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HHS OIG Response to COVID-19 Challenges

May 27, 2020

The largest of the federal Offices of Inspectors General is at the Department of Health and Human Services (HHS OIG). As we have written before, Offices of Inspectors General are critical in protecting taxpayer dollars from fraud. Among other things, OIGs help whistleblowers and the Department of Justice (DOJ) enforce the False Claims Act.

Given HHS’s immense responsibilities and budget, the large size of its OIG is fitting. HHS’s Centers for Medicare and Medicaid Services (CMS) administers programs that reimburse medical items and services for millions of Americans. Medicare and Medicaid constitute a significant part of the federal budget. Also, CMS oversees more than 15,000 Medicare- and Medicaid-certified nursing homes in the United States.

In addition, HHS programs and agencies play a key role in health care, medical research, clinical trials, infection control and prevention, hospital preparedness, approval of pharmaceuticals, diagnostics, and medical devices, and stocking and managing the Strategic National Stockpile (SNS). These include, for example, the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Assistant Secretary for Preparedness and Response (ASPR), and the Biomedical Advanced Research and Development Agency (BARDA).

HHS is Spending Hundreds of Billions of Dollars in Response to COVID-19

In the last two months, Congress has passed several laws to respond to the coronavirus pandemic. These include the Coronavirus Aid, Relief, and Economics Security (CARES) Act (P.L. 116-136), the Coronavirus Preparedness and Response Supplemental Appropriations Act (P.L. 116-123), and the Families First Coronavirus Response Act (P.L. 116-127). To date, these total more than $2 trillion. Currently, Congress is considering at least another $3 trillion as part of the HEROES Act.

As of mid-May 2020, Congress has appropriated over $250 billion to HHS as part of this coronavirus response. This includes money to fund research and studies into vaccines, medicines, and diagnostic testing, to acquire personal protective equipment, medicines, diagnostics, and ventilators for the Strategic National Stockpile, to approve and distribute the same, and to fund the manufacture of potential vaccines, tests, and treatments. Congress authorized over $175 billion for a Public Health and Social Services Emergency Fund for healthcare provider relief.

Due to COVID-19, HHS is expending substantial monies from other appropriations. Medicare and Medicaid costs are increasing. A disproportionate number of cornonavirus patients are Medicare or Medicaid beneficiaries receiving treatment in a hospital, nursing home, or other long term care facility.

Updated HHS OIG Work Plan Includes COVID-19 Audits and Examinations

Each month, HHS OIG updates its Work Plan “to meet priorities and to anticipate and respond to emerging issues with the resources available.” The Work Plan reflects the steps the OIG plans to take to audit, evaluate, and inspect the programs within HHS and the beneficiaries of those programs and recipients of HHS funding. Not surprisingly, recent updates show the OIG pivoting to HHS’s response to COVID-19.

The April 2020 update shows the OIG focusing within HHS to evaluate how well its components responded to the immediate coronavirus public health crisis. We all remember insufficient diagnostic testing, shortages in personal protective equipment, and the rush to approve tests and laboratories.

More recently, an update on May 20, 2020 includes additional COVID-19 related items. HHS-OIG plans to audit nursing homes, hospitals, and other providers that receive HHS funding and treat Medicare and Medicaid patients.

According to recent Work Plan updates, below is a sampling of what HHS-OIG will be examining and reporting on.

CDC, FDA, and ASPR Response to the Immediate Public Health Crisis

  • Audit of HHS’s Production and Distribution of COVID-19 Lab Test Kits: HHS OIG will review the CDC’s process of producing and distributing the COVID-19 test kits to state public health laboratories. The OIG plans “to review the controls that HHS has in place to produce and distribute the COVID-19 test kits and whether CDC has designed and implemented controls to mitigate any potential risks.”
  • Audit of ASPR’s Operation of the Strategic National Stockpile in Response to the Coronavirus Disease Pandemic: The Strategic National Stockpile (SNS) is a repository of supplies such as ventilators, personal protective equipment, and medicines for use in the event of a national emergency. HHS-OIG will assess “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: In a declared national public health emergency, the FDA has the authority to issue an Emergency Use Authorization (EUA) that allows “for the use of certain unapproved medical products, or unapproved uses of certain approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when there are no adequate, approved, and available alternatives.” It fell to the FDA to issue the first COVID-19 EUA for a diagnostic test to the CDC. In addition, the FDA issued subsequent EUAs to other laboratories. HHS OIG will examine the FDA’s “processes and any challenges it may have faced regarding EUAs for COVID-19 diagnostic tests and serological tests for antibodies developed in response to the viral infection.”

