The HHS Office of Inspector General (OIG) aims to protect the integrity of federal healthcare programs and their beneficiaries by finding and preventing fraud, waste, and abuse. To do so, the OIG publishes a continuously updated list of its Active Work Plan Items, among other activities. Therefore, all healthcare organizations and providers need to take measures to ensure adherence to the necessary guidelines. Regular monitoring of OIG Work Plan monthly updates and incorporating some of the issues can improve healthcare compliance programs and help healthcare organizations prevent potential troubles.
The OIG uses several factors when deciding what audits to include in its OIG Work Plan and covers a very wide range of issues. Audits address compliance with regulations and payments by government programs, but also the performance of state and local government agencies in carrying out programs mandated by Congress. For instance, the majority of OIG Work Plan 2020 addresses challenges posed by the COVID-19 pandemic.
OIG Work Plan Monthly Updates for July
The July OIG Work Plan monthly updates include a wide number of issues, such as:
- Audit of Child Care Development Fund Childcare Services during Coronavirus Disease 2019 Pandemic
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. As childcare services are critical in emergency situations, the Administration for Children and Families’ Office of Child Care directed Lead Agencies to a 2017 Information Memorandum (IM). This memorandum explains the flexibilities and waivers that Lead Agencies have to respond to emergencies, like the COVID-19 pandemic. One of OIG Work Plan monthly updates is 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.
- Centers for Medicare & Medicaid Services and States Implement Policy Modifications to Ensure that Medicaid Beneficiaries Continue to Receive Prescriptions
All states provide coverage for outpatient prescription drugs within their State Medicaid programs and the coronavirus disease highlights the need to efficiently and effectively respond to protect the needs of Medicaid beneficiaries. Therefore, one of OIG’s objectives is to review actions taken or planned by states and DC to ensure Medicaid beneficiaries continue to receive prescriptions during the COVID-19 pandemic.
- Use of Medicare Telehealth Services during the COVID-19 Pandemic
In response to the coronavirus disease 2019 (COVID-19) pandemic, CMS made a number of changes that allowed Medicare beneficiaries to access a wider range of telehealth services without having to travel to a health care facility. Now, CMS is exploring whether telehealth flexibilities should be extended, based on Medicare Parts B and C data. However, it is necessary to identify program integrity risks with Medicare telehealth services to ensure their appropriate use and reimbursement during the pandemic.
- Analysis of New Rural Add-On Payment Methodology
Section 50208 of the Bipartisan Budget Act of 2018 (the BBA) extended rural add-on payments for home health episodes and visits ending during calendar years 2019 through 2022. It also mandated the implementation of a new methodology for applying for those payments. One of July OIG Work Plan monthly updates is to perform an analysis of Medicare home health claims for calendar years 2019 through 2021.
- Biosimilar Trends in Medicare Part D
Biologic drugs are among the most expensive drugs on the U.S. market. Biosimilar drugs are highly similar and have no clinically meaningful difference from their reference biologics and they also tend to be less expensive than their reference biologics. However, limited coverage of biosimilars by Part D plans and formulary tier placement may discourage the use of less expensive biosimilars. One of the OIG Work Plan monthly updates is to describe utilization and cost trends of biosimilars and reference biologics covered by Part D over time.
- Assessing Trends Related to the Use of Psychotropic Drugs in Nursing Homes
Previous OIG work found that elderly nursing home residents who were prescribed antipsychotic drugs were at risk for harm. Policymakers continue to raise concerns about whether CMS has made sufficient progress in reducing the use of antipsychotic drugs to care for the elderly. OIG will report the changes over time for the use of psychotropic drugs for elderly nursing home residents and citations and civil monetary penalties assessed to nursing homes regarding psychotropic drugs. The report will also include the presence of diagnoses that exclude nursing home residents from CMS’s measure of the use of antipsychotic drugs.
- Expedited Provider Enrollment during COVID-19 Emergency
As a result of the coronavirus disease 2019 (COVID-19) pandemic, Medicaid provider enrollment through State Medicaid agencies has been expedited under the SSA §1135 Authority to Waive Requirements during National Emergencies. One of the OIG Work Plan monthly updates is to determine whether the State agency and providers complied with Federal and State requirements for newly enrolled providers under the national emergency declaration. This update also includes establishing if the State has tracking controls for these providers as well as giving providers adequate guidance on waived enrollment requirements.Use this step-by-step guide on exclusion screening to develop and maintain effective healthcare compliance programs, ensure adherence with different regulations, and stay audit-ready.
- Audit of CMS’s Controls over the Expanded Accelerated and Advance Payment Program Payments and Recovery
The OIG plans to provide details of the effectiveness of CMS controls over its Accelerated and Advance Payment Program (AAP) payments to providers and payment recovery. This involves obtaining data and meeting with program officials to understand CMS’s eligibility determination process for AAP payments. Also, it is necessary to determine the steps CMS will have taken to recover such funds in compliance with the CARES Act.
