Elisabeth Belmont, general counsel of MaineHealth system.

Elisabeth Belmont is corporate counsel at MaineHealth in Portland, Maine, the state's largest integrated health system with combined annual revenues in excess of $2 billion, a position that she has held since 1998. 

As of March 5, testing had not turned up any confirmed cases in Maine of COVID-19, the novel coronavirus first detected in China, but a few cases had been detected in neighboring New Hampshire and Massachusetts, and state and health care officials in Maine were preparing for its possible arrival with about a dozen Mainers being tested on Friday. MaineHealth also serves northern New Hampshire.

Prior to attaining her current role, Belmont served in a similar role at Maine Medical Center, the system's flagship hospital prior to a corporate reorganization. Belmont is a past president of the American Health Lawyers Association, where she's also held other leadership posts, and is author and editor of publications on emergency and pan-flu preparedness, among others. She lectures nationally on emergency preparedness.

Corporate Counsel asked Belmont about how in-house counsel at hospitals and health care organizations such as her own are responding to the outbreak in the United States of COVID-19 or should be responding. Some of her emailed comments have been edited for length.

Corporate Counsel: What is the in-house counsel's specific role in a health care setting in the context of the current COVID-19 coronavirus outbreak?

Elisabeth Belmont: Corporate counsel advise health care clients on the best means of discharging their legal obligations given the impending risk of a coronavirus outbreak or pandemic, although its timing, duration, location, severity and other variables currently are unknown. 

They assist health care clients with crisis management and related communications by advising on rapidly developing factual scenarios within the context of both legal obligations and employers' disaster recovery and business continuity plans.  

They also assist health care clients to update emergency preparedness policies, procedures and protocols based upon evolving advice from governmental authorities and health officials on the coronavirus outbreak or pandemic.

In advising on a coronavirus outbreak or pandemic, in-house counsel will be faced with a myriad of issues that require him or her to distinguish between business and legal risks, and work with senior management to identify risk mitigation approaches to each one.

CC: What are the main challenges you face as corporate counsel of a large health care organization facing this possible epidemic or pandemic?   

EB: Health care organizations need to address the increased need for patient care at the same time clinical staff may become ill and unable to work. Are plans in place to cross-train personnel to provide patient care? Have plans been established to house medical and other personnel at the facility to limit the exposure of family members to the pandemic strain? To what extent will quarantined health care personnel in their workplaces have access to basic services and care for their families?

Issues regarding patient consent to treatment may also arise involving mandatory treatment, isolation or quarantine. Federal and state statutes grant public health authorities the power to isolate or quarantine and, in some cases, order vaccinations, screenings or treatment for individuals who have contacted or been exposed to the influenza pandemic. 

Is the health care organization familiar with the federal government's isolation and quarantine authority?

In particular, is the organization aware that the Centers for Disease Control and Prevention, through its Division of Global Migration and Quarantine, is empowered to detain, medically examine or conditionally release persons suspected of carrying certain communicable diseases?

When focusing on therapeutic measures to address coronavirus or its complications, providers will need to continue treatment of a patient's chronic co-morbid conditions. Additionally, they may need to respond to acute complications of the chronic condition that may arise in association with coronavirus and will need to consider whether and how coronavirus, and the treatments for coronavirus, may affect dosage and administration of chronic concomitant drug therapy. Anticipation of the effects of co-morbidities can lead to improved patient outcomes.

Preparing adequately for a coronavirus pandemic may require health care organizations to overcome their traditional fears of liability and address altered standards of care that may become necessary in an pandemic situation: Has the organization developed modified treatment protocols and treatment/care plans that reflect reasonably anticipated limitations in capability and are scalable based on the scope of the pandemic? Does the health care organization's research-related policies and procedures address implementation of modified standards for research and the use of investigational drugs in public health emergencies as approved by regulatory agencies?

CC: What are some of the other concerns that a chief legal officer or corporate counsel at a health care system have in this type of public health emergency?

EB: The general public seems to share a perception that all pandemic patients will receive life-sustaining technology, medications and services from health care providers. The inevitable scarcity of resources during a public health emergency will raise ethical concerns about the allocation of scarce health care resources. 

During a pandemic, for example, makeshift facilities may be established to house or to treat patients; however, patients in these facilities may demand to be transferred to hospitals or other buildings that are better equipped or more comfortable. 

• During a pandemic, has the health care organization considered how patients' ethical and legal rights to autonomy in treatment are affected, and how has this been communicated to both staff and patients, and their families?
• Has the health care organization established multiple lines of communication with other response agencies? Has the health care organization worked with other response agencies to clarify the relative roles of the responding agencies; specify the relative priorities of the response effort; and finally, exercise use of different communications methods, given that failures of primary communications realistically will occur? 
• Has the health care organization reviewed its contracts with mission-critical vendors and suppliers to evaluate the possible impact of force majeure clauses on the ability of the organization to respond to a coronavirus pandemic?
• Has the health care organization reviewed their safety programs and emergency preparedness plans to ensure that they include updated infection disease protocols that are compliant with current [Occupational Safety and Health Administration] and state health and safety regulations?
• Has the health care organization circulated information to employees reminding them of best hygiene practices and respiratory virus infection prevention measures to counteract fear and stigma?
• Has the health care organization requested that employees limit all nonessential travel to affected regions?

CC: What are your concerns around the use of personal protective equipment such as face masks? 

EB: Experts caution that using a face mask without proper fitting and training could actually increase your risk. The CDC recommends that health care workers wear a specific type of mask called a NIOSH-approved N-95 respirator, and not a surgical mask. Unlike NIOSH-approved N95s, face masks are loose-fitting and provide only barrier protection against droplets, including large respiratory particles. 

I believe that it is important for a health care organization to educate its employees and patients on accepted infection control practices for coronavirus (e.g., CDC precautions for respiratory viruses) and dispel untruthful rumors about ineffective infection control practices.

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