Infectious Disease

Rheumatology providers, patients prepare for end of COVID emergency

April 07, 2023

7 min read

Source/Disclosures

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Disclosures:
Kim participated in consulting, advisory board, or speaker’s bureau for Alexion Pharmaceuticals, ANI Pharmaceuticals, AstraZeneca, Aurinia Pharmaceuticals, Exagen Diagnostics, Inc., GlaxoSmithKline, Kypha Inc., Pfizer and received funding support under a sponsored research agreement from GlaxoSmithKline. Sparks reports receiving research support from Bristol Myers Squibb and consulting for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Gilead Sciences, Inova Diagnostics, Janssen, Optum, and Pfizer unrelated to this work. Yazdany reports consulting with AstraZeneca and Eli Lilly & Co.

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May 11 will mark the end of the 3-year COVID-19 national public health emergency, as announced earlier this year by President Joe Biden and HHS.

In the immediate short-term, this will mean the end of free laboratory and over the counter COVID-19 tests, depending on patients’ individual insurance or Medicare status. Facilities will no longer have the ability to rapidly increase capacity in response to surges, and the federal government will no longer mandate that laboratories report COVID test results to the CDC. In the long term, it means that vaccines and antiviral treatments will remain free only as long as federal supplies last.

Al Kim and quote

According to experts, preparing for the impact this may have on the rheumatology community is essential to keeping patients healthy.

Jeffrey A Sparks

“This is a complex issue, the decision to end the public health emergency related to the pandemic,” Jeffrey A Sparks, md, MMSc, director of immuno-oncology and autoimmunity at the Brigham and Women’s Hospital division of rheumatology, inflammation and immunity, told Healio.

Like many — if not most — health care professionals, Sparks does not believe the pandemic is over.

“Some people are ready for it to be over, and others would like to keep the emergency protocols in place,” he said, liking the current declaration to when federal masking mandates ceased. “When the mask mandate ended, there was a huge backlash and outcry for some, while others applauded it.”

For opponents of the declaration ending the COVID-19 emergency protocols, many of the primary concerns are financial. COVID-19 testing and treatment strategies that are currently free will now eventually come with a cost for patients depending on the their insurance status.

Moreover, Pfizer and Moderna have announced the prices of their mRNA COVID-19 vaccines, which may range between $82 and $130 per dose, again depending on insurance.

However, not all rheumatologists have immediate concerns about President Biden’s declaration, at least in terms of the financial burden on patients.

Jinoos Yazdany

“In the short term, I expect that the impacts on people with rheumatic conditions will be smaller,” Jinoos Yazdany, MD MPH, chief of rheumatology at the Zuckerberg San Francisco General Hospital, at the University of California, San Francisco, told Healio. “This is because the federal government has purchased a supply of vaccines and antiviral medications. As long as those supplies last, people will be able to access these for free.”

Although Sparks acknowledged that the short- to medium-term could, in fact, be manageable for patients with rheumatic diseases due to government-subsidized supplies, he argued that sorting out the payment details for COVID-19 management is likely to evolve into another yet obstacle for rheumatology patients to overcome.

“Many of our patients are already mired in bureaucracy for their medications,” he said. “What concerns me is that additional hurdles could deter patients from pursuing COVID prevention and treatment measures.”

meanwhile, Alfred Kim, MD PhD, Assistant professor of medicine and director of the Lupus Center at the Washington University School of Medicine, in St. Louis, warned there may be “unintended consequences” of ending the emergency protocols, including sending a message to the public that the pandemic is definitely finished .

“The wording may confirm what many are thinking, which is that the pandemic is over, even if it is not,” he said.

According to Kim, the relaxation of masking protocols and other safety measures could also increase patient anxiety.

“These social and political aspects are not as easy to address as the clinical aspects,” he added.

As May 11 approaches, rheumatologists can expect a host of questions on these topics from their patients, if they are not fielding those questions already. Understanding the landscape will be critical to keeping patients safe and healthy as the financial and regulatory grounds shift.

Not all patients will be affected equally’

Although Yazdany is hopeful that patients under the rheumatology umbrella will be spared too much financial hardship for COVID-19 care in the immediate future, she highlighted one point about the economics of President Biden’s declaration that was echoed in various forms by both Kim and Sparks: The details are still unclear.

“The most concerning part is going to be the confusion that will ensue because not all people will be affected equally,” Kim added.

For example, patients on Medicare and some with private insurance are likely to have to pay out-of-pocket for home COVID-19 tests.

“Patients on Medicaid will still be covered,” Kim said.

One solution to the problem of home testing could be to stockpile them now.

