So The Public Health Emergency Is Over. Now What?

More than three years into the COVID-19 pandemic, the public health emergency (PHE) is finally ending. The first PHE was declared in early 2020, and it’s been renewed every 90 days since. However, President Joe Biden recently announced that the current PHE – scheduled to expire 11 May – will not be extended.

Biden’s decision means the administration believes the pandemic has moved to the endemic stage, similar to the seasonal flu, a view supported by data from the US Department of Health and Human Services (HHS).

For instance, over the past two years, according to HHS, some 270 million Americans have received at least one dose of the COVID-19 vaccine, which health official say accounts for the decline in cases since the peak of the Omicron surge in January 2022. Additionally, deaths and hospitalizations have each dropped 80%.

However, despite these positive trends, health officials continue to emphasize COVID-19 remains a concern as Americans are still contracting – and dying from – the virus.

As of 22 February 2023, the Centers for Disease Control and Prevention (CDC) reports a total of 103,268,408 COVID-19 cases in the US, with the current seven-day average of weekly new cases (33,733) decreasing 9.2% compared with the previous average during the same period (37,135). The current seven-daily average of new deaths (344) decreased 15.2% compared with the previous same day average (405).

Allowing the PHE to expire, the administration says, gives the government and providers adequate time to make whatever preparation is necessary for life after the emergency.

Abruptly ending the PHE, according to the Office of Management and Budget (OMB), would create chaos and uncertainly across the entirety of the health care landscape and would especially impact Americans with government insurance, as many of those plans have had special considerations during the pandemic. For example, Medicare beneficiaries were allowed free at-home testing and treatment.

The Centers for Medicare & Medicaid Services (CMS) has published a fact sheet on the PHE ending that includes information on vaccines, testing, and treatments; telehealth services; health care access for health care professionals; and inpatient hospital care at home.

But to further help average Americans understand what the ending of the PHE will mean for them, Medtech Insight spoke to Dr. David Feldman, chief medical officer at The Doctors Company, about how it will affect – or not affect – patients.

“The first thing I would say is that the average physician probably doesn't even know the details of the public health emergency,” Feldman said, noting doctors are not responsible for the day-to-day administrative operations of their practice and do not pay much attention to them.

“I think the impact on telemedicine has less to do with public health emergency and more to do with the changing environment and the landscape in each state and I think it's a good thing. I think it's net positive.” – David Feldman

As Feldman also noted, much of a doctor’s medical practice is under state, not federal, control. “The public health emergency is a national thing and so much of what regulates medicine is state,” he said. “Doctors and nurses are licensed in individual states.”

So, in Feldman’s view, the PHE ending is not going to have much impact on the daily interaction between doctors and their patients.

“I just don't believe that doctors are going to base how they communicate with patients on whether there's a public health emergency or not,” he said. For example, he does not expect physicians to change how they would diagnose or treat a patient based on whether or not a particular treatment is covered – or no longer covered – because of the change in the PHE. “I don't see doctors changing their decision any more now than they normally would.”

Feldman also pointed out that except for emergency situations, an administrative assistant in a doctor’s office will ask for a patient’s insurance information regardless of whether there is a PHE or not. “They’re not going to ask if what you’re coming in for is related to the public health emergency, so I don't see where it's going to impact a patient's ability to see a physician.”

Change, No Change

According to HHS, the administration’s continued response to COVID-19 is not dependent on the PHE and “there are significant flexibilities and actions that will not be affected” during the transition out of the emergency.

HHS also says the administration will continue to ensure that COVID-19 vaccines and treatments will be widely accessible to all who need them, while the FDA pathways for emergency use authorizations (EUAs) for tests, vaccines, and treatments will also remain in place for now.

Further, major telehealth provisions put in place during the pandemic for Medicare and Medicaid beneficiaries will continue, which Feldman said he does not see changing.

DAVID FELDMAN

“A lot of doctors that typically see patients in their office have adopted telemedicine, which I think is great. It's a very patient friendly tool, but it needs to be used appropriately,” he said. “But I think the impact on telemedicine has less to do with public health emergency and more to do with the changing environment and the landscape in each state and I think it's a good thing. I think it's net positive.”

Though they vary by state, most states enacted significant flexible provisions for Medicaid coverage of telehealth services during the pandemic and, according to HHS, most of those changes will not be affected when the PHE ends.

“Similar to Medicare, these telehealth flexibilities can provide an essential lifeline to many, particularly for individuals in rural areas and those with limited mobility,” HHS says, adding the vast majority of flexibilities will remain in place through December 2024.

In November, CMS extended coverage for some telehealth services to last 151 days after the PHE ends. (Also see "CMS Extends Telehealth Coverage For 2023" - Medtech Insight, 4 Nov, 2022.)

Devices and diagnostics

With the ending of the PHE, HHS says the FDA’s ability to detect early shortages of critical devices related to COVID-19 will be more limited. During the emergency, manufacturers of certain medical devices related to the diagnosis and treatment of COVID-19 were required to notify the FDA “of a permanent discontinuance” or “an interruption in the manufacture of the device that is likely to lead to a meaningful disruption in the supply of that device.” This requirement will end with the PHE.

While FDA will still maintain its authority to detect and address other potential medical product shortages, the agency is seeking congressional authorization to extend this requirement for device manufacturers to notify it of significant interruptions and discontinuances of critical devices outside of a PHE, which the agency says will strengthen its ability to help prevent or mitigate device shortages.

“The long and short of it is physicians are not going to base their care whether or not there's a public health emergency or not.” – David Feldman

The PHE expiration will also affect coverage for COVID-19 testing.

Though Medicare beneficiaries enrolled in Part B will continue to have coverage without cost sharing for laboratory-conducted COVID-19 tests when ordered by a provider, they will no longer have access to free over-the-counter (OTC) COVID-19 tests.

The requirement for private insurance companies to cover COVID-19 tests without cost-sharing, both for OTC and laboratory tests, will also end, though coverage for the tests may continue if plans choose to cover them.

However, Medicaid programs must provide coverage without cost-sharing for COVID-19 testing until the last day of the first calendar quarter that begins one year after the last day of the PHE, which means mandatory coverage will end on 30 September 2024, after which coverage may vary by state.

While Feldman believes the health care community and the country at large will handle the PHE ending without much difficulty, he is concerned about the polarization in the country that has only deepened during the pandemic. 

“I think there’s this unfortunate sense that science isn't believable anymore and that worries me,” he said. “And maybe the ending of the public health emergency is just another way of saying none of this stuff matters anymore. I worry about that because we have to believe in science otherwise it’s chaos.”

But whether the transition from the PHE back to “normal” is smooth or bumpy, Feldman doesn’t believe it will make a difference in how doctors approach treating their patients.

“The long and short of it is physicians are not going to base their care whether or not there's a public health emergency or not,” he said. “They're going to take care of their patients based upon taking care of their patients, and that's the way it should be.”