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Real-Time Strategies for Healthcare Providers: Preparing for Government Investigations and Litigation Arising From the COVID-19 Pandemic

Medical professionals are on the front line in the fight against COVID-19. In these most trying circumstances, we know everyone is acting in the best interests of the patients, with compassion, and with prudence. Nonetheless, you should begin to think about what comes after the war. Our experience in past disasters and crises unfortunately teaches us that regulators, government investigators, and plaintiffs’ lawyers will often seek to second-guess and question every course of conduct and decision. Here are several practical strategies for helping ensure that you can show you acted with integrity and in the best interests of your patients.

  1. Document your staff’s response efforts to the greatest extent possible. If you depart from your standard policies and procedures or your emergency response plan, document the reasons why. Treat the entire COVID-19 response effort, for example, like the actions taken in the emergency room environment, and effectively use a scribe to document actions, incoming and outgoing communications, and decisions.

  2. Monitor updates and other guidance issued by the CDC, FDA, CMS, and OSHA, and adapt your policies and protocols as needed to account for changes. The guidance from regulators is changing or being otherwise updated frequently — in some cases, daily. If exigent circumstances require departing from this guidance, seek counsel before acting, and, when necessary, document the reasons for any departure.

  3. Do not assume that following the guidance and emergency authorizations issued by regulatory agencies or professional associations will protect you from scrutiny if you depart from your normal standard of care. This guidance is frequently qualified and often conflicting. Do not act based on what you read on a website or what other people tell you, even those who are trying to be helpful. Seek guidance from legal counsel whenever possible before acting.

  4. Manage and anticipate risk proactively by seeking specific government authorization for any significant change in policies and practices that could pose a serious risk of harm to patients or employees. State and federal regulators are acting quickly to authorize the use of new medical devices, device modifications, and drug therapies. Do not act unilaterally.

  5. Educate your staff to be thoughtful about their written communications and to choose their words carefully to reduce the risk that their words could later be misconstrued or mischaracterized. Many investigations and lawsuits are fueled by ill-considered and unfortunate wording that is read out of context.

  6. Encourage collaborative and frank verbal discussions with your staff. Listen to their complaints and act upon them to the extent appropriate and practicable. The media are looking for opportunities to publicize healthcare worker concerns, legitimate or not. If employees know their concerns will be heard by their employers, they will feel supported and will be far less likely to resort to voicing their complaints to the media.

  7. Protect privilege and confidentiality. Remind employees that they must respect their obligations to protect the confidentiality of their patients and of commercially sensitive information even in times of emergency. To mitigate the risk of unauthorized disclosures, include a confidentiality legend on internal documents about important matters and mark your communications with in-house and external counsel as confidential and privileged. And remember that HIPAA remains in effect, even where CMS has provided for limited waivers.

  8. Retain all relevant documents and follow your document retention policies. It is very important that you keep any and all directives or guidance you receive from government and regulatory agencies so the circumstances under which you are working are clear — even years in the future when memories have faded. If you are given a verbal directive from a government agency, document it, including who provided the directive and when.

  9. Coordinate the messaging from your leadership groups. Speak with one voice to provide consistent, accurate, and uniform information to staff and the public.

© 2020 Jones Walker LLP

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About this Author

Pauline F. Hardin Litigation Attorney Jones Walker New Orleans, LA
Partner

Pauline Hardin is a partner in the Litigation Practice Group. She focuses on criminal litigation as well as business, commercial, and labor disputes.


Pauline has tried more than 150 jury trials across the spectrum of criminal and commercial litigation. She routinely handles bet-the-company and high-stakes matters, and also draws on her experience to help clients facing grand jury investigations by avoiding prosecution, or when facing criminal charges, by negotiating plea agreements or going to trial.

Pauline focuses on representing companies and individuals...

504.582.8110
Mike W. Magner Litigation Attorney Jones Walker New Orleans, LA
Partner

Mike Magner is a partner in the Litigation Practice Group. A former federal prosecutor, he represents clients in a wide range of commercial disputes, investigations, and white-collar criminal matters.


Mike is a preeminent and widely respected trial attorney and Fellow of the American College of Trial Lawyers. He has more than 35 years of experience litigating complex criminal and civil matters, including more than 45 jury trials. He provides preventive and litigation services for businesses and individuals in corporate and white-collar criminal matters. He also represents individuals and companies in connection with grand jury and other investigations.

Mike has particular experience in anti-corruption compliance and litigation matters on the domestic and international levels, with broad experience in civil and criminal RICO matters. He served as a federal prosecutor in New Orleans for 20 years. In that role, he was a key member of the team that successfully prosecuted former Louisiana Gov. Edwin Edwards, following a five-month trial. He was also the lead prosecutor in the Department of Justice's long-term investigation and prosecution of judicial and related public corruption known as "Operation Wrinkled Robe." In recognition of his work, Mike was awarded the Department of Justice's highest award for litigation, the John Marshall Award, as well as the Director's Award for Superior Performance by a Litigative Team.

He has also served as a supervisor of the US Attorney's Office's Anti-Terrorism/Crisis Response Unit, Organized Crime Strike Force, and Violent Crime Unit, and has tried cases in virtually all sections of the US District Court for the Eastern and Middle districts of Louisiana.

Mike is particularly adept in handling long-term, complex white-collar investigations and trials, including export control, mail and wire fraud, government contract fraud, bribery, money laundering, police misconduct, and civil rights violations. In 2011, he served as the Federal Bureau of Investigation's advisor to the Kenyan Anti-Corruption Commission in Nairobi, Kenya, where he was embedded in their principal headquarters for nearly two months, and provided training to KACC's investigators, auditors, and attorneys on corruption compliance, investigative, and prosecution matters. He has also trained foreign judges and prosecutors in Central Asia and Africa and has regularly trained federal prosecutors through the Attorney General's Advocacy Institute.

Following Hurricane Katrina, Mike prosecuted the first criminal case upon the re-opening of federal court and also successfully tried several high-profile civil rights cases against New Orleans policemen. He was the US Department of Justice's first counsel for emergency management and crisis response in the Office of Director, Executive Office for US Attorneys in Washington, DC, for 18 months, where he represented the DOJ at various White House-level emergency exercises and planning meetings relating to the federal government’s response to major criminal events, natural disasters, and pandemics. While with the DOJ, Mike was also selected as a trained evaluator of other US Attorneys' Offices throughout the country on various substantive legal areas, as well as ethics and professionalism. 

Mike is also an associate professor at the Tulane Law School, where he teaches a course in trial advocacy.

504.582.8316
Avery B. Pardee Litigation Attorney Jones Walker New Orleans, LA
Partner

Avery Pardee is a partner in the Litigation Practice Group. She focuses her practice on criminal defense, internal and government investigations, and commercial litigation.


Avery has significant experience defending and advising individuals, publicly traded companies, private businesses, and other entities with respect to internal investigations, government investigations, criminal prosecutions, parallel proceedings, and compliance with a host of federal and state regulations and laws. She regularly conducts internal investigations, assists with responses to...

504.582.8358