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Active Work Plan Items

Work Plan Home | Recently Added | Work Plan Archive
Active Work Plan Items reflect OIG audits, evaluations, and inspections that are underway or planned. Search the Work Plan using any words or numbers or download the Active Work Plan Items into a spreadsheet. Download the Work Plan
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
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 Administration for Children and Families Audit of Child Care Development Fund Childcare Services During Coronavirus Disease 2019 Pandemic Office of Audit Services 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.
Completed OS COVID-19 Hospital Response Office of Evaluation and Inspections OEI-06-20-00300 2020 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. This study will provide insights from hospital administrators about hospital needs and concerns in diagnosing and treating patients with the COVID-19. We will interview administrators from a sample of approximately 400 hospitals nationwide regarding their hospitals' needs to diagnose and treat patients with COVID-19, as well as other emergency preparedness and response issues, including ensuring the availability of personal protective equipment for hospital staff. The sample of hospitals includes a range of hospital types, sizes, and locations, including rural and critical access hospitals. The results of this study will provide HHS operating and staff divisions with timely feedback on how they can support hospitals in responding to COVID-19.
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
2020 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 OS Highlights of OIG's Emergency Preparedness Work: Insights for COVID-19 Response Office of Evaluation and Inspections OEI-12-20-00370 2020 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 the Department to efficiently and effectively respond to protect the nation against the spread of the virus. OIG has produced numerous evaluations and audits examining HHS's emergency preparedness and response efforts. This review will highlight relevant issues from OIG's body of work on emergency preparedness and response to inform HHS's ongoing COVID-19 response efforts. This work product will synthesize key findings and recommendations from this body of work to inform and assist HHS in its ongoing response efforts.
March 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
FY 2020
FY 2020
FY 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.
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 2020 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 2020 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.
March 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 2020 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.
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 2020 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.
March 2020 Administration for Community Living 2019 Performance Data for the Senior Medicare Patrol Projects Office of Evaluation and Inspections OEI-02-20-00150 2020 In 1997, Senior Medicare Patrol (SMP) projects were established to recruit and train retired professionals and other senior citizens to prevent, recognize, and report health care fraud, errors, and abuse. The initiative stemmed from recommendations in a congressional committee report accompanying the Omnibus Consolidated Appropriations Act of 1997. OIG reports these performance data annually. We will review performance data and documentation relating to Medicare and Medicaid recoveries, savings, and cost avoidance for SMP projects. ACL requested this information, which will support its efforts to evaluate and improve the performance of its projects.
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 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 FDA 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.
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 Food and Drug Administration FDA's Tobacco Retailer Compliance Check Inspection Program Office of Evaluation and Inspections OEI-01-20-00240 2021 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.
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 Ensuring Dual-Eligible Beneficiaries' Access to Drugs Under Part D: Mandatory Review Office of Evaluation and Inspections OEI-05-20-00190 2020 Dual-eligible beneficiaries are enrolled in Medicaid but qualify for prescription drug coverage under Medicare Part D. As long as Part D plans meet certain limitations outlined in 42 CFR § 423.120, they have discretion to include different Part D drugs and drug utilization tools in their formularies. We will review the extent to which drug formularies developed by Part D sponsors include drugs commonly used by dual-eligible beneficiaries as required. The Affordable Care Act, § 3313, requires OIG to conduct this review annually.
February 2020 Centers for Medicare & Medicaid Services The Impact of Health Risk Assessments on Risk-Adjusted Payments in Medicare Advantage Office of Evaluation and Inspections OEI-03-17-00471 2020 Under Medicare Part C, the CMS makes advanced monthly payments to Medicare Advantage (MA) organizations for each beneficiary enrolled. CMS risk-adjusts these payments based on beneficiaries' demographic information and clinical diagnoses from the prior year to pay MA organizations more for beneficiaries with higher expected costs. MA organizations submit to CMS encounter data, which are records of services provided to beneficiaries, including all diagnoses. Currently, CMS includes diagnoses from health risk assessments, which are visits to evaluate a beneficiary's health risks, when calculating risk scores and risk-adjusted payments. This is allowed regardless of whether these diagnoses are supported by another service rendered to the beneficiary during that year. This study will determine the extent to which diagnoses solely generated by health risk assessments were associated with higher risk scores and higher MA payments.
February 2020 Centers for Medicare & Medicaid Services Medicare Capital Payments to New Hospitals Office of Audit Services W-00-20-35843 2020 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 2020 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 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 FDA 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.
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 2020 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 2020 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.
February 2020 OS, ACF, ACL, AHRQ, CDC, FDA, HRSA, NIH, SAMHSA Audit of HHS Information Technology Recovery Readiness Office of Audit Services W-00-20-42025 2020 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
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.
January 2020 Centers for Medicare & Medicaid Services Medicaid-Audit of Medicaid Eligibility Determinations for States in Cycle 1 of CMS's PERM Review Office of Audit Services W-00-20-31540 2020 The Improper Payments Information Act of 2002 requires the heads of Federal agencies to annually review programs they administer 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. In 2017, CMS published a new final rule implementing changes to PERM and Medicaid Eligibility Quality Control (MEQC) programs. These changes aimed to reduce State burden, improve program integrity, and promote State accountability through policy and operational improvements to the PERM and MEQC programs. PERM produces an improper payment rate based on reviews of the fee-for-service, managed care, and eligibility components of Medicaid. We will assess the adequacy of the PERM program by determining whether the Federal contractor conducted eligibility reviews in accordance with Federal PERM requirements.
January 2020 National Institutes of Health Audit of National Institutes of Health's Compliance With Information Technology Controls Within the Electronic Health Records System Office of Audit Services A-18-19-06003; W-00-19-42020 2020 The National Institutes of Health (NIH) comprises 27 separate Institutes and Centers and is the primary Federal agency for conducting and supporting biomedical research to enhance health, lengthen life, and reduce illness and disability. Within NIH, certain Institutes and Centers provide direct patient care. NIH uses an electronic health records (EHR) system to help facilitate effective care. 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 operations of NIH. We will determine whether select EHR system controls are in place in accordance with Federal requirements and assess EHR interoperability challenges.
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
2020 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 2020 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 Centers for Medicare & Medicaid Services National Background Check Program for Long-Term-Care Providers: Assessment of State Programs Concluded in 2019 Office of Evaluation and Inspections OEI-07-20-00180 2020 The Patient Protection and Affordable Care Act (ACA) authorizes CMS to provide grants to States to implement background check programs for prospective employees and providers of long-term-care services. The ACA requires OIG to evaluate this grant program, known as the National Background Check Program, after its completion (ACA § 6201). For States that concluded their grant in 2019, we will review the implementation of select Program requirements for conducting background checks on prospective employees of long-term-care facilities and providers who would have direct access to patients. We will determine the outcomes of the States' programs and whether the checks led to any unintended consequences.
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 2020 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 Centers for Medicare & Medicaid Services Additional Programming Code for Toolkit: Using Data Analysis To Calculate Opioid Levels and Identify Patients at Risk of Misuse or Overdose Office of Evaluation and Inspections OEI-02-17-00561 2020 In June 2018, the Office of Evaluation and Inspections (OEI) released a new product entitled Toolkit: Using Data Analysis To Calculate Opioid Levels and Identify Patients at Risk of Misuse or Overdose (OEI-02-17-00560). The toolkit, which is based on the methodology we developed for our recent opioid data briefs, provides detailed steps for using prescription claims data to analyze patients' opioid levels and to identify certain patients who are at risk of opioid misuse or overdose. We released the toolkit with SAS programming code. We will extend the reach of the toolkit and issue the programming code in two commonly used coding languages, R and SQL, for our public and private partners to use to further combat the opioid crisis.
