delivery of Medicaid personal care services. EVV requirements were included in the Cures Act in response to longstanding fraud, waste, and abuse concerns associated with Medicaid personal care services. This evaluation will assess the availability and completeness of EVV data and examine how State Medicaid agencies and others use these data for program integrity purposes. Financial Stewardship; Managed Care; Non-institutional care; Quality of Care; People with Disabilities; Elderly; Medicaid
June 2024 Centers for Medicare and Medicaid Services Durable Medical Equipment Fraud and Safeguards in Medicare Office of Evaluation and Inspections OEI-02-24-00310 2025 Each year, Medicare payments for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) top more than $7 billion in traditional Medicare alone. Although CMS has a number of safeguards in place to prevent bad actors from billing DMEPOS in Medicare, fraudulent billing for DMEPOS continues to be a major concern. Recent cases demonstrate that DMEPOS continues to be a target of fraudulent billing and that new schemes have developed. Our review will provide information about current fraud schemes and the safeguards and monitoring that CMS has to prevent fraud, waste, and abuse. These findings will result in multiple products. The first product will look at billing for DMEPOS in Medicare Advantage, specifically by suppliers that are not enrolled in Medicare fee-for-service. Financial Stewardship; Medical Supplies and Equipment; Managed Care; Elderly; Medicare B
June 2024 Centers for Medicare and Medicaid Services Audit To Determine Whether CMS Oversight of Its Preclusion List Ensured That Certain Revoked Providers Did Not Receive Payment for Medicare Part C and Part D Services Office of Audit Services WA-24-0051 (W-00-24-35916) 2025 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 enrollees. CMS maintains a list known as the Preclusion List that includes excluded providers and other providers who have been or could have been revoked from the Medicare program for conduct that CMS determines is detrimental to the best interest of the Medicare program. Federal regulations prohibit sponsors from making payments for services provided or prescriptions written by providers on the Preclusion List. We will analyze CMS data to identify any revoked providers not included on the Preclusion List; report on why they were not included, as determined by CMS; and point out potential vulnerabilities in not including revoked providers on the Preclusion List. Managed Care; Prescription Drug; Financial Stewardship; Medicare C; Medicare B
June 2024 Centers for Medicare and Medicaid Services Audits of Medicare Part C Supplemental Benefits Office of Audit Services W-00-24-35917 (WA-24-0052) 2025 Under the Medicare Advantage (MA) program, an MA organization can offer supplemental benefits, which are items or services that are not covered by traditional Medicare, to its enrollees. MA organizations must design the supplemental benefits to improve enrollees' health, allow enrollees to manage their chronic conditions, or support enrollees' access to care. Over the past 5 years, the types of supplemental benefits-and payments for them—have grown considerably, and per-person payments from CMS to MA organizations for these benefits have more than doubled. For this series of audits, we will determine whether MA organizations complied with Federal requirements for the supplemental benefits offered to their enrollees. Managed Care; Medicare C
June 2024 Centers for Medicare and Medicaid Services Audit of CMS Contract Closeout Process Office of Audit Services WA-24-0053 (W-00-24-35918) 2025 As one of the largest contracting agencies in the Federal Government, HHS performed contracting actions (i.e., award and modifications) totaling $38.5 billion in FY 2023. CMS was responsible for $7.4 billion, or 19 percent of HHS contracting action spending, in FY 2023. Prior OIG work identified issues with HHS contract closeout processes and procedures that are required after a contracting officer receives evidence of completing a contract. The closeout process: (1) ensures that goods and services are provided as intended, (2) validates final costs and payments, and (3) frees up excess funds for possible use elsewhere. We will determine whether CMS closed contracts according to Federal regulations and HHS policies and procedures. Contracts; Departmental Operational Issues; Financial Issues; Medicare A
June 2024 Centers for Medicare and Medicaid Services Medicare Advantage Organizations' Use of Prior Authorization for Post-Acute Care Office of Evaluation and Inspections OEI 09-24-00330 2026 Medicare Advantage plans must cover at least the same services as original Medicare, but Medicare Advantage Organizations (MAOs) may impose additional administrative requirements, such as requiring prior authorization before certain services can be provided. Prior OIG work found that MAOs sometimes denied prior authorization requests for post-acute care after a qualifying hospital stay even though the requests met Medicare coverage rules. We will examine selected MAOs' processes for reviewing prior authorization requests for post-acute care in long-term acute care hospitals, inpatient rehabilitation facilities, and skilled nursing facilities. We will also review the extent to which the selected MAOs denied requests for post-acute care and examine the care settings to which patients were discharged from the hospital. Managed Care; Nursing Homes, Nursing Facilities, and Assisted Living Facilities; Medicare C
June 2024 Centers for Medicare and Medicaid Services Medicaid Managed Care: CMS's Oversight of Whether States Return the Required Federal Share of Medical Loss Ratio Remittances Office of Evaluation and Inspections OEI-03-23-00041 2025 With its 2016 Medicaid managed care regulations, CMS established medical loss ratios (MLRs) as a policy tool to ensure appropriate stewardship of managed care funds. The Federal MLR is the percentage of premium revenue that a managed care plan spent on covered health care services and quality improvement activities during a 12 month period. Federal MLR regulations allow States to require Medicaid managed care plans to meet a minimum MLR of at least 85 percent. States that set minimum MLRs with remittance requirements for their managed care plans could receive MLR remittance payments if plans fail to achieve at least the State-set minimum MLR. A minimum MLR with a remittance requirement limits financial risks for State and Federal governments. CMS is responsible for ensuring that States return to CMS the required Federal share of any MLR remittance payments that States receive from their plans. Our evaluation will determine whether and how CMS tracked that States returned to CMS the required Federal share of MLR remittances for the 2017-2018 and 2018-2019 MLR reporting periods. Departmental Operational Issues; Financial Stewardship; Managed Care; Medicaid
Completed Health and Human Services Review of Medicare Administrative Contractor Information Security Program Evaluations for FY 2023 (MMA 912) Office of Audit Services WA-24-0032 (W-00-24-42029);
A-01-24-00001
2023 The President signed into law the Geospatial Data Act of 2018 (GDA) as P.L. No. 115-254 on October 5, 2018. GDA fosters efficient management of geospatial data, technologies, and infrastructure through enhanced coordination among Federal, State, local, and Tribal Governments, the private sector, and academia. GDA establishes responsibilities and reporting requirements for covered agencies. Additionally, GDA requires the inspector general of each executive department (or the senior ethics official of each executive department without an inspector general) to submit to Congress not less than once every 2 years an audit of the collection, production, acquisition, maintenance, distribution, use, and preservation of geospatial data by Federal agencies.

The purpose of this audit is to determine the Department of Health and Human Services' progress toward compliance with GDA.

May 2024 Office of the Secretary Audit of FY 2024 HHS Consolidated Financial Statements Office of Audit Services WA-24-0042 (W-00-24-40009; W-00-24-40012) 2025 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 24-01, "Audit Requirements for Federal Financial Statements." The audited consolidated FY 2024 financial statements for HHS are due to OMB by November 15, 2024. We plan to perform a number of ancillary financial-related reviews pertaining to the audit of the FY 2024 financial statements. The purpose of the ancillary financial-related reviews is to fulfill requirements in OMB Bulletin 24-01, §§ 6.1 through 12. Financial Stewardship; Other Funding
May 2024 Centers for Medicare and Medicaid Services Nationwide Audits of Organ Procurement Organizations and Certified Transplant Centers Office of Audit Services WA-24-0043 (W-00-24-35913) 2025 Organ Procurement Organizations (OPOs) are not-for-profit organizations that perform or coordinate the procurement, preservation, and transportation of organs to hospitals for transplantation into patients who are on a waiting list to receive a transplant. Certified Transplant Centers (CTCs) are components within transplant hospitals that provide transplantation of particular types of organs. CTCs are reimbursed by Medicare for certain costs associated with the acquisition of organs from OPOs or other CTCs for transplants involving Medicare patients. Federal regulations (42 CFR part 486, subpart G) include Medicare conditions for coverage for OPOs, and other Federal statutes, regulations, and guidance specify Medicare requirements for the acquisition of organs. Prior OIG audits determined that OPOs did not comply with Medicare requirements for reporting overhead costs, administrative and general costs, and organ statistics. We will determine whether costs reported by OPOs and CTCs were allowable, reasonable, and according to Medicare requirements, and whether OPOs met required process performance and outcome measures. Financial Stewardship, Hospitals, Public Health Issues, Quality of Care, People with Disabilities, Elderly, Medicare A
May 2024 HHS, OS HHS's Compliance With Federal Regulations Related to Operating Systems and Software Beyond End of Life Office of Audit Services W-00-23-42044 2024 Operating systems, software, and applications that are no longer supported by their respective vendors and/or providers present risks to HHS and Operating Division (OpDiv) networks. Threat actors may exploit a known vulnerability in unsupported software, which could lead to a detrimental result including but not limited to data exfiltration (e.g., loss of personal identifiable information), data destruction, compromised intellectual property, and/or reputational harm. We will determine whether HHS and select OpDivs are in compliance with Federal requirements on the usage of unsupported software. In addition, we will determine whether HHS has effective oversight and mitigation controls in place to ensure that unsupported assets do not place HHS mission-critical systems and data at risk. Departmental Operational Issues, Information Technology and Cybersecurity, Other Funding
May 2024 Centers for Medicare and Medicaid Services Puerto Rico Medicaid Contracting and Procurement Oversight Office of Audit Services WA-24-0006 (W-00-24-31573) 2025 The Puerto Rico Medicaid program is a 100-percent managed-care program that provides health services to more than 1 million enrollees. In December 2022, Congress provided the Commonwealth of Puerto Rico additional funding for the program under the Consolidated Appropriations Act, 2023, until FY 2027. The law requires OIG to submit to Congress a report on whether Puerto Rico complied with the law's Medicaid contracting and procurement oversight requirements. We will determine whether Puerto Rico: (1) complied with applicable provisions of the Consolidated Appropriations Act, 2023; and (2) designed, implemented, and effectively operated an internal controls system for Medicaid contracts covered by this law in compliance with Federal procurement standards. Contracts, Financial Stewardship, Medicaid
May 2024 Administration for Children and Families Unaccompanied Children Placed in Foster Care Office of Evaluation and Inspections OEI-07-24-00320 2025 The Administration for Children and Families Office of Refugee Resettlement (ORR) operates the Unaccompanied Children Program to provide care and placement for children without lawful immigration status who do not have a parent or guardian in the United States who can assume custody. In some cases, ORR places unaccompanied children into foster care-these children remain in the custody of ORR, but the foster care families and providers are generally State-licensed. We will evaluate ORR's use of foster care for unaccompanied children and the ways in which it intersects with State foster care programs. Dependent Care, Children and Families, Grants
Completed Centers for Disease Control and Prevention and Substance Abuse and Mental Health Services Administration Audit of the Office of National Drug Control Program Performance Measurements and Targets Reported for the FY 2023 Annual Drug Control Assessment Office of Audit Services WA-24-0047 (W-00-24-59490);
A-03-24-00353
2025 The Office of National Drug Control Policy (ONDCP) leads and coordinates the Nation's drug policy to improve the health and lives of the American people. ONDCP is responsible for the development and implementation of the National Drug Control Strategy and Budget (Strategy). ONDCP coordinates across 19 Federal agencies and oversees a $41 billion budget as part of a whole-of-government approach to addressing substance use disorder and the overdose epidemic. ONDCP evaluates the effectiveness of national drug control policy efforts, the Strategy's goals and objectives, and each National Drug Control Program agency's program-level measures.

In the Federal agencies' fiscal year 2023 data reported to ONDCP, the Department of Health and Human Services' agencies reported on programs aiming to reduce overdose deaths; however, some of the related performance measures were submitted without conclusive data. We will review the Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration performance measures and targets to determine how they were developed and reported and whether the agencies encountered challenges implementing them.
Departmental Operational Issuess, Public Health Issues, Substance Abuse Disorders
May 2024 Office of the Secretary Audit of FY 2024 CMS Financial Statements Office of Audit Services WA-24-0018 (W-00-24-40008) 2025 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 24-01, "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. Departmental Operational Issuess, Public Health Issues, Substance Abuse Disorders
April 2024 Centers for Medicare and Medicaid Services Medicaid Nursing Facility Supplemental Payments Office of Audit Services WA-24-0038 (W-00-24-31579) 2025 CMS has approved Medicaid nursing facility upper payment limit (UPL) supplemental payment programs in several States. In these States, nursing facilities may be eligible for supplemental payments that, when combined with a base payment, may not exceed a reasonable estimate of the amount that Medicare would pay for the services. Under the UPL supplemental payment programs, a State may use a variety of financing mechanisms to fund that State's share of supplemental payments. We will determine whether payments States claimed under their Medicaid supplemental payment programs complied with Federal and State requirements, and describe how those payments were distributed and used. Financial Stewardship, Nursing Homes, Nursing Facilities, and Assisted Living Facilities, Quality of Care, Elderly, Medicaid
April 2024 Centers for Medicare and Medicaid Services Audit of Vertically Integrated Medicare Part D Sponsors Office of Audit Services WA-24-0037 (W-00-24-35912) 2026 CMS oversees prescription drug coverage for Medicare Part D enrollees. CMS contracts with health insurers, known as plan sponsors, who are responsible for delivering the benefit through a network of pharmacy providers. Under Part D, sponsors often contract with pharmacy benefit managers (PBMs) to manage or administer the drug benefit on a sponsor's behalf. PBM services may include contracting with pharmacies to establish pharmacy networks and negotiate pharmacy reimbursement rates.

In recent years, the pharmaceutical market has experienced a wave of vertical integration between PBMs, health insurers, and pharmacies. Concern has been raised about the vertically integrated model. One such concern is that, by owning many links in the chain, a vertically integrated Medicare Part D sponsor may inflate drug prices. We will determine the impact of related entity transactions within select vertically integrated entities on the prices for covered Part D drugs.
Financial Stewardship, Prescription Drug, Medicare D
April 2024 Administration for Children and Families Audit of the Office of Refugee Resettlement's Monitoring of Compliance With Employee Background Check Requirements for Unaccompanied Children Program Care Providers That Are No Longer State Licensed Office of Audit Services WA-24-0041 (W-00-24-20041) 2025 The Office of Refugee Resettlement (ORR), a program office of the Administration for Children and Families within HHS, manages the Unaccompanied Children Program. To help safeguard children in the Unaccompanied Children Program, Federal regulations and ORR policy require all care providers to conduct background investigations on all employees and contractors who may have contact with children in ORR care prior to hiring them and permitting access to the children. The care providers are generally licensed under the laws of their respective State and are monitored by State licensing agencies to ensure compliance with standards of care. Some ORR-funded care providers operate in States that no longer license or perform oversight of the facilities. We plan to determine whether ORR monitored unlicensed facilities' compliance with its background check requirements. Specifically, we will determine whether the FBI fingerprint checks of national and State registries occurred for employees at unlicensed ORR-funded facilities. Quality of Care, Children and Families, Grants
Completed Centers for Medicare and Medicaid Services Ensuring Dual-Eligible Enrollees' Access to Drugs Under Part D: Mandatory Review Office of Evaluation and Inspections OEI-05-24-00210 2024 Dual-eligible enrollees-that is, people enrolled in both Medicaid and Medicare-receive prescription drug coverage under Medicare Part D. As long as Part D plans meet certain limitations outlined in 42 CFR § 423.120, Part D sponsors have discretion to include different Part D drugs in their formularies. As required under section 3313 of the Patient Protection and Affordable Care Act, we will conduct an annual study of the extent to which formularies used by Part D plans include drugs commonly used by dual-eligible enrollees. This study will focus on Part D plans' 2024 formularies. Prescription Drug, Medicare D
April 2024 Centers for Medicare and Medicaid Services Utilization of Peripheral Vascular Procedures and CMS's Related Program Integrity Efforts Office of Evaluation and Inspections OEI-01-24-00250 2025 The use of peripheral vascular procedures in the Medicare population has increased over the past decade. In 2022, Medicare paid more than $600 million for atherectomies and angioplasties with and without a stent in peripheral arteries. These minimally invasive surgeries aim to improve blood flow when arteries narrow or become blocked because of peripheral arterial disease but are recommended only after patients have tried medical and exercise therapy, and have lifestyle-limiting symptoms. In addition, CMS and whistleblower fraud investigations have identified these surgeries as vulnerable to improper payments. This work will determine trends in Medicare fee-for-service for surgeries in peripheral arteries over several years and identify paid claims that exhibit questionable characteristics. We will also describe the program integrity activities that CMS and its contractors have taken to combat fraud, waste, and abuse specific to procedures in peripheral arteries. Financial Stewardship, Physician and Healthcare Practitioners, Quality of Care
March 2024 Centers for Medicare and Medicaid Services Assessing the Accuracy of Nursing Home Falls Reporting in MDS Assessments Office of Evaluation and Inspections OEI-05-24-00180;
OEI-05-24-00181
2025 In the Medicare and Medicaid programs, when a nursing home resident experiences a fall, the nursing home is required to report that fall, and the severity of any resulting injury, in a patient assessment. CMS then uses this information to determine, for each Medicare-certified nursing home, the percentage of residents experiencing falls resulting in major injury. This percentage is posted on CMS's Care Compare website to give consumers information about the relative performance of each nursing home. In this study, we will assess the accuracy of the patient assessment data used to calculate nursing home falls rates. Specifically, we will identify hospitalizations due to falls with major injury among Medicare enrollees receiving nursing home care using Medicare claims. In the first study, we will assess the extent to which those falls were reported by nursing homes in patient assessments. We will examine the characteristics of the people who did not have their falls reported. Finally, we will examine the characteristics of nursing homes that did not report falls among their residents. In the second product, we will provide additional details about the falls with major injury and hospitalization that we identify, which could include the amount of time spent in the hospital, the cost of the hospital stays to the Medicare program and enrollees, and outcomes. Nursing Homes, Nursing Facilities, and Assisted Living Facilities, People with Disabilities, Elderly, Medicare A, Medicare C, Medicaid
March 2024 Centers for Medicare and Medicaid Services, Centers for Disease Control and Prevention Medicare Inpatient Hospital Billing for Sepsis Office of Evaluation and Inspections OEI-02-24-00230 2025 Sepsis is the body's extreme response to an infection. It is a life-threatening, emergency medical issue that often progresses quickly and responds best to early intervention. The definition of and guidance for sepsis have changed over the years in attempts to identify it more accurately. The definition of sepsis was updated in 2016 by an international task force to better differentiate sepsis from a general infection. This narrower definition is widely recognized by groups such as the World Health Organization. However, CMS and CDC currently recognize an older, broader definition. Sepsis is a frequently billed diagnosis in Medicare. There are concerns that hospitals may be taking advantage of this broader definition, as they have a financial incentive to do so. This study will analyze Medicare claims to assess patterns in the inpatient hospital billing of sepsis in 2023 and describe how the billing of sepsis varied among hospitals. We will also estimate the costs to Medicare associated with using the broader, rather than the narrower, definition of sepsis. Financial Stewardship, Hospitals, Elderly, Medicare A
Completed Administration for Community Living, Administration on Aging 2023 Performance Data for Senior Medicare Patrol Projects Office of Evaluation and Inspections OEI-02-24-00260 2024 In 1997, Senior Medicare Patrol (SMP) projects were established to recruit and train retired professionals and other volunteers to prevent, recognize, and report health care fraud, errors, and abuse. The initiative, which stemmed from recommendations in a congressional committee report accompanying the Omnibus Consolidated Appropriations Act of 1997, continues today. OIG reports SMP performance data annually. We will review performance data and documentation relating to Medicare and Medicaid recoveries, savings, and cost avoidance for SMP projects. The Administration for Community Living requested this information, which will support its efforts to evaluate and improve the performance of its projects. Quality of Care, Elderly
March 2024 Centers for Medicare and Medicaid Services Effects of Vertical Integration on Medicare Part D Office of Evaluation and Inspections OEI-BL-24-00240 2025 Approximately three-quarters of Medicare Part D enrollees receive their prescription drug benefits through plans offered by five large companies. These large plan sponsors are vertically integrated operations affiliated with their own pharmacy benefit managers and, in many cases, their own mail-order and specialty pharmacies. Congress, the Medicare Payment Advisory Commission, and the media have raised concerns that vertical integration leads to higher prescription drug costs. This study will use existing pricing, payment, and rebate data to provide broader insight into the effect of vertical integration on Part D costs for both the Medicare program and its enrollees. Financial Stewardship, Prescription Drug, Elderly, Medicare D
March 2024 Agency for Healthcare Research and Quality Patient Safety Organizations: Key Insights, Challenges, and Opportunities Office of Evaluation and Inspections OEI-01-24-00150 2025 Despite nationwide efforts to improve patient safety, patient harm events in hospitals remain a serious concern. The Patient Safety Organization (PSO) program, authorized by the Patient Safety and Quality Improvement Act of 2005, is the flagship Federal program to facilitate patient harm reporting and learning on a national scale. However, in the years since the PSO program was created, OIG work has found consistently high patient harm rates in hospitals and a lack of hospital identification of these events, which are areas that the PSO program was designed to address. OIG work has also found that, although many hospitals find value in PSOs, hospitals find it challenging to navigate the legal protections that surround their work with PSOs. This study will build on previous OIG work by determining the extent to which hospitals participate in the PSO program nationwide and identifying the program's successes and challenges. We will also identify opportunities for the PSO program to mitigate these challenges and leverage new strategies to improve patient safety. Food, Drug, and Device Safety, Hospitals, Quality of Care, Other Funding
Cancelled Centers for Medicare and Medicaid Services Audit of Nursing Facility Drug Overdoses Office of Audit Services WA-24-0030 (W-00-24-31578) 2025 Drug abuse and overdose deaths are at epidemic levels in the United States. According to the Centers for Disease Control and Prevention, more than 1 million Americans died from an overdose during 1999-2021, with 80,000 of those deaths occurring in 2021. People who have had at least one overdose are more likely to have another. For every drug overdose that results in death, there are many more nonfatal overdoses, each one with its own emotional and economic toll. We will determine whether selected nursing facilities complied with quality-of-care requirements and reported, investigated, and implemented corrective actions for potential illegal drug usage and significant pain medication errors involving opioid overdoses. Nursing Homes, Nursing Facilities, and Assisted Living Facilities, Quality of Care, People with Disabilities, Medicare A, Medicaid
