Against the backdrop of a nation in the grip of a prolonged pandemic caused by the COVID-19 coronavirus and its rising death toll of more than 143,700 Americans, the federal government late Thursday extended the nation’s public health emergency (PHE), which was due to expire July 25.
Health and Human Services (HHS) Secretary Alex M. Azar II issued the declaration, which reads: “As a result of the continued consequences of Coronavirus Disease 2019 (COVID-19) pandemic, on this date and after consultation with public health officials as necessary, I, Alex M. Azar II, Secretary of Health and Human Services, pursuant to the authority vested in me under section 319 of the Public Health Service Act, do hereby renew, effective July 25, 2020, my January 31, 2020, determination that I previously renewed on April 21, 2020, that a public health emergency exists and has existed since January 27, 2020, nationwide.”
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 the U.S. Department of Health and Human Services (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.
It is also my expectation an additional PHE Extension beyond this new one will happen. There are many discretionary actions the Secretary may take to respond to the PHE including the following:
Under section 1135 of the Social Security Act (SSA), the following Medicare, Medicaid, CHIP and HIPAA requirements may be waived or modified:
- Conditions of participation or other certification requirements, or program participation and similar requirements for individual providers or types of providers
- Pre-approval requirements for providers, or healthcare items or services
- Requirements that physicians and other healthcare professionals hold licenses in the state in which they provide services if they have a license from another state and are not affirmatively barred from practice in that state or any state in the emergency area
- Sanctions under the Emergency Medical Treatment and Active Labor Act (EMTALA) for redirection of an individual to another location to receive a medical screening examination, pursuant to a state emergency preparedness plan, or transfer of an individual who has not been stabilized if the transfer arises out of the circumstances of the emergency
- Sanctions related to Stark self-referral prohibitions, which could apply when a physician refers a patient for services to a provider in which the physician has a financial interest
- Limitations on payments to permit Medicare+Choice enrollees to use out-of-network providers in an emergency situation
- Sanctions and penalties arising from noncompliance with HIPAA privacy regulations relating to: a) obtaining a patient’s agreement to speak with family members or friends, or honoring a patient’s request to opt out of the facility directory; b) distributing a notice of privacy practices; or c) the patient’s right to request privacy restrictions or confidential communications.
For a complete breakdown on the PHE’s implications, check out the CMS list of questions and answers on the subject by clicking here.
Programming Note: Listen to Sean Weiss report this story live during the next edition Monitor Mondays, July 27, 10 a.m. EST.
Read the proclamation here: https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-23June2020.aspx