September 23, 2020

Volume X, Number 267

September 23, 2020

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September 22, 2020

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September 21, 2020

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COVID-19: Updated - Planning for Life After 1135 Waivers and Other Regulatory Flexibility Ends

Absent further action, the current public health emergency (PHE) declared by Secretary Azar is set to expire on July 25, 2020. As a reminder, the PHE declaration is both (i) a precondition for the U.S. Department of Health and Human Services (HHS or Department) and Centers for Medicare & Medicaid Services (CMS) maintaining regulatory waivers under Section 1135 of the Social Security Act and (ii) the duration period for certain regulatory flexibility provided by HHS in the two Interim Final Rules with Comment Period (IFCs) that were issued at the end of March and April. Given the ongoing pandemic and statements of various officials in the administration, we believe it is highly likely that the PHE will be extended. Further, HHS has previously issued PHE declarations with a retroactive effective date—for example, the initial COVID-19 PHE was declared January 31, 2020 to be effective January 27, 2020, which gives greater comfort in the event Secretary Azar does not act by this Saturday.  

As COVID-19 cases continue to climb, the American Hospital Association and the National Governors Association have urged Secretary Azar to extend the PHE. Michael Caputo, HHS spokesperson, tweeted on June 29, 2020 that HHS plans on extending the current PHE declaration, but the Department has made no formal announcement yet. Additionally, Secretary Azar and Vice President Mike Pence suggested on July 6, 2020 that the administration plans on extending the PHE declaration but made no firm commitment to do so. The precipitous termination of 1135 waivers and IFC flexibility that would be caused by nonrenewal of the PHE stands in contrast to CMS’s earlier indication that it would likely adopt a “glide path” when removing the temporary flexibilities. In addition, CMS is exploring making certain regulatory flexibilities permanent; though, any glide path process is yet to be determined, and extension of the PHE remains pending. 

Again, given the current status of the COVID-19 pandemic, we expect that further extension of the PHE is very likely to occur. Nonetheless, health care providers should be aware that there may be a technical expiration of the PHE if it is not formally extended on or before July 25, 2020. Likewise, we recommend affected entities closely monitor whether the expected forthcoming extension results in any substantive changes to the future availability of waivers.

Copyright 2020 K & L GatesNational Law Review, Volume X, Number 205


About this Author

 Rebecca M. Schaefer healthcare & Transactional Attorney K & L Gates Law Firm North Carolina

Rebecca Schaefer is a partner at the firm’s Research Triangle Park office. She is a member of the health care practice group, focusing her practice on healthcare regulatory and transactional matters. Ms. Schaefer has specialized knowledge of issues affecting academic medical centers, including those related to faculty practices, clinical research, mission support, governance and privacy. She provides counseling to health systems, physician practice groups and in-house pharmacies related to strategic affiliations, joint ventures, and compliance matters.  

Prior to...

Darlene S. Davis, KL Gates, Healthcare transactional matters lawyer, HIPAA privacy attorney

Ms. Davis is a partner in the Research Triangle Park office. She focuses her practice exclusively on health law, primarily representing academic medical centers, health systems, hospitals, home health agencies, hospices, nursing homes, and ancillary service providers, such as laboratories, pharmacies, and durable medical equipment suppliers.

In that capacity, she advises clients on a wide range of regulatory and transactional matters, including the HIPAA privacy, security and breach notification rules; Medicare and Medicaid enrollment and certification, coverage and reimbursement; North Carolina licensure rules; the 340B drug pricing program; contracting; health care regulatory diligence; and compliance with fraud and abuse laws (including Stark Law and Anti-Kickback Statute).

Gabriel T. Scott Health Care Attorney K&L Gates Research Triangle Park, NC

Gabriel Scott is an associate in the firm’s Research Triangle Park office where he practices health law. Mr. Scott applies his prior experience in government, private practice, and healthcare delivery to assist clients in identifying practical legal solutions to complex regulatory matters. His practice focuses on resolving compliance and reimbursement issues for hospitals and other healthcare providers, with an emphasis on:

  • Advising clients on a wide range of regulatory and transactional matters, including Medicare enrollment, state licensure, patient...
Cheryl E. Choice Health Care K&L Gates Pittsburgh, PA

Cheryl Choice is an associate in the firm’s Pittsburgh office. She is a member of the health care and FDA practice group.

Ms. Choice was the first person selected as a Pitt Law / K&L Gates Legal Fellow and has been active with the firm’s diversity and inclusion matters, as well as the firm’s pro bono work.

Primary Practice

  • Health Care

Secondary Practices

  • Food, Drugs, Medical Devices and Cosmetics (FDA)