Each month, we are pleased to share the most recent additions to the HHS Office of Inspector General (OIG) Work Plan items. HHS OIG updates its Work Plan monthly with new changes to the active list. Let’s take a look at the new updates from this month.
What is the OIG Work Plan?
The HHS OIG Work Plan sets forth various projects that OIG plans to undertake during the fiscal year (FY) and beyond.
Projects listed in the Work Plan span HHS’s operating divisions, including the following:
- Centers for Medicare & Medicaid Services (CMS)
- Public health agencies such as the Centers for Disease Control and Prevention (CDC)
- National Institutes of Health (NIH)
- Administration for Children and Families (ACF)
- Administration for Community Living (ACL)
- Various state and local governments – evaluating the use of federal funds as well as the administration of HHS
*Some of the projects described in the Work Plan are statutorily required.
The April agenda includes 10 new items from HHS Office of Inspector General (OIG). Let’s walk through this latest release so you can address it within your compliance program, if applicable.
- Audit of HHS’s Production and Distribution of COVID-19 Lab Test Kits
- A Review of HHS’s Suspension and Debarment in Protecting the Integrity of Federal Awards
- Opioid Use in Medicare Part D in 2019
- States’ Oversight of Medicaid Managed Care Medical Loss Ratios
- CMS’s Internal Controls Over Hospital Preparedness for Emerging Infectious Disease Epidemics Such as Coronavirus Disease 2019
- Audit of ASPR’s Operation of the Strategic National Stockpile in Response to the COVID-19 Disease Pandemic
- The Food and Drug Administration’s Role in Facilitating Testing for COVID-19
Audit of HHS’s Production and Distribution of COVID-19 Lab Test Kits
A crucial element of responding to COVID-19 involves ramping up lab testing for all communities during the pandemic. The Centers for Disease Control (CDC) is responsible for quickly responding to new viral diseases by developing and distributing testing kits to state public health laboratories.
HHS OIG will be reviewing the controls that are in place to produce and distribute COVID-19 lab test kits and whether the CDC has mitigated potential risks by designing and implementing safety controls.
A Review of HHS’s Suspension and Debarment in Protecting the Integrity of Federal Awards
The U.S. Department of Health and Human Services is continuously evaluating and protecting the integrity of federal healthcare programs. Because of the number of grants and funds awarded from HHS (3rd largest federal contracting agency), it’s important to have an effective suspension and debarment program.
HHS OIG will be conducting a study to help describe the actions taken to protect awards and the effective characteristics or improvements necessary for the HHS’ Suspension and Debarment Program.
Opioid Use in Medicare Part D in 2019
In 2018, there were 46,802 opioid-related overdose deaths reported to HHS OIG. The devastation that the opioid epidemic has caused throughout the United States has been felt throughout many regions, none more concentrated than the number of overdose deaths in Appalachia.
In addition to a 2018 study, HHS OIG will be conducting a Medicare Part D data brief for opioid use in 2019. The review will include data on spending for opioids, the number of beneficiaries who received large amounts of opioids, and prescribers who ordered large quantities of opioids to Medicare beneficiaries.
States’ Oversight of Medicaid Managed Care Medical Loss Ratios
Federal and state governments utilize medical loss ratio (MLR) requirements from Medicaid managed care plans to assess growth in Medicaid spending. A common concern is that managed care plans could potentially be keeping funds for administration and profit rather than spending the majority of Medicaid capitation payments on care for beneficiaries.
Managed Care plans are required to collect MLR data and provide a percentage back to each state with any additional underlying data. Determining each state’s oversight of Medicaid managed care MLRs helps states set appropriate managed care payment rates and control Medicaid costs.
CMS’s Internal Controls Over Hospital Preparedness for Emerging Infectious Disease Epidemics Such as Coronavirus Disease 2019
The U.S. healthcare system is being stretched thin and having to adapt quickly to respond to the COVID-19 pandemic. It’s essential for hospitals and healthcare organizations to have an emergency preparedness plan to respond to emerging infectious disease epidemics such as Coronavirus.
We’ve seen many exceptions and waivers in recent months from the Centers for Medicare and Medicaid Services (CMS), HHS OIG, and others to help curb the spread of COVID-19 and increase access to care. The most prevalent changes have come with the expansion of interstate licensure waivers and portability, as well as telehealth and telemedicine services.
Thankfully, CMS just recently began requiring hospitals participating in Medicare to include planning for emerging infectious diseases in their emergency preparedness guidance. HHS OIG will be auditing the internal controls over hospitals for this planning, and hospital compliance with CMS requirements for emergency preparedness.
Audit of ASPR’s Operation of the Strategic National Stockpile in Response to the COVID-19 Disease Pandemic
In the event of a national emergency, the U.S. Strategic National Stockpile was created by Congress in 1999, and has changed oversight and operations from the CDC to the HHS Assistant Secretary for Preparedness and Response (ASPR) in 2018.
OIG will be determining whether ASPR’s operation of the Stockpile was effective in response to the coronavirus disease 2019 (COVID-19) pandemic.
The Food and Drug Administration’s Role in Facilitating Testing for COVID-19
According to Section 564 of the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) can issue an Emergency Use Authorization (EUA). When administered, a EUA allows the use of certain unapproved medical products or uses of such unapproved medical products to be used to diagnose, treat, or prevent serious or life-threatening diseases when there are no adequate, approved, and available alternatives.
Recently, the FDA issued the first COVID-19 EUA for a CDC diagnostic test and subsequent EUAs to other testing laboratories. HHS OIG will be examining the EUA processes from the FDA in responding to COVID-19 and any challenges faced for diagnostic and antibodies testing.