March 2024 Centers for Medicare and Medicaid Services Audit of Diabetes Drugs Under Medicare Part D Office of Audit Services WA-24-0035 (W-00-24-35910) 2025 In 2022, six type 2 diabetes drugs accounted for more than half of all Medicare Part D payments for diabetes drugs. Diabetes drugs are meant to lower blood sugar levels and often result in weight loss. Part D spending for one of these six drugs, Ozempic, more than tripled between 2020 and 2022, with expenditures jumping from $1.5 billion to $4.6 billion. Other diabetes drugs are experiencing similar growth and could overshadow Ozempic. Part D payments for a type 2 diabetes drug, such as Ozempic, for a use that Medicare does not cover as a medically accepted indication is not in compliance with Medicare requirements and presents an opportunity for fraudulent, excessive, or unnecessary Part D payments. Furthermore, drugs that are used for weight loss are specifically excluded from Medicare Part D coverage. We will obtain Part D data for prescribed diabetes drugs and any related Part B service claims. We will determine whether they were billed according to Medicare requirements. Departmental Operational Issues, Food, Drug, and Device Safety, Prescription Drug, Public Health Issues, Medicare D
March 2024 Centers for Medicare and Medicaid Services Audit of Medicaid Select Diabetes and Weight Loss Drugs Office of Audit Services WA-24-0036 (W-00-24-35911) 2025 Medicaid utilization of and gross spending on select diabetes and weight loss drugs have rapidly increased in recent years. The select diabetes drugs were approved to help control blood sugar levels for individuals with type 2 diabetes; however, these drugs are known to be used for weight loss. Most States cover these drugs to treat Medicaid enrollees with diabetes. Additionally, some States cover similar types of drugs that were approved for weight loss. We will identify national Medicaid utilization for select diabetes and weight loss drugs and select one or more States to review. Departmental Operational Issues, Food, Drug, and Device Safety, Prescription Drug, Public Health Issues, Medicaid
Completed Centers for Medicare and Medicaid Services OIG Oversight of Medicaid Fraud Control Units Office of Evaluation and Inspections OEI-09-23-00230;
OEI-07-23-00240;
OEI-03-24-00070;
OEI-09-24-00200;
2025 The 53 Medicaid Fraud Control Units (MFCUs)-located in the 50 States, the District of Columbia, Puerto Rico, and the Virgin Islands-investigate and prosecute Medicaid provider fraud as well as complaints of abuse or neglect in health care facilities, board and care facilities, and of Medicaid beneficiaries in noninstitutional or other settings. OIG provides oversight for MFCUs and administers a Federal grant award to fund a portion of each MFCU's operational costs. OIG, in exercising oversight for MFCUs, annually recertifies each MFCU and assesses each MFCU's performance and compliance with Federal requirements. OIG also provides technical assistance and training, and identifies effective practices in MFCU management and operations. We will perform onsite reviews of a sample of MFCUs. We will also issue an annual report that will analyze the statistical information that was reported by MFCUs, describing in the aggregate the outcomes of MFCU criminal and civil cases. The report will also identify trends in MFCU case results. OIG Statutory Authority and Regulatory Matters, Medicaid
February 2024 OS Audit of HHS Program Support Center's Process for Disbursing Grant Payments Office of Audit Services WA-24-0033 (W-00-24-42046) 2025 The Department of Health and Human Services' (HHS's) Program Support Center (PSC) administers one of the most widely utilized grants payment systems in the Federal government. Payment Management Services, a component of PSC, provides grant and grant-like payments, cash management, and grant accounting support services to HHS and other Federal departments and agencies. Payment Management Services is responsible for the development, operation, and maintenance of the Payment Management System (PMS) and processes more than 70% of civilian grant payments made by the Federal government. The PMS expedites the flow of grant payments between the Federal government and grant recipients, provides grant recipient payment and expenditure data to awarding agencies, and helps manage cash advances to grant recipients. With significant surges in attacks against governmental systems including e-mail phishing campaigns, it is essential that effective controls are established to prevent fraud and protect personally identifiable information (PII) from unauthorized access. OIG will gather information and conduct reviews of PSC and Payment Management Services relevant policies, procedures, and cybersecurity controls to determine whether the PMS was designed and operating with effective controls. Information Technology and Cybersecurity, Grants
Completed Centers for Medicare and Medicaid Services National Background Check Program for Long-Term Care Providers: A Final Assessment Office of Evaluation and Inspections OEI-07-24-00100 2025 The National Background Check Program (NBCP) provides grants to States to develop programs for conducting background checks of prospective long-term care provider employees. NBCP was launched through legislation enacted in 2010 and included a mandate for OIG to produce an evaluation of NBCP within 180 days of the program's completion. This report will be the final report in a series to fulfill this mandate. When NBCP ends, we will determine the extent to which States conducted background checks during and after program participation. We will determine the cost of conducting background checks, the number of applicants who received a background check, and those who were disqualified from employment during and after NBCP participation. Additionally, we will determine whether States experienced unintended consequences, the program's impact on reducing the number of incidents of neglect, abuse, and misappropriation of resident property, and the long-term impact of the program. Nursing Homes, Nursing Facilities, and Assisted Living Facilities, Elderly, Grants
February 2024 Health and Human Services / Office of the Secretary Audit of NIH's Oversight of the All of Us Research Program Award Recipients Office of Audit Services W-00-24-42045 2025 The National Institutes of Health (NIH) is the primary Federal agency for conducting and supporting biomedical research. The All of Us Research Program (AoURP) is a major component of the Precision Medicine Initiative overseen by the NIH. The AoURP is responsible for building a national research cohort of more than 1 million participants who provide their personal health information to NIH so that researchers, providers, and patients can work together to build a better future for health care. Without appropriate security and privacy controls to protect AoURP data, the AoURP and its award recipients cannot effectively minimize information security and cybersecurity risks to an acceptable level.

The purpose of this audit is to determine whether the AoURP's award recipients: (1) limit program research data access, (2) implement information security and privacy controls, and (3) remediate information security and privacy weaknesses in accordance with Federal requirements.
Information Technology and Cybersecurity, Other Funding
January 2024 Centers for Medicare and Medicaid Services Optometrists Billing for Part B Services for Medicare Enrollees in Nursing Facilities Office of Audit Services WA-24-0026 (W-00-24-35909) 2025 Medicare Part B covers many medical services (e.g., optometry services, mobile x rays, and psychological therapy) provided to enrollees, including those residing in nursing facilities (NFs). NFs are required to provide services necessary to ensure their residents attain or maintain sound health. Sometimes, an NF does not have the staff to meet residents' needs and arranges for services to be furnished by outside resources. Some of these services are provided by optometrists who, like many other providers, often visit NFs. Their on-site services include following up on cataract surgeries, treating dry or itchy eyes, and providing annual eye exams because transportation to and from an NF might be difficult for some enrollees. Opportunities for fraudulent, excessive, or unnecessary Part B billing exist because an NF may not be aware of the services for which a provider is billing when submitting a claim to Medicare. We will identify line items billed by optometrists for services performed in an NF. We will review medical records to determine whether the services were appropriately documented and billed according to Medicare requirements. Nursing Homes, Nursing Facilities, and Assisted Living Facilities, Elderly, Medicare B
January 2024 Centers for Medicare and Medicaid Services Audit of Medicaid's Hospice Inpatient and Aggregate Cap Calculations Office of Audit Services WA-24-0025 (W-00-24-31577) 2025 Under Medicare, CMS requires two annual limits to ensure that hospice care does not exceed the cost of conventional medical care at the end of life: the inpatient cap and the aggregate cap. Under Medicaid, however, CMS only requires States to calculate the hospice inpatient cap, and calculating the aggregate cap is optional for each State. If a State applies the hospice caps, any amount paid to a hospice for its claims in excess of each cap is considered an overpayment and must be repaid to Medicaid. We will audit selected States to determine whether the hospice caps were calculated correctly, whether cap overpayments were collected, and whether the Federal share of the collected cap overpayments was properly refunded. Financial Stewardship, Medicaid
January 2024 Centers for Medicare and Medicaid Services Audit of CMS Oversight of States' Use of Third-Party Contractors To Conduct Nursing Home Surveys Office of Audit Services WA-24-0024 (W-00-24-31576) 2025 Prior OIG reviews of nursing homes have identified multiple issues related to the backlog of required nursing home surveys conducted by State survey agencies. To combat this backlog, State survey agencies have increasingly used third-party contractors to conduct surveys. CMS may also rely on these same third-party contractors to conduct comparative surveys to ensure that States meet Section 1864 requirements. We will review this area to determine whether CMS provides adequate oversight of States' use of third-party contractors to conduct nursing home surveys in accordance with Federal requirements. Contracts, Nursing Homes, Nursing Facilities, and Assisted Living Facilities, Quality of Care, Elderly, Medicaid
January 2024 National Institutes of Health NIH's Use and Oversight of Its Other Transaction Authority Office of Evaluation and Inspections OEI-04-24-00140 2025 The National Institutes of Health (NIH) is one of very few Federal entities with the authority to award Other Transactions (OTs). OTs are, by definition, awards other than procurement contracts, cooperative agreements, or grants. OTs are intentionally flexible and are generally not subject to the Federal Acquisition Regulation, the Uniform Guidance, or other regulations, unless otherwise noted in the terms and conditions of the OT award. As such, OTs are higher risk than traditional awards and should generally only be used when the objectives of a federally funded project cannot be accomplished under a traditional award, such as a contract or grant. This study will analyze NIH's use of OTs and determine the extent to which NIH is documenting required and encouraged parts of OTs. Additionally, we will determine what mechanisms NIH uses to oversee funds awarded through OTs to help ensure the effective stewardship of NIH funds. Financial Stewardship, Other Funding
January 2024 Centers for Medicare and Medicaid Services Evaluating Availability of Maternal Health Care Providers in Medicaid Managed Care Office of Evaluation and Inspections OEI-05-24-00090 2025 Pregnant people in the United States experience worse pregnancy outcomes than people in any other high-income country, and significant racial and geographic disparities exist. Maternal health care can improve pregnancy outcomes; however, many pregnant people in the United States lack access to maternal health care. Medicaid is the Nation's largest maternal health care payor, financing more than 40 percent of all U.S. births, and many pregnant people enrolled in Medicaid are enrolled in managed care plans. This study will use encounter data to evaluate the availability of maternal health care providers to people enrolled in Medicaid managed care. Managed Care, Physician and Healthcare Practitioners, Children and Families, Other Minorities, Medicaid
January 2024 Office of the Secretary HHS Compliance with the Payment Integrity Information Act of 2019 Office of Audit Services W-00-24-40037 2025 The Payment Integrity Information Act of 2019 (PIIA) 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 PIAA and OMB Circular A-123, Appendix C, Requirements for Payment Integrity Improvement, OIG will review HHS compliance with PIAA 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. Financial Stewardship, Other Funding
January 2024 Health and Human Services Audit of Department of Health and Human Services Hybrid Work Environment Office of Audit Services WA-24-0027 (W-00-24-59489) 2025 Hybrid work is a flexible work model that supports a blend of onsite work, telework, remote work, mobile work, and/or dispersed teams. Under the Office of Personnel Management (OPM) guidelines, Federal agencies have discretion to define the types of arrangements and parameters for participation within hybrid work policies and agreements. In exercising this discretion, OPM, in its most recent guidance dated November 2021, directs agencies to consider individual employee needs and preferences as long as hybrid work does not diminish employee performance or agency operations. OPM has reported an increase in the percentage of Department of Health and Human Services (HHS) -eligible employees teleworking since December 2010, when the Telework Enhancement Act was enacted. In addition, increased telework flexibilities were granted in response to the pandemic beginning in March 2020, leading to more employees teleworking. There has been congressional and public interest in hybrid work policies within the Federal workforce to ensure that a hybrid work environment does not impede or impair management of the Federal workforce and that taxpayer money is properly spent. Our objective is to describe HHS's hybrid workforce environment since the expiration of the COVID-19 public health emergency (PHE). Furthermore, as part of this audit we will include an analysis of HHS policies and procedures for its hybrid workforce before, during, and after the PHE. Departmental Operational Issues, Other Funding
December 2023 Centers for Medicare and Medicaid Services Audit of Medicare Payments for Emergency Department Services Provided in Nonemergency Department Sites of Service Office of Audit Services WA-23-0041 (W-00-23-35904) 2025 An emergency department is defined as an organized hospital-based facility for the provision of unscheduled or episodic services to patients who present for immediate medical attention. Certain Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes should be used only if a Medicare enrollee is seen in the emergency department and the services described by the codes' definitions are provided. Medicare reimburses providers based on the patient's documented service needs at the time of the visit and based on the site of service. This audit will determine whether Medicare appropriately paid hospitals and physicians for emergency department services provided in nonemergency department sites of service. Financial Stewardship, Hospitals, Physician and Healthcare Practitioners, Medicare B
December 2023 Centers for Medicare and Medicaid Services Audits of Pharmacy Support for Prescription Drug Event Data Office of Audit Services WA-24-0014 (W-00-24-35907) 2025 Medicare Part D plan sponsors must submit prescription drug event (PDE) records, which are summary records of pharmacy drug claims, for the Secretary of Health and Human Services to determine payments to the plans (SSA § 1860D-15(f)(1)). For selected pharmacies, we will determine whether PDE records were adequately supported by inventory purchases and complied with applicable Federal requirements. Prescription Drug, Medicaid, Medicare D
December 2023 Indian Health Service Audit of Tribal Controls Over Indian Health Service Sanitation Facilities Construction Program Costs Office of Audit Services WA-24-0012 (W-00-24-59487) 2025 Under the Infrastructure Investment and Jobs Act, Congress allocated $3.5 billion to the Indian Health Service (IHS) Sanitation Facilities Construction (SFC) Program to provide American Indian and Alaska Native homes and communities with essential water supply, sewage disposal, and solid waste disposal facilities. We plan to perform a series of audits that will examine internal controls in place over SFC program construction projects that are managed by an agreement between IHS and a Tribe, or managed by a Tribe that has assumed sole responsibility for a project. For each audit, our objective will be to determine whether IHS Area Offices or Tribes implemented internal controls for awarding, monitoring, and reporting SFC program projects according to applicable Federal and Tribal requirements. Contracts, Departmental Operational Issues, Financial Stewardship, Public Health Issues, Native Americans, Grants
December 2023 Administration for Strategic Preparedness and Response Audits of Strategic National Stockpile Sites Office of Audit Services WA-24-0022 (W-00-24-59488);
SRS-A-25-001;
A-04-24-02044;
A-04-24-02046
2025 The Strategic National Stockpile (SNS) is a repository of medical countermeasures for use during public health emergencies. Prior OIG audits identified systemic issues that could place the SNS inventory at risk. In 2018, oversight of the SNS was transferred from the Centers for Disease Control and Prevention to the Administration for Strategic Preparedness and Response (ASPR). We plan to conduct a series of audits to determine whether ASPR established adequate controls for maintaining: (1) physical security over SNS sites and (2) records of inventory. Departmental Operational Issues, Emergency Preparedness and Response, Public Health Issues, Other Funding
December 2023 Food and Drug Administration Food and Drug Administration's Oversight of the Submission of Applicable Clinical Trial Results to ClinicalTrials.gov Office of Audit Services WA-24-0005 (W-00-24-59485) 2025 The Food and Drug Administration (FDA) is responsible for ensuring that results of applicable clinical trials are reported to ClinicalTrials.gov within 1 year of the completion date. Clinical trials are vital to human medical advances because they help determine whether interventions are safe and effective, and it is essential to have transparency with the public about clinical trial results. FDA monitors compliance with reporting requirements through various methods, including evidence collected during inspections conducted as part of FDA's Bioresearch Monitoring Program. FDA may notify a responsible party that has not met reporting requirements and allow 30 days to remedy the noncompliance. If a responsible party remains noncompliant, FDA may initiate a corrective action, including seeking civil monetary penalties. We will conduct an audit to determine whether FDA notified responsible parties of noncompliance with the requirement to submit the results of applicable clinical trials in accordance with Federal requirements. Food, Drug, and Device Safety, Other Funding
December 2023 Centers for Medicare and Medicaid Services Medicare Payments for Home Dialysis Services Office of Audit Services WA-24-0016 (W-00-24-35908) 2025 Medicare Part B covers outpatient dialysis services for enrollees diagnosed with end-stage renal disease (ESRD). Treatments can be provided in an outpatient or home setting and must be monitored by certified ESRD facilities. Prior OIG work identified inappropriate Medicare payments for dialysis services. Specifically, OIG identified claims for which there were neither dialysis treatment notes for home dialysis sessions nor documentation of the dispensing or administration of medication billed. Additionally, OIG found claims with medication billed exceeding a physician-prescribed amount, as well as other issues with comprehensive assessments, plans of care, and physicians' monthly progress notes. We will review claims for Medicare Part B home dialysis services provided to ESRD patients to determine whether such services complied with Medicare requirements. Also, we will review the impact of home dialysis services on enrollees and whether enrollees' quality of care could be affected. Financial Stewardship, Quality of Care, Elderly, Medicare B
Completed Centers for Medicare and Medicaid Services Medicare Advantage Payments Generated by Health Risk Assessments for 2023 Office of Evaluation and Inspections OEI-03-23-00380 2025 Health risk assessments (HRAs) are conducted by physicians or other health care professionals to collect information about patients' health status, health risks, and daily activities. Prior OIG work has highlighted concerns about the extent to which Medicare Advantage Organizations (MAOs) use HRAs to improve care, as intended, and the sufficiency of oversight by CMS. This prior work found that diagnoses that MAOs reported only on HRAs-and on no other service records that year-resulted in an estimated $2.6 billion in risk-adjusted payments for 2017. OIG's findings raised concerns about the quality and coordination of care for enrollees, the validity of diagnoses reported on HRAs, and the appropriateness of payments generated by HRAs for 2017. For this data snapshot, we will determine the extent to which diagnoses reported only on HRAs (or added to HRAs by chart reviews) generated estimated riskadjusted payments for 2023. We also will determine whether enrollees with certain demographic characteristics were overrepresented among the enrollees who had diagnoses reported only on HRAs (or added to HRAs by chart reviews) that generated payments. Finally, we will interview CMS to identify the actions it has taken to address the impact of HRAs on Medicare Advantage payment integrity and quality of care. Departmental Operational Issues, Financial Stewardship, Managed Care, Quality of Care, Elderly, Other Minorities, Medicare C
November 2023 Centers for Medicare and Medicaid Services Medicare Payments Compared to the Prices Available to Consumers and Suppliers for Continuous Glucose Monitors and Sensors Office of Evaluation and Inspections OEI-04-23-00430 2025 We will compare Medicare payments to suppliers' acquisition costs and prices otherwise available to consumers for selected continuous glucose monitors (CGMs) and their sensors to determine if there are potential cost savings for Medicare and enrollees. In 2022, Medicare Part B allowed more than $1.1 billion in payments for CGMs and sensors. If we find that Medicare payments for CGMs greatly exceed their acquisition costs, then CMS has authority to adjust payment rates for CGMs and sensors through two methods: CMS can adjust the fee schedule prices using its inherent reasonableness authority, or it can introduce an item into the Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program. Medical Supplies and Equipment, Medicare B
November 2023 Administration for Children and Families Assessing the Alaska Foster Care Agency's Compliance, Challenges, and Successes When American Indian and Alaska Native Children Go Missing From Care Office of Evaluation and Inspections OEI-07-23-00480 2025 American Indian and Alaska Native (AI/AN) children are disproportionately represented among missing children and are more likely to go missing from a foster care placement than any other location. When children go missing from foster care, they may experience serious negative consequences, including a heightened risk of human trafficking, as well as poorer outcomes related to health, safety, education, employment, and subsequent criminal justice system involvement. For AI/AN children who went missing from Alaska's foster care system (Alaska), this evaluation will review foster care case files and related documentation to determine whether Alaska complied with Federal and State rules before, during, and after the children went missing from care (e.g., attempted to locate the children while they were missing, provided children with services after they returned to care). This study will also examine whether Alaska involved children's Tribes throughout this process and attempt to gain perspectives from both the State and the Tribes about challenges and successes in these cases. Mental Health, Public Health Issues, Children and Families, Native Americans, Other Funding
Completed Centers for Medicare and Medicaid Services Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the First Quarter 2024 Office of Evaluation and Inspections OEI-03-24-00070 2024 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. Section 1847A(d)(1)-(3) of the Social Security Act mandates that the Office of Inspector General (OIG) compare ASPs with average manufacturer prices (AMPs) and the widely available market price, if any. If OIG finds that the ASP for a drug exceeded the AMP by 5 percent in the two previous quarters or three of the previous four quarters, the Secretary of Health and Human Services may substitute the reimbursement amount with a lower calculated rate. This quarterly memo summarizes the results of OIG's comparison analysis based on ASP and AMP data reported for the first quarter 2024. 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
Completed Centers for Medicare and Medicaid Services Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Fourth Quarter 2023 Office of Evaluation and Inspections OEI-03-24-00060 2024 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. Section 1847A(d)(1)-(3) of the Social Security Act mandates that the Office of Inspector General (OIG) compare ASPs with average manufacturer prices (AMPs) and the widely available market price, if any. If OIG finds that the ASP for a drug exceeded the AMP by 5 percent in the two previous quarters or three of the previous four quarters, the Secretary of Health and Human Services may substitute the reimbursement amount with a lower calculated rate. This quarterly memo summarizes the results of OIG's comparison analysis based on ASP and AMP data reported for the fourth quarter 2023. 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
Completed Centers for Medicare and Medicaid Services Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Third Quarter 2023 Office of Evaluation and Inspections OEI-03-24-00050;
OEI-BL-24-00070
2025 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. Section 1847A(d)(1)-(3) of the Social Security Act mandates that the Office of Inspector General (OIG) compare ASPs with average manufacturer prices (AMPs) and the widely available market price, if any. If OIG finds that the ASP for a drug exceeded the AMP by 5 percent in the two previous quarters or three of the previous four quarters, the Secretary of Health and Human Services may substitute the reimbursement amount with a lower calculated rate. This quarterly memo summarizes the results of OIG's comparison analysis based on ASP and AMP data reported for the third quarter 2023. 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