- Geographic Distribution of Provider Relief Funds to Communities Disproportionately Impacted by Adverse COVID-19 Outcomes
According to information on rates of infection and outcomes for the ongoing COVID-19 pandemic, there are numerous racial, ethnic, and socioeconomic disparities in rates of adverse outcomes from COVID-19. One of the OIG Work Plan monthly updates is to review the locations of hospitals that received Provider Relief Funds. Particular attention will be paid to hospitals located in communities of color and economically disadvantaged communities that were disproportionately impacted by adverse COVID-19 outcomes.
- CDC’s Collection and Use of Data on Disparities in COVID-19 Cases and Outcomes
Reports also document a disproportionate burden of infection and deaths among communities of color and economically disadvantaged communities. That is why it is necessary to examine the Centers for Disease Control and Prevention (CDC) data to assess racial, ethnic, and socioeconomic disparities in COVID-19 cases and outcomes. OIG will also review how CDC uses those data as part of its activities to address the COVID-19 pandemic and how to best protect communities of color and economically disadvantaged communities in the future.
- Audit of HHS’s Awarding of Ventilator Production Contracts under the Defense Production Act in Response to COVID-19
To address the COVID-19 pandemic, the President used his authority under the Defense Production Act of 1950 to direct the Department of Health and Human Services to facilitate the supply of materials for the production of ventilators. OIG will focus on the top five highest dollar value contracts awarded by the Office of the Assistant Secretary for Preparedness and Response (ASPR) for supplying these ventilators. Such a review will determine whether these contracts complied with Federal requirements and HHS policies and procedures.
- Audit of Indian Health Service’s Coverage of COVID-19 Testing
The Families First Coronavirus Response Act provided $64 million in additional resources for COVID-19 response activities through the Indian Health Service (IHS). The Paycheck Protection Program and Health Care Enhancement Act provided $750 million for COVID-19 testing and testing-related services through IHS. Therefore, it is necessary to audit IHS’s allocation and utilization of funding to urban Indian organizations, IHS Federal health programs, and Tribal health programs.
- End-Stage Renal Disease Networks’ Responsibilities during COVID-19
CDC has stated that beneficiaries with serious underlying medical conditions, such as end-stage renal disease (ESRD), are at higher risk for severe illness from COVID-19. ESRD treatment facilities are organized into groups called Networks. In addition to Network Organizations, the ESRD National Coordinating Center (NCC) supports and coordinates activities for the ESRD program on a national level. One of OIG Work Plan monthly updates is to interview Network Organizations, NCC, and CMS officials to identify the actions taken to aid dialysis clinics and patients in response to COVID-19.Find out how to prevent exclusion from Medicare, Medicaid, or other federal healthcare programs by preventing OIG Corporate Integrity Agreement violations and meeting compliance-related obligations.
OIG Work Plan Monthly Updates for August
Some of the items on the August agenda are:
- A Review of Medicare Data to Understand Hospital Utilization during COVID-19
Coronavirus disease 2019 (COVID-19) can significantly tax hospitals and disproportionately affect Medicare beneficiaries, and affect much of a State or a locality, due to the rising demand for hospital resources. Based on Medicare claims data, one of the August OIG Work Plan updates is to analyze the effects of COVID-19 on hospitalized Medicare beneficiaries and the hospital resources needed to care for them.
- Quality of Maternal Healthcare in Indian Health Service Hospitals
Maternal mortality and morbidity are increasing in the United States, and up to 60 percent of maternal deaths may be preventable. OIG 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.
- Incidence of Adverse Events in Indian Health Service Hospitals
The Indian Health Service (IHS) operates 26 hospitals that provide free inpatient care to eligible American Indians and Alaska Natives, but many of these hospitals are located in remote areas and have low average daily patient censuses. One of OIG’s plans is to identify adverse and temporary harm events at IHS hospitals in FY 2017 and estimate the incidence and preventability of these events.
- Rates of Estimated Payments from Chart Reviews and Health Risk Assessments across Medicare Advantage Organizations
The Medicare Advantage (MA) program provided coverage to 23 million beneficiaries in 2019 at a cost of $264 billion. A current OIG evaluation examines the extent to which diagnoses solely generated by health risk assessments (HRAs) were associated with higher risk scores and higher MA payments. One of the August OIG Work Plan monthly updates is to combine data from these evaluations to perform new analyses. They will determine whether certain MAOs and parent organizations had higher or lower amounts of risk-adjusted payments from both chart reviews and HRAs relative to their peers.
- Accuracy of Nursing Home Compare Website’s Reported Health, Fire Safety, and Emergency Preparedness Deficiencies
CMS’s Nursing Home Compare website provides information on nursing homes that participate in the Medicare or Medicaid programs. OIG plans to review the information reported on Nursing Home Compare and determine whether the information is accurate and can be relied upon by consumers to compare and select nursing homes.