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 2020 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 Centers for Medicare & Medicaid Services Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the First Quarter of 2020 Office of Evaluation and Inspections OEI-03-20-00060 2020 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. This quarterly memo summarizes the results of OIGs comparison analysis based on ASP and AMP data reported for the first quarter of 2020. The memo specifically reports the number of drugs OIG identified that met the criteria for substitution of a lower reimbursement amount.
November 2019 Centers for Medicare & Medicaid Services Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Fourth Quarter of 2019 Office of Evaluation and Inspections OEI-03-20-00050 2020 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 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. This quarterly memo summarizes the results of OIGs comparison analysis based on ASP and AMP data reported for the fourth quarter of 2019. The memo specifically reports the number of drugs OIG identified that met the criteria for substitution of a lower reimbursement amount.
Completed Centers for Medicare & Medicaid Services Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Third Quarter of 2019 Office of Evaluation and Inspections OEI-03-20-00040 2020 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 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. This quarterly memo summarizes the results of OIGs comparison analysis based on ASP and AMP data reported for the third quarter of 2019. The memo specifically reports the number of drugs OIG identified that met the criteria for substitution of a lower reimbursement amount.
November 2019 Centers for Medicare & Medicaid Services Medicare Payments for Stelara Office of Evaluation and Inspections OEI-BL-19-00500 2020 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.
November 2019 Centers for Medicare & Medicaid Services Medicare Part B Drug Payments: Impact of Price Substitutions Based on 2018 Average Sales Prices Office of Evaluation and Inspections OEI-03-20-00130 2020 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 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. Over the past decade, OIG has produced annual reports aggregating the results of our mandated quarterly ASP to AMP comparisons. This annual report will quantify the savings to Medicare and its beneficiaries that are a direct result of CMS's price substitution policy based on 2018 ASPs and may offer recommendations for Medicare to achieve additional savings.
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 Recommendation Followup Memo: Excluding Noncovered Versions When Setting Payment for Part B Drugs Office of Evaluation and Inspections OEI-BL-20-00100 2020 In a November 2017 report, OIG found that CMS and a Federal court interpret relevant statute to require the inclusion, in limited circumstances, of versions of drugs not generally covered under Part B when setting Medicare payment amounts. This interpretation resulted in Medicare and its beneficiaries paying an extra $366 million from 2014 through 2016 for two high-cost drugs. OIG recommended that CMS seek a legislative change that would provide the agency flexibility to determine when non-covered versions of a drug should be included in Part B payment amount calculations. CMS did not concur with our recommendation, citing concerns related to beneficiary access and operational implications. This study will examine the financial costs to Medicare and its beneficiaries of continuing to include noncovered versions when setting Part B amounts in 2017 and 2018. It will also provide data to address CMS's concerns about potential beneficiary access issues related to our earlier recommendation.
November 2019 Centers for Medicare & Medicaid Services Medicare Advantage Organizations' Collection of Ordering Provider Identifiers Office of Evaluation and Inspections OEI-03-19-00430 2021 The availability of ordering provider identifiers in the Medicare Advantage (MA) encounter data is essential for using these data to identify and prevent potential fraud, waste, and abuse. However, CMS does not require MA organizations (MAOs) to submit National Provider Identifiers (NPIs) for ordering providers. In past work, OIG found that nearly two-thirds of records for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS), clinical laboratory, imaging, and home health services reviewed did not include the NPI for the ordering provider. OIG recommended that CMS require MAOs to submit ordering provider identifiers. This study will determine the extent to which MAOs obtain the NPIs of providers who order DMEPOS, clinical laboratory services, imaging services, and home health services for MA enrollees and will determine how MAOs that do not obtain these identifiers are conducting routine monitoring, auditing, and oversight of these types of services. In addition, this study will provide updated information on how many MAOs voluntarily submit NPIs of providers who order DMEPOS, clinical laboratory services, imaging services, and home health services to CMS.
November 2019 Centers for Medicare & Medicaid Services Fiscal Year 2020 OIG Oversight of Medicaid Fraud Control Units Office of Evaluation and Inspections OEI-06-19-00110, OEI-06-19-00510, OEI-12-19-00450, OEI-12-19-00170, OEI-12-19-00530 2020 The 53 MFCUs, located in the 50 States, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands, 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.
November 2019 Centers for Medicare & Medicaid Services Medicaid Fraud Control Units Fiscal Year 2020 Annual Report Office of Evaluation and Inspections OEI-09-20-00110 2020 OIG provides guidance to the Medicaid Fraud Control Units (MFCUs), assesses MFCUs' compliance with Federal regulations and policy, and evaluates MFCUs' adherence to published performance standards. This annual report will analyze the statistical information that was reported by the MFCUs, describing in the aggregate the outcomes of MFCU criminal and civil cases. This report will also identify trends in MFCU case results.
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 2020 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 2020 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 2020 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 2020 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 2020 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 2020 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.
October 2019 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 2020 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.
September 2019 Administration for Children and Families ORR-Funded Facilities' Efforts to Ensure Health and Safety of Unaccompanied Children Office of Evaluation and Inspections OEI-09-18-00430 2020 The Unaccompanied Alien Children (UAC) program, operated by the Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), provides temporary shelter, care, and other related services to unaccompanied children in its custody. These children are often cared for in facilities operated by grantees that receive funding from ORR. We will identify vulnerabilities in facilities' efforts to protect children in their care from harm and to provide needed physical and mental health services, including efforts to address trauma. OIG will also explore the challenges facilities face, including challenges presented by external factors such as HHS policies and management decisions. This review will focus on the care and well-being of all children residing in ORR-funded facilities, including the subset of children who were separated and deemed ineligible for reunification. For these children, OIG will also explore efforts made to contact and reunify with their parents and/or identify a suitable sponsor. OIG will gather information for this review by rapidly deploying multidisciplinary teams of evaluators, auditors, investigators, and lawyers to conduct comprehensive facility visits across the country. OIG will also conduct interviews with decision makers, including HHS senior leadership.
September 2019 Centers for Medicare & Medicaid Services Specialty Drug Coverage and Reimbursement in Medicaid Office of Evaluation and Inspections OEI-03-17-00430 2020 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 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 2020 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 2020 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.
August 2019 Centers for Medicare & Medicaid Services Review of the Medicare DRG Window Policy Office of Evaluation and Inspections OEI-05-19-00380 2020 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.
August 2019 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.
August 2019 Centers for Medicare & Medicaid Services Nursing Homes: CMS Oversight of State Survey Agencies Office of Evaluation and Inspections OEI-06-19-00460 2020 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.
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 Use of Telehealth to Provide Behavioral Health Services in Medicaid Managed Care Office of Evaluation and Inspections OEI-02-19-00400 2020 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.
August 2019 Centers for Medicare & Medicaid Services Medicaid Assisted Living Services Office of Audit Services W-00-19-31541 2020 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 2020 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 2020 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).
July 2019 Indian Health Service Quality of Maternal Healthcare in Indian Health Service Hospitals Office of Evaluation and Inspections OEI-06-19-00190 2020 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.
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 Centers for Medicare & Medicaid Services Review of Centers for Medicare & Medicaid Services' Strategic Communication Contracts Office of Audit Services W-00-19-36000 2020 The Federal Acquisition Regulation (FAR) guides the acquisition process by which executive agencies of the Federal Government acquire goods and services by contract with appropriated funds. HHS Acquisition Regulation establishes acquisition policies and procedures that implement and supplement the FAR. OIG is reviewing CMS's awarding of contracts for strategic communications work. We will determine compliance with applicable Federal statutes, regulations, and HHS policies and procedures.
