March 1, 2021

Volume XI, Number 60

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March 01, 2021

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Bringing Clarity to Section 1135 and Other Waivers amid the COVID-19 Emergency

On a daily basis, if not more frequently, we are astounded by our clients’ efforts to prepare for and respond to the COVID-19 pandemic.  As the federal government works to respond to the COVID-19 pandemic, guidance from HHS and CMS with respect to waiver of Social Security Act requirements has been rapidly evolving, seemingly overlapping, and emitting from various agencies, leaving many confused about the scope and applicability of the waivers, whether one “supersedes” another, as well as whether any affirmative steps need to be taken in order to “procure” or properly operate under the terms of a waiver.  To help resolve any confusion, outlined below is a summary of the authority for these waivers, how they work together, how and when they apply, and where gaps remain.  

 

  • On March 13, 2019, HHS Secretary Azar, invoking Section 1135 of the Social Security Act, authorized and identified the areas of law that may be waived in response to the COVID-19 emergency. The Secretary’s invocation is available here   However, the invocation itself neither effectuated any waiver nor specified the extent to which these areas of law would actually be waived, with the exception of the HIPAA waiver, for which the parameters of the waiver are specified in the invocation.

  • Rather, the Secretary’s invocation allowed individual providers, associations of providers, and states to submit requests for the implementation of an authorized waiver.  It also allowed CMS to implement waivers affecting any provider, group of providers, or geographic area(s), without waiting for the receipt of any request from a provider, association, or state.

  • Under the authority created by the Secretary’s invocation, and also on March 13, CMS published blanket waivers that apply to all health care providers, nationally.  Providers may conduct their operations subject to these blanket waivers immediately, and with no further action required.  These blanket waivers are available here.

  • Subsequently, on March 16, CMS published an additional blanket waiver to allow Medicare payment for office, hospital, and other visits provided via telehealth. This waiver is described here: [1]  Again, providers may conduct their telehealth operations subject to this blanket waiver immediately, and with no further action required.

  • However, CMS has not published blanket waivers to the full extent authorized by the Secretary. For instance, while the Secretary authorized waivers of sanctions under EMTALA and the Stark Law, CMS has not published a blanket waiver with respect to either of those laws.  The Secretary also authorized waivers of Federal health care program conditions of participation, certification requirements, and “similar” requirements; countless of these conditions and requirements are not subject to CMS’ blanket waivers.

  • If, in preparing for or responding to the COVID-19 emergency, a provider would like to or feels it must operate without regard to a law identified in the Secretary’s declaration (g., EMTALA, the Stark Law, any program condition of participation), but which CMS has not yet waived in blanket fashion, it must submit a request to do so to its CMS Regional Office.

 

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Copyright © 2020, Sheppard Mullin Richter & Hampton LLP.National Law Review, Volume X, Number 81
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About this Author

Partner

Mr. Paddock's practice primarily involves healthcare fraud and abuse matters, particularly those relating to civil False Claims Act, physician self-referral (Stark Law), and anti-kickback issues. He often advises clients on compliance and transactional matters, the conduct of internal investigations related to potential fraud and abuse issues, and responding to and defending against government anti-fraud and abuse enforcement efforts and regulatory inquiries, including qui tam and government allegations of False Claims Act violations. He is an active member of...

202-747-1954
Associate

Ms. Kraus focuses her practice on representing healthcare entities in regulatory compliance matters.  Ms. Kraus advises clients on compliance with federal and state fraud and abuse laws, assists clients in responding to government investigations, and represents clients in False Claims Act litigation.  Ms. Kraus also assists clients with regulatory due diligence in transactional matters, and through advocacy with federal and state regulators, and leverages her background in health policy to help clients maximize opportunities in the changing healthcare landscape...

202-747-2645
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