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HHS Modifies PREP Act Declaration to Expand Telehealth

On December 3, 2020, HHS issued a Fourth Amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”), which, in part, expands access to certain telehealth services during the COVID-19 public health emergency (“PHE”).  Most notably, this amendment preempts state professional licensure laws with respect to “Covered Countermeasures” that are provided through telehealth to combat COVID 19.

The PREP Act, enacted in December 2005, allows the HHS Secretary to issue a declaration that provides immunity from liability for certain claims during a public health emergency, especially for providers and entities involved in developing and administering treatments and countermeasures aimed at combating the emergency.

According to the Fourth Amendment:

  • In order to maximize the utility of telehealth, the Secretary declares that the term “qualified person” under 42 U.S.C. 247d-6d(i)(8)(B) now additionally includes health care personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the health care personnel are permitted to practice.
  • When ordering and administering Covered Countermeasures through telehealth to patients in a state where the health care personnel are not already permitted to do so, the health care personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients through telehealth in the state where the health care personnel are licensed or otherwise permitted to practice.
  • Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures through telehealth is preempted. Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services.

A copy of the HHS Press Release may be accessed here.

The Fourth Amendment does not create a general licensure exception for all clinical services provided through telehealth. Rather, this amendment is expressly limited to the administration and provision of “Covered Countermeasures.” Covered Countermeasures, as further defined in the operative statute, include: (a) “qualified pandemic or epidemic products;” (b) “security countermeasures;” (c) certain drugs, biological products and devices that are authorized for emergency use; and (d) certain respiratory protective devices.

Practitioners who deliver clinical services through telehealth are generally required to maintain a professional license in the state where the patient is located at the time of the service (the “originating site”) – absent an applicable exception. The variable licensure requirements, state to state, represent one of traditional barriers to telehealth practice. The Fourth Amendment to the PREP Act seeks to remove this barrier – at least with respect to Covered Countermeasures. Notably, this action follows similar measures recently taken by the U.S. Department of Veterans Affairs (“VA”), through an interim final rule, to permit VA health care professionals to practice across state lines, regardless of state licensing requirements, as long as such practice is in accordance with the scope and requirements of their VA employment.

These efforts highlight the difficulty presented by the variable state licensure requirements. In the two instances above, HHS and the VA take the position, respectively, that they are authorized to preempt state law under these more limited circumstances. Otherwise, health care providers will need to remain mindful of the state licensure requirements applicable to the originating site, as well any state-specific scope of practice requirements (often minimally applicable to APRNs and PAs), prescription requirements/prohibitions, and other professional practice rules applicable to the anticipated telehealth service.

Practical Takeaways

Health care providers who intend to provide or administer services through telehealth pursuant to the PREP Act should consider the following prior to rendering such services:

  • Providers must ensure the telehealth service to be provided constitutes a legitimate “Covered Countermeasure” as defined in the statute; otherwise professional licensure in the state where the patient is likely required (absent an applicable exception).
  • Providers should be mindful of, and must comply with, all state and federal requirements applicable to the telehealth service to be provided unless such requirements have been expressly preempted by the Fourth Amendment.
  • Providers should also be mindful of, and must comply with, all state and federal technology requirements applicable to the telehealth service – particularly those services that will involve the prescription of medications.