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 2020 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 2020 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 Risk Assessment of Department of Health and Human Services Grant Closeout Process Office of Audit Services W-00-19-55000 2020 The Grants Oversight and New Efficiency (GONE) Act, P.L. 114-117, enacted on January 28, 2016, established mandatory reporting requirements for Federal Departments and Inspectors General Offices related to grant awards and cooperative agreements expired for 2 or more years that have not been closed out. GONE Act section 2(a)(1) requires that Departments provide a report listing each Federal grant award by time period of expiration, with zero dollar balances, and with undisbursed balances. GONE Act section 2(a)(1)(b) and (c) also require Departments to describe challenges leading to delays in grant closeout and, for the 30 oldest Federal grant awards, to explain why the grant has not been closed out. GONE Act section 2(c) requires Inspectors General of Departments with greater than $500 million in annual grant funding to conduct a risk assessment of their Departments' grants closeout process. This review will fulfill the HHS-OIG's responsibilities under Section 2(c) of the GONE Act. The objective of our review will be to conduct a risk assessment of the Department of Health and Human Services grant closeout process
June 2019 OS Review of Office of Intergovernmental and External Affairs Charge Card Programs Office of Audit Services W-00-19-59443 2020 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 Accuracy of Drug Manufacturers' Quarterly Pricing Data Office of Evaluation and Inspections OEI-03-19-00200 2020 CMS uses manufacturer-reported average sales price (ASP) and average manufacturer price (AMP) data to calculate Medicaid rebate amounts and Part B drug reimbursements. When these data are not accurate, CMS and States might not set appropriate reimbursement or rebate amounts for drugs. This can result in CMS, States, and Medicare beneficiaries paying more for these drugs. The Social Security Act provides a mechanism for monitoring market prices and limiting potentially excessive ASP-based payment amounts by requiring the OIG to compare ASPs with AMPs. As part of this comparison, each quarter OIG manually reviews publicly available documentation from manufacturers’ websites and other sources, as appropriate, to validate the drug product and pricing information for selected national drug codes (NDCs). OIG may correct data associated with certain NDCs or exclude certain drug codes from the quarterly comparison if it identifies potential errors or inconsistent data. This study will determine the number of NDCs reported to CMS by manufacturers that contained potential errors in ASP and/or AMP data as well as the number of drug codes excluded from quarterly comparisons because of potential errors in the manufacturers' data.
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 Characteristics of Part D Beneficiaries at Serious Risk of Opioid Misuse or Overdose Office of Evaluation and Inspections OEI-02-19-00130 2020 In 2017, there were an estimated 49,000 opioid-related overdose deaths in the United States. In a recent data brief, Opioid Use in Medicare Part D Remains Concerning, OIG found that about 71,000 Part D beneficiaries were at serious risk of misuse or overdose in 2017. Gaining a deeper understanding of the beneficiaries OIG identified as at serious risk of misuse or overdose is an important next step in addressing the crisis. This study will provide needed information about: (1) the characteristics of these beneficiaries, including their demographics and diagnoses; (2) the opioid utilization of these beneficiaries; and (3) the extent to which these beneficiaries have had adverse health effects related to opioids and any overdose incidents.
June 2019 Centers for Medicare & Medicaid Services Medicare Payments for Clinical Diagnostic Laboratory Tests in 2018: Year 1 of New Payment Rates Office of Evaluation and Inspections OEI-09-18-00100 2020 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, with no beneficiary copayment. In 2017, Medicare paid $7.1 billion for lab tests, a total that has changed very little in the 4-year period from 2014 through 2017. The Protecting Access to Medicare Act of 2014 (PAMA) requires CMS to set payment rates for lab tests using current charges in the private health-care market, under Title XVIII of the Social Security Act. (Pub. L. No. 113-93 § 216(c)(2)(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. In accordance with PAMA, we will publicly release an analysis of the top 25 laboratory tests by expenditures for 2018, the first year of payments made under the new system for setting payment rates.
June 2019 Centers for Medicare & Medicaid Services Utilization and Pricing Trends for Naloxone in Medicaid Office of Evaluation and Inspections OEI-BL-18-00360 2020 Opioid abuse and overdose deaths are at epidemic levels in the United States. In response, both the U.S. Surgeon General and CMS have stated that increasing access to naloxone, especially among members of the public who are at risk or who know someone at risk, is a top priority. Naloxone is a medication designed to rapidly reverse opioid overdose. However, many stakeholders have expressed concerns that the high cost of naloxone may impede increased access. Medicaid could play a significant role in addressing the issue of naloxone access because the program covers nearly 40 percent of nonelderly adults with opioid addiction. The proposed data brief would (1) trend utilization of and expenditures for naloxone in Medicaid over a 5-year period; (2) determine how the cost-per-dose for naloxone under Medicaid compares to other available prices; and (3) determine the proportion of all naloxone distributed in the U.S. that was paid under Medicaid between 2014 and 2018. This information can help stakeholders determine how to cost-effectively increase naloxone access to affected Medicaid-eligible beneficiaries.
June 2019 Substance Abuse and Mental Health Services Administration Data Brief: Early Results from the Opioid State Targeted Response Grants Office of Evaluation and Inspections OEI-BL-18-00460 2020 The 21st Century Cures Act authorized $1 billion in Opioid State Targeted Response (Opioid STR) grants, to be awarded and overseen by the Substance Abuse and Mental Health Services Administration (SAMHSA). As described by SAMHSA, the purpose of these grants is to "address the opioid crisis by increasing access to treatment, reducing unmet treatment need, and reducing opioid overdose related deaths through the provision of prevention, treatment and recovery activities for opioid use disorder." The majority of funds must be used for opioid treatment services using clinically appropriate evidence-based practices, particularly the use of medication assisted treatment. We will review early results of the Opioid STR grants. In particular, we will describe States' use of Opioid STR grant funds in the first year of the program, including the populations reached and the extent to which Opioid STR grant-funded treatment included medication assisted treatment.
June 2019 Centers for Medicare & Medicaid Services Involuntary Transfer and Discharge in Nursing Homes Office of Evaluation and Inspections OEI-01-18-00250 2020 The involuntary transfer or discharge of a resident of a nursing home can be unsafe and a 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 involuntary 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 recently highlighted the rise in nursing home evictions. CMS estimates that as many as one-third of all residents in long-term care facilities are involuntarily discharged. We will determine the extent to which State long-term care ombudsmen address involuntary transfers and discharges from nursing homes and the extent to which State survey agencies investigated and took enforcement actions against nursing homes for inappropriate involuntary transfers and discharges. We will also examine the extent to which nursing homes meet CMS requirements for involuntary transfers and discharges.
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 Blood Lead Screening Tests, Followup Services, and Treatment for Medicaid-Enrolled Children Office of Evaluation and Inspections OEI-07-18-00370 2020 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.
June 2019 Administration for Children and Families ACF Oversight of Guardian Ad Litem Requirements and Reporting Office of Evaluation and Inspections OEI-12-16-00120 2020 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.
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 Office of the Assistant Secretary for Preparedness and Response Examining Healthcare Coalitions' Partnerships With Non-Hospital-Based Facilities in Community Preparedness Efforts Office of Evaluation and Inspections OEI-04-18-00080 2020 Healthcare Coalitions (HCCs) are groups of public and private health care organizations, emergency preparedness planners, responders, and other types of health officials in specified jurisdictions. HCCs receive funding through the Office of the Assistant Secretary for Preparedness and Response (ASPR) Hospital Preparedness Program (HPP). HPP guidance states that HCCs should create jurisdictional emergency response plans that take into consideration the needs of vulnerable populations, including persons with mental illnesses. Many vulnerable populations depend on non-hospital-based facilities, such as community mental health centers, for monitoring and care during and after disasters. However, prior OIG work found that non-hospital-based health care facilities commonly lacked comprehensive emergency response plans. Prompted in part by this work, CMS implemented new emergency preparedness requirements that apply to all facilities receiving Medicare or Medicaid reimbursement. While HPP and CMS emergency preparedness requirements are components of different programs managed by different agencies, the implementation of each is affected by the other. The HPP directs HCCs to leverage the CMS-required emergency response plans of its partners, especially those that serve vulnerable populations. At the same time, some non-hospital-based facilities may depend on the expertise and resources of HCC partners to meet CMS emergency preparedness requirements. We will examine the extent to which HCCs ensure "a successful whole community response" by integrating non-hospital-based facilities into their emergency preparedness activities and technological strategies. We will also assess ASPR's oversight and support—including its coordination with CMS—of HCCs' integration of non-hospital-based facilities.
