Waivers for State Licensure Requirements for Delivery of COVID-19 Countermeasures

Tuesday, December 8, 2020

In a fourth modification to the March 17, 2020, Public Readiness and Emergency Preparedness Act (PREP Act), the US Division of Well being and Human Companies (HHS) has expanded entry to COVID-19 Lined Countermeasures by means of telehealth and clarified the scope of legal responsibility protections supplied by the PREP Act. Specifically, the declaration is necessary to telehealth suppliers as a result of it seems to preempt, underneath sure circumstances, state legal guidelines which have restricted cross-border observe of drugs utilizing telehealth. Healthcare suppliers ought to take notice that the licensure exception and any immunity protections are restricted to healthcare suppliers who’re ordering or administering a Lined Countermeasure and there’s no indication of intent to increase past these centered measures.

In Depth

Late final week, the US Division of Well being and Human Companies (HHS) introduced a fourth modification to the Public Readiness and Emergency Preparedness Act (PREP Act) declaration dated March 17, 2020, which is meant to increase entry to COVID-19 Lined Countermeasures by means of telehealth and make clear the scope of legal responsibility protections supplied by the PREP Act. Based on HHS, the modification authorizes telehealth suppliers to order or administer Lined Countermeasures (outlined beneath) for sufferers who’re positioned in different states and it extends legal responsibility protections underneath the PREP Act to coated individuals for beneficial actions associated to any Lined Countermeasures approved or authorized by the Meals and Drug Administration (FDA) for COVID-19 and to any respiratory protecting machine authorized by the Nationwide Institute for Occupational Security and Well being to be used throughout the public well being emergency (PHE).

What’s the PREP Act?

The PREP Act, which was enacted in 2005, supplies the HHS Secretary with the authority to make declarations that present immunity from legal responsibility underneath sure circumstances, together with “claims of loss brought about, arising out of, regarding, or ensuing from administration or use of countermeasures to illnesses, threats and circumstances; decided by the secretary to represent a gift, or credible threat of a future public well being emergency; and to entities and people concerned within the improvement, manufacture, testing, distribution, administration, and use of such countermeasures.” The preliminary PREP Act declaration associated to the present PHE was issued in mid-March 2020 and there have been three different amendments to the declaration earlier than this newest one.

Be aware {that a} PREP Act declaration and a PHE declaration are completely different—they’re made primarily based on completely different public well being determinations and have completely different authorized results. For instance, the PREP Act declaration could also be made earlier than a PHE declaration and its legal responsibility protections can apply to actions that precede and comply with the PHE declaration.

Why is that this newest modification to the declaration significantly related to telehealth suppliers?

This newest declaration has captured the eye of telehealth suppliers as a result of it seems to preempt, underneath sure circumstances, state legal guidelines which have restricted cross-border observe of drugs utilizing telehealth. Particularly, Part V.e of the amended declaration now supplies that “[w]hen ordering and administering Lined Countermeasures by the use of telehealth to sufferers in a state the place the healthcare personnel usually are not already permitted to observe, the healthcare personnel should adjust to all necessities for ordering and administering Lined Countermeasures to sufferers by the use of telehealth within the state the place the healthcare personnel are permitted to observe. Any state legislation that prohibits or successfully prohibits such a professional individual from ordering and administering Lined Countermeasures by the use of telehealth is preempted. Nothing on this Declaration shall preempt state legal guidelines that let extra individuals to ship telehealth companies.”

In its description of the modification, the Secretary notes that “[t]elehealth is widely known as a useful instrument to advertise public well being throughout this pandemic,” and references assessments of the utility of telehealth companies by the Facilities for Illness Management and Prevention and help for the utilization of telehealth companies by HSS and its element businesses and workplaces, together with the Facilities for Medicare and Medicaid Companies and the Workplace for Civil Rights.

What’s a “Lined Countermeasure”?

Below the March 10, 2020, HHS PREP Act declaration, a Lined Countermeasure is a product comparable to a drug, diagnostic, machine or vaccine that’s used to diagnose, mitigate, forestall, deal with, or remedy COVID-19 or the transmission of SARS-CoV-2 (or a virus mutated from SARS-CoV-2) or any critical or life-threatening illness or situation brought about by means of a Lined Countermeasure. A Lined Countermeasure may be a product or know-how meant to reinforce one other Lined Countermeasure or a tool used within the administration of one other Lined Countermeasure. With a view to qualify as a Lined Countermeasure, the product or know-how should be appropriately cleared or authorized by the FDA or approved for emergency use in accordance with the Federal Meals, Drug and Beauty Act.

Within the telehealth context, Lined Countermeasures comparable to diagnostic exams or vaccines could also be ordered by telehealth suppliers after a digital encounter with a affected person and stuffed or administered by the affected person’s pharmacy or laboratory.

What’s the implication on state licensing legal guidelines and why does this matter? What about different telehealth guidelines?

Any state legal guidelines that prohibit a professional individual from ordering or administering a Lined Countermeasure by means of telehealth is preempted, together with licensing legal guidelines.

State licensure has been extraordinarily burdensome for telehealth suppliers. Typically, a supplier should be licensed within the state wherein a affected person is positioned on the time of the telehealth go to, until a licensure exception applies. Whereas many states waived licensure necessities or applied streamlined registration processes in response to COVID-19, the waivers in lots of states are expiring or have expired, or have been narrowly drafted leading to restricted utility. In sum, every state has completely different skilled licensure guidelines, which may make multistate telehealth packages difficult to implement. Whereas this modification is a really slender exception to licensure necessities as a result of it’s restricted to Lined Countermeasures, it would probably help within the implementation of multistate testing and vaccination packages. Telehealth suppliers will nonetheless have to adjust to relevant state guidelines (supplied that these guidelines don’t prohibit or successfully prohibit the ordering or administering Lined Measures). As well as, acts that represent “willful misconduct” usually are not shielded from the PREP Act. Healthcare suppliers nonetheless should present care that meets the relevant customary of care.

Is the assertion of preemption discovered on this newest declaration efficient?

The Workplace of the Normal Counsel (OGC) of HHS would probably advise that it’s efficient for preempting state licensure guidelines for telehealth suppliers engaged in Lined Countermeasures. HHS Advisory Opinion 20-02 units forth the argument for preemption underneath the PREP Act with respect to pharmacists with the ability to administer COVID-19 exams unbiased of state licensing legal guidelines. The reasoning set forth on this opinion applies to the cross-border observe by physicians as nicely. As famous within the opinion, pharmacists, pharmacies and one commerce affiliation requested the OGC whether or not the PREP Act preempts state licensing legal guidelines that limit the power of pharmacists to order and administer COVID-19 diagnostic exams the place HHS has expressly approved pharmacists, underneath the PREP Act, to order and administer these exams. The opinion concludes that the PREP Act, along with the Secretary’s March 10, 2020, PREP Act declaration, preempts any state or native requirement that prohibits or successfully prohibits a pharmacist from ordering and administering a COVID-19 diagnostic take a look at that the FDA has approved, which might embody state licensure guidelines.

What are the important thing takeaways?

The licensure exception and any immunity protections are restricted to healthcare suppliers who’re ordering or administering a “Lined Countermeasure,” and there’s no indication that it’s meant to increase past these centered measures. Even when a supplier can leverage this licensure exception to help the supply of Lined Countermeasures, telehealth suppliers should nonetheless adjust to relevant state telehealth legal guidelines that aren’t coated underneath this modification (i.e., these that don’t prohibit or successfully prohibit the ordering or administering of Lined Countermeasures).