Healthcare providers working together to help mitigate COVID-19 received some clarifying news about managing risk. But there are still many steps to managing the PREP Act and the new Amendment Four just released by the Health and Human Services Department. The HHS Secretary recently announced expanding liability protection in the PREP Act, which also includes distribution of COVID-19 vaccines. I’m Melissa Siebert, a partner at Shook, Hardy and Bacon, a national trial firm serving health, science and technology industries.
Joining me to discuss this latest amendment to the PREP Act is my colleague Anna Pieschel, a partner at the firm who helps health care providers and medical products manufacturers manage risk and find solutions for challenging liability issues. Anna has been working with hospital systems and others to manage their operations and liability considerations as impacted by COVID-19, including the PREP Act. Hi, Anna!
I just have a few questions for you. First, what exactly is the PREP Act and what changes were made in the Fourth Amendment?
The PREP Act authorizes the Secretary of Health and Human Services to issue a declaration, and in that declaration, he provides for liability protections to certain individuals and entities, called “Covered Persons,” and these liability protections are against any claim of loss caused by, arising out of, relating to, or resulting from a laundry list of things—manufacture, distribution, administration, or use of certain medical countermeasures, called “Covered Countermeasures.” There are some exceptions, but in a nutshell, that’s the PREP Act.
After the initial COVID PREP Act Declaration, there were a series of amendments. The Fourth Amendment is a little bit of a grab-bag in terms of its specific changes to the original Declaration, but all of the changes had this common theme, I think, of simplification of the “requirements” for administering a COVID-19 vaccine. Some of the changes and clarifications that I think may be particularly relevant for healthcare-related clients include:
- A clarification that the PREP Act applies when Covered Countermeasures are distributed through private channels, not just through the Government.
- Creation of PREP Act preemption of some state licensing requirements with respect to providing certain services via telehealth or telemedicine.
- Modification and clarification about the training requirements for certain licensed pharmacists and pharmacy interns to administer routine childhood vaccinations, and now, COVID-19 vaccines.
- And finally, explicit direction that the PREP Act can, in fact, apply when a provider does not administer a Covered Countermeasure (not just when a he or she does).
You just said that the Fourth Amendment more clearly indicates that the PREP Act applies in instances when a Covered Countermeasure is not administered. Is that a change from before?
Well, you know, it kind of depends on who you ask! I, myself, would argue that the PREP Act, by its very terms, has always applied to not giving someone a Covered Countermeasure in certain circumstances. But, before COVID-19, at least one court (in New York) ruled that the PREP Act does not apply when a Covered Countermeasure—in that case it was a vaccine—is not administered, just when it is. This becomes a significant issue for healthcare providers when an injury allegedly occurs because some Covered Countermeasure wasn’t used. The New York case I mentioned illustrates this very clearly: there, someone was not eligible to receive an H1N1 flu vaccine based on state guidance, which allowed for vaccines only for certain categories of people, based on limited vaccine supply. This person wasn’t given the vaccine, and then contracted and ultimately died from H1N1.
When you think about it from a COVID-19 perspective, you can see how this kind of non-administration could happen—just think about reported shortages, and even just limited supplies of things like medical devices, PPE, testing equipment, and vaccines. And that’s just what we’ve experienced thus far during this public health emergency.
In light of this type of caselaw, in late October, HHS’s Office of the General Counsel issued an advisory opinion that signaled strong disagreement, I’ll say, with the New York court’s ruling and suggested the PREP Act already applied to circumstances when a person was not given a Covered Countermeasure.
So, in December, we get the Fourth Amendment. The Fourth Amendment made explicit that potential PREP Act coverage existed for not giving a Covered Countermeasure, and it did it in two different ways:
First, it noted that “prioritization or purposeful allocation of a Covered Countermeasure, particularly if done in accordance with a public health authority’s directive, can fall within the PREP Act.”
Second, to further help courts interpret what is largely untested law in the PREP Act, the Fourth Amendment expressly states that the PREP Act Declaration must be read in light of the HHS Advisory Opinions (which includes that late October opinion I mentioned in addition to three others).
