By Virginia Alverson Mimmack & Sara Harris
On December 3, 2020, the federal government took a significant step to reduce barriers to healthcare practitioners’ ability to provide COVID-19-related telehealth services across state lines by amending its previous declaration under the Public Readiness and Emergency Preparedness Act (PREP Act). The PREP Act authorizes the Secretary of the U.S. Department of Health and Human Services (HHS) to issue a PREP Act declaration in response to a public health emergency. A PREP Act declaration provides immunity from tort liability claims (except for willful misconduct) to individuals or organizations involved in the manufacture, distribution, or dispensing of medical countermeasures.[1]
On March 17, 2020, the Secretary of HHS published a declaration under the PREP Act to provide liability immunity for activities related to medical countermeasures against the ongoing COVID-19 pandemic. HHS recently expanded that protection from tort claims to include immunity for healthcare personnel using telehealth to order or administer “covered countermeasures” for patients in a state other than the state where the healthcare provider is licensed,[2] thus allowing physicians the ability to treat patients located in states where they are not licensed as long as it is solely for the purpose of combating COVID-19. To be clear, physicians cannot use this exception to practice in states where they are not licensed to prevent, diagnose, or treat any condition other than COVID-19.
Background
For practitioners, governors, state legislators, and others in the healthcare industry, the ongoing state of emergency has drawn attention to the challenging reality of state law-regulated healthcare occupations licensing. Because each state has its own criteria for licensure, physicians, nurse practitioners, and many other healthcare professionals generally cannot render services to patients located in states in which they are not licensed to practice. In ordinary times, this patchwork regulatory regime has made multi-state licensure such a time-consuming undertaking that providers and their employers often turn to consultants to navigate the process. During the COVID-19 pandemic, these restrictions have created a significant obstacle to linking qualified providers with stressed healthcare systems in areas of need.
Many governors have implemented emergency orders allowing out-of-state healthcare providers to obtain temporary licensure to assist in the COVID-19 outbreak. Numerous states also have laws allowing physicians, nurses, and other practitioners to enter the state to provide care on a volunteer basis during a state of emergency. However, these pathways for out-of-state healthcare practitioners to render care are temporary. Some states have already let certain telehealth-related emergency orders lapse. And even though many states’ emergency waivers have made cross-border licensure and practice easier, such waivers still require practitioners seeking to provide telehealth services to be licensed in the state where the patient resides. It is important to note that these existing emergency waivers and temporary licenses will still be required for physicians who want to provide any service that is not directly related to COVID-19.
The Fourth Amendment to the March 2020 Prep Act Declaration
As noted above, the March 2020 PREP Act Declaration provides individuals or organizations involved in manufacturing, distributing, or dispensing medical countermeasures with immunity from liability for tort claims (except claims for willful misconduct) arising out of efforts to combat the coronavirus pandemic. The HHS Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act states:
Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures by means of telehealth is preempted.
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COVID-19 is a global challenge that requires a whole-of-nation response. There are substantial federal legal and policy issues, and substantial federal legal and policy interests…in having a unified, whole-of-nation response to the COVID-19 pandemic among federal, state, local, and private-sector entities. The world is facing an unprecedented pandemic. To effectively respond, there must be a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world.[3]
As this remarkable language suggests, the PREP Act not only provides immunity for “covered persons,” such as physicians and pharmacists, who could otherwise be sued in state court for negligence claims, but also expressly preempts any state or local law that would prohibit qualified providers from administering covered countermeasures provided for in the PREP Act Declaration and its amendments.[4]
Moreover, in a substantial departure from state law standards, under the Fourth Amendment, “the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients through telehealth in the state where the healthcare personnel are licensed or otherwise permitted to practice,” not the state where the patient is located.
This trailblazing declaration under the PREP Act will significantly expand access to critical services via telehealth across state lines by permitting what most state laws do not: regardless of the state in which a healthcare provider is licensed, a provider in one state may now provide patients in any other state with professional services to prevent, diagnose, treat, or cure the harms related to SARS-CoV-2 and COVID-19.