June 2019 Indian Health Service Incidence of Adverse Events in Indian Health Service Hospitals Office of Evaluation and Inspections OEI-06-17-00530 2020 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 Substance Abuse and Mental Health Services Administration Access to Buprenorphine-Waivered Providers for the Treatment of Opioid Use Disorder Office of Evaluation and Inspections OEI-12-17-00240 2020 SAMHSA estimates that 2.5 million people have an opioid use disorder related to prescription pain relievers and/or heroin. Medication-Assisted Treatment (MAT), including buprenorphine, 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 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 treatment through SAMHSA's buprenorphine waiver program, which permits providers to prescribe buprenorphine to patients in office settings, rather than traditional opioid treatment facilities. We will examine the number, location, and patient capacity of providers who have obtained buprenorphine waivers from SAMHSA. We will also determine the extent to which waivered providers are located in areas with the greatest need for MAT services, the number of patients they report treating with buprenorphine, and the factors that may either facilitate or hinder the provision of buprenorphine in an office setting.
June 2019 Food and Drug Administration FDA Oversight of Risk Evaluation and Mitigation Strategies To Address Prescription Opioid Abuse Office of Evaluation and Inspections OEI-01-17-00510 2020 Opioid abuse and overdose deaths are at epidemic levels in the United States. The Food and Drug Administration Amendments Act of 2007 provided the Food and Drug Administration (FDA) with the authority to require pharmaceutical companies to develop Risk Evaluation and Mitigation Strategies (REMS) when FDA determines that the risk of using a drug outweighs its benefit. Through the REMS program, FDA intends to "increase the number of prescribers who receive training on pain management and safe prescribing of opioid drugs in order to decrease inappropriate opioid prescribing."" We will describe how FDA determined the need for opioid REMS and determine the extent to which FDA has held pharmaceutical companies with required opioid REMS accountable for REMS assessments. We will also determine the extent to which FDA has held opioid REMS sponsors accountable for REMS goals to mitigate risks of misuse, abuse, addiction, overdose, and serious complications because of medication errors.
Completed Food and Drug Administration Drug Traceability Test Office of Evaluation and Inspections OEI-05-17-00460 2020 Potentially dangerous drugs, including diverted, counterfeit, and imported unapproved drugs, can enter the supply chain and pose a threat to public health and safety. The Drug Supply Chain Security Act (DSCSA) provides the Food and Drug Administration (FDA) and others with new tools to prevent the introduction of harmful drugs into the supply chain and to identify and remove them. DSCSA requires trading partners to exchange drug product tracing information when they take ownership of drugs, resulting in a tracing record that FDA and others can use to investigate suspect and illegitimate drugs. Ensuring that DSCSA’s drug product tracing requirements function as intended will help FDA to respond effectively to potentially harmful drugs in the supply chain. We will determine the extent to which selected drugs can be traced from the dispenser back to the manufacturer. This study—part of OIG’s body of work in this area—builds on our previous examinations of trading partners’ early experiences exchanging drug product tracing information by testing the accuracy of those tracing records.
June 2019 Centers for Medicare & Medicaid Services Comparison of Provider-Based and Freestanding Clinics Office of Audit Services W-07-18-02815 2020 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;
W-00-19-35712;
W-00-16-35712;
W-00-16-35501;
W-00-17-35712;
various reviews
2020 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 2020 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.
June 2019 Centers for Medicare & Medicaid Services Part D Pharmacy Enrollment Office of Evaluation and Inspections OEI-02-15-00440 2020 Since the inception of Part D, numerous OIG reports have raised concerns about Centers for Medicare & Medicaid Services's oversight of or actions to address fraud in the Part D benefit. Recent law enforcement actions have highlighted the role pharmacies can play in prescription drug fraud. When problems occur, Centers for Medicare & Medicaid Services must rely on Part D plan sponsors to follow up and take action against pharmacies. Currently, Part D pharmacies are not required to enroll in Medicare. However, they may enroll for other reasons. For example, pharmacies that bill Medicare for DMEPOS under Medicare Part B must enroll in Medicare Fee-for-Service. As a result, Centers for Medicare & Medicaid Services screens these pharmacies to ensure that they meet the requirements to be a Medicare provider. Centers for Medicare & Medicaid Services also has the authority to revoke their enrollment. We will review Centers for Medicare & Medicaid Services's ability to oversee pharmacies that bill for Part D drugs and determine the extent to which pharmacies that bill for Part D drugs, especially those identified as high risk, are enrolled in Medicare Fee-for-Service.
May 2019 Health Resources & Services Administration Access to Medication-Assisted Treatment at Health Centers Office of Evaluation and Inspections OEI-BL-19-00320 2020 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.
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 2020 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 2020 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 Administration for Children and Families Deficiencies in a State Foster Care System Office of Audit Services W-00-19-25063 2020 Title IV-E of the Social Security Act (the Act) established the Federal Foster Care Program, which helps States to provide safe and stable out-of-home care for children who meet certain eligibility requirements until the children are safely returned home, placed permanently with adoptive families, placed in other planned arrangements for permanency, or age out of the system. Under Title IV-E of the Act, States must establish procedures to ensure compliance with the health and safety requirements for children in foster care. We will determine whether the foster care group homes in the State are in compliance with applicable health and safety requirements and assess whether the group homes complied with the criminal background check requirements. We will review the State agency's oversight process to ensure that it meets licensing requirements for foster care group homes. In addition, we will determine whether the State agency has developed procedures to locate children who are missing from foster care, investigate each instance of a child who goes missing, and take corrective actions as necessary.
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 2020 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 2020 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 2020 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 2020 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-04-15-06190;
W-00-19-31497
2020 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 National Institutes of Health Potential Duplication of NIH Research Grant Funding Office of Audit Services W-00-19-51003 2020 The National Institutes of Health (NIH) has 27 Institutes and Centers that manage research initiatives that include awarding grant funding. 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 the 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 plan to review NIH's efforts to ensure the integrity of its grant application and selection process by testing NIH's internal controls for identifying and addressing potentially duplicative grant funding and overlap within its 27 Institutes and Centers. The objective of our review will be to determine whether NIH's internal controls were effective in ensuring that grantees did not receive duplicative NIH grant funding.
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 2020 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.
March 2019 Centers for Medicare & Medicaid Services States' Compliance with FFS and MCO Provider Enrollment Requirements Office of Evaluation and Inspections OEI-05-19-00060 2020 Provider enrollment is a key program integrity tool to protect Medicaid from fraudulent and abusive providers. The 21st Century Cures Act (the Cures Act) requires States to enroll all Medicaid providers, both those in Medicaid fee-for-service (FFS) and managed care organizations (MCOs). This study, mandated by the Cures Act, will survey State Medicaid agencies about their enrollment of FFS and managed care providers and implementation of required provider enrollment screening activities.
