By BILLEE WARD, ESQ.
As the year 2020 began, it would have been difficult for most Americans to imagine how life as we knew it at that time would change in the coming months and years. You likely recall generally, if not specifically, that on January 31, 2020, the Secretary of the U.S. Department of Health and Human Services (HHS) declared the novel coronavirus (COVID-19) a Public Health Emergency (PHE) under Section 319 of the Public Health Services Act. Approximately six weeks later, by Proclamation 9994 on March 13, 2020, Former President Trump declared a National Emergency (NE) concerning COVID-19. These actions set the stage for a variety of measures being taken at various levels of state and federal government to address the emergency circumstances that existed at that time. Such measures included new policies, emergency pathways, waivers, and other measures providing for flexibility in relation to health and other benefits, access to care and treatment, development and availability of COVID-19 countermeasures, enforcement of fraud and abuse and other laws, and the list goes on and on.
After having been extended, the PHE and NE are currently set to expire on March 1, 2023 and April 11, 2023, respectively. Acknowledging that we are at a very different stage in the pandemic than when these declarations were originally made, the Biden Administration recently announced its plan to issue one final extension of both of these declarations to May 11, 2023, at which time both emergency declarations will end. In light of the various measures that have been implemented since we were first introduced to COVID-19, the end of the emergency declarations will trigger a transition period in relation to various issues impacting the healthcare industry.
Governmental agencies such as the Centers for Medicare and Medicaid Services (“CMS”), the Substance Abuse and Mental Health Services Administration (“SAMHSA”), and the Food and Drug Administration (“FDA”) have undertaken to assess the temporary measures implemented to address the pandemic and determine which measures will end, which will be extended temporarily, and which will be made permanent as we transition away from the emergency phase of COVID-19. In this vein, the FDA released guidance on March 10, 2023 to clarify which of that agency’s guidance documents will remain in place even though originally tied to the PHE. SAMHSA has also clarified some of its policies including announcing that it will extend expanded access to methadone take-home doses for opioid use disorder treatment, and implement continued access to buprenorphine in opioid treatment programs by telehealth without the need for an in-person examination. In contrast, CMS has announced that the waivers of sanctions under the Stark Law it issued on March 30, 2020 for COVID-19 purposes will terminate when the PHE ends, and that “parties must immediately comply with all provisions of the physician self-referral law” as of May 11, 2023. Similarly, the Office of Inspector General’s enforcement of the Anti-Kickback Statute will return to pre-COVID-19 status in contrast to the enforcement discretion it announced in 2020 with regard to remuneration related to COVID-19.
These are only a few examples of the temporary measures being assessed as a result of the Biden Administration’s announcement, and the need for awareness, education and preparation in planning for the coming end of the declared COVID-19 emergencies. Healthcare institutions, providers, payors and suppliers will need to be cognizant of the pending expiration of the declared emergencies.
Our Dickinson Wright attorneys are experienced in the various legal issues impacted by the end of these emergency declarations, and can provide such additional information and assistance as you may need in assessing and navigating the impact on you or your business.