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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.

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Announced or Revised	Agency	Title	Component	Report Number(s)	Expected Issue Date (FY)	Summary
Announced or Revised	Agency	Title	Component	Report Number(s)	Expected Issue Date (FY)	Summary
January 2021	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	2021	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.
January 2021	Centers for Medicare and Medicaid Services	Medicare Part D Payments During Covered Part A SNF Stay	Office of Audit Services	W-00-21-35866	2022	Medicare Part A prospective payments to skilled nursing facilities (SNFs) cover most services, including drugs and biologicals furnished by the SNF for use in the facility for the care and treatment of beneficiaries. Accordingly, Medicare Part D drug plans should not pay for prescription drugs related to posthospital SNF care because these drugs are already included in the consolidated payment for Part A SNF stays. We will determine whether Medicare Part D paid for drugs that should have been paid under Part A SNF stays.
January 2021	Centers for Medicare and Medicaid Services	Background Checks for Nursing Home Employees	Office of Audit Services	W-00-21-31553	2022	Federal regulation 42 CFR 483.12(a)(3) provides beneficiaries who rely on long-term care services with protection from abuse, neglect, and theft by preventing prospective employees with disqualifying offenses from being employed by these care providers and facilities. The National Background Check Program was enacted by legislation in 2010 to assist States in developing and improving systems for conducting Federal and State background checks. Prior OIG work has shown that not all States complied with the National Background Check Program for Long-Term Care Providers. We will determine whether Medicaid beneficiaries in nursing homes in selected States were adequately safeguarded from caregivers with a criminal history of abuse, neglect, exploitation, mistreatment of residents, or misappropriation of resident property, according to Federal requirements.
January 2021	Administration for Children and Families	Audit of Delinquent Noncustodial Parents' Tax Refund and Economic Impact Payment Intercepts	Office of Audit Services	W-00-21-20030	2022	The Child Support Enforcement Program (the program) is a Federal, State, and local partnership, established in 1975 under Title IV-D of the Social Security Act, to collect child support payments from noncustodial parents for distribution to custodial parents. The Coronavirus Aid, Relief, and Economic Security (CARES) Act, signed into law on March 27, 2020, provides qualifying individuals with a recovery rebate (economic impact payment) of up to $1,200 (or $2,400 if married and filing jointly), plus up to $500 for each qualifying child. Congress added a number of exemptions concerning the economic impact payments within the CARES Act; however, it did not exempt child support debt. According to estimates, up to 10.5 million noncustodial parents are delinquent in their payment of child support and could have their economic impact payments intercepted. Based on the significant impact that the CARES Act will have on the collection of delinquent child support due to the intercept of economic impact payments, we determined that the focus of our audit would be to determine whether selected State(s) have policies and procedures in place to ensure that State child support programs collected and distributed delinquent child support under the Federal Tax Refund Offset program. The failure to have effective procedures in place to ensure the collection and distribution of delinquent child support can result in essential child support funds not being provided to custodial parents during the COVID-19 pandemic.
January 2021	Centers for Medicare and Medicaid Services	Audit of Home Health Services Provided as Telehealth During the COVID-19 Public Health Emergency	Office of Audit Services	W-00-21-35864	2022	On March 13, 2020, President Trump declared a national emergency in response to the COVID-19 pandemic, which allowed the Centers for Medicare & Medicaid Services (CMS) to take proactive steps to support the response to COVID-19 through the use of section 1135 waivers. By means of this authority, CMS waived certain requirements in order to expand Medicare telehealth benefits to health care professionals who were previously ineligible, including physical therapists, occupational therapists, speech language pathologists, and others. CMS also amended regulations to allow home health agencies to use telecommunications systems in conjunction with in-person visits. The amended regulations state that: (1) the use of technology must be related to the skilled services being furnished, and (2) the use of technology must be included in the plan of care with a description of how the technology will help achieve goals without substituting for an in-person visit. We will evaluate home health services provided by agencies during the COVID-19 public health emergency to determine which types of skilled services were furnished via telehealth, and whether those services were administered and billed in accordance with Medicare requirements. We will report as overpayments any services that were improperly billed. We will make appropriate recommendations to CMS based on the results of our review.
January 2021	Centers for Medicare and Medicaid Services	Duplicate Payments Made by Medicare and the Department of Veterans Affairs' Veterans Community Care Program	Office of Audit Services	W-00-21-35865	2022	The Veterans Community Care Program (VCCP) authorizes the Department of Veterans Affairs (VA) to furnish hospital care and medical services to eligible veterans through agreements with non-VA providers. Duplicate claims may be improperly paid by both Medicare and the VCCP if claims for services are billed to both programs. Because Medicare regulations prohibit payment for services that are paid for either directly or indirectly by another Government entity, subject to a few exceptions, Medicare is not responsible for payment of claims for services in which the VCCP has paid for those services. The payments associated with these claims are considered overpayments. This audit is a collaborative effort with VA-OIG to determine whether the VCCP and Medicare paid duplicate claims for the same medical services.
January 2021	Centers for Medicare and Medicaid Services	Medicaid Claims for Federal Reimbursement Using Managed-Care Proxy Methodology	Office of Audit Services	W-00-21-31554	2022	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.
January 2021	Centers for Medicare and Medicaid Services	Audits of Medicare Part B Telehealth Services During the COVID-19 Public Health Emergency	Office of Audit Services	W-00-21-35862	2021	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 order, 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.
January 2021	Centers for Medicare and Medicaid Services	Home Health Agencies' Challenges and Strategies in Responding to the COVID-19 Pandemic	Office of Evaluation and Inspections	OEI-01-21-00110	2022	Home health agencies (HHAs) have faced unprecedented challenges to providing care during the COVID-19 pandemic. Reported challenges include, but are not limited to, procuring necessary equipment and supplies, implementing telehealth to treat patients remotely, and addressing staffing shortages. However, the full spectrum of these challenges, including how challenges have evolved over time, is unknown. HHAs have used strategies to address these challenges, but the array of strategies and the extent to which HHAs found them helpful are also unknown. This nationwide study will provide insights into the strategies HHAs have used to address the challenges presented by COVID-19, including how well their emergency preparedness plans served them during the COVID-19 pandemic.
December 2020	Centers for Medicare and Medicaid Services	Risk Assessment at a State Medicaid Agency	Office of Audit Services	W-00-21-31552	2022	One goal of the President's Management Agenda is to maximize grant funding by applying a risk-based, data-driven framework that balances compliance requirements with demonstrating successful results to the American taxpayer. Enterprise Risk Management-based risk assessments can help organizations quickly understand and prioritize critical, enterprisewide risks, and develop plans to maximize as well as mitigate and manage risk. We will perform an Enterprise Risk Management-based risk assessment at one State Medicaid agency to identify internal control weaknesses and process risks.
December 2020	Centers for Medicare and Medicaid Services	Followup Review on Medicare Claims for Outpatient Services Provided During Inpatient Stays	Office of Audit Services	W-00-21-35861	2021	A prior OIG review (A-09-16-02026) identified that Medicare inappropriately paid acute-care hospitals for outpatient services they provided to beneficiaries who were inpatients of other facilities (i.e., long-term care hospitals (LTCHs), inpatient rehabilitation facilities (IRFs), inpatient psychiatric facilities (IPFs), and critical-access hospitals). It was found that none of the $51.6 million we reviewed, representing 129,792 claims, should have been paid because the inpatient facilities were responsible for payments. In addition, beneficiaries were held responsible for unnecessary deductibles and coinsurance totaling $14.3 million paid to acute-care hospitals for those outpatient services. In addition, it was found that Medicare overpaid acute-care hospitals because the common working file (CWF) edits that should have prevented or detected the overpayments were not working properly. Federal regulations state that the inpatient hospital services provided to Medicare beneficiaries are paid under Medicare Part A. These include inpatient stays at LTCHs, IRFs, and IPFs. Federal regulations also state that Medicare does not pay any provider other than the inpatient hospital for services provided to the beneficiary while the beneficiary is an inpatient of the hospital. The hospital must furnish all necessary covered services to the beneficiary either directly or under arrangements. This provision also applies to LTCHs, IRFs, and IPFs. This audit is a followup to determine whether CMS corrected the CWF edits and ensured that the edits were working properly.
December 2020	Administration for Community Living	Strategies for the Implementation of Model Practices in Group Homes: Lessons From an Administration for Community Living Grant Program	Office of Evaluation and Inspections	OEI-07-20-00690	2022	Group homes are private homes designed to provide housing, meals, housekeeping, personal care services, and supports to individuals with a disability. These settings offer individuals with developmental disabilities greater opportunities to achieve positive outcomes in life; however, there may be a lack of infrastructure in place to provide sufficient oversight to detect abuse or neglect. OIG collaborated with the Administration for Community Living (ACL) and the HHS Office for Civil Rights to publish a Joint Report that developed Model Practices that would improve the health and safety of individuals who live in group homes. Additionally, ACL provides the Living Well grant for enhancing the quality, effectiveness, and monitoring of home and community-based services for individuals with developmental disabilities. We will evaluate grantees that have received a Living Well grant and that are implementing one or more of the suggested Model Practices developed in the Joint Report. Living Well grant recipients are not required to implement Model Practices suggested in the Joint Report; however, many of the grant goals align with the suggested Model Practices. We will describe the extent to which Model Practices have been implemented, the strategies used to implement Model Practices, and the impact that implementing Model Practices has had on reducing risk factors for incidents of abuse and neglect of beneficiaries.
December 2020	Centers for Medicare and Medicaid Services	Comparison of T-MSIS Prescription Drug Payment Data to Actual Pharmacy Reimbursements for Medicaid Managed Care	Office of Evaluation and Inspections	OEI-03-20-00560	2022	Effective oversight of growing prescription drug costs in Medicaid requires accurate and consistent data. Managed-care organizations (MCOs) are responsible for the majority of Medicaid enrollment and prescription drug reimbursements. The Centers for Medicare and Medicaid Services (CMS) established the Transformed Medicaid Statistical Information System (T-MSIS) to provide CMS, States, and other stakeholders with accurate and reliable Medicaid claims and encounter data to safeguard the Medicaid program. However, States' managed‑care drug claims data reported in T-MSIS may not uniformly represent drug payments across the Medicaid program. The data may contain the amounts MCOs or their pharmacy benefit managers (PBMs) paid to pharmacies or the amounts MCOs paid to their PBMs, which could include certain PBM fees known as "spread." CMS and States have expressed concerns that the use of spread pricing by PBMs lacks transparency and may inflate Medicaid drug costs. This evaluation will identify how States report managed-care drug payment data to T‑MSIS and determine the extent to which these data represent pharmacy reimbursements. Furthermore, we will identify how States ensure the accuracy of their T-MSIS managed-care drug claims data and use these data to oversee managed-care prescription drug expenditures and the PBMs' spread‑pricing practices.
December 2020	Centers for Medicare and Medicaid Services	Supplier Acquisition Costs for Urinary Supplies	Office of Evaluation and Inspections	OEI-04-20-00620	2022	We will compare current Medicare reimbursement rates to supplier acquisition costs for selected urinary supplies to determine whether Medicare may be paying too much for these items. Medicare Part B payments for urinary supplies, including intermittent urinary catheter tips and intermittent urinary catheters with insertion supplies, has increased from $125 million in 2010 to $298 million in 2019. CMS could reduce payment rates for urinary supplies through two methods: CMS can adjust the fee schedule price, or it may introduce an item into the Competitive Bidding Program (CBP). To facilitate CMS decision making, we will provide cost information and additional context regarding the extent that urinary supplies are a good fit for potential introduction into the CBP.
December 2020	Assistant Secretary for Preparedness and Response	Audit of the Assistant Secretary for Preparedness and Response Oversight of the Hospital Preparedness Program With Respect to Crisis Standards of Care	Office of Audit Services	W-00-21-59451	2022	The HHS Assistant Secretary for Preparedness and Response (ASPR) administers the Hospital Preparedness Program (HPP), which awards grants to State, territorial, and major metropolitan public health agencies to advance preparedness in health care systems for emergencies and disasters. Crisis standards of care are guidelines for how providers ration resources, such as ventilators, during mass casualty events, such as pandemics. State public health agencies receiving HPP funds must issue these guidelines, and providers can choose to adopt them. An HHS awarding agency must administer Federal awards in a manner that ensures that programs are implemented in full accordance with U.S. statutory and public policy requirements, including the prohibition of discrimination. Recipients of Federal funds are required to comply with an award's terms and conditions as well as Federal civil rights laws. The objective of our audit is to conduct a grant performance review of ASPR's oversight of the HPP program with respect to awardees' adopting crisis standards of care that comply with Federal nondiscrimination laws.
December 2020	Centers for Medicare and Medicaid Services	Race and Ethnicity Data for Medicare Beneficiaries	Office of Evaluation and Inspections	OEI-02-21-00100	2022	Accurate, complete, and appropriately detailed race and ethnicity data for Medicare beneficiaries are critical to identifying and mitigating health disparities. As racial and ethnic disparities have emerged among those impacted by COVID-19, the availability and quality of data on race and ethnicity has garnered greater attention and scrutiny. This study will describe the extent to which Medicare's race and ethnicity data for beneficiaries are complete and accurate. We will compare these data to data from other sources. We will also determine the extent to which the Medicare beneficiary race and ethnicity data align with Federal data standards.
December 2020	Centers for Medicare & Medicaid Services	Medicare Part B Payments for Psychotherapy Services	Office of Audit Services	W-00-17-35801; A-09-17-xxxxx	2021	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.
November 2020	Centers for Medicare and Medicaid Services	CMS Oversight of the Two-Midnight Rule for Inpatient Admissions	Office of Audit Services	W-00-20-35857	2021	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.
November 2020	Centers for Medicare and Medicaid Services	Medicare Part D Compounded Drugs	Office of Audit Services	W-00-21-35415	2022	In 2016, OIG called attention to significant growth in spending for compounded drugs. Specifically, OIG found that Medicare Part D spending for compounded topical drugs grew by 625 percent during 2006—2015. OIG has been involved in an increasing number of fraud investigations related to compounded drugs. We will conduct a risk assessment of CMS's oversight of pharmacies compounding drugs for beneficiaries to determine whether systemic vulnerabilities affecting the integrity of Medicare Part D; specifically, we will assess the risk that pharmacies did not meet Federal and State requirements.
November 2020	Centers for Medicare and Medicaid Services	Medicaid and ACA Enrollment Processes During the COVID-19 Pandemic	Office of Evaluation and Inspections	OEI-09-20-00590	2022	Economic and health impacts caused by the COVID-19 pandemic have left States facing increases in new applications for health insurance through the Medicaid and ACA Marketplace programs. Responding to the pandemic, including meeting the new enrollment and oversight demands, has taxed State health care systems. This evaluation will assess efforts by the States and CMS to effectively enroll residents impacted by the COVID-19 pandemic in Medicaid and ACA Marketplace plans. By identifying effective practices or any breakdowns in enrollment and oversight systems, this review would help improve the efficiency of State health insurance enrollment processes under both emergency and more typical conditions.
November 2020	Centers for Medicare and Medicaid Services	Nursing Homes' Compliance With Facility-Initiated Discharge Requirements	Office of Evaluation and Inspections	OEI-01-18-00251	2022	A facility-initiated transfer or discharge of a resident from a nursing home can be an unsafe and traumatic experience for the resident and his or her family. To address these concerns, Congress passed the Nursing Home Reform Act of 1987 to protect residents against inappropriate facility-initiated transfer and discharge. However, data from the National Ombudsman Reporting System show that from 2011 through 2016, the Long-Term Care Ombudsman Program, established to advocate for older Americans by the Older Americans Act of 1965, cited complaints related to "discharge/eviction" more frequently than any other concern. In addition, the media has highlighted the rise in nursing home evictions. We have ongoing work determining the extent to which State long-term care ombudsmen, State survey agencies, and CMS address facility-initiated discharges from nursing homes. To complement this ongoing work, we will examine the extent to which nursing homes meet CMS requirements for facility-initiated discharges.
November 2020	Centers for Disease Control and Prevention	Grantees' Use of President's Emergency Plan for AIDS Relief Funds	Office of Audit Services	W-00-19-57300; W-00-20-57300; W-00-21-57301	2021	Through the President's Emergency Plan for AIDS Relief (PEPFAR), the Centers for Disease Control and Prevention (CDC) has altered the course of the global acquired immunodeficiency syndrome (AIDS) epidemic, saving millions of lives, improving the lives of countless others, and preventing millions of infections around the world. CDC received more than $1.9 billion in FY 2019 PEPFAR funds (about 95 percent of all PEPFAR funds received by HHS) to accelerate progress toward achieving an AIDS‑free generation and to create a lasting infrastructure that allows partner countries to respond to a range of health challenges and threats. To date, OIG has conducted a series of PEPFAR audits at CDC offices in five countries on three continents (Africa, North America, and Asia). OIG's PEPFAR oversight has helped CDC and other HHS staff learn important grant and program integrity lessons that apply to ongoing and future responses to infectious diseases. In previous audits of CDC offices in the United States and foreign countries, OIG identified noncompliance with policies, inadequate monitoring of grantees, and internal control weaknesses in the awarding of PEPFAR funds. We will determine whether CDC has: (1) effectively awarded, monitored and accounted for PEPFAR funds in accordance with Federal regulations, HHS Departmental regulations, and the Office of the U.S. Global AIDS Coordinator and Global Health Diplomacy guidance; and (2) taken corrective action to implement internal controls, including adhering to policies and procedures for awarding and monitoring PEPFAR funds.
November 2020	Centers for Medicare & Medicaid Services	Facility-Initiated Discharge in Nursing Homes	Office of Evaluation and Inspections	OEI-01-18-00250	2022	The transfer or discharge of a resident initiated by a nursing home can be an unsafe and traumatic experience for the resident and his or her family. To address these concerns, Congress passed the Nursing Home Reform Act of 1987 to protect residents against inappropriate facility-initiated discharges. However, data from the National Ombudsman Reporting System show that from 2011 through 2016, the Long-Term Care Ombudsman Program, established to advocate for older Americans by the Older Americans Act of 1965, cited complaints related to "discharge/eviction" more frequently than any other concern. In addition, the media has recently highlighted the rise in nursing home evictions. CMS estimates that as many as one-third of all residents in long-term care facilities may experience a facility-initiated transfer or discharge. In other work, we are examining the extent to which nursing homes meet CMS requirements for facility-initiated discharges. In this work, we will determine the extent to which State long-term care ombudsmen, State survey agencies, and CMS address facility-initiated discharges from nursing homes.
November 2020	Centers for Medicare & Medicaid Services	Audit of Medicaid Components for States in Cycle 1 of CMS's PERM Review	Office of Audit Services	W-00-20-31540	2021	The Improper Payments Information Act of 2002 requires the heads of Federal agencies to annually review programs they administer in order to identify programs that may be susceptible to significant improper payments and estimate the amount of improper payments. The Medicaid program has been identified as a program at risk for significant improper payments. CMS developed the Payment Error Rate Measurement (PERM) program to measure improper payments in the Medicaid program. PERM produces an improper payment rate based on reviews of the fee-for-service, managed care, and eligibility components of Medicaid. In 2017, CMS published a new, final rule implementing substantive changes to the PERM program that, among other things, were aimed at improving program integrity and promoting State accountability through policy and operational improvements. We will assess the adequacy of the PERM program by determining the accuracy of determinations for the eligibility, fee-for-service, and managed care components of the PERM error rate.
October 2020	Health Resources and Services Administration	Audit of HRSA's Controls Over Medicare Providers' Compliance with the Attestation, Submitted-Revenue-Information, and Quarterly Use-of-Funds Reporting Requirements Related to the $50 Billion General Distribution of the Provider Relief Fund	Office of Audit Services	W-00-21-59060	2021	A combined $175 billion in funding from the Coronavirus Aid, Relief, and Economic Security (CARES) Act and the Paycheck Protection Program and Health Care Enhancement Act constitutes the Provider Relief Fund (PRF), which provides relief funds to hospitals and other health care providers for health-care-related expenses or lost revenue attributable to COVID-19 and to ensure that uninsured Americans can get testing and treatment for COVID-19. HHS allocated $50 billion for a General Distribution to Medicare providers. Providers that receive PRF funds are subject to certain requirements for attestation, submission of revenue information, and reporting of quarterly use-of-funds to HHS. A provider that received a PRF payment and retained it for at least 90 days without contacting HHS regarding the payment is deemed to have accepted its terms and conditions. Further, a provider must submit general revenue data after receiving or when applying to receive a payment. Finally, according to the CARES Act, Division B, Title V, Section 15011(b)(2), no later than 10 days after the end of each calendar quarter, a provider that received more than $150,000 in total funds for the coronavirus response and related activities shall submit a report to HHS regarding the use of those funds. As part of the OIG's oversight of the $50 billion General Distribution of the PRF, we will provide a snapshot of the effectiveness of the Health Resources and Services Administration's (HRSA's) controls over Medicare providers' compliance with the attestation, submitted-revenue-information, and quarterly use-of-funds reporting requirements. Specifically, we will review HRSA's internal controls and assess its policies and procedures related to these areas.
October 2020	Centers for Medicare and Medicaid Services	Medicare Telehealth Services During the COVID-19 Pandemic: Program Integrity Risks	Office of Evaluation and Inspections	OEI-02-20-00720	2021	In response to the COVID-19 pandemic, CMS implemented a number of waivers and flexibilities that allowed Medicare beneficiaries to access a wider range of telehealth services without having to travel to a health care facility. This review will be based on Medicare Parts B and C data and will identify program integrity risks associated with Medicare telehealth services during the pandemic. We will analyze providers' billing patterns for telehealth services. We will also describe key characteristics of providers that may pose a program integrity risk to the Medicare program.
October 2020	Administration for Children and Families	Audit of National Domestic Violence Hotline and Shelter-in-Place Orders During the COVID-19 Pandemic	Office of Audit Services	W-00-20-20028	2021	The COVID-19 pandemic poses special challenges for victims of domestic violence. Because of economic and other uncertainties surrounding the pandemic and the shelter-in-place orders in effect for most States, abusers may exert further power and control over their partners. Victims in these States are more socially isolated and have fewer opportunities to connect with others who may be able to assist them. Isolated victims may be less likely to use crisis hotlines because their abusers are close by, and victims may face repercussions if they reach out for help. For fiscal year 2020, the Administration for Children and Families allocated $12 million for the National Domestic Violence Hotline (the Hotline). The Hotline operates a 24-hour, national, toll-free, and confidential telephone hotline for victims of domestic violence. It maintains a comprehensive resource database on services for these victims and is the only 24/7 center in the Nation that has access to service providers and shelters across the United States. The Coronavirus Aid, Relief, and Economic Security Act provided additional funding of $2 million for the Hotline, including hotline services provided remotely. Our objectives are to identify: (1) trends with the Hotline data that occurred during nationwide shelter-in-place orders and (2) whether the Hotline faced challenges that occurred during States' shelter-in-place orders and actions it has taken to address these challenges while continuing to support those affected by domestic violence.
October 2020	Indian Health Service	Indian Health Service Use of Critical Care Response Teams To Support Health Care Facilities During the COVID-19 Pandemic	Office of Evaluation and Inspections	OEI-06-20-0070	2021	The Indian Health Service (IHS) is charged with providing comprehensive health care for approximately 2.6 million American Indians and Alaska Natives (AI/ANs). It is critical to ensure safe and accessible health care for AI/ANs during the COVID-19 pandemic. Prior OIG work found that IHS facilities often lack sufficient clinical and other staff, and identified numerous problems caused by staffing shortages, including limited patient access to specialists and problems with the use of contracted staff. The COVID-19 pandemic may exacerbate staffing shortages as IHS and Tribal hospitals continue to see more COVID-19 patients. As a response, IHS contracted additional staff by forming a Critical Care Response Team pilot program, which is designed to provide urgent medical care for COVID-19 patients in facilities with insufficient staffing. The teams are also charged with preparing and training frontline health care staff on evidence-based and best practices, supporting clinical decision making, and providing consultations and advice on hospital operations and how to manage critically ill patients. As of September 29, 2020, IHS had deployed five teams to provide services at six IHS-operated facilities and three tribally operated facilities and planned to make the program a longer-term part of IHS operations. Doing so could help remedy longstanding staffing shortages at IHS facilities. However, problems identified in prior OIG work indicate that IHS may have difficulty managing this contracted resource and integrating the teams into facility practices. OIG's review will use interviews with IHS and contracted staff, as well as document reviews, to assess IHS use of the Critical Care Response Teams, including development, management, and oversight of the teams, and IHS selection criteria for determining which facilities would receive deployments.
October 2020	Centers for Medicare and Medicaid Services	Ineligible Providers in Medicare Part C and Part D	Office of Audit Services	W-00-20-35859	2021	CMS contracts with Medicare Advantage plans and private prescription drug plans (collectively known as "sponsors") to offer Part C and Part D managed care benefits to eligible beneficiaries. Federal law prohibits Medicare payments for services provided or prescriptions written by individuals or entities who are excluded from Federal health care programs (excluded providers) when the sponsor knows or has reason to know of the exclusion. Federal regulations also prohibit Medicare payments to ineligible providers whose billing privileges have been deactivated, denied, or revoked. We will conduct a nationwide audit of Medicare Part C and Part D managed care data for calendar years 2018 and 2019 to identify ineligible providers that had been excluded, precluded, or deactivated as Medicare providers but provided services through Part C and D sponsors. Our audit will determine whether Part C and Part D sponsors complied with Federal requirements on preventing ineligible providers from rendering services to Medicare beneficiaries.
October 2020	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	2021	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.
October 2020	Centers for Medicare and Medicaid Services	Joint Work With State Agencies	Office of Audit Services	W-00-21-40002	2021	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.
October 2020	ACF, CDC, CMS, HRSA, IHS, NIH, SAMHSA	Mandatory Review of HHS Agencies' Annual Accounting of National Drug Control Program Funds	Office of Audit Services	W-00-21-52312	2021	The Office of National Drug Control Policy circular, Accounting of Drug Control Funding and Performance Summary requires agencies expending funds on National Drug Control Program activities to submit an accounting of the expenditure 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.
October 2020	Centers for Medicare and Medicaid Services	Risk Assessment of Puerto Rico Medicaid Program	Office of Audit Services	W-00-20-31544	2021	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.
October 2020	Administration for Children and Families	Audit of States' Efforts To Locate IV-E Eligible Children Missing From Foster Care	Office of Audit Services	W-00-20-20027; W-00-21-20027	2021	Title IV-E of the Social Security Act established the Federal Foster Care Program, which helps States provide safe and stable out-of-home care for children who meet certain eligibility requirements until they are safely returned home, placed permanently with adoptive families, or placed in other planned arrangements. We will examine whether States' reporting of their missing foster children is in accordance with Federal and State requirements. We will conduct a survey to determine the approaches that State agencies have adopted pertaining to missing Title IV-E foster children for the period July 1, 2019, through September 30, 2020. Our objective is to determine whether selected State agencies are in compliance with Federal and State regulations pertaining to reporting and locating missing Title IV-E foster children to ensure the safe return of each child. Also, we will analyze historical data concerning missing foster children to determine whether there is a correlation between missing Title IV-E foster children and State agencies' policies and procedures.
October 2020	Centers for Medicare and Medicaid Services	OIG Oversight of State Medicaid Fraud Control Units	Office of Evaluation and Inspections	OEI-06-19-00510; OEI-12-20-00650; OEI-12-20-00610; OEI-06-20-00550; OEI-12-20-00200	2021	The 50 State MFCUs, located in 49 States and the District of Columbia, investigate and prosecute Medicaid provider fraud as well as complaints of patient abuse or neglect in Medicaid-funded facilities and board and care facilities. OIG provides oversight for the MFCUs and administers a Federal grant award that provides 75 percent of each MFCU's funding. As part of OIG's oversight, we provide guidance to the MFCUs; assess their adherence to Federal regulations, policy, and performance standards; and collect and analyze performance data. We also provide technical assistance and training and identify effective practices in MFCU management and operations. We will perform on-site reviews of a sample of MFCUs.
Completed (partial)	Centers for Medicare and Medicaid Services	Comparison of Average Sales Prices and Average Manufacturer Prices	Office of Evaluation and Inspections	OEI-03-21-00050; OEI-03-21-00060; OEI-03-21-00070; OEI-03-21-00080	2021	When Congress established average sales price (ASP) as the basis for Medicare Part B drug reimbursement, it also provided a mechanism for monitoring market prices and limiting potentially excessive Medicare payment amounts. The Social Security Act mandates that the OIG compare ASPs with average manufacturer prices (AMPs). If OIG finds that the ASP for a drug exceeds the AMP by 5 percent in the two previous quarters or three of the previous four quarters, the Secretary of Health and Human Services may substitute the reimbursement amount with a lower calculated rate. These quarterly memos summarize the results of OIG's comparison analysis based on ASP and AMP data. The memo specifically reports the number of drugs OIG identified that met the criteria for substitution of a lower reimbursement amount.
October 2020	CDC, ACF	Public Health Actions Affecting Unaccompanied Children: Coordination Between CDC and the Office of Refugee Resettlement	Office of Evaluation and Inspections	OEI-BL-20-00670	2021	The Unaccompanied Alien Children (UAC) Program, operated by the Office of Refugee Resettlement (ORR), provides care and placement for children without lawful immigration status who do not have a parent or guardian in the United States available to take custody. In March 2020, the Centers for Disease Control and Prevention (CDC) issued a public health order intended to reduce the spread of COVID-19. Pursuant to the CDC order, the Department of Homeland Security has substantially reduced the number of children referred to the UAC Program, instead expelling such children immediately or detaining them in hotels until they are repatriated. Effective coordination between CDC and ORR is critical to ensure that HHS fulfills its responsibilities toward vulnerable children. We will assess the extent to which CDC has coordinated with ORR to ensure that the UAC Program has sufficient and timely information for effective capacity planning. We will also assess CDC's actions to determine and carry out its responsibilities toward children detained pursuant to the public health order and the extent to which CDC has consulted with ORR on issues pertaining to children's welfare.
October 2020	Administration for Children and Families	Separated Children Placed in Office of Refugee Resettlement Care: Update	Office of Evaluation and Inspections	OEI-BL-20-00680	2021	The Unaccompanied Alien Children (UAC) Program, operated by the Office of Refugee Resettlement (ORR), provides care and placement for children without lawful immigration status who do not have a parent or guardian in the United States available to take custody. The UAC Program serves children who arrive in the United States unaccompanied, as well as children who are separated from their parents or legal guardians by immigration authorities after entering the country (i.e., separated children). Under a June 26, 2018, Federal court order, families entering the United States without authorization cannot be separated at the border by immigration authorities unless the parent meets certain criteria, such as having a criminal history. We will determine the total number of separated children referred to ORR after June 26, 2018. We will also determine key characteristics of this population, identify the reasons for their separation, and compare their outcomes (e.g., length of time in care) to the UAC Program child population overall.
October 2020	Health Resources and Services Administration	Audit of Health Resources and Services Administration's COVID-19 Uninsured Program	Office of Audit Services	W-00-20-30053	2021	To address the COVID-19 pandemic, the Families First Coronavirus Response Act (FFCRA) and the Paycheck Protection Program and Health Care Enhancement Act (PPP) together appropriated $2 billion to reimburse providers for costs associated with conducting COVID-19 testing and testing-related items and services for the uninsured. Additionally, a portion of the $175 billion appropriated to the Provider Relief Fund by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) and PPP will be used for treating uninsured individuals with a confirmed COVID-19 diagnosis. HHS, through the Health Resources and Services Administration (HRSA), launched the COVID-19 Uninsured Program Portal, a single electronic claims processing system for health care providers for submitting claims for reimbursements for diagnostic testing and treating uninsured individuals. We will determine whether claims for COVID-19 diagnostic testing and treatment services reimbursed by HHS through HRSA's COVID-19 Uninsured Program complied with Federal requirements.
October 2020	National Institutes of Health	Compliance With Federal Requirements for Other Transaction Agreements at the National Institutes of Health's National Heart, Lung, and Blood Institute	Office of Audit Services	W-00-20-57302	2021	Other Transaction Agreements (OTAs) are special Federal funding instruments often used to advance high-impact, cutting-edge research programs in engagements with traditional and nontraditional research partners. OTAs are subject to Federal fiscal law; however, OTAs are not subject to other laws, rules, or regulations specific to traditional Federal grants and contracts. Only agencies that receive specific statutory authority may use OTAs. The National Institutes of Health's National Heart, Lung, and Blood Institute (NHLBI) has received such authority and between fiscal year 2017 and 2019 has issued OTAs valued at over $80 million. We will audit NHLBI's processes for awarding and administering OTAs and determine whether NHLBI has complied with Federal requirements applicable to its OTA authority.
October 2020	OS, CDC, CMS	COVID-19 Testing Data From Federal Programs	Office of Evaluation and Inspections	OEI-09-20-00660	2021	The Coronavirus Aid, Relief, and Economic Security (CARES) Act created the Pandemic Response Accountability Committee (PRAC). PRAC's mission is to promote transparency and support the coordinated oversight of the Federal Government's coronavirus response in order to prevent and detect fraud, waste, abuse, and mismanagement and to mitigate major risks that cross program and agency boundaries. PRAC members include Offices of Inspectors General (OIG) at Federal agencies, some of which operate, utilize, or are otherwise impacted by health care programs. Within PRAC, the Health Subgroup has identified major risks areas, including COVID-19 testing, that are critical to the Federal Government's response efforts. PRAC's Health Subgroup includes OIGs from the Departments of Defense (DOD), Education, Health and Human Services (HHS), Justice (DOJ), Labor (DOL), and Veterans Affairs (VA), as well as the Office of Personnal Management (OPM). HHS-OIG will work with PRAC to produce a data brief describing COVID-19 testing in Federal health-related programs managed or operated by DOD, DOJ, DOL, HHS, OPM, and the VA. The data brief can help provide transparency and inform policymakers about COVID-19 testing resources in Federal programs. This project will involve coordination with OIGs from the six agencies.
October 2020	Centers for Medicare and Medicaid Services	Use of Medicare Telehealth Services During the COVID-19 Pandemic	Office of Evaluation and Inspections	OEI-02-20-00520	2021	In response to the coronavirus disease 2019 (COVID-19) pandemic, CMS made a number of changes that allowed Medicare beneficiaries to access a wider range of telehealth services without having to travel to a health care facility. Although these changes are currently temporary, CMS is exploring whether telehealth flexibilities should be extended. These two concurrent reviews will be based on Medicare Parts B and C data and will examine the use of telehealth services in Medicare during the COVID-19 pandemic. The first review will examine the extent to which telehealth services are being used by Medicare beneficiaries, how the use of these services compares to the use of the same services delivered face-to-face, and the different types of providers and beneficiaries using telehealth services. The second review will identify program integrity risks with Medicare telehealth services to ensure their appropriate use and reimbursement during the COVID-19 pandemic.
October 2020	Administration for Children and Families	ACF Oversight of Guardian Ad Litem Requirements and Reporting	Office of Evaluation and Inspections	OEI-12-16-00120	2021	As a condition of receiving Child Abuse Prevention and Treatment Act (CAPTA) State grant funding, States must ensure that every child involved in an abuse or neglect judicial proceeding is appointed a trained guardian ad litem (GAL) to obtain a first-hand understanding of the child's situation and needs. States self-certify, through signed assurances to the Administration for Children and Families (ACF), that they have adhered to this requirement. This review will determine the extent to which ACF oversees States' compliance with CAPTA's GAL requirement. We will also identify challenges States face that prevent complete and accurate reporting to ACF regarding court representation of child victims.
October 2020	Food and Drug Administration	An Assessment of the U.S. Food and Drug Administration's Postmarket Surveillance of Medical Devices	Office of Evaluation and Inspections	OEI-01-19-00470	2022	As the information that the U.S. Food and Drug Administration (FDA) receives about medical device safety and effectiveness is increasingly gathered in the postmarket setting, it is more important than ever that FDA’s postmarket safety surveillance system can effectively identify and act on safety signals. We will assess and describe how FDA's established passive postmarket surveillance system identifies and tracks safety concerns, and assess FDA's response to those concerns. We will also describe how elements of FDA's newer surveillance system initiatives, such as the Unique Device Identification system, are being integrated into the passive postmarket surveillance system. In addition, we will describe how FDA plans to integrate these initiatives into the National Evaluation System for health Technology, its in-development active postmarket surveillance system.
Completed	Centers for Medicare and Medicaid Services	Nursing Home Oversight During the COVID-19 Pandemic	Office of Evaluation and Inspections	OEI-01-20-00430	2021	Onsite surveys of nursing homes are a fundamental safeguard to ensure that nursing home residents are safe and receive high-quality care. In response to the coronavirus disease 2019 (COVID-19) pandemic, CMS directed State Survey Agencies (SSAs) to suspend standard onsite surveys and most onsite surveys for complaints. CMS directed SSAs to conduct onsite surveys in response to the most serious complaints (i.e., those involving immediate jeopardy) and complaints related to infection control, and to conduct targeted infection control surveys, which are abbreviated surveys focused on infection control policies and practices within facilities. Using recent complaint and survey data for all nursing homes, this study will examine the extent to which SSAs and CMS are conducting onsite surveys in nursing homes related to serious complaints and targeted infection control, in accord with CMS's recent guidance to suspend certain onsite surveys. We will also identify any barriers that CMS and SSAs face in conducting onsite surveys, as well as potential solutions.
September 2020	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	2021	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.
September 2020	Centers for Medicare and Medicaid Services	Infection Control at Home Health Agencies During the COVID-19 Pandemic	Office of Audit Services	W-00-20-35858	2021	The coronavirus that causes the respiratory disease COVID-19 is especially dangerous for adults aged 65 years and older and those with underlying medical conditions. Medicare beneficiaries receiving home health services may be at a high risk of developing severe illness from COVID-19. Home health services are covered for the elderly and disabled under the Medicare program. Home health services may include skilled nursing care, physical therapy, speech-language pathology, occupational therapy, and medical supplies. Home health agencies (HHAs) must meet certain requirements to participate in the Medicare and Medicaid programs, including meeting infection prevention and control standards. On March 10, 2020, CMS issued a State Survey Directors Letter, "Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) in Home Health Agencies (HHAs)," to provide HHAs with guidance on addressing the outbreak and minimizing transmission. Home health workers often travel to several homes on a weekly basis, which increases their risk of exposure to the COVID-19 and increases the risk of infection among Medicare beneficiaries. HHAs must maintain a coordinated agencywide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases. We will interview corporate officers from the three HHA providers with the largest market share in 2019 as well as HHAs that have recently been cited by CMS for infection control and prevention deficiencies to determine the extent to which their infection control and prevention policy and procedures comply with CMS guidance regarding COVID-19.
September 2020	Food and Drug Administration	Review of the Food and Drug Administration's Contract Closeout Actions	Office of Audit Services	W-00-20-59423	2021	As one of the largest contracting agencies in the Federal Government, HHS performed contracting actions (awards and modifications) totaling almost $26.5 billion in fiscal year 2019. Prior OIG work identified issues regarding contract closeout, which is required once a contracting officer receives evidence of receipt of property and final payment, or evidence of physical completion of a contract. The closeout process generally provides a last chance to detect and recover improper contract payments, and delayed closeout poses a financial risk to agency funds. Also, the closeout process: (1) ensures that goods and services were provided as intended; (2) validates final costs and payments; and (3) frees excess funds for possible use elsewhere. We will determine whether FDA closed contracts in accordance with the Federal Acquisition Regulation and departmental guidance. We will also determine whether the FDA identified contracts when they became eligible for closeout.
September 2020	Centers for Medicare and Medicaid Services	Medicare Advantage Organizations' Use of Ordering Provider Identifiers for Program Integrity Oversight	Office of Evaluation and Inspections	OEI-03-19-00432	2021	National Provider Identifiers (NPIs) for ordering providers are essential for safeguarding the program integrity of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS), clinical laboratory services, imaging services, and home health services in Medicare. However, CMS does not require Medicare Advantage organizations (MAOs) to collect NPIs for ordering providers. In past work, the Office of Inspector General (OIG) found that—although nearly two-thirds of Medicare Advantage encounter data records that MAOs submitted to CMS for DMEPOS, clinical laboratory, imaging, and home health services reviewed did not include the NPI for the ordering provider—almost all MAOs have the ability to collect ordering provider NPIs, and that many MAOs do collect these data. OIG recommended that CMS require MAOs to submit ordering provider identifiers. This issue brief will determine the extent to which MAOs conduct oversight of DMEPOS, clinical laboratory services, imaging services, and home health services using ordering provider identifiers.
September 2020	National Institutes of Health	NIH-Funded Clinical Trials Reported to ClinicalTrials.gov	Office of Audit Services	W-00-20-51020	2022	The National Institutes of Health (NIH) provides funds to awardees to conduct clinical trials involving human subjects. These trials are intended to evaluate the effects of drugs or medical devices regulated by the FDA, as well as other interventions that are not regulated by the FDA. Clinical trials are vital to medical advances because they test new and existing health-related interventions, helping us understand whether they are safe and effective for humans when used as intended. Having information about the results of clinical trials fosters improved patient safety by giving doctors, researchers, and the public at large access to information that may inform medical decisions, help focus on areas in need of study, and maximize the public's investment—and trust—in research. Federal law, regulations, and NIH award terms and conditions generally require NIH awardees to submit the results of certain clinical trials to NIH within 1 year after the earlier of the estimated or the completion date of the applicable clinical trial. NIH has extended this requirement to all clinical trials that receive NIH funding. NIH is required to post the results of these trials on Clinical Trials.gov within 30 days of receiving them. We will conduct an audit at NIH to determine whether NIH ensured that awardees of NIH-funded clinical trials complied with Federal reporting requirements.
August 2020	Centers for Medicare and Medicaid Services	Audit of Medicare Payments for Inpatient Discharges Billed by Hospitals for Beneficiaries Diagnosed With COVID-19	Office of Audit Services	W-00-20-35856	2022	Section 3710 of the Coronavirus Aid, Relief, and Economic Security Act directs the Secretary to increase the weighting factor that would otherwise apply to the assigned diagnosis-related group by 20 percent for an individual who is diagnosed with COVID-19 and discharged during the COVID-19 public health emergency period. We will audit whether payments made by Medicare for COVID-19 inpatient discharges billed by hospitals complied with Federal requirements.
August 2020	Centers for Medicare and Medicaid Services	Audit of CARES Act Provider Relief Funds—General and Targeted Distributions to Hospitals	Office of Audit Services	W-00-20-35855	2021	The Coronavirus Aid, Relief, and Economic Security (CARES) Act and the Paycheck Protection Program and Health Care Enhancement Act appropriated $175 billion for the Provider Relief Fund (PRF) to support health care providers affected by the COVID-19 pandemic. In April 2020, the Health Resources and Services Administration began distributing the funds through general distributions to Medicare providers based on 2018 net patient revenue and targeted distributions for certain provider types (e.g., providers in areas particularly impacted by COVID-19, skilled nursing providers, and providers in rural areas). Providers such as hospitals may be eligible for PRF payments from the general and targeted distributions. We will select for audit a statistical sample of providers that received general and/or targeted distributions. Our objective is to determine whether providers that received PRF payments complied with certain Federal requirements, and the terms and conditions for reporting and expending PRF funds.
August 2020	Centers for Medicare and Medicaid Services	Infection Control and Emergency Preparedness at Dialysis Centers During the COVID-19 Pandemic	Office of Audit Services	W-00-20-35852	2021	CDC has stated that beneficiaries with serious underlying medical conditions, such as end-stage renal disease (ESRD), are at higher risk for severe illness from COVID-19. Regardless of the current pandemic, dialysis patients are at high risk of infection because of weakened immune systems, coexisting conditions such as diabetes, and treatments requiring frequent use of catheters or insertions of needles to access the bloodstream. ESRD facility conditions for coverage regarding infection control and emergency preparedness are defined in 42 CFR 494 Subpart B. On March 30, 2020, CMS issued a revised memorandum providing guidance for infection control and prevention of COVID-19 in dialysis facilities. We will interview corporate officers from the three ESRD service companies covering more than 75 percent of CY 2018 Medicare reimbursements and 71 percent of dialysis clinics. Our objective is to determine whether ESRD facilities implemented additional infection control and emergency preparedness procedures in accordance with CMS and CDC guidance to safeguard high risk ESRD beneficiaries during the COVID-19 pandemic.
August 2020	HHS	Audit of Foundational Cybersecurity Controls for the U.S. Healthcare COVID-19 Portal and Protect.HHS.gov	Office of Audit Services	W-00-20-42031	2021	The Protect.HHS.gov ecosystem and the U.S. Healthcare COVID-19 portal are both critically important systems contributing to the Federal pandemic response. The data collected by these systems are utilized in the response to COVID-19 by, for example, tracking the movement of the virus, identifying potential stresses in the health care delivery system, and provide information about the distribution of supplies. Without proper cybersecurity, the integrity and availability of the data are at risk and the impact to public health efforts could be significant if decisionmakers cannot rely on COVID-19 data from States, communities, and hospitals. We will determine whether HHS has implemented foundational cybersecurity controls to ensure the integrity and availability of Protect.HHS.gov and the U.S. Healthcare COVID-19 portal.
August 2020	Indian Health Service	Audit of the Distribution of Supplies From Indian Health Service's National Supply Service Center in Response to COVID-19	Office of Audit Services	W-00-20-20026	2021	COVID-19 has created unprecedented challenges for the U.S. hospital system, including Indian Health Service (IHS), Tribal, and Urban Indian Health Program (UIHP) facilities. American Indians and Alaska Natives (AI/AN) are particularly vulnerable to COVID-19 due to the relatively high rates of diabetes, cancer, heart disease, and asthma among these populations. These vulnerabilities can be heightened by the strong familial structures in AI/AN communities, in which families commonly live in multigenerational homes. Such socially cohesive communities provide a broad range of benefits to their members, but paradoxically these strong structures make it all the more difficult to maintain physical distancing during a pandemic. IHS has received funding for medical supplies and equipment through the COVID-19 relief bills allocated to IHS, Tribal, and UIHP facilities. The objective of this audit is to determine whether IHS had adequate internal controls to ensure that medical supplies and equipment were effectively distributed to the National Supply Service Center's customers in response to the COVID-19 pandemic.
August 2020	Centers for Medicare and Medicaid Services	Accuracy of Nursing Home Compare Website's Reported Health, Fire Safety, and Emergency Preparedness Deficiencies	Office of Audit Services	W-00-20-31551	2021	CMS's Nursing Home Compare website provides information on nursing homes that participate in the Medicare or Medicaid programs. CMS reports the information for consumers to research and make decisions when selecting a nursing home. Included in the information are a nursing home's quality ratings; the results of recent health, fire safety, and emergency preparedness inspections; staffing levels; quality-of-care measures; and penalties assessed by CMS. We will review the information reported on Nursing Home Compare and determine whether the information is accurate and can be relied upon by consumers to compare and select nursing homes.
August 2020	Centers for Medicare and Medicaid Services	Rates of Estimated Payments From Chart Reviews and Health Risk Assessments Across Medicare Advantage Organizations	Office of Evaluation and Inspections	OEI-03-17-00474	2021	The Medicare Advantage (MA) program provided coverage to 23 million beneficiaries in 2019 at a cost of $264 billion. CMS risk-adjusts these payments by using beneficiaries' diagnoses to pay higher capitated payments to MA organizations (MAOs) for beneficiaries expected to have greater health care needs. This payment policy may create financial incentives for MAOs to misrepresent beneficiaries' health status and make them appear to have additional illnesses and other conditions that would command higher payment. A previous OIG evaluation identified $6.7 billion in estimated 2017 risk-adjusted payments resulting from diagnoses that MAOs reported only on chart reviews, and not on any records of services provided to beneficiaries in 2016. Findings from this evaluation raise concerns about the completeness of payment data that MAOs submit to CMS, the validity of diagnoses on chart reviews, and the quality of care provided to beneficiaries. A current OIG evaluation examines the extent to which diagnoses solely generated by health risk assessments (HRAs) were associated with higher risk scores and higher MA payments. We will combine data from these evaluations to perform new analyses that will determine whether certain MAOs and parent organizations had higher or lower amounts of risk-adjusted payments from both chart reviews and HRAs relative to their peers.
August 2020	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	2021	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.
August 2020	Centers for Medicare and Medicaid Services	Swing-Bed Services at Nationwide Critical Access Hospitals	Office of Audit Services	W-00-20-35853	2021	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.
August 2020	Assistant Secretary for Preparedness and Response	Audit of Obligations and Expenditures Made From Biomedical Advanced Research and Development Authority FY 2018 and FY 2019 Appropriations	Office of Audit Services	W-00-20-59449	2021	The Office of the Assistant Secretary for Preparedness and Response (ASPR) leads the Nation's medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. The Biomedical Advanced Research and Development Authority (BARDA), part of ASPR, aids in safeguarding our nation from pandemic influenza and emerging infectious diseases, and supports the transition of medical countermeasures, such as vaccines, from research through advanced development. Congressional FY 2018 and FY 2019 appropriations for BARDA were made available to support advanced research and development pursuant to section 319L of the Public Health Service Act and other administrative expenses of BARDA. We intend to audit the obligations and expenditures made from these appropriations to determine whether they were used for their intended purpose in accordance with Federal requirements.
Completed	Indian Health Service	Incidence of Adverse Events in Indian Health Service Hospitals	Office of Evaluation and Inspections	OEI-06-17-00530	2021	The Indian Health Service (IHS) operates 26 hospitals that provide free inpatient care to eligible American Indians and Alaska Natives. Many of these hospitals are located in remote areas and have low average daily patient censuses. We will identify adverse and temporary harm events at IHS hospitals in FY 2017. We will estimate the incidence and preventability of these events by reviewing medical records associated with a sample of inpatient stays in IHS hospitals. We will also assess the extent to which IHS hospitals recorded these events in their incident reporting systems.
Completed	Indian Health Service	Quality of Maternal Healthcare in Indian Health Service Hospitals	Office of Evaluation and Inspections	OEI-06-19-00190	2021	Maternal mortality and morbidity are increasing in the United States, and up to 60 percent of maternal deaths may be preventable.[1], [2], [3] The American College of Obstetricians and Gynecologists issues guidance on safe practices during labor and delivery intended to help reduce maternal mortality and other complications. Failure to follow recommended practices is not necessarily improper and does not always cause patient harm, but it may indicate substandard quality of care. We will use medical record reviews by an obstetrician/gynecologist specializing in patient safety to identify and describe examples of potentially substandard care during labor and delivery in IHS hospitals. These anecdotes may help IHS to target hospital improvement efforts. We will also identify factors that may be related to the potentially substandard care.
Completed	Centers for Medicare & Medicaid Services	Specialty Drug Coverage and Reimbursement in Medicaid	Office of Evaluation and Inspections	OEI-03-17-00430	2021	Medicaid spending on specialty drugs has rapidly increased. There is no standard definition for specialty drugs. They may be expensive; be difficult to handle, monitor or administer; or treat rare, complex or chronic conditions. We will describe States' definitions of, and payment methodologies for, Medicaid specialty drugs and determine how much States paid for specialty drugs. We will also review strategies that States use to manage specialty drug costs, such as formularies, cost sharing, step therapy, and prior authorization.
August 2020	Centers for Medicare and Medicaid Services	A Review of Medicare Data To Understand Hospital Utilization During COVID-19	Office of Evaluation and Inspections	OEI-02-20-00410	2021	Coronavirus disease 2019 (COVID-19) can significantly tax hospitals and disproportionately affect Medicare beneficiaries. COVID-19 can affect much of a State or a locality at the same time, rapidly increasing the demand for hospital resources. Using Medicare claims data, this review will analyze the effects of COVID-19 on hospitalized Medicare beneficiaries and the hospital resources needed to care for them. Specifically, it will review utilization of the treatments provided and paid for by Medicare for patients with COVID-19 in selected localities that have known outbreaks. It will also describe the extent to which hospital utilization for Medicare beneficiaries changed over time.
Completed (Partial)	Centers for Medicare & Medicaid Services	Federal Marketplace Enrollment Systems	Office of Audit Services	A-09-18-01000; W-00-19-59441; W-00-18-59436; A-02-19-02005	2021	OIG is developing new work focused on Federal Marketplace enrollment systems, which may include inquiries into operational readiness, internal controls, and IT security for the fifth open enrollment period. This work may build on prior OIG work addressing Marketplace operations.
