What’s Next for the Public Health Emergency?

July 15, 2022.  That’s the new end-date for the COVID-19 public health emergency (PHE) after Secretary of Health and Human Services (HHS) Xavier Becerra renewed the PHE for 90 days last week.  HHS has continually renewed the PHE over the last two years, and as the pandemic extends into its third year, many are wondering when the federal government will finally let the PHE expire.

A Brief History of the PHE

The Trump administration first declared a PHE for the COVID-19 pandemic in late January 2020.  Since then, HHS has continually renewed the PHE for 90-day periods.  Shortly after President Joe Biden took office, HHS promised to provide 60 days’ notice before ending the PHE to give health care providers and states time to prepare.  In his recent appearances before several congressional committees on his department’s budget request, HHS Secretary Becerra has reaffirmed the administration’s commitment to providing 60 days’ notice.    

Calls to end the PHE grow: Pandemic fatigue is growing and in recent months, Republican lawmakers have been pushing for the administration to let the PHE end as a signal that the country is going back to normal.  Back in February 2022, 71 House Republicans proclaimed in a letter to the administration that as long as the PHE remains in effect, it “sends the message that the country is still in a crisis that requires emergency powers.”

But health care stakeholders are saying “not so fast” on ending the PHE.  A number of emergency measures are tied to the PHE that have become a vital part of the health care system, and a 60-day notice would provide some time to allow providers and patients to prepare accordingly.  These emergency measures include:

The federal government has taken steps to ensure some of these measures don’t come to an immediate end once the PHE expires.  For instance, the omnibus signed into law last month extends certain telehealth services for Medicare beneficiaries for 151 days (5 months) after the PHE, and additional Medicaid funds provided to states to allow them to maintain current enrollment levels would last under the end of the quarter when the PHE expires.

However, Congress has yet to enact any permanent fixes, specifically regarding telehealth flexibilities that are popular with both providers and patients.  On top of this, many providers are still reeling with staffing shortages and the high cost of contract labor necessary to fill in critical gaps. However well-intentioned, the cushioning provided by Congress combined with the administration’s 60-day notice still leaves health care stakeholders without enough time to prepare for a post-pandemic world.

What happens next?  As long as the administration is committed to providing 60 days’ notice, HHS is likely to make a decision on whether or not to extend the PHE, that’s currently set to end on July 16, no later than Monday, May 16 – less than one month away.  While it’s hard to predict exactly what will happen by mid-May, a lack of permanent fixes from Congress to address popular PHE-tied measures and pressure from health care providers likely means HHS is likely to extend the PHE this summer

A 90-day extension beginning in mid-July would mean a new expiration date of October 13, 2022 – less than a month away from the 2022 midterm elections.  If Congress fails to enact legislation to address temporary pandemic measures this summer, the administration would be wise to renew the PHE once again this fall – otherwise, it would be forced to reckon with the political fallout of starting the expiration countdown for popular emergency health measures.    Additionally, letting the PHE expire will trigger health care coverage cliffs and without new laws in place to allow the states and providers a smoother transition to a post-pandemic world will be far worse for patients.  Thus, the PHE is likely to remain in effect for the rest of 2022.

What Would the End of the Public Health Emergency Mean for EUAs?

The current public health emergency (PHE) is set to expire on April 16.  While the Biden administration is likely to extend the PHE, administration officials have yet to comment on their specific plans.  Uncertainty over the end of the PHE has fueled conversations over what the implications would look like for temporary health care policies that expire once the PHE officially concludes. 

Blog posts from the last two weeks have looked at how the end of the PHE would affect Medicare’s temporary telehealth waivers and Medicaid coverage.  This week’s blog post focuses on how ending the PHE would impact the Food and Drug Administration’s (FDA) emergency use authorizations (EUAs).