November 2023 ASPR, CDC, CMS Case Study: Preparedness and Response for Disruptions in Health Care in Select Communities During and After Hurricanes Fiona and Ian Office of Evaluation and Inspections OEI-04-23-00420 2025 In 2022, Hurricanes Fiona and Ian made landfall as Category 4 hurricanes, resulting in more than $115 billion in damages and causing the deaths of more than 170 people. In Puerto Rico, Florida, and South Carolina, several health care facilities such as hospitals, end-stage renal disease facilities, and community health centers experienced disruptions in services caused by factors such as power outages, water shortages, and/or staffing shortages. This study will describe specific disruptions in health care during and after Hurricanes Fiona and Ian for select communities in Puerto Rico, Florida, and South Carolina. We will determine how and the extent to which select communities prepared to prevent these specific disruptions, as well as how Puerto Rico, Florida, and South Carolina oversaw and supported communities prior to the hurricanes. We will determine how and to what extent select communities addressed these specific disruptions during and after the hurricanes, as well as how Puerto Rico, Florida, and South Carolina oversaw and supported these response activities. We will examine HHS's support and oversight of Puerto Rico's, Florida's, and South Carolina's compliance with meeting performance measures and standards for health care preparedness and response. We will also assess which HHS resources were used for both preparedness and response activities, and whether any relevant resources were not used and why. This study will help improve how HHS and States oversee and support public health and health care delivery systems in preparing for and responding to public health emergencies, including hurricanes. Emergency Preparedness and Response, Other Funding
Completed Centers for Medicare and Medicaid Services Medicare Part B Drug Payments: Impact of Price Substitutions Based on 2022 Average Sales Prices Office of Evaluation and Inspections OEI-03-24-00080 2025 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. Section 1847A(d)(1)-(3) of the Social Security Act mandates that the Office of Inspector General (OIG) compare ASPs with average manufacturer prices (AMPs) and the widely available market price, if any. If OIG finds that the ASP for a drug exceeded the AMP by 5 percent in the two previous quarters or three of the previous four quarters, the Secretary of Health and Human Services may substitute the reimbursement amount with a lower calculated rate. Over the past decade, OIG has produced annual reports aggregating the results of our mandated quarterly ASP-to-AMP comparisons. This annual report will quantify the savings to Medicare and its beneficiaries that are a direct result of CMS's price substitution policy based on 2022 ASPs, and may offer recommendations for Medicare to achieve additional savings. Prescription Drug, Elderly, Medicare B
November 2023 Centers for Medicare and Medicaid Services Medicare Part D Formulary Coverage of Humira Biosimilars Office of Evaluation and Inspections OEI-05-23-00520 2025 Humira-one of the best selling prescription drugs in the world and one of the most costly drugs for the Medicare Part D program-faced its first competition in the United States in 2023, ending nearly 20 years of market exclusivity. Launches of multiple biosimilars for Humira in 2023, including one interchangeable version, have presented an opportunity to increase access to lower cost drugs and, ultimately, significantly reduce Part D drug spending. However, a lack of Part D formulary coverage for Humira's biosimilars, or preferential formulary placement for Humira, could limit the wider use of these biosimilars, as well as limit any potential spending reductions for the Part D program and its enrollees. Our study will determine how often Part D formularies covered Humira biosimilars after they became available and describe differences in cost-sharing or utilization management requirements, as well as list prices, for Humira Prescription Drug, Medicare D
Completed (Partial) Centers for Medicare and Medicaid Services Audit of Emergency Preparedness, Infection Prevention and Control, and Life Safety at Intermediate Care Facilities for Individuals With Intellectual Disabilities Office of Audit Services WA-24-0010 (W-00-24-31574);
A-01-24-00001
2025 An Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID) is an institution that provides health and/or rehabilitation services to individuals with intellectual disabilities under the Medicaid program. ICF/IID services are covered by Medicaid when they are provided in a residential facility licensed and certified by a State survey agency as an ICF/IID. Medicaid covers ICF/IID services for more than 100,000 individuals with intellectual disabilities and other related conditions. ICF/IIDs face significant challenges in the event of emergencies such as fires, emerging infectious disease outbreaks, and natural disasters. Previous OIG audits on infection prevention and control, emergency preparedness, and life safety at nursing homes identified multiple issues that put Medicaid enrollees at increased risk. Our objective is to determine whether selected States' ICF/IIDs complied with Federal requirements for infection prevention and control, emergency preparedness, and life safety. Emergency Preparedness and Response, Public Health Issues, Quality of Care, People with Disabilities, Medicaid
November 2023 Centers for Medicare and Medicaid Services Audit of Nursing Homes' Nurse Staffing Hours Reported in CMS's Payroll-Based Journal Office of Audit Services WA-24-0011 (W-00-24-31575) 2025 Nursing homes are required to electronically submit complete and accurate direct care staffing information to CMS's Payroll-Based Journal (PBJ) system on a quarterly basis. Direct care staff include nurse and non-nurse staff who, through interpersonal contact with nursing home residents or resident care management, provide care and services to residents to allow them to attain or maintain the highest practicable physical, mental, and psychosocial well-being. CMS and other stakeholders use the staffing information in the PBJ to: (1) measure nursing home performance, (2) better understand the relationship between nursing home staffing levels and the quality of care that nursing homes provide, (3) identify noncompliance with Federal nurse staffing regulations, and (4) facilitate the development of nursing home staffing measures. We will review the nurse staffing hours reported in the PBJ to determine whether the reported hours are accurate. Nursing Homes, Nursing Facilities, and Assisted Living Facilities, Elderly, Medicare A, Medicaid
November 2023 Centers for Medicare and Medicaid Services Medicare Part C Audits of Documentation Supporting Specific Diagnosis Codes Office of Audit Services WA-24-0004 (W-00-24-35906) 2026 Payments to Medicare Advantage (MA) organizations are risk-adjusted based on each enrollee's health status (SSA § 1853(a)). 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. In general, MA organizations receive higher payments for enrollees with more complex diagnoses. 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 to determine whether the diagnoses submitted complied with Federal requirements. Departmental Operational Issues, Financial Stewardship, Managed Care, OIG Statutory Authority and Regulatory Matters, Elderly, Medicare C
November 2023 Centers for Medicare and Medicaid Services Audits of Medicare Part C Health Risk Assessment Diagnosis Codes Office of Audit Services WA-24-0003 (W-00-24-35905) 2025 Payments to Medicare Advantage (MA) organizations are risk-adjusted based on each enrollee's health status (SSA § 1853(a)). One tool that MA organizations use to collect risk-adjusted data is the health risk assessment (HRA), which gathers information about enrollees, including health status and health risks. 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. For these audits, the focus is on enrollees whose diagnoses, reported only on HRAs, mapped to a hierarchical condition category and resulted in increased risk-adjusted payments from CMS to MA organizations. We will determine whether these diagnosis codes, as submitted by MA organizations to CMS for use in CMS's risk-adjustment program, complied with Federal requirements. Departmental Operational Issues, Financial Stewardship, Managed Care, OIG Statutory Authority and Regulatory Matters, Elderly, Medicare C
November 2023 Indian Health Service, United States Public Health Service Commissioned Corps Audit of the Background Verification Process of Commissioned Corps Officers Assigned to Tribal and Indian Health Service Health Programs Office of Audit Services WA-24-0008 (W-00-24-59486) 2025 The United States Public Health Service Commissioned Corps is a branch of the Nation's uniformed services committed to the service of public health. Commissioned Corps Officers (CCOs) advance the Nation's public health by serving in agencies across the Government as physicians, nurses, dentists, scientists, engineers, and other professionals to fight disease, conduct research, and care for patients in underserved communities across the Nation and throughout the world. CCOs may be assigned to the Indian Health Service (IHS), which can place a CCO at Tribal or IHS health programs. The Indian Child Protection and Family Violence Prevention Act (P.L. No. 101-630) requires background investigations, including Federal Bureau of Investigation fingerprinting, for individuals whose duties involve contact with children. Federal regulations require periodic reinvestigations of CCOs. Prior OIG audit work identified that Federal employees assigned to Tribal and IHS health programs did not always meet Federal background investigation requirements for individuals in contact with American Indian children. We will determine whether CCOs assigned to provide health care services to Tribal and IHS health programs received background investigations and reinvestigations in accordance with Federal requirements. Physician and Healthcare Practitioners, Quality of Care, Children and Families, Native Americans, Other Funding
November 2023 National Institutes of Health Audit of the National Institutes of Health's Efforts To Ensure a Safe and Respectful Workplace Office of Audit Services WA-24-0001 (W-00-24-59484) 2025 The 2022 Consolidated Appropriations Act (P.L. 117-103) mandated the NIH Director to require NIH-funded institutions to report to the NIH "when individuals identified as principal investigator or as key personnel in an NIH notice of award are removed from their position or are otherwise disciplined due to concerns about harassment, bullying, retaliation, or hostile working conditions." NIH expects recipient institutions to have policies and practices in place that foster an environment free from harassment and other forms of inappropriate conduct that can result in a hostile work environment. NIH recipients should provide safe and respectful working conditions for their employees to foster work environments that promote innovation by leveraging different backgrounds, experiences, and points of view. We will determine: (1) whether NIH has implemented the Federal requirement for NIH-funded institutions to report individuals who have been removed or disciplined due to concerns about harassment, bullying, retaliation, or hostile working conditions, and (2) how NIH has used the reported information to improve work environments and promote a diverse workforce at NIH-funded institutions. Departmental Operational Issues, Laboratories, Other Minorities, Grants
October 2023 Office of the Assistant Secretary for Health, Office of Minority Health Audit of Morehouse School of Medicine's National Infrastructure for Mitigating the Impact of COVID-19 Initiative Office of Audit Services WA-24-0038 (W-00-24-59482) 2025 The National Infrastructure for Mitigating the Impact of COVID-19 (NIMIC) initiative seeks to develop and coordinate a strategic and structured national network of national, State, Territorial, Tribal, and local public and community-based organizations that will mitigate the impact of COVID-19 on racial and ethnic minority, rural, and socially vulnerable populations. The NIMIC initiative is a 3-year, $40 million cooperative agreement between HHS's Office of Minority Health and the Morehouse School of Medicine to fight COVID-19 in racial and ethnic minority, rural, and socially vulnerable communities. The Morehouse School of Medicine is leading the initiative to coordinate a strategic network to deliver COVID-19-related information to communities hardest hit by the pandemic. The NIMIC initiative is expected to result in: (1) improving the reach of COVID-19-related public health messaging to racial and ethnic minority, rural, and socially vulnerable populations; (2) increasing connections to health care and social services for racial and ethnic minority, rural, and socially vulnerable populations; (3) decreasing disparities in COVID-19 testing and vaccination rates among racial and ethnic minority populations in highly impacted geographic areas; and (4) enhancing State, Territorial, and Tribal capacities and infrastructures to support response, recovery, and resilience among racial and ethnic minority, rural, and socially vulnerable populations. We intend to determine which strategies the Morehouse School of Medicine implemented to achieve the goals of the NIMIC initiative, and whether the Morehouse School of Medicine met the project goals and complied with Federal regulations. COVID-19, Emergency Preparedness and Response, Public Health Issues, Native Americans, Other Minorities, Grants
October 2023 Administration for Children and Families Audit of Accuracy of CCDF Attendance Records at Minnesota Child Care Centers Office of Audit Services WA-23-0039- (W-00-23-20039) 2026 Reauthorized in the Child Care and Development Block Grant Act of 2014, the Child Care and Development Fund (CCDF) is the primary Federal funding source devoted to subsidizing the child care expenditures of low-income families. Prior OIG audit work identified issues with the completeness and accuracy of child care attendance records and with related billings for child care services. Using a risk-based approach, we plan to select Minnesota and possibly additional States for a review to determine whether the State(s) complied with Federal and State requirements related to attendance records and whether payments for services at child care centers were allowable. Dependent Care, Financial Stewardship, Public Health Issues, Children and Families, Grants
October 2023 Administration for Children and Families National Snapshot of Recent Trends in the Refugee Resettlement Program Office of Audit Services WA-23-0040 (W-00-23-59483) 2025 Under the Refugee Resettlement Program, the Administration for Children and Families, Office of Refugee Resettlement (ORR) provides funding for benefits and services to facilitate the successful resettlement in the United States of refugees and other eligible individuals, and to help them attain self-sufficiency. These benefits and services include cash, medical assistance, employment services, and child care. The number of refugees needing assistance has been the highest in several decades, which has thereby increased the cost of and challenges to assisting individuals in achieving self-sufficiency. We will: (1) summarize nationwide data on ORR's Refugee Resettlement Program from October 1, 2020, through December 31, 2022, (2) identify recent trends in program participation and outcomes, and (3) identify any challenges encountered by organizations funded to administer the Refugee Resettlement Program. Departmental Operational Issues, Financial Stewardship, Other Minorities, Grants
October 2023 Administration for Children and Families Audit of Efforts of State Agencies to Ensure the Safety of Children in Foster Care Office of Audit Services WA-23-0043 (W-00-24-20040) 2025 The Federal Foster Care Program, which is administered at the Federal level by the Administration for Children and Families, helps States provide safe and stable out-of-home care for children. We plan to conduct two nationwide audits that focus on related aspects of State agencies' efforts to ensure the safety of children in foster care placements. One audit will examine the States' use of temporary emergency placements not designed to house children, such as hotels or offices, when a permanent placement is unavailable. The second audit will determine whether critical incidents involving serious physical injury or sexual abuse to a child in foster care are being reported in accordance with Federal and State requirements. Dependent Care, Financial Stewardship, Public Health Issues, Quality of Care, Children and Families, Grants
Completed (partial) OS Review of HHS Government Purchase, Travel, and Integrated Charge Card Programs Office of Audit Services W-00-24-59041;
OAS-25-04-007;
A-04-24-02041
2025 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. The Office of Management and Budget (OMB) has instructed IGs to submit status reports on purchase and travel card audit recommendations for compilation and transmission to Congress and the Government Accountability Office. We will periodically conduct risk assessments of HHS's charge card programs (i.e., purchase, travel, or integrated cards) used to pay for commercial goods, services, and travel expense and will conduct audits of those programs as warranted. We will also submit status reports on related audit recommendations to OMB as required. Departmental Operational Issues; OIG Statutory Authority and Regulatory Matters; Grants
Completed HRSA, CMS Mandatory Review of HHS Agencies' Annual Accounting of National Drug Control Program Funds Office of Audit Services W-00-24-52312;
OAS-25-03-016;
OAS-25-03-018
2025 The Office of National Drug Control Policy circular: National Drug Control Program Agency Compliance Reviews requires agencies expending funds on National Drug Control Program activities to submit an accounting of such funds made during the previous fiscal year (21 U.S.C. § 1704). The policy also requires that an agency submit with its annual accounting an authentication provided by the agency's OIG that expresses a conclusion on the reliability of the agency's assertions. The circular states that if in an agency's prior year drug-related obligations were less than $50 million, the agency would not be subject to these authentication requirements. We will review how HHS agencies complied with this circular and will submit the authentication with respect to the HHS agencies' annual accounting, beginning with FY 2020, once every three years. OIG Statutory Authority and Regulatory Matters, Substance Abuse Disorders, Other Funding
October 2023 Centers for Medicare and Medicaid Services Timeliness of Mental Health Care Following a Suicide Attempt or Intentional Self-Harm Incident for Children Enrolled in Medicaid Office of Evaluation and Inspections OEI-07-23-00510 2025 Rates of suicide attempts and intentional self-harm among youth are on the rise. A previous suicide attempt is the most important predictor of death by suicide, and the risk of death by suicide is highest in the period immediately after a hospitalization or emergency department visit for a suicide attempt or intentional self-harm incident. As such, providing timely mental health followup care is critical to decreasing the likelihood of rehospitalization and preventing suicide. We will conduct an evaluation to assess whether children enrolled in Medicaid and the Children's Health Insurance Program (CHIP) who had an emergency department visit or hospitalization for a suicide attempt or intentional self-harm incident received mental health followup care within established timeframes. We will also examine whether certain groups of children in our population were less likely to receive timely mental health followup care after a hospitalization or emergency department visit. Finally, we will interview subject matter experts to identify the challenges and best practices that States encountered when working to ensure that youth enrolled in Medicaid and CHIP receive timely mental health followup care. Managed Care, Mental Health, Non-institutional care, Public Health Issues, Children and Families, Medicaid
September 2023 Centers for Medicare and Medicaid Services Audit of Round 2021 of the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program Office of Audit Services WA-23-0033 (W-00-23-35901) 2025 CMS administers a competitive bidding program under which prices for selected durable medical equipment, prosthetics, orthotics, and supplies furnished in specified areas are determined through a competitive bidding process. Federal law requires OIG to assess the process used by CMS to conduct the competitive bidding and subsequent pricing determinations under the first two rounds. Federal law also permits OIG to continue to verify such calculations for subsequent rounds (Medicare Improvements for Patients and Providers Act of 2008, § 154(a)(1)(A)(iv), adding subparagraph 42 U.S.C. § 1395w-3(a)(1)(E)). We will review the process used by CMS to conduct competitive bidding and to make subsequent pricing determinations during round 2021 of the competitive bidding program. Financial Stewardship, Medical Supplies and Equipment, OIG Statutory Authority and Regulatory Matters, Medicare B
September 2023 Centers for Medicare and Medicaid Services Audits of Medicare Part C Unlinked Chart Review Diagnosis Codes Office of Audit Services WA-23-0037 (W-00-23-35903) 2026 Payments to Medicare Advantage (MA) organizations are risk-adjusted on the basis of each enrollee's health status (SSA § 1853(a)). MA organizations are required to submit risk adjustment data to CMS according to CMS instructions (42 CFR § 422.310(b)). CMS allows MA organizations to conduct chart reviews of enrollee medical record documentation to identify diagnosis codes that providers either: (1) did not originally provide the MA organization or (2) provided the MA organization in error. For some chart reviews known as unlinked chart reviews, CMS does not require that the MA organization identify the specific date of service for previously unidentified diagnosis codes. CMS also allows MA organizations to submit chart review results to CMS for inclusion in calculating each enrollee's risk score. Miscoded diagnoses may cause CMS to pay MA organizations improper amounts. For these audits, we will focus on enrollees who had diagnoses identified from unlinked chart reviews that resulted in increased risk-adjusted payments from CMS to MA organizations. For these enrollees, we will determine whether all of the diagnosis codes that the MA organizations submitted to CMS for use in CMS's risk adjustment program, including the diagnosis codes submitted via unlinked chart reviews, complied with Federal requirements. Departmental Operational Issues, Financial Stewardship, Managed Care, OIG Statutory Authority and Regulatory Matters, Elderly, Medicare C
August 2023 Centers for Medicare and Medicaid Services Maintaining Buprenorphine Treatment for Medicare Enrollees With Opioid Use Disorder Office of Evaluation and Inspections OEI-02-23-00360 2025 Opioid-related overdose deaths in the United States remain high, at an estimated 82,310 in 2021. Ensuring that individuals who start treatment for opioid use disorder stay in treatment for as long as necessary is critical to addressing the opioid crisis. Yet, little is known about the extent to which people enrolled in Medicare Part D maintain buprenorphine treatment, which is the most common medication for the treatment of opioid use disorder in Medicare Part D. Research has shown that discontinuing treatment medications-such as buprenorphine-increases the likelihood of overdose deaths. Moreover, longer retention in treatment is also associated with improved outcomes, such as decreased rates of emergency room visits. This study will look at the extent to which people enrolled in Medicare Part D maintain buprenorphine treatment for at least 6 months. It will also look at the extent to which these enrollees-including the setting in which they start their treatment and the services they receive-differ from enrollees who do not maintain treatment. Prescription Drug, Substance Abuse Disorders, Medicare D
August 2023 Administration for Children and Families Audit of the Administration for Children and Families Transitional Living Program Office of Audit Services WA-23-0029 (W-00-23-59481) 2025 HHS's Administration for Children and Families (ACF) provides funds to public and nonprofit organizations for administering the Transitional Living Program (TLP). TLP supports the delivery of various services to youths aged 16 through 21 who are experiencing homelessness. The services consist of: (1) providing shelter (i.e., group homes, maternity group homes, host family homes, and supervised apartments); (2) a service coordination plan that refers youths experiencing homelessness to social services, law enforcement, educational services, vocational training, child welfare, legal services, affordable child care, or child education programs; and (3) a transitional living plan that provides basic life skills, money management, job attainment skills, counseling, mental and physical health care, other youth development services, and after-care resources to support the transition from supervised participation to independent living. In fiscal year (FY) 2022, ACF provided more than $53 million to fund 225 TLP awards to 175 grant recipients across the United States. We will determine whether selected TLP grant recipients provided services to youths experiencing homelessness according to Federal requirements. Non-institutional care, Public Health Issues, Quality of Care, Children and Families, Grants
August 2023 Health Resources and Services Administration Audit of Health Centers' Use of COVID-19 Supplemental Grant Funding and Reimbursement From the HRSA COVID-19 Uninsured Program Office of Audit Services WA-23-0022 (W-00-23-59479) 2025 The Health Resources and Services Administration (HRSA) awarded supplemental grant funding totaling approximately $8.1 billion to 1,387 health centers nationwide in fiscal years 2020 through 2022 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 expanding COVID-19 testing and administering COVID-19 vaccines. Separately, during the same period, the HRSA Uninsured Program (UIP) reimbursed providers more than $24.5 billion for conducting COVID-19 diagnostic testing and providing testing-related items and services to uninsured individuals. The UIP terms and conditions stated that recipients should consider payments from the UIP to be payment in full for COVID-19 testing and/or testing-related items, vaccine administration, care, or treatment. According to HRSA, health centers should have accepted any UIP payments as payment in full and should not have charged any of the same costs to their COVID-19 supplemental grant funding, including the difference between the amount claimed to the UIP and the amount they were reimbursed by the UIP.
Prior OIG work identified that some health centers charged costs for processing COVID-19 tests to their COVID-19 supplemental grant funding and also submitted claims and received reimbursement for the same services from the UIP. We will determine if health centers that submitted claims for COVID-19 testing and received reimbursement from the UIP also received reimbursement from grant funding for the same costs.
COVID-19, Emergency Preparedness and Response, Financial Stewardship, Public Health Issues, Grants
August 2023 Centers for Medicare and Medicaid Services Medicare Part B Payments for Over-the-Counter COVID-19 Tests During the PHE Demonstration Office of Audit Services WA-23-0034 (W-00-23-35902) 2025 On April 4, 2022, CMS launched the Medicare Over-the-Counter COVID-19 Test (OTC test) Demonstration (Demonstration) to cover and pay for OTC tests for people with Medicare Part B benefits, including people enrolled in Medicare Advantage plans (enrollee), for the remainder of the COVID-19 Public Health Emergency. During the Demonstration period, Medicare covered for each enrollee up to eight OTC tests per calendar month. If an enrollee received more than eight OTC tests in a calendar month, the enrollee may have had to pay out-of-pocket costs for the extra tests unless the enrollee had additional health coverage. We will determine whether Medicare paid eligible pharmacies and health care providers for OTC tests according to the Demonstration. COVID-19, Financial Stewardship, Medical Supplies and Equipment, Medicare B
Completed Centers for Medicare and Medicaid Services Medicare Part C High-Risk Diagnosis Codes Tool Kit Office of Audit Services A-07-23-01213 2024 Payments to Medicare Advantage (MA) organizations are risk adjusted on the basis of each enrollee's health status (SSA § 1853(a)). MA organizations are required to submit risk adjustment data to CMS according to CMS instructions (42 CFR § 422.310(b)). Miscoded diagnoses may cause CMS to pay MA organizations improper amounts. For this toolkit, we will develop a resource that will provide highly technical information to assist MA organizations with analyzing the accuracy of the risk adjustment data that they receive from their providers and submit to CMS. We will provide this information as a starting point to allow MA organizations to research enrollees who receive diagnoses that are at high risk for being miscoded and to take appropriate action if needed. Departmental Operational Issues, Financial Stewardship, Managed Care, OIG Statutory Authority and Regulatory Matters, Elderly, Medicare C
July 2023 Centers for Medicare and Medicaid Services Audit of Nursing Homes' Emergency Power Systems Office of Audit Services WA-23-0026 (W-00-23-31571) 2025 Recent severe weather events have highlighted the need for and importance of emergency power systems for nursing homes. Nursing homes are required to provide an alternate source of energy (usually a generator) to maintain temperatures to protect residents' health and safety, as well as for food storage, emergency lighting, fire protection, and sewage disposal (if applicable), or to evacuate the residents. Nursing homes with generators must have them installed in a safe location and are required to perform weekly maintenance checks. During our onsite inspections of 154 nursing homes in eight States as part of our recent life safety and emergency preparedness audits, we found numerous facilities that had generators that were more than 30 years old. We will conduct an audit to determine the age of emergency power systems in use by nursing homes and whether those systems are capable of delivering reliable and adequate emergency power, including power to HVAC systems, and whether they have been maintained in accordance with Federal requirements. Emergency Preparedness and Response, Nursing Homes, Nursing Facilities, and Assisted Living Facilities, Quality of Care, Elderly, People with Disabilities, Medicare A, Medicaid
Revised Health Resources and Services Administration Audit of the Rural Communities Opioid Response Program Office of Audit Services WA-23-0023 (W-00-23-59480) 2025 The opioid crisis has impacted rural communities where barriers to treatment services limit access to care. The Rural Communities Opioid Response Program (RCORP) is a multiyear initiative that addresses the barriers to treatment for substance use disorder, including opioid use disorder. RCORP works toward HHS's goal of ending the opioid epidemic and is supported through the Health Resources and Services Administration's (HRSA's) Federal Office of Rural Health Policy. In 2019, HRSA awarded $8.3 million to 12 eligible rural hospitals, clinics, and Tribal organizations through its RCORP-Medication-Assisted Treatment (MAT) Expansion grant to support establishing or expanding MAT in rural communities. The Notice of Funding Opportunity outlined core activities and set three proposed benchmarks the grant recipients were required or expected to meet during the 3-year grant period. We will review the 12 recipients of RCORP-MAT Expansion grants to determine whether the recipients met the required core activities and proposed benchmarks within the grant period. Public Health Issues, Substance Abuse Disorders, Grants
July 2023 Centers for Medicare and Medicaid Services Audit of Ambulance Services Supplemental Payment Program Office of Audit Services WA-23-0024 (W-00-23-31570) 2025 Some States have implemented uncompensated care payment programs that allow ambulance providers to receive supplemental payments for services provided to Medicaid beneficiaries and uninsured patients. We will conduct audits of selected States to determine whether the States' claims for Federal reimbursement for supplement payments to these providers complied with Federal and State requirements. Financial Stewardship, Medicaid
July 2023 Centers for Medicare and Medicaid Services CMS Oversight of States' Preparation of the CMS-64 Report Office of Audit Services WA-23-0030 (W-00-23-31572) 2025 The Medicaid program provides medical assistance to low-income individuals and individuals with disabilities. The Federal and State governments jointly fund and administer the Medicaid program. At the Federal level, CMS administers the program. The Federal Government pays its share of a State's Medicaid expenditures based on the Federal Medical Assistance Percentage, which varies depending on the State's relative per capita income. Within 30 days after the end of each quarter, States report expenditures and the associated Federal share on the CMS-64 report. The amounts that States report must represent actual expenditures. CMS is responsible for reviewing the CMS-64 report to ensure that the expenditures reported are consistent with Medicaid requirements and matched with the correct amount of Federal funds. CMS works with States to resolve any questionable expenditures. We will determine the effectiveness of CMS's oversight of Medicaid State expenditures reported on CMS-64 reports for the quarter ended September 30, 2022. Departmental Operational Issues, Financial Stewardship, Medicaid
July 2023 Centers for Medicare and Medicaid Services CMS May Make Increased Payments to MA Organizations for Diagnoses That Were Reported on Physicians' Claims But Were Not Confirmed on a Concurrent Inpatient Stay Office of Audit Services WA-23-0032 (W-00-23-35900) 2025 Payments to Medicare Advantage (MA) organizations are risk adjusted on the basis of each enrollee's health status (SSA § 1853(a)). 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. For this review, we will focus on enrollees who had a diagnosis on a physician or outpatient claim that did not appear on a concurrent inpatient claim. In these instances, the diagnosis codes from the physician or outpatient claim-ostensibly, potentially unconfirmed diagnosis codes that misrepresented the health status of the enrollee-were submitted to CMS and resulted in increased payments to MA organizations. If these occurrences were reviewed as part of a Risk Adjustment Data Validation (RADV) audit (or during a subsequent RADV appeals process), CMS could potentially review the claims collectively, instead of separately, in order to ensure the accuracy of the enrollee's health status. We will identify the increased payments to MA organizations that were based on any unconfirmed and inaccurate diagnoses. Departmental Operational Issues, Financial Stewardship, OIG Statutory Authority and Regulatory Matters, Elderly, Medicare C
Completed Office of the Secretary Review of HHS's Compliance with the Federal Information Security Modernization Act of 2014 (FISMA) Office of Audit Services W-00-23-42001;
W-00-24-42001
2024 The Federal Information Security Modernization Act of 2014 (FISMA) and OMB Circular A-130, "Managing Information as a Strategic Resource," require that agencies and their contractors maintain programs that provide adequate security for all information collected, processed, transmitted, stored, and/or disseminated in general support systems and major applications. FISMA requires each agency's inspector general to conduct an annual, independent evaluation to determine the effectiveness of the information security program and practices of an agency. We will review HHS's and selected HHS operating divisions' compliance with FISMA. The purpose of this audit is to determine whether HHS's overall information technology security program and practices were effective as they relate to Federal information security requirements. Information Technology and Cybersecurity, Other Funding
July 2023 Centers for Medicare and Medicaid Services The Role of Patient Selection Criteria in Ensuring Equitable Access to Kidney Transplantation Office of Evaluation and Inspections OEI-01-23-00290 2025 A transplant program at a hospital with a Medicare provider agreement must meet Medicare Conditions of Participation (CoPs) in order to receive CMS approval for providing transplant services. CoPs for transplant programs include a requirement that programs use written patient selection criteria to determine a patient's suitability for placement on the waiting list for a transplant and that patient selection criteria ensure the fair and nondiscriminatory distribution of organs. However, CMS stops short of defining patient selection criteria, and inequities in access to organ transplants persist. This study will evaluate how kidney transplant programs' patient selection criteria and related processes may affect the fair and nondiscriminatory distribution of organs. In addition, this study will assess how CMS monitors programs' compliance with, and takes corrective action regarding, its requirement that each program's patient selection criteria ensure the fair and nondiscriminatory distribution of organs. Hospitals, Other Minorities, Medicare A, Medicare B
June 2023 National Institutes of Health National Institutes of Health Oversight of Extramural Recipients' Emergency Preparedness for Biospecimen Research Office of Evaluation and Inspections OEI-04-23-00280 2025 The Payment Integrity Information Act of 2019 (PIIA) 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 PIAA and OMB Circular A-123, Appendix C, Requirements for Payment Integrity Improvement, OIG will review HHS compliance with PIAA 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.
June 2023 Food and Drug Administration The Impact of the COVID-19 Pandemic on FDA's Domestic Food Facility Inspections Office of Evaluation and Inspections OEI-02-23-00300 2025 Food facility inspections are one of the Food and Drug Administration's (FDA's) most effective preventive tools for protecting public health. The Food Safety Modernization Act (FSMA) requires FDA to inspect domestic food facilities at regular intervals, based on risk. Domestic food facilities designated as high-risk are required to be inspected every 3 years, whereas non-high-risk facilities are required to be inspected every 5 years. The COVID-19 pandemic curtailed FDA's ability to conduct required food facility inspections in 2020 and 2021 as scheduled, impacting its ability to meet FSMA mandates. This review will look at the impact of COVID-19 on FDA's domestic food facility inspections, the extent to which FDA has completed food facility inspections within required timeframes, and how FDA has addressed the backlog created by the COVID-19 pandemic. Even prior to the pandemic, OIG found that FDA faced challenges in meeting its required inspection timeframes and that FDA did not always conduct timely followup of violations identified. This review will also determine the extent to which FDA identified significant violations, and whether FDA conducted followup inspections to see if these significant violations were corrected. COVID-19, Food, Drug, and Device Safety, Public Health Issues, Other Funding
June 2023 Centers for Medicare and Medicaid Services State Medicaid Agencies' Perspectives of Managed Care Plans' Referral of Fraud Office of Evaluation and Inspections OEI-03-23-00340 2025 For Medicaid managed care, States contract with and oversee private health insurance companies, known as managed care plans, which have the primary responsibility for processing, paying, and monitoring claims from providers in their networks. As such, States play a critical role in safeguarding the Medicaid program's integrity. For example, States are required to: (1) monitor plans' compliance with the program integrity provisions of their contracts (including the provisions related to fraud referrals), (2) determine whether potential fraud reflects a credible allegation of fraud, and (3) take action against providers upon the identification of a credible allegation of fraud. According to Federal regulations, States' contracts with managed care plans must require the plans to promptly refer any potential fraud, waste, or abuse to State Medicaid agencies or Medicaid Fraud Control Units. However, both OIG and CMS have ongoing concerns about States' and plans' efforts to combat fraud, including a lack of fraud referrals. This evaluation will determine whether State contractual requirements support managed care plans' submission of fraud referrals, determine how States evaluate the volume and quality of the fraud referrals made by managed care plans, identify the factors that States believe incentivize managed care plans to refer fraud, and determine the challenges States face regarding fraud referrals from managed care plans. This work may also identify ways to increase the total number of managed care plans' fraud referrals and ensure the quality and timeliness of these referrals. Financial Stewardship, Managed Care, Medicaid
June 2023 Centers for Medicare and Medicaid Services Nationwide Audits of Medicare Part C High-Risk Diagnosis Codes Office of Audit Services WA-23-0019 (W-00-23-35896) 2025 Payments to Medicare Advantage (MA) organizations are risk-adjusted on the basis of the health status of each enrollee. MA organizations are required to submit risk-adjustment data to CMS according to CMS instructions (42 CFR § 422.310(b)). Miscoded diagnoses may cause CMS to pay MA organizations improper amounts (The Act §§ 1853(a)). For these audits, we will focus on enrollees who received diagnoses that are at high risk for being miscoded and resulted in increased risk-adjusted payments from CMS to MA organizations. We will determine whether these diagnosis codes, as submitted by MA organizations to CMS for use in CMS's risk-adjustment program, complied with Federal requirements. Managed Care, OIG Statutory Authority and Regulatory Matters, Medicare C
June 2023 Centers for Medicare and Medicaid Services Audit of Selected, High-Risk Medicare Hospice General Inpatient Services Office of Audit Services WA-23-0020 (W-00-23-35897) 2025 Medicare pays hospices a daily reimbursement rate for each day an individual is enrolled to receive the hospice benefit. The reimbursement rate for hospice general inpatient (GIP) care is the second-highest daily rate that Medicare pays for hospice services. GIP care is provided only for pain control or acute or chronic symptom management that cannot be managed in other settings. It is intended to be short-term care. For this audit, we will focus on claims for enrollees who were transferred to GIP care immediately after an inpatient hospital stay for a period during which the enrollee's inpatient stay reached or exceeded the geometric mean length of stay for the assigned diagnosis-related group. These hospice GIP claims are at high risk for inappropriate billing because GIP care may exceed an enrollee's needs or may not be provided. We will determine whether hospice providers that billed for GIP care complied with Medicare requirements. Financial Stewardship, Non-institutional care, Medicare A
Completed National Institutes of Health NIH Contract Closeout Process Office of Audit Services WA-23-0015 (W-00-23-59478);
A-04-23-03585
2024 As one of the largest contracting agencies in the Federal Government, HHS performed contracting actions (i.e., awards and modifications) totaling almost $39 billion in FY 2022. The National Institutes of Health (NIH) was responsible for $8.5 billion, or approximately 22 percent, of HHS contracting actions in FY 2022. NIH invests approximately $41.7 billion annually in medical research and is the largest Federal funding source for health research and development. Prior OIG work identified issues with the HHS contract closeout processes and procedures that are required once a contracting officer receives evidence of completion of the contract. The closeout process: (1) ensures that goods and services were provided as intended, (2) validates final costs and payments, and (3) frees up excess funds for possible use elsewhere. We will determine whether NIH closed contracts according to Federal regulations and HHS policies and procedures. Contracts, Departmental Operational Issues, Financial Stewardship, Other Funding
Completed (Partial) Administration for Children and Families Audits of Child Abuse Prevention and Treatment Act State Grants Office of Audit Services WA-23-0018 (W-00-23-20038);
OAS-25-01-01;
A-01-23-02500
2026 Abuse and neglect against a child younger than 18 years old by a parent, caregiver, or another person in a custodial role can have a long-term impact on the child's health, opportunity, and well-being. The Child Abuse Prevention and Treatment Act (CAPTA) provides funds to assist States in child abuse and neglect prevention, assessment, investigation, prosecution, and treatment activities. In Federal FY 2022, the Administration for Children and Families awarded $91.6 million in CAPTA State grant funding to 50 States, the District of Columbia, and Puerto Rico to improve their child protective services. The funds were distributed based on the relative share of the child population (younger than age 18). Using a risk-based approach, we will conduct audits of CAPTA State grant funding to determine whether awardees complied with Federal and State requirements for the intake, assessment, screening, and investigation of reports of child abuse or neglect. Public Health Issues, Children and Families, Grants
May 2023 CMS, AHRQ Hospital Identification of Patient Harm Events Office of Evaluation and Inspections OEI-06-18-00401 2025 Hospitals collect information about patient harm events to meet Medicare requirements to measure, analyze, and track adverse patient harm events. Incident reporting systems enable providers and hospital staff to report information about patient safety incidents when they occur. In addition to general incident reporting systems, hospitals use other surveillance systems to capture events within specific hospital departments, such as the hospital pharmacy, or to capture specific types of adverse events, such as infections. Hospitals analyze this information to identify trends and root causes of safety issues to improve care and prevent recurrences of harm events. We will determine the extent to which hospitals identify patient harm events and report those events to external entities. We will use harm events OIG identified through medical review for the study Adverse Events in Hospitals: A Quarter of Medicare Patients Experienced Harm in October 2018 (OEI-06-18-00400) as the basis for this review. Hospitals, Quality of Care, Medicare A
Active Centers for Disease Control and Prevention Foreign Assistance to Combat HIV/AIDS, Tuberculosis, and Malaria Inspectors General Coordinated PEPFAR Oversight Plan Office of Audit Services WA-23-0017 (W-00-23-57304);
A-04-23-01027
2025 The U.S. Government provides foreign assistance to fight HIV/AIDS, tuberculosis, and malaria-three of the world's deadliest infectious diseases-in order to help stem human suffering, economic loss, and political instability in developing countries. In 2003, President George W. Bush established the President's Emergency Plan for AIDS Relief (PEPFAR) and Congress passed the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act (the Act). The Act established the Office of the U.S. Global AIDS Coordinator and Health Diplomacy (OGAC) at the Department of State and gave OGAC primary responsibility for coordinating all resources and international activities of the U.S. Government for combating the HIV/AIDS pandemic. OGAC allocates funds to PEPFAR-implementing agencies, particularly HHS's Centers for Disease Control and Prevention (CDC) and the U.S. Agency for International Development (USAID). CDC and USAID, in turn, provide funds for HIV treatment, care, and prevention activities through grants, cooperative agreements, and contracts with selected implementing partners such as U.S.-based and international nongovernmental organizations and partner-country governmental entities. The inspectors general of the implementing agencies are required to coordinate their activities and jointly develop coordinated annual plans for oversight to avoid duplication and maximize efficiency. This plan includes our planned work related to CDC's oversight and recipients' use of PEPFAR funding. Departmental Operational Issues, Financial Stewardship, Public Health Issues, Grants, Other Funding
May 2023 Administration for Children and Families Audits of American Rescue Plan Act of 2021 Funding for the Child Care and Development Fund Office of Audit Services WA-23-0016 (W-00-23-20037);
OEI-09-23-00230
2024 The Child Care and Development Fund (CCDF) is a Federal and State partnership program that provides financial assistance to improve the access to quality child care for low-income families so parents can work or attend a job training or educational program. The American Rescue Plan Act of 2021 (ARP) appropriated $39 billion in child care stabilization grants and supplemental discretionary CCDF funds to be used to respond to the COVID-19 pandemic. These funds provided States, Territories, and Tribes with additional program flexibilities but were also subject to different restrictions than States' annual CCDF funding. According to HHS's Administration for Children and Families (ACF), this funding served more than 200,000 child care providers and benefited as many as 9.5 million children. We will determine how States used these funds, identify any risk areas, and review ACF's oversight of ARP child care stabilization funds. In a separate series of audits, we will determine whether selected States used ARP child care stabilization and supplemental CCDF discretionary funds in accordance with Federal and any applicable State requirements. COVID-19, Financial Stewardship, Children and Families, Grants
Completed National Institutes of Health Superfund Financial Activities at the National Institute of Environmental Health Sciences Office of Audit Services W-00-23-59050:
A-04-23-03586
2024 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
April 2023 Centers for Disease Control and Prevention The Centers for Disease Control and Prevention's Public Health Crisis Response Cooperative Agreement Program Awards Office of Audit Services WA-23-0012 (W-00-23-59477) 2025 The Public Health Crisis Response Cooperative Agreement program, administered by the Centers for Disease Control and Prevention (CDC), provides awards to State, local, and Tribal governments to enhance the Nation's ability to rapidly respond to public health emergencies. The program was appropriated more than $2.7 billion through the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, and the American Rescue Plan Act of 2021 to provide program recipients with the resources to prevent, prepare for, and respond to the COVID-19 pandemic. Due to the speed at which CDC awarded these funds, program recipients may not have established adequate procedures to ensure that funds were appropriately used. We plan to perform a series of audits on select cooperative agreements with recipients. For each audit, our objective will be to determine whether recipients used the program funds according to Federal requirements and applicable award terms and conditions. COVID-19, Emergency Preparedness and Response, Grants
Completed (partial) Centers for Medicare and Medicaid Services Use of Remote Patient Monitoring Services in Medicare Office of Evaluation and Inspections OEI-02-23-00260;
OEI-02-23-00261
2025 The use of remote patient monitoring services in Medicare has the potential to exponentially expand. However, there is currently limited research on the use of remote patient monitoring services, such as the types of patients and providers who use these services, and the health conditions that are monitored through these services, among other details. This review will be based on Medicare fee-for-service claims and Medicare Advantage encounter data for remote patient monitoring services. It will look at the extent to which the use of remote patient monitoring services has changed, the nature of remote patient monitoring services being used by Medicare enrollees, and the characteristics of enrollees using remote patient monitoring services. This review will also determine the extent to which provider billing for remote patient monitoring services may indicate fraud, waste, or abuse. Managed Care, Physician and Healthcare Practitioners, Elderly, Medicare B, Medicare C
March 2023 Centers for Medicare and Medicaid Services State Survey Agency Processes for Overseeing Nursing Home Preparedness Office of Evaluation and Inspections OEI-04-23-00030 2025OEI-02-23-00300 Historically, nursing homes have experienced challenges preparing for and responding to emergencies. To address these challenges, HHS has taken steps to bolster nursing home emergency preparedness and response through regulations such as CMS's Conditions of Participation (CoPs). However, prior OIG reviews and continued challenges during recent emergencies have highlighted gaps, including gaps related to State Survey Agency (SA) reviews of nursing home adherence to the CoPs. This evaluation will determine: (1) what processes SAs use to oversee nursing home emergency preparedness; (2) what promising practices, challenges, and/or limitations exist within those processes; and (3) how CMS or other HHS agencies can best support SAs. Emergency Preparedness and Response, Nursing Homes, Nursing Facilities, and Assisted Living Facilities, Public Health Issues, Elderly, People with Disabilities, Medicaid
February 2023 Centers for Medicare and Medicaid Services In-Depth Review of Nursing Home Citations Related to the Use of Antipsychotic Drugs Office of Evaluation and Inspections OEI-02-23-00200;
OEI-02-23-00201
2025 The potentially inappropriate use of antipsychotic drugs among nursing home residents remains concerning despite efforts to decrease their use over the last decade. Antipsychotic drugs were developed to treat schizophrenia—a serious mental disorder that is generally diagnosed before the age of 30. These powerful drugs are known to have severe side effects, particularly among elderly individuals with dementia. In 2008, the Food and Drug Administration issued a boxed warning against the use of all antipsychotic drugs among elderly individuals with dementia because of the increased risk of death. OIG has raised concerns about the high use of antipsychotic drugs among nursing home residents. In response, CMS took steps to discourage the use of these drugs by, for example, developing publicly reported quality measures related to the use of antipsychotic drugs among nursing home residents. More recently, OIG has raised concerns about the potential falsification of schizophrenia diagnoses to make the use of antipsychotic drugs appear appropriate and avoid Federal attention. We will conduct an in-depth review of survey reports to: (1) examine the nature of nursing home citations related to the use of antipsychotic drugs and (2) identify vulnerabilities that contribute to the inappropriate use of these drugs. Nursing Homes, Nursing Facilities, and Assisted Living Facilities, Quality of Care, Elderly, Medicare A
February 2023 Centers for Medicare and Medicaid Services Securing Medicaid and Medicare Payments to Providers Office of Evaluation and Inspections OEI-07-23-00180 2025 Federal and State Governments reimburse health care providers and facilities electronically for providing health care services. Sometimes a provider or facility may change financial institutions to receive payment by using an electronic funds transfer (EFT) authorization request. However, since at least 2020 OIG has investigated schemes that have allegedly exploited vulnerabilities in EFT authorization forms to redirect provider reimbursements to their own bank accounts. Many State Medicaid agencies and Medicare Administrative Contractors (MACs) have been victims of this type of fraud over the past 3 years. We will collect information from States, MACs, and Medicaid Managed Care Organizations about EFT vulnerabilities and assess the feasibility of possible solutions to strengthen EFT fraud prevention efforts. In addition, we will collect information about any actions taken by CMS to address EFT fraud and assess the feasibility of CMS systems playing a role in fraud prevention efforts. Financial Stewardship, Medicare A, Medicare B, Medicare C, Medicare D
Revised Substance Abuse and Mental Health Services Administration Audit of Substance Abuse and Mental Health Services Administration's FindTreatment.gov Office of Audit Services WA-23-0009 (W-00-23-59476) 2025 Substance use disorders (SUDs) impact the lives of millions of Americans. Drug overdose deaths in the United States increased by 28.5 percent during the 12-month period ending in April 2021. An individual who experiences an SUD may also experience a co-occurring mental disorder and vice versa. Nearly one in five U.S. adults (52.9 million in 2020) lives with a mental illness. In accordance with the 21st Century Cures Act (P.L. 114-255, § 9006), the Substance Abuse and Mental Health Services Administration (SAMHSA) maintains FindTreatment.gov, which is a searchable, online database of facility locations where individuals can seek substance use disorder and mental health treatment in the United States and U.S. Territories. We will conduct an audit to determine whether SAMHSA reported on FindTreatment.gov accurate, complete, and timely information on SUD and mental health treatment facilities. Mental Health, Public Health Issues, Substance Abuse Disorders, Other Funding
January 2023 Centers for Medicare and Medicaid Services Assessment of CMS's Early Use of Payroll-Based Journal Data To Improve Enforcement of Nursing Home Staffing Standards Office of Evaluation and Inspections OEI-04-22-00550 2025 In October 2022, CMS began to provide State Survey Agency surveyors (State surveyors) with extracts of Payroll-Based Journal (PBJ) staffing data for use in annual nursing home certification surveys (also known as “inspections”). CMS instructed State surveyors to use this data to investigate specific instances of noncompliance with hourly staffing standards (for example, the requirement to have a registered nurse on duty for a minimum of 8 hours per day). Additionally, CMS instructed State surveyors to review PBJ data for indications of whether a nursing home has met the requirement to have sufficient staffing. Our objective is to assess the early results of CMS's strategy to use PBJ data to improve the enforcement of Federal nursing home staffing standards by State surveyors. We will review CMS's plan for monitoring the success of the strategy and explore State surveyors' experiences with using the data in their surveys. Nursing Homes, Nursing Facilities, and Assisted Living Facilities, People with Disabilities, Elderly, Medicaid, Medicare A
Completed Centers for Medicare and Medicaid Services Access to Providers Prescribing or Dispensing Medications for Opioid Use Disorder in Medicare and Medicaid Office of Evaluation and Inspections OEI-BL-23-00160 2025 Deaths from opioid overdoses have surged to unprecedented levels during the COVID-19 pandemic. As of April 2021, 100,000 people had died due to drug overdoses in just the preceding 12 months, an increase of 28 percent from the same period the year before. Access to medications for opioid use disorder (MOUD) is essential for addressing high rates of opioid addiction and overdose mortality. Medicare and Medicaid play important roles in providing MOUD, but concerns about access to MOUD through these programs persist. About 16 percent of Medicare beneficiaries diagnosed with opioid use disorder received MOUD through Medicare in 2020, and only 44 percent of Medicaid beneficiaries under age 65 with opioid use disorder received any treatment through Medicaid in 2017. To improve access, the Federal government has recently expanded MOUD coverage through Medicare and Medicaid. This study will determine what percentage of providers are treating Medicare or Medicaid patients with MOUD. It will also identify geographic areas where access to MOUD remains challenging for people enrolled in Medicare and Medicaid. Physician and Healthcare Practitioners, Prescription Drug, Public Health Issues, Substance Abuse Disorders, Medicaid, Medicare B, Medicare C, Medicare D
January 2023 Centers for Medicare and Medicaid Services Audit of Medicaid Collections During COVID-19 Federal Medical Assistance Percentage Increase Office of Audit Services WA-23-0007 (W-00-23-31569) 2025 The Federal Government pays its share of a State's Medicaid expenditures based on the Federal Medical Assistance Percentage (FMAP), which varies depending on a State's relative per capita income. In response to the pandemic, the Families First Coronavirus Response Act provided a temporary 6.2-percentage-point increase to each qualifying State's and Territory's FMAP effective January 1, 2020. States must refund the Federal share of overpayments and other collections, which decreases the amount of Federal funding States receive for a quarter. CMS instructs States to make refunds of the Federal share at the FMAP at which the original expenditures were reimbursed. We will audit selected States to determine whether those States used the correct FMAP when making refunds of the Federal share. COVID-19, Medicaid
Revised Centers for Medicare and Medicaid Services Medicare Advantage Organizations' Efforts To Reduce Racial and Ethnic Health Disparities Office of Evaluation and Inspections OEI-03-23-00060 2025 HHS, in alignment with the 2021 Executive Order 13985 Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, has pursued addressing health disparities among members of certain racial and ethnic communities. CMS has developed a plan that aims to build the capacity of health care stakeholders, including Medicare Advantage Organizations (MAOs), to take action to reduce health disparities. CMS has provided MAOs with a variety of resources and tools for addressing racial and ethnic health disparities including annual reports, technical assistance, and trainings. This evaluation will identify the actions that MAOs have developed to reduce racial and ethnic disparities in access to care, quality of care, and health outcomes. We will also identify any challenges and successes MAOs have experienced in their efforts to reduce these health disparities. Departmental Operational Issues, Managed Care, Public Health Issues, Quality of Care, Elderly, Other Minorities, Medicare C
December 2022 Centers for Medicare and Medicaid Services Audit of Medicare Part B Opioid Use Disorder Treatment Services Provided by Opioid Treatment Programs-Bundled Payments and Telehealth Services Office of Audit Services WA-23-0006 (W-00-23-35895) 2025

Substance use disorders involving drugs or alcohol can cause serious health problems and even death. Medication for substance use disorders, including opioid use disorder (OUD), is used to sustain recovery and prevent overdoses. Currently, there are three Food and Drug Administration (FDA)-approved medications to treat OUD: buprenorphine, methadone, and naltrexone. Treatment for OUD is provided in several settings, including freestanding opioid treatment programs (OTPs).

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 for services furnished on or after January 1, 2020, as required by the SUPPORT Act. Section 1834(w)(2) of the Social Security Act authorized the HHS Secretary to implement the Medicare OTP benefit by using one or more payment bundles. Under section 1861(jjj) of the Social Security Act, OUD treatment services include FDA-approved treatment medication, dispensing and administration of treatment medication, substance use counseling, individual and group therapy, toxicology testing, and other items and services that the HHS Secretary determines are appropriate.

We will review the OUD treatment services that were reimbursed under the bundle payments provided to people enrolled in Medicare. We will determine the types, delivery methods (i.e., in person or via telehealth), and frequency of OUD treatment services provided to Medicare enrollees by OTPs that received bundled payments. We will compare the bundled payments for OUD treatment services with the reimbursement amount of the actual OUD treatment services if the services were not part of the bundled payment. We will also determine whether these services complied with certain Medicare requirements.

Financial Stewardship, Non-institutional care, Physician and Healthcare Practitioners, Public Health Issues, Quality of Care, Substance Abuse Disorders, Medicare B
December 2022 Centers for Medicare and Medicaid Services CMS's Oversight of Federal Medical Loss Ratio Requirements in Medicaid Managed Care Office of Evaluation and Inspections OEI-03-23-00040 2025 With its 2016 Medicaid managed care regulations, CMS chose medical loss ratios (MLRs) as a policy tool to ensure appropriate stewardship of managed care funds. The Federal MLR is the percentage of premium revenue that a managed care plan spent on covered health care services and quality improvement activities during a 12-month period. Federal MLR requirements help ensure that managed care plans spend most of their revenue on services related to the health of their enrollees, thereby limiting the amount that plans can spend on administration and keep as profit. As part of the process for setting capitation rates, Federal regulations require States to set their plans' capitation rates so that plans will reasonably achieve MLRs of at least 85 percent-the Federal MLR standard. States must take into account their plans' reported MLRs when setting future capitation rates. OIG has previously found weaknesses in States' oversight of the completeness and accuracy of their plans' MLR reporting. CMS plays a vital role in overseeing States' implementation of Federal MLR requirements, as it is responsible for the review and approval of States' capitation rates for their managed care plans, including review of State-submitted MLR data. OIG's evaluation will determine: (1) how CMS has incorporated MLR data in its review of States' capitation rate certifications; (2) the oversight activities that CMS conducts to ensure that States submit to CMS complete and accurate MLR data; and (3) whether CMS has ensured that States have used MLR data, as required, to set actuarially sound capitation rates. Departmental Operational Issues, Financial Stewardship, Managed Care, Medicaid
Revised National Institutes of Health NIH Recipient Institutions' Reporting of Monetary Donations That Support Research Office of Evaluation and Inspections OEI-03-22-00570 2025 Recipient institutions that receive funding from the National Institutes of Health (NIH) play a key role in protecting the integrity and security of U.S. biomedical research, in part, by identifying investigators' Other Support (which includes all resources made available to an investigator in support of and/or related to all of their research endeavors) and reporting this information to NIH during the grant award process. Recipient institutions' failure to comply with these reporting requirements hinders NIH's ability to conduct effective oversight. When an investigator receives a monetary donation where there is no expectation of anything in return (e.g., time, services, specific research activities), NIH considers this a gift and does not require recipient institutions to report it as Other Support. However, NIH has not issued specific guidance to recipient institutions on how specific and/or explicit the donor's expectation must be for such funds to be considered Other Support and not a gift. This evaluation will identify how recipient institutions determine whether monetary donations that support investigators' research are gifts or should be reported to NIH as Other Support. Departmental Operational Issues, Financial Stewardship, Grants
completed National Institutes of Health NIH Grant Closeout Process Office of Audit Services WA-23-0001 (W-00-23-59475);
A-04-23-08097
2024 The National Institutes of Health (NIH) invests approximately $41.7 billion annually in medical research and is the largest Federal funding source for health research and development. Prior OIG work identified issues regarding NIH's grant post-award closeout processes. A closeout of an award is the process by which NIH determines that all applicable administrative actions and all required work under an award have been completed by the recipient and NIH (45 CFR § 75.381). We will determine whether NIH closed its grants in accordance with Federal requirements and departmental guidance. We will also determine which actions NIH took to address noncompliance with closeout requirements. Departmental Operational Issues, Financial Stewardship, Grants
Completed Administration for Children and Families States' Oversight of Residential Facilities To Protect Children From Maltreatment Office of Evaluation and Inspections OEI-07-22-00530 2024 States monitor and license federally funded residential facilities for children, but policymakers and the media have reported on incidents of child abuse and neglect (collectively referred to as maltreatment) that raise concerns about the effectiveness of States' oversight efforts to protect children in these settings. We will interview State child welfare and licensing agencies to assess how they monitor and address reports of maltreatment in child residential facilities. Identification of gaps in State oversight of residential facilities for children and potential promising practices (e.g., innovative policies or activities that could help address maltreatment) could help the Administration for Children and Families and States improve their oversight and better protect the children placed in these facilities. Quality of Care, Children and Families, Grants
November 2022 Health Resources and Service Administration Access to Medications for Opioid Use Disorder at Health Centers Office of Evaluation and Inspections OEI-BL-22-00520 2025 Access to medications for opioid use disorder (MOUDs) is essential for addressing the opioid epidemic in the United States. However, patients continue to encounter barriers to accessing affordable and quality treatment services. OIG will examine access to MOUDs through health centers funded by the Health Resources and Services Administration (HRSA). Health centers play a pivotal role in expanding access to MOUDs in the primary care setting because they provide high-quality and comprehensive care regardless of patients' ability to pay. HRSA has also awarded funding to health centers to expand access to substance use disorder treatment. This study will provide critical information on expanding MOUD access through HRSA's Health Center Program. We will examine how many health centers provide MOUD services, which types of services they provide (e.g., specific medications and behavioral health services, such as counseling), and how many patients health centers are treating with MOUDs. We will also examine the factors that may either facilitate or hinder the provision of MOUDs at health centers. Mental Health, Physician and Healthcare Practitioners, Prescription Drug, Public Health Issues, Quality of Care, Substance Abuse Disorders, Other Minorities, Grants, Medicaid, Medicare D, Private Insurance
November 2022 Centers for Medicare and Medicaid Services Review of Medicare Payments for Trauma Claims Office of Audit Services WA-23-0004 (W-00-23-35893) 2025 There have been concerns about trauma centers improperly billing for trauma team activation that is not medically necessary. In addition, we found some providers have received trauma team activation payments without proper designation or verification. Currently, CMS does not track which providers are designated or verified as trauma centers. We will determine the amount of Medicare overpayments and Medicare charges that affect future hospital payments, and we will identify providers that are not trauma centers or that billed for medically unnecessary trauma team activations. Financial Stewardship, Hospitals, Medicare A, Medicare B
Revised Centers for Medicare and Medicaid Services Audit of Medicaid Nursing Facility Use of Funds Related to Direct Patient Care Office of Audit Services WA-23-0003 (W-00-23-31568) 2025 Improving safety, quality, and transparency of Medicaid nursing facility care is a top priority to ensure that seniors, people with disabilities, and others living in nursing homes receive reliable, high-quality care. States have broad flexibility when establishing Medicaid base and supplemental payments to provide adequate, performance-driven nursing facility rates. We will judgmentally select three facilities in selected States (one each from the following facility types: for-profit, not-for-profit, and governmental) to determine what percentage of Medicaid nursing facility revenue is being expended on direct patient care. Financial Stewardship, Nursing Homes, Nursing Facilities, and Assisted Living Facilities, Quality of Care, People with Disabilities, Elderly, Medicaid
October 2022 Centers for Medicare and Medicaid Services Potentially Preventable Hospitalizations of Medicare-Eligible Skilled Nursing Facility Residents Office of Audit Services WA-23-0002 (W-00-23-35892) 2024 Prior OIG work identified nursing facilities with high rates of Medicaid enrollee transfers to hospitals for a urinary tract infection (UTI), a condition that is often preventable and treatable in the nursing facility setting without requiring hospitalization. The audits disclosed that the nursing facilities often did not provide UTI prevention and detection services in accordance with its residents' care plans, increasing the residents' risk for infection and hospitalization. Previous CMS studies found that five conditions (pneumonia, congestive heart failure, UTIs, dehydration, and chronic obstructive pulmonary disease/asthma) constituted 78 percent of the long-term care resident transfers to hospitals. Additionally, sepsis is often considered a preventable condition when the underlying cause of sepsis is preventable. OIG's review of claims shows that skilled nursing facility (SNF) residents often present with one of these six conditions (pneumonia, congestive heart failure, UTIs, dehydration, chronic obstructive pulmonary disease/asthma, and sepsis) on inpatient hospitalization. We will review inpatient hospitalizations of SNF residents with any of these six conditions and determine whether the SNF provided services to residents in accordance with their care plans and professional standards of practice (42 CFR §483.21 and 42 CFR § 483.25). Hospitals, Nursing Homes, Nursing Facilities, and Assisted Living Facilities, Quality of Care, Elderly, Medicare A, Medicare B
Revised Centers for Disease Control and Prevention CDC Oversight of the President's Emergency Plan for AIDS Relief Funds Office of Audit Services W-00-23-57301 2025 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 to improve methods for finding, treating, and preventing HIV. CDC received more than $5.4 billion for FY 2019 through FY 2021 (about 97 percent of the funds received by HHS during the three FYs) 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, HHS-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 U.S. and foreign countries, OIG identified noncompliance with policies, inadequate monitoring of recipients, 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
September 2022 Centers for Medicare and Medicaid Services Medicaid Managed Care Plans' Focus on Fraud Referrals Office of Evaluation and Inspections OEI-03-22-00410 2025 For Medicaid managed care, States contract with private health insurance companies, or managed care plans, that have the primary responsibility for processing, paying, and monitoring the claims of providers in their networks. As such, managed care plans play a critical role in safeguarding Medicaid program integrity. According to Federal regulations, State contracts with managed care plans must require that plans promptly refer any potential fraud, waste, or abuse to State Medicaid agencies or Medicaid Fraud Control Units (MFCUs). However, both OIG and CMS have ongoing concerns about managed care plans' efforts to combat fraud, including concerns about a lack of fraud referrals. This evaluation will determine the number of potential fraud referrals managed care plans made to States, MFCUs, and other entities; determine whether managed care plan processes support the referral of potential fraud; and identify the factors that influence whether managed care plans make referrals. This work may identify ways to increase the total number of managed care plan referrals and ensure the quality and timeliness of referrals. Financial Stewardship, Managed Care, Medicaid
Revised Centers for Medicare and Medicaid Services Hospital Price Transparency Office of Audit Services WA-22-0013 (W-00-22-35890) 2025 CMS issued a final rule effective January 1, 2021, to improve transparency in health care costs by requiring hospitals to make their prices readily available for consumers. The rule applies to all hospitals regardless of how they are paid. CMS's final rule provided specific instructions on which items were to be included on the list as well as gross charges for each item or service, payer-specific negotiated charges for each item or service, the discounted cash price, and codes used by a hospital to identify each item or service. CMS has also outlined its monitoring and enforcement plan to ensure hospital compliance. Potential actions CMS may take for noncompliance include providing a written warning listing violations, requiring a hospital to create a corrective action plan, and imposing civil monetary penalties.

To evaluate CMS's monitoring and enforcement of the hospital price transparency rule, we will review the controls in place at CMS and statistically sample hospitals to determine whether CMS's controls are sufficient to ensure that hospital pricing information is readily available to patients as required by Federal law. Additionally, if hospitals are not in compliance with CMS's rule for listing their charges, we will contact the hospitals to determine the reason for noncompliance and determine whether CMS identified the noncompliance and imposed consequences on the hospitals.
Financial Stewardship, Hospitals, Medicare A
Revised Centers for Medicare and Medicaid Services Inpatient Rehabilitation Facility Nationwide Audit Office of Audit Services WA-22-0014 (W-00-22-35891) 2024 Inpatient rehabilitation facilities (IRFs) provide intensive inpatient rehabilitation therapy for patients who have complex nursing, medical management, and rehabilitation needs that require hospital-level treatment in an inpatient environment. In fiscal year 2021, Medicare paid approximately $8.7 billion for 373,000 IRF stays nationwide. The Centers for Medicare & Medicaid Services (CMS) has consistently found high IRF error rates through its Comprehensive Error Rate Testing program. For an IRF claim to be considered reasonable and necessary, it must meet certain coverage and documentation requirements. We issued a nationwide audit of IRF claims in September 2018, Many Inpatient Rehabilitation Facility Stays Did Not Meet Medicare Coverage and Documentation Requirements (A-01-15-00500), that found that medical record documentation for 175 of 220 sampled IRF stays did not support that the IRF care was reasonable and necessary in accordance with Medicare requirements. Our Hospital Compliance audits also frequently include IRF claims and have similarly found high error rates. In response to these findings, IRF stakeholders have stated that Medicare audit contractors and OIG have misconstrued the IRF coverage regulations. To better understand which claims IRFs believe are properly payable by Medicare, OIG needs more information from the IRF stakeholders. We plan to determine whether there are areas in which CMS can clarify Medicare IRF claims payment criteria. In addition, we will follow up on recommendations from our prior IRF audit, A-01-15-00500. We believe data and input from IRF stakeholders are critical to identifying any specific areas that might require clarification and will result in more meaningful recommendations and a greater positive impact on the program. This audit will be an independent performance audit in accordance with Generally Accepted Government Auditing Standards. Financial Stewardship, Hospitals, Medicare A
Completed Administration for Children and Families Protecting Children in Foster Care From Identity Theft Office of Evaluation and Inspections OEI-07-22-00510 2025 The more than 600,000 children served by U.S. foster care each year are especially vulnerable to identity theft because their personally identifiable information can be accessed by the many adults they encounter during their time in care, including noncustodial family members, foster parents, and social services personnel. Congress enacted two laws that include requirements intended to protect children in foster care from identity theft: the Child and Family Services Improvement and Innovation Act and the Preventing Sex Trafficking and Strengthening Families Act. These laws require States to conduct annual credit checks for children aged 14 or older in foster care and to help these children interpret and resolve any inaccuracies identified in credit reports. The surge in reports of identity theft and stakeholder concerns could indicate that credit checks and the resolution of credit reports may not be occurring as required by Federal law. We will evaluate records of children in foster care to determine the extent to which, in calendar year 2021: (1) State child welfare agencies implemented practices to conduct credit checks for children in foster care, (2) State child welfare agencies identified children in foster care who had credit reports that indicated identity theft, (3) State child welfare agencies supported children in foster care in interpreting credit reports and resolving cases of identity theft, and (4) the Administration for Children and Families recommended and States took preventative measures to protect children in foster care from identity theft. We will also examine demographic data to determine whether there are disparities in the provision of credit checks, the prevalence of identity theft, or the provision of preventative measures. Financial Stewardship, Quality of Care, Children and Families, Grants
Revised Indian Health Service Audit of Internal Controls in Place To Identify, Record, and Track Indian Health Service Sanitation Facilities Construction Program Costs Office of Audit Services WA-22-0009 (W-00-22-59474) 2025 Under the Infrastructure Investment and Jobs Act, Congress allocated $3.5 billion to the Indian Health Service (IHS) Sanitation Facilities Construction (SFC) Program to provide American Indian and Alaska Native (AI/AN) homes and communities with essential water supply, sewage disposal, and solid waste disposal facilities. The IHS Sanitation Deficiency System (SDS) is an inventory of sanitation projects developed to address existing sanitation deficiencies in AI/AN communities. As of December 31, 2021, the SDS showed 1,513 sanitation projects totaling $3.4 billion in eligible costs and $735 million in ineligible costs. Ineligible costs are the costs associated with serving commercial, industrial, or agricultural establishments, including nursing homes, health clinics, schools, hospitals, hospital quarters, and non-AI/AN homes. Our audit will determine whether IHS has internal controls to: (1) identify, record, and track project costs in the SDS and (2) ensure that appropriated funds are not used for ineligible SFC project costs. Departmental Operational Issues, Financial Stewardship, Public Health Issues, Native Americans, Grants
Revised Centers for Medicare and Medicaid Services Skilled Nursing Facilities' Medicare Payments to Related Parties Office of Audit Services WA-22-0004 (W-00-22-35887) 2025 Understanding skilled nursing facilities' (SNFs') costs is crucial to understanding the factors that contribute to nursing home performance and how nursing homes deliver care to beneficiaries. The cost of services, facilities, and supplies furnished to a provider by an organization related to the provider by common ownership or control may be included in the allowable cost of the provider in an amount equal to the related organization's cost. However, such cost must not exceed the price of comparable services, facilities, and supplies that could be purchased elsewhere. Medicare requires that a reported amount be the lower of either the actual cost to the related organization or the market price for comparable services, facilities, or supplies, thereby removing any incentive to realize profits through these transactions. We will determine whether SNFs are reporting related-party costs in accordance with Federal regulations. We will also determine whether a SNF's allocation of Medicare funds could impact beneficiary care, such as whether overhead costs might have increased while allocations for patient care decreased, potentially reducing care. Financial Stewardship, Nursing Homes, Nursing Facilities, and Assisted Living Facilities, Medicare A
Revised Office of the Secretary Reporting of Security Incidents by HHS-Contracted Service Providers Office of Audit Services W-00-22-42042 2024 In accordance with the Federal Information Security Management Act and OMB Circular A-130, Federal agencies are required to ensure external service providers that are processing, storing, or transmitting Federal information or operating information systems on behalf of the Federal Government meet the same security requirements as Federal agencies. These requirements include policies and procedures for detecting and reporting security incidents. We will conduct an audit to evaluate the effectiveness of controls at selected HHS divisions to ensure service providers are identifying and reporting cybersecurity incidents. The purpose of this audit is to determine whether HHS has effective controls that ensure service providers identify and report cybersecurity incidents in a timely manner. Information Technology and Cybersecurity, Other Funding
Revised Centers for Medicare and Medicaid Services CMS's Emergency Preparedness Related to Clinical Laboratories During the COVID-19 Public Health Emergency Office of Audit Services WA-22-0010 (W-00-22-35889) 2025 Laboratory tests are a critically important part of early detection, diagnosis, monitoring, and treatment of disease. During public health emergencies or disasters, CMS has the authority to provide regulatory flexibilities and waivers to ensure that Medicare beneficiaries continue to have access to needed health care. To help health care providers and suppliers prepare for these emergencies or disasters, CMS adopted a final rule (the Emergency Preparedness Rule) in September 2016. The rule required those providers and suppliers to: (1) plan adequately for both natural and manmade disasters; (2) coordinate with Federal, State, Tribal, and regional and local emergency preparedness systems; and (3) adequately prepare to meet the needs of patients during disasters and emergency situations. The rule covers 17 facility types (e.g., hospitals, hospices, and long-term care facilities) but does not cover clinical laboratories. Continued laboratory testing during a public health emergency as well as timely and reliable testing for novel infectious diseases are important for the health of Medicare beneficiaries. Effective testing for novel infectious diseases (including COVID-19) are essential in helping to slow the spread of these diseases by identifying those who are infected and enabling treatment or isolation if needed. We will conduct an audit to determine whether CMS's emergency preparedness for clinical laboratories could be improved. Specifically, we will look at CMS's emergency preparedness to ensure that: (1) beneficiaries maintain access to all types of laboratory tests, including laboratory tests for novel infectious diseases during a public health emergency, and (2) laboratories have the ability to develop and deliver timely and accurate testing for novel infectious diseases during a public health emergency.

COVID-19, Emergency Preparedness and Response, Laboratories, Public Health Issues, Elderly, Medicare B
Completed Centers for Medicare and Medicaid Services States' Medicaid Eligibility and Enrollment Actions Concluding the COVID-19 Public Health Emergency Office of Audit Services WA-22-0012 (W-00-22-31567);
A-02-24-01001;
A-07-24-07013
2025 In response to the COVID-19 pandemic, section 6008 of the Families First Coronavirus Response Act (FFCRA) provides a temporary increase of 6.2 percentage points to each qualifying State's and Territory's Federal Medical Assistance Percentage (FMAP), effective January 1, 2020. To receive the increased FMAP, FFCRA requires States to provide benefits to individuals who were enrolled in Medicaid at the start of the COVID-19 public health emergency (PHE) or become enrolled in Medicaid during the emergency period. These individuals should remain eligible for Medicaid through the last day of the month in which the COVID-19 PHE ends (continuous enrollment period), unless the individual requests a voluntary termination of eligibility, or the individual ceases to be a resident of the State. Within the 12-month period in which the COVID-19 PHE ends, States must initiate all renewals, post-enrollment verifications, and redeterminations for all individuals enrolled when the continuous enrollment expires. At the conclusion of the COVID-19 PHE, we will review the States' required Medicaid eligibility and enrollment actions. We will determine whether States completed pending Medicaid eligibility and enrollment actions in accordance with CMS requirements that take effect after the COVID-19 PHE. COVID-19, Departmental Operational Issues, Medicaid
Revised National Institutes of Health Audit of National Institutes of Health's Data Integrity Controls for the Sequence Read Archive Data Office of Audit Services WA-22-0005 (W-00-22-42043) 2024 The National Center for Biotechnology Information (NCBI), part of the National Library of Medicine, hosts one of the National Institutes of Health's largest and most diverse datasets, the Sequence Read Archive (SRA). SRA is a broad collection of experimental DNA and RNA sequences that represent genome diversity. In 2019, SRA held 9 million records in 2 formats. The original format (23 petabytes) is received by NCBI from submitters and is instrument and experiment specific; these data are stored to tape. NCBI then transforms these original data into standard SRA normalized format (12.7 petabytes) for redistribution. Through this SRA normalized database, which is cloud based and accessed via NCBI servers, researchers can search metadata to locate the sequence reads for further analyses. SRA usage follows International Nucleotide Sequence Database Collaboration principles, which state that data are shared without restriction, that the individual submitting the data must be the owner of the data, and that ownership of the data remains with the submitter even after submission. This audit will concentrate on system integrity controls, including malicious code protection and data input validation as well as other Federal requirements for normalizing and archiving SRA data. The audit objective will be to determine whether NIH has implemented adequate system integrity controls to ensure the reliability of SRA data. Public Health Issues, Other Funding
Completed Centers for Medicare and Medicaid Services Congressional Mandate: Noncovered Versions of Part B Drugs Office of Evaluation and Inspections OEI-BL-22-00380;
OEI-BL-24-00030;
OEI-BL-24-00070
2024 Under the Consolidated Appropriations Act, 2021, Congress enacted provisions requiring CMS to remove noncovered self-administered versions of Cimzia and Orencia from Part B payment amount calculations beginning in July 2021. Through the same legislation, Congress required OIG to conduct studies to identify additional drugs for which noncovered self-administered versions are included in Part B payment amounts, and to determine whether they should be excluded from Part B payment amount calculations. In response, OIG will conduct periodic studies identifying drugs for which noncovered self-administered versions were included in Part B payment amounts. In general, for the drugs that OIG identifies, CMS is required to remove noncovered self-administered versions from payment amount calculations in subsequent quarters if the exclusions would result in lower payment amounts; however, the statute provides CMS with some discretion in addressing the requirement. Financial Stewardship, OIG Statutory Authority and Regulatory Matters, Prescription Drug, Elderly, Medicare B
Completed Centers for Disease Control and Prevention Audit of CDC's COVID-19 'Vaccinate with Confidence' Strategy Office of Audit Services WA-22-0007 (W-00-22-59473);
A-06-22-04004
2025 HHS announced the availability of $1 billion in supplemental American Rescue Plan Act of 2021 (ARP) (P.L. 117-2) funding for the Centers for Disease Control and Prevention (CDC) to support its COVID-19 strategy, "Vaccinate with Confidence: Strategy to Reinforce Confidence in COVID-19 Vaccines," which includes building trust, empowering health care personnel, and engaging communities and individuals. CDC defines "vaccine confidence" as the belief that vaccines work, are safe, and are part of a trustworthy medical system. Strong confidence in COVID-19 vaccines within communities could lead to more adults, adolescents, and children getting vaccinated. From the $1 billion in supplemental funding, CDC awarded State, Tribal, local, and Territorial (STLT) recipients a combined $250 million for developing and implementing a vaccine confidence strategy, supporting efforts to build vaccine confidence, and conducting outreach to build trust in COVID-19 vaccines, the health care personnel who provide them, and the system that approves and distributes them. These funds may be used for television, radio, internet, and other media and communications technologies; used for in-person activities; be focused to address specific needs of communities and populations with low vaccination rates; and include the dissemination of scientific and evidence-based, vaccine-related information. For the first audit, we will determine how much of each STLT recipient's award had been expended at the time of our audit, identify the best practices used and potential barriers STLT recipients faced when spending the supplemental ARP funds, and determine whether CDC provided oversight to STLT recipients in developing and implementing a vaccine confidence strategy. For the second audit, we will determine whether select STLT recipients used supplemental ARP funding in accordance with Federal requirements and applicable award terms and conditions, and for underserved communities. COVID-19, Emergency Preparedness and Response, Financial Stewardship, Grants
Revised Centers for Medicare and Medicaid Services Medicare Payments for Intermittent Urinary Catheters Office of Audit Services WA-22-0008 (W-00-22-35888) 2025 Medicare covers reasonable and necessary durable medical equipment, prosthetics, and orthotics supplies (DMEPOS), such as intermittent urinary catheters (Social Security Act § 1861 (n) and (s)(8), and 1862(a)(1)(A)). For calendar year 2021, Medicare paid more than $308 million for intermittent urinary catheters. Prior reviews performed by OIG and CMS contractors have identified high improper payment rates for urological supplies (including intermittent urinary catheters) that did not meet Medicare requirements. Upon request, a supplier must provide documentation from the physician or treating practitioner indicating that the urological supplies were reasonable and necessary for the beneficiary's condition (42 CFR § 410.38(d)(3)). We will audit Medicare payments for intermittent urinary catheters to determine whether claims submitted by DMEPOS suppliers complied with Medicare requirements and guidance. Medical Supplies and Equipment, Medicare B
Completed Food and Drug Administration Food and Drug Administration's Actions Regarding the Abbott Infant Formula Recall Office of Audit Services WA-22-0006 (W-00-22-59472);
A-01-22-01502
2024 The Federal Food, Drug, and Cosmetic Act requires the Food and Drug Administration (FDA) to safeguard the Nation's food supply, including infant formula, and ensure that all ingredients are safe. As part of its oversight activities, FDA conducts inspections at infant formula manufacturers and can require infant formula manufacturers to recall adulterated infant formula that presents a risk to human health. We will determine whether FDA followed the inspections and recall process for infant formula in accordance with Federal requirements. Specifically, we will review FDA's actions leading up to the infant formula recall at the Abbott facility in February 2022 to determine whether FDA followed applicable policies and procedures to: (1) conduct inspections of the manufacturing facility and (2) oversee Abbott's initiation of the infant formula recall. Food, Drug, and Device Safety, Public Health Issues, Children and Families, Other Funding
Completed (partial) Centers for Medicare and Medicaid Services Medicare Administrative Contractor Cost Report Settlements with Audit Office of Audit Services W-00-22-35886;
A-06-22-05000;
A-06-23-05001;
A-06-24-05000
2025 HHS contracts with Medicare Administrative Contractors (MACs) to process claims and cost reports and determine payment amounts to providers (Social Security Act, § 1874A(a)). MACs determine the total amount of reimbursement based on providers' cost reports. MACs perform a desk review, and at their discretion, may perform either a field audit or an in-house audit to determine the cost report's adequacy, completeness, and accuracy. Generally, some cost reports that have been audited and settled are later reopened to correct audit adjustments. CMS has stated that it does not maintain data related to the number of cost reports that are reopened, the monetary adjustments to the settlement made as a result of reopenings, or the types and/or causes of adjustments. Our objective will be to: (1) quantify the extent to which the MAC amends audit adjustments after cost reports have been audited and settled, and whether the audit adjustments contain obvious errors or are inconsistent with the law, regulations and rulings, or general instructions; (2) quantify the effect of amended audit adjustments; and (3) gain an understanding of the types and/or causes of amended audit adjustments. Initially, we will audit a single MAC, and based on the results, we may expand this work to others. Departmental Operational Issues, Hospitals, Nursing Homes, Nursing Facilities, and Assisted Living Facilities, Medicare A, Medicare B
Completed (partial) Centers for Medicare and Medicaid Services States' and MCOs' Compliance With Mental Health Parity Requirements Office of Audit Services WA-22-0003 (W-00-22-31565);
A-02-22-01016
2025 The Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) promotes equal access to treatment for mental health and substance use disorder (MH/SUD) by prohibiting coverage limitations that apply more restrictively to MH/SUD benefits than medical or surgical benefits. Such limitations could include higher copayments, separate deductibles, and stricter preauthorization or medical necessity reviews, as compared to other covered medical treatments. Federal regulations require managed care organizations (MCOs) with plans that provide services to Medicaid enrollees to comply with the parity provisions of MHPAEA. Federal regulations require that States or their MCOs, as applicable, conduct analyses to demonstrate compliance with parity requirements. CMS reviews States' parity analyses as part of its review of States' MCO contracts. We will audit CMS's oversight of States' compliance with Federal parity requirements, including whether States and their MCOs conducted the required parity analyses and whether States ensured that their MCOs complied with certain parity requirements for MH/SUD benefits.

Hospitals, Managed Care, Mental Health, Substance Abuse Disorders, Medicaid
Revised Administration for Children and Families Audit of the Low Income Home Energy Assistance Program for Fiscal Years 2021 and 2022 Office of Audit Services WA-22-0001 (W-00-22-20036) 2025 The Low Income Home Energy Assistance Program (LIHEAP) assists low income households in meeting their immediate home energy needs. LIHEAP funds can be used to help pay for heating and cooling, crisis assistance, and services (such as counseling) to reduce the need for energy assistance. At the Federal level, LIHEAP is administered by the Administration for Children and Families (ACF). States either administer the LIHEAP program or award LIHEAP funds to subgrantees that administer the program on a State's behalf. Federal requirements allow for 10 percent of total grant funds to be used for planning and administering LIHEAP. Previous OIG and Government Accountability Office audits revealed that ACF oversight of LIHEAP was not adequate to ensure that States and subgrantees consistently administered grant funds in accordance with Federal requirements. Since March 2020, the Federal Government has appropriated $9.3 billion for LIHEAP through the Coronavirus Aid, Relief, and Economic Security Act, the American Rescue Plan Act, the Infrastructure Investment and Jobs Act, and the annual LIHEAP block grant. We plan to conduct a series of audits of LIHEAP in high-risk States to determine whether the selected States monitored subgrantees to ensure compliance with Federal and State LIHEAP requirements. COVID-19, Financial Stewardship, Children and Families, Grants
Completed Indian Health Service Indian Health Service's Capacity to Manage Infrastructure Investment and Jobs Act Funding Appropriated to Sanitation Facilities Construction Projects Office of Evaluation and Inspections OEI-06-22-00320
OEI-06-24-00010
2025 The Indian Health Service (IHS) Sanitation Facilities Construction (SFC) Program works in partnership with Tribes to prevent the spread of disease by providing American Indian and Alaska Native homes and communities with essential water supply, sewage disposal, and solid waste disposal facilities. In fiscal year 2021, IHS identified a need of more than $3.4 billion for SFC projects affecting more than 248,000 new and existing homes. To address that need, Congress appropriated $3.5 billion for SFC projects through the Infrastructure Investment and Jobs Act. OIG is conducting a two-phase evaluation to assess IHS's capacity to administer and oversee the supplemental $3.5 billion. In the first phase, OIG conducted preliminary research of IHS's capacity and shared early observations with the agency in September 2022 (OEI-06-22-00320) to help IHS preemptively address challenges. In the second phase (OEI-06-24-00010), OIG will further assess IHS's capacity by more deeply examining the previously identified challenges, as well as any new or anticipated issues and IHS's efforts to overcome challenges and incorporate lessons learned. Contracts, Financial Stewardship, Native Americans, Other Funding
Completed Centers for Medicare and Medicaid Services Strategies To Improve Access to Maternal Health Care in Medicaid Managed Care Office of Evaluation and Inspections OEI-05-22-00330 2025 Pregnant people in the United States experience the worst pregnancy outcomes in the developed world, and significant disparities exist. Maternal health care can improve pregnant people's pregnancy outcomes; however, many pregnant people in the United States lack access to maternal health care. Medicaid is the Nation's largest maternal health care payor, financing more than 42 percent of all U.S. births, and many pregnant Medicaid beneficiaries are enrolled in managed care plans. This study will identify strategies to increase access overall and reduce disparities in access to maternal health care for Medicaid beneficiaries enrolled in managed care. Managed Care, Mental Health, Substance Abuse Disorders, Children and Families, Native Americans, Other Minorities, Medicaid
Revised Administration for Children and Families Audit of the Administration for Children and Families Awarding of an Unaccompanied Children Program Sole Source Contract to Family Endeavors, Inc. Office of Audit Services W-00-22-20035 2025 The Office of Refugee Resettlement (ORR), a program office of HHS's Administration for Children and Families (ACF), manages the Unaccompanied Children Program. In fiscal year 2021, an influx of unaccompanied children began arriving at the U.S. southern border, coinciding with the Nation's ongoing efforts to control the spread of COVID-19. As a result, ACF identified a need to increase the number of shelter beds in its provider network and entered into contracts for shelter and related services for unaccompanied children. These contracts included services for a new type of provider facility known as an emergency intake site (EIS). ACF awarded a sole source contract to Family Endeavors, Inc., a nonprofit social service agency, to operate as an EIS and provide services for unaccompanied children. Congress has expressed concerns about and the media has reported on ACF's awarding of the sole source contract to Family Endeavors, Inc. We will determine whether ACF awarded this sole source contract in accordance with Federal statutes and regulations, as well as HHS policies and procedures. Contracts, Emergency Preparedness and Response, Children and Families, Other Funding
Revised Centers for Medicare and Medicaid Services Medicare Part B Add-On Payments for COVID-19 Tests Office of Audit Services W-00-22-35884 2025 Laboratory tests are critical for early detection, diagnosis, monitoring, and treatment of disease. Effective testing for COVID-19 is essential to slow its spread by identifying those with the virus and enabling treatment or isolation. On October 15, 2020, CMS announced actions to incentivize prompt COVID-19 test turnaround times by paying more for expedited results. CMS has identified that timelier test results benefit individual patients, their immediate communities, and the public at large. Starting in 2021, the amended Administrative Ruling (CMS 2020-1-R2) lowered the base payment amount for COVID-19 clinical diagnostic laboratory tests (CDLTs) that use high-throughput technology to $75 in accordance with CMS's assessment of the resources needed for those tests. The amended ruling also established an additional $25 add-on payment for a COVID-19 CDLT that uses high-throughput technology if the laboratory: (1) completed the test in 2 calendar days or less and (2) completed a majority of the CDLTs that use high-throughput technology in 2 calendar days or less for all their patients (not just their Medicare patients) in the previous month. For this audit, we will review providers' supporting documentation for the COVID-19 CDLT add-on payments to determine whether the documentation complied with Medicare requirements.

COVID-19, Laboratories, Medicare B
Completed Centers for Medicare and Medicaid Services Followup Review of Inpatient Claims Under the Post-Acute-Care Transfer Policy (PACT) Office of Audit Services A-09-23-03016 2024 Medicare makes the full Medicare Severity Diagnosis-Related Group (MS-DRG) payment to a hospital that discharges an inpatient beneficiary "to home." However, for certain qualifying MS-DRGs under the post-acute-care transfer policy, Medicare pays hospitals a per diem rate when an inpatient beneficiary is transferred to post-acute care. The per diem payment cannot exceed the full payment that would have been made if the beneficiary had been discharged to home. A prior OIG review identified Medicare overpayments to hospitals that did not comply with the post-acute-care transfer policy (42 CFR § 412.4(c)). OIG's review found that the CMS Common Working File (CWF) edits that detected inpatient claims under the post-acute care transfer policy were working appropriately. However, some Medicare contractors did not receive automatic notifications of improperly billed claims or did not act to adjust those claims. As a result, OIG recommended that CMS recover the identified overpayments in line with its policies and procedures and ensure that the Medicare contractors are receiving the notifications and are acting to recover the overpayments. CMS concurred with all OIG recommendations and detailed how they were addressed. This followup audit will determine whether CMS's CWF edits are working properly in detecting inpatient claims under the post-acute-care transfer policy and are automatically recovering overpayments, and whether Medicare contractors are receiving the automatic notifications and acting to recover overpayments. Hospitals, OIG Statutory Authority and Regulatory Matters, Medicare A
Completed Centers for Medicare and Medicaid Services Medicaid Rehabilitation Services Made by Community Residence Providers Office of Audit Services A-02-22-01011 2024 States can provide optional rehabilitation services under Medicaid programs available to adults with developmental disabilities and children and adolescents with serious emotional issues in certain community residential settings (e.g., group homes or supervised apartments). These residential rehabilitation services may include training and assistance with daily living skills, medication management, socialization, substance use disorder services, and parental training. Services are designed to improve or maintain the beneficiary's ability to remain and function in the community, as well as develop greater independence. Prior OIG audits of these services, over a decade ago, identified significant deficiencies. We will determine whether States claimed Federal Medicaid reimbursement for rehabilitation services provided by community residence providers in accordance with Federal and State requirements. In addition, we will determine whether previously audited States have made improvements to their Medicaid community residence rehabilitation programs based on the prior recommendations. Financial Stewardship, Mental Health, Non-institutional care, Quality of Care, Substance Abuse Disorders, People with Disabilities, Medicaid
Completed (Partial) Centers for Medicare and Medicaid Services Electronic Visit Verification System for Medicaid In-Home Services Office of Audit Services W-00-22-31564;
A-07-23-03255
2025 All States were required to implement an electronic visit verification (EVV) system for personal care services (PCS) by January 1, 2020, and for home health services by January 1, 2023. CMS granted the vast majority of States a 1-year extension (to January 1, 2021) for meeting EVV requirements for PCS. EVV was developed to address weaknesses in PCS that contribute to improper payments, questionable quality of care, and significant fraud. Our objectives will be to determine whether selected States: (1) implemented an EVV system according to Federal and State requirements, and (2) complied with Federal and State requirements when claiming Medicaid in home PCS. Information Technology and Cybersecurity; Non-institutional care; Quality of Care; Medicaid
Completed Centers for Medicare and Medicaid Services Identifying Gaps in the Receipt of Recommended Care Among Medicaid Beneficiaries with HIV Office of Evaluation and Inspections OEI-05-22-00240;
OEI-05-22-00242
2025 People with HIV can improve their health and prevent HIV transmissions by receiving recommended HIV care. But certain groups with HIV, such as African Americans, are less likely to receive regular HIV care compared to other groups. Medicaid plays an important role in providing care to people with HIV, as it is the single largest source of insurance for people living with HIV. This study will identify the extent to which Medicaid beneficiaries diagnosed with HIV receive care that aligns with the widely used Federal performance measures, both overall and by selected demographic factors that include race/ethnicity, sex, and location. Identification of potential gaps and disparities in care can help CMS, States, and managed care organizations identify areas for improvement to ensure that Medicaid beneficiaries with HIV receive care that improves health outcomes and reduces HIV transmission. Managed Care, Public Health Issues, Quality of Care, Other Minorities, Medicaid
Completed (partial) Centers for Medicare and Medicaid Services Medicaid Estate Recovery Program Office of Audit Services W-00-22-31561;
A-07-22-03254
2025 Several States have not implemented all the requirements of their Medicaid Estate Recovery Programs; therefore, they might be running the programs ineffectively and not recovering certain long-term care costs due from the applicable estates of deceased Medicaid recipients. We will determine whether State agencies, under their Medicaid Estate Recovery Programs: (1) had policies and procedures to comply with Federal and State requirements, (2) attempted to recover the applicable reimbursement costs for certain long-term care, (3) accurately reported Medicaid estate recovery amounts associated with certain long-term care services on the CMS-64, and (4) identified the costs incurred to recover from the estates. Financial Stewardship, Nursing Homes, Nursing Facilities, and Assisted Living Facilities, Medicaid
Completed (partial) Centers for Medicare and Medicaid Services Achieved Savings Rebate Program-Offset of Rebates on CMS-64 Office of Audit Services W-00-22-31562;
A-04-22-04089
2024 The Social Security Act (the Act) Section 1115 gives CMS authority to approve experimental, pilot or demonstration projects that it considers likely to assist in promoting the objectives of the Medicaid program. States may then use CMS-approved waivers to have Managed Care Organizations (MCOs) provide care to Medicaid beneficiaries. Under these arrangements, States make capitation payments to the MCOs in return for the MCOs providing the patient care for the Medicaid beneficiaries. Some States place limitations on MCOs' earnings, for example, limiting the profits they may earn or requiring a certain percentage of their revenues to be spent on medical expenses. States with such limitations may require the MCOs to return a portion of the capitation payments when the MCOs exceed those limitations. According to the Act, § 1903(d)(3)(A) States are required to refund to the Federal Government the Federal share of any amounts recovered during any fiscal quarter. Additionally, 45 CFR § 75.406(a) requires recipients of Federal awards (which includes State Medicaid agencies) to credit to the Federal award the Federal share of reduction-of-expenditure type transactions, such as rebates, purchase discounts, or allowances when those transactions relate to allowable costs. For selected States, we will determine whether the States properly offset against CMS-64 expenditures refunds of capitation payments received from MCOs. Financial Stewardship, Medicaid
Completed Administration for Children and Families Audit of States' Child Support Administrative Costs Office of Audit Services A-01-18-02501;
A-01-22-02500
2024 The Child Support Enforcement Program, established in 1975 under Title IV-D of the Social Security Act, functions as a Federal, State, and local partnership to collect child support payments from noncustodial parents for distribution to custodial parents. Within the Department of Health and Human Services, Administration for Children and Families, the Office of Child Support Enforcement provides Federal oversight of the program. In most States, a single State agency performs the day-to-day operations, but in others counties operate the program, and States administer it. Program responsibilities include locating noncustodial parents—those who are not the primary caregivers or do not have custody or control —, establishing paternity and support orders, and collecting and distributing child support payments. Costs to carry out these responsibilities are administrative and uncapped, so the Federal share of the program increases as States spend more on program administration. Based on a risk assessment, we will select States for review to determine whether program administrative costs claimed were allowable and allocable in accordance with Federal and State requirements. Grants, Children and Families, Financial Stewardship
Revised Administration for Children and Families Audit of the Administration for Children and Families Awarding and Monitoring of Unaccompanied Children Program Contracts for Emergency Intake Sites Office of Audit Services W-00-22-20033 2025 The Office of Refugee Resettlement (ORR), a program office of the Administration for Children and Families (ACF) within HHS, manages the Unaccompanied Children Program. In fiscal year 2021, an influx of unaccompanied children began arriving at the U.S. southern border, coinciding with the Nation's ongoing efforts to control the spread of COVID-19. As a result, ACF identified a need to increase the number of shelter beds in its provider network and entered into contracts for shelter and related services for unaccompanied children. In addition, ACF opened a new type of provider facility known as an emergency intake site (EIS). We will determine whether ACF awarded, monitored, and terminated contracts for EISs in accordance with Federal statutes and regulations, as well as HHS policies and procedures. Contracts, Emergency Preparedness and Response, Children and Families, Other Funding
Completed Centers for Disease Control and Prevention Audit of CDC's COVID-19 Awards to Selected State Departments of Health Office of Audit Services W-00-22-59469;
A-04-22-02035; A-04-22-02037
2025 In response to the COVID-19 pandemic in the United States, the Secretary of HHS declared a public health emergency on January 31, 2020. During 2020, Congress approved five COVID-19 appropriation bills: (a) Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123), (b) Families First Coronavirus Response Act (P.L. 116-127), (c) CARES Act (Coronavirus Aid, Relief, and Economic Security Act) (P.L. 116-136), (d) Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139), and (e) Coronavirus Response and Relief Supplemental Appropriations Act, 2021 (P.L. 116-260). The CDC distributed funds from these appropriations through existing grants and cooperative agreements to provide support for core public health response activities, such as epidemiology, surveillance, laboratory capacity, infection control, mitigation, and communications. These distributions increased some States’ normal annual award amounts by approximately three to four times. Prior OIG audits have identified potential risk areas related to influxes of appropriations to States. Our objective will be to determine whether selected State Departments of Health used their CDC COVID-19 funding in accordance with award requirements. Emergency Preparedness and Response, Financial Stewardship, Grants, People with Disabilities, Medicare D
Completed (partial) Centers for Disease Control and Prevention Audit of the Centers for Disease Control and Prevention Grants to Recipients for COVID-19 Screening Testing at Schools Office of Audit Services W-00-22-59468;
W-00-23-59468;
A-05-22-00010;
W-00-24-59468
2025 The Centers for Disease Control and Prevention's (CDC's) Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) program provides strategic investments aimed at reducing infectious disease-related illnesses and death through its cooperative agreement with health departments throughout the United States. Financial resources and technical assistance are provided each year to 64 jurisdictions to support activities related to surveillance, detection, response, and prevention of infectious diseases. The American Rescue Plan (ARP) Act of 2021, enacted March 11, 2021 (P.L. No. 117-2), provides additional relief to address COVID-19's continued impact on the economy, public health, State and local governments, individuals, and businesses. The CDC, through the ELC program, provided $10 billion in ARP funding to States to support COVID-19 screening testing for teachers, staff, and students to assist schools in reopening safely for in-person instruction. The $10 billion, under the ELC reopening school awards, was awarded to the current 64 ELC jurisdictions according to a population-based formula. Our first audit will determine whether the CDC provided effective oversight to the ELC recipients in implementing the screening testing programs. Our second phase of audits will determine whether select ELC recipients had controls in place to monitor schools in implementing COVID-19 screening testing programs. In addition, we will determine whether select ELC recipients and schools used the ARP funding in accordance with Federal requirements and the applicable grant terms. COVID-19, Emergency Preparedness and Response, Financial Stewardship, Laboratories, Medical Supplies and Equipment, Children and Families, Grants
Completed Administration for Community Living Audit of Administration for Community Living's Coronavirus Aid, Relief, and Economic Security Act Funding for the Older American Act Nutrition Services Program Office of Audit Services W-00-22-59467;
A-07-22-04130;
A-06-22-01004
2025 Through the Older Americans Act (OAA) Nutrition Services Program, the Administration for Community Living provides grants to States and U.S. territories to help support nutrition services nationwide for individuals 60 or older. These services include both home-delivered meals and meals served in group settings (congregate settings), such as senior centers and faith-based locations. In March 2020, many State and local governments across the country instituted stay-at-home orders that confined individuals to their homes except to shop for essentials or seek medical attention. Because seniors were at a higher risk of hospitalization and death due to complications of COVID-19, the Centers for Disease Control and Prevention advised them to have limited interactions with the general public. Consequently, many of the congregate meal locations closed, and those that did not were cautioned to prioritize safety for clients and providers. Thus, COVID-19 increased the need for home-delivered meals. On April 21, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) provided approximately $480 million for the OAA Nutrition Services Program to expand “drive-through” or “grab-and-go" meals for older adults who previously would have participated in congregate meal programs. Our audit will determine whether CARES Act OAA Nutrition Services Program funds were used in accordance with Federal and State requirements. COVID-19, Financial Stewardship, Elderly, Grants
Revised Administration for Children and Families Audit of the Administration for Children and Families Awarding and Monitoring of an Unaccompanied Children Program Sole Source Contract to Deloitte Consulting LLP Office of Audit Services W-00-22-20029 2025 The Office of Refugee Resettlement (ORR), a program office of the Administration for Children and Families (ACF) within the Department of Health and Human Services (HHS), manages the Unaccompanied Children Program. In fiscal year 2021, an influx of unaccompanied children began arriving at the U.S. southern border, coinciding with the Nation's ongoing efforts to control the spread of COVID-19. As a result, ACF identified a need to increase the number of shelter beds in its provider network and entered into contracts for shelter and related services for unaccompanied children. ACF awarded a sole source contract to Deloitte Consulting LLP to provide professional support services to address the influx of children at the southern border. We will determine whether ACF awarded and monitored this sole source contract in accordance with Federal statutes, Federal regulations, and HHS policies and procedures. Contracts, Emergency Preparedness and Response, Children and Families, Other Funding
Revised Health Resources and Services Administration Hospital's Compliance With the Provider Relief Fund Balance Billing Requirement for Out - of - Network Patients Office of Audit Services W-00-22-35878 2025 The Coronavirus Aid, Relief, and Economic Security (CARES) Act, Paycheck Protection and Health Care Enhancement Act, and Consolidated Appropriations Act, 2021, appropriated a combined $178 billion in relief funds to hospitals and other health care providers. This funding, known as the Provider Relief Fund (PRF), is administered by the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) and is intended to reimburse eligible health care providers for health care-related expenses or lost revenue attributable to COVID-19 and to ensure that Americans could get testing and treatment for COVID-19. Under the PRF terms and conditions, hospitals are eligible for PRF distribution payments if they attest to specific requirements, including a requirement that providers, such as hospitals, must not pursue the collection of out-of-pocket payments from presumptive or actual COVID-19 patients in excess of what the patients otherwise would have been required to pay if the care had been provided by in-network providers. We refer to this limitation on balance billing, commonly referred to as "surprise billing," as the "balance billing requirement." We will perform a nationwide audit to determine whether hospitals that received PRF payments and attested to the associated terms and conditions complied with the balance billing requirement for COVID‑19 inpatients. We will assess how bills were calculated for out‑of-network patients admitted for COVID-19 treatment, review supporting documentation for compliance, and assess procedural controls and monitoring to ensure compliance with the balance billing requirement. COVID-19, Financial Stewardship, Hospitals, Public Health Issues, Medicare C, Private Insurance, Other Funding
Revised Centers for Medicare and Medicaid Services Nationwide Review of Hospice Beneficiary Eligibility Office of Audit Services W-00-22-35883 2024 Hospice care can provide comfort to beneficiaries, families, and caregivers at the end of beneficiarie's lives. To be eligible for hospice care, they must be entitled to Medicare Part A and be certified as being terminally ill. The certification of terminal illness for hospice benefits shall be based on the clinical judgment of the hospice medical director or physician member of the interdisciplinary group, and the beneficiarie's attending physician, if they have one, regarding the normal course of their illness. OAS has performed several compliance audits of individual hospice providers in recent years, and each of those audit reports identified findings related to beneficiary eligibility. We will perform a nationwide review of hospice eligibility, focusing on those hospice beneficiaries that haven't had an inpatient hospital stay or an emergency room visit in certain periods prior to their start of hospice care. Departmental Operational Issues, Financial Stewardship, Non-institutional care, Elderly, Medicare A
Revised Centers for Medicare and Medicaid Services Medicare Administrative Contractor Cost Report Oversight - Contract Review Office of Audit Services W-00-22-35881 2025 In accordance with their CMS contracts, Medicare administrative contractors (MACs) are responsible for accepting, auditing, and settling provider Medicare cost reports. The MAC performs desk reviews of all cost reports and audits as warranted prior to settlement of the cost report to determine adequacy, completeness, and accuracy and reasonableness of the data in the cost report. We will review the MACs cost report oversight by verifying the number of desk reviews and the number of audits performed in accordance with the CMS contract and identify non-compliance issues. Following this review, we will conduct additional reviews that will include MAC audit findings and recommendations to determine whether the provider implemented the recommendations and took corrective action. Finally, we will examine CMS's oversight of the MAC cost report desk reviews/audits. Our audit's objective is to determine whether the individual MACs met requirements stated in the MAC contracts. Contracts, Financial Stewardship, Medicare A
