As a claims organization, it’s up to us to keep our clients and their customers informed on current issues and deliver peace of mind. The healthcare, product liability and life sciences space is constantly evolving, but we’re keeping an eye on the following areas related to the coronavirus (COVID-19) outbreak and sharing resources and information to help you remain prepared.

• Restrictions in senior living facilities
• Medical malpractice claims against providers
• Drug and medical device shortages
• Vaccine development

Restrictions in senior living facilities

The elderly make up one of the most vulnerable populations facing the threat of the coronavirus. In an effort to reduce the spread of the virus, senior living facilities and nursing homes have been advised by healthcare administrators — and in many cases ordered — to isolate residents and patients. For impacted facilities, this means group activities are cancelled, non-essential visitors are limited or blocked and shared meal spaces are banned. While these restrictive measures may potentially decrease the risk of seniors being affected by COVID-19, they may lead to an increase in other types of risks, including:

• Injuries from falls while residents are segregated from others
• Choking as a result of eating in isolation
• Infections due to patients laying in their own excrement
• Decubitus if turning and repositioning is not diligently performed by staff
• Rising mortality rates as a result of hospitals cancelling surgeries due to the COVID-19 pandemic

There’s also the potential for workers to be less diligent in their approach to caregiving in fear of contracting the COVID-19 virus themselves. This can lead to residents and patients not receiving the typical level of urgent care they need for underlying medical conditions. Dementia patients may not understand quarantine and be fearful. Civil rights violations may be raised due to quarantining residents against their will.

Questions abound within the uncertainty. Will there be enough workers to treat these residents as the virus is spread to the nurses and aides who care for this high-risk population? Will there be enough ventilators and supplies available as compromised residents and patients develop COVID-19? How will the government intervene to address potential worker and supply shortages during this public health emergency?

As we navigate the uncertainties, our level of preparedness becomes even more critical. Most of the same general principles of disaster planning — measures we may have ramped up in recent years in response to increased natural threats like hurricanes and wildfires — are still relevant as we work to protect the safety and well-being of residents in long-term care and other healthcare facilities during a pandemic. Remember to “work your plan and plan your work”; rely upon your tested emergency preparedness policies and procedures, and maintain a level of agility as conditions change.

In the U.S., the Centers for Medicare & Medicaid Services (CMS) provides resources that can help as facilities look to maintain care and compliance:

• CMS’ Current Emergencies page includes a collection of coronavirus-related updates and links for healthcare facilities and providers— latest news, clinical and technical guidance, partner resources and more
• CMS’ general Emergency Preparedness Rule outlines national emergency preparedness requirements to ensure adequate planning for both natural and man-made disasters, and coordination with federal, state, tribal, regional and local emergency preparedness systems

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Medical malpractice claims against providers

As time goes on, we should expect to see the introduction of medical malpractice claims and suits related to COVID-19. Allegations may include:

Failure to develop and implement a plan for emergency preparedness

• The medical facility and office staff members should be trained in appropriate screening procedures based on the Centers for Disease Control and Prevention (CDC) guidelines. Informative signage should be appropriately positioned on the property and relevant information should be available on the provider’s website.

Failure to develop and implement a plan for infection control

• In addition to the standard precautions for infection control, the medical provider should have a designated exam room with dedicated patient care equipment. Planning should ensure an adequate quantity of masks, N95 respirators and other necessary supplies.

Patient abandonment

• This claim may be introduced in the event that a patient is denied entry to the provider due to acute respiratory symptoms. This not only places the patient at risk but potentially exposes everyone else with whom the patient comes into contact.

Failure to diagnose and treat

• When there is a reasonable presumption that a patient may have been exposed to COVID-19, based on CDC guidelines, contact the local or state health department to determine if the patient needs to be tested. All communication with these organizations — as well as recommendations for treatment in the event of a positive test — should be thoroughly documented. Detailed records should also be kept of any provider or staff who had contact with the patient.

Discrimination against people with disabilities

• When there is a shortage of ventilators and other necessary equipment, tough decisions may need to be made. A disabled person may not be as likely to receive available resources as someone healthier with a better chance of survival. Medical ethics committees should develop criteria and be prepared to address these issues.

It is important to note that the lack of adequate testing and medical supplies will have an impact on nearly every aspect of planning, prevention and delivery of care. Providers will need to be vigilant in their ongoing assessment of needs and available resources, and keep thorough documentation of all efforts to meet the demand.