March 2019 IHS
NIH
HRSA
CDC
HHS Agencies' Annual Accounting of Drug-Control Funds - Mandatory Review Office of Audit Services W-00-18-52312 Triennially The Office of National Drug Control Policy circular requires that agencies expending funds on National Drug Control Program activities submit an annual accounting of the expenditure of such funds (21 U.S.C. § 1704). The policy also requires that an agency submit with its annual accounting an authentication by the agency's OIG that expresses a conclusion on the reliability of the agency's assertions. We will review HHS agencies' compliance with the circular. We will also submit the authentication with respect to HHS's FY 2016 annual accounting.
Completed (partial) OS Review of HHS Government Purchase, Travel, and Integrated Charge Card Programs Office of Audit Services W-00-19-59041 2020 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 2020 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
2020 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 2020 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
2020 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.
Completed (partial) National Institutes of Health Vetting Peer Reviewers at NIH's Center for Scientific Review: Strengths and Limitations Office of Evaluation and Inspections OEI-01-19-00160; OEI-05-19-00240 2020 The National Institutes of Health's (NIH's) peer review process is central to the integrity of evaluating and selecting grant applications. The Director of NIH has expressed concern about the increasing risks to the security of intellectual property and to the integrity of peer review. Specifically, peer reviewers who inappropriately share confidential information in grant applications present a risk to intellectual property and undermine the integrity of peer review. 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 the effectiveness of NIH's and grantee institutions' efforts to protect intellectual property derived from NIH-supported research. In this study, which will result in two reports, OIG will describe and assess NIH's process for vetting prospective peer reviewers, as well as NIH's oversight of peer reviewers beyond the vetting process.
February 2019 Centers for Medicare & Medicaid Services Medicare Part B Payments for Podiatry and Ancillary Services Office of Audit Services W-00-19-35818 2020 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 Inventory of its Information Technology Resources and Information Systems Office of Audit Services W-00-19-42020 2020 The National Institutes of Health (NIH) has 27 Institutes and Centers, and each has its own specific set of research priorities. As such, the IT resources and information systems used by each of the Institutes and Centers may vary considerably. Federal law requires agencies to maintain an accurate inventory of IT resources and information systems. Revised in 2016, Office of Management and Budget (OMB) Circular A-130, Managing Information as a Strategic Resource, requires that all Federal agencies identify information technology (IT) resources and maintain an inventory of agency information systems. 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 operations of NIH. We will determine whether NIH has complied with the applicable requirements relating to its IT resources and information systems.
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 2020 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.
February 2019 National Institutes of Health NIH's Peer Review Process for Evaluating Grants Office of Evaluation and Inspections OEI-01-19-00140 2020 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.
February 2019 Centers for Medicare & Medicaid Services Nursing Facility Staffing: Reported Levels and CMS Oversight Office of Evaluation and Inspections OEI-04-18-00451 2020 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.
January 2019 Centers for Medicare & Medicaid Services States' Compliance with New Requirements to Prevent Medicaid Payments to Terminated Providers Office of Evaluation and Inspections OEI-03-19-00070 2020 To prevent terminated providers from treating Medicaid enrollees or receiving Medicaid payments, the 21st Century Cures Act (Cures Act) requires CMS to provide information to all States on Medicaid providers that have been terminated for cause. This study, mandated by the Cures Act, will examine the extent to which terminated providers included in CMS's terminations database have been terminated from all State Medicaid programs and the amount of Medicaid payments for items/services associated with terminated providers. Additionally, this study will examine the extent to which State contracts with managed care entities include a provision that terminated providers are excluded from all managed care networks.
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 2020 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.
December 2018 Centers for Medicare & Medicaid Services Assessing Inpatient Hospital Billing for Medicare Beneficiaries Office of Evaluation and Inspections OEI-02-18-00380 2020 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.
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 2020 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.
November 2018 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 2020 In more than 60 countries, grantees of the Centers for Disease Control and Prevention (CDC), such as ministries of health and other partners, work to control the spread of acquired immunodeficiency syndrome (AIDS). In fiscal year 2017, CDC awarded more than $1.5 billion in President's Emergency Plan for AIDS Relief (PEPFAR) funds 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 of grantees in eight countries in Africa and Asia. OIG's PEPFAR oversight has helped grantees learn important grant and program integrity lessons that apply to ongoing and future responses to infectious diseases. In previous audits of foreign PEPFAR grantees, OIG identified unallowable expenditures and internal control weaknesses. We will determine whether selected foreign and domestic grantees managed PEPFAR funds in accordance with award requirements.
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 2020 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 2020 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.
October 2018 Centers for Medicare & Medicaid Services CMS Medicare Beneficiary Identifier Card Office of Audit Services W-00-18-35817 2020 The Medicare Access and CHIP Reauthorization Act of 2015 requires CMS to remove Social Security Numbers from Medicare cards and, as a result, CMS is replacing the existing health insurance claim number with a Medicare Beneficiary Identifier (MBI). We will conduct a series of reviews to assess controls in place to distribute and implement usage of the MBI. We will (1) determine the number and nature of Medicare cards returned as undeliverable and the extent to which CMS tracks and follows up on Medicare cards returned as undeliverable, (2) assess CMS’s safeguards in place to protect the MBI, and (3) conduct a review of payments to providers to determine whether Medicare cards deemed high risk and cards mailed and returned as undeliverable are being used for inappropriate items and services.
October 2018 Administration for Children and Families States' Use of the Child Welfare Information Systems To Monitor Medication Prescribed to Children in Foster Care Office of Audit Services W-00-18-59434; A-05-18-00007 2020 Psychotropic and opioid drugs are among those that may be prescribed to children in foster care. Psychotropic medications treat mental health disorders such as schizophrenia, depression, bipolar disorder, anxiety disorders, and attention deficit/hyperactivity disorder. Prescription opioids include narcotics to manage pain from surgery, injury, or illness, and have a high risk for abuse and misuse. To receive certain Federal funding for child welfare services, States are required to have a plan for overseeing and coordinating health care services for any child in foster care placement, including protocols for the appropriate use and monitoring of medications (the Social Security Act § 422(b)(15)(A)). The Comprehensive Child Welfare Information System (CCWIS) is a federally funded information system for State child welfare agencies to support case management for children and families receiving child welfare services. We will review States' use of the CCWIS for monitoring psychotropic and opioid medications prescribed to children in foster care. Because the Administration for Children and Families (ACF) oversees States’ foster care programs, we will also determine the extent to which ACF ensures that children in foster care receive medications in accordance with State requirements.
September 2018 Indian Health Service Review of Opioid Use in Indian Health Service Office of Evaluation and Inspections OEI-05-18-00470 2020 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.
September 2018 Administration for Children and Families Follow-up Review of Head Start Grantee Office of Audit Services W-00-17-20009 2020 A community-based, not-for-profit organization was awarded a Head Start grant to provide early childcare, social services, education, health, nutrition, and related services to children and their families at three centers in the Bronx, New York. The Administration for Children and Families requested that the Office of Inspector General conduct an audit of this grantee because of its high risk of noncompliance with Federal requirements. We will determine whether this grantee claimed Head Start costs that were allowable under applicable Federal regulations and the terms of the grant. The review will focus on two specific areas: the related-party transactions and the restitution of embezzled funds.
Completed (parital) Centers for Medicare & Medicaid Services Review of States' Oversight of Opioids Office of Audit Services A-09-18-01005;
W-00-18-59440
2020 Opioid abuse and overdose deaths are at crisis levels in the United States, with more than 42,000 Americans dying from opioid use in 2016. We will analyze data from 2013 to 2016 on opioid overdose trends from the Centers for Disease Control and Prevention in order to select multiple States for review. We will review the oversight of opioid prescribing and monitoring of opioid use in the selected States. Specifically, we will review policies and procedures, data analytics, programs, outreach, and other efforts. To support HHS's ongoing efforts to identify and disseminate effective practices to address the opioid epidemic in the United States, we will highlight these state-wide efforts.
