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HHS Advisory Opinion Reiterates Broad Scope of PREP Act Immunity for “Program Planners” Following Applicable Public Health Guidance

On October 22, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a new Advisory Opinion addressing the availability of immunity for “program planners” following applicable public health guidance under the Public Readiness and Emergency Preparedness (“PREP”) Act, 42 U.S.C. 247d-6d. The Advisory Opinion reflects a striking challenge to interpretation of the PREP Act provided by recent court opinions and should provide strong support for providers and other entities arguing for broader application of the PREP Act going forward. 

By way of background, the PREP Act provides immunity for a “covered person” from “suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure.”1 42 U.S.C. 247d-6d(a)(1). The term “covered person” includes manufacturers and distributors of covered countermeasures, qualified persons who administer, prescribe, or dispense covered countermeasures, and – relevant to the Advisory Opinion – “program planners.” Id. at 247d-6d(i)(2). The term “program planner” means:

A State or local government, including an Indian tribe, a person employed by the State or local government, or other person who supervised or administered a program with respect to the administration, dispensing, distribution, provision, or use of a security countermeasure or a qualified pandemic or epidemic product, including a person who has established requirements, provided policy guidance, or supplied technical or scientific advice or assistance or provides a facility to administer or use a covered countermeasure in accordance with a [Declaration of Public Health Emergency].

Id. at 247d-6d(i)(6). 

The Advisory Opinion emphasizes that potentially any individual or organization can be a “program planner” and receive PREP Act coverage, provided they are performing the functions of a program planner in accordance with the March 17, 2020 Declaration issued by the Secretary of HHS, 85 Fed. Reg. 15198 (“March 17 Declaration”). The March 17 Declaration specifies that a covered person must comply with the public-health guidance issued by an Authority Having Jurisdiction (i.e., an applicable public health agency) over the person’s activity or location in order to qualify for PREP Act immunity. See 85 Fed. Reg. at 15202. 

According to the Advisory Opinion, if there are conflicts between applicable public-health guidance, PREP Act coverage will apply to a covered person using a covered countermeasure in accordance with any of the guidance. However, if there is an order of precedence under applicable law or the guidance itself, the covered person must follow the guidance that takes precedence. By way of example, if a governor’s order on using face masks preempts a mayor’s order under state law, the covered person must follow the governor’s order in order to fall within PREP Act coverage. 

According to HHS, the PREP Act should be interpreted broadly as applied to the activities of program planners in their management of programs intended to combat COVID-19 in accordance with applicable public health guidance. In a pertinent example, HHS poses a hypothetical in which a pharmacy prioritizes certain populations to receive a COVID-19 vaccine, consistent with the Centers for Disease Control and Prevention’s (“CDC”) guidance prioritizing those populations when there are limited supplies of a vaccine. If a pharmacy prioritizes those populations, and declines to administer a vaccine to someone outside that priority group, the PREP Act should apply if that person decides to sue the pharmacy. The pharmacy is a program planner and should be covered by the PREP Act when administering a program with respect to the administration of a covered countermeasure. Administration of a covered countermeasure (the vaccine) includes both “physical provision of the countermeasure to recipients” and “activities and decisions relating to . . . management and operation of locations for purpose[s] of distributing and dispensing countermeasures.” 85 Fed. Reg. at 15202. Management and operation of vaccine distribution involves decisions about who should receive those vaccines when the supply is limited. To the extent that the pharmacy followed CDC prioritization guidelines, it is following an Authority Having jurisdiction, and should benefit from PREP Act coverage.

The Advisory Opinion observes that a key PREP Act case, Casabianca v. Mount Sinai Medical Center, 1014 N.Y. Slip. Op. 33583(U), 2014 WL 10413521 (N.Y. Sup. Dec. 12, 2014) was “wrong” to the extent that its ruling was inconsistent with the current guidance. In Casabianca, a hospital did not administer a vaccine to a plaintiff who did not fall within priority guidelines established by the CDC, New York State Department of Health, and New York City Department of Health for the H1N1 vaccine. That plaintiff contracted the swine flu and died. The court held that the PREP Act immunity did not apply because it was only available to the actual use of a vaccine, not to the withholding of a vaccine. Id. at *4. In HHS’s view, the court should have found that the PREP Act applied to the hospital’s management of its vaccine program, which included decisions about who should and should not receive the vaccine. 

The Casabianca case has been widely cited in the PREP Act context for the idea that the PREP Act applies only to action, not inaction. The Advisory Opinion, while not binding authority, will help buttress arguments for expansive availability of PREP Act immunity for health care providers and other entities taking steps in compliance with applicable public health guidance to make covered countermeasures available, even when those steps involve withholding countermeasures from some individuals. 

As the Advisory Opinion notes, COVID-19 entails unprecedented uncertainty, given the evolution of public health guidance over time. The PREP Act exists, in part, to remove legal uncertainty and risk arising from the uncertain external environment and should be interpreted broadly to avoid hindering efforts taken to combat the pandemic. 

Footnotes:

1 A “covered countermeasure” generally includes products that (i) the FDA has approved, cleared, licensed, or authorized for emergency or investigational use, and (ii) that are used to address COVID-19 or associated health threats, including harms that COVID-19 might otherwise cause. Advisory Op. at p. 2. 

Disclaimer: This post does not offer specific legal advice, nor does it create an attorney-client relationship. You should not reach any legal conclusions based on the information contained in this post without first seeking the advice of counsel.

About the Author

Elizabeth M. Hein is an Associate in the Firm’s Health Care Practice Group, providing legal services to the Firm’s health care clients in litigation, regulatory, and compliance matters.

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