Reference:
https://www.thedoctors.com/articles/2019-novel-coronavirus-and-patient-safety-in-the-medical-office/

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Drug and medical device shortages

The coronavirus outbreak has sparked significant concerns among drug and device manufacturers about the potential supply chain distributions, given the large number of ingredients sourced in China, disruption to production around the world, and the high demand everywhere for supplies such as personal protective equipment and ventilators. The U.S. Food and Drug Administration recently asked for more than 180 drug manufacturers to evaluate their supply chains. This brings up some questions: What is the amount of time a hospital/health system needs to be stocked with drugs/medical supplies so they can last X number of months without receiving new shipments? Does CMS require this in every hospital’s disaster preparedness policy?

As it stands, CMS requires hospitals to:

• Have an emergency management committee and plans
• Conduct a hazard vulnerability analysis (to include off-site locations)
• Comply with local and state regulations

According to CMS, the hospital is required to "develop an understanding of their capabilities and limitations in order to make effective decisions concerning the progressive curtailment or stopping of services in an organized and prioritized way so as to maintain those services most applicable to the emergency situation for as long as possible. The issues for analysis are to be high priority issues identified in the hazard vulnerability analysis. The anticipated actions, emergency supply inventory, access to emergency supplies capability, and emergency services are to be based upon that assessment process. Exercises can be used to validate or adjust the sustainability plan. If any of the organization's controlling authorities, such as a local/state/region/federal charter, requires the organization to remain open for a specified period of time, then the organization is to comply. [EM.02.01.01]"

CMS won't be prescriptive in giving direction on how long the hospital needs to be stocked up with medical/supplies, etc. Going forward, hospitals/health systems may want to revisit how long they need to be stocked up. Hopefully, we will not experience another situation like COVID-19 again, but you can never be sure.

Reference:
https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Emergency-Prep-Rule

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Vaccine development

For many people, including President Trump, the question around a vaccine remains: Isn’t there a way to speed this process up? The White House is focused on quickly developing treatments and vaccines for the United States, but government scientists have repeatedly reminded us that when it comes to vaccines, they can only move so fast.

Multiple drug manufacturers are aggressively pursuing viable options; the World Health Organization (WHO) notes that at least 20 vaccines are being developed. In fact, human trials have already begun, using an experimental vaccine from biotechnology company Moderna Therapeutics in partnership with the National Institutes of Health. However, as fast as these companies are moving, WHO cautions that it may be 18 months before a vaccine is approved and ready for the public.

While we wait for treatments and a vaccine, one factor that could slow the spread of the coronavirus is the changing of the seasons. As we spend less time in confined spaces, human behavior changes. Some viruses become less transmissible as the temperature and humidity rises during the summer months. This means that the viruses themselves may not live as long on surfaces in these conditions. Of course, this is still unknown. The weather across China did not seem to impact the course of the outbreak. And we all now face more time in confined spaces under expanding quarantine measures.

To end this outbreak for good, we’ll need antiviral treatments or a vaccine. Those are in production, but it still could be a year or more before the safety and efficacy of these pharmaceuticals are proven. In medicine, effectiveness is not guaranteed.

It will be interesting to see if any liability challenges are raised against the pharmaceutical company that creates a COVID-19 vaccine. In the United States, vaccine manufacturers have attained an extremely high level of liability protection through legislation and judicial interpretation. As outlined in this article by the Emory Law Journal, the 1986 National Childhood Vaccine Injury Act (the Vaccine Act); the 2005 Public Readiness and Emergency Preparedness Act; and Bruesewitz v. Wyeth LLC, the U.S. Supreme Court’s decision interpreting the Vaccine Act, together give vaccine manufacturers almost complete liability protection from damages for vaccine harms. In contrast, a June 2017 decision by the Court of Justice of the European Union confirmed that an injured person can seek compensation in civil court if they believe a vaccine is unreasonably dangerous or defective.

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Look for additional insights from our team on healthcare and liability concerns related to COVID-19. In part two of this blog, we will take a closer look at ways organizations can prepare for claim-related challenges during the pandemic.

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Contributors:

• Mike Brendel, AVP, Specialty Operations, Professional Liability, Sedgwick
• Chris Grant, AVP, Specialty Operations, Professional Liability, Sedgwick
• Mindi Bieber, AVP, Specialty Operations, Professional Liability, Sedgwick
• John Walsh, AVP, Specialty Operations, Professional Liability, Sedgwick