August 2018 Centers for Medicare & Medicaid Services Potential Abuse and Neglect of Children Receiving Medicaid Benefits Office of Audit Services W-00-18-31533 2020 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.
August 2018 Centers for Medicare & Medicaid Services CMS Oversight of Nursing Facility Staffing Levels Office of Evaluation and Inspections OEI-04-18-00450 2020 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. We will examine nursing staffing levels reported by facilities to the Payroll-Based Journal and CMS's efforts to ensure data accuracy and improve resident quality of care by both enforcing minimum requirements and incentivizing high quality staffing above minimum requirements.
August 2018 Centers for Medicare & Medicaid Services Hospitals' Compliance with Medicare's Transfer Policy With the Resumption of Home Health Services and the Use of Condition Codes Office of Audit Services W-00-18-35815 2020 Medicare payments to acute care hospitals for inpatient stays under Medicare Part A are made on the basis of prospectively set rates. Normally, Medicare pays a hospital discharging a beneficiary the full amount for the corresponding diagnosis-related group (DRG). In contrast, a hospital that transfers a beneficiary to another facility or to home health services is paid a graduated per diem rate, not to exceed the full DRG payment. When transferring a patient to home health services, the hospital can apply specific condition codes to the claim and receive the full DRG payment. The hospital is responsible for coding the bill on the basis of its discharge plan for the patient or adjusting the claim if it finds out that the patient received postacute care after the discharge. We will determine whether Medicare appropriately paid hospitals' inpatient claims subject to the postacute care transfer policy when (1) patients resumed home health services after discharge or (2) hospitals applied condition codes to claims to receive a full DRG payment.
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 2020 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.
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 2020 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 Health Resources and Services Administration HRSA's Oversight of Funds for Access Increases in Mental Health and Substance Abuse Services (AIMS) Office of Audit Services W-00-18-59439 2020 The Health Resources and Services Administration (HRSA) administers Access Increases in Mental Health and Substance Abuse Services (AIMS) grants. In 2017, HRSA awarded $200.5 million in AIMS grants to 1,178 health centers nation-wide. These supplemental funding grants are meant to expand access for existing Health Center Program grant recipients to mental health and substance abuse services, focusing on the treatment, prevention, and awareness of opioid abuse. HRSA intends for health centers to enhance these services by increasing personnel, leveraging health information technology, and providing training to support the expansion of mental health and substance abuse services and their integration into primary care. We will review HRSA's internal controls to determine whether they are suitable for (1) awarding AIMS grants and (2) monitoring AIMS grant recipients.
July 2018 Centers for Medicare & Medicaid Services Increased Payments For Transfer Claims With Outliers Office of Audit Services W-00-18-35814 2020 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 2020 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.
July 2018 Substance Abuse and Mental Health Services Administration SAMHSA's Oversight of Accreditation Bodies for Opioid Treatment Programs Office of Audit Services W-00-18-59035 2020 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.
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 Review of Home Health Claims for Services With 5 to 10 Skilled Visits Office of Audit Services W-00-18-35813 2020 If a home health agency (HHA) provides four or fewer visits from a skilled service provider that are included under home health coverage (excluding visits providing only services listed in 42 CFR § 409.49) in an episode, the HHA will be paid a standardized per-visit payment based on visit type. Such payment adjustments, and the episodes themselves, are called Low Utilization Payment Adjustments (LUPA). Once a fifth visit is provided, an HHA will instead receive a full 60-day payment based on episode of care. Since OIG has not reviewed payments for LUPA, we will review supporting documentation to determine whether home health claims with 5 to 10 skilled visits in a payment episode in which the beneficiary was discharged home met the conditions for coverage and were adequately supported as required by Federal guidance.
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 2020 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 2020 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 2020 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
2020 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 2020 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 2020 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 2020 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 2020 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 2020 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 Review of Refugee Cash and Medical Assistance Payments Office of Audit Services A-04-18-02011;
A-04-18-02017;
A-05-18-00040;
W-00-18-31400;
W-00-18-20018; A-04-18-02010
2020 The Refugee Act of 1980 created the Refugee Resettlement Program (RRP) to help refugees resettle and achieve economic self-sufficiency as quickly as possible after arriving in the United States. The Act provides Federal grants to States for cash and medical assistance, social services, and targeted assistance to help qualified refugees. Within HHS, the Administration for Children and Families, Office of Refugee Resettlement (ORR), runs the RRP program. ORR provides time-limited benefits and services to eligible refugee populations through Refugee Cash Assistance (RCA) and Refugee Medical Assistance (RMA) grants to States (although non-State entities may serve as grantees under certain circumstances). The RRP reimburses States the cost that they would normally incur to provide refugees cash and medical assistance under existing Federal and State assistance programs. RCA and RMA are available to refugees for up to 8 months immediately following their date of entry into the United States and are only available after a refugee fails to qualify for cash assistance under Temporary Assistance for Needy Families or health benefits under Medicaid. In fiscal year 2015, ORR obligated $286 million to States for the RRP program. We will determine whether RCA/RMA payments to beneficiaries made by the State agency or a replacement designee, as applicable, were allowable in accordance with Federal guidelines.
Completed (partial) Centers for Medicare & Medicaid Services Medicare Payments for Overlapping Part A Inpatient Claims and Part B Outpatient Claims Office of Audit Services A-09-17-03035;
A-09-16-02026;
W-00-16-35752
2020 Overlapping claims can happen when a beneficiary is an inpatient of one hospital and then sent to another hospital to obtain outpatient services that are not available at the originating hospital. Certain items, supplies, and services furnished to inpatients are covered under Medicare Part A and should not be billed separately to Medicare Part B (42 CFR §§ 409.10 and 410.3; Medicare Claims Processing Manual, Ch. 3 § 10.4). Durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) claims for beneficiaries who received DMEPOS items while in an inpatient stay in a hospital should not be billed to Medicare separately. The payments associated with these claims are considered overpayments because Medicare does not allow separate payment for DMEPOS when a beneficiary is in a covered inpatient stay (Medicare Claims Processing Manual, Ch. 20 § 01). We will review the CMS Common Working File (CWF) edits that should deny claims for DMEPOS items furnished during an inpatient stay. Prior OIG reviews and investigations have identified this area as at risk for noncompliance with Medicare billing requirements. We will review Medicare payments to certain types of inpatient hospitals to determine whether claims billed to Part B for certain items, supplies, and services provided during inpatient stays were made in accord with Federal requirements.
Completed (partial) Administration for Children and Families Child Support Administrative Cost Audit Office of Audit Services A-01-18-02501;
W-00-18-20016
2020 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;
W-00-18-59433
2020 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 2020 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 2020 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
February 2018 Centers for Medicare & Medicaid Services Review of Statistical Methods Within the Medicare Fee-For-Service Administrative Appeal Process Office of Audit Services W-00-18-35806 2020 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.
January 2018 Centers for Medicare & Medicaid Services Potential Abuse and Neglect of Medicare Beneficiaries Office of Audit Services W-00-18-35805 2019 Medicare beneficiaries, including elders and disabled persons, are being treated at inpatient and outpatient medical facilities for conditions that may be the result of abuse or neglect. The Elder Justice Act recognizes an older person's rights, including the right to be free of abuse, neglect, and exploitation. In addition, all 50 States have mandated reporter laws for the reporting of the potential abuse or neglect of elders and vulnerable persons. Prior OIG reviews have shown that there are problems with the quality of care and the reporting and investigation of potential abuse or neglect at group homes, nursing homes, and skilled nursing facilities. By analyzing the treating medical facilities' diagnoses, we will determine the prevalence of the potential abuse or neglect of Medicare beneficiaries. We will also determine whether the potential abuse or neglect occurred at a medical facility or at another location, such as the Medicare beneficiary's home.