July 2020	Centers for Medicare and Medicaid Services	End Stage Renal Disease Networks' Responsibilities During COVID-19	Office of Audit Services	W-00-20-35851	2021	CDC has stated that beneficiaries with serious underlying medical conditions, such as end stage renal Disease (ESRD), are at higher risk for severe illness from COVID-19. As per the CDC, prompt detection, triage, and isolation of potentially infectious patients are essential to prevent unnecessary exposures among patients and health care personnel at dialysis facilities. ESRD treatment facilities are organized into groups called Networks. Network Organizations under CMS contracts develop relationships with dialysis professionals, providers, and patients, and create a collaborative environment to improve patient care. The Network Organizations' contracts include statutory responsibilities and quality improvement activities that could be important in protecting ESRD beneficiaries during the COVID-19 pandemic. In addition to Network Organizations, the ESRD National Coordinating Center (NCC) supports and coordinates activities for the ESRD program on a national level. We will interview Network Organizations, NCC, and CMS officials to identify the actions Network Organizations are taking to aid dialysis clinics and patients in response to COVID-19 and keep CMS abreast of quality-of-care issues resulting from COVID-19.
July 2020	Indian Health Service	Audit of Indian Health Service's Coverage of COVID-19 Testing	Office of Audit Services	W-00-20-20025	2021	The Families First Coronavirus Response Act provided $64 million in additional resources for COVID-19 response activities through the Indian Health Service (IHS) and requires coverage, without cost-sharing, for COVID-19 testing for American Indians/Alaska Natives, who receive health services. The Paycheck Protection Program and Health Care Enhancement Act provided $750 million for COVID-19 testing and testing-related services through IHS. From these two Acts, funding for COVID-19 testing to urban Indian organizations total $53 million and funding to IHS Federal health programs and Tribal health programs total $611 million. We will audit IHS's allocation and utilization of funding to urban Indian organizations, IHS Federal health programs and Tribal health programs. Specifically, our objectives will be to determine whether: (1) IHS allocated the COVID-19 funds to ensure that testing supplies were available to meet community needs, and (2) COVID-19 funds were used by IHS and grantees for testing, including other testing-related services, in accordance with Federal requirements.
July 2020	Assistant Secretary for Preparedness and Response	Audit of HHS's Awarding of Ventilator Production Contracts Under the Defense Production Act in Response to COVID-19	Office of Audit Services	W-00-20-59450	2021	To address the COVID-19 pandemic, the President used his authority under the Defense Production Act of 1950 to direct the Department of Health and Human Services to facilitate the supply of materials for the production of ventilators. In response, the Office of the Assistant Secretary for Preparedness and Response (ASPR) awarded 10 contracts totaling more than $2.9 billion to supply more than 187,000 ventilators for the Strategic National Stockpile by the end of 2020. This work will focus on the top five highest dollar value contracts awarded by ASPR for supplying these ventilators. We plan to determine whether ASPR's awarding and monitoring of these contracts complied with Federal requirements and HHS policies and procedures.
July 2020	Centers for Disease Control and Prevention	CDC's Collection and Use of Data on Disparities in COVID-19 Cases and Outcomes	Office of Evaluation and Inspections	OEI-05-20-00540	2021	With emerging information on rates of infection and outcomes for the ongoing coronavirus disease 2019 (COVID-19), numerous reports document a disproportionate burden of infection and deaths among communities of color and economically disadvantaged communities. This study will examine data that the Centers for Disease Control and Prevention (CDC) collects and maintains that can be used to assess racial, ethnic, and socioeconomic disparities in COVID-19 cases and outcomes, as well as how CDC uses those data as part of its activities to address the COVID-19 pandemic. We will also examine CDC's lessons learned about how to best protect communities of color and economically disadvantaged communities in future public health emergencies.
July 2020	OS, HRSA, CDC	Geographic Distribution of Provider Relief Funds to Communities Disproportionately Impacted by Adverse COVID-19 Outcomes	Office of Evaluation and Inspections	OEI-05-20-00580	2021	As information on rates of infection and outcomes for the ongoing COVID-19 pandemic emerges, numerous reports document racial, ethnic, and socioeconomic disparities in rates of adverse outcomes from COVID-19, including death. This study will review the locations of hospitals that received Provider Relief Funds, with particular attention to hospitals located in communities of color and economically disadvantaged communities that were disproportionately impacted by adverse COVID-19 outcomes (i.e., hospitalization or death).
July 2020	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	2021	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.
July 2020	Centers for Medicare and Medicaid Services	Medicaid: Expedited Provider Enrollment During COVID-19 Emergency	Office of Audit Services	W-00-20-31547	2021	As a result of the coronavirus disease 2019 (COVID-19) pandemic, Medicaid provider enrollment through State Medicaid agencies has been expedited under the SSA §1135 Authority to Waive Requirements during National Emergencies. Rapid loosening of established provider screening and background check requirements may limit a State's ability to identify providers who are not eligible to participate in Medicaid. Our objective is to determine whether the State agency and providers complied with Federal and State requirements for newly enrolled providers under the national emergency declaration and if the State established tracking controls for these providers as well as giving providers adequate guidance on waived enrollment requirements.
July 2020	Centers for Medicare and Medicaid Services	Assessing Trends Related to the Use of Psychotropic Drugs in Nursing Homes	Office of Evaluation and Inspections	OEI-07-20-00500	2021	Previous OIG work found that elderly nursing home residents who were prescribed antipsychotic drugs—a type of psychotropic drug—were at risk for harm. CMS concurred with some OIG recommendations and developed new initiatives. However, policymakers continue to raise concerns about whether CMS has made sufficient progress in reducing the use of antipsychotic drugs to care for the elderly. We will report the changes over time for the following: (1) the use of psychotropic drugs for elderly nursing home residents; (2) citations and civil monetary penalties assessed to nursing homes regarding psychotropic drugs; and (3) the presence of diagnoses that exclude nursing home residents from CMS's measure of the use of antipsychotic drugs.
July 2020	Centers for Medicare and Medicaid Services	Hospital Collection Effort for Medicare Bad Debt Basic Health Program Eligibility Determinations	Office of Audit Services	W-00-20-35849	2021	Medicare allows providers to claim reimbursement for a portion of these uncollectible deductibles and coinsurance (known as “bad debt”) once the provider establishes that reasonable collection efforts were made, that the debt was uncollectible, and that there was no likelihood of future recovery based on sound business judgment. Reasonable collection efforts can include billings, followup letters, phone calls, and personal contact. We plan to select a random sample of hospitals and review the policies and procedures in place related to collecting deductibles and coinsurance, offering financial assistance, identifying bad debt, and accounting for the receipt of previously reimbursed bad debt. In addition, we will select a judgmental sample of claims with high-dollar bad-debt amounts (coinsurance or deductible) and determine how the hospitals adhered to Federal criteria in treating these bad debts. Our audit will determine whether hospitals' policies and procedures for collecting Medicare deductible and coinsurance amounts from beneficiaries are in compliance with Federal regulations for the reimbursement of bad debt.
July 2020	Centers for Medicare and Medicaid Services	Basic Health Program Eligibility Determinations	Office of Audit Services	W-00-20-31549	2021	We will determine whether States made Basic Health Program (BHP) payments on behalf of beneficiaries who did not meet Federal and State eligibility requirements. Section 1331 of the Affordable Care Act (ACA) gives States the option to create a BHP that provides health benefits coverage for low-income residents, citizens or lawfully present non-citizens, who would otherwise be eligible to purchase coverage through the Health Insurance Marketplace. The option also gives States the ability to provide more affordable coverage for these low-income residents and improve continuity of care for people whose income fluctuates above and below Medicaid and Children's Health Insurance Program levels. The BHP is funded primarily by Federal funds and must include 10 essential health benefits specified by the ACA.
July 2020	Centers for Medicare and Medicaid Services	Biosimilar Trends in Medicare Part D	Office of Evaluation and Inspections	OEI-05-20-00480	2022	Biologic drugs—generally large, complex molecules produced in a living system—are among the most expensive drugs on the U.S. market. Biosimilar drugs are highly similar and have no clinically meaningful difference from their reference biologics; they also tend to be less expensive than their reference biologics. Medicare Part D and beneficiaries have the potential to spend less on prescription drugs with the increased use of biosimilars rather than their reference biologics, but use of biosimilars remains low. Limited coverage of biosimilars by Part D plans and formulary tier placement may discourage the use of less expensive biosimilars. Our study will describe utilization and cost trends of biosimilars and reference biologics covered by Part D over time. In addition, we will determine how much Medicare and beneficiaries paid for biosimilars and reference biologics covered by Part D in 2019, and then compare those costs to determine how much Part D and beneficiaries would have spent with increased use of biosimilars.
July 2020	Centers for Medicare and Medicaid Services	Beneficiary Cost-Sharing in Part D	Office of Evaluation and Inspections	OEI-02-20-00460	2021	A priority of OIG and HHS is to lower drug spending for people and programs. In Medicare Part D, as drug costs rise, the amount that beneficiaries pay out-of-pocket also increases. This amount—known as beneficiary cost-sharing—is not capped in Part D. As a result, some beneficiaries may have high out-of-pocket costs for their prescriptions. If beneficiaries' costs become unaffordable, they may skip doses of medication or forgo purchasing it altogether. This data brief will provide in-depth data on the amount beneficiaries pay out-of-pocket for Part D drugs. It will also determine the proportion of beneficiaries who have high cost-sharing and describe these beneficiaries and the drugs they commonly receive, including the proportion of drugs that are high cost.
July 2020	Centers for Medicare and Medicaid Services	Analysis of New Rural Add-On Payment Methodology	Office of Audit Services	W-00-20-35850	2021	Section 50208 of the Bipartisan Budget Act of 2018 (the BBA) extended rural add-on payments for home health episodes and visits ending during calendar years (CYs) 2019 through 2022, and mandated implementation of a new methodology for applying those payments. Beginning in CY 2019, rural add-on payments were provided in varying amounts according to classification in one of three rural categories: (1) high utilization, (2) low population density, and (3) all other. The BBA requires home health claims to indicate the code for the county in which the home health service is provided. CMS has instructed providers to use value code 85 to report the county code and will return claims for correction when the code is missing or invalid. The BBA also mandated that, no later than January 1, 2023, HHS-OIG submit to Congress an analysis of Medicare home health claims and utilization of home health services by county (or equivalent area) and recommendations, as appropriate, based on such analysis. To meet that mandate, we will perform an analysis of Medicare home health claims for CYs 2019 through 2021. We will trend the claim data and cost reports to determine what impact, if any, the new rural add-on methodology has had on home health agency providers and the utilization of home health services in rural areas.
July 2020	Centers for Medicare and Medicaid Services	Centers for Medicare & Medicaid Services and States Implement Policy Modifications To Ensure That Medicaid Beneficiaries Continue To Receive Prescriptions	Office of Audit Services	W-00-20-31550	2021	Medicaid is a joint Federal-State program that pays for medical assistance for individuals and families with low incomes. All States currently provide coverage for outpatient prescription drugs within their State Medicaid programs. Under section 1135 of the Act, CMS may temporarily waive or modify certain Medicaid requirements to ensure that sufficient health care items and services are available to meet the needs of beneficiaries in times of an emergency. The coronavirus disease 2019 (COVID-19) pandemic highlights the need for States to efficiently and effectively respond to protect the needs of Medicaid beneficiaries. This audit will provide insights from State officials on action taken by States and DC to ensure Medicaid beneficiaries continue to receive prescriptions during the COVID-19 pandemic. We will interview State officials from several States and DC to determine actions taken or planned. Our objective is to review actions taken or planned by States and DC to ensure Medicaid beneficiaries continue to receive prescriptions during the COVID-19 pandemic.
Completed (partial)	Administration for Children and Families	Audit of Child Care and Development Fund Child Care Services During Coronavirus Disease 2019 Pandemic	Office of Audit Services	A-07-20-06092; W-00-20-20022	2021	The Child Care and Development Fund (CCDF) program provides subsidized childcare services to low-income families, families receiving temporary public assistance, and families transitioning from public assistance, so family members can work or attend training or education. CCDF regulations require State, territorial, and Tribal Lead Agencies to have a Statewide Disaster Plan (or Disaster Plan for a Tribe's service area). These Disaster Plans incorporate guidelines for continuation of childcare subsidies and childcare services. These regulations also allow Lead Agencies broad flexibility to operate the CCDF program and adapt policies to maintain continuity of services for families affected by coronavirus disease 2019 (COVID-19). Childcare services are critical in emergency situations; they allow healthcare workers, first responders, and other essential workers to continue working during an emergency response. On March 13, 2020, the Administration for Children and Families' Office of Child Care, which administers the CCDF program at the Federal level, directed Lead Agencies to a 2017 Information Memorandum (IM). The IM explains the flexibilities and waivers that Lead Agencies have to respond to emergencies, like the COVID-19 pandemic. We intend to identify the approaches that Lead Agencies have adopted in response to the COVID-19 pandemic to ensure the health and safety of the children and the providers in their CCDF childcare program.
June 2020	Centers for Medicare and Medicaid Services	Trend Analysis of Medicare Laboratory Billing for Potential Fraud and Abuse With COVID-19 Add-on Testing	Office of Evaluation and Inspections	OEI-09-20-00510	2021	The coronavirus disease 2019 (COVID-19) pandemic has led to an unprecedented demand for diagnostic laboratory testing to determine whether an individual has the virus. Beyond the COVID-19 tests, laboratories can also perform add-on tests, for example to confirm or rule out diagnosis other than COVID-19. However, OIG has program integrity concerns related to add-on tests in conjuction with COVID-19 testing, particularly related to potentially fraudulent billing for associated respiratory pathogen panel (RPP) tests, allergy tests, or genetic tests. The Centers for Medicare & Medicaid Services has relaxed rules related to COVID-19 testing and other associated diagnostic laboratory testing to no longer require an order from the treating physician or nonphysician practitioner (NPP) during the COVID-19 public health emergency. Relaxation of the physician ordering/NPP rules could allow unscrupulous actors more leeway for fraudulent billing of unnecessary add-on testing. This study will examine Medicare claims data for laboratory testing to identify trends in the use of RPP, allergy, and genetic testing and identify patterns of billing by laboratories that may indicate fraud and abuse.
June 2020	Centers for Medicare and Medicaid Services	Medicaid—Telehealth Expansion During COVID-19 Emergency	Office of Audit Services	W-00-20-31548	2021	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.
June 2020	Administration for Children and Families	Audit of Foster Care Services During Coronavirus Disease 2019 (COVID-19)	Office of Audit Services	W-00-20-20024	2021	Title IV-E of the Social Security Act (the Act), as amended, authorizes the Federal Foster Care Program, which helps provide safe and stable out-of-home care for children until the children are safely returned home, placed permanently with adoptive families, or placed in other planned arrangements for permanency. Title IV-B of the Act authorizes Federal funding to States to promote flexibility in the development and expansion of coordinated child and family services programs. In response to COVID-19, on April 15, 2020, the Children's Bureau—the operating division of the Administration for Children and Families (ACF) that administers the Title IV-B and Title IV-E programs at the Federal level—provided flexibility to State Title IV-E agencies related to (1) fingerprint-based criminal record checks requirements for prospective foster parents (allowing for name-based checks until fingerprint-based checks can safely be done), and (2) caseworker visit requirements (allowing videoconferencing visits to count toward the requirement that 50 percent of visits must occur in the child's home). On April 27, 2020, the Children's Bureau reminded States of additional flexibilities afforded by the Statute, including the authority to modify foster family licensing standards as long as the standards are applied to all of these placements in accordance with the requirements of the Statute. Additionally, States have the authority to set their own foster care maintenance payment rates including, at their own discretion, enhancing those rates for children who test positive for COVID-19. We intend to survey all States and identify the States that adopted any new licensing regulations or policies and procedures as a result of the existing flexibilities in the Statute and the waivers provided by ACF. Based on the information gathered, we plan to identify three States and conduct separate audits to ensure foster care providers are safeguarding the health and safety of children during the COVID-19 pandemic and identify any vulnerabilities or gaps in policies or procedures that could place these children at risk. As part of these audits, we would ensure that criminal record checks for foster parents conducted via name-based checks were ultimately conducted through fingerprints whenever determined safe to do so.
June 2020	Centers for Medicare and Medicaid Services	Meeting the Challenges Presented by COVID-19: Nursing Homes	Office of Evaluation and Inspections	OEI-02-20-00490	2021	The coronavirus disease 2019 (COVID-19) pandemic has created unprecedented challenges for nursing homes. These challenges include procuring critical supplies, testing residents and staff, isolating high numbers of contagious residents, caring for those afflicted, and protecting staff on a scale never before experienced in this country. This nationwide, two-part study on nursing homes will examine how the COVID-19 pandemic has affected nursing homes. The first part will describe the characteristics of the nursing homes that were hardest hit by the pandemic (i.e. homes with high numbers of residents who had COVID-19 or had died). The second part will describe the strategies nursing homes have used to mitigate the effects of COVID-19 on their residents and staff in the face of these unique circumstances.
June 2020	Substance Abuse and Mental Health Services Administration	Opioid Treatment Program Challenges During the COVID-19 Pandemic	Office of Audit Services	W-00-20-59447	2021	The United States faces two simultaneous nationwide public health emergencies: the opioid epidemic and the coronavirus disease 2019 (COVID‑19) pandemic. Recently released Centers for Disease Control and Prevention data identified that in 2018, there were nearly 47,000 opioid-related overdose deaths in the United States. In addition, as of May 28, 2020, over 100,000 U.S. citizens had died from complications related to COVID-19. Because of the widespread transmission of COVID-19, Federal, State, Tribal, and local government agencies have recommended and implemented extensive community mitigation activities, including issuing orders to residents to stay at home and practice social distancing, to help slow and contain the spread of the virus. We plan to identify the challenges that opioid treatment programs (OTPs) are encountering during the COVID-19 pandemic. In addition, we will identify the actions that OTPs are taking to address those challenges while ensuring the continuity of needed services and protecting the health and safety of their clients and staff.
June 2020	Centers for Medicare and Medicaid Services	Audit of Nursing Homes' Reporting of COVID-19 Information Under CMS's New Requirements	Office of Audit Services	W-00-20-31546	2021	In response to the coronavirus disease 2019 (COVID-19) public health emergency, CMS added requirements to an existing regulation that requires nursing homes to report to State and local health departments communicable diseases, health care-associated infections, and potential outbreaks. Under one requirement, these facilities must now report COVID-19 data (such as information on suspected and confirmed infections, and deaths among residents and staff) to the Centers for Disease Control and Prevention through its National Healthcare Safety Network system. The data must be reported in a standardized format at least weekly. We will assess nursing homes' reporting of CMS-required information related to the COVID-19 public health emergency. Specifically, we will determine whether the data reported by nursing homes were complete, accurate, and reliable.
Completed	Centers for Medicare and Medicaid Services	Medicare Payments for Clinical Diagnostic Laboratory Tests in 2019: Year 2 of the New Fee Schedule Rates	Office of Evaluation and Inspections	OEI-09-20-00450	2021	Medicare is the largest payer of clinical laboratory services in the Nation. Medicare Part B covers most lab tests and pays 100 percent of allowable charges. The Protecting Access to Medicare Act of 2014 (PAMA) requires CMS to set Medicare payment rates for lab tests using private payer rates collected from labs (PAMA, Pub. L. No. 113-93 § 216(a)). On January 1, 2018, CMS began paying for lab tests under the new system mandated by PAMA. PAMA requires OIG to publicly release an annual analysis of the top 25 laboratory tests by expenditures under Title XVIII of the Social Security Act (PAMA, § 216(c)(2)(A)). In addition, PAMA mandates that OIG conduct analyses it determines appropriate with respect to the implementation and effect of the new payment system (PAMA, § 216(c)(2)(B)). In accordance with PAMA, we will publicly release an analysis of the top 25 laboratory tests by expenditures for 2019 and analyze the payments made under the new payment system in 2019, the second year of payments made under the new system for setting payment rates
June 2020	Office of the Secretary	Audit of Cost Allocation Services' Negotiation and Approval of Indirect Cost Rates for Nonprofit Organizations	Office of Audit Services	W-00-20-51003	2021	Cost Allocation Services (CAS), which is within the Department of Health and Human Services (HHS) Program Support Center, is designated as the Agency to negotiate facility and administrative indirect cost rate agreements for nonprofit organizations receiving the largest dollar value of Federal funds from HHS grant or contract funds. The indirect cost rate agreements are used by grantee institutions to charge Federal programs for administrative and facility costs associated with conducting Federal programs. Previous OIG audits of nonprofit organizations have raised concerns about the indirect cost rate negotiations and subsequent agreements. Our objective will be to assess CAS's indirect rate setting process and determine its compliance with Federal regulations when negotiating and approving indirect cost rates for nonprofit organizations.
June 2020	Centers for Medicare and Medicaid Services	Advanced Care Planning Services: Compliance With Medicare Requirements	Office of Audit Services	W-00-20-35848	2021	In 2016, Medicare began paying for Advanced Care Planning (ACP), which is a face-to-face service through which a Medicare physician (or other qualified health care professional) and a patient discuss the patient's wishes for health care if he or she becomes unable to make decisions about care. It allows Medicare beneficiaries to make important decisions, giving them control over the type of care they receive and when they receive it. Previous reviews have shown improper payments due to a lack of clinical documentation to support face-to-face services, clinical documentation of the time spent discussing ACP, or both. We plan to perform a nationwide audit to determine whether Medicare providers for ACP services complied with Federal regulations.
June 2020	Centers for Medicare and Medicaid Services	Opioid Use in Medicare Part D in 2020	Office of Evaluation and Inspections	OEI-02-20-00400	2021	The opioid crisis remains a public health emergency. In 2018, there were nearly 47,000 opioid-related overdose deaths in the United States. Identifying patients who are at risk of overdose or abuse is key to addressing this crisis. The coronavirus disease 2019 (COVID-19) pandemic has made this need even more pressing. The National Institutes of Health recently issued a warning that individuals with opioid use disorder could be particularly hard hit by COVID-19, as it is a respiratory virus that attacks the lungs. Respiratory disease is known to increase the mortality risk among people taking opioids. This data brief will provide information on opioid utilization among beneficiaries enrolled in Medicare Part D in 2020. It will build on our series of annual reports, including the July 2019 data brief Opioid Use Decreased in Medicare Part D, While Medication-Assisted Treatment Increased, OEI-02-19-00390. It will provide 2020 data on Part D spending for opioids and the number of beneficiaries who received extreme amounts of opioids through Part D and those who appeared to be doctor-shopping. It will also identify prescribers who ordered opioids for large numbers of these beneficiaries.
June 2020	HHS	Audit of the Department of Health and Human Services' Progress Toward Compliance With the Geospatial Data Act of 2018	Office of Audit Services	W-00-20-42029	2021	The President signed into law the Geospatial Data Act of 2018 (GDA) as P.L. No. 115254 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.
June 2020	Substance Abuse and Mental Health Services Administration	Data Snapshot: Medication-Assisted Treatment From Providers Waivered at the Highest Patient-Limit Level	Office of Evaluation and Inspections	OEI-BL-20-00260	2021	Despite the well-documented effectiveness of medication-assisted treatment (MAT) to address opioid use disorder, individuals often encounter barriers to accessing this type of treatment. As followup to recent OIG work on access to MAT through the Substance Abuse and Mental Health Services Administration's (SAMHSA) Buprenorphine Waiver Program, we will examine the number of patients who received MAT from providers waivered at the highest patient-limit level (i.e., 275 patients). In our prior report, we found that although only 8 percent of waivered providers were at the 275-limit level, this group could collectively treat 1 million patients at any one time. However, recent studies by SAMHSA and others found that waivered providers are not prescribing at or near their patient-limit capacity. SAMHSA requires that 275-limit waivered providers annually report the number of patients they are treating. Utilizing these data, this snapshot will report how many patients are receiving MAT services from 275-limit waivered providers. We will also report how many of these providers are located in high-need counties and how many are treating at or near their capacity limit. We will also determine how many 275-limit waivered providers have reported their patient data to SAMHSA, as required.
June 2020	Centers for Medicare and Medicaid Services	Utilization of Medication-Assisted Treatment in Medicare	Office of Evaluation and Inspections	OEI-02-20-00390	2021	The opioid crisis remains a public health emergency. The current coronavirus disease 2019 (COVID-19) pandemic makes the need to focus on the opioid crisis even more pressing. The National Institutes of Health recently issued a warning that individuals with opioid use disorder could be particularly hard hit by COVID-19. An important step in addressing the crisis is to focus on concerns about access to treatment. Recent OIG studies have found that the utilization of drugs for medication-assisted treatment (MAT) is low and that concerns exist related to access. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act requires Medicare to cover certain treatment services provided by opioid treatment programs, including methadone. This study will assess the extent to which Medicare beneficiaries with opioid use disorder are receiving MAT drugs through Medicare and the extent to which they are receiving counseling or behavioral therapies. It will also determine whether Medicare beneficiaries with opioid use disorder who are not receiving MAT drugs have certain characteristics in common.
June 2020	Centers for Medicare and Medicaid Services	Results of UPICs' Benefit Integrity Activities	Office of Evaluation and Inspections	OEI-03-20-00330	2022	The Unified Program Integrity Contractors (UPICs) are the only benefit integrity contractors that safeguard both the Medicare and Medicaid programs from fraud, waste, and abuse. The Medicare and Medicaid programs provide health coverage to more than 100 million Americans. UPICs must effectively detect and deter fraud, waste, and abuse. This study will continue OIG's work examining the results from benefit integrity contractors' identification and investigation of fraud, waste, and abuse. It also will identify any barriers and challenges UPICs have experienced while conducting unified benefit integrity activities across Medicare and Medicaid.
June 2020	Administration for Children and Families	Audit of Grantee's Expenditures Under the Additional Supplemental Appropriations for Disaster Relief Requirement Act, 2018	Office of Audit Services	W-00-20-20023	2021	On February 9, 2018, the Bipartisan Budget Act of 2018 (P.L. 115-123) included division B, subdivision 1, the Further Additional Supplemental Appropriations for Disaster Relief Requirement Act, 2018, which provided disaster relief totaling approximately $89.3 billion. Of this, HHS was allocated $5.97 billion ($1.07 billion for discretionary programs and $4.9 billion for Medicaid). OIG received $2 million to provide oversight of HHS's activities and to ensure that program activities and funds expended for recovery and response efforts related to hurricanes Harvey, Irma, and Maria achieved their intended purposes to help individuals and communities in need. For this series of reviews, we will determine whether Further Additional Supplemental Appropriations for Disaster Relief Requirement Act, 2018, recipients claimed allowable costs in accordance with Federal requirements.
