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As new COVID-19 cases set records nationwide and public health officials sound the alarm over limited hospital capacity, the federal government last week used the PREP Act to expanded its support of telehealth, offering more protections for healthcare providers that serve patients from other states.
What is the PREP Act?
The Public Readiness and Emergency Preparedness Act ( PREP Act) has been around for fifteen years, passed by the U.S. Congress and signed into law by then-president George W. Bush in 2005. The law provides drug makers immunity from liability and puts management of litigation against pharmaceutical companies under the Secretary of the Department of Health and Human Services (DHHS). The legislation has been controversial from the beginning, drafted at the urging of vaccine manufacturers that said such legal protections were required to make vaccine development financially feasible. UPDATE: In April 2020, in connection with the COVID-19 pandemic, the Office for Civil Rights (OCR) at the Department of Health and Human Services (HHS) announced the Notification of Enforcement Discretion, which allows healthcare providers to use widely available communication apps, such as [name of the app], for telehealth services without the risk of incurring HIPAA fines. For more information, check out this recent Paubox blog post.How is the PREP Act used?
The PREP Act allows the DHHS Secretary to issue declarations for specific public health emergencies. Each declaration provides immunity from liability for "entities and individuals involved in the development, manufacture, testing, distribution, administration, and use" of countermeasures to diseases and other health threats. It does not excuse "willful misconduct," however. A PREP Act declaration specifically provides immunity from liability; it is separate from other types of emergency declarations. It is also separate from the COVID-19 HIPAA liability waivers established earlier this year via state-level public health liability laws. In the first year of the PREP Act's existence, declarations provided liability shields for drugs developed for the treatment of smallpox, anthrax, the Zika virus, botulinum toxin, pandemic influenza, and Acute Radiation Syndrome. A dozen years later, a declaration was issued to address ebola.How has the PREP Act been applied to COVID-19?
The first PREP Act declaration addressing medical countermeasures against COVID-19 was issued in March 2020. Since then, there have been four amendments, issued in April, June, August, and most recently last week. The most recent fourth amendment specifically addresses and expands access to COVID-19 countermeasures involving telehealth.How has telehealth been expanded under the PREP Act?
The latest amendment authorizes healthcare workers to order or administer "covered countermeasures," such as an FDA-approved COVID-19 diagnostic test, via telehealth. This would allow medical professionals to work with patients in a state other than their own. While many states have decided to permit healthcare personnel in other states to provide telehealth services to patients within their borders, not all states have done so. Not only does this amendment strengthen these capabilities, but it overrides any state law that prohibits medical providers from doing so. The need for expanded telehealth was validated early during the pandemic when DHHS expanded the use of telehealth for Medicare services. According to the department, the number of seniors receiving telehealth primary care visits each weak rose from about 14,000 in January 2020 to nearly 1.7 million in April 2020. SEE ALSO: Top 5 Telehealth Software Services