“There is still an allotment of tests that the government is paying for,” Sparks said. “Collecting as many as possible would be something patients should consider doing.”

However, most home COVID-19 tests approved by the FDA have a shelf-life of just 4 to 6 months from manufacture date. Additionally, and perhaps more concerningly, they have been associated with declining accuracy, particularly regarding newer variants, and often necessitate a clinician-administered PCR test. This, too, is likely to come with a financial burden.

“There may be a copay for a PCR test for patients with commercial insurance,” Kim said. “It will be largely dependent on the federal supply.”

Again, patients on Medicaid should have access to free PCR testing through 2024, as long as the supply holds up, according to Kim. However, what will happen after this time point remains to be seen.

The situation will likely be similar for antiviral medications, while COVID-19 vaccines will continue to be free for patients through private insurance and Medicare, according to experts.

“For patients on Medicaid, vaccines will be free through 2024 as part of the American Rescue Plan,” Kim said.

Meanwhile, Yazdany expressed concern that uninsured patients could be subject to high costs for both COVID-19 vaccines and antiviral treatments. This in turn could exacerbate health disparities that are already present in the current health care system, she added.

“After supplies run out, I am worried that people who are uninsured will be faced with high out-of-pocket costs for vaccines and antivirals, which risks worsening the health disparities already brought to light during the pandemic,” Yazdany said. “People with Medicare may face cost-sharing for antivirals. For example, they may need to pay deductibles and other pharmacy costs through their Part D plans for Paxlovid (nirmatrelvir/ritonavir, Pfizer).”

Additionally, the availability of these necessary vaccines, treatments and tests will likely be beyond the control of the practicing rheumatologist, according to Kim.

“For both PCR tests and antivirals, availability will depend on logistics, the supply chain, and other factors,” he said. “All of this could be subject to change depending on these factors. This is going to cause a tone of confusion.”

According to Sparks, when the federal government’s supplies will run out, and costs to patients kick in, it will yet represent another barrier to vaccination and “increase hesitancy even more.”

“At this point, we need fewer barriers to vaccination, not more,” he said.

Rheumatologists are accustomed to managing barriers to care and confusion among their patients. However, all of this will necessitate ongoing conversations in the clinic.

‘Patients might feel ostracized’

“There are certainly some of our patients who are comfortable returning to pre-pandemic norms,” ​​Sparks said. “In theory, they are OK with the emergency phase being over.”

Yazdany underscored this point, stating that for people who are vaccinated and have access to health care, the future is “looking brighter.”

“But many of my immunocompromised patients are still worried about COVID-19,” she added.

Patients dealing with various types of immunosuppression are much more concerned about their personal risk, according to Sparks.

“Some would prefer to continue masking, social distancing and eating outside,” he said. “Because of this, many of our patients might feel ostracized. A lot of them view this decision as catering toward the general population that wants to move on from COVID.”

This sense — that world is eventually going to move on from COVID-19, regardless of the impact on immunocompromised or other vulnerable populations — necessitates a bit of forethought for rheumatologists and their patients, according to Kim.

“One consideration is, ‘What will be the variants of concern circulating 6 to 12 months from now, when some of the protocols are expiring?'” he said. “We have to react.”

On the positive side, Kim believes that time may ultimately result in better vaccines. “Hopefully, we can formulate them to react appropriately to those circulating variants,” he said.

If the circulating variants remain relatively stable, prior immunity via previous infection or vaccination and boosting may have a protective effect, even for immunocompromised patients, Kim added.

“But new variants could be more evasive,” he said. “This is something that we need to consider.”

Regarding treatments, Kim anticipates the advent of novel monoclonal antibodies and antivirals.

“We may also get better pre- or post-exposure prophylaxis therapies,” he said.

Meanwhile, encourage patients to enter clinical trials for novel anti-COVID-19 medications could be a good way to circumvent costs, according to Kim.

“The caveat is that the trials are still placebo-controlled, so our patients may not be getting any protection at all,” he said.

It was with this in mind that Kim reiterated the necessity of gathering as many available COVID-19-related resources as possible before May 11.

“Patients should work closely with their providers for anything else,” he said.

Sparks added that he is encouraged that there is some “nuance” with regard to when certain provisions will end — albeit based on stockpiling of resources.

“Rather than just ending everything entirely, some think there could have been some middle ground or gradual de-escalation of the protocols,” he said.

Sparks added that he would be in favor of certain exceptions for patients with pre-existing conditions or who are immunocompromised. However, it remains to be seen whether those conditions would come to fruition before or after May 11.

Until then, Sparks states he is at least encouraged that certain segments of the population are able to wear masks without issue or harassment.

“In a way, we have arrived at a new normal in that regard,” he said.

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