Nursing Homes: Infection Prevention and Control and Emergency Preparedness

More than 1.3 million Americans live in approximately 15,450 Medicare- and Medicaid-certified nursing homes in the United States. The CDC has identified nursing home residents as high risk for severe illness from coronavirus. CMS requires nursing homes to have infection prevention and control policies and emergency preparedness plans that meet federal requirements. Under CMS’s direction, State Survey Agencies (SSAs) are to inspect and audit facilities and order them to correct any deficiencies.

Unfortunately, the coronavirus has hit nursing home residents and staff disproportionately hard. Appropriately, the May update has two items aimed at nursing homes:

  • Audit of Nursing Home Infection Prevention and Control Program Deficiencies: “To reduce the likelihood of contracting and spreading COVID-19 at these nursing homes, effective internal controls must be in place.” Nevertheless, the Work Plan notes that “As of February 2020, State Survey Agencies have cited more than 6,600 of these nursing homes (nearly 43 percent) for infection prevention and control program deficiencies, including lack of a correction plan in place for these deficiencies.” In this audit, HHS OIG’s “objective is to determine whether selected nursing homes have programs for infection prevention and control and emergency preparedness in accordance with Federal requirements.”
  • Nursing Home Oversight During COVID-19: HHS OIG will “use recent complaint and survey data for all nursing homes … to examine the extent to which SSAs and CMS are conducting onsite surveys in nursing homes related to serious complaints and targeted infection control, in accord with CMS’s recent guidance ….” Further, it will “identify any barriers that CMS and SSAs face in conducting onsite surveys, as well as potential solutions.”

Nursing home residents are among our most vulnerable citizens. Unfortunately, COVID-19 infections and deaths have disproportionately afflicted nursing home residents and staff. Therefore, the CARES Act includes $200 million to support nursing home infection control. These HHS OIG audits are important for accountability and for drawing lessons for the future.

Healthcare Providers: $175 Billion in Relief Funds

The CARES Act appropriated $175 billion to HHS for a Provider Relief Fund (PRF) to assist eligible healthcare providers. As of late May, HHS reportedly has disbursed $72 billion from the PRF. Recently, the New York Times reported that some of the wealthiest hospital systems in the United States have received billions in bailout money while smaller, poorer, struggling systems are receiving tiny amounts by comparison.

To receive money (Payment) from the PRF, a provider must certify to HHS that:

  • it “billed Medicare in 2019; provides or provided after January 31, 2020 diagnoses, testing, or care for individuals with possible or actual cases of COVID-19; is not currently terminated from participation in Medicare or precluded from receiving payment through Medicare Advantage or Part D; is not currently excluded from participation in Medicare, Medicaid, and other Federal health care programs; and does not currently have Medicare billing privileges revoked.”
  • “the Payment will only be used to prevent, prepare for, and respond to coronavirus, and that the Payment shall reimburse the Recipient only for health care related expenses or lost revenues that are attributable to coronavirus.”
  • it “will not use the Payment to reimburse expenses or losses that have been reimbursed from other sources or that other sources are obligated to reimburse.”

Additional terms and conditions for receipt of PRF funds can be found here.

In its Audit of CARES Act Provider Relief Funds-Distribution of $50 Billion to Health Care Providers, HHS OIG, will, among other things, review PRF payments for compliance with CARES Act requirements. Also, it will examine “whether HHS controls over PRF payments ensured that payments were correctly calculated and disbursed.”

HHS OIG Mission Is to Protect Public Health and Hundreds of Billions of Taxpayer Dollars

Agencies within HHS are critical to managing the public health crisis caused by the coronavirus pandemic. The HHS OIG plays an essential role by overseeing the agencies and programs within HHS charged with protecting our health. It also provides oversight for the hundreds of billions of dollars HHS is spending in response to COVID-19. Further, HHS OIG investigates fraud allegations brought by whistleblowers under the False Claims Act and holds bad actors accountable. To protect public health and preserve taxpayer dollars, we depend on dedicated OIG staff and courageous whistleblowers.

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