June 2020	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	2021	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.
May 2020	Centers for Medicare and Medicaid Services	Audit of Nursing Home Infection Prevention and Control Program Deficiencies	Office of Audit Services	W-00-20-31545	2021	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.
May 2020	OS	Audit of CARES Act Provider Relief Funds—Distribution of $50 Billion to Health Care Providers	Office of Audit Services	W-00-20-35847	2021	This work will examine the effectiveness of HHS controls over the awarding and disbursement of $50 billion in Provider Relief Fund (PRF) payments to hospitals and other providers. We will obtain data and interview program officials to gain an understanding of how PRF payments were calculated and review PRF payments for compliance with Coronavirus Aid, Relief, and Economic Security (CARES) Act requirements. Among other things, we will seek to determine whether HHS controls over PRF payments ensured that payments were correctly calculated and disbursed to eligible providers.
May 2020	Centers for Medicare and Medicaid Services	Blood Lead Screening Tests for Medicaid-Enrolled Children	Office of Evaluation and Inspections	OEI-07-18-00371	2021	Under the Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) benefit, Medicaid-enrolled children are required to receive blood lead screenings, followup services, and treatment for conditions identified through screenings. This work expands on previous OIG work in EPSDT screenings and will incorporate State health department data to supplement screening rates for Medicaid-enrolled children who may receive lead screenings in other settings. Additionally, this work will identify barriers to and opportunities for improving required lead screenings and boosting education and outreach for practitioners, parents, and caregivers.
Completed	Indian Health Service	Implementation of Indian Health Service Patient Protection Policies in Healthcare Facilities	Office of Evaluation and Inspections	OEI-06-19-00331	2021	Details surrounding the recent convictions of a former Indian Health Service (IHS) physician for patient abuse raised concerns about IHS policies and procedures to prevent and address patient abuse. IHS partners with 573 federally recognized Tribes to provide healthcare services to its 2.6 million American Indian and Alaska Native beneficiaries, and IHS directly operates 24 hospitals, 51 health centers, 24 health stations, and 2 school health centers. In February 2019, IHS issued new policies to protect children from sexual abuse by healthcare providers. This study is conducted in two phases. Phase 1 inventoried and examined IHS nation-wide policies and procedures for preventing, reporting, and addressing patient abuse and identified progress and potential challenges to their effective implementation. Phase 2 will evaluate the sufficiency and implementation of these policies at the facility level. We will administer a survey to leadership at all IHS-operated healthcare facilities, conduct interviews with leadership and staff at selected facilities, and review relevant supporting documentation.
May 2020	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	2021	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.
May 2020	Centers for Medicare and Medicaid Services	Medicare Part D Payments for Transmucosal Immediate-Release Fentanyl Drugs	Office of Audit Services	W-00-20-35846	2021	Transmucosal Immediate-Release Fentanyl (TIRF) drugs are a Schedule II controlled substance. Medicare Part D covers TIRF drugs only for managing breakthrough pain in adult cancer patients who are already receiving and are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. We will determine whether TIRF drugs were appropriately dispensed in Medicare Part D in accordance with Medicare requirements.
May 2020	National Institutes of Health	Audit of National Institutes of Health's Cybersecurity Provisions and Related Efforts to the Grant Program	Office of Audit Services	W-00-20-42027	2021	The purpose of this audit is to determine if NIH has controls in place to ensure grants have appropriate cybersecurity provisions. The National Institutes of Health (NIH) is comprised of 27 separate components called Institutes and Centers and is the primary Federal agency responsible for conducting and supporting biomedical research for the purpose of enhancing health, lengthening life, and reducing illness and disability. Annually, NIH invests nearly $39.2 billion in medical research projects on a number of common and rare diseases, including cancer, Alzheimer's, diabetes, arthritis, heart ailments, and AIDS. More than 80 percent of the NIH's funding is awarded through approximately 50,000 competitive grants to more than 300,000 researchers at more than 2,500 universities, medical schools, and other research institutions in every State and around the world. Specifically, the audit will review NIH's policies and procedures to determine if NIH has controls or requirements in place to ensure grants have appropriate cybersecurity provisions, and review NIH's policies and procedures to test and verify that adequate cybersecurity is in place over the grantee research data.
May 2020	Centers for Medicare and Medicaid Services	Monitoring Psychotropic Drug Use in Nursing Homes	Office of Evaluation and Inspections	OEI-07-19-00490	2021	Previous OIG work found that elderly nursing home residents who were prescribed antipsychotics, a type of psychotropic drug, were at risk for harm. In response, the Centers for Medicare & Medicaid Services (CMS) took steps to address the risk of harm to nursing home residents. One such step was introducing a quality measure to track the rates of antipsychotic drug use in residents without an appropriate diagnosis. Recently, CMS and researchers expressed concerns that some nursing homes underreport antipsychotic drug use and may inaccurately report certain patient diagnoses in order to avoid CMS monitoring. Additionally, research on antipsychotic drug use has highlighted the need to closely monitor all psychotropic drug use to accurately oversee drug use in nursing homes. We will determine the extent to which there are inconsistencies, if any, between (1) Medicare claims data for residents prescribed psychotropic drugs compared to nursing home self-reported data on residents who received psychotropic drugs, and (2) Medicare claims data as it relates to the diagnoses that exclude residents from monitoring in the antipsychotic quality measure compared to nursing home self-reported data on resident diagnoses.
Completed	Indian Health Service	Review of Opioid Use in Indian Health Service	Office of Evaluation and Inspections	OEI-05-18-00470	2021	Opioid abuse and overdose deaths are at crisis levels in the United States, with approximately 49,000 Americans dying from opioids in 2017, an increase from more than 42,000 in 2016. Consistent with previous OIG work in Medicare Part D and Medicaid, we will determine the extent to which beneficiaries are receiving extreme amounts of opioids through Indian Health Service (IHS), as well as IHS-employed prescribers and IHS-run pharmacies that have questionable prescribing or dispensing patterns. This review will also determine how IHS prevents and detects opioid misuse or abuse, as well as how it enforces its opioid-related policies.
May 2020	Centers for Medicare & Medicaid Services	Assessing Inpatient Hospital Billing for Medicare Beneficiaries	Office of Evaluation and Inspections	OEI-02-18-00380	2021	In 2016, hospitals billed Medicare $114 billion for inpatient hospital stays, accounting for 17 percent of all Medicare payments. The Centers for Medicare & Medicaid Services and the Office of Inspector General have identified problems with upcoding in hospital billing: the practice of mis- or over-coding to increase payment. We will conduct a two-part study to assess inpatient hospital billing. The first part will analyze Medicare claims data to provide landscape information about hospital billing. We will determine how inpatient hospital billing has changed over time and describe how inpatient billing varied among hospitals. We will then use the results of this analysis to target certain hospitals or codes for a medical review to determine the extent to which the hospitals billed incorrect codes.
May 2020	National Institutes of Health	NIH's Peer Review Process for Evaluating Grants	Office of Evaluation and Inspections	OEI-01-19-00140	2021	To fulfill its mission, the National Institutes of Health (NIH) funds extramural research through a grant-making process "that strives to eliminate bias." The initial level of review is conducted by a scientific review group (SRG) consisting of peer reviewers who have expertise in the subject matter of the grant applications. NIH officials within each relevant Institute or Center (IC) then rank and package the applications for the second level of review by an Advisory Council composed of nationally recognized experts. The Director of NIH has expressed concern about the increasing risks to the integrity of peer review, including the risk of peer reviewers attempting to influence funding decisions inappropriately. The Departments of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (Public Law No. 115-245) and its Accompanying Report directed OIG to examine NIH's efforts to ensure the integrity of its grant evaluation and selection processes, of which peer review is a key component. OIG will determine the extent to which select ICs follow their grant application processes related to SRGs. We will also determine how staff and Directors of the ICs review the results of the SRGs and develop their funding recommendations for the Advisory Council.
May 2020	Centers for Medicare & Medicaid Services	Nursing Facility Staffing: Reported Levels and CMS Oversight	Office of Evaluation and Inspections	OEI-04-18-00451	2021	Staffing levels in nursing facilities can impact residents' quality of care. Nursing facilities that receive Medicaid and Medicare payments must provide sufficient licensed nursing services 24 hours a day, including a registered nurse for at least 8 consecutive hours every day. CMS uses auditable daily staffing data, called the Payroll-Based Journal, to analyze staffing patterns and populate the staffing component of the Nursing Home Compare website—a site that enables the public to compare the results of health and safety inspections, the quality of care provided at nursing facilities, and staffing at nursing facilities. The first of two reports will be a data brief that describes nursing staffing levels reported by facilities to the Payroll-Based Journal. The second report will examine CMS's efforts to ensure data accuracy and improve resident quality of care.
May 2020	Health Resources & Services Administration	Access to Medication-Assisted Treatment at Health Centers	Office of Evaluation and Inspections	OEI-BL-19-00320	2021	Medication-assisted treatment (MAT) is a significant component of the treatment protocols for opioid use disorder and plays a large role in combating the opioid epidemic in the United States. Congress has taken sustained action to support MAT services through broadened prescribing authorities, increased Federal funding, and enhanced insurance protections. However, a treatment gap continues to exist where less than 1 percent of the people in the United States who need treatment for substance use disorder receive it. OIG will examine access to MAT through health centers funded by the Health Resources and Services Administration (HRSA). Health centers are key entities to expand access to MAT because they provide both primary care and behavioral healthcare services and accept patients regardless of their ability to pay. Additionally, in recent years, HRSA has awarded grant funding specifically to expand access to substance use disorder treatment at health center sites. We will examine how many health centers provide MAT services, what types of services they provide (e.g., specific medications, behavioral health services such as counseling), how many of their providers are waivered to prescribe MAT drugs, and how many patients they are treating with MAT. We will also examine the factors that may either facilitate or hinder the provision of MAT in health centers.
May 2020	Centers for Medicare & Medicaid Services	Blood Lead Screening Tests, Followup Services, and Treatment for Medicaid-Enrolled Children	Office of Evaluation and Inspections	OEI-07-18-00370	2021	There is no safe level of lead exposure for children. In the absence of timely screening, followup services, and treatment, children remain vulnerable to cognitive deficiencies associated with lead exposure. Medicaid-enrolled children are required to receive blood lead screenings. Under the Early and Periodic Screening, Diagnostic, and Treatment program, children are also entitled to receive followup services and treatment for conditions identified through screenings (e.g., elevated blood lead levels (EBLLs). Although previous OIG reports identified low rates of lead screenings, an evaluation of followup services for Medicaid-enrolled children with EBLLs has not been done. We will identify the percentage of children under 26 months of age who (1) received required blood lead screenings, (2) had EBLLs, and (3) received needed followup services and treatment. Additionally, we will determine why children with EBLLs did not receive screening, followup services, and treatment and the extent to which the Centers for Medicare & Medicaid Services provided guidance and technical assistance to States.
May 2020	Centers for Medicare & Medicaid Services	Use of Telehealth to Provide Behavioral Health Services in Medicaid Managed Care	Office of Evaluation and Inspections	OEI-02-19-00400	2021	Telehealth is the use of telecommunications and information technology to provide access to health assessment, diagnosis, intervention, consultation, supervision, and information across distance. Telehealth can increase beneficiaries' access to healthcare and reduce healthcare spending. All 50 States and the District of Columbia currently provide some coverage under Medicaid of telehealth; however, limited information is available about how States use telehealth to provide behavioral health services to Medicaid managed care enrollees. This review will focus on selected States. It will analyze how these States and managed care organizations (MCOs) use telehealth to provide behavioral healthcare. It will also review selected States' monitoring and oversight of MCOs' behavioral health services provided via telehealth. Finally, it will identify States' and MCOs' practices on how to maximize the benefits and minimize the risks of providing behavioral healthcare via telehealth.
May 2020	Centers for Medicare & Medicaid Services	Nursing Homes: CMS Oversight of State Survey Agencies	Office of Evaluation and Inspections	OEI-06-19-00460	2021	CMS enters into agreements with State survey agencies (SAs) to conduct surveys to determine whether nursing homes are compliant with Medicare requirements. Recent reports by OIG found problems in SA performance, including not verifying whether nursing homes corrected deficiencies and not investigating complaints in a timely manner. CMS evaluates SA performance in fulfilling their surveying responsibilities, including through Federal monitoring surveys and performance thresholds described in the State Performance Standards System. When there is inadequate SA performance, CMS may impose a sanction or remedy, such as providing for training of survey teams, requiring the SA to submit a corrective action plan, or reducing the State’s allotment of Federal financial participation. We will describe CMS's efforts to work with SAs to improve performance by conducting interviews and reviewing supporting documentation about CMS's monitoring efforts. We will also identify any challenges or barriers that may impede CMS's ability to help SAs improve performance.
May 2020	Centers for Medicare & Medicaid Services	Review of the Medicare DRG Window Policy	Office of Evaluation and Inspections	OEI-05-19-00380	2021	Outpatient services directly related to an inpatient admission are considered part of the inpatient payment and are not separately payable by Medicare. The diagnosis-related group (DRG) window policy defines when CMS considers outpatient services to be an extension of inpatient admissions, and generally includes services that are (1) provided within the 3 days immediately preceding an inpatient admission to an acute-care hospital, (2) diagnostic services or admission-related nondiagnostic services, and (3) provided by the admitting hospital or by an entity wholly owned or operated by the admitting hospital. Building on previous OIG work, we will determine the number of admission-related outpatient services that were not covered by the DRG window policy in 2018, including services that were provided prior to the start of the DRG window and services that were provided at hospitals that shared a common owner. We will also determine the amounts that Medicare and beneficiaries would have saved in 2018 if the DRG window policy had been updated to include more days and other hospital ownership structures. In addition, we will interview CMS staff to identify other payment models that CMS could use to pay for outpatient services related to inpatient admissions.
May 2020	Centers for Medicare & Medicaid Services	Medicare Payments for Stelara	Office of Evaluation and Inspections	OEI-BL-19-00500	2021	Since 2016, total Medicare Part B payments to physicians for Stelara-an expensive drug used to treat certain autoimmune diseases that is often self-injected by patients in their home-have increased substantially. Such a large increase in payments for a drug that would not typically be covered under Part B raises questions about what is driving the growth, including the possibility of improper billing. In this study, OIG will (1) determine whether versions of Stelara that are typically self-injected meet the criteria for Medicare Part B coverage, (2) identify factors that may be causing the substantial growth in payments, and (3) determine whether claims for Stelara show evidence of improper billing by physicians.
May 2020	Food & Drug Administration	Data Brief: How Often Are High-Expenditure Orphan Drugs Being Used for Their Orphan Indications in Medicare	Office of Evaluation and Inspections	OEI-BL-20-00080	2021	The Orphan Drug Act was enacted in 1983 to provide financial incentives and marketing exclusivity for manufacturers to develop drugs for rare diseases that occur so infrequently that there would be no reasonable expectation to generate a profit. In recent years, an increasing number of orphan designations have been granted for existing drugs that already have high sales and utilization for non-orphan indications. For example, 7 of the top 10 drugs in 2017 global sales have been granted orphan designations, with all but one having Food and Drug Administration approval for non-orphan indications as well. OIG will determine (1) how many high-expenditure Medicare drugs have orphan designations and (2) the extent to which these drugs are utilized for their orphan designated indications in Medicare.
May 2020	Food and Drug Administration	FDA's Tobacco Retailer Compliance Check Inspection Program	Office of Evaluation and Inspections	OEI-01-20-00240	2022	Youth tobacco use, specifically e-cigarette use, continues to grow at an alarming rate. The Centers for Disease Control and Prevention (CDC) found that e-cigarette use among youth increased by more than 1.5 million users (38 percent) between 2017 and 2018. FDA's Retailer Compliance Check Inspection program plays a key role in its Youth Tobacco Prevention Plan. Under the program, FDA contractors, generally States, carry out undercover buy inspections of tobacco retailers to ensure that they comply with restrictions on sales to minors. They also conduct advertising and labeling inspections to ensure that retailers comply with limitations on marketing of tobacco products. Since the program began in 2010, contractors have carried out over 1 million inspections. The first time FDA finds violations during a tobacco retailer inspection, FDA generally issues a warning letter. When followup inspections reveal subsequent violations, FDA may seek to impose civil monetary penalties and no-tobacco-sale orders that prevent retailers with repeated violations from selling tobacco products indefinitely or for a specified period of time. We will determine the extent and nature of inspections, violations, and enforcement actions by inspection type, on a State-by-State basis, and over time. We will also assess FDA's direction and oversight of the program, including how it targets inspection priorities and holds contractors responsible for their performance.
May 2020	Centers for Medicare and Medicaid Services	CMS Oversight of Hospital Management of Networked Medical Device Security Through the Medicare Conditions of Participation	Office of Evaluation and Inspections	OEI-01-20-00220	2021	Networked medical devices are common and include infusion pumps, pacemakers, and diagnostic imaging equipment. These devices can be used to deliver care, transfer patient data, and/or remotely monitor patients. However, if hospitals do not have proper cybersecurity controls in place, the devices could be compromised, which could lead to adverse outcomes, such as loss of device functionality and patient harm. The Centers for Medicare & Medicaid Services' (CMS's) protocol for assessing hospitals' compliance with the Conditions of Participation (CoP) does not explicitly address cybersecurity practices for networked medical devices. It is unclear whether the survey protocols of accreditation organizations (AOs), which must meet or exceed those of CMS, evaluate cybersecurity when they review hospitals' compliance with the CoP. We will determine if any of the AOs address cybersecurity of networked medical devices when they assess compliance with accreditation requirements. For those that do, we will describe how they have done so and their experiences with hospitals. We will also identify any changes to their survey protocols that CMS or AOs are considering to address cybersecurity of networked medical devices.
May 2020	ACF CDC HHS	Assessing HHS Agencies' Adherence to Health, Safety, and Operational Protocols During Repatriation and Quarantine Efforts for the COVID-19 Outbreak	Office of Evaluation and Inspections	OEI-04-20-00340; OEI-04-20-00350; OEI-04-20-00360	2021 2021 2021	The U.S. Department of Health and Human Services (HHS) plays a lead role in preparing for and responding to public health emergencies. The current novel coronavirus (COVID-19) pandemic highlights the need for HHS to efficiently and effectively respond to protect the nation. OIG will evaluate how HHS staff were deployed, trained, and protected when assigned tasks that could entail potential exposure to COVID-19, such as work at quarantine sites and at ports of entry. We will analyze steps taken to protect HHS staff and, in turn, the public, during pre-deployment, deployment, and post-deployment. We will also review the extent to which HHS has established mechanisms to identify and correct any vulnerabilities in deployment protocols. We plan to issue multiple work products reporting findings for the Administration for Children and Families (ACF), Centers for Disease Control and Prevention (CDC), and the Department overall.
April 2020	Food and Drug Administration	The Food and Drug Administration's Role in Facilitating Testing for COVID-19	Office of Evaluation and Inspections	OEI-01-20-00380	2021	When the Secretary of the Department of Health and Human Services determines that there is a public health emergency and declares that circumstances exist justifying an Emergency Use Authorization (EUA), the Food and Drug Administration (FDA) can issue an EUA under section 564 of the Federal Food, Drug, and Cosmetic Act. An EUA allows for the use of certain unapproved medical products, or unapproved uses of certain approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when there are no adequate, approved, and available alternatives. FDA issued the first COVID-19 EUA for a diagnostic test to the Centers for Disease Control and Prevention and issued subsequent EUAs to other laboratories. This work will examine FDA’s EUA processes and any challenges it may have faced regarding EUAs for COVID-19 diagnostic tests and serological tests for antibodies developed in response to the viral infection.
April 2020	Assistant Secretary for Preparedness and Response	Audit of ASPR's Operation of the Strategic National Stockpile in Response to the COVID-19 Disease Pandemic	Office of Audit Services	W-00-20-59446	2021	The Strategic National Stockpile (Stockpile) is a repository of supplies for use in the event of a national emergency in the United States or its territories. Originally funded by Congress in Fiscal Year 1999 and operated by the Centers for Disease Control and Prevention, the Assistant Secretary for Preparedness and Response (ASPR) at the Department of Health and Human Services has been responsible since 2018 for the operation of the Stockpile. OIG has historically reviewed various aspects of the Department's emergency preparedness and response. We plan to determine whether ASPR's operation of the Stockpile was effective in response to the coronavirus disease 2019 (COVID-19) pandemic.
April 2020	Centers for Disease Control and Prevention	Audit of HHS's Production and Distribution of COVID-19 Lab Test Kits	Office of Audit Services	W-00-20-57303	2021	When a new viral disease emerges, CDC uses its expertise and biosafety laboratories to develop and distribute tests to state public health laboratories. CDC uses confirmed viral samples from initial patients to develop these tests. To ensure that it has a functioning test, CDC conducts quality assurance reviews. After validating that it has a functioning test, CDC sends the tests to state public health labs for their use. During the early phases of identification and spread of the novel coronavirus in the United States in 2020, CDC developed testing kits, called the CDC 2019-Novel Coronavirus Real-Time Reverse Transcriptase-PCR Diagnostic Panel (CDC 2019-nCoV Real Time RT-PCR), and sent the kits to qualified laboratories to identify COVID-19 cases. We plan to review the controls that HHS has in place to produce and distribute the COVID-19 test kits and whether CDC has designed and implemented controls to mitigate any potential risks. The objective of our audit will be to review CDC’s process of producing and distributing the COVID-19 test kits.
April 2020	Administration for Children and Families	Health and Safety Monitoring in Head Start	Office of Evaluation and Inspections	OEI-BL-19-00560	2021	Head Start serves roughly 1 million vulnerable children and their families annually at a cost of $10.06 billion as of fiscal year 2020. Prior OIG work identified significant health and safety violations at some Head Start facilities. We will examine how the Office of Head Start (OHS) monitors and enforces Federal health and safety standards in Head Start facilities. Additionally, we will describe recent trends in health and safety violations and assess whether OHS consistently and effectively monitors grantees to ensure children’s safety.
April 2020	ASFR	A Review of HHS's Suspension and Debarment in Protecting the Integrity of Federal Awards	Office of Evaluation and Inspections	OEI-04-19-00570	2021	HHS is the largest grant-making agency and third largest contracting agency in the Federal Government. Thus, it is important for HHS to have an effective suspension and debarment program. An effective suspension and debarment program protects the integrity of Government grants, contracts, loans, and other assistance programs by preventing awardees who demonstrate a lack of honesty, integrity, or performance from receiving additional Federal awards (i.e., grants, contracts, loans, and other forms of assistance). This study will describe the actions that HHS is taking to protect its awards and will determine the effective and potentially ineffective characteristics of the Department's suspension and debarment program.
April 2020	Administration for Children and Families	Case Study of the Missouri Foster Care System: Identifying System Vulnerabilities Related to Children Who Ran Away	Office of Evaluation and Inspections	OEI-07-19-00372	2021	In August 2019, the OIG Office of Investigations (OI), along with the Department of Justice (DOJ) and local law enforcement, targeted Missouri metropolitan areas to locate children who ran away from foster care. The Missouri foster care system, DOJ, and OIG OI, located 58 children. Running away from foster care is associated with 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. This study will review the foster care case files of these located children to determine whether documentation exists demonstrating that the State provided the children with required services (e.g., monthly caseworker visits, safety planning) leading up to when the children went missing from foster care, and evidence that the State actively attempted to find the children after they went missing. Further, we will review what services the State provided these children after they returned to foster care. We will evaluate whether the Missouri foster care system followed applicable Federal and State laws, policies, and procedures to protect these children.
April 2020	Centers for Medicare and Medicaid Services	States' Oversight of Medicaid Managed Care Medical Loss Ratios	Office of Evaluation and Inspections	OEI-03-20-00230	2021	Medical loss ratio (MLR) requirements in Medicaid managed care are a method to address State and Federal concerns about the growth in Medicaid spending. Federal MLR requirements are intended to ensure that Medicaid managed care plans spend the majority of the Medicaid capitation payments that they receive from the State on beneficiaries' medical care rather than on administration and profit. Pursuant to the May 2016 Medicaid managed care final rule, States must include requirements in managed care plan contracts for plans to collect MLR data, calculate an MLR percentage, and report that percentage and related, underlying data to the State. States' collection of complete and accurate MLR data from their managed care plans is a critical first step for determining Medicaid managed care MLR performance nation-wide. Complete and accurate MLR data will also enable States to set appropriate managed care payment rates to control Medicaid costs. This work will provide timely, nation-wide data on MLR performance in Medicaid managed care and identify the actions that States have taken to ensure the completeness and accuracy of their managed care plans' MLR data.
April 2020	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	W-00-20-35845	2021	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.
April 2020	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	2021	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.
Completed (partial)	Centers for Medicare & Medicaid Services	Health and Safety Standards in Social Services for Adults	Office of Audit Services	A-05-16-00044; A-05-17-00030; A-05-17-00009; A-05-17-00028; W-00-20-31503	2021	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.
March 2020	Centers for Medicare and Medicaid Services	Medicaid Nursing Home Life Safety and Emergency Preparedness Reviews	Office of Audit Services	W-00-20-31525	2021	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.
March 2020	Administration for Children and Families	Emergency Preparedness and Response at Care Provider Facilities in the Office of Refugee Resettlement's Unaccompanied Alien Children Program	Office of Audit Services	W-00-20-20021	2021	The Emergency Supplemental Appropriations for Humanitarian Assistance and Security at the Southern Border Act, 2019 (P.L. 116-26) appropriated $2.9 billion for the Unaccompanied Alien Children (UAC) Program. Within this $2.9 billion, title IV of P.L. 116-26 provided $5 million for OIG to conduct additional oversight of the UAC Program, which is managed by HHS's Office of Refugee Resettlement (ORR). As part of OIG's oversight of ORR, we plan to review UAC Program emergency preparedness and response plans and procedures. The ORR Guide Children Entering the United States Unaccompanied states that UAC care providers are responsible for safety planning for each facility, including development of a written safety plan for all UAC children in its care and program staff. This written plan should address emergency situations such as evacuations (e.g., due to hurricane, fire, or other emergency), medical and mental health emergencies, and disease outbreaks (such as COVID-19). Each facility must also have policies and procedures for identifying, reporting, and controlling communicable diseases (for example, coronaviruses). In addition, each licensed care provider facility must adhere to State licensing requirements regarding emergency preparedness and response. Our objective will be to determine whether selected care provider facilities followed Federal and State requirements in preparing for and responding to emergency events.
