Public Health

Mifepristone, latest COVID variants, U.S. public health emergency ending with Andrea Garcia, JD, MPH

. 10 MIN READ

AMA Update covers a range of health care topics affecting the lives of physicians, residents, medical students and patients. From private practice and health system leaders to scientists and public health officials, hear from the experts in medicine on COVID-19, medical education, advocacy issues, burnout, vaccines and more.

In today’s AMA Update, AMA Vice President of Science, Medicine and Public Health Andrea Garcia, JD, MPH, shares what physicians and patients need to know about the end of the COVID-19 Public Health Emergency on May 11, 2023. Also covering the latest on abortion pill access, XBB.1.16 and XBB.1.9.1 trends, as well as a possible link between conjunctivitis and Arcturus variant. AMA Chief Experience Officer Todd Unger hosts.

Public Health Emergency (PHE) and COVID-19 Emergency Declarations resources available:

Learn more at the AMA COVID-19 resource center.

Speaker

  • Andrea Garcia, JD, MPH, vice president, science, medicine & public health, American Medical Association

AMA Recovery Plan for America’s Physicians

After fighting for physicians during the pandemic, the AMA is taking on the next extraordinary challenge: Renewing the nation’s commitment to physicians.

Unger: Hello and welcome to the AMA Update video and podcast series. Today, we have our weekly look at the headlines, including developments with mifepristone, COVID and the end of the public health emergency. With us today, as always, is the AMA's Vice President of Science, Medicine and Public Health, Andrea Garcia in Chicago. I'm Todd Unger, AMA's chief experience officer, also in Chicago. Welcome back, Andrea.

Garcia: Thanks. It's good to be here today.

Unger: Well, it's been a couple of weeks since we talked about mifepristone, continuing developments on that front. What do we need to know about today?

Garcia: Yeah, so as a quick recap, mifepristone is approved by the FDA as a safe and effective way to end a pregnancy in the first 10 weeks of gestation. It's also commonly used to help manage miscarriages. And when we talked last, the Fifth Circuit Court of Appeals had partially upheld the FDA's approval of that drug but with some limitations, including on how the drug could be dispensed.

We then saw the Biden administration file an emergency appeal, asking the Supreme Court to issue a stay up to put that lower court ruling on hold until that appeals process can play out.

Unger: And what was the decision there?

Garcia: Yeah, so the Supreme Court did issue that stay. So that lower court ruling is on hold, so preserving access to mifepristone for now. Mifepristone is going to continue to be available under existing FDA approvals nationwide, pending, of course, the appeal of that lower court ruling, which will be to look at whether FDA properly approved use of the drug more than 20 years ago.

Again, we know this case could have serious long-term implications and undermine FDA's authority to determine the safety and effectiveness of medications. If that happens, we know there will certainly be profound harm to patients and also widespread uncertainty.

Unger: Indeed. We're going to continue to track this particular issue as it makes its way through the lower courts and also take a deeper dive on this decision and its implications with AMA president Dr. Jack Resneck in an upcoming AMA Update. Andrea, switching gears now to COVID, cases, deaths, hospitalizations all continuing to trend downward. However, there are still concerns about two new variants. Tell us more.

Garcia: So the two new variants that we've been talking about are XBB.1.16 and XBB.1.9.1. XBB.1.16 does seem to be spreading faster out of those two variants here in the U.S. And according to the CDC numbers, it accounts for about 12% of new COVID cases. So that's up by about 4% from last week.

Unger: And there have been some headlines suggesting that the symptoms might be different with this particular variant. Tell us more about that.

Garcia: Yeah, so according to The Washington Post and some other news outlets, and of course, what we've also been hearing from physicians is that with XBB.1.16, they are seeing conjunctivitis or pink eye in some of the patients with this variant. Experts haven't conclusively linked conjunctivitis to the variant. But anecdotal reports suggest this could be the case, particularly among children.

As physicians know, pinkeye can be caused by allergies, by injury, by bacterial or viral infections. So it's not just COVID. And it can occur both in children and adults. Experts are saying that although people who are diagnosed with COVID do sometimes present with conjunctivitis, it's really still too early to tell whether there's a greater chance of pinkeye associated with the new variant.

Unger: And, of course, pink eye, every parent's favorite thing, we'll keep an eye on that well in terms of the relationship there with this new variant. And what about the other variant? Is it also gaining traction in the U.S.?

