The official declaration of the COVID-19 pandemic as a Public Health Emergency (PHE) is due to expire this Saturday, July 25, which means that all of the associated regulatory waivers and flexibilities will expire unless the HHS Secretary issues a declaration extending the PHE under the Public Health Services (PHS) Act.
On June 30, HHS spokesman Michael Caputo issued a tweet that HHS intends to extend the COVID-19 PHE prior to the June 25th expiration date. Based on this tweet, many news organizations and bloggers claimed that HHS had already extended the PHE, but this is simply not the case without the formal declaration of the extension. This is why you have to be careful with where and from whom you receive your information. As this blog post goes live, there has been no extension issued!
That said, I do believe the declaration will be issued, given the state of COVID-19 across the country and the fact that the virus is likely to flourish in the fall with the arrival of colder weather. The latter prospect, also called the “second wave” of COVID-19 infection, is my belief based on all the scientific data I have reviewed and conversations I have shared with members of the Georgia Governor’s Task Force.
Thus, a 90-day extension of the PHE is inevitable, especially given President Trump’s comments on Tuesday that the pandemic is likely to “get worse before it gets better.” What’s more, I believe that HHS will have to issue another extension of the PHE by the end of 2020 to carry us into the spring of 2021. I know this is not the news any of us want, because we all want to reclaim our previous lives and get back to some sense of normalcy, whatever that is!
Exactly what does the PHE do?
So, what does an extension of the PHE mean and what pieces will have the greatest impact on our industry?
In a nutshell, the PHE declaration gives tremendous emergency powers to HHS, including the ability to authorize new drugs and treatments without the usual regulatory approval process, the ability to temporarily waive regulations binding healthcare providers and healthcare organizations, the ability to relax other rules on a sub-regulatory basis (i.e. without having to released proposed and final rules or engage in public comment periods), and much more.
The reason that telehealth services have suddenly exploded into a starring role during various state and local lockdowns is because the PHE declaration gave CMS the power to eliminate a massive tangle of regulations that previously relegated telehealth services to specific niche scenarios.
For a complete breakdown on the PHE’s implications, check out the CMS list of questions and answers on the subject by clicking here.
What to do next…
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