Background:  An EUA allows the FDA to authorize unapproved medical products or unapproved uses of approved medical products – like vaccines and treatments – to be used to diagnose, treat, or prevent serious or life-threatening diseases in cases where there are no adequate, approved, and available alternatives.  Since the start of the COVID-19 PHE on January 31, 2020, the FDA issued hundreds of EUAs for pharmaceutical and medical devices related to COVID-19.

How? Section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act allows the FDA to issue four different types of EUAs during a PHE for diagnostics, respiratory equipment, medical devices, and drugs/biologics.  However, the FDA still has the authority to issue an EUA outside of a PHE thanks to the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013, which grants Department of Health and Human Services flexibility to declare that “circumstances exist” outside of a PHE to allow EUAs to be issued.

What does the end of the PHE mean for the EUAs?  Unlike the other temporary authorities related to telehealth and Medicaid, all EUAs that are issued by the FDA remain in effect until the FDA withdraws the EUA declaration.  For instance, the EUA declarations issued for the Zika and Ebola pandemics were never withdrawn and are currently in effect, even though their respective PHEs have long since expired. 

However, one FDA policy, separate from EUAs, will expire at the conclusion of the PHE – enforcement discretion.  This policy allows the FDA to waive enforcement of its usual requirements for pre-market approval to allow drug products to be modified for additional uses without full approval from the agency.  In contrast, drug products approved via an EUA must still meet specific criteria on safety and effectiveness.  Once the PHE ends, the FDA will revert to its regular enforcement policies, and all products where enforcement discretion once applied must then meet all standard FDA legal requirements in order to continue to be sold in the US.  

Planning for a Post-EUA Future

Unlike the EUAs for Zika and Ebola treatments, the FDA has communicated that it doesn’t want the COVID-19 EUAs to stick around forever and manufacturers should expect an “eventual resumption of normal operations.”  To this end, the FDA issued two draft guidance documents in late December to help facilitate a return to normal:

Uncertain Future for Stakeholders

On February 22, the FDA held a webinar for industry stakeholders about its draft guidance documents on its post-pandemic transition plans, and like their counterparts in telehealth and Medicaid, the stakeholders from the pharmaceutical and medical device industries had a lot of questions. 

  • Of the four EUA declarations, three are specific to devices, and it’s not clear if the agency will withdraw those EUAs all at once or at different times.
  • The webinar did not offer stakeholders a clear answer on whether HHS issues the advance notice on withdrawing the EUA declarations first, or FDA will finalize its two guidance documents on its transition plans.   Instead, FDA staff told attendees that whatever happens first depends on the course of the pandemic.  If hospitalizations continue to decline and stay low, HHS may pull the EUA declarations first; otherwise, finalization of the guidance documents could come sooner.
  • The FDA says more guidance is on the way, but it’s unknown when it will be released.  According to FDA staff, this would pertain to the types of data FDA will consider when transitioning a drug product from an EUA to formal market access, such as how real-world evidence will be considered. 

While pharmaceutical industry stakeholders can feel relieved that EUAs won’t expire with the end of the PHE and that the FDA is making plans for a post-pandemic world, question about what that world will look like simply add to the narrative that the federal government’s take on health care policies once the PHE ends need significant refinement.

The PHE Was Just Extended. What Does That Mean?

So, what exactly happens to those regulatory flexibilities and emergency measures when the pandemic ends?  On April 15, the Department of Health and Human Services (HHS) extended the PHE for a 90-day period beginning on April 21 and ending on July 19.  HHS won’t keep doing this forever – so what happens when the PHE is no longer renewed? 

The PHE So Far

HHS first declared the COVID-19 PHE on January 27, 2020, and HHS has since renewed the PHE four times, each for 90 days.  When Acting Health and Human Services Secretary Norris Cochran  sent a letter to state governors on January 21, 2021 estimating  the PHE will likely remain in place for the entirety of 2021,” many thought the current extension would run through the calendar year, but Secretary Xavier Becerra extended the PHE through July 19, following the pattern of 90-day renewals as stipulated by the Public Health Service Act.  The January 2021 letter indicated that when HHS decides to terminate the declaration and/or let the PHE expire, the Department will provide states with 60 days’ notice. 