Completed (partial) Centers for Medicare & Medicaid Services Hospitals Billing for Severe Malnutrition on Medicare Claims Office of Audit Services A-03-17-00005;
W-00-17-35804
2020 Many elderly Medicare patients, especially those who are severely ill, are malnourished. Malnutrition can result from the treatment of another condition, inadequate treatment or neglect, or the general deterioration of a patient's health. Medicare sets forth a number of Federal requirements, including the Social Security Act § 1862(a)(1)(A), related to billing for the treatment of severe malnutrition. Hospitals are allowed to bill for the treatment of malnutrition on the basis of the severity of the condition—mild, moderate, or severe, and whether it affects patient care. Severe malnutrition is classified as a major complication or comorbidity (MCC). Adding an MCC to a Medicare claim can result in a higher Medicare payment because the claim is coded at a higher Diagnosis Related Group. This review will assess the accuracy of Medicare payments for the treatment of severe malnutrition. We will determine whether providers are complying with Medicare billing requirements when assigning diagnosis codes for the treatment of severe types of malnutrition on inpatient hospital claims.
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 2020 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 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;
A-06-17-04003
2020 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
2020 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 Medicaid Services Delivered Using Telecommunication Systems Office of Audit Services W-00-18-31527; A-06-18-00000 2020 Medicaid pays for telemedicine, telehealth, and telemonitoring services delivered through a range of interactive video, audio or data transmission (telecommunications). Medicaid programs are seeing a significant increase in claims for these services and expect this trend to continue. We will determine whether selected States’ Medicaid payments for services delivered using telecommunication systems were allowable in accord with Medicaid requirements.
November 2017 Centers for Medicare & Medicaid Services Use of Funds by Medicaid Managed Care Organizations Office of Audit Services W-00-18-31526 2020 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 2020 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 2020 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) Administration for Children and Families Unaccompanied Children Program Grantee Reviews Office of Audit Services A-02-16-02013;
A-04-16-03566;
A-02-16-02007;
W-00-16-25060;
various reviews
2020 Under the Homeland Security Act of 2002, § 462, the Office of Refugee Resettlement (ORR) administers the Unaccompanied Children (UC) program. The UC program provides temporary shelter, care, and other related services to unaccompanied children in its custody. Before FY 2012, about 8,000 children were served annually in this program. In FY 2014, the number of children increased to over 57,500. The UC grant program totaled $911 million for FY 2014. We will review whether selected grantees met applicable grant terms and conditions of the program. Specifically, this work will determine whether a grantee met certain safety standards applicable for the care of UC children in its custody and used funding in accordance with Federal requirements.
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
2020 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
2020 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
2020 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;
W-00-17-35538;
various reviews
2020 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
2020 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
2020 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
2020 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 2020 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 2020 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.
October 2017 Centers for Medicare & Medicaid Services Medicare Part D Eligibility Verification Transactions Office of Audit Services W-00-17-35751 2020 An E1 transaction is a Medicare Eligibility Verification transaction that the pharmacy submits to the Part D transaction facilitator to determine a beneficiary's eligibility to the Part D program and other drug coverage information. 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 balance (Centers for Medicare & Medicaid Services, Medicare Prescription Drug Benefit Manual, Pub. No. 100-18, Ch. 14, § 30.4). We will review Centers for Medicare & Medicaid Services's oversight of E1 transactions processed by contractors and whether the E1 transactions were created and used for intended purposes. We will also review E1 transactions to assess the validity of the data.
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
2020 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.
October 2017 Centers for Medicare & Medicaid Services Quality of Sponsor Data Used in Calculating Coverage-Gap Discounts Office of Audit Services W-00-16-35611; W-00-17-35611; various reviews 2020 HHS is required to establish a Medicare coverage-gap discount program to provide relief to beneficiaries who are responsible for paying all drug costs during their coverage gaps (SSA § 1860D14A, as amended by the Patient Protection and Affordable Care Act § 3301). Sponsors track beneficiary payment information and the drug cost data necessary to calculate eligibility for the program. We will review data submitted by Part D sponsors for use in calculating the coverage gap discount to assess the accuracy of the data and determine whether beneficiary payments are correct and amounts paid to sponsors are supported.
October 2017 Centers for Medicare & Medicaid Services Review of Funding to Establish the Federally Facilitated Marketplace Office of Audit Services W-00-16-55000 2020 HHS operates the Federally Facilitated Marketplace (FFM) in each State that did not establish and does not operate its own State marketplace. Centers for Medicare & Medicaid Services is accountable for the Federal funds involved in establishing the FFM. A previous OIG audit noted that Centers for Medicare & Medicaid Services did not identify all FFM contract costs and did not properly validate the amounts to withhold for defect resolution. We will identify the source and amount of funding used to establish the FFM. We will determine whether HHS had overall visibility and accountability for funds used by Centers for Medicare & Medicaid Services for the FFM; whether there were appropriate budgeting and management of these funds; how funds were tracked by HHS and Centers for Medicare & Medicaid Services; and whether the funds were used in accordance with appropriation law with regard to purpose, time, and amount (31 U.S.C. § 1502 and 31 U.S.C. § 1341(a)(1)). In addition, we will determine whether the amount that HHS and Centers for Medicare & Medicaid Services identified as FFM funding was accurate and complete.
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.
October 2017 Other HHS Government Purchase, Travel, and Integrated Charge Card Programs - Mandatory Review Office of Audit Services W-00-19-59041 2020 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. OMB 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 GAO. We will review HHS's charge card programs (e.g., 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.
September 2017 Centers for Medicare & Medicaid Services Federal Marketplace Enrollment Systems Office of Audit Services W-00-18-59436 2020 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.
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
2020 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;
A-09-18-03022;
W-00-18-35538;
W-00-17-31525; A-02-17-00000
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;
W-00-18-35514; A-03-18-xxxxx
2020 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.
Completed (partial) Substance Abuse and Mental Health Services Administration Controls Over Opioid Treatment Programs Office of Audit Services A-02-17-02009 W-00-17-59035; A-02-16-02002 2020 Substance Abuse and Mental Health Services Administration funds State agencies' opioid treatment programs through its Substance Abuse Prevention and Treatment Block Grant program. Opioid abuse is a compelling public health concern, and in the past OIG has recommended better security protocols to reduce thefts of opioids from hospitals and pharmacies. We will determine whether a State agency is effectively monitoring its opioid treatment programs' services and medications in accordance with the federal guidelines for opioid treatment programs established under 42 CFR Part 8. We will also determine whether program expenditures are allowable in accordance with Federal requirements outlined in 45 CFR Part 75, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards.
August 2017 Centers for Medicare & Medicaid Services Medicare Part B Payments for Psychotherapy Services Office of Audit Services W-00-17-35801; A-09-17-xxxxx 2020 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.
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;
2020 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 Medicare Part B Payments for Ambulance Services Subject to Part A Skilled Nursing Facility Consolidated Billing Requirements Office of Audit Services A-01-17-00506 W-00-17-35794; A-01-17-00506 2020 Medicare Part A prospective payments to skilled nursing facilities (SNFs) include most of the services that outside suppliers provide to SNF residents. Pursuant to 1862(a)(18) and 1842(b)(6)(E) of the Social Security Act, outside suppliers, including ambulance suppliers, must bill and receive payment from the SNF, not Medicare, for services provided to beneficiaries in SNF stays covered under Medicare Part A. Prior Office of Inspector General reports have identified high error rates and significant overpayments for services subject to SNF consolidated billing. We will determine whether ambulance services paid by Medicare Part B were subject to Part A SNF consolidated billing requirements. We will also assess the effectiveness of edits in CMS's Common Working File to prevent and detect Part B overpayments for ambulance transportation subject to consolidated billing.
