Getting ready for the end of the federal PHE 

By Jenna K. Godlewski and Alice V. Harris, Nexsen Pruet 

The current extension of the federal public health emergency declared as a result of the COVID-19 pandemic (“PHE”) will expire on Oct. 15, 2022. As the need wanes for the waivers and flexibilities implemented due to the PHE, there has been great speculation on when the PHE will end. 

 On Aug. 18, 2022, the Centers for Medicare & Medicaid Servicesclearly sent a message that the end is near and providers need to prepare for the “return to normal” business practices. 

The CMS roadmaps for understanding the status of PHE waivers and flexibilities 

During the COVID-19 PHE, CMS used a variety of tools including emergency waivers, regulations, enforcement discretion, and sub-regulatory guidance to ensure access to care while also giving health care providers needed flexibilities to respond to COVID-19.  CMS is now signaling that the end of the PHE is near, and, with it, many of the flexibilities will end.  

In a blog post called “Creating a Roadmap for the End of the COVID-19 Public Health Emergency,[1]” (“CMS Blog Post”) CMS reminded providers that many of the waivers and flexibilities will be terminated when the PHE ends.  CMS also confirmed that it will give a 60-day notice prior to the termination of the PHE.  Throughout the blog post, CMS advises providers to prepare by returning to the health and safety protocols and billing practices in place prior to the pandemic. 

During the PHE, CMS processed over 250,000 section 1135(b) waiver requests, so the process of unwinding the extensive waivers and flexibilities is complex. To assist providers with understanding the status of the waivers and flexibilities, CMS released fact sheets[2] summarizing which waivers and flexibilities have already been terminated, which have been made permanent, and which will end at the end of the PHE.  There are over 35 CMS fact sheets which include fact sheets for the following providers: 

• Physicians and other clinicians 
• Hospitals and CAHs, ASCs and CMHCs 

• Teaching hospitals, teaching physicians and medical residents 
• Long-term care agencies (skilled nursing facilities and/or nursing facilities) 
• Home health agencies 
• Hospice 
• Inpatient rehabilitation facilities 

• Long-term care hospitals and extended neoplastic disease care hospitals 
• Rural health clinics and federally qualified health centers 
• Laboratories 
• Medicare shared savings programs 
• Durable medical equipment, prosthetics, orthotics and supplies 

• Medicare advantage and Part D plans 
• Ambulances 
• End stage renal disease facilities 

CMS states in the CMS Blog Post that the waivers listed in the fact sheet for each provider type will be terminated when the PHE ends unless specifically stated otherwise. As an example of extending a waiver, the use of Audio-Only Telehealth for certain services, has been extended for 151 days past the termination of the PHE.[3] 

The CMS Blog Post also advises providers that it found additional requirements implemented for certain providers as a result of the PHE to be valuable and, therefore, will not be terminated with the PHE. For example, CMS has extended the requirement for long term care facilities to report resident and staff infections and deaths related to COVID-19 through December 2024. 

Advice to providers: Prepare to implement a 60-day plan to be compliant when the federal PHE ends 

It is likely the PHE will be extended past Oct. 15, 2022, since notice has not yet been given that it will be terminated. However, due to the message conveyed in the CMS blog post, providers should create a “60-day plan” now to ensure compliance with CMS policies and regulations well in advance of the termination of the PHE.  Core elements of a “60-day plan” plan should include the following considerations: 

• Understand the waivers and flexibilities that are still being utilized by your organization, and whether they will expire with the end of the PHE, or have been temporarily or permanently extended. 
• Implement policies and procedures that adhere to CMS policies and regulations that were in place prior to the pandemic. 
• Educate and your providers and staff on the “new” policies and procedures and explain the importance of swift implementation. 

• Conduct internal audits prior to the termination of the PHE to ensure the waivers and/or flexibilities are no longer being used. 
• Ensure that any additional requirements imposed on your organization during the PHE that are not expiring with the PHE are still being performed. 

Risks of not preparing 

It is very likely CMS will conduct audits in the future to ensure that providers are no longer utilizing waivers and flexibilities that have been terminated. To avoid overpayments, civil monetary penalties, provider enrollment issues, administrative liability, and False Claim Act liability, providers must react quickly to be compliant with CMS policies that are shifting to the post-pandemic world. 

Harris is an experienced health care, reimbursement, and compliance attorney based in Nexsen Pruet’s Columbia, S.C., office, where she assists hospitals, health care systems, physician practices, skilled nursing facilities, hospice agencies, home health care agencies and other health care providers with a wide variety of matters. Godlewski focuses solely on health care law and assists medical practices across the country on reimbursement, regulatory, and compliance matters.