CDC will no longer recommend COVID-19 shots for healthy children, pregnant women

HHS Secretary Robert F. Kennedy Jr. on Tuesday announced that CDC will no longer recommend routine COVID-19 shots for healthy children and pregnant women.

"As of today, the Covid vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule," Kennedy said. "Last year, the Biden administration urged healthy children to get yet another Covid shot, despite the lack of any clinical data to support the repeat booster strategy in children."

The change comes a week after FDA Commissioner Marty Makary announced the agency plans to restrict the use of COVID-19 shots to older adults and children and adults with underlying medical conditions.

Currently, COVID-19 cases, including hospitalizations and deaths, are down, but the virus continues to circulate throughout communities.

"We still have children in our emergency department with Covid. When we see them, they have bronchiolitis or bronchitis," said Paul Offit, director of the Vaccine Education Center at Children's Hospital of Pennsylvania. "Do they consider that not worthy of prevention?"

Dorit Reiss, a law professor at UC Law San Francisco, said it's extraordinary that a health secretary would remove vaccines from a CDC vaccine schedule without undergoing a consultation process or asking the advice of the Advisory Committee on Immunization Practices.

"There is a process, and it hasn't been followed," Reiss said, suggesting the lack of process could make the decision vulnerable to being overturned if it's challenged in court.

Reiss also noted, in an article published in the New England Journal of Medicine last week announcing a new approach to the use of COVID-19 booster shots, that FDA Commissioner Marty Makary and Vinay Prasad, who oversees FDA's Center for Biologics Evaluation and Research, listed pregnancy as one of the medical conditions that warrants COVID-19 vaccination.

(Lovelace Jr./Edwards, NBC News, 5/27; Goodman, CNN, 5/27; Branswell, STAT, 5/27)

FDA advisors recommend changes to COVID-19 vaccines

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that drugmakers who make COVID-19 vaccines should update their shots to target the coronavirus variant JN.1, which is closer to the strains currently on the rise.

The recommendation came after drugmakers presented data to the panel showing that vaccines based on viruses related to JN.1 produce strong protection against the latest versions of the virus, like LP.8.1, which has become the dominant strain in the United States.

During the meeting, VRBPAC members appeared split on whether to advise FDA to tell drugmakers to update their vaccine target, with a number of members suggesting manufacturers should be given the option to either update or remain with the same target.

Some committee members also seemed concerned that if FDA recommended a strain change, manufacturers could face new testing requirements that could delay delivery of vaccines this fall.

Ultimately, the committee voted unanimously to have COVID-19 vaccines target a JN.1 version of the coronavirus.

Meanwhile, a day before the meeting, Moderna announced it has withdrawn its application seeking FDA approval for its combination flu and COVID-19 vaccine candidate in order to wait for efficacy data from a late-stage trial of its influenza shot. The announcement came a day after FDA said it would require new clinical trials for approval of annual COVID-19 boosters for healthy people under the age of 65.

(Branswell, STAT+ [subscription required], 5/22; Stein, "Shots," NPR, 5/22; Mishra, Reuters, 5/21)

"We will have some studies completed by September, and those studies will mainly be replication studies of studies that have already been done," Kennedy said. "We're also deploying new teams of scientists, 15 groups of scientists. We're going to send those grants out to bid within three weeks."

"As I said, we're going to begin to have a lot of information by September," Kennedy added. "We're not going to stop the studies in September. We're going to be definitive. And the more definitive you are, the more it drives public policy."

(O'Connell-Domenech, The Hill, 5/23; Rubin, Axios, 5/23)

CMS issues update on hospital price transparency requirements

CMS last week issued new guidance requiring hospitals to post the actual prices of their products and services instead of estimates and said it's soliciting public feedback on how it can increase hospital compliance by providing understandable pricing data.

"Transparency in healthcare is essential, not optional," said Stephanie Carlton, CMS chief of staff and deputy administrator. "Americans deserve to know exactly what they're paying for and what they're getting in return."

In the guidance, CMS says it's requiring hospitals to include a "standard charge dollar amount" in their machine-readable files whenever possible. This amount should include gross charges, cash prices, payer-specific negotiated rates, and any minimum negotiated charges, which is the lowest charge a hospital can negotiate for products and services across all payers.

"CMS expects that, for most contracting scenarios, hospitals' payer-specific negotiated charges can be expressed as a dollar amount," the guidance says.

In any cases where hospitals can't list charges in actual amounts, CMS said charges should be listed as percentages, with additional details provided elsewhere in the data file explaining the factors used to calculate them.

In a statement, Ariel Levin, director of policy at the American Hospital Association, said the organization "supports price transparency and recognizes the importance of compliance with the regulations regarding both hospital and insurance price transparency. We are reviewing today's proposals in detail and welcome further collaboration with the administration to ensure that patients are able to get the information they need to make informed decisions about their care."

(Early, Modern Healthcare, 5/22)

Providers should expect more downside risk in Medicare payment models, CMMI official says

Earlier this month, Abe Sutton, director of the Center for Medicare and Medicaid Innovation (CMMI), said providers should expect to see more Medicare alternative payment models involving downside risk.

"We've found at the innovation center that when we have 'upside-only' payment models, there's not necessarily an incentive ... for participants to change how they engage in care delivery," Sutton said. "We found more impact for those with downside exposure in our models ... So we want to move more providers to be in risk-based models for downside risks," in which participants potentially risk losing money if they don't meet a model's performance goals.

Sutton also outlined a new approach CMMI is taking to its work focusing on three specific pillars: promoting evidence-based prevention, empowering people to achieve their health goals, and driving choice and competition.

"Much of this takes the form of new technology and tools for people," Sutton said, noting that CMMI issued a request for information to solicit ideas for tools to use in value-based care. "How should we reimburse for new technology models, and how should we think about what payment models look like for that? That's something that we've been putting a lot of thought into."

One issue Sutton noted was how to get patients to more actively participate in their health.

"What's the incentive for me to proactively engage and think differently? Well, one incentive might be, 'Hey, it's your health outcomes,' but sometimes it's hard to translate that — it's sometimes hard to see how me doing this activity will result in me feeling better 2 months from now," Sutton said. "And so making that information clear and translating it into incentives that people respond to — maybe that takes the form of gift cards. Maybe it takes the form of sharing in savings or credits towards your premium amounts for Part B. So we're thinking through the incentives there."

(Frieden, MedPage Today, 5/13)