C.J. Wolf, MD provides enforcement action summaries for the YouCompli blog. These summaries provide real-world examples of regulators’ response to practices that don’t fully comply with regulations. This month’s article looks at COVID enforcements.
Healthcare compliance history has shown that when the government disperses significant funds, audits and enforcement associated with the disbursement of those funds will shortly follow.
The Federal government spent unprecedented trillions of dollars throughout the COVID public health emergency (PHE). So, it should come as no surprise that we are seeing significant auditing and enforcement activity.
In April 2022, officials at the U.S. Department of Justice (DOJ) announced major enforcement actions and said that they are “dedicated to rooting out schemes that have exploited the pandemic. Today’s enforcement action reinforces our commitment to using all available tools to hold accountable medical professionals, corporate executives, and others who have placed greed above care during an unprecedented public health emergency.”
Those enforcement efforts have not slowed down. Let’s look at a few.
Cutting in line for immunizations
Remember when immunizations for COVID first became available? There was a prioritization of giving the most vulnerable individuals the first opportunity to receive the immunization. Among these were long-term care residents. One of the programs to prioritize these individuals was the Centers for Disease Control and Prevention’s (CDC) Pharmacy Partnership for Long-Term Care Program. The program was specifically designed to vaccinate long-term care facility residents and staff when doses of COVID-19 vaccine became available. MorseLife Nursing Home Health System was alleged to have provided vaccines to individuals who were not eligible under this program. MorseLife agreed to pay $1.75 million to settle the False Claims Act allegations.
The government alleged MorseLife knew the program covered only long-term care residents and staff but invited hundreds of ineligible people to receive vaccinations. Some of those ineligible people were board members and their families, donors, and potential donors. What’s more, the vice chairman of the board and his brother reportedly invited close to 300 people to receive the vaccine. The DOJ announcement included a text message from the CEO to an ineligible person that said, “I will find you when you come in the morning and we’re going to make you an employee of Morse . . . Guarantee you get the vaccine.”
Infection control measures
The Attorney General (AG) of Massachusetts sued a nursing home and its owner for failing to properly institute infection control protocols including failure to isolate residents who may have been infected with COVID.
The AG said, “Residents of long-term care facilities across Massachusetts and their families deserve to feel confident that they will be cared for and protected. We’re taking action against Sea View Retreat, Inc. because of their failure to implement basic, potentially lifesaving COVID-19 mitigation measures to protect their vulnerable residents at the start of the pandemic.”
Some of the allegations included failing to isolate multiple residents who were suspected, symptomatic, or known to have tested positive for COVID-19. It was also alleged the nursing home did not promptly test a symptomatic resident for COVID-19 and did not implement facility-wide infection control and prevention measures.
The initial complaints that sparked the AG’s investigation came from the Massachusetts Department of Health.
Vaccination cards have held an important place in many wallets and purses during the pandemic. This documentation was often required to demonstrate vaccination status. Many jurisdictions had restrictions in place so they could minimize the spread of the infection. At times, vaccination status records were needed to travel or to enter certain venues or participate in certain activities. Different kinds of fraud and abuse have sprung up in relation to vaccination cards.
Among some of the more recent enforcement actions are:
- Two individuals were sentenced for stealing and selling CDC COVID-19 vaccination record cards
- A South Carolina director of nursing pleaded guilty to lying about producing fraudulent COVID-19 vaccination record cards.
- A court in Ohio issued a decree to shut down a woman’s production and selling of fake COVID-19 vaccination cards.
Considerations for healthcare compliance officers
These enforcement efforts should prompt compliance officers to proactively consider risks from the PHE:
- For any special disbursement of COVID funds or grants received, make sure to review the fine print about the strings attached to those funds. The government does not give funds without some metric or deliverable that they expect you to meet. Compliance officers should make sure their organizations are delivering on their promises.
- Confirm there are internal controls, checks, and balances for critical steps. For example, check to make sure vaccination cards are locked and secured. Verify who has authority to distribute cards. Make sure there are inventory processes in place to confirm cards don’t go missing.
- Many providers, like nursing homes, were required to follow strict infection control procedures. Compliance officers should review policies to make sure they are up-to-date and understood by staff. Also make sure you are periodically auditing and monitoring to ensure policies are being followed and not just sitting on a shelf.
These audits and assessments will help you get ahead of potential inquiries from regulators. If the anomalies were a result of fraud rather than the haste and chaos of the early days of COVID, it’s especially important to start documenting them. (Read more about how enforcement officials like to work with compliance professionals.) If you spot suspicious or problematic patterns, you can start work to remedy them and self-report as appropriate.