Key healthcare regulatory flexibilities that were enacted to help the industry respond to the COVID-19 pandemic are set to expire Thursday as the public health emergency ends.
Some flexibilities, however, have been temporarily extended and may become permanent.
The scheduled ending of the PHE, announced in January, comes a week after the World Health Organization announced that COVID was no longer a global health emergency, although the organization warned that “the global risk assessment remains high.”
There were fewer coronavirus deaths reported in 2022 than in 2021 in the United States, but the disease still killed 500 people a day last year. And scientists have warned that further surges, like the rise of the omicron variant in late 2021 and early last year, are still a threat.
Anand Parekh, chief medical adviser for the Bipartisan Policy Center, said he believes the timing is appropriate for ending the public health emergency, as long as a focus remains on vaccines, testing and treatment.
“These are the tools that got us through the pandemic, and I think they’re going to be critical moving forward as well,” he said.
Testing and Vaccines
Vaccines, which have been crucial to curbing the threat of the virus, will remain free for the vast majority of people in the U.S.
Private insurers are required to cover vaccines as part of the Affordable Care Act preventive services mandate, though that mandate is currently being challenged in court.
Medicare and Medicaid will continue to fully cover the shots. The uninsured will be able to receive free vaccinations for as long as the federal government’s stockpile has vaccine supplies.
During the PHE, private insurers and Medicare have been required to cover up to eight over-the-counter COVID-19 tests per month, without cost sharing. With the period ended, private insurers are likely to require cost-sharing going forward, which could reduce people’s willingness to take a test if they feel symptoms.
“Diagnostic testing is a critical means to mitigate disease transmission, but the end of free testing will result in diminished access and a less effective defense against the spread of the virus,” according to a blog post last week from the Georgetown University Center on Health Insurance Reforms.
Medicaid will continue to cover the tests through September 2024.
Soon after the pandemic began to impact the U.S., the CMS suspended some requirements for telehealth care as patients heeded stay-at-home orders and avoided going to routine medical appointments
The CMS relaxed guidelines on what platforms could be used for telehealth and which medicines could be prescribed. The agency also approved audio-only telehealth visits.
While some of those flexibilities are ending, many will continue through this year or next.
Jacob Harper, a partner at law firm Morgan Lewis, said extending flexibilities allows providers to conduct more long-term planning for investments and infrastructure, but that providers are still unclear on what the landscape will look like in January 2025.
“I'm in a sense glad that the PHE is ending,” Harper said. “I think that while providers certainly have enjoyed those flexibilities, I think it's time now to move onto sort of healthcare 2.0, or at least the next phase of it, and develop more permanent policies as we go forward here.”
One key regulatory change during the PHE allowed doctors to prescribe controlled substances like Adderall, oxycodone and opioid use disorder drugs virtually, without in-person meeting requirements. Patient advocate and doctors groups urged for prescribing flexibilities to become permanent, saying that the policies helped people access treatment, especially for opioid use disorder.
On Tuesday, the U.S. Drug Enforcement Agency said prescribing flexibilities would continue for the next six months as it considers comments on proposed telehealth rules that would have imposed stricter requirements for digital prescribing.
The ability to receive telemental health services without an in-person meeting has been extended through the end of 2024. Waivers for geographic and site origination requirements have also been extended, as well as the ability to have audio-only visits.
Congress could take action to make some of these changes permanent, with Harper adding that there is legislative appetite to do so.
“It's a very bipartisan, bicameral issue,” he said. “Because of that bipartisanship, it tends to get punted to the back a little bit, until it's like, ‘We have to do this now or never.’”
Flexibilities ending with the PHE include those that allowed providers to practice across state lines. Providers will also again be required to have an established patient relationship before initiating telehealth visits.
The data and experiences gathered from the regulation rollbacks will help providers understand the evolving role telehealth has in healthcare, Bipartisan Policy Center’s Parekh said.
“We need to continue learning to better understand where and how telehealth provides the most impactful benefits,” he said.
Changes for hospitals
In an effort to offset the cost of complex medical care, Medicare began providing 20% add-on payments for COVID patients during the pandemic.
Those extra payments and other hospital flexibilities are slated to end Thursday, including hospital without walls programming that allowed facilities to treat patients in outside locations like tents, convention centers or vacant stores.
Also, hospitals will once again be required to have a nursing plan of care for each patient, and flexibilities on discharging patients to skilled nursing facilities will be removed. Hospitals have been struggling with bottlenecks because of a lack of nursing home capacity, leading to longer lengths of stay for health systems.
Parekh noted that hospitals have been able to prepare since January, though the changes came as margins for many remain below pre-pandemic levels.
The Centers for Disease Control and Prevention will continue most of its COVID data tracking, but it will no longer publish three reports and expects its reporting cadence to change.
Without the PHE, the CDC can no longer require reporting of negative coronavirus tests via COVID Electronic Laboratory Reporting.
This means the agency cannot report percentages of positive tests, and community transmission levels will be discontinued.
Although monthly case reporting, hospitalizations and mortality rates by vaccination status reports will also be halted, the CDC said in a briefing that its COVID-19 monitoring continues to be a “public health priority” during the PHE transition.