Garcia: So yeah, last week, XBB.1.9.1 accounted for about 7% of COVID cases. This week, it increased about 2%. So we're seeing it responsible for about 9% of new COVID cases in the U.S. XBB.1.5, although we're seeing it waning week by week, it's still the dominant variant here. It's accounting for about 68% of all new COVID cases.

Unger: Well, in general, good news about COVID cases being down. And with that, the Biden administration has made some announcements ahead of summer travel. What can you tell us about that, Andrea?

Garcia: Yeah, in keeping with that overall trend we're seeing of easing restrictions, we saw the Department of Homeland Security announced earlier this week that beginning on May 12, it's no longer going to require U.S. travelers entering the country via land ports of entry and ferry terminals to be fully vaccinated against COVID and provide proof of vaccination upon request. DHS also intends to rescind those Title 19 travel restrictions in alignment with the end of the public health emergency and the termination of the presidential proclamation on air travel.

We know the White House first ordered the vaccine requirement for international travelers back in October of 2021. And we, of course, have seen many other countries already ease or end their vaccine requirements for travelers.

Unger: And, Andrea, as we've discussed before, the public health emergency is set to expire on May 11. And that's going to bring some changes with it. Tell us more about how it's going to impact the CDC.

Garcia: Well, the agency has said it's going to continue to work to reduce those negative impacts of COVID even after the public health emergency ends. And I think what that looks like is going to continue to evolve. We know data collection, for example, is one consideration.

We know the reporting of the CDC COVID community levels and the COVID transmission levels are going to be impacted. Those are going to sunset. They're going to be removed from the site on May 11.

But we can expect some other data reporting to continue, such as cases and death reporting, the genomic surveillance with the different variants, sentinel surveillance. And then some of the wastewater and travel genomic surveillance will also be continuing. We know hospital data reporting is set to continue through April 30 of 2024. But we could see that reduced from the current daily reporting to a lower frequency.

I think we know we've talked about this here. Hospitalizations are a lagging indicator. It takes a person generally 7 to 10 days to be hospitalized with a COVID infection. So we're likely going to lose some of that capacity of that early warning of an uptick in COVID spread. I think the hope, though, is that with wastewater testing in communities and for air travelers, that we'll continue to see some of those early warning signals. And that'll fill some of those gaps.

Unger: Andrea, what about testing? Will we still collect data through lab reporting?

Garcia: So that end of the public health emergency declaration revokes the CARES Act authority that gave HHS the ability to require laboratory results reporting. So this could result in states and local authorities receiving some less consistent and comprehensive laboratory data, which is then going to affect the quality of data that is reported by those jurisdictions to the CDC.

Unger: So what exactly does that mean?

Garcia: So the change is going to primarily affect the negative result reporting. And that's because laboratories and health care providers may still be required to report positive cases based on state and local laws or regulations. So if that happens, we're no longer going to have that percent positivity metric, which we've come to talk about quite frequently here, and to rely on to understand transmission levels.

Those transmission levels are used by hospitals and mandated by CMS to determine the prevention measures and mitigation strategies we're using in health setting. So CDC is still determining how they're going to address these changes to health care guidance without the use of transmission levels. So there's definitely going to be more to come on that in the coming weeks.

Unger: I guess the other big question really centers on vaccines and therapeutics. Are those going to continue to be available?

Garcia: So the short answer is yes. And the CDC has said it's actively working with other federal government agencies to maintain that equitable access to vaccines, to testing and to therapeutics to the extent possible. We know that out-of-pocket expenses for certain treatments may change. And that's going to depend on an individual's health care coverage.

Medicaid programs are going to continue to cover COVID treatments without cost sharing through September 30 of 2024. And then after that, coverage and cost sharing may vary by state. And then just to clarify, that end of the public health emergency doesn't mean the end of the national vaccine distribution program or the availability of vaccine commercially. It just means we're not going to have access to that comprehensive data regarding who's being vaccinated.

And that's going to impact the CDC's ability to monitor that implementation of the vaccine recommendations. We're not going to be able to identify those unvaccinated populations who may be susceptible to COVID or to as readily evaluate vaccine effectiveness. So this is definitely going to be a transition.

We're going to continue to track those important changes for physicians and for patients. And in the meantime, we do have some resources linked in the description of this episode to help answer questions.

Unger: Well, thank you very much, Andrea. Sounds like change is definitely afoot. We'll wrap up today, but be back to you next week for more information. Thanks for joining us.

We'll be back soon with another AMA Update. And, of course, you can find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us today. Please take care.


Disclaimer: The viewpoints expressed in this video are those of the participants and/or do not necessarily reflect the views and policies of the AMA.

FEATURED STORIES