March 2020	Centers for Medicare and Medicaid Services	Medicare Part B Payments to Physicians for Co-Surgery Procedures	Office of Audit Services	W-00-20-35844	2021	Under Medicare Part B, when the individual skills of two surgeons are necessary to perform a specific surgical procedure or distinct parts of a surgical procedure (or procedures) simultaneously on the same patient during the same operative session (co-surgery), each surgeon should report the specific procedure(s) by billing the same procedure code(s) with a modifier "62." By appending modifier "62" to the procedure code(s), the fee schedule amount applicable to the payment for each co-surgeon is 62.5 percent of the global surgery fee schedule amount. We plan to audit a sample of claim line items—specifically where different physicians billed for the same co-surgery procedure code, for the same beneficiary, on the same date of service. Our objective is to determine whether Medicare Part B payments to physicians for co-surgery procedures were properly made.
March 2020	National Institutes of Health	Grantee Institutions' Actions To Strengthen Policies in Response to Concerns Regarding Potential Foreign Influence on NIH-Funded Research	Office of Evaluation and Inspections	OEI-03-20-00210	2021	The National Institutes of Health (NIH) requires grantee institutions to report their researchers' financial interests and affiliations with foreign entities. NIH and Congress have raised concerns that the failure by some NIH-funded researchers to disclose to grantee institutions substantial contributions of resources from other organizations, including foreign governments, threatens to distort decisions about the appropriate use of NIH funds. In response to these concerns, NIH has taken steps to improve the accurate reporting of all sources of research support, financial interests, and affiliations. In July 2019, NIH released a notice to its extramural research community clarifying its policy regarding other support, including foreign affiliations. Given NIH's efforts to increase awareness among its grantee institutions regarding financial interests and foreign influence, this evaluation will focus on grantee institutions' policies and procedures related to (1) ensuring that researchers report all foreign affiliations (including foreign positions and scientific appointments, financial interests in foreign entities, research support from foreign entities, and any other foreign affiliations) and (2) reviewing the foreign affiliations that researchers report. This evaluation will also determine to what extent grantee institutions have updated or revised these policies and procedures to address recent concerns and NIH guidance.
March 2020	Substance Abuse and Mental Health Services Administration	Audit of Substance Abuse Mental Health Services Administration's Primary Risks for Major Disasters Preparedness and Response	Office of Audit Services	W-00-20-59444	2021	The Additional Supplemental Appropriations for Disaster Relief Act, 2019 (P.L. 116-20), enacted June 6, 2019, included $322 million in emergency supplemental funding to HHS. Within HHS, the Substance Abuse Mental Health Services Administration (SAMHSA) was appropriated $100 million for Health Surveillance and Program Support for grants, contracts, and cooperative agreements for behavioral health treatment, treatment of substance use disorders, crisis counseling, and other related helplines, and for other similar programs to provide support to individuals impacted by a covered disaster or emergency. Our objective will be to identify SAMHSA’s potential risks for preparing for and responding to hurricanes and other natural disasters and to determine whether SAMHSA had designed and implemented controls and strategies to mitigate these potential risks.
March 2020	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	2021	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.
February 2020	Office of the Secretary	HHS Compliance with the Improper Payment Elimination and Recovery Act	Office of Audit Services	W-00-20-40037	2021	The Improper Payments Information Act of 2002 (IPIA), as amended by the Improper Payments Elimination and Recovery Act of 2010 (IPERA) and the Improper Payments Elimination and Recovery Improvement Act of 2012 (IPERIA), requires the head of each Federal agency with programs or activities that may be susceptible to significant improper payments to report certain information to Congress. For any program or activity with estimated improper payments exceeding $10 million and 1.5 percent, or $100 million regardless of the improper payment rate, HHS must report to Congress improper payment estimates, corrective action plans, and reduction targets. Pursuant to IPERA and OMB Circular A-123, Appendix C, Requirements for Payment Integrity Improvement, OIG will review HHS compliance with IPIA, as amended, as well as how HHS assesses the programs it reports and the accuracy and completeness of the reporting in HHS's Agency Financial Report. We will make recommendations as needed. We will use the independent external auditor contracted to audit the annual CMS and HHS Financial Statement Audits to perform this work.
February 2020	Office of the Secretary	Superfund Financial Activities at the National Institute of Environmental Health Sciences	Office of Audit Services	W-00-20-59050	2021	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.
February 2020	Office of the Secretary	Audit of FY 2020 HHS Consolidated Financial Statements	Office of Audit Services	W-00-20-40009	2021	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 OMB Bulletin 19-03, "Audit Requirements for Federal Financial Statements. The audited consolidated FYs 2020 and 2021 financial statements for HHS are due to OMB by November 15, 2020 and 2021, respectively. We plan to perform a number of ancillary financial-related reviews pertaining to the audits of the FYs 2020 and 2021 financial statements. The purpose of the financial-related reviews is to fulfill requirements in OMB Bulletin 19-03, §§ 6.1 through 13.
February 2020	Centers for Medicare & Medicaid Services	Medicare Capital Payments to New Hospitals	Office of Audit Services	W-00-20-35843	2021	Hospitals are reimbursed through Medicare Part A for Medicare-related capital costs (e.g., depreciation, interest, rent, and property-related insurance and taxes costs). New hospitals are paid on a cost basis for their first 2 years of operation. Beyond the first 2 years, hospitals' Medicare-related capital costs are paid through the inpatient prospective payments system under which a portion of their payment for each discharge is intended to cover capital costs. We will determine the potential impact for Medicare if capital payments to new hospitals were paid through the prospective payments system for the first 2 years.
February 2020	Centers for Medicare & Medicaid Services	Nationwide Audit of Medicare Part D Eligibility Verification Transactions	Office of Audit Services	W-00-20-35751	2022	An E1 transaction is a Medicare Part D eligibility verification transaction that the pharmacy submits to the Part D transaction facilitator to bill for a prescription or determine drug coverage billing order. The Part D transaction facilitator returns information to the pharmacy that is needed to submit the prescription drug event. E1 transactions are part of the real-time process of the Coordination of Benefits and calculating the true out-of-pocket costs (CMS, Medicare Prescription Drug Benefit Manual, Pub. No. 100-18, chapter 14, § 30.4). We will review CMS's oversight of E1 transactions processed by contractors and determine whether the E1 transactions were created and used for intended purposes.
February 2020	Centers for Medicare & Medicaid Services	Medicaid MCO PBM Pricing	Office of Audit Services	W-00-20-31542	2022	The State Medicaid agency and the Federal Government are responsible for financial risk for the costs of Medicaid services. Managed care organizations (MCOs) contract with State Medicaid agencies to ensure that beneficiaries receive covered Medicaid services including prescription drugs. MCOs may contract with pharmacy benefit managers (PBMs) to manage or administer the prescription drug benefits on their behalf. Spread pricing is a practice where a PBM charges an MCO more for a drug than the amount a PBM pays a pharmacy. Our audit will determine whether States provide adequate oversight of Medicaid MCOs to ensure accountability over amounts paid for prescription drug benefits to its PBMs.
February 2020	Centers for Medicare & Medicaid Services	Data Brief: Characteristics of Hospitals With Wage Indexes in the Bottom Quartile for the Fiscal Year 2020 Inpatient Prospective Payment System	Office of Audit Services	W-00-20-35727	2021	In the inpatient prospective payment system (IPPS), CMS uses wage indexes when it adjusts Medicare hospital payments annually to reflect labor prices in local labor markets. In the FY 2020 IPPS final rule, CMS stated agreement with the hypothesis that certain wage index policies had created barriers to hospitals with low wage index values from being able to increase employee compensation because of the 4-year lag between when hospitals increase the compensation and when those increases are reflected in the calculation of the wage index. Accordingly, in the FY 2020, CMS is instituting a new policy to raise the IPPS wage indexes of the hospitals in the bottom quartile of wage indexes, giving them the opportunity to raise wages in the relatively near future. In this data brief, we will analyze certain characteristics of the hospitals in that FY 2020 bottom quartile to provide information to CMS and other stakeholders during the roll-out year of CMS's new bottom quartile wage index adjustment.
February 2020	Centers for Medicare & Medicaid Services	Audit of CMS's Assessment of National Security Risks to Genomic Testing Data	Office of Audit Services	A-18-20-06200	2021	CMS, one of the world's largest purchasers of health care, administers Medicare and Medicaid. In 1988, Congress enacted the Clinical Laboratory Improvement Amendments (CLIA). CLIA established "quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed." CMS is responsible for implementing CLIA, including laboratory registration, fee collection, onsite surveys, and enforcement. OIG is conducting this audit in response to congressional request, which expressed concerns to OIG that U.S. taxpayer money could potentially be used to pay for genetic testing at laboratories that have partnerships with foreign governments. OIG will determine whether CMS has established an effective enterprise risk management process and conducts risk assessments that consider emerging national security threats in accordance with Federal requirements.
January 2020	Centers for Medicare & Medicaid Services	Early Discharges From Inpatient Rehabilitation Facilities to Home Health Services	Office of Audit Services	W-00-20-35831	2021	Under the inpatient rehabilitation facility (IRF) prospective payment system (PPS), the Centers for Medicare & Medicaid Services (CMS) established an IRF transfer payment policy based on a per diem amount for each case-mix group (CMG) for which the discharge occurred before the average length of stay for the respective CMG. The IRF transfer payment policy applies to early IRF transfers to another IRF, an inpatient hospital, a nursing home that accepts payments under Medicare or Medicaid, or a long-term-care facility. CMS excluded IRF discharges to home health services from this policy because the home health agency PPS had just been developed and claims data were not available for CMS to analyze. CMS was concerned, however, about IRF incentives to discharge patients prematurely under the IRF PPS to home health services. Our objective is to determine how an IRF transfer payment policy for early discharges to home health services would financially affect Medicare Part A and IRFs.
January 2020	Administration for Children and Families	Audit of Office of Refugee Resettlement's Placement and Transfer of Children in the Unaccompanied Alien Children Program	Office of Audit Services	W-00-20-20002	2021	The Unaccompanied Alien Children Program, managed by the Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), provides temporary shelter, care, and other related services to unaccompanied children. ORR funds a network of approximately 170 state-licensed care provider facilities for children in its custody. The ORR Guide: Children Entering the United States Unaccompanied details the policies for initial placement of children in and transfer between ORR care provider facilities. ORR must make every effort to place and keep each child in the least restrictive setting available that is in the child's best interest. Our objective will be to determine whether ORR followed its policies, procedures, and guidance both when making initial placements in care provider facilities funded by ORR and when transferring children between those facilities. We will also determine how frequently children are transferred between care provider facilities, the reason for transfers and denials of transfers, and any challenges that care provider facilities face when children are identified as requiring a transfer.
Completed (partial)	Centers for Medicare & Medicaid Services	Medicare Part B Payments for Laboratory Services	Office of Audit Services	A-06-16-02002; A-09-16-02034; A-06-17-04002; A-04-18-08063; W-00-17-35726; W-00-20-35726; various reviews	2021	Medicare covers diagnostic clinical laboratory services that are ordered by a physician who is treating a beneficiary and who uses the results in the management of the beneficiary's specific medical problem (42 CFR 410.32(a)). These covered services can be furnished in hospital laboratories (for outpatient or nonhospital patients), physician office laboratories, independent laboratories, dialysis facility laboratories, nursing facility laboratories, and other institutions. Previous OIG audits, investigations, and inspections have identified areas of billing for clinical laboratory services that are at risk for noncompliance with Medicare billing requirements. Payments to service providers are precluded unless the provider furnishes on request the information necessary to determine the amounts due (the Social Security Act § 1833(e)). We will review Medicare payments for clinical laboratory services to determine laboratories' compliance with selected billing requirements. We will focus on claims for clinical laboratory services that may be at risk for overpayments. For example, our reviews will focus on the improper use of claim line modifiers for a code pair, genetic testing, and urine drug testing services. We may use the results of these reviews to identify laboratories or other institutions that routinely submit improper claims.
December 2019	Office of the Assistant Secretary for Preparedness and Response	Technology Use in Emergency Response: Experiences From Recent California Wildfires	Office of Evaluation and Inspections	OEI-09-19-00540	2021	Technology offers the potential for efficient and accurate medical response in the event of an emergency or disaster. In the recent California wildfires, some responders used technology-driven tools such as data analytics to locate vulnerable Medicare beneficiaries in a disaster zone and a network of health information exchanges to access patients' electronic medical records and deliver care away from their typical care setting. This case study will examine two uses of technology that were deployed during the 2017 and 2018 California wildfires, the emPOWER program and PULSE (Patient Unified Lookup System) system, to aid in emergency response. We will interview implementers and users of these tools from the Office of the Assistant Secretary for Preparedness Response, Office of the National Coordinator, State agencies, and local counties on their experiences with the adoption, implementation, and deployment of these tools; the benefits derived from these tools; and any challenges that were overcome. We will use these lessons learned to identify strategies that entities can use to incorporate technology in emergency preparedness and response. To the extent possible, we will also gather data about the reach of these tools, such as how many individuals benefited from using them.
December 2019	Administration for Children and Families	Emergency Preparedness and Response at Care Provider Facilities in the Office of Refugee Resettlement's Unaccompanied Alien Children Program	Office of Audit Services	W-00-20-20021	2021	The Emergency Supplemental Appropriations for Humanitarian Assistance and Security at the Southern Border Act, 2019 (P.L. 116 -26) appropriated $2.9 billion for the Unaccompanied Alien Children (UAC) program. Within this $2.9 billion, title IV of P.L. 116-26, provided $5 million for OIG to conduct additional oversight of the UAC program, which is managed by HHS's Office of Refugee Resettlement (ORR). As part of OIG's oversight of ORR, we plan to review UAC Program emergency preparedness and response plans and procedures. The ORR Guide "Children Entering the United States Unaccompanied" states that UAC care providers are responsible for safety planning for each facility, to include a written safety plan for all UAC children in its care and program staff. In addition, each licensed care provider facility must adhere to State licensing requirements in regard to emergency preparedness and response. Our objective will be to determine whether selected care provider facilities followed Federal and State requirements in preparing for and responding to emergency events.
December 2019	Centers for Disease Control and Prevention	Audit of Centers for Disease Control and Prevention's Cybersecurity Controls Over the Vaccine Adverse Event Reporting System	Office of Audit Services	W-00-20-42026	2021	The Centers for Disease Control and Prevention (CDC) serves as the lead HHS operating division responsible for developing and testing methods of disease prevention and control, implementing operational programs relating to environmental health problems, and conducting health promotion programs and educational activities designed to improve the health of the American people. The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program run by CDC and the Food and Drug Administration (FDA). VAERS serves as an early warning system to detect possible safety issues with U.S. vaccines by collecting information about adverse events (possible side effects or health problems) that occur after vaccination. We will determine whether select VAERS cybersecurity controls are in place, in accordance with Federal requirements.
December 2019	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	2021	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.
November 2019	Centers for Medicare & Medicaid Services	Medicaid Concurrent Eligibility	Office of Audit Services	W-00-19-31539	2021	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.
November 2019	OS, ACF, AHRQ, CDC, FDA, HRSA, NIH, OIG	Audit of HHS Information Technology Recovery Readiness	Office of Audit Services	W-00-20-42025	2021	HHS is responsible for administering programs that support the health and welfare of one in four Americans. HHS also leads the nation's medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. To ensure continuity of this extensive mission and in accordance with Federal mandates, HHS must have effective contingency plans in place to ensure that it continues to meet its mission in the event of a disaster or major disruption. We will determine whether HHS has effective contingency planning for its information technology systems
November 2019	Administration for Children and Families	Review of Office of Refugee Resettlement's Awarding of a No-Bid Contract for the Unaccompanied Alien Children Program	Office of Audit Services	W-00-20-20001	2021	The Unaccompanied Alien Children (UAC) Program, managed by the Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), provides temporary shelter, care, and other related services to unaccompanied children. ORR funds a network of approximately 170 state-licensed care provider facilities for children in its custody. Operating under cooperative agreements and contracts with ORR, these facilities provide housing, food, medical care, mental health services, recreational activities, and educational services for the children in their care. ORR also operates influx facilities to provide temporary emergency shelter and services for children, usually on federally owned or leased property, and these facilities are not state-licensed. ORR contracted with Comprehensive Health Service, LLC (CHS), a for-profit medical management services provider, to operate a temporary influx care facility located in Homestead, Florida. The Federal Acquisition Regulation (FAR) guides the acquisition process by which executive agencies of the U.S. Government acquire goods and services by contract with appropriated funds. The HHS Acquisition Regulation establishes uniform HHS acquisition policies and procedures that implement and supplement the FAR. The contract that ORR awarded to CHS was a 7-month no-bid contract totaling over $341 million for support services for emergency temporary shelter operations. We will determine whether ORR awarded the $341 million contract with CHS in accordance with Federal statutes, regulations, and HHS's policies and procedures.
November 2019	Indian Health Service	Review of Background Verification Process at Tribally Operated Health Facilities	Office of Audit Services	W-00-20-51001	2021	The Indian Health Service's (IHS's) mission is to partner with American Indians and Alaska Natives to elevate their physical, mental, social, and spiritual health to the highest level. The goal of IHS is to ensure that comprehensive, culturally acceptable personal and public health services are available and accessible to all of the approximately 2.6 million members of the 573 federally recognized Tribes. In 1975, Congress recognized the importance of Tribal decision making in Tribal affairs and the nation-to-nation relationship between the United States and Tribes through the passage of the Indian Self-Determination and Education Assistance Act (ISDEAA) (P.L. No. 93-638). Under ISDEAA, federally recognized Tribes administer their own healthcare programs and services that IHS would otherwise provide through P.L. No. 93-638 funding agreements with IHS. In 2019, a pediatrician who worked at several IHS health facilities during a 21-year period was convicted of sexually abusing children served at these facilities. Congressional officials have expressed concerns about safeguards for Indian children and specifically about IHS failing to address this pediatrician's history of offenses at the various IHS health facilities where he was employed. The Indian Child Protection and Family Violence Prevention Act (P. L. No. 101-630), requires background checks, including Federal Bureau of Investigation fingerprinting, for employees whose job duties involve contact with children. Prior OIG audit work identified two Tribal health facilities that did not meet Federal requirements for background verifications for employees in contact with children. We will determine whether the tribally operated health facilities met Federal and Tribal requirements for background verification of employees, contractors, and volunteers in contact with children served by the facilities.
November 2019	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	2021	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.
October 2019	Centers for Medicare & Medicaid Services	Review of Hospice Inpatient and Aggregate Cap Calculations	Office of Audit Services	W-00-19-35826	2021	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.
October 2019	Centers for Medicare & Medicaid Services	Medicare Part B Payments for Speech-Language Pathology	Office of Audit Services	W-00-19-35827	2021	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.
October 2019	Centers for Medicare & Medicaid Services	Review of Medicare Payments for Power Mobility Device Repairs	Office of Audit Services	W-00-19-35828	2021	Medicare Part B covers medically necessary power mobility devices (PMDs), such as power wheelchairs, and PMD repairs that are reasonable and necessary to make the equipment serviceable. For calendar year 2018, Medicare Part B paid approximately $46.7 million for PMD repairs, including replacement parts needed to repair PMDs. Durable medical equipment (DME) suppliers must maintain documentation from the physician or treating practitioner indicating that the PMD being repaired continued to be medically necessary and that the repairs were reasonable and necessary. DME suppliers must also maintain detailed records describing the need for and nature of all repairs, which includes a justification for the replaced parts and the labor time. In addition, if the expense for repairs exceeds the estimated expense of purchasing or renting another PMD for the remaining period of medical need, no payment can be made for the amount of the excess. We will audit Medicare payments for PMD repairs to determine whether suppliers complied with Medicare requirements.
October 2019	Centers for Medicare & Medicaid Services	Review of Medicare Part B Urine Drug Testing Services	Office of Audit Services	W-00-20-35829	2021	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.
October 2019	Centers for Medicare & Medicaid Services	Supplier Compliance with Medicare Requirements for Replacement of Positive Airway Pressure Device Supplies	Office of Audit Services	W-00-20-35830	2021	Beneficiaries receiving continuous positive airway pressure or respiratory assist device (collectively known as positive airway pressure (PAP) devices) therapy require replacement of supplies (e.g., mask, tubing, headgear, and filters) when they wear out or are exhausted. Medicare payments for these replacement supplies in 2017 and 2018 were approximately $945.8 million. Prior OIG work found that most Medicare claims that suppliers submitted for replacement PAP device supplies did not comply with Medicare requirements. For supplies and accessories used periodically, orders must specify the type of supplies needed, the frequency of use, if applicable, and the quantity to be dispensed, and suppliers must not automatically ship refills on a predetermined basis (Centers for Medicare & Medicaid Services Medicare Program Integrity Manual, Pub. 100-08, Ch. 5, §§ 5.2.3 and 5.2.8). We will review claims for frequently replaced PAP device supplies at selected suppliers to determine whether documentation requirements for medical necessity, frequency of replacement and other Medicare requirements are met.
August 2019	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	2021	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.
August 2019	Centers for Medicare & Medicaid Services	States' Medicaid Agency Claims for Indian Health Service Expenditures	Office of Audit Services	W-00-19-31538	2021	The Federal government pays its share of a State's Medicaid expenditures based on the Federal Medical Assistance Percentage (FMAP), which varies depending on the State's relative per capita income. States' regular FMAPs range from a low of 50 percent to a high of 83 percent; however, States receive a 100-percent FMAP for expenditures related to services received through Indian Health Service (IHS) facilities. In Federal fiscal years 2016 through 2018, States claimed $6.6 billion in expenditures at the IHS services FMAP, all of which was federally funded. We will analyze selected States' methodologies for identifying expenditures claimed at the IHS services FMAP and determine whether the States claimed these expenditures in accordance with Federal requirements.
Completed	Centers for Medicare & Medicaid Services	Opioids in Medicaid: Review of Extreme Use and Overprescribing in the Appalachian Region	Office of Evaluation and Inspections	OEI-05-19-00410	2021	Opioid abuse and overdose deaths remain at crisis levels in the United States and the Appalachian region. In 2017, opioids were involved in nearly 48,000 overdose deaths nation-wide, and the opioid overdose death rate was 72 percent higher in Appalachian counties than non-Appalachian counties. These issues are of particular concern for Medicaid beneficiaries, who are more likely to have chronic conditions and comorbidities that require pain relief, especially those beneficiaries who qualify through a disability. Consistent with previous OIG work in Medicaid and Medicare Part D, we will identify beneficiaries who received extreme amounts of opioids through Medicaid, beneficiaries who appear to be doctor or pharmacy shopping, and prescribers associated with these beneficiaries.
Completed	Centers for Medicare & Medicaid Services	Medicare Market Shares for Diabetic Testing Strips from April to June 2019	Office of Evaluation and Inspections	OEI-04-19-00480; OEI-04-19-00481	2020	Section 1847(b)(10)(B) of the Social Security Act (the Act) requires OIG to study and submit a report on the Medicare market share of diabetic testing strips (DTS) before each round of the Medicare competitive bidding program. These data briefs assist CMS in ensuring that bidding suppliers meet the statutory requirement located at section 1847(b)(10)(A) of the Act, known as the 50-percent rule. Section 50414 of the Bipartisan Budget Act of 2018 amended section 1847(b)(10)(A) by requiring that, for bids to furnish DTS on or after January 1, 2019, CMS must use both mail order and non-mail order data when assessing compliance with the 50-percent rule. Prior to that amendment, OIG reported only mail order data in its data briefs used for CMS's assessment of compliance with the 50-percent rule. For this series, the first data brief will determine the Medicare market share of mail order DTS for the 3‑month period of April through June 2019. The second data brief will determine the Medicare market share of non-mail order DTS for the same 3‑month period. This will be the fifth series of OIG data briefs describing the Medicare market share of DTS that OIG has produced since 2010 and the second series that will include both mail order and non-mail order DTS data.
Removed	Administration for Children and Families	Nation-Wide Evaluation of the Prevention of Child Sex Trafficking in Foster Care	Office of Evaluation and Inspections	OEI-07-19-00370		To be eligible to receive Federal funding under Title IV-E of the Social Security Act, States are required to submit State plans demonstrating that the State has developed policies and procedures related to identifying and providing services for children in foster care who are, or are at risk of becoming, a victim of sex trafficking. This study will evaluate the policies and procedures of all 50 States and the District of Columbia to determine (1) how States screen children in foster care to identify those who are, or are at risk of becoming, a victim of sex trafficking; and (2) how States determine appropriate services for children in foster care who are identified as, or are at risk of becoming, a victim of sex trafficking. The study will also examine the extent to which the Administration for Children and Families conducts oversight and provides guidance to States regarding children in foster care who are, or are at risk of becoming, a victim of sex trafficking.
August 2019	Administration for Children and Families	States' Prevention of Child Sex Trafficking in Foster Care	Office of Evaluation and Inspections	OEI-07-19-00371	2021	In 2013, the Administration for Children and Families reviewed statistics from several studies and found that up to 90 percent of children who were victims of sex trafficking had been involved with child welfare services, which include foster care. States are required by Federal law to develop policies and procedures related to identifying and providing services for children in foster care who are, or are at risk of becoming, a victim of sex trafficking. For select States, we will use foster care case file documentation to evaluate (1) the extent to which children were screened to determine whether they are, or are at risk of becoming, a victim of sex trafficking by using the States' policies and procedures; and (2) the extent to which children in foster care who are, or are at risk of becoming, a victim of sex trafficking were provided needed services.
August 2019	Centers for Medicare & Medicaid Services	Medicaid Assisted Living Services	Office of Audit Services	W-00-19-31541	2021	Medicaid may provide assisted living services to beneficiaries who are medically eligible for placement in a nursing home but opt for a less medically intensive, lower-cost setting. These services may include personal care (e.g., assistance with dressing and bathing), homemaker services (e.g., housecleaning and laundry), personal emergency response services, and therapy services (i.e., physical, speech, and occupational). A 2018 Government Accountability Office report indicated that improved Federal oversight of beneficiary health and welfare is needed in States' administration of Medicaid assisted living services. We will determine whether assisted living providers are meeting quality-of-care requirements for Medicaid beneficiaries residing in assisted living facilities and whether the providers properly claimed Medicaid reimbursement for services in accordance with Federal and State requirements.
