WASHINGTON — The Biden administration’s plan to unwind the public health emergency tied to the COVID-19 pandemic will spur a whirlwind of changes related to telehealth, Medicaid, pharmaceuticals and other priorities.
Many Republicans have said the May 11 end date announced Monday is not soon enough, with the House voting this week on a bill to roll back that and three other pandemic policies immediately. Democrats have said the time is needed to weigh which flexibilities and funding may need to continue.
Still, U.S. plans to end the emergencies stand in contrast to the opinions of other global health leaders, with World Health Organization Director-General Tedros Adhanom Ghebreyesus on Monday saying the pandemic is nearing a “transition point.” He aligned himself with a WHO committee that said it “requires a focused commitment of WHO, its Member States and international organizations” and that “long-term public health action is critically needed.”
Sen. Bernie Sanders, the incoming chairman of the Health, Education, Labor and Pensions Committee, also seemed wary.
“We are seeing a massive amount of sickness right now. And there’s no reason to believe — and I hope that it’s otherwise — that that’s going to change in the immediate future,” said Sanders, I-Vt.
But many argue that there is no longer a justification for the public health emergency, even though unwinding the flexibilities associated with that will take time.
“You can even argue that there’s more tools to deal with COVID-19 than there are to deal with any other respiratory virus,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.
Cost sharing, payment changes
Ending the public health emergency means people will likely have to pay more out of pocket for COVID-19 testing and treatment, and planned price increases among COVID-19 vaccines and treatments have drawn congressional scrutiny.
Both Moderna and Pfizer plan to increase prices from the government rate of around $25 to $30 per dose to as much as $130.
Sens. Elizabeth Warren of Massachusetts and Peter Welch of Vermont accused Pfizer of “pure and deadly greed” over the news in December. Sanders labeled Moderna’s expected increase “unconscionable” last month.
For the millions of people enrolled in Medicare, meanwhile, cost-sharing requirements for COVID-19 treatments will resume when the public health emergency ends. Enrollees will also likely have to pay full cost for at-home tests. The same goes for Medicaid beneficiaries, although cost sharing for testing and treatments will resume in 2024 under a provision in a COVID-19 relief law.
And while private insurers were required to provide or pay for eight free COVID-19 tests per month during the public health emergency, that provision will expire when the PHE does. Insured individuals will still have access to COVID-19 vaccines after the end of the emergency, but uninsured people will no longer be eligible for free COVID-19 testing, vaccines or treatment through Medicaid.
“Throughout the pandemic, people have been able to get what they need, regardless of their ability to pay. And we’ll be moving into a phase where that will be different,” said Natalie Davis, CEO of health advocacy group United States of Care.
But commercializing the products will have its upside, Adalja said, including the ability to freely market products that federal officials and many experts believe are underutilized, like Paxlovid.
“Love them or hate them, pharmaceutical reps actually are effective at increasing awareness,” he said. “And television commercials are also effective at drawing and getting people to demand the drug.”
The unwinding of the PHE also means it may be more difficult for Congress to gain consensus on other COVID-related spending.
The American Hospital Association said it will continue asking Congress for additional help navigating workforce challenges, cost increases for equipment and drugs, sicker patients and disrupted supply chains.
Ashish Jha, the White House’s COVID-19 response coordinator, tweeted that the Biden administration is “committed to ensuring that uninsured Americans continue to face as few financial barriers as possible to access vaccines, treatments and tests.”
Other expiring provisions include a 20 percent Medicare payment boost for hospitals aimed at offsetting the cost of treating COVID-19 patients.
But Medicare coverage of telehealth, a flexibility that occurred because of the public health emergency, will largely continue through 2024 because of a provision in the fiscal 2023 omnibus spending law.
Lawmakers are likely to extend coverage past that date, either permanently or temporarily, depending on forthcoming data about cost and effectiveness.
