(CNN) — A much-anticipated new vaccine that protects newborns against respiratory syncytial virus may not be available to some families this season due to uncertainty about insurance coverage.
When the U.S. Food and Drug Administration approved the antibody nirsevimab in July, pediatricians and parents were ecstatic. Every winter, respiratory syncytial virus fills hospitals with babies struggling to breathe. According to the Centers for Disease Control and Prevention, as many as 80,000 children under the age of 5 are hospitalized each year in the United States and as many as 300 die from the virus.
“Every pediatrician is ecstatic that this preventive tool is available to newborns because we see what happens when healthy babies become infected with this horrific disease,” said Dr. Sallie Permar, chair of the Department of Pediatrics at Weill Cornell Medical College and New York State. What happens when you get an infection.” – Presbyterian Hospital.
The new vaccine, branded as Beyfortus, reduced the risk of hospitalization from RSV in infants by 80% in clinical trials. It promises to be a game-changer for the youngest patients.
But on Wednesday, members of the American Academy of Pediatrics met with CDC Director Dr. Mandy Cohen for a more somber conversation. Many health care providers say they don’t know how to pay for the shots and may not be able to get them this year. Hospitals are also trying to figure out how to pay for it.
“We’re excited to have something available, but to be so close and still not have it in our arms is tragic,” said Permar, who also works with the nonprofit Securing Their Future, which Advocate for children’s access to vaccines.
RSV season has begun, and doctors now acknowledge that Beyfortus may not be widely available this virus season.
“I think it’s really challenging because for the first time in human history we can prevent RSV in infants, but the ability to get those vaccines or antibodies available this year is going to be very difficult,” pediatrician Dr. Buddy Creech explain. is a professor at Vanderbilt University and president of the Pediatric Infectious Diseases Society.
“We have this great product, we got it approved within 11 hours of RSV season, and now we’re working hard to roll it out so it’s maximally effective. “It may take a little while.” “
Legal loopholes may delay coverage
Under the Affordable Care Act, most health insurance plans must cover the cost of immunizations like Beyfortus at no cost to the patient. But because of a loophole in the law, insurers have a year to add new products to their plans, but it’s unclear how quickly they will move or how much they will cover.
The directors of the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services sent letters to insurance companies last week clarifying their legal requirements for three new RSV vaccinations, two designed to protect infants and one intended to Adult 60 – and emphasized the importance of shooting.
Many insurance companies have expressed enthusiasm for the new RSV vaccine, saying they understand its value in keeping people out of the hospital. Personally, hospital care is much more expensive.
But new immunizations are expensive, and those costs are likely to increase when targeting so many people.
Beyfortus is not a traditional vaccine. This is a dose of long-acting antibodies designed to protect babies during the six months when they are most vulnerable to the virus. Like other antibody products, it’s expensive: about $500 per dose.
Some doctors believe they cannot afford the expense without knowing whether they will recoup the cost.
“The problem is, it’s much more expensive than any other product, and they don’t know if they’re going to get paid,” said Dr. Sean O’Leary, chairman of the American Academy of Pediatrics’ committee on infectious diseases.
Pediatric clinics operate on razor-thin margins. O’Leary, who is also a professor of pediatric infectious diseases at the University of Colorado Anschutz Medical College, said vaccines are typically the second-largest expense after personnel costs.
Beyfortus is recommended for every healthy newborn, and for some exercises, many babies need to be cared for.
“For a mid-sized clinic, you can easily spend hundreds of thousands of dollars. If they don’t know what they’re going to get in return, the financial risk is too great,” O’Leary added.
O’Leary said the American Academy of Pediatrics and other advocates have been urging insurers to detail coverage for Beyfortus, but so far, they have not done so.
While the Affordable Care Act protects people in most health plans from having to pay out of pocket for the vaccine, it doesn’t protect doctors from covering some of the cost. Typically, pediatric offices negotiate reimbursement with insurance companies, and rates can vary between providers.
O’Leary said some people have been reluctant to risk ordering shots because clinics don’t know where the numbers will fall.
“In Colorado, for example, we’ve gotten assurances from the four major payers that they will pay it, but we haven’t seen the amount yet. Just because they say they’re going to pay it doesn’t mean they’re going to pay it all price,” he said.
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The injection of Beyfortus should be given as close to birth as possible, so ideally the newborn can be given it at the hospital or birthing center where it was delivered. But hospitals typically get a one-time fee from insurance companies to cover the cost of delivery, and Beyfortus’s cost has not yet been factored into that.
Creech said he has heard from hospitals that they may try to address the problem by giving the vaccine to babies after they are “discharged” to an outpatient clinic or to another room in the same facility.
O’Leary said he’s heard pediatricians are taking various approaches to test Beyfortus’ health insurance coverage. Some people only order small doses to see how their payers reimburse them. If they don’t get enough money back, they plan to renegotiate. Others plan to offer the vaccine only to high-risk infants, similar to how the older vaccine Synagis is administered.
“I did hear of one clinic where there were so many needs from families within the clinic and they said ‘OK, but you have to pay $500 upfront and if we get paid, we’ll refund it.'” They got a lot of requests, “O’Leary said.
Sanofi, one of the companies marketing Beyfortus, is also offering extended payment terms to doctors who order directly from the company so they can order the vaccine immediately and pay the company at the end of the RSV season, a spokesman said.
The company said that as of October 1, it covers more than 90% of babies nationwide.
Some health system plans only assume the financial risk given to Beyfortus until insurance coverage begins.
Permar, chief of pediatrics at NewYork-Presbyterian Hospital, said she and “others” convinced their health system, which has 11 hospitals serving children, to take the financial risk of offering vaccinations this year.
“We assume all these reimbursements will catch up,” she said, “but we have to take some risks first. That’s a hard pill to swallow when we think about how challenging health care reimbursement is.”
O’Leary said he expected the rollout to be difficult, but it’s actually going better than expected in some ways because people are working hard to make it happen.
Vanderbilt’s Creech agrees.
“So I think hospitals are going to be creative; pediatricians are going to be creative, but if federal payers and insurance companies and the CDC can be equally creative and flexible, we’re going to see a win for patients, “He said.
Government relaxes rules to expand access
Steps were taken months ago to try to ensure wider access to antibody shots.
In August, the CDC moved quickly to add Beyfortus to its routine childhood immunization schedule, which will eventually trigger full insurance coverage. It also added it to the Childhood Vaccines Program, which provides free vaccines to children who would otherwise not have access to them. About half of the babies born in the United States each year are eligible for immunization through the program.
Many pediatricians participate in the childhood vaccine program, but only about 12 percent of hospitals do because its regulations can be burdensome in some cases.
For example, in order to join the program, providers must agree to carry all vaccines covered by the program. They must also agree to match government-supplied vaccines with their own purchased vaccine stocks and cannot mix stocks. The rule is intended to prevent government-paid vaccines from going to patients whose insurance covers the costs.
On Tuesday, the CDC relaxed some of those rules so that states can allow hospitals and birthing centers to administer more limited immