Civil Liability Immunity for Massachusetts Health Care Providers

On April 17, 2020, Massachusetts Governor Charles Baker signed Senate No. 2640 into law. The new law protects “health care facilities” and “health care professionals” from civil liability for legal claims arising out of healthcare services provided during the Massachusetts COVID-19 emergency if certain standards are met. A copy of Senate No. 2640 codified as Chapter 64 of the Acts of 2020 (Immunity Statute) can be found here.

Governor Baker cited the need to fill gaps in protection for health care providers from civil liability available under the PREP Act as a reason for filing the bill that became Senate No. 2640. The Massachusetts action came after the Secretary of the federal Department of Health and Human Services (Secretary) issued a declaration on February 4, 2020 under the PREP Act that provided immunity to “covered persons” (e.g., manufacturers, distributors and qualified persons prescribing or administering “covered countermeasures”) engaged in the distribution and administration of testing, drugs and medical devices for the diagnosis and treatment of COVID-19. “Covered countermeasures” includes, for example, federally approved drugs to treat COVID-19 and federally approved devices used for treatment, and to limit the spread, of COVID-19. A PREP Act Declaration is specifically for the purpose of limiting civil liability.

The PREP Act in Massachusetts

Citing a desire to maximize PREP Act protections in Massachusetts, Governor Baker issued a Declaration of Authorized Health Care Activities Pursuant to the PREP Act on April 8, 2020. A copy of the Governor’s Declaration can be found here.

Under the Governor’s declaration, PREP Act immunity from civil liability is available to “Health Care Professionals”, “Health Care Facilities” and “Program Planners” engaged in the prescription, administration, delivery, distribution, or dispensing of drugs and medical devices for the diagnosis, cure, prevention, treatment or mitigation of COVID-19 or as part of the state’s response to the COVID-19 outbreak. In addition, immunity extends to any Program Planner involved in the supervision or administration of Health Care Facility programs for the treatment, diagnosis, prevention, or mitigation of COVID-19. The categories defined in the Governor’s declaration as eligible for PREP Act protections are:

• “Health care facility” includes hospitals, mental health facilities, skilled nursing facilities, assisted living residences, rest homes, community health centers, home health agencies, and sites designated by the Commissioner of Public Health to provide COVID-19 care services (field hospitals, for example).
• “Health Care Professional” includes, for example, all licensed, registered, or certified health care or emergency workers who are carrying out their duties within the scope of their licenses, registrations, or certifications.
• “Program Planner” includes, for example, state or local governments, government employees, or any other person or entity who supervises or administers a program for the treatment, diagnosis, prevention, and mitigation of COVID-19.

Willful misconduct is not protected under the PREP Act or under Governor Baker’s PREP Act declaration.

The Massachusetts Immunity Statute

According to Governor Baker, the purpose of the Immunity Statute is to “…provide broader liability protections appropriate to the scope of the challenge our health care providers are confronting. This legislation would protect health care professionals, including doctors, nurses, and emergency medical technicians, and certain health care facilities from liability and suit when the care they provide is impacted by the COVID-19 emergency.” 

The Immunity Statute gives protection from civil liability for claims arising out of the COVID-19 emergency to “health care facilities” and “health care professionals” who deliver “health care services” in good faith during the COVID-19 emergency. The care must be provided pursuant to a “COVID-19 emergency rule” and be impacted by treatment conditions resulting from the COVID-19 outbreak or COVID-19 emergency rules.

The immunity covers health care services that involve not only the diagnoses and treatment of an individual with a confirmed or suspected case of COVID-19 but also the care of any other individual who presents at a health care facility or to a health care professional during the period of the COVID-19 emergency. The intent of the statute is not just to protect those caring for COVID-19 patients, but more broadly to recognize the difficulty of providing care generally under the crisis conditions of a pandemic.

Volunteer organizations that make their facilities available to the state to support the state’s activities during the COVID-19 emergency are also protected from civil liability under the Immunity Statute.

The statutory definitions include the following:

• “Health care services” include services provided by a health care facility or health care professional relating to COVID-19, or care of any other individual who presents at a health care facility or to a health care professional during the period of the COVID-19 emergency.
• “Health care facility” includes hospitals, mental health facilities, skilled nursing facilities, assisted living residences, rest homes, community health centers, home health agencies, and sites designated by the Commissioner of Public Health to provide COVID-19 care services (field hospitals, for example).
• “Health care professionals” include, for example, physicians, nurses, nursing home administrators, psychologists, social workers, student trainees in medical professions, out-of-state physicians with temporary Massachusetts licenses, facility administrators, executives, supervisors, board members and trustees and any other person responsible for directing, supervising or managing a health care facility or its personnel.
• “COVID-19 emergency rule” means a federal or state policy, rule or guidance that waives, suspends or modifies otherwise applicable state or federal law, regulations or standards regarding either scope of practice, conditions of licensure, including modifications authorizing health care professionals licensed in another state to practice in the commonwealth, or the delivery of care, including those regarding the standard of care. 

The following acts or omissions are excluded from protection under the Immunity Statute: gross negligence, recklessness, or conduct with an intent to harm, or discrimination based on race, ethnicity, national origin, religion, disability, sexual orientation, or gender identity. In addition, immunity does not extend to deceptive acts or practices, fraud, consumer protection actions brought by the Massachusetts Attorney General, or false claims actions brought by the state.

The Immunity Statute applies to claims arising between March 10, 2020 (the date of the Covid-19 emergency order issued by Governor Baker), and the date that the Governor terminates or rescinds the emergency order.

Immunity in Practice

A health care facility or professional confronted with possible civil liability based on acts or omissions that occurred during the Covid-19 emergency should determine whether immunity is available under either the PREP Act or the Immunity Statute. PREP Act immunity has an advantage because willful misconduct is the sole basis for exclusion from coverage.

Qualifying under the Immunity Statute is more complicated. A health care facility or professional must meet all three of the following elements to qualify: health care services must be arranged for or provided pursuant to a COVID-19 emergency rule, must be impacted by treatment conditions resulting from the Covid-19 outbreak or Covid-19 emergency rules, and must be delivered in good faith.

Determining whether health care services have been provided pursuant to a COVID-19 emergency rule may prove difficult because the Immunity Statute does not define or provide guidance on the meaning of “arranging for or providing health care services pursuant” to a COVID-19 emergency rule. The Massachusetts Department of Public Health and the Centers for Disease Control have adopted numerous Covid-19 emergency measures and in many instances, it is not clear whether a particular measure falls within the Covid-19 emergency rule definition of “waives, suspends or modifies otherwise applicable state or federal law, regulations or standards regarding either scope of practice, conditions of licensure, or the delivery of care, including those regarding the standard of care”. As a result, courts and other factfinders will engage in a case-by-case factual inquiry to determine (i) whether a health care facility or professional delivered health care services under a COVID-19 emergency rule, and (ii) whether the care or treatment was impacted by conditions that resulted from the COVID-19 outbreak or a COVID-19 emergency rule.

The Takeaway

The PREP Act and the Immunity Statute provide a significant shield against civil liability in Massachusetts for health care institutions, individual professionals, and related parties engaged in the effort to control the COVID-19 epidemic. Protection under the PREP Act is more readily available for those who qualify because willful misconduct is the sole reason for exclusion from its benefits. The Immunity Statute provides broad, but not unlimited immunity to health care facilities and professionals delivering care and treatment during the pandemic. Questions as to the extent of its coverage will require legal analysis on a case-by-case basis and require proof that a negligent act or omission occurred under a COVID-19 emergency rule and was impacted by the crisis