States, meanwhile, are redetermining eligibility for Medicaid and CHIP and preparing for the end of temporary flexibilities secured through pandemic-related waivers.
Under the March 2020 COVID-19 relief law, states that receive enhanced federal Medicaid funding were barred from dropping individuals from the program during the emergency. CMS data released Tuesday showed that as of October, more than 91 million individuals were enrolled in Medicaid or CHIP.
But a 2023 omnibus provision allows states to begin redetermining beneficiary eligibility as early as Wednesday without penalty. The continuous coverage requirement will end March 31. Supplemental Nutrition Assistance Program benefits will also drop to pre-pandemic levels in March.
States must complete their redetermination process by May 2024.
The administration issued state guidance on ways to limit increases in the uninsured rate as states try to educate residents about other options like marketplace coverage if their income would now disqualify them for Medicaid.
“We have been working on several fronts to prepare for this and to ensure the transition is as seamless as possible. Our priority right now is to promote awareness and to help our clients understand the timeline and the steps that need to be taken to redetermine eligibility,” said Cecile Erwin Young, Texas Health and Human Services executive commissioner.
States will also have to prepare for fewer administrative flexibilities that are tied to the public health emergency. Since March 2020, every state has sought special, quick policy changes from CMS through what are known as 1135 Waivers, which are used for health crises and disasters, or via state plan amendments.
Many state temporary changes — such as eliminating drug cost sharing, allowing early drug refills or easing restrictions on treating Medicaid patients in another state — must end when the public health emergency does or sooner if requested by the state.
Drugs and devices
The Food and Drug Administration has issued hundreds of emergency authorizations for vaccines, therapeutics and tests that are linked to but not necessarily dependent on the public health emergency. The authorizations are in effect under separate declarations that HHS made under Section 564 of the Food, Drug and Cosmetics Act in light of the pandemic and can continue beyond the emergency.
The FDA promises “a sufficient period” for manufacturers and other stakeholders to transition once the emergency declarations are terminated. Draft guidance for medical devices proposes a 180-day advance notice.
FDA spokesperson Michael Felberbaum said the agency plans to publish details in the Federal Register about how the end of the public health emergency will impact existing guidelines, and which policies it plans to end or extend.
But emergency authorizations will continue, he said.
“Existing emergency use authorizations (EUAs) for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met,” he said in an email.
Pharmacists were granted additional powers through the Public Readiness and Emergency Preparedness Act, or PREP Act, another emergency waiver that is linked to but not dependent upon the public health emergency. Under PREP authorities, HHS granted pharmacists and pharmacy technicians the ability to order and administer COVID-19 tests, vaccines and therapeutics for patients as young as 3 years old.
Those authorities run through Oct. 1, 2024, but because pharmacists operate largely under state laws, the intersection of federal and state policies will be unclear once the emergency expires in May. Pharmacists are also still receiving vaccines from the CDC’s Federal Retail Pharmacy Program.
“So are we going to have a bifurcated system?” said Ronna Hauser, senior vice president at the National Community Pharmacists Association. “You know, our authorities are different depending on how we’re procuring the product.”
Industry groups like the NCPA and the National Association of Chain Drug Stores have been urging Congress, the states and the Biden administration to make the flexibilities permanent beyond COVID-19.
Senate HELP Committee leaders said this week that they want to make this a priority.
“I’d like to say that those things that actually worked from the PHE can actually be continued either by state or by federal law,” incoming HELP ranking member Bill Cassidy, R-La., said. “If you can teach somebody how to give a vaccine safely, they’ve been doing it safely throughout the PHE and they can continue to do so, then that’s a reasonable thing.”
Rep. Earl L. “Buddy” Carter, R-Ga., a pharmacist, also supports expanding pharmacists’ capabilities.
“When I first came to Washington eight years ago, I said that the only way we’re ever going to get health care costs under control is to have health care professionals practicing to the full extent of their license. And that’s extremely important,” he said. “Pharmacists proved that during the pandemic.”