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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Coordinate the messaging from your leadership groups. Speak with one voice to provide consistent, accurate, and uniform information to staff and the public.
Jones Walker is working with clients in a wide range of capacities to help them shift from reacting to COVID-19 to getting out ahead of it. If you have questions about how we can help, please feel free to contact the Jones Walker attorney with whom you usually work or any member of the firm’s Corporate Compliance & White Collar Defense Practice Group.
The information in this advisory is provided to our clients for general information purposes and is not intended as legal advice. Always seek counsel before taking any action related to compliance risk.