Anna, how will this new fourth amendment impact the administration of COVID-19 vaccines?
Well, Melissa, to fully answer that, I need to go back to the third PREP Act Amendment, which started the ball rolling. The Third Amendment defined “Covered Persons” to include pharmacists and pharmacy interns who administer childhood vaccines—the decline in administration of ACIP recommended childhood vaccines during the pandemic is an issue of great concern.
Then, the Fourth Amendment further built on the definition of “Covered Persons” to now include those same pharmacists and pharmacy interns if they also gave an FDA-authorized or FDA-licensed COVID-19 vaccine to anybody over the age of three.
Now, admittedly, it’s not as simple as just willy-nilly administering a COVID vaccine and BAM! Getting PREP Act protection. The vaccine has to be distributed and administered appropriately in order to be protected activity, and the determination about appropriateness will need to incorporate government directives from lots and lots of different areas.
For example, the FDA’s emergency use authorization for the Pfizer COVID vaccine states that “vaccination providers will administer the vaccine in accordance with the authorization and will participate and comply with the terms and training required by CDC’s COVID-19 Vaccination Program.” So you are going to have several layers of federal guidance from different sources.
In addition, states are developing their own vaccination plans, which also should be followed to ensure potential application of the PREP Act. These state plans may include things like provider registration, mandatory information that you have to get from vaccine recipients, methods of recording adverse events, and things like that. Shook can and does help clients work through this patchwork quilt of statutory and regulatory requirements in order to be able to safely and effectively provide services during the public health emergency caused by the COVID-19 pandemic.
Another area we’d like to ask you about is telehealth, which certainly has come to the forefront during the pandemic. More and more healthcare providers are providing telehealth services as a safer option during the pandemic. What does the new amendment state about these services, if anything?
That is a great question, Melissa. So, in the Fourth Amendment, the term “qualified person” is now defined to include “healthcare personnel using telehealth in order to order or administer Covered Countermeasures”—that magic term—“for patients in a state other than the state where the healthcare personnel are permitted to practice.” Essentially, if you’re licensed in one state, you can provide telemedicine services within those parameters to a patient who may be located in a different state. All that said, the provider still has to comply with the requirements for ordering and administering that are incumbent on them in their own state of licensure.
But if all of that is done—all of those requirements are satisfied—the Fourth Amendment provides that “Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures through telehealth is preempted.” So that’s a really important statement.
While a lot of healthcare providers were excited about this portion of the Amendment, I have urge caution. At least at this point, it doesn’t look like the Fourth Amendment intends to preempt all state licensing requirements in all circumstances—just when ordering and administering Covered Countermeasures.
In addition, I’ve got to point out that many states have enacted their own temporary rules with respect to the practice of telemedicine and licensure. Providers need to be keenly aware of what their state does or does not permit them to do via telemedicine or telehealth services as well.
Anna, thanks for clarifying that. I know that’s a question that we’ve been receiving a lot about telehealth.
Shook has a lot of experience in the healthcare industry. Can you explain to those that are listening to this podcast how Shook might be able to help them, as healthcare providers, navigate the evolving PREP Act?
Oh, man, Melissa, I could go on for days and days about the PREP Act—I love it! Even with what we’ve covered here today, we’ve only just scratched the surface of some of the intricacies of the PREP Act. This is where I think Shook really shines. We work with direct healthcare providers as well as others who provide healthcare-related services, helping them navigate the winding road of PREP Act immunity.
We work to ensure planning around use and administration of Covered Countermeasures complies with the PREP Act. We also investigate and clarify the PREP Act’s interaction with a variety of state and local laws and regulations. Lastly—and possibly most importantly—as the need arises, Shook vigorously defends clients in litigation over the applicability of the PREP Act. With every advisory opinion, amendment, and court ruling on the PREP Act, Shook is right there with our clients, hand in hand, ready to provide counsel, advice, and ultimately action.
Anna, thank you. You can read more about Shook’s COVID and PREP Act updates and amendments on our website. Thanks for listening, everyone.