Completed (partial) Centers for Medicare & Medicaid Services Assertive Community Treatment Program Office of Audit Services A-02-17-01008;
W-00-17-31521; A-02-17-01009; A-02-17-01020
2020 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
2020 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.
July 2017 Centers for Medicare & Medicaid Services Review of Medicare Payments for Nonphysician Outpatient Services Provided Under the Inpatient Prospective Payment System Office of Audit Services W-00-17-35799; A-01-17-00508 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).

July 2017 Centers for Medicare & Medicaid Services Medicaid Claims for Opioid Treatment Program Services Office of Audit Services W-00-17-31523; A-02-17-01021 2020 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
2020 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.
Completed (partial) Centers for Medicare & Medicaid Services Review of Quality Measures Data Reported by Accountable Care Organizations in the Medicare Shared Savings Program Office of Audit Services W-00-18-35798; A-09-17-03023 2020 The Medicare Shared Savings Program (MSSP) was established by section 3022 of the Patient Protection and Affordable Care Act to facilitate coordination and cooperation among providers, improve quality of care for Medicare fee-for-service beneficiaries, and reduce unnecessary costs. Eligible providers and suppliers may voluntarily participate in the MSSP by creating or joining an Accountable Care Organization (ACO). ACOs that lower health care costs and meet quality performance standards for their beneficiary populations are eligible to share in any savings that the ACOs generate for the Medicare program (earned shared savings). To demonstrate that they are providing appropriate, high-quality care while reducing costs, ACOs are required to report complete and accurate data on quality measures and to satisfy minimum levels of certain quality measures as set by CMS. CMS assesses an ACO's overall quality performance by calculating a single quality performance score across all quality measures reported by the ACO. This score is used in part to calculate the ACO's earned shared savings. We will review MSSP ACOs that received earned shared savings payments to determine whether they reported quality measures data in accordance with Federal requirements. Our review is part of several OIG reviews that will examine various aspects of the ACOs under the MSSP.
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
2020 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
2020 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.
Completed (partial) Centers for Medicare & Medicaid Services Health-Care-Acquired Conditions - Prohibition on Federal Reimbursements Office of Audit Services A-02-16-01022;
A-06-16-08004;
A-07-16-03216;
A-06-16-02003;
A-03-16-00205;
A-06-16-01001;
W-00-16-31452 various reviews
2020 As of July 1, 2011, Federal payments to States are prohibited for any amounts expended for providing medical assistance for health-care-acquired conditions (SSA § 1903 and Patient Protection and Affordable Care Act § 2702). Federal regulations prohibit Medicaid payments by States for services related to health-care-acquired conditions and for provider preventable conditions as defined by Centers for Medicare & Medicaid Services or included in the Medicaid State Plan (42 CFR § 447.26). We will determine whether selected States made Medicaid payments for hospital care associated with health-care-acquired conditions and provider preventable conditions and quantify the amount of Medicaid payments for such conditions.
Completed (parital) Centers for Medicare & Medicaid Services Dental Services for Children - Inappropriate Billing Office of Audit Services A-02-16-01020;
W-00-17-31135
2020 Dental services are required for most Medicaid-eligible individuals under age 21 as a component of the Early and Periodic Screening, Diagnostic, and Treatment services benefit (SSA §§ 1905(a)(4)(B) and 1905(r)). Federal regulations define dental services as diagnostic, preventative, or corrective procedures provided by or under the supervision of a dentist (42 CFR § 440.100). Services include the treatment of teeth and the associated structure of the oral cavity and disease, injury, or impairment that may affect the oral cavity or general health of the recipient. Previous OIG work indicated that some dental providers may be inappropriately billing for services. We will review Medicaid payments by States for dental services to determine whether States have properly claimed Federal reimbursement.
Completed (partial) Centers for Medicare & Medicaid Services Community First Choice State Plan Option Under the Affordable Care Act Office of Audit Services A-06-17-08002;
W-00-17-31495
2020 Section 2401 of the Patient Protection and Affordable Care Act added section 1915(k) to the SSA, a new Medicaid State plan option that allows States to provide statewide home and community-based attendant services and support to individuals who would otherwise require an institutional level of care. States taking up the option will receive a 6-percent increase in their FMAP for Community First Choice (CFC) services. To be eligible for CFC services, beneficiaries must otherwise require an institutional level of care and meet financial eligibility criteria. We will review CFC payments to determine whether the payments are proper and allowable.
Completed (partial) Centers for Medicare & Medicaid Services State Use of Provider Taxes to Generate Federal Funding Office of Audit Services A-03-16-00202;
W-00-17-31455; various reviews
2020 Many States finance a portion of their Medicaid spending by imposing taxes on health care providers. Federal regulations define and set forth the standard for permissible health-care-related taxes (42 CFR §§ 433.55 and 433.68). Previous OIG work raised concerns about States' use of health-care-related taxes. We will review State health-care-related taxes imposed on various Medicaid providers to determine whether the taxes comply with applicable Federal requirements. Our work will focus on the mechanism States use to raise revenue through provider taxes and determine the amount of Federal funding generated.
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
2020 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
2020 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
2020 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
2020 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 2020 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 2020 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 2020 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;
W-00-17-31516; various reviews
2020 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 Positive Airway Pressure Device Supplies - Supplier Compliance with Documentation Requirements for Frequency and Medical Necessity Office of Audit Services A-04-17-04056;
W-00-17-35787
2020 Beneficiaries receiving continuous positive airway pressure or respiratory assist device therapy (PAP) require replacement of the device's supplies (e.g. mask, tubing, headgear, and filters) when they wear out or are exhausted. Medicare payments for these supplies in 2014 and 2015 were approximately $953 million. Prior OIG work found that suppliers automatically shipped PAP device supplies when no physician orders for refills were in effect. For supplies and accessories used periodically, orders or certificates of medical necessity must specify the type of supplies needed and the frequency with which they must be replaced, used, or consumed (Centers for Medicare & Medicaid Services's Medicare Program Integrity Manual, Pub. 100-08, Ch. 5, §§ 5.2.3 and 5.9). Beneficiaries or their caregivers must specifically request refills of repetitive services and/or supplies before suppliers dispense them (Centers for Medicare & Medicaid Services's Medicare Claims Processing Manual, Pub. 100-04, Ch. 20, § 200). We will review claims for frequently replaced PAP device supplies to determine whether documentation requirements for medical necessity, frequency of replacement, and other Medicare requirements are met. (W-00-16-35240; W-00-17-35787)
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
2020 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.
November 2016 Centers for Medicare & Medicaid Services Outpatient Outlier Payments for Short-Stay Claims Office of Audit Services W-00-16-35775; A-06-16-01002 2020 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
2020 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
2020 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
2020 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 2020 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 2020 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
2020 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 2020 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.
Completed (partial) National Institutes of Health Controls over Subcontracting of National Institutes of Health Grant and Contract Work Office of Audit Services A-05-17-00016;
A-02-17-02006;
W-00-16-51001; various reviews
2020 Cost principles for Educational Institutions at 45 CFR Part 75 are used in determining the allowable costs of work performed by colleges and universities under sponsored agreements. The principles will also be used in determining the costs of work performed by such institutions under subgrants, cost-reimbursement subcontracts, and other awards made to them under sponsored agreements. We will assess colleges' and universities' controls over the subcontracting of National Institutes of Health grant and contract work. Specifically, we will determine whether colleges and universities effectively monitor the services subcontracted to other organizations and ensure that Federal funds are spent on allowable goods and services in compliance with selected cost principles and the terms and conditions of the grants and subcontracts. We will conduct reviews at selected organizations based on the dollar value of Federal grants received and on input from National Institutes of Health.