HHS Expands COVID-19 Telehealth Capabilities in PREP Act Amendment

The federal government is expanding the telehealth platform for diagnostic tests and other devices that may be used to address the coronavirus pandemic.

The US Department of Health and Human Services has issued its fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness (PREP) Act, adding connected health channels to increase access to countermeasures against COVID-19.

“During the pandemic, the Trump Administration has made broader use of the PREP Act to expand access to potentially life-saving countermeasures than we’ve ever done before in a public health emergency,” HHS Secretary Alex Azar said in a December 3 press release. “This new use of the PREP Act will help expand access to important services via telehealth, increase availability of authorized PPE, and make it easier to administer eventual COVID-19 vaccines.”

More specifically, the order allows healthcare providers to use telehealth in any state to administer what are called Covered Countermeasures, such as diagnostic tests that have received Emergency Use Authorization (EUA) from the US Food and Drug Administration.

The order targets a significant barrier to telehealth expansion: state and federal rules that prohibit providers from using telehealth to treat patients in other states. The federal government and some states have enacted emergency measures during the ongoing public health emergency to facilitate license portability and interstate licensure, but the issue is still very murky.

The HHS order defines a “qualified person” as a healthcare provider using telehealth to order or administer Covered Countermeasures for patients in other states. This would include certain pharmacists, pharmacy interns and pharmacy technicians who order or administer certain COVID-19 tests or vaccines.

“When ordering and administering Covered Countermeasures through telehealth to patients in a state where the healthcare personnel are not already permitted to do so, 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,” the amendment reads. “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.”

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, including “claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions; determined by the secretary to constitute a present, or credible risk of a future public health emergency; and to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures.”

Previous declarations have been issued to deal with the Ebola virus, Zika virus, anthrax, smallpox, acute radiation syndrome, botulinum toxin, the influenza pandemic and nerve agents and insecticides.