For example, a physician licensed only in California may now provide COVID-19 diagnostic testing for patients in Texas without fear of exposure to most tort claims (e.g. personal injury claims) that could otherwise be pursued in state or federal court. Other covered countermeasures may also include prescribing, dispensing, or administering vaccines, treatment medications, medical devices, or other FDA regulated products used to address the pandemic.
As indicated above, the Fourth Amendment preempts any state law that prohibits or restricts a practitioner from using telehealth across state lines for purposes related to providing COVID-19 covered countermeasures. The Fourth Amendment does not, however, prohibit states from enacting laws that allow for even easier licensure options, whether for telehealth or more generally.
Looking Ahead
Historically, when public health crises subside, policymakers have tended to allow licensure and scope-of-practice waivers to expire, barriers to go back up. That was what the healthcare industry saw following the H1N1 flu outbreaks in the 2010s, for example. But that trend may not hold in this case. Notably, several states enacted simplified licensing laws prior to the pandemic. In 2019, for example, Arizona passed a licensing reciprocity law that allows licensing boards to recognize out-of-state occupational licenses for individuals who have been licensed in their profession for at least one year, are in good standing in each state of licensure, pay applicable fees, and meet a few other criteria.[5] Pennsylvania is another state that has made the licensure process less burdensome recently.[6]
While there are currently very few other examples of such laws at the state level, in the wake of the pandemic, it is possible that policymakers may be more inclined follow the federal government’s lead and enact laws to require state regulatory boards to license or otherwise certify healthcare practitioners already licensed in any of the 50 states or the District of Columbia. Another route states may consider includes a framework for a limited license or certification for practitioners licensed in any other state who seek only to provide telehealth services to patients.
Whatever path states follow in the next several years as the threat of the coronavirus dissipates, one thing is clear. Telehealth, now “widely recognized as a valuable tool to promote public health,” isn’t going anywhere.[7]
Takeaways
- This is a major development, but the Fourth Amendment does not create absolute immunity. The amendment applies only to telehealth services used to provide, administer, or dispense COVID-19-specific covered countermeasures.
- The Fourth Amendment also makes clear that providers offering these covered countermeasures must continue to comply with state and federal laws that apply to the use of telehealth technology, scope of practice requirements, and prescribing, among others.
- The Fourth Amendment does not create a general licensure framework. If a provider’s services do not constitute a covered countermeasure, as defined in the PREP Act, the provider must be licensed in the state where the patient is located (unless an applicable emergency licensure, waiver, or other exception exists).
- Providers considering offering covered countermeasures via telehealth should consult with legal counsel.
[1] See 42 U.S.C. § 247d-6d(c) (excluding actions or omissions by a covered person that constitute as “willful misconduct”).
[2] See 42 U.S.C. § 247d-6d(i)(1) (defining “covered countermeasure” to include (a) “qualified pandemic or epidemic products;” (b) “security countermeasures;” (c) certain drugs, biological products and devices authorized for emergency use; and (d) certain approved respiratory protective devices.).
[3] Fourth Amendment.
[4] See 42 U.S.C. § 247d-6d(b)(8) (providing for preemption of any state law or local requirement that is “different from, or is in conflict with” the PREP Act requirements).
[5] See AZ Stat. § 32-4302 et seq.
[6] See 2019 Act 41.
[7] Fourth Amendment.
Meet Our Authors |
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Virginia Alverson Mimmack Partner, Practice Chair Healthcare 214.953.5875 vmimmack@jw.com |
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Sara K. Harris Associate Labor & Employment 214.953.6074 sharris@jw.com |
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Please note: This article and any resources presented on the JW Coronavirus Insights & Resources site are for informational purposes only, do not constitute legal or medical advice, and are not a substitute for legal advice from qualified counsel. The laws of other states and nations may be entirely different from what is described. Your use of these materials does not create an attorney-client relationship between you and Jackson Walker. The facts and results of each case will vary, and no particular result can be guaranteed.