August 2019	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	2021	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.
August 2019	Centers for Medicare & Medicaid Services	Review of Medicare Facet Joint Procedures	Office of Audit Services	W-00-19-35825	2021	Facet joint injections are an interventional technique used to diagnose or treat back pain. Several previous reviews found significant billing errors in this area, including a prior OIG review. We will review whether payments made by Medicare for facet joint procedures billed by physicians complied with Federal requirements (Social Security Act, § 1833(e), 42 CFR § 424.32(a)(1), and 42 CFR §414.40).
June 2019	Centers for Medicare & Medicaid Services	Overturned Denials in Medicaid Managed Care	Office of Evaluation and Inspections	OEI-09-19-00350	2021	Managed care organizations (MCOs) contract with State Medicaid agencies to provide beneficiaries with Medicaid services. MCOs must cover services in at least the same amount, duration, and scope that would be covered under Medicaid fee-for-service. However, capitated payment models in managed care may create an incentive for MCOs to inappropriately limit or deny access to covered services to increase profits. We will review the extent to which selected MCOs' denied services and payments were overturned upon appeal. We will also review any concerns about the selected MCOs' performance related to denials and appeals that were identified through State oversight and monitoring efforts.
June 2019	Food and Drug Administration	Review of the Food and Drug Administration's Foreign Drug Inspection Process	Office of Audit Services	W-00-19-50000	2021	The Food and Drug Administration (FDA) is responsible for overseeing the safety and effectiveness of all drugs marketed in the United States. However, FDA's oversight of the nation's drug supply chain has become increasingly complicated because many drugs used in the U.S. are manufactured overseas. FDA estimates that nearly 40 percent of finished drugs and approximately 80 percent of active pharmaceutical ingredients are manufactured in registered establishments in more than 150 countries. To ensure that drugs are manufactured in compliance with current good manufacturing practice regulations, FDA conducts inspections of foreign facilities that manufacture drugs for the U.S. market. At the end of an inspection, observations are made and a determination of whether any condition or practice violates Federal requirements. FDA may take additional actions to ensure that the violations are corrected. In May 2017, FDA began implementing major programmatic changes to enhance its ability to protect public health. FDA's major programmatic changes included a structural realignment of its Office of Regulatory Affairs (ORA) and an agreement between FDA's Center for Drug Evaluation and Research and ORA that aligns and coordinates FDA's field professionals who conduct inspections and its review staff who evaluate drug products. Recently, Congress raised concerns about the safety of certain drugs manufactured overseas and the challenges that FDA faces with its foreign drug inspection process. Our review will determine whether recent programmatic changes have improved FDA’s foreign drug inspection process.
June 2019	Centers for Medicare & Medicaid Services	Review of Medicare Part B Claims for Intravitreal Injections of Eylea and Lucentis	Office of Audit Services	W-00-19-30100	2021	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.
June 2019	OS	Review of Office of Intergovernmental and External Affairs Charge Card Programs	Office of Audit Services	W-00-19-59443	2021	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.
June 2019	Centers for Medicare & Medicaid Services	Quality of Medicaid Encounter Data	Office of Evaluation and Inspections	OEI-02-19-00180	2021	Effective oversight of Medicaid requires a national Medicaid dataset. Although all States submit Transformed Medicaid Statistical Information System (T-MSIS) data, OIG has consistently identified deficiencies in the quality of managed care encounter data, including inaccurate and missing information, which can render the data of limited use. We will determine whether the encounter data for selected States contain the required elements and include the quality data needed to more effectively oversee the Medicaid program. We will also determine what steps these States have taken to ensure that all required data elements are submitted to T-MSIS and identify any factors that contributed to data quality issues. This study will be based on a review of three to five States.
June 2019	Centers for Medicare & Medicaid Services	Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries - 10-Year Update	Office of Evaluation and Inspections	OEI-06-18-00400	2021	OIG has conducted studies about adverse events (patient harm) in various healthcare settings since 2008, with 15 reports released or in process through 2019. The series includes a congressionally-mandated study released in 2010 that found that 27 percent of Medicare beneficiaries experienced adverse events or temporary harm events while hospitalized in 2008. The current study will replicate the methodology used in the prior work for a sample of Medicare beneficiaries admitted to acute-care hospitals in 2018. We will measure the incidence of adverse events and temporary harm events, the extent to which the harms were preventable given better care, and the associated costs to Medicare. We will compare the 2018 results with the prior study results to assess progress in reducing harm at the 10-year mark, and identify differences in harm rates, types, contributing factors, preventability, and costs.
June 2019	Centers for Medicare & Medicaid Services	Inappropriate Denial of Services and Payment in Medicare Advantage	Office of Evaluation and Inspections	OEI-09-18-00260	2021	Capitated payment models are based on payment per person rather than payment per service provided. A central concern about the capitated payment model used in Medicare Advantage is the incentive to inappropriately deny access to, or reimbursement for, health care services in an attempt to increase profits for managed care plans. We will conduct medical record reviews to determine the extent to which beneficiaries and providers were denied preauthorization or payment for medically necessary services covered by Medicare. To the extent possible, we will determine the reasons for any inappropriate denials and the types of services involved.
June 2019	Centers for Medicare & Medicaid Services	Comparison of Provider-Based and Freestanding Clinics	Office of Audit Services	W-07-18-02815	2021	Provider-based facilities often receive higher payments for some services than freestanding clinics. The requirements that a facility must meet to be treated as provider-based are at 42 CFR § 413.65(d). We will review and compare Medicare payments for physician office visits in provider-based clinics and freestanding clinics to determine the difference in payments made to the clinics for similar procedures. We will also assess the potential impact on Medicare and beneficiaries of hospitals' claiming provider-based status for such facilities.
Completed (partial)	Centers for Medicare & Medicaid Services	Home Health Compliance with Medicare Requirements	Office of Audit Services	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; W-00-19-35712; W-00-16-35712; W-00-16-35501; W-00-17-35712; various reviews	2021	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.
June 2019	Other	OIG Reviews of Non-Federal Audits	Office of Audit Services	W-00-19-40005	2021	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.
April 2019	Health Resources & Services Administration	Access Increases in Mental Health and Substance Abuse Services Funding for Health Centers	Office of Audit Services	W-00-19-59442	2021	As part of HHS's efforts to fight the national opioid epidemic, the Health Resources and Services Administration (HRSA) awarded $200 million in Access Increases in Mental Health and Substance Abuse Services (AIMS) supplemental funding to 1,178 health centers nation-wide. Health centers use AIMS funding to expand access to critical mental health services and substance abuse services focusing on the treatment, prevention, and awareness of opioid abuse. The AIMS funding was awarded to health centers in September 2017 and covers 12-month budget periods from January 2018 through June 2018. AIMS funding can be used to increase mental health and substance abuse services personnel, leverage health information technology, and provide additional training. We will determine whether health centers used their AIMS funding in accordance with Federal requirements and grant terms.
April 2019	Centers for Medicare & Medicaid Services	Review of State Uncompensated Care Pools	Office of Audit Services	W-00-19-31537	2021	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.
April 2019	Substance Abuse and Mental Health Services Administration	Projects for Assistance in Transition from Homelessness Program	Office of Audit Services	W-00-19-50100	2021	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.
April 2019	Centers for Medicare & Medicaid Services	Medicaid Managed Care Organization Denials	Office of Audit Services	W-00-19-31535	2022	The State Medicaid agency and the Federal Government are responsible for financial risk for the costs of Medicaid services. Managed care organizations (MCOs) contract with State Medicaid agencies to ensure that beneficiaries receive covered Medicaid services. The contractual arrangement shifts financial risk for the costs of Medicaid services from the State Medicaid agency and the Federal Government to the MCO, which can create an incentive to deny beneficiaries' access to covered services. Our review will determine whether Medicaid MCOs complied with Federal requirements when denying access to requested medical and dental services and drug prescriptions that required prior authorization.
April 2019	Centers for Medicare & Medicaid Services	Review of Monthly ESRD-Related Visits Billed by Physicians or Other Qualified Healthcare Professionals	Office of Audit Services	W-00-19-35822	2021	Most physicians and other practitioners (e.g., clinical nurse specialists, nurse practitioners, or physician’s assistants) who manage the care of patients who receive outpatient dialysis services at end-stage renal disease (ESRD) facilities are paid a monthly capitation payment (MCP) for ESRD-related physician services. The MCP amount is based on the number of visits provided within each month and the age of the ESRD beneficiary. The physician or other practitioner can bill only one of three current procedural terminology (CPT) codes for ESRD-related visits of one per month, two to three per month, or four or more per month (CMS, Medicare Claims Processing Manual, Pub. No. 100-04, chapter 8, § 140.1). The Comprehensive Error Rate Testing program's special study of the Healthcare Common Procedure Coding System codes for ESRD-related services found that for some codes, approximately one-third of the payments for ESRD-related services were improper payments due to insufficient documentation, incorrect coding, or no documentation submitted (CMS, Medicare Quarterly Provider Compliance Newsletter Guidance to Address Billing Errors, volume 5, issue 3, April 2015). We will review whether physicians or other qualified healthcare professionals billed monthly ESRD-related visits in accordance with Federal requirements (Social Security Act, §§ 1815(a) and 1833(e)).
April 2019	Centers for Medicare & Medicaid Services	Medicaid Personal Care Services	Office of Audit Services	W-00-19-31536	2022	Personal care services (PCS) is a Medicaid benefit for the elderly, people with disabilities, and people with chronic or temporary conditions. It assists them with activities of daily living and helps them remain in their homes and communities. Examples of PCS include bathing, dressing, light housework, money management, meal preparation, and transportation. Prior OIG reviews identified significant problems with States’ compliance with PCS requirements. Some reviews also showed that program safeguards intended to ensure medical necessity, patient safety, and quality, and prevent improper payments were often ineffective. We will determine whether improvements have been made to the oversight and monitoring of PCS and whether those improvements have reduced the number of PCS claims not in compliance with Federal and State requirements.
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-04-15-06190; W-00-19-31497	2021	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.
March 2019	Centers for Medicare & Medicaid Services	Post-Hospital Skilled Nursing Facility Care Provided to Dually Eligible Beneficiaries	Office of Audit Services	W-00-19-35821	2021	Skilled nursing facilities (SNFs) are specially qualified facilities that provide extended care services, such as skilled nursing care, rehabilitation services, and other services to Medicare beneficiaries who meet certain conditions. During previous OIG reviews, we noted that some nursing facility residents who were receiving Medicaid-covered nursing home care were admitted to a hospital and returned to the same facility to receive Medicare-covered post-hospital SNF care. In some cases, hospital physicians discharged beneficiaries to "home" rather than "SNF," yet nursing facility physicians certified that skilled care was needed. Because Medicare pays substantially more for SNF care than Medicaid for nursing home care, nursing facilities have financial incentives to increase the level of care to "skilled." We will determine whether the post-hospital SNF care provided to dually eligible beneficiaries met the level of care requirements. Specifically, we will determine whether (1) the SNF level of care was certified by a physician (e.g., a hospital or SNF physician) or a physician extender (i.e., a nurse practitioner, clinical nurse specialist, or physician assistant); (2) the condition treated at the SNF was a condition for which the beneficiary received inpatient hospital services or a condition that arose while the beneficiary was receiving care in a SNF for a condition for which the beneficiary received inpatient hospital services; (3) daily skilled care was required; (4) the services delivered were reasonable and necessary for the treatment of a beneficiary's illness or injury; and (5) improper Medicare payments were made on the claims we review. We will also determine whether any of the hospital admissions we review were potentially avoidable.
Completed (partial)	OS	Review of HHS Government Purchase, Travel, and Integrated Charge Card Programs	Office of Audit Services	A-04-19-06234; W-00-19-59041	2021	The Government Charge Card Abuse Prevention Act of 2012 (Charge Card Act) requires Inspectors General (IGs) to conduct periodic risk assessments of their agencies’ charge card programs to analyze the risks of illegal, improper, or erroneous purchases. The Charge Card Act requires IGs to use the risk assessments to determine the necessary scope, frequency, and number of IG audits or reviews of the charge card programs. It requires Federal agencies to establish and maintain safeguards and internal controls for purchase cards, convenience checks, travel cards, and integrated cards. The Office of Management and Budget has instructed IGs to submit annual status reports on purchase and travel card audit recommendations beginning January 31, 2014, for compilation and transmission to Congress and the Government Accountability Office. We will review HHS’s charge card programs (i.e., purchase, travel, or integrated cards) to assess the risks of illegal, improper, or erroneous purchases. HHS’s charge card programs enable cardholders to pay for commercial goods, services, and travel expenses.
March 2019	OS	OIG DATA Act Readiness Review (2016) and Data Completeness and Accuracy (2017, 2019, 2021). (Performing a scaled down version on an interim basis for FY 2018.)	Office of Audit Services	W-00-19-41021	2021	On May 9, 2014, the President signed the DATA Act of 2014, which mandated the establishment of Government-wide data standards for financial and payment data by May 2015, and agency reporting of consistent, reliable, and searchable financial and payment data by May 2017, to be displayed for taxpayers and policymakers on USASpending.gov. The DATA Act also requires OIG to review a statistically valid sampling of the spending data submitted under this Act by HHS and submit to Congress and make publically available a report assessing the completeness, timeliness, quality, and accuracy of the data sampled and the implementation and use of data standards by HHS. We will use the independent external auditor contracted to audit the annual CMS and HHS Financial Statement Audits to perform this work.
March 2019	OS	Review of HHS's Compliance with the Federal Information Security Modernization Act of 2014 (FISMA)	Office of Audit Services	W-00-19-42001; W-00-19-40016	2021	The Federal Information Security Modernization Act (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, or disseminated in general support systems and major applications. FISMA requires the Inspectors General to conduct an annual independent evaluation to determine the effectiveness of the information security program and practices of its agency. We will review HHS's and selected HHS operating divisions' compliance with FISMA.
Completed	OS	Audit of FY 2019 HHS Consolidated Financial Statements	Office of Audit Services	A-17-19-00001; W-00-19-40009	2020	The HHS financial statement audit determines whether the financial statements present fairly, in all material respects, the financial position of the audited entity for the specified time period. We will retain an independent external auditor and review the independent auditor's work papers to determine whether financial statement audits of HHS and its components were conducted in accordance with Federal requirements. The financial statement audit is required by Chief Financial Officers Act of 1990, as amended by the Government Management Reform Act of 1994, and performed in accordance with Generally Accepted Government Auditing Standards and Office of Management and Budget (OMB) Bulletin 19-01, "Audit Requirements for Federal Financial Statements." The audited consolidated FYs 2019 and 2020 financial statements for HHS are due to OMB by November 15, 2019 and 2020, respectively. We plan to perform a number of ancillary financial-related reviews pertaining to the audits of the FYs 2019 and 2020 financial statements. The purpose of the ancillary financial-related reviews is to fulfill requirements in OMB Bulletin 19-01, §§ 6.1 through 12.
March 2019	Centers for Medicare & Medicaid Services	Audit of FY 2019 CMS Financial Statements	Office of Audit Services	W-00-19-40008	2021	The CMS financial statement audit determines whether the financial statements present fairly, in all material respects, the financial position of the audited entity for the specified time period (Chief Financial Officers Act of 1990, as amended; Government Management Reform Act of 1994; Federal Financial Management Improvement Act of 1996; Generally Accepted Government Auditing Standards; and Office of Management and Budget Bulletin 19-01, "Audit Requirements for Federal Financial Statements"). We will retain an independent external auditor and review the independent auditor's work papers to determine whether the financial statement audit of CMS was conducted in accordance with Federal requirements.
Completed	Centers for Medicare & Medicaid Services	Review of Medicare Administrative Contractor Information Security Program Evaluations for FY 2018 (MMA 912)	Office of Audit Services	A-18-19-11300; W-00-18-35777; W-00-19-41010	2020	Federal law requires independent evaluations of the security programs of Medicare Administrative Contractors and requires OIG to assess such evaluations and report the results of its assessments to Congress (Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 912). We will review independent evaluations of information systems security programs of Medicare Administrative Contractors. We will report to Congress on our assessment of the scope and sufficiency of the independent evaluations and summarize their results.
Completed (partial)	National Institutes of Health	Superfund Financial Activities at the National Institute of Environmental Health Sciences	Office of Audit Services	A-04-19-04071; A-09-18-03020; W-00-19-35094; W-00-19-59050	2021	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.
February 2019	Centers for Medicare & Medicaid Services	Medicare Part B Payments for Podiatry and Ancillary Services	Office of Audit Services	W-00-19-35818	2021	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.
February 2019	National Institutes of Health	NIH's Pre-Award Process for Assessing Risk of Grant Applicants and Post-Award Process for Oversight of Grantees	Office of Audit Services	W-00-19-51002	2021	Extramural research grants accounted for more than 80 percent of the $37 billion that the National Institutes of Health (NIH) received for FY 2018 from Congress. Before making a Federal award, NIH is required to determine whether a party is eligible to receive Federal funds. Even if eligible, a party may be subject to certain conditions because of the risk(s) associated with making the Federal award. The Departments of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (Public Law No. 115-245) and its Accompanying Report directed that OIG examine NIH's oversight of its grantees' compliance with NIH policies, including NIH efforts to ensure the integrity of its grant application and selection processes. We will conduct audits at NIH's Institutes and Centers to review their (i) pre-award process for assessing risk of potential recipients of Federal funds, and (ii) post-award process for overseeing and monitoring of grantees on the basis of risks identified during the pre-award process.
Completed	Centers for Medicare & Medicaid Services	Followup Review on Inpatient Claims Subject to the Post-Acute-Care Transfer Policy	Office of Audit Services	A-09-19-03007; W-00-19-35820	2020	Medicare makes the full Medicare Severity Diagnosis-Related Group (MS-DRG) payment to a hospital that discharges an inpatient beneficiary "to home." Under the post-acute-care transfer policy, however, for certain qualifying MS-DRGs, Medicare pays a hospital that transfers an inpatient beneficiary to post-acute care a per diem rate for each day of the stay, not to exceed the full MS-DRG payment that would have been made if the inpatient beneficiary had been discharged to home. A prior OIG review identified Medicare overpayments to hospitals that did not comply with Medicare's post-acute-care transfer policy (42 CFR § 412.4(c)). We found that hospitals transferred patients to certain post-acute-care settings but improperly claimed the higher reimbursement associated with discharges "to home." Specifically, these hospitals used incorrect patient discharge status codes on their claims by indicating that their patients were discharged "to home" rather than transferred to a post-acute-care setting (e.g., home health services, skilled nursing facilities (SNFs), non-Inpatient Prospective Payment System (IPPS) hospitals or hospital units). OIG's review found that CMS common working file (CWF) edits related to transfers to home health care, SNFs, and non-IPPS hospitals were not working properly. As a result, OIG recommended that CMS correct the CWF edits, ensure they are working properly, and recover the identified overpayments in accordance with its policies and procedures. CMS agreed with the recommendations and stated that it will update the CWF edits. This followup audit will determine whether CMS corrected the CWF edits and ensured they are working properly.
January 2019	Centers for Medicare & Medicaid Services	Medicare Outpatient Outlier Payments for Claims With Credits for Replaced Medical Devices	Office of Audit Services	W-00-19-35819	2021	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.
January 2019	Centers for Medicare & Medicaid Services	Duplicate Payments for Home Health Services Covered Under Medicare and Medicaid	Office of Audit Services	W-00-19-31141	2020	Medicare Home Health Agency (HHA) coverage requirements state that an HHA is responsible for providing all services either directly or under arrangement while a beneficiary is under a home health plan of care authorized by a physician. Consequently, Medicare pays a single HHA overseeing that plan. "Dual eligible beneficiaries" generally describes beneficiaries eligible for both Medicare and Medicaid. Medicare pays covered medical services first for dual eligible beneficiaries because Medicaid is generally the payer of last resort. We will determine whether States made Medicaid payments for home health services for dual eligible beneficiaries who are also covered under Medicare.
November 2018	Centers for Disease Control and Prevention	CDC's Oversight of the President's Emergency Plan for AIDS Relief Funds	Office of Audit Services	W-00-19-57301; W-00-20-57301	2021	Through the President's Emergency Plan for AIDS Relief (PEPFAR), the Centers for Disease Control and Prevention (CDC) has altered the course of the global acquired immunodeficiency syndrome (AIDS) epidemic, saving millions of lives, improving the lives of countless others, and preventing millions of infections around the world. CDC received more than $1.7 billion of fiscal year 2017 PEPFAR funds (about 97 percent of the funds received by HHS) to accelerate progress toward achieving an AIDS-free generation and create a lasting infrastructure that allows partner countries to respond to a range of health challenges and threats. To date, OIG has conducted a series of PEPFAR audits at CDC in five countries in Africa, North America, and Asia. OIG's oversight of PEPFAR has helped CDC and other HHS staff learn important grant and program integrity lessons that apply to ongoing and future responses to infectious diseases. In previous audits of CDC offices in the United States and foreign countries, OIG identified noncompliance with policies, inadequate monitoring of grantees, and internal control weaknesses in the award of PEPFAR funds. We will determine whether CDC has taken corrective action to ensure it has improved and implemented internal controls, including adhering to policies and procedures for awarding and monitoring PEPFAR funds.
October 2018	Administration for Children and Families	Child Care and Development Fund: Provider Compliance with State Criminal Background Check Requirements	Office of Audit Services	W-00-18-20020	2021	Reauthorized in the Child Care and Development Block Grant Act of 2014 (CCDBG Act), the Child Care and Development Fund is the primary source of Federal subsidies of childcare costs to low-income families. All licensed, regulated, and registered childcare providers, as well as all childcare providers eligible to deliver childcare services, are subject to the CCDBG Act's requirements for criminal background checks. The CCDBG Act mandates that a State have policies and procedures in place that meet the criminal background check requirements. To determine whether the States' monitoring process has ensured compliance by childcare providers with States' requirements for criminal background checks established under the CCDBG Act, we will assess provider compliance with the criminal background record check requirements that have been established by each State.
October 2018	Centers for Medicare & Medicaid Services	Medicaid Capitation Payments Made on Behalf of Incarcerated Individuals	Office of Audit Services	W-00-18-31534; various reviews	2022	States contract with Medicaid managed care organizations to provide specific services to enrolled Medicaid beneficiaries, usually in return for a predetermined periodic payment, known as a capitation payment. Section 1905 of Title XIX of the Social Security Act, 42 CFR § 435, and guidance from the Centers for Medicare & Medicaid Services state that Federal financial participation is not available for services provided to inmates of public institutions, except when the inmate is not in a prison setting and becomes an inpatient in a medical institution. We will determine whether select States made unallowable capitation payments to Medicaid managed care organizations on behalf of individuals who were incarcerated.
August 2018	Centers for Medicare & Medicaid Services	Potential Abuse and Neglect of Children Receiving Medicaid Benefits	Office of Audit Services	W-00-18-31533	2022	Medicaid beneficiaries, including children, are treated at inpatient and outpatient medical facilities for conditions that may be the result of abuse or neglect. Although all States have laws mandating reporting of suspected child abuse, these laws vary considerably in their definitions, scope, and procedures. Prior OIG reviews have highlighted problems with the quality of care and the reporting and investigation of potential abuse or neglect of vulnerable beneficiary populations at group homes, nursing homes, and skilled nursing facilities. On the basis of diagnoses from medical facilities treating conditions potentially related to abuse or neglect, we will determine the prevalence of Medicaid claims indicating potential abuse or neglect of children receiving Medicaid benefits.
Completed	Administration for Children and Families	Review of Federal Programs Administered by American Indian and Alaska Native Tribes	Office of Audit Services	A-06-18-07002; W-00-18-25062	2020	HHS provides Federal funds to American Indian and Alaska Native (AI/AN) tribes for various programs, including Head Start, Child Care and Development Block Grant, and Indian Self-Determination programs. There are approximately 6.6 million AI/ANs who are members of the 567 federally recognized tribes located in 36 States. OIG has identified as one of HHS's top management challenges ensuring the effective delivery of crucial services to AI/ANs and protecting funds from fraud, waste, and abuse. Prior OIG audits found that grantees did not always operate Federal programs, including Head Start, in accordance with Federal regulations and did not always manage and account for Federal funds in accordance with Federal requirements. We will audit tribal programs serving AI/AN communities to determine whether the tribes operated these programs and managed HHS funds in accordance with Federal requirements.
August 2018	Centers for Medicare & Medicaid Services	Physicians Billing for Critical Care Evaluation and Management Services	Office of Audit Services	W-00-18-35816; various reviews	2021	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.
Completed (partial)	Substance Abuse and Mental Health Services Administration	SAMHSA's Oversight of Accreditation Bodies for Opioid Treatment Programs	Office of Audit Services	A-09-18-01007; W-00-20-59035	2021	The Substance Abuse and Mental Health Services Administration (SAMHSA) estimates that 2.5 million people have an opioid use disorder related to prescription pain relievers and/or heroin. Medication-Assisted Treatment (MAT), provided by opioid treatment programs (OTPs), is a significant component of the treatment protocols for opioid use disorder and plays a large role in combating the opioid epidemic in the United States. SAMHSA issued final regulations to establish an oversight system for the treatment of substance use disorders with MAT. These regulations (42 CFR Part 8) established procedures for an entity to become an approved accreditation body, which evaluates OTPs and ensures SAMHSA's opioid dependency treatment standards are met. Our objective is to determine whether SAMHSA's oversight of accreditation bodies complied with Federal requirements. This series of audits will include SAMHSA-approved accrediting bodies that have accredited OTPs.
August 2018	Administration for Children and Families	ACF Child Care Development Fund: Program Integrity	Office of Audit Services	W-00-18-20019	2020	The Child Care and Development Fund (CCDF) program provides subsidized childcare to low-income families, families receiving temporary public assistance, and families transitioning from public assistance so family members can work or attend training or education. Each State must develop, and submit to the Administration for Children and Families (ACF) for approval, a plan that identifies the purposes for which CCDF funds will be spent for a 3-year grant period and designates a lead agency responsible for administering childcare programs. States receive block grants and other Federal funds (approximately $5.77 billion annually) to operate their childcare programs. Prior OIG work identified vulnerabilities in States' internal controls for the CCDF program and a national CCDF payment error rate of 5.74 percent. We will determine whether State agencies complied with Federal and State requirements when making payments to licensed providers under these childcare programs for Federal fiscal years 2016 through 2018.
August 2018	Centers for Medicare & Medicaid Services	Penetration Test of the Affordable Care Act Website and Associated Systems	Office of Audit Services	W-00-18-42000	2020	Under provisions of the Affordable Care Act (ACA), the HealthCare.gov website and related systems were established as part of the Federally Facilitated Marketplace (FFM) to provide consumers with access to health care coverage through private, qualified health plans or through Federal programs such as Medicaid. In 2017, more than nine million people enrolled in health care coverage through FFM. We will conduct a penetration test of ACA systems to determine whether the Centers for Medicare & Medicaid Services has implemented effective information security controls.
July 2018	All STAFFDIV/ OPDIVs	Identification of HHS Cybersecurity Vulnerabilities	Office of Audit Services	W-00-18-42021; W-00-18-42022	2021	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.
July 2018	Centers for Medicare & Medicaid Services	Increased Payments For Transfer Claims With Outliers	Office of Audit Services	W-00-18-35814	2021	While the transfer rule reduces the Diagnosis Related Group (DRG), Disproportionate Share Hospital (DSH), and Indirect Medical Education (IME) payments on a Medicare beneficiary's claim, the methodology for calculating cost outlier payments can result in such payments being higher than what would have been paid in a nontransfer context. Under the transfer rule, CMS reduces the DRG payment by applying a graduated per diem payment on the Medicare claim of the hospital transferring the patient to another setting early in the patient's hospital stay. Because DSH and IME payments are determined as a percentage of the reduced DRG payment, they are also reduced. By contrast, by reducing the threshold above which a claim qualifies as an outlier, the application of the outlier methodology at 42 CFR Sec. 412.80(b) can result in an increase in the outlier payment in transfer cases. We will produce a report describing the extent to which additional Medicare outlier payments negate the reduction in DRG, DSH, and IME payments of transfer claims.
July 2018	Centers for Medicare & Medicaid Services	Review of Post-Operative Services Provided in the Global Surgery Period	Office of Audit Services	W-00-18-35810	2021	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.
June 2018	Centers for Medicare & Medicaid Services	CMS's Contingency Planning for Information Technology Systems	Office of Audit Services	W-00-18-42023	2020	CMS, the provider of health care for one in four Americans, administers Medicare, Medicaid, the Children's Health Insurance Program, and other programs to improve the health and well-being of all Americans. To ensure the continuity of this extensive mission and in accordance with Federal mandates, CMS has identified the essential functions that support the Agency's mission. We will determine if CMS's contingency planning for information technology systems ensures the continuity of its mission essential functions and meets Federal requirements.
June 2018	Centers for Medicare & Medicaid Services	Medicare Part B Payments for End-Stage Renal Disease Dialysis Services	Office of Audit Services	W-00-18-35811	2021	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.
June 2018	Administration for Children and Families, CDC, & HRSA	State and Territory Response and Recovery Activities for the 2017 Hurricanes	Office of Audit Services	W-00-18- 59438	2021	OIG will conduct reviews of selected States' and one territory's hurricane preparedness and response activities to provide the necessary resources to ensure the safety of HHS beneficiaries affected by the 2017 Hurricanes Harvey, Irma, and Maria. We will determine the extent to which State and territory emergency preparedness plans included necessary activities to enhance ongoing response and recovery operations and strengthen public health and medical response capabilities. We will also assess the effectiveness of State and territory implementation of emergency preparedness response and recovery activities related to the 2017 Hurricanes.
June 2018	Centers for Medicare & Medicaid Services	Medicare Payments Made Outside of the Hospice Benefit	Office of Audit Services	W-00-17-35797, W-00-18-35797	2021	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.
Completed (partial)	Substance Abuse and Mental Health Services Administration	Prescription Opioid Drug Abuse and Misuse Prevention - Prescription Drug Monitoring Programs	Office of Audit Services	A-09-18-01001; A-04-18-02012; A-02-18-02001; A-09-18-01006; W-00-18-59428	2021	Opioid abuse and related overdoses are a national epidemic. According to the Centers for Disease Control and Prevention (CDC), more than 33,000 people died in 2015 from overdoses involving opioids, both prescription and illicit, an increase from approximately 28,000 deaths in 2014. HHS, through CDC and the Substance Abuse and Mental Health Services Administration (SAMHSA), provides funding to States to prevent opioid abuse and misuse. Funding is provided by CDC’s Prescription Drug Overdose: Prevention for States program and SAMHSA's Strategic Prevention Framework for Prescription Drugs program. Our objectives are to identify actions State agencies have taken using Federal funds for enhancing prescription drug monitoring programs (PDMPs) to achieve program goals -- improving safe prescribing practices and preventing prescription drug abuse and misuse. We will also determine whether State agencies complied with Federal requirements. This series of audits includes States that have had a high number of overdose deaths, have a significant increase in the rate of drug overdose deaths, or received HHS funding to enhance their PDMPs.
May 2018	Centers for Medicare & Medicaid Services	Medicare Part B Outpatient Cardiac and Pulmonary Rehabilitation Services	Office of Audit Services	W-00-18-35808	2021	Medicare Part B covers outpatient cardiac and pulmonary rehabilitation services. For these services to be covered, however, they must be medically necessary and comply with certain documentation requirements. Previous OIG work identified outpatient cardiac and pulmonary rehabilitation service claims that did not comply with Federal requirements. We will assess whether Medicare payments for outpatient cardiac and pulmonary rehabilitation services were allowable in accordance with Medicare requirements. We will also determine whether potential risks in outpatient cardiac and pulmonary rehabilitation programs continue to exist.
May 2018	Centers for Medicare & Medicaid Services	Noninvasive Home Ventilators - Compliance With Medicare Requirements	Office of Audit Services	W-00-18-35809	2021	For items such as noninvasive home ventilators (NHVs) and respiratory assist devices (RADs) to be covered by Medicare, they must be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Depending on the severity of the beneficiary's condition, an NHV or RAD may be reasonable and necessary. NHVs can operate in several modes, i.e., traditional ventilator mode, RAD mode, and basic continuous positive airway pressure (CPAP) mode. The higher cost of the NHVs' combination of noninvasive interface and multimodal capability creates a greater risk that a beneficiary will be provided an NHV when a less expensive device such as a RAD or CPAP device is warranted for the patient's medical condition. Prior OIG work identified significant growth in Medicare billing for NHVs in the years since they reached the market. We will determine whether claims for NHVs were medically necessary for the treatment of beneficiaries' diagnosed illnesses and whether the claims complied with Medicare payment and documentation requirements.
May 2018	Centers for Medicare & Medicaid Services	States' Procurement of Private Contracting Services for the Medicaid Management Information System	Office of Audit Services	W-00-18-31532	2021	The Medicaid Management Information System (MMIS) is an integrated group of procedures and computer processing operations designed to meet principal objectives such as processing medical claims. Medicaid reimburses States' MMIS administrative costs at enhanced rates of 90 and 75 percent. Many States use private contractors to design, develop, and operate their MMIS. When procuring MMIS contracting services, States are required to follow the same policies and procedures used for procurements paid with non-Federal funds. Additionally, States must receive CMS's prior approval to receive enhanced Federal matching funds for MMIS administrative costs related to private contractors. States have reportedly had issues with private MMIS contractors, including with initial procurements. We will determine if selected States followed applicable Federal and State requirements related to procuring private MMIS contracting services and claiming Federal Medicaid reimbursement.
Completed	Administration for Children and Families	Review of Sole Incumbent Grantees' Compliance With Head Start Program Requirements	Office of Audit Services	A-01-18-02502; A-01-18-02503; W-00-18-20017	2020	Head Start - the largest Federal investment in early childhood education - is a nation-wide grant program to promote school readiness in children from low-income families. The Improving Head Start for School Readiness Act of 2007 required the Administration for Children and Families (ACF) to begin awarding 5-year grants for Head Start and to require grantees that ACF determines are not providing a high-quality and comprehensive Head Start program to “recompete” - i.e., to participate in open competition for funding renewal. ACF implemented a system to assess a subset of grantees each year and determine which grantees will be required to recompete. Prior OIG work on the Head Start Grant recompetition process found that many of the grantees required to recompete were the sole applicants for their respective grants, and thus faced no competition. As a result, ACF either reselected the incumbent grantee or appointed a temporary grantee to avoid a disruption of Head Start services. We will review select sole applicant grantees that ACF reselected after the recompetition process. We will determine whether these grantees complied with Head Start's health, safety, and financial management requirements.
April 2018	Centers for Medicare & Medicaid Services	Medicaid Nursing Home Supplemental Payments	Office of Audit Services	W-00-18-31530	2021	CMS approved a nursing home supplemental payment program in certain States that pays the difference between Medicare and Medicaid rates for nursing home services. In some of these programs, local governments fund the States' share of the supplemental payments through intergovernmental transfers. Prior OIG and Government Accountability Office audits have found that Federal supplemental payments often benefit the State and local governments more than the nursing homes. We will review the nursing home supplemental payment program's flow of funding and determine how the funds are being used.
April 2018	Centers for Medicare & Medicaid Services	CMS Medicare Overpayment Recoveries Related to Recommendations in OIG Audit Reports	Office of Audit Services	W-00-18-35807	2021	HHS is responsible for resolving Federal audit report recommendations related to its activities, grantees, and contractors within 6 months after formal receipt of the audit reports. From October 1, 2014, to December 31, 2016, OIG issued 153 audit reports that related to the Medicare program and that contained 193 monetary recommendations totaling $648 million. Of the $648 million in recommended overpayment recoveries, CMS agreed to collect $566 million applicable to 190 recommendations. We will determine the extent to which CMS: (1) collected agreed upon Medicare overpayments identified in OIG audit reports and (2) took corrective action in response to the recommendations in our prior audit report examining CMS' overpayment recoveries (A-04-10-03059). In that report, we recommended that CMS enhance its systems and procedures for recording, collecting, and reporting overpayments. We also recommended that CMS provide guidance to its contractors on how to document that overpayments were actually collected.
Completed (partial)	Administration for Children and Families	Child Support Administrative Cost Audit	Office of Audit Services	A-01-18-02501; W-00-18-20016	2021	The Child Support Enforcement (CSE) Program is a Federal, State, and local partnership established in 1975 under Title IV-D of the Social Security Act to collect child support payments from noncustodial parents for distribution to custodial parents. Within the Department of Health and Human Services, Administration for Children and Families, the Office of Child Support Enforcement (OCSE) provides Federal oversight of the CSE Program. All 50 States, the District of Columbia, Guam, Puerto Rico, and the Virgin Islands operate individual CSE programs and are entitled to Federal matching funds. The Federal Government and the States share CSE program costs at the rate of 66 percent and 34 percent, respectively. OCSE must conduct audits of State agencies, including assessing whether Federal and other funds disbursed to State programs are spent appropriately and fully accounted for (42 U.S.C.§ 652(a)(4)(C) (ii)(I)). Responsibilities of the CSE Program include locating noncustodial parents—those who are not the primary caregivers for or do not have custody or control of their children; establishing paternity and support orders; and collecting and distributing child support payments. All costs incurred to carry out these responsibilities are considered administrative costs. Based on a previous report of the Government Accountability Office and OCSE's inability to perform administrative cost audits, Federal funds are at risk. We will review the administrative costs of select States' CSE programs and certain categories of those costs to determine if they comply with Federal and State requirements
Completed (partial)	Office of the Assistant Secretary for Financial Resources	Grantee Compliance With Cost Principles for Organizations With Multiple HHS Discretionary Funding Sources	Office of Audit Services	A-05-18-00008; A-06-18-02002; W-00-18-59433	2021	Department of Health and Human Services (HHS) grantees must maintain financial management systems that contain written procedures for determining the reasonableness, allocability, and allowability of costs in accordance with applicable Federal cost principles and the terms and conditions of the award (45 CFR § 75.302(b)(7)). Grantees also must maintain accounting records that are supported by source documentation (45 CFR § 75.302(b)(3)) and financial management systems that provide for accurate and complete disclosure of the financial results of each project or program sponsored by HHS (45 CFR § 75.302(b)(2)). We will review select grantees receiving HHS grant funding from multiple sources to determine whether they are allocating and claiming costs in accordance with Federal requirements. We will also review procedures in place for HHS oversight and coordination between the participating grant programs.
March 2018	Indian Health Service	Financial and Administrative Review at Indian Health Service Area Offices	Office of Audit Services	W-00-18-59435	2021	The Indian Health Service (IHS) provides health services to approximately 2.2 million American Indians and Alaska Natives in 567 federally recognized Tribes located in 35 States. These services are funded through annual appropriations distributed among IHS headquarter offices and 12 regional offices called Area Offices. These services are provided through IHS and Tribal facilities that operate (1) IHS direct health care service programs, (2) tribally operated health care service programs authorized under Titles I and V of the Indian Self-Determination and Education Assistance Act (P.L. No. 93-638), and (3) Urban Indian Health Program services and resource centers. Congress has expressed concern about IHS's administrative and financial management of program funds. We will examine how an IHS Area Office monitors and allocates appropriations received from IHS headquarter offices within its geographic area. We will examine an Area Office with respect to (1) accounting for IHS annual appropriations and (2) allocating IHS appropriations to service units within the Area Office's geographic area.
March 2018	Centers for Medicare & Medicaid Services	Medicaid School-Based Costs Claimed Based on Contingency Fee Contractor Coding	Office of Audit Services	W-00-18-31529	2021	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
Completed (partial)	Centers for Medicare & Medicaid Services	Review of Statistical Methods Within the Medicare Fee-For-Service Administrative Appeal Process	Office of Audit Services	A-05-18-00024; W-00-18-35806	2021	Medicare program integrity contractors are authorized to use statistical sampling to identify and recover improper payments. Providers may contest these statistical estimates through the administrative appeals process. If a statistical estimate is overturned during the administrative appeals process, then the provider is liable for any overpayment upheld in the sample rather than the full, extrapolated total. The difference between these amounts is often substantial. The Medicare Administrative Contractors (MACs) and Qualified Independent Contractors (QICs) are responsible for the first two levels of the appeals process and thus play a critical role in deciding which extrapolations will be upheld. We will determine whether the MACs and QICs are reviewing statistical estimates in an appropriate and consistent manner as part of the fee-for-service appeal process.
December 2017	Centers for Medicare & Medicaid Services	Review of CMS Systems Used to Pay Medicare Advantage Organizations	Office of Audit Services	W-00-18-35804	2021	Medicare Advantage (MA) organizations submit to CMS diagnoses on their beneficiaries; in turn, CMS categorizes certain diagnoses into groups of clinically related diseases called hierarchical condition categories (HCC). For instances in which a diagnosis maps to a HCC, CMS increases the risk-adjusted payment. CMS has designed its Medicare Part C systems to capture the necessary data in order to make these increased payments to MA organizations. As CMS transitions to a new data system to make these payments, OIG will conduct analysis to inform both use of current systems and the transition to a new system. We will review the continuity of data maintained on current Medicare Part C systems. Specifically, we will review instances in which CMS made an increased payment to an MA organization for a HCC and determine whether CMS's systems properly contained a requisite diagnosis code that mapped to that HCC.
Completed (partial)	Centers for Medicare & Medicaid Services	State Compliance With Requirements for Reporting and Monitoring Critical Incidents	Office of Audit Services	A-09-17-02006 A-06-17-04003; A-04-17-04063; W-00-17-31040; A-02-17-01026; A-03-17-00202;A-04-17-03084; A-04-17-04063; A-04-17-08058; A-06-17-01003; A-06-17-02005	2021	The Centers for Medicare & Medicaid Services requires States to implement an incident reporting system to protect the health and welfare of the Medicaid beneficiaries who receive services in community-based settings or nursing facilities. During prior audits, OIG found that some States did not always comply with Federal and State requirements for reporting and monitoring critical incidents such as abuse and neglect. We will review additional State Medicaid Agencies to determine whether the selected States are in compliance with the requirements for reporting and monitoring critical incidents. Our work will focus on Medicaid beneficiaries residing in both community-based settings and nursing facilities.
Completed	Indian Health Service	Impact of the Indian Health Service's Delivery of Information Technology/Information Security Services and Opioid Prescribing Practices	Office of Audit Services	A-18-17-11400; W-00-17-42020	2020	The Indian Health Service (IHS) has a decentralized management structure that is separated into two major categories: Headquarters and 12 Area Offices. The Area Offices are responsible for overseeing 26 hospitals, 59 health centers, and 32 health stations, some of which are located in remote locations. The Office of Inspector General found that hospitals with limited cybersecurity resources struggle to implement information technology improvements and update the IHS electronic heath record system. In addition, IHS faces challenges in combating the opioid abuse epidemic. We will analyze and compare information technology/information security (IT/IS) operations and opioid prescribing practices at five IHS hospitals to determine whether (1) IHS's decentralized management structure has affected its ability to deliver adequate IT/IS services in accordance with Federal requirements and (2) hospitals prescribed and dispensed opioids in accordance with IHS policies and procedures.
Completed (partial) 2017	Centers for Medicare & Medicaid Services	Payment Credits for Replaced Medical Devices That Were Implanted	Office of Audit Services	A-05-16-00059; W-00-16-35745; W-00-18-35745	2021	Certain medical devices are implanted during inpatient or outpatient procedures. Such devices may require replacement because of defects, recalls, mechanical complication, and other factors. Under certain circumstances, Federal regulations require reductions in Medicare payments for inpatient, outpatient, and ambulatory surgical center (ASC) claims for the replacement of implanted devices due to recalls or failures (42 CFR §§ 412.89, 419.45, and 416.179). Prior OIG reviews have determined that Medicare administrative contractors made improper payments to hospitals for inpatient and outpatient claims for replaced medical devices. We will determine whether Medicare payments for replaced medical devices were made in accord with Medicare requirements.
November 2017	Centers for Medicare & Medicaid Services	Use of Funds by Medicaid Managed Care Organizations	Office of Audit Services	W-00-18-31526	2022	Managed care is a health care delivery system organized to manage cost, utilization, and quality. In 2015, Federal Medicaid managed care payments were approximately $161.8 billion, which was more than 40 percent of the $349.8 billion in total Federal expenditures for Medicaid. States continue to expand their use of managed care. To deliver services to Medicaid managed care enrollees, States contract with managed care organizations (MCOs) and make monthly payments, called a capitation payment, to those plans to provide enrollees with Medicaid-covered services. Appropriately set capitation rates help to ensure that adequate payments are made to provide services to beneficiaries. We will examine how Medicaid funds received by MCOs are used to provide services to enrollees.
October 2017	Centers for Medicare & Medicaid Services	Review of Medicare Payments for Bariatric Surgeries	Office of Audit Services	W-00-17-35226	2021	Bariatric surgery is performed to treat comorbid conditions associated with morbid obesity. (A comorbid condition exists simultaneously with another medical condition.) Medicare Parts A and B cover certain bariatric procedures if the beneficiary has (1) a body mass index of 35 or higher, (2) at least one comorbidity related to obesity, and (3) been previously unsuccessful with medical treatment for obesity (CMS, Medicare National Coverage Determinations Manual, Pub. No. 100-03, chapter 1, part 2, § 100.1). Treatments for obesity alone are not covered. The Comprehensive Error Rate Testing program's special study of certain Healthcare Common Procedure Coding System codes for bariatric surgical procedures found that approximately 98 percent of improper payments lacked sufficient documentation to support the procedures (CMS, Medicare Quarterly Provider Compliance Newsletter, "Guidance to Address Billing Errors," volume 4, issue 4, July 2014). We will review supporting documentation to determine whether the bariatric services performed met the conditions for coverage and were supported in accordance with Federal requirements (Social Security Act, §§ 1815(a) and 1833(e)).
October 2017	Administration for Children and Families	States' Accuracy of Reporting TANF Spending Information	Office of Audit Services	W-00-17-25100	2021	The Temporary Assistance for Needy Families (TANF) program is designed to help needy families achieve self-sufficiency. States receive block grants ($16.5 billion annually) to design and operate programs that accomplish one of the four purposes of the TANF program. States must report expenditures to ACF on a quarterly basis. Effective FY 2015, States will report actual transfers, expenditures, and unliquidated obligations (henceforth referred to as expenditures) made with each open grant year award during a fiscal year on form ACF-196R. Each quarterly report will reflect expenditures cumulative through that quarter for the fiscal year, resulting in a fourth quarter report that reflects actual expenditures made with the grant year award funds for the fiscal year. States will no longer report expenditures cumulative through the current reporting period. We will determine the accuracy of States' reporting of TANF spending information using the new form ACF-196R.
Completed (partial)	Centers for Disease Control and Prevention	Grantee's Use of President's Emergency Plan for AIDS Relief Funds	Office of Audit Services	A-04-18-01009; A-04-18-01008; A-04-17-01002; A-04-16-04051; A-04-17-01003; W-00-18-57300	2021	President's Emergency Plan for AIDS Relief (PEPFAR) funds support international programs for acquired immunodeficiency syndrome (AIDS) prevention, treatment, and care. CDC received PEPFAR funds from the annual HHS appropriation and the Foreign Operations appropriation. In previous audits of foreign PEPFAR grantees, we identified unallowable expenditures and internal control weaknesses. We will review (1) whether CDC effectively accounted for and monitored PEPFAR funds and (2) whether selected foreign grantees managed PEPFAR funds received under the PEPFAR program in accordance with award requirements. In addition, we plan to prepare a report to summarize the findings for all foreign grantee audits and recommendations for CDC to take corrective action.
Completed (partial)	Centers for Medicare & Medicaid Services	States' Collection of Rebates on Physician-Administered Drugs	Office of Audit Services	A-02-16-01012; A-06-16-00018; A-05-16-00013; A-05-16-00014; W-00-16-31400; various reviews	2021	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.
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; W-00-16-31483; various reviews	2021	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.
Completed	Centers for Medicare & Medicaid Services	Reconciliations of Outlier Payments	Office of Audit Services	A-05-16-00060 W-00-16-35451; W-00-16-35781; various reviews	2020	Outliers are additional payments that Medicare provides to hospitals for beneficiaries who incur unusually high costs. The original outlier payments are based on the cost-to-charge ratio from the most recently settled cost report. The actual cost-to-charge ratio for the year in which the service was provided is available only at the time of cost report settlement for that year. Centers for Medicare & Medicaid Services performs outlier reconciliations at the time of cost report settlement. Without timely reconciliations and final settlements, the cost reports remain open and funds may not be properly returned to the Medicare Trust Fund (42 CFR § 412.84(i)(4)). We will review Medicare outlier payments to hospitals to determine whether Centers for Medicare & Medicaid Services performed necessary reconciliations in a timely manner to enable Medicare contractors to perform final settlement of the hospitals' associated cost reports. We will also determine whether the Medicare contractors referred all hospitals that meet the criteria for outlier reconciliations to Centers for Medicare & Medicaid Services.
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; W-00-17-35538; various reviews	2021	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
Completed	Centers for Medicare & Medicaid Services	Review of Hospital Wage Data Used to Calculate Medicare Payments	Office of Audit Services	A-01-17-00510; A-01-17-00500; A-01-17-00509; W-00-16-35452; W-00-17-35725; various reviews	2020	Hospitals report wage data annually to Centers for Medicare & Medicaid Services, which is then used to calculate wage index rates to account for different geographic area labor market costs. Prior OIG wage index work identified hundreds of millions of dollars in incorrectly reported wage data and resulted in policy changes by Centers for Medicare & Medicaid Services with regard to how hospitals reported deferred compensation costs. We will review hospital controls over the reporting of wage data used to calculate wage indexes for Medicare payments (SSA §§ 1886(d)(3) and 1886(d)(3)(E)).
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	2021	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.
Completed (partial)	Centers for Medicare & Medicaid Services	Contractor Pension Cost Requirements	Office of Audit Services	A-07-17-00528; W-00-17-35067; various reviews	2021	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
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; W-00-17-35095; various reviews	2021	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.
October 2017	Other	Review of Centers for Medicare & Medicaid Services Action on CERT Data	Office of Audit Services	W-00-17-35788	2021	Since 2003, Centers for Medicare & Medicaid Services has utilized the Comprehensive Error Rate Testing (CERT) program to establish a national error rate for Medicare Fee-for-Service payments as mandated by the Improper Payments Information Act of 2002. We issued a report in 2010 identifying error-prone providers and recommended that Centers for Medicare & Medicaid Services target these specific providers that contributed significantly to payment errors in the CERT program for provider-based reviews. Improper error rates and payments have not decreased in recent years. The FY 2015 reported national error rate for Medicare Fee-for-Service payments was approximately 12.1 percent, with improper payments estimated at $43.3 billion. We will determine if Centers for Medicare & Medicaid Services took action on our previous recommendation to use CERT data to target error-prone providers and reduce payment errors. Additionally, we will analyze CERT data to identify errors and potential patterns where further interventions could reduce payment errors.
October 2017	Centers for Medicare & Medicaid Services	Risk Adjustment Data - Sufficiency of Documentation Supporting Diagnoses	Office of Audit Services	W-00-16-35078; various reviews	2021	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.
Completed (partial)	Centers for Medicare & Medicaid Services	Documentation of Pharmacies' Prescription Drug Event Data	Office of Audit Services	A-07-16-06068; W-00-17-35411; various reviews	2021	Drug plan sponsors must submit prescription drug event records, which is a summary record of individual drug claim transactions at the pharmacy, for the HHS Secretary to determine payments to the plans (SSA § 1860D-15(f)(1)). We will determine whether Medicare Part D prescription drug event records submitted by the selected pharmacies were adequately supported and complied with applicable Federal requirements. We will also conduct additional reviews of selected retail pharmacies identified in a prior OIG report as having questionable Part D billing.
Completed (partial)	Other	Penetration Testing of HHS and Operating Division Networks	Office of Audit Services	A-18-17-08200; W-00-17-42000; various reviews	2020	Penetration tests are used to identify methods of gaining access to a system by using tools and techniques known to be employed by hackers. Computer hacker groups are increasingly active in attempts to compromise government systems, release sensitive data to the public, or use such data to commit fraud. We will conduct network and web application penetration testing to determine HHS's and its operating divisions' network security posture and determine whether these networks and applications are susceptible to hackers.
