Best Practices from China on COVID-19, Emerging Standards of Care at Home, and Related Legal Considerations

March 10, 2020
Firm Publication

As novel coronavirus disease (COVID-19) outbreaks spread across the globe and the number of confirmed cases in the United States rise, healthcare providers nationwide are in the process of preparing for a potential pandemic.

Government officials and healthcare experts alike continue to warn of COVID-19’s inevitable spread, and with the virus’s spread will come an influx of patients filling hospital, clinic, and doctors’ office waiting rooms.

Since COVID-19 is thought to be transmitted from person-to-person through respiratory droplets, healthcare providers should consider the legal risks related to patient exposure to COVID-19 in crowded waiting rooms. Deviating from the standard of care in a way that causes harm to a patient can lead to medical malpractice claims, and it is not difficult to imagine patients or their families making such claims if they believe they contracted COVID-19 at a healthcare facility and can show evidence of an emerging standard of care to limit or eliminate patient-to-patient contact in such facilities.

Bass, Berry & Sims spoke with one physician on the front lines of the COVID-19 epidemic. Joseph Bagley Shumway, MD is Chief Medical Officer and a practicing OB-GYN at United Family Healthcare (NYSE: NFH), a premier private seven-hospital health system based throughout China. Dr. Shumway provided us with the insights he has learned as an American physician now practicing in China – especially in light of the COVID-19 outbreak. “Given the new issues of Coronavirus, we need to approach the delivery of medicine differently. We need new healthcare delivery standards,” said Dr. Shumway.

Dr. Shumway provided several suggestions for healthcare providers to move toward being  “minimum contact hospitals or clinics” in the COVID-19 era, which notably centered around the absence of waiting rooms, pharmacy visits, and standard check-in and check-out at reception. Minimal, streamlined contact is aimed at preventing risks to patients, practitioners, and the public.

Building on Dr. Shumway’s tips for “minimum contact hospitals or clinics,” below are the trends developing globally as alternatives to the traditional patient waiting room along with the legal implications to consider before such innovative ideas can be implemented within the United States.

  1. “Drive-Thru Testing.” South Korea is reportedly utilizing a fast-food drive-thru inspired testing protocol whereby patients are tested for COVID-19 by hazmat suit-clad healthcare workers all from the comfort of their cars. Healthcare professionals at designated testing sites can check for fever and respiratory ailments and perform swab tests through car windows on patients that remain in their cars. We have heard that some U.S. local health departments are requiring potential COVID-19 patients to remain in their cars, and are coming out to test them.  In connection with broadening similar ideas in the United States, healthcare providers should consider the following (at a minimum):
    • Whether state or local licensure or permits are required.
    • Any legal implications if services are provided off hospital grounds; Centers for Medicare & Medicaid Services (CMS) requires that temporary inpatient locations be added to a hospital’s 855A enrollment and comply with all provider-based location requirements. It is likely that any new outpatient testing locations would similarly need to be added to the provider’s Medicare enrollment.
    • Whether insurance covers any damage to people or property that could result from services provided in this new type of location.
    • The necessary policies, procedures, and protocols to keep healthcare professionals safe as they weave between vehicles to provide testing.
  2. “Digital Lines” and Text Messaging. Dr. Shumway provided an increasingly popular alternative to waiting rooms: all patients (whether or not they are being tested for COVID-19) are put into a digital queue and receive a text message when it is time for their appointments. Patients can wait wherever they choose before their appointments. Waiting rooms are skipped entirely as patients are brought directly to a private room upon arrival. Considerations for this method could include the following:
    • Risks associated with allowing (and even encouraging) sick patients to wait for their appointments in other public spaces such as nearby coffee shops or parks.
    • Obtaining consent to send patients text messages and ensuring patients’ privacy.
    • Potential Emergency Medical Treatment and Labor Act (EMTALA) implications due to patients presenting at an emergency room only to be told to wait elsewhere until they can be seen by a healthcare professional; particularly if the patient, to his or her detriment, opts not to return due to long waits.
  3. Telemedicine. The Centers for Disease Control and Prevention (CDC) and other agencies and experts are encouraging the use of telemedicine as a means to prevent patients that can be cared for at home from coming to facilities only to expose themselves and others to germs. For some healthcare facilities, this would involve utilizing their existing telehealth infrastructure; for others, this may mean developing and implementing telemedicine technologies for the first time. Both should consider the following potential legal risks and barriers:
    • Proper licensure of healthcare professionals in all jurisdictions in which the telehealth patients receiving services reside.
    • Reimbursement implications, given the ever-evolving telemedicine policies for commercial and government payors, some of which require that to be reimbursed, patients be located in an originating site (i.e., a hospital, physician office).
    • Need for adequate telehealth technologies by both patients and providers as well as state-specific technology requirements.
    • Limitations involving the services that can be provided via telemedicine (i.e., consultations and assessments only) and the likelihood for human error if patients administer swab tests themselves.

When implementing any of these alternatives, as well as general COVID-19 preparation, healthcare providers should review and update their emergency preparedness and infection control policies and procedures to ensure compliance with applicable federal, state, and local laws. This should include a review of both mandatory rules, such as the CMS’ Emergency Preparedness Rule and The Joint Commission standards, as well as voluntary guidance, including the CDC COVID-19 guidance and preparedness assessments and tools. Be sure to track pending legislation that could impact your organization and necessitate compliance with new requirements.

Epidemiologists and other health experts largely agree that hospitals and other healthcare providers may be overwhelmed with patients in the coming weeks. To the extent your organization can adopt and implement any of the above-mentioned practices in a timely, compliant fashion, there is the potential for both decreased risk of medical malpractice claims as well as business benefits such as increased patient satisfaction, reduced risk to the workforce, and healthcare delivery options that distinguish your entity from competitors.

If you have any questions regarding the alternatives outlined above or how to prepare your organization as COVID-19 spreads, please contact the authors or one of our healthcare attorneys.

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