Originally published by our sister publication Infectious Disease Special Edition

By Gina Shaw

On May 11, the government’s COVID-19 public health emergency and national health emergency designations officially came to an end after more than three years. But certain emergency declarations have ended while others have not, and even for those declarations that have ended, some specific provisions extend beyond the May 11 expiration date. 

Confused? So are we.

What Ended on May 11? 

Two declarations expired: the public health emergency (PHE) initially declared by the secretary of the Department of Health and Human Services (HHS) in late January 2020, under Section 319 of the Public Health Service Act, and extended multiple times since then; and the national emergency declaration issued by former President Donald Trump in March 2020, under Section 201 of the National Emergencies Act, and extended by both the Trump and Biden administrations.

What did not end?

Two other key provisions did not end:
1. A separate emergency declaration also issued by the HHS secretary under Section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, which allows emergency use authorization (EUA) of certain drugs and biological products for COVID-19. It’s unclear when this EUA will end, but it did not end on May 11.

2. A declaration under the Public Readiness and Emergency Preparedness (PREP) Act (part of the Public Health Service Act) also issued by the HHS secretary, which provides liability immunity for activities related to COVID-19 medical countermeasures. The secretary has set the end date for this declaration as Oct. 1, 2024.

"Today marks the end of the COVID-19 public health emergency in the United States. We have come a long way since Jan. 31, 2020, when the COVID-19 pandemic was first declared a public health emergency, but none of us will ever forget how the pandemic changed our nation and impacted the lives of so many people," said Carlos del Rio, MD, FIDSA, the president of the Infectious Diseases Society of America.

"Treatments and vaccines that didn’t exist three years ago are now effective tools against the virus. Without them we would not have crossed today’s important threshold. Vaccination provides the best protection against severe COVID-19 disease, including hospitalization and death, and being up to date on vaccines will continue to be important. The end of the official public health emergency does not mean the end of COVID-19 infections and deaths, and it is critical to continue to collect and monitor data so that we can be alerted quickly to outbreaks or new variants and adjust mitigation measures as needed," he said.

What Does All This Mean for Providers and Patients?

The PHE and national emergency declarations have protected consumers from having to pay many out-of-pocket costs for COVID-19 vaccines, tests and treatments. Now, insurers largely have the flexibility to charge what the market will bear.

During the PHE, Medicare and Medicaid beneficiaries paid no cost sharing for COVID-19 tests (up to eight tests per month) or vaccines. Private payors were also required to cover at least eight COVID-19 tests per month, along with testing-related services, without cost sharing or prior authorization, and to cover vaccines without cost sharing even when provided by out-of-network providers. All those requirements ended with the PHE on May 11.

But because the FDA emergency is not yet ending, vaccines will be covered by the government until its stockpile is exhausted, at which point they will be covered by private or public insurance for those who have health coverage. The government also has a large stockpile of the antiviral nirmatrelvir and ritonavir (Paxlovid, Pfizer), so that will continue to be available without cost sharing under the FDA EUA until it runs out, at which point how much patients pay for the drug will be determined by insurance.

“It’s not clear what different insurance plans will do in terms of reimbursement and coverage for vaccines and testing, but obviously, many more people will have out-of-pocket costs,” said infectious disease specialist Carl Fichtenbaum, MD, the Gregory W. Rouan, MD, Endowed Professor of Internal Medicine at the University of Cincinnati. “And without subsidies for testing, a lot of people who get sick with ‘colds’ that may be COVID will not test, so we will have less ability to monitor the spread of the disease.”

As with many other provisions of the PHE, there may also be state-by-state variations. For example, California state laws added six months to the federal PHE requirements on health plans to continue covering COVID-19 tests, vaccines and treatment from any licensed provider with no prior authorization or cost sharing. “That means that until Nov. 11, we can basically continue to give medications, tests and vaccines to people for free with no copays, regardless of insurance, but that is not true in other states,” said infectious disease specialist Peter Chin-Hong, MD, a professor of medicine at the University of California, San Francisco.

Nuances of coverage and out-of-pocket costs vary by payor type. “It’s going to be confusing to the average person what is covered and what is not, and I’m concerned that this confusion will lead to people fearing they’ll be saddled with too many expenses so they just won’t bother to find out,” Dr. Chin-Hong said.

Vaccine Availability in Pharmacies

“The PREP Act allows pharmacists to administer vaccines, including COVID-19 as well as other standard vaccines, to conduct testing for flu and respiratory syncytial virus (RSV) as well as COVID-19, and to initiate certain therapies including Paxlovid,” said Tom Kraus, the vice president of government relations for the American Society of Health-System Pharmacists (ASHP).

The act also allows healthcare providers licensed in one state to vaccinate against COVID-19 in another state, and physicians and nurses whose licenses have expired within the last five years to provide COVID-19 vaccinations.

This April, HHS announced that it would extend these authorities until December 2024, but the provision allowing pharmacists, pharmacy technicians and students to administer routine childhood vaccines did expire as of May 11. 

Telehealth

All states temporarily waived some aspects of state licensure requirements for telehealth services, allowing providers with equivalent licenses in other states to practice via telehealth. In some states, those waivers have already expired; in others, they will expire with the end of the PHE; and in still others, long-term provisions for interstate telemedicine have been put in place.

The Consolidated Appropriations Act (CAA) of 2023 extended Medicare’s coverage of telehealth for two years, allowing Medicare patients to receive telehealth services at home via either audio?video or audio-only technology. Many private payors, however, have changed their reimbursement policies for audio-only telehealth.

The end of the PHE also means the end of the HHS’s waiver of potential HIPAA penalties for providers who use widely accessible services like FaceTime or Skype for telemedicine, whether related to COVID-19 or not. “This was really beneficial for patients, and providers will have less flexibility for telemedicine,” Dr. Chin-Hong said.

Some provisions of the PHE have their own “sunset” dates. For example, the Centers for Medicare & Medicaid Services (CMS) has been paying $40 per dose for administering COVID-19 vaccines in outpatient settings, but effective Jan. 1 of the year after the PHE concludes (Jan. 1, 2024), the payment rate will align with that for administering other Part B vaccines.

With the end of the PHE, the CDC will still get data about COVID-19 cases, but the frequency and granularity are likely to slow down, according to Dr. Chin-Hong. “It’s like operating with [petroleum jelly] in your eyes because you won’t have minute-to-minute and community-specific data. We won’t have a ‘COVID weather report’ like we used to have.”

Dr. Fichtenbaum predicted that much of the funding driving research and discovery that came from PHE orders also will dwindle. “Research may slow and the discovery of new antiviral agents may also slow. As with many health issues that come up, we initially put in a lot of resources and energy, we make headway, but don’t completely solve the problem. Then we say it is time to move on to the next one,” said Dr. Fichtenbaum.   

Dr. del Rio urged officials to continue to fund public health.

"More than 1 million people in the United States lost their lives to COVID-19 infection, and many others live with the lingering physical and mental effects of the virus known as long COVID. COVID-19 made existing health disparities worse. Black and Hispanic people had higher rates of infection, hospitalizations and death due to COVID-19, and the inequities that contributed to those disparities must be addressed as part of pandemic preparedness.

"New health threats are on the horizon. The time to invest resources in preparedness is now, not when the next pathogen starts to spread. A well-funded infrastructure for public health, research and health care and a workforce trained in infectious diseases and biopreparedness is needed to protect the American people," he said.


The sources reported no relevant financial disclosures.