- Audit of the Distribution of Supplies from Indian Health Service’s National Supply Service Center in Response to COVID-19
COVID-19 has created challenges for different segments of the U.S. hospital system, including the Indian Health Service (IHS), Tribal, and Urban Indian Health Program (UIHP) facilities. American Indians and Alaska Natives (AI/AN) commonly live in socially cohesive communities making it all the more difficult to maintain physical distancing during a pandemic. OIG plans to determine whether IHS had adequate internal controls to ensure that medical supplies and equipment were effectively distributed to the National Supply Service Center’s customers in response to the COVID-19 pandemic.
- Audit of Foundational Cybersecurity Controls for the U.S. Healthcare COVID-19 Portal and Protect.HHS.gov
The Protect.HHS.gov ecosystem and the U.S. Healthcare COVID-19 portal are both critically important systems contributing to the Federal pandemic response as the data collected by these systems are utilized in the response to COVID-19. Without proper cybersecurity, the integrity and availability of the data are at risk. Consequently, it is necessary to determine whether HHS has implemented foundational cybersecurity controls to ensure the integrity and availability of Protect.HHS.gov and the U.S. Healthcare COVID-19 portal.
- Infection Control and Emergency Preparedness at Dialysis Centers during the COVID-19 Pandemic
On March 30, 2020, CMS issued a revised memorandum providing guidance for infection control and prevention of COVID-19 in dialysis facilities. One of the August OIG Work Plan monthly updates is to determine whether end-stage renal disease ESRD facilities implemented additional infection control and emergency preparedness procedures to safeguard high-risk ESRD beneficiaries during the COVID-19 pandemic.
- Audit of CARES Act Provider Relief Funds—General and Targeted Distributions to Hospitals
The CARES Act and the Paycheck Protection Program and Health Care Enhancement Act appropriated $175 billion for the Provider Relief Fund (PRF) to support health care providers affected by the COVID-19 pandemic. In April 2020, the Health Resources and Services Administration began distributing the funds through general distributions to Medicare providers. Therefore, it is necessary to determine whether providers that received PRF payments complied with certain Federal requirements and the terms and conditions for reporting and expending PRF funds.
- Audit of Medicare Payments for Inpatient Discharges Billed by Hospitals for Beneficiaries Diagnosed With COVID-19
Section 3710 of the CARES Act directs the Secretary to increase the weighting factor that would otherwise apply to the assigned diagnosis-related group by 20 percent for an individual who is diagnosed with COVID-19 and discharged during the COVID-19 public health emergency period. OIG will audit whether payments made by Medicare for COVID-19 inpatient discharges billed by hospitals complied with Federal requirements.Learn about the OIG exclusion criteria used in the process of imposing exclusions and find out how to establish a comprehensive approach to screening providers and organizations against various exclusion lists.
OIG Work Plan Monthly Updates for September
There are 3 new items in the September release of the OIG Work Plan monthly updates:
- NIH-Funded Clinical Trials Reported to ClinicalTrials.gov
The National Institutes of Health (NIH) provides funds to awardees to conduct clinical trials involving human subjects. These trials are intended to evaluate the effects of drugs or medical devices regulated by the FDA, as well as other interventions that are not regulated by the FDA. One of September’s OIG Work Plan monthly updates is to determine whether NIH ensured that awardees of NIH-funded clinical trials complied with Federal reporting requirements.
- Medicare Advantage Organizations’ Use of Ordering Provider Identifiers for Program Integrity Oversight
National Provider Identifiers (NPIs) for ordering providers are essential for safeguarding the program integrity of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS), clinical laboratory services, imaging services, and home health services in Medicare. However, CMS does not require Medicare Advantage organizations (MAOs) to collect NPIs for ordering providers. Therefore, it is necessary to determine the extent to which MAOs conduct oversight of DMEPOS, clinical laboratory services, imaging services, and home health services using ordering provider identifiers.
- Review of the Food and Drug Administration’s Contract Closeout Actions
As one of the largest contracting agencies in the Federal Government, HHS performed contracting actions totaling almost $26.5 billion in the fiscal year 2019. Prior OIG work identified issues regarding contract closeout, which is required once a contracting officer receives evidence of receipt of property and final payment, or evidence of physical completion of a contract. One of OIG Work Plan monthly updates is to determine whether FDA closed contracts in accordance with the Federal Acquisition Regulation and departmental guidance.
Meeting Healthcare Compliance Standards
To be effective, a healthcare compliance program needs to demonstrate the organization’s commitment to following the law and ethical standards. As a continuously updated document with new projects added throughout the year, the OIG Work Plan serves as a framework of audits, inspections, and evaluations that can help healthcare organizations identify key risk areas and make timely and necessary changes.
Providers and entities in the areas identified in the OIG Work Plan monthly updates, such as issues related to the COVID-19 response, should ensure they comply with OIG’s guidance. Paying close attention to the OIG’s areas of interest and enforcement priorities helps healthcare organizations make timely updates of relevant policies and procedures. While following the OIG Work Plan monthly updates and keeping track of different guidelines can be complex, the right exclusion screening software can simplify the entire process. Such an approach can help healthcare organizations meet strict compliance standards, stay audit-ready, and set higher standards when it comes to protecting patients and their data.