When Will the PHE End?

Do you remember when President George W. Bush relayed the message that the war in Iraq was over during his famed aircraft carrier speech on May 1, 2003, and then the war continued for many years?  Is that what will happen with the PHE?

As it goes, there isn’t a requirement that  HHS outline any specific criteria to be met for the PHE to end.  The Health and Human Services Secretary has the option of declaring the PHE over, or he may simply not extend the current emergency.  For their part,  the American Health Care Association offered one suggestion – that the  PHE be lifted if roughly 70% of the population has been vaccinated, or less than 500 COVID-19 deaths have occurred for 14 consecutive days . 

Key Measures Linked to the PHE

Both Congress and the Administration have advanced key COVID-19 relief measures whose expiration dates are linked to the termination of the PHE.  Below is a list of pivotal relief measures and their central provisions.

  • Certain measures included in COVID-19 relief legislation.  Many policies tied to the PHE are included in the Families First Coronavirus Response Act, enacted March 18, 2020, the CARES Act, enacted March 27, 2020, and the American Rescue Plan Act, enacted March 11, 2021.  Some of these measures expire at the conclusion of the PHE, while others have a specific end date beyond the PHE, such as the one year or one calendar quarter after the termination of the PHE.  Key provisions include:
    • Enhanced coverage and no cost-sharing for COVID-19 testing and vaccines under Medicare, Medicare Advantage, Medicaid, CHIP, and TRICARE.
    • Waived or modified Medicare requirements for telehealth, such as the restriction on use of a telephone and the requirement for face-to-face visits between home dialysis patients and physicians.
    • Increased Medicaid federal match rate to 6.2%.
    • Waived site-neutral payment rate provisions for long-term care hospitals.
    • Continued payments to providers via the Medicare Hospital Accelerated Payment Program.
    • Recalculated Medicaid disproportionate share hospital allotment.
  • Temporary regulatory flexibilities under CMS.  In interim final rules published on March 31, May 8, September 2, and November 2, 2020, the Centers for Medicare and Medicaid Services (CMS) has relaxed numerous Medicare and Medicaid rules for the duration of the PHE.  Examples include testing and reporting requirements for long-term care facilities, enhanced Medicare reimbursement for certain COVID-19 treatments, and price transparency requirements for COVID-19 tests.  The interim final rules also include a number of telehealth provisions, with notable examples including:
    • Waived requirements on the types of practitioners that can furnish Medicare telehealth services to include all practitioners eligible for Medicare reimbursement, including physical therapists, occupational therapists, and speech language pathologists.   
    • Modified reporting requirements for remote physiological monitoring services.
    • Payment parity for audio-only telephone services.
    • Allowing hospitals to bill for services provided remotely by hospital-based practitioners to Medicare beneficiaries registered as outpatients.
    • Allowing teaching physicians to review services provided by resident physicians remotely via audio-visual communications technology.
  • Section 1135 Waivers.  Since the start of the pandemic, CMS has invoked Section 1135 waiver authority to issue a blanket waiver and a series of state-specific waivers that expand telehealth coverage, allow clinicians to practice across state lines, and suspend some reporting requirements.  All of these waivers are set to expire at the conclusion of the PHE.
  • HIPAA Enforcement.  The HHS Office of Civil Rights has relaxed certain HIPAA privacy rules for the duration of the PHE that apply to telehealth technologies, testing sites, and web-based scheduling platforms for COVID-19 vaccination appointments.  
  • Stark and Anti-Kickback Statute.  The HHS Office of the Inspector General has issued guidance discouraging enforcement of pandemic response activities until the end of the PHE that could be viewed as problematic under the anti-kickback statute and the Stark Laws. 
  • Controlled Substances. Both the Substance Abuse and Mental Health Services Administration and the Drug Enforcement Administration have issued guidance allowing more flexibility for providers and opioid treatment programs to prescribe controlled substances during the PHE.