September 2017	Office of the Assistant Secretary for Administration	HHS Incident Response Capability	Office of Audit Services	A-18-17-04002	2020	FISMA requires Federal agencies to implement policies and procedures for detecting, reporting, and responding to security incidents. Increased threats to critical cyber-based infrastructure systems have created a need for Government agencies to increase their computer security efforts. Incidents involving cyber security and privacy threats, such as malware, malicious user activity, and vulnerabilities associated with highly interconnected technology require a skilled and rapid response to reduce their likelihood and to reduce or mitigate loss or destruction of data, loss of funds, loss of productivity, and damage to the agency's reputation. We will determine whether HHS has sufficiently implemented incident response capabilities to safeguard the Department's information technology systems and data.
Completed (partial)	Centers for Medicare & Medicaid Services	Medicaid Health Home Services for Beneficiaries with Chronic Conditions	Office of Audit Services	A-02-17-01004; W-00-17-31524; A-02-17-00000	2021	Section 1945 of the Social Security Act created an optional Medicaid State Plan benefit for States to establish "health homes" to coordinate care for people with Medicaid who have chronic medical conditions. States receive a 90-percent enhanced Federal Medical Assistance Percentage (FMAP) for health home services valid through the first eight quarters of the program. The State option to provide health home services to eligible Medicaid beneficiaries became effective on January 1, 2011. As of May 2017, CMS has approved Medicaid State plan amendments for 21 States and the District of Columbia for health home programs. More than 1 million Medicaid beneficiaries have been enrolled in these programs. We will review Medicaid health home programs for compliance with relevant Federal and State requirements.
Completed (partial)	Centers for Medicare & Medicaid Services	Medicaid Nursing Home Life Safety Reviews	Office of Audit Services	A-02-17-01027; W-00-17-31525;	2020	CMS recently updated its health care facilities' life safety and emergency preparedness requirements to improve protections for all Medicare and Medicaid beneficiaries, including those residing in LTC facilities. These updates include requirements that facilities install expanded sprinkler and smoke detector systems to protect residents from the hazards of fire and develop an emergency preparedness plan that facilities must review, test, update, and train residents on annually. The plan must include provisions for sheltering in place and evacuation. OIG is reviewing this area because residents of LTC facilities are particularly vulnerable to the risk of fires, since many of these residents have limited or no mobility. Our objective is to determine if LTC facilities that received Medicare or Medicaid funds complied with new Federal requirements for life safety and emergency preparedness for the period May 4, 2016, through November 15, 2017.
Completed (partial)	Centers for Medicare & Medicaid Services	Part D Sponsors Reporting of Direct and Indirect Remunerations	Office of Audit Services	A-03-18-00006; A-03-18-00007; W-00-18-35514; A-03-18-xxxxx	2021	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.
August 2017	Centers for Medicare & Medicaid Services	Ventilation Devices: Reasonableness of Medicare Payments Compared to Amounts Paid in the Open Market	Office of Audit Services	W-00-17-35803; A-05-xx-xxxxx	2020	Medicare reimbursement for ventilation devices has risen from $51 million in 2011 to $72 million in 2015. However, unlike similar items for which Medicare has seen reduced costs through competitive bidding, ventilation devices have not been competitively bid. We will determine the reasonableness of the fee schedule prices that Medicare and beneficiaries pay for ventilation devices compared to prices on the open market to identify potential wasteful spending in the Medicare program.
Completed (partial)	Centers for Medicare & Medicaid Services	Consumer-Directed Personal Assistance Program	Office of Audit Services	A-02-16-01026; W-00-16-31035;	2021	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.
Completed (partial)	Centers for Medicare & Medicaid Services	Assertive Community Treatment Program	Office of Audit Services	A-02-17-01008; A-02-17-01020; A-02-17-01009; W-00-17-31521	2021	The Assertive Community Treatment (ACT) program offers treatment, rehabilitation, and support services using a person-centered, recovery-based approach to individuals who have been diagnosed with severe and persistent mental illness. Individuals receive ACT services including assertive outreach, mental health treatment, health, vocational, integrated dual disorder treatment, family education, wellness skills, community linkages, and peer support from a mobile, multidisciplinary team in community settings. Prior OIG work has shown vulnerabilities in States mental health programs and their rate-setting methodologies, resulting in Medicaid payments that do not comply with Federal and State requirements. We will determine whether (1) Medicaid payments for ACT services complied with Federal and State requirements and (2) the payment rate for ACT services met the Federal requirement that payment for services be consistent with efficiency, economy, and quality of care.
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; W-00-17-31522; A-05-17-00000	2021	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.
July 2017	Centers for Medicare & Medicaid Services	Nationwide Medicare Electronic Health Record Incentive Payments to Hospitals	Office of Audit Services	W-00-17-35795; A-09-17-03020	2020	Medicare incentive payments were authorized over a 5-year period to hospitals that adopted electronic health record (EHR) technology (Recovery Act, 4102). From January 1, 2011, through December 31, 2016, the Centers for Medicare & Medicaid Services (CMS) made Medicare EHR incentive payments to hospitals totaling $14.6 billion. The Government Accountability Office identified improper incentive payments as the primary risk to the Medicare EHR incentive program. A Department of Health and Human Services, Office of Inspector General (OIG), report describes the obstacles that CMS faces in overseeing the Medicare EHR incentive program. In addition, previous OIG reviews of Medicaid EHR incentive payments found that State agencies overpaid hospitals by $66.7 million and would in the future overpay these hospitals an additional $13.2 million. These overpayments resulted from inaccuracies in the hospitals calculations of total incentive payments. We will review the hospitals incentive payment calculations to identify potential overpayments that the hospitals would have received as a result of the inaccuracies.
Completed	Centers for Medicare & Medicaid Services	Review of Medicare Payments for Nonphysician Outpatient Services Provided Under the Inpatient Prospective Payment System	Office of Audit Services	A-01-17-00508; W-00-17-35799;	2020	Under the Medicare Part A inpatient prospective payment system (IPPS), hospitals are paid a predetermined amount per discharge for inpatient hospital services furnished to Medicare beneficiaries, as long as the beneficiary has at least one benefit day at the time of admission. The prospective payment amount represents the total Medicare payment for the inpatient operating costs associated with a beneficiary's hospital stay. Inpatient operating costs include routine services, ancillary services (e.g., radiology and laboratory services), special care unit costs, malpractice insurance costs, and preadmission services. Accordingly, hospitals generally receive no additional payments for nonphysician outpatient services furnished shortly before and during inpatient stays. Medicare makes a duplicate payment if it makes a separate Part B payment to providers for such nonphysician outpatient services. Prior Office of Inspector General reviews identified significant overpayments to hospital outpatient providers for nonphysician services furnished shortly before or during inpatient stays. Our recent work indicated that providers are still billing inappropriately and contractors continue to make inappropriate payments for these nonphysician outpatient services. Additionally, Medicare payment system controls are not preventing or detecting overpayments for incorrectly billed services. Our objective is to determine whether nationwide Medicare payments to hospital outpatient providers were correct for nonphysician outpatient services provided within 3 days prior to the date of admission, on the date of admission, or during IPPS stays (excluding date of discharge).
Completed (partial)	Centers for Medicare & Medicaid Services	Medicaid Claims for Opioid Treatment Program Services	Office of Audit Services	A-02-17-01021; W-00-17-31523	2021	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.
Completed (partial)	Centers for Medicare & Medicaid Services	Medicaid Targeted Case Management	Office of Audit Services	A-07-16-03215; A-07-17-03219; W-00-17-31082; A-07-17-03219	2022	The Social Security Act, § 1915(g)(2), defines case management services as those assisting individuals eligible under the State plan in gaining access to needed medical, social, educational, and other services. Case management services do not include the direct delivery of an underlying medical, educational, social, or other service for which an eligible individual has been referred. Payments for case management services may not duplicate payments made to public agencies under other program authorities for the same service. Prior OIG work in one State identified 18 percent of such claims as unallowable, with an additional 20 percent as potentially unallowable. We will determine whether Medicaid payments for targeted case management services in selected States were made in accord with Federal requirements.
November 2016	Centers for Medicare & Medicaid Services	Treatment of Authorized Generic Drugs	Office of Audit Services	W-00-17-31499	2019	An authorized generic drug is one that the manufacturer holding the title to the original new drug application permits another manufacturer to sell under a different national drug code.'' Provisions in 42 CFR § 447.506(b) provide that the manufacturer holding title to the original new drug application of the authorized generic drug must include the sales of this drug in its average manufacturer price (AMP) only when such drugs are being sold by the manufacturer directly to a wholesaler. Manufacturers that also include the sales of an authorized generic to a secondary manufacturer could lower the AMP and, consequently, a lower rebate would be paid to the State. We will review drug manufacturers' treatment of sales of authorized generics in their calculation of AMP for the Medicaid drug rebate program. We will determine whether manufacturers included sales of authorized generics to secondary manufacturers in their AMP calculations.
Completed (partial)	Centers for Medicare & Medicaid Services	Oversight and Effectiveness of Medicaid Waivers	Office of Audit Services	A-03-17-00200; A-02-17-01005; A-04-17-04058; W-00-17-31513	2021	More States are using waivers to alter their Medicaid program in significant ways. Oversight of State waiver programs present challenges to ensure that payments made under the waivers are consistent with regards to efficiency, economy, and quality of care and do not inflate Federal costs. We will determine the extent to which selected States made use of Medicaid waivers and if costs associated with the waivers are efficient, economic, and do not inflate Federal costs. We will also look at Centers for Medicare & Medicaid Services's oversight of State Medicaid waivers.
Completed (partial)	Centers for Medicare & Medicaid Services	Transportation Services - Compliance with Federal and State Requirements	Office of Audit Services	A-05-16-00021; A-07-16-03209; W-00-16-31121 various reviews	2021	Federal regulationsrequire States to ensure necessary transportation for Medicaid beneficiaries to and from providers (42 CFR § 431.53). Each State may have different Medicaid coverage criteria, reimbursement rates, rules governing covered services, and beneficiary eligibility for services. We will determine the appropriateness of Medicaid payments by States to providers for transportation services.
November 2016	Centers for Medicare & Medicaid Services	State Compliance with Federal Certified Public Expenditures Regulations	Office of Audit Services	W-00-17-31110; various reviews	2019	Public entities (e.g., public hospitals) may certify that they spent funds on Medicaid items or services that are eligible for Federal matching funds. These funds are referred to as certified public expenditures (CPEs) and may be claimed as the State's share of Medicaid expenditures as long as the CPEs comply with Federal regulations and are being used for the required purposes (42 CFR § 433.51 and 45 CFR § 95.13.) We will determine whether States comply with Federal regulations for claiming CPEs, which are normally generated by local governments as part of their contribution to the coverage of Medicaid services.
Completed (partial)	Centers for Medicare & Medicaid Services	State Cost Allocations That Deviate from Acceptable Practices	Office of Audit Services	A-02-17-01006; A-07-18-04107; W-00-17-31467; various reviews	2021	Previous OIG reviews of school- and community-based administrative claims found significant unallowable payments that were based on random moment sampling systems. Such systems must be documented to support the propriety of the costs assigned to Federal awards (OMB Circular A87, Cost Principles for State, Local, and Indian Tribal Governments, Attachment A, § C.1.j). A State must claim Federal financial participation for costs associated with a program only in accordance with its approved cost allocation plan. (45 CFR § 95.517(a).) We will review public assistance cost allocation plans and processes for selected States to determine whether the States claimed Medicaid costs that were supported and allocated on the basis of random moment sampling systems that deviated from acceptable statistical sampling practices.
Completed (partial)	Centers for Medicare & Medicaid Services	Enhanced Federal Medical Assistance Percentage	Office of Audit Services	A-06-17-09003; W-00-17-31480; various reviews	2021	The ACA, § 2001, authorized the use of an FMAP of 100 percent for individuals who are newly eligible because of Medicaid expansion. In addition, the ACA, § 1202, required that Medicaid payments to primary care providers be at least those of the Medicare rates in effect for CYs 2013 and 2014. States can claim 100 percent FMAP for the difference between the Medicare rate and the States' Medicaid rate. We will review States' Medicaid claims to determine whether the States correctly applied enhanced FMAP payment provisions of the ACA.
Completed (partial)	Centers for Medicare & Medicaid Services	Duplicate Payments for Beneficiaries with Multiple Medicaid Identification Numbers	Office of Audit Services	A-04-16-07061; W-00-16-31374; various reviews	2021	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.
Completed (partial)	Centers for Medicare & Medicaid Services	Medical Loss Ratio - Recoveries of MCO Remittances from Profit-Limiting Arrangements	Office of Audit Services	A-06-18-09001; W-00-18-31508	2022	When a State recovers a prior expenditure, it must refund the Federal share by reporting the recovery to Centers for Medicare & Medicaid Services at the FMAP used to calculate the amount it had originally received (SSA § 1903(d)(2); Centers for Medicare & Medicaid Services State Medicaid Manual, § 2500.6(B)). In its final rule (81 Fed. Reg. 27498 (May 6, 2016)), Centers for Medicare & Medicaid Services encouraged States to adopt provisions in contracts with managed care plans that would require remittances from the MCOs if a minimum medical loss ratio is not met. A medical loss ratio is a tool that can help ensure that the majority of capitated payments are used to deliver services to beneficiaries. Prior OIG reviews found that some States have adopted such remittance provisions. We will review States and managed care plans with contract provisions that require remittances from managed care plans if a minimum percentage of total costs to be expended for medical services (medical loss ratio) is not met. We will determine whether the Federal share of recoveries of MCO payments that States received through profit-limiting methodologies is returned to the Federal Government. Centers for Medicare & Medicaid Services reimburses each State at the FMAP for the quarter in which the expenditure was made (SSA § 1903(a)(1)).
November 2016	Centers for Medicare & Medicaid Services	Managed Long-Term-Care Reimbursements	Office of Audit Services	W-00-17-31510	2022	Medicaid managed care plans are subject to Federal requirements (42 CFR Part 438). Some States contract with MCOs to provide long-term services. We will review States' reimbursements made to managed long-term-care plans to determine whether those reimbursements complied with certain Federal and State requirements.
November 2016	Centers for Medicare & Medicaid Services	Medicaid Managed Care Reimbursement	Office of Audit Services	W-00-17-31471; various reviews	2022	States contract with MCOs to provide coverage for specific services to enrolled Medicaid beneficiaries. In return for covering those services, MCOs are paid a set monthly capitation payment. Previous work by GAO found that Centers for Medicare & Medicaid Services's oversight of States' rate-setting required improvement and that States may not audit or independently verify the MCO-reported data used to set rates (GAO-10-810). We will review States' managed care plan reimbursements to determine whether MCOs are appropriately and correctly reimbursed for services provided. We will ensure that the data used to set rates are reliable and include only costs for services covered under the State plan or costs of services authorized by Centers for Medicare & Medicaid Services (42 CFR § 438.6(e)). We will also verify that payments made under a risk-sharing mechanism and incentive payments made to MCOs are within the limits set forth in Federal regulations (42 CFR § 438.6(c)(5)(ii) and 42 CFR § 438.6(c)(5)(iii) and (iv)).mary
November 2016	Centers for Medicare & Medicaid Services	Third-Party Liability Payment Collections in Medicaid	Office of Audit Services	W-00-17-31517; A-05-17-00000	2021	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.
November 2016	Centers for Medicare & Medicaid Services	Accountable Care in Medicaid	Office of Audit Services	W-00-17-31518; various reviews	2020	The Medicaid program is experiencing a shift toward new models that promote accountability for the cost and quality of care delivered to patients and focus on better, more efficient coordination of care. Several delivery system reform initiatives in Medicaid, including, for example, medical homes and accountable care organizations, focus on accountable care and include elements such as implementing value-based payment structures, measuring quality improvement, and collecting and analyzing data. We will review selected accountable care models in Medicaid for compliance with relevant State and Federal requirements.
Completed (partial)	Centers for Medicare & Medicaid Services	Delivery System Reform Incentive Payments	Office of Audit Services	A-02-17-01007; A-06-17-09002; W-00-17-31516; various reviews	2021	Delivery System Reform Incentive Payments are incentive payments made under Section 1115 waivers to hospitals and other providers that develop programs or strategies to enhance access to health care, increase the quality and cost-effectiveness of care, and increase the health of patients and families served. States must be able to demonstrate outcomes and ensure accountability for allocated funding. These incentive payments have significantly increased funding to providers for their efforts related to the quality of services. For example, one State made incentive payments totaling more than $6 billion in a 5-year period. We will ensure that select States adhered to applicable Federal and State requirements when they made incentive payments to providers.
November 2016	Centers for Medicare & Medicaid Services	Inpatient Psychiatric Facility Outlier Payments	Office of Audit Services	W-00-16-35778	2020	Inpatient Psychiatric Facilities, either freestanding hospitals or specialized hospital-based units, provide active psychiatric treatment to meet the urgent needs of those experiencing an acute mental health crisis, which may involve mental illnesses or alcohol- or drug-related problems. From FY 2014 to FY 2015, the number of claims with outlier payments increased by 28 percent, and total Medicare payments for stays that resulted in outlier payments increased from $450.2 million to $534.6 million (19 percent). We will determine whether Inpatient Psychiatric Facilities nationwide complied with Medicare documentation, coverage, and coding requirements for stays that resulted in outlier payments.
Completed (partial)	Centers for Medicare & Medicaid Services	Medicaid Eligibility Determinations in Selected States	Office of Audit Services	A-09-16-02023; A-04-16-08047; A-02-16-01005; A-07-16-04228; W-00-16-31140; various reviews	2021	The ACA, § 2001, required significant changes affecting State processes for Medicaid enrollment, modified criteria for Medicaid eligibility, and authorized the use of an enhanced FMAP of 100 percent for newly eligible individuals. We will determine the extent to which selected States made inaccurate Medicaid eligibility determinations. We will examine eligibility inaccuracy for Medicaid beneficiaries in selected States that expanded their Medicaid programs pursuant to the Patient Protection and Affordable Care Act and in States that did not. We will also assess whether and how the selected States addressed issues that contributed to inaccurate determinations. For some States, we will calculate a Medicaid eligibility error rate and determine the amount of payments associated with beneficiaries who received incorrect eligibility determinations.
Completed (partial)	Centers for Medicare & Medicaid Services	Outpatient Outlier Payments for Short-Stay Claims	Office of Audit Services	A-06-16-01002; W-00-16-35775	2021	CMS makes an additional payment (an outlier payment) for hospital outpatient services when a hospital's charges, adjusted to cost, exceed a fixed multiple of the normal Medicare payment (Social Security Act (SSA) § 1833(t)(5)). The purpose of the outlier payment is to ensure beneficiary access to services by having Medicare share in the financial loss incurred by a provider associated with extraordinarily expensive individual cases. Prior OIG reports have concluded that hospitals' high charges, unrelated to cost, lead to excessive inpatient outlier payments. We will determine the extent of potential Medicare savings if hospital outpatient short stays (same day or over one midnight) were ineligible for an outlier payments. Prior to a nationwide review, we plan to perform several reviews at one or more hospitals to determine whether outpatient outlier payments to hospitals are associated with extraordinarily expensive individual cases.
Completed	Centers for Medicare & Medicaid Services	Orthotic Braces - Reasonableness of Medicare Payments Compared to Amounts Paid by Other Payers	Office of Audit Services	A-05-17-00033; W-00-17-35756; various reviews	2020	Since 2009, Medicare payments for orthotic braces, including back and knee, have more than doubled and almost tripled for certain types of knee braces. We will determine the reasonableness of Medicare fee schedule amounts for orthotic braces. We will compare Medicare payments made for orthotic braces to amounts paid by non-Medicare payers, such as private insurance companies, to identify potentially wasteful spending. We will estimate the financial impact on Medicare and on beneficiaries of aligning the fee schedule for orthotic braces with those of non-Medicare payers.
Completed (partial)	Centers for Medicare & Medicaid Services	Orthotic Braces - Supplier Compliance with Payment Requirements	Office of Audit Services	A-09-17-03030; A-09-17-03027; W-00-17-35749	2021	Medicare requires that suppliers claims for DMEPOS be "reasonable and necessary" (SSA § 1862(a)(1)(A)). Further, local coverage determinations issued by the four Medicare contractors that process DMEPOS claims include utilization guidelines and documentation requirements for orthotic braces. Prior OIG work indicated that some DMEPOS suppliers were billing for services that were medically unnecessary (e.g., beneficiaries receiving multiple braces and referring physician did not see the beneficiary) or were not documented in accordance with Medicare requirements. We will review Medicare Part B payments for orthotic braces to determine whether they were medically necessary and were supported in accordance with Medicare requirements.
Completed (partial)	Centers for Medicare & Medicaid Services	Payments for Medicare Services, Supplies, and DMEPOS Referred or Ordered by Physicians Compliance	Office of Audit Services	A-09-17-03002; W-00-17-35748	2021	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.
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; various reviews	2021	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.
Completed (partial)	Centers for Medicare & Medicaid Services	Sleep Disorder Clinics - High Use of Sleep-Testing Procedures	Office of Audit Services	A-04-17-07069; W-00-17-35521; various reviews	2021	An OIG analysis of CY 2010 Medicare payments for Current Procedural Terminology[1] codes 95810 and 95811, which totaled approximately $415 million, showed high utilization associated with these sleep-testing procedures. To the extent that repeated diagnostic testing is performed on the same beneficiary and the prior test results are still pertinent, repeated tests may not be reasonable and necessary. Medicare will not pay for items or services that are not "reasonable and necessary" (SSA § 1862(a)(1)(A)). We will examine Medicare payments to physicians, hospital outpatient departments, and independent diagnostic testing facilities for sleep-testing procedures to assess payment appropriateness and whether they were in accordance with other Medicare requirements. Requirements for coverage of sleep tests under Part B are located in Centers for Medicare & Medicaid Services's Medicare Benefit Policy Manual, Pub. No. 100-02, Ch. 15, §70.
November 2016	Centers for Medicare & Medicaid Services	Hospice Home Care - Frequency of Nurse On-Site Visits to Assess Quality of Care and Services	Office of Audit Services	W-00-16-35777	2020	In 2013, more than 1.3 million Medicare beneficiaries received hospice services from more than 3,900 hospice providers, and Medicare hospice expenditures totaled $15.1 billion. Hospices are required to comply with all Federal, State, and local laws and regulations related to the health and safety of patients (42 CFR § 418.116). Medicare requires that a registered nurse make an on-site visit to the patient's home at least once every 14 days to assess the quality of care and services provided by the hospice aide and to ensure that services ordered by the hospice interdisciplinary group meet the patient's needs (42 CFR § 418.76(h)(1)(i)). We will determine whether registered nurses made required on-site visits to the homes of Medicare beneficiaries who were in hospice care.
November 2016	Centers for Medicare & Medicaid Services	Review of Hospices' Compliance with Medicare Requirements	Office of Audit Services	W-00-16-35783; various reviews	2021	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.
November 2016	Centers for Medicare & Medicaid Services	Skilled Nursing Facility Reimbursement	Office of Audit Services	W-00-16-35784	2020	Some SNF patients require total assistance with their activities of daily living and have complex nursing and physical, speech, and occupational therapy needs. SNFs are required to periodically assess their patients using a tool called the Minimum Data Set that helps classify each patient into a resource utilization group for payment. Medicare payment for SNF services varies based on the activities of daily living score and the therapy minutes received by the beneficiary and reported on the Minimum Data Set. The more care and therapy the patient requires, the higher the Medicare payment. Previous OIG work found that SNFs are billing for higher levels of therapy than were provided or were reasonable or necessary. We will review the documentation at selected SNFs to determine if it meets the requirements for each particular resource utilization group.
Completed (partial)	Centers for Medicare & Medicaid Services	Medicare Payments for Chronic Care Management	Office of Audit Services	A-07-17-05101; W-00-17-35785	2021	Chronic Care Management (CCM) is defined as the non-face-to-face services provided to Medicare beneficiaries who have multiple (two or more), significant chronic conditions (Alzheimer's disease, arthritis, cancer, diabetes, etc.) that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline. These significant chronic conditions are expected to last at least 12 months or until the death of the patient. CCM cannot be billed during the same service period as transitional care management, home health care supervision/hospice care, or certain end-stage renal disease services. Beginning January 1, 2015, Medicare paid separately for CCM under the Medicare Physician Fee Schedule and under the American Medical Association Current Procedural Terminology. We will determine whether payments for CCM services were in accordance with Medicare requirements.
November 2016	Centers for Medicare & Medicaid Services	Medicare Payments for Transitional Care Management	Office of Audit Services	W-00-17-35786	2021	Transitional Care Management (TCM) includes services provided to a patient whose medical and/or psychosocial problems require moderate or high-complexity medical decision-making during transitions in care from an inpatient hospital setting (including acute hospital, rehabilitation hospital, long-term acute care hospital), partial hospital, observation status in a hospital, or skilled nursing facility/nursing facility, to the patient's community setting (home, domicile, rest home, or assisted living). Beginning January 1, 2013, Medicare covered TCM services and paid for them under the Medicare Physician Fee Schedule. Medicare-covered services, including chronic care management, end-stage renal disease, and prolonged services without direct patient contact, cannot be billed during the same service period as TCM. We will determine whether payments for TCM services were in accordance with Medicare requirements.
November 2016	Indian Health Services	Purchase Referred Care Program	Office of Audit Services	W-00-16-51004	2020	Indian Health Services provides Federal health services to 2.2 million American Indians and Alaska Natives in 567 Federally recognized tribes. Indian Health Services can provide health care directly or may fund tribes to independently deliver health care. When an Indian Health Services or tribal facility is not available, or does not provide the required care, patients are referred to the purchased/referred care (PRC) program, which coordinates needed services through private health care providers. PRC program funds grew 17.2 percent from $779.9 million in FY 2011 to $914.1 million in FY 2016. We are initiating this audit because of the significant magnitude and growth of PRC program funds and previous reports by GAO that highlighted problems with the program. This audit will focus on Indian Health Services-administered PRC program services, which totaled $333.7 million in FY 2016. We will determine whether Indian Health Services PRC program services were provided in compliance with the purpose, time, and amount requirements specified in appropriation statutes and Indian Health Services requirements.