Completed (partial) Centers for Disease Control and Prevention Grantees' Use of President's Emergency Plan for AIDS Relief Funds Office of Audit Services W-00-20-57300;
W-00-21-57300;
W-00-24-57300;
A-04-20-01017;
A-04-21-01023;
A-04-21-01021
2025 In more than 60 countries, Centers for Disease Control and Prevention (CDC) grantees such as ministries of health and other partners work to control the HIV/AIDS epidemic. CDC awarded more than $5.5 billion in President's Emergency Plan for AIDS Relief (PEPFAR) funds to grantees during FYs 2018 through 2020 (about 96 percent of PEPFAR funds received by HHS during the three FYs) to accelerate HIV treatment and prevention worldwide by using public health, innovation, and data-driven approaches to achieve the global goal of HIV/AIDS epidemic control. To date, HHS-OIG has conducted 21 audits of grantees in 8 countries on 2 continents (Africa and Asia). OIG's PEPFAR oversight has helped grant recipients learn important grant and program integrity lessons that apply to ongoing and future responses to infectious diseases. In previous audits of foreign PEPFAR grantees, OIG identified unallowable expenditures, inadequate accounting systems, and internal control weaknesses. We will determine whether selected foreign or domestic grantees: (1) managed and expended PEPFAR funds in accordance with award requirements, and (2) have controls to mitigate potential risk to the PEPFAR program. Public Health Issues, Grants
Revised Centers for Medicare and Medicaid Services Race and Ethnicity Data for Medicaid Beneficiaries Office of Evaluation and Inspections OEI-02-22-00130 2025 Complete and consistent race and ethnicity data for Medicaid beneficiaries are critical to identifying and addressing health disparities. As the COVID-19 pandemic has highlighted disparities among racial and ethnic groups, the availability and quality of data on race and ethnicity warrants a closer look in order to accurately and appropriately mitigate health disparities within the Medicaid population. This study will evaluate the extent to which Medicaid's race and ethnicity data for beneficiaries as reported to T-MSIS are complete and consistent across States. We will also determine the extent to which the data align with Federal data collection standards for race and ethnicity. Other: Health Disparities, Native Americans, Other Minorities, Medicaid
Completed (partial) Centers for Medicare and Medicaid Services Availability of Behavioral Health in Medicare Fee-For-Service, Medicare Advantage, and Medicaid Managed Care Office of Evaluation and Inspections OEI-02-22-00050;
OEI-09-21-00410;
OEI-02-23-00540
2025 More than half of all Americans will be diagnosed with a behavioral health condition in their lifetime, estimates indicate, and many experts say that the need for behavioral health services has grown dramatically during the COVID-19 pandemic. Medicare and Medicaid beneficiaries often have unmet behavioral health needs and face difficulty accessing appropriate services. To address these concerns, OIG will conduct a three-part study to examine access to behavioral health care in Medicare fee-for-service, Medicare Advantage, and Medicaid managed care. For selected localities, this study will determine: (1) the ratio of behavioral health providers to beneficiaries within each of these three programs; (2) the extent to which behavioral health providers have availability to accept new patients and schedule appointments within each of the three programs; and (3) the extent to which behavioral health providers listed in networks of managed care plans provided services to the plans' beneficiaries. Combined, these studies will provide significant insight into the accessibility of behavioral health providers within each of these three programs. Managed Care, Mental Health, Physician and Healthcare Practitioners, Quality of Care, Substance Abuse Disorders, Medicaid, Medicare B, Medicare C
Completed (partial) OS, ACF, CMS, CDC, FDA HHS Cloud Infrastructure as a Service Security Audits Office of Audit Services W-00-22-42041;
A-18-22-08020
2025 Federal agencies are increasingly adopting cloud computing services to address information technology needs. During FY 2020, HHS reported that more than 21 percent of its systems were in the cloud. In view of the increase in cloud adoption across HHS, we are concerned that HHS may not be aware of all cybersecurity risks associated with its Infrastructure as a Service (IaaS) cloud environments. The Federal Risk and Authorization Management Program and National Institute of Standards and Technology requirements establish that agencies protect any Federal information that is collected, maintained, and processed by cloud service platforms. We will perform a series of audits to assess the security of the HHS OpDivs' cloud IaaS configurations and test whether attack vectors exist that adversaries could leverage to access HHS data. We will determine whether HHS OpDivs have properly identified and inventoried their IaaS cloud assets. In addition, we will determine whether HHS and OpDivs have implemented effective cybersecurity controls for their cloud IaaS environments in accordance with Federal and HHS security requirements and guidelines. Departmental Operational Issues, Other Funding
Revised 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 2024 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, Medicare C
Revised Centers for Medicare and Medicaid Services Medicaid Inpatient Hospital Claims With Severe Malnutrition Office of Audit Services W-00-22-31558 2025 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
Completed Centers for Medicare and Medicaid Services Medicare Payments for Inpatient Claims With Mechanical Ventilation Office of Audit Services A-09-22-03002 2024 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
Completed Administration for Children and Families Audit of Unaccompanied Children Data Cybersecurity Controls Office of Audit Services A-18-22-03200 2025 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
Revised 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 2024 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
Completed (partial) Health Resources and Services Administration COVID-19 Pandemic Relief Funding and Its Effects on Nursing Homes in Select Locations: Pandemic Response Accountability Committee Impact Study Office of Evaluation and Inspections OEI-06-22-00040;
OEI-06-22-00440;
OEI-06-22-00450;
OEI-06-22-00460;
OEI-06-22-00470;
OEI-06-22-00480
2025 The Pandemic Response Accountability Committee (PRAC) is producing a report about COVID-19 pandemic relief funding in six communities selected by PRAC for review. As part of PRAC's efforts, OIG will review Provider Relief Fund (PRF) payments and their effects on nursing homes in the selected locations. Congress and HHS have used the PRF to support nursing homes and other health care providers during the pandemic. HHS allocated $9.5 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. In addition to contributing to PRAC's report for the five locations with nursing homes that received PRF payments, OIG will use interviews and other data collected as part of those efforts to produce its own evaluation of nursing home use of PRF payments and Health Resources and Services Administration oversight. COVID-19, Emergency Preparedness and Response, Nursing Homes, Nursing Facilities, and Assisted Living Facilities, Public Health Issues, Quality of Care, Elderly, Other Funding
Revised CDC, NIH, AHRQ Cybersecurity Testing of HHS and Consumer Mobile Applications Office of Audit Services W-00-22-42040 2025 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
Completed (partial) 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;
A-02-21-02010
2024 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
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 2025 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 (partial) Food and Drug Administration Review of the FDA's Accelerated Approval Pathway Office of Evaluation and Inspections OEI-01-21-00400;
OEI-01-21-00401
2024 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
Completed 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;
A-09-21-01001
2024 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
Completed 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;
A-02-22-02001
2024 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
Completed 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 2024 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
Completed 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 2025 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
Completed (partial) 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;
A-18-21-11400
2025 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
Revised Centers for Medicare and Medicaid Services Audit of Medicaid Applied Behavior Analysis for Children Diagnosed With Autism Office of Audit Services W-00-24-31555 2025 Autism can cause significant social, communication, and behavioral challenges for children. According to the Centers for Disease Control and Prevention, research has shown that early intervention and therapy can improve social and behavioral development in children diagnosed with autism. A common therapy 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
Revised 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 2025 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
Completed (partial) Centers for Medicare and Medicaid Services Audits of Medicare Payments for Spinal Pain Management Services Office of Audit Services A-09-21-03002;
SRS-A-25-006;
A-09-20-03003;
A-09-20-03010;
A-09-22-03006;
A-07-21-00618
2025 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
Completed (partial) 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;
A-09-22-06001
2025 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
Completed Indian Health Service Audit of Background Verification Process at IHS-Operated Health Facilities Office of Audit Services W-00-21-59454;
W-00-23-59454;
A-02-21-02004;
A-02-23-02006
2025 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
Revised Centers for Medicare & Medicaid Services Skilled Nursing Facility Reimbursement Office of Audit Services W-00-21-35784 2024 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
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 2025 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
Completed Centers for Medicare and Medicaid Services Audits of Medicare Part B Laboratory Services During the COVID-19 Pandemic Office of Audit Services A-09-21-03004 2024 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
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 2025 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
Completed (Partial) Centers for Medicare and Medicaid Services Medicare Part D Payments During Covered Part A SNF Stay Office of Audit Services W-00-21-35866;
A-09-21-03008
2024 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, and Assisted Living Facilities; Prescription Drug; Elderly Medicare D
Completed (partial) Centers for Medicare and Medicaid Services Background Checks for Nursing Home Employees Office of Audit Services W-00-21-31553;
A-06-21-02000;
A-04-23-08100
2025 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, Nursing Facilities, and Assisted Living Facilities; Elderly; Medicaid
Completed Centers for Medicare and Medicaid Services Medicaid Claims for Federal Reimbursement Using Managed-Care Proxy Methodology Office of Audit Services W-00-21-31554 2025 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
Completed (partial) 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-00-22-35862;
W-00-21-35862;
A-05-22-00015;
A-01-21-00501
2025 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 B
Revised Centers for Medicare and Medicaid Services Risk Assessment at a State Medicaid Agency Office of Audit Services W-00-21-31552 2025 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
Completed 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 2024 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
Completed (partial) Centers for Medicare & Medicaid Services Medicare Part B Payments for Psychotherapy Services Office of Audit Services W-00-17-35801;
W-00-21-35801;
A-09-21-03021;
A-09-18-03004;
A-02-19-01012;
A-09-19-03018;
A-02-21-01005
2025 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; Physician and Health Care Providers; 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;
A-09-21-03022
2025 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
Revised Centers for Medicare and Medicaid Services Medicare Part D Compounded Drugs Office of Audit Services W-00-21-35415 2025 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
Completed 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 A-09-21-06001 2023 A combined $178 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.
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 2024 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
Completed (Partial) Centers for Medicare and Medicaid Services Joint Work With State Agencies Office of Audit Services W-00-21-40002;
A-09-23-02004
2025 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
Completed (partial) Centers for Medicare and Medicaid Services Risk Assessment of Puerto Rico Medicaid Program Office of Audit Services W-00-20-31544;
W-00-21-31544;
W-00-23-31544;
W-00-24-31544;
A-02-21-01004;
A-02-21-01005
2024 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 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 2025 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
Revised Health Resources and Service Administration Audit of CARES Act Provider Relief Funds: General and Targeted Distributions to Providers Office of Audit Services W-00-20-35855 2025 The Coronavirus Aid, Relief, and Economic Security (CARES) Act and the Paycheck Protection Program and Health Care Enhancement Act appropriated $178 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 judgemental 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
Completed 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;
A-03-20-03003
2024 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 2025 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
Completed 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;
A-05-20-00053;
A-05-23-00005
2025 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
Completed Centers for Medicare and Medicaid Services Medicaid—Telehealth Expansion During COVID-19 Emergency Office of Audit Services A-05-21-00035;
A-07-21-03250
2024 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
Completed (partial) 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;
A-18-20-08005;
A-18-20-08004;
A-18-20-08003;
A-18-21-09003;
A-18-21-09004;
A-18-21-09001;
A-18-22-09005;
A-18-22-09010;
A-18-22-09009
2025 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
Completed (Partial) Centers for Medicare and Medicaid Services Audit of Nursing Home Infection Prevention and Control Program Deficiencies Office of Audit Services W-00-20-31545;
A-01-20-00005;
A-01-20-00004;
A-01-22-00001
2025 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
Completed (partial) 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;
A-07-20-05127;
A-05-20-00033;
A-02-22-02001;
A-04-20-03583
2026 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
Complete (Partial) Centers for Medicare & Medicaid Services Medicare Payments for Stelara Office of Evaluation and Inspections OEI-BL-19-00500;
OEI-BL-19-00501;
OEI-BL-19-00500
2025 Stelara (ustekinumab) is a high-cost prescription biologic approved to treat certain autoimmune diseases. Subcutaneous (under-the-skin) versions of Stelara are typically self-injected and covered under Medicare Part D. Prior to 2023, Medicare Part B also covered subcutaneous versions of Stelara when the injection was administered by a physician; however, Medicare Administrative Contractors now exclude Stelara injections under a policy designed to omit self-administered drugs from Part B coverage. The period during which Stelara was covered under Parts B and D provides a unique opportunity to examine how coverage determinations affect payments made by the Medicare program and costs for its enrollees. OIG will produce two work products related to Medicare payments and utilization trends for the subcutaneous versions of Stelara. The first product will focus on a cost comparison for enrollees with traditional fee-for-service Medicare Part B and standalone Part D drug plans. The second evaluation will focus on Medicare enrollee utilization patterns by setting—Stelara obtained in a physician's office (i.e., where injections would typically be administered by a health care provider) and Stelara obtained through a pharmacy (i.e., where injections would typically be self-administered at home). 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
2024 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
Completed (partial) 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;
W-00-21-31543;
A-07-21-03247
2025 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-04-22-00134;
A-05-17-00009;
A-05-17-00028;
W-00-20-31503;
W-00-22-31503;
A-05-17-00028
2025 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
Completed Centers for Medicare and Medicaid Services Medicaid Nursing Home Life Safety and Emergency Preparedness Reviews Office of Audit Services W-00-20-31525;
W-00-22-31525:
W-00-23-31525;
A-02-21-01010;
A-04-22-08093;
A-09-22-02006;
A-03-22-00206;
A-06-22-09007;
A-07-22-07009;
A-01-23-00003
2025 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
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 2024 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 Centers for Medicare & Medicaid Services Nationwide Audit of Medicare Part D Eligibility Verification Transactions Office of Audit Services W-00-20-35751 2025 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
Completed (partial) Centers for Medicare & Medicaid Services Medicaid MCO PBM Pricing Office of Audit Services W-00-20-31542;
A-03-20-00200
2024 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
Completed (partial) Centers for Medicare & Medicaid Services Audits of Selected Independent Clinical Laboratory Billing Requirements 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;
A-09-20-03027;
A-09-21-03006;
A-09-22-03010;
W-00-17-35726;
W-00-20-35726;
W-00-22-35726;
W-00-21-35726;
W-00-21-35829;
W-00-22-35829;
WA-24-0023 (W-00-24-35726);
various reviews
2025 Medicare covers diagnostic clinical laboratory services that are ordered by a physician who is treating a beneficiary and who uses the results in managing 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 heightened risk for noncompliance with Medicare billing requirements. Payments to a service provider are precluded unless the provider furnishes on request the information necessary to determine the amount due (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 heightened 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 will use the results of these reviews to identify laboratories or other institutions that routinely submit improper claims, including providers that regularly bill Medicare for definitive drug testing at the highest reimbursement amount allowed. 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-00-21-59441;
W-00-22-59441;
A-06-20-07003;
A-01-20-01501;
W-00-24-59441;
A-02-22-02002;
A-06-22-01005
2025 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;
W-00-21-31539;
W-00-21-35726;
A-05-20-00025;
A-05-21-00028;
W-00-22-31539;
W-00-23-31539;
W-00-24-31539;
A-05-22-00018;
A-05-23-00008
2025 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 (partial) Centers for Medicare & Medicaid Services Medicare Advantage Risk-Adjustment Data - Targeted Review of Documentation Supporting Specific Diagnosis Codes Office of Audit Services W-00-20-35079;
W-00-18-35079;
W-00-19-35079;
W-00-17-35079;
W-00-21-35079;
W-00-24-35079;
A-07-20-01197;
A-07-20-01202;
A-06-19-05002;
A-01-18-00504;
A-07-20-01198;
A-05-22-00020;
A-02-22-01001;
various reviews
2025 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;
A-06-21-08004
2025 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
Completed 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 2024 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
Completed Centers for Medicare & Medicaid Services Review of Medicare Part B Urine Drug Testing Services Office of Audit Services A-09-20-03017 2024 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 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 2024 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 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 2025 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
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
2025 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
Completed OS Review of Office of Intergovernmental and External Affairs Charge Card Programs Office of Audit Services W-00-19-59443;
A-03-19-00501;
W-00-22-59443;
A-03-22-00500
2024 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
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
2025 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 2024 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
Completed (partial) Centers for Medicare & Medicaid Services Review of State Uncompensated Care Pools Office of Audit Services W-00-19-31537;
A-04-19-04070
2025 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;
A-02-21-02001;
A-02-21-02008;
W-00-23-50100
2025 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
Completed (partial) Centers for Medicare and Medicaid Services Medicaid Managed Care Organizations' Denials Office of Audit Services W-00-19-31535;
W-00-20-31535;
A-03-20-00201;
W-00-21-31535;
W-00-22-31535;
W-00-24-31535;
A-02-21-01016;
A-07-22-07007
2025 The State Medicaid agency and the Federal Government are responsible for the financial risk for the costs of Medicaid services. State Medicaid agencies contract with managed care organizations (MCOs) to ensure that beneficiaries receive covered Medicaid services. The contractual arrangement shifts the financial risk from the State Medicaid agency and the Federal Government to MCOs, which can create an incentive for MCOs to deny beneficiaries' access to covered services. Our audits will determine whether Medicaid MCOs complied with Federal requirements when denying access to requested medical and dental services, behavioral health services, and associated drug prescriptions that required prior authorization. Managed Care, Medicaid
Completed (partial) Centers for Medicare & Medicaid Services Medicaid Personal Care Services Office of Audit Services A-02-19-01016;
W-00-19-31536
2025 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;
W-00-21-31497;
W-00-22-31497;
W-00-23-31497;
A-03-22-00203;
A-04-19-07082;
A-04-21-09005;
A-03-22-00205
2025 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 Medicare Part B Payments for Podiatry and Ancillary Services Office of Audit Services W-00-19-35818; W-00-21-35818 2025 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 Centers for Medicare & Medicaid Services Medicare Outpatient Outlier Payments for Claims With Credits for Replaced Medical Devices Office of Audit Services A-07-19-00560 2024 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 (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;
A-03-20-00002;
various reviews
2024 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) All STAFFDIV/
OPDIVs
Identification of HHS Cybersecurity Vulnerabilities Office of Audit Services W-00-18-42021;
W-00-18-42022;
W-00-20-42022;
A-18-20-08200;
A-18-20-08001
2025 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 Review of Post-Operative Services Provided in the Global Surgery Period Office of Audit Services W-00-18-35810; W-00-22-35810 2025 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
Completed Centers for Medicare & Medicaid Services Medicare Part B Payments for End-Stage Renal Disease Dialysis Services Office of Audit Services A-05-20-00010 2024 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
Completed (partial) Centers for Medicare & Medicaid Services Medicare Payments Made Outside of the Hospice Benefit Office of Audit Services W-00-20-35797;
A-09-20-03026;
A-09-20-03015
2025 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 Medicaid School-Based Costs Claimed Based on Contingency Fee Contractor Coding Office of Audit Services A-04-18-07075;
W-00-18-31529;
A-02-20-01012;
A-02-18-01019
2025 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
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;
W-00-21-31400;
W-00-22-31400;
A-07-21-07003;
A-07-21-06096;
A-07-21-06101;
A-07-21-07002;
A-04-21-08089;
A-04-21-07098;
A-04-21-08090;
A-04-22-07102;
A-07-21-06103;
A-07-22-07010;
various reviews
2025 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
2025 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;
A-02-20-01004;
A-04-21-08084;
W-00-20-35538;
W-00-17-35538;
W-00-23-35538;
various reviews
2025 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
2024 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 W-00-17-35067;
W-00-22-35094;
W-00-23-35067;
A-07-23-00632;
A-07-23-00633;
A-07-22-00627;
A-07-23-00635;
A-07-23-00631;
various reviews;
See Work Plan narrative for additional audits
2025 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;
W-00-23-35095;
A-07-21-00604;
A-07-21-00605;
A-07-22-00625;
A-07-22-00624;
A-07-22-00626;
A-07-23-00629;
A-07-23-00630;
A-07-23-00636;
A-07-23-00637;
various reviews
2025 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;
A-07-17-01169;
A-03-18-00002;
A-05-18-00020;
A-04-18-03085;
A-04-20-07090;
A-06-18-02001;
W-00-18-35078;
A-09-18-03007;
A-04-19-07082;
W-00-19-35078
2025 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 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-03-19-00002
2025 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;
W-00-20-31035;
A-07-20-03243
2025 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;
A-07-21-02834;
W-00-17-31522;
A-05-17-00000;
W-00-23-31522;
A-06-20-04004;
A-07-19-02816;
A-06-23-04004
2025 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
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;
A-09-20-02009;
A-01-20-00006;
A-09-21-02001
2025 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;
A-07-21-03246;
A-07-22-03253
2025 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 (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;
A-04-20-07094;
W-00-20-31374;
W-00-16-31374;
W-00-21-31374;
A-04-21-07097;

various reviews
2025 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
Revised Centers for Medicare & Medicaid Services Managed Long-Term-Care Reimbursements Office of Audit Services W-00-17-31510 2024 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
Completed (partial) Centers for Medicare & Medicaid Services Third-Party Liability Payment Collections in Medicaid Office of Audit Services A-05-21-00013 2024 Medicaid beneficiaries may have additional health insurance through third-party sources. Previous OIG work described problems that State Medicaid agencies had in identifying and collecting third-party payments. States are to take all reasonable measures to ascertain the legal liabilities of third parties with respect to health care items and services (SSA § 1902(a)(25)). Medicaid is the payer of last resort and providers are to identify and refund overpayments received. We will determine if States have taken action to ensure that Medicaid is the payer of last resort by identifying whether a third-party payer exists and if the State correctly reports the third-party liability to Centers for Medicare & Medicaid Services. tags
Completed 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 2024 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
2024 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;
A-02-19-01018;
A-02-20-01001
2025 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