Previewing a Post-PHE World

As vaccinations increase and jurisdictions gradually reopen, the fate of temporary policies that expire at the end of the PHE remains unclear.  Fortunately, recent actions by federal officials offer clues as to how some of temporary policies may be retained, particularly those relating to telehealth.  As expressed by then-CMS Administrator Seema Verma in December 2020, congressional action will be essential to ensuring expanded telehealth coverage and other flexibilities can be made permanent.  Since then, policymakers have been providing suggestions to lawmakers on what to do with telehealth after the PHE ends.  In its March 15, 2021 report to Congress, for example, the Medicare Payment Advisory Commission recommended continuing some telehealth flexibilities one to two years following the end of the PHE to evaluate whether the temporary policies should be adopted permanently.  The report also provided the following recommendations to Congress:

  • Continue Medicare coverage for telehealth services, regardless of a beneficiary’s location.
  • Discontinue allowing providers to reduce or waive cost-sharing for telehealth.
  • Continue coverage of audio-only services if there is a clinical benefit.

Additionally, members of Congress have put forth their own proposals to permanently expand telehealth.  Key legislation introduced so far includes:

  • H.R. 366, the “Protecting Access to Post-COVID–19 Telehealth Act of 2021,” introduced by Rep. Mike Thompson (D-CA), which would eliminate most geographic and originating site restrictions on the use of telehealth in Medicare and authorize CMS to continue reimbursement for telehealth for 90 days beyond the end of the PHE.
  • H.R. 787, the “Expanding Student Access to Mental Health Services Act,” introduced by Rep. Rick Allen (R-GA), which would permanently expand telehealth services for students.
  • H.R. 937, the “Tech to Save Moms Act,” introduced by Rep. Eddie Bernie Johnson (D-TX), which would integrate telehealth models into maternity care services.

While the federal government may not yet have a specific plan on how it intends to handle temporary regulatory flexibilities once the pandemic expires, recent action from legislators and policymakers suggest a desire to keep at least some policies around permanently. 

HELP Hearing Explores Ways to Rebuild Public Health Workforce

The COVID-19 pandemic represents an “unmitigated attack” on providers and first responders, which has left workers “fatigued emotionally and physically” according to public health experts at a March 9 hearing of the Senate Health, Education, Labor, and Pensions Committee on the COVID-19 response.

The nation’s public health system had been “hollowed out over the past 10 years” said Ashish Jha (Brown University) due to years of underinvestment and chronic personnel shortages.  

As a result, the challenges facing front-line health care workers according to Mary Ann Fuchs (Duke University) include a lack of access to personal protective equipment, confusion over changing policies, and exhaustion from surge staffing.  Fuchs also described the growing toll on health care workers’ emotional well-being due to fears of exposing family members to the virus and the trauma of constantly treating critically ill patients.  Washington State Secretary of Health Umair Shah similarly observed “compassion fatigue” among behavioral health providers as they face their own mental health pressures, and he noted outdated information technology systems such as faxes have complicated workers’ response efforts.  The result of these pressures, explained Fuchs, is the exacerbation of high rates of depression, burnout, addiction, and suicide among providers that existed before COVID-19.  As a consequence, Fuchs said the pandemic threatens to increase already-high turnover rates among health care workers.

To tackle stressors on the health workforce, the panelists recommended:

  • greater access to behavioral health resources that provide assessment and short-term counseling for providers
  • more support of workplace violence initiatives
  • new ways for paying primary care physicians
  • focus on diversity and equity to ensure workers represent the communities they serve
  • expansion of the public health workforce to include specialists and paraprofessionals

The panel underscored that rebuilding the nation’s public health system is essential to prepare for the next pandemic.  As described by Jha, economic development, climate change, and globalization are thrusting the world into a new “age of pandemics,” which underscores the need to continue to invest in the public health workforce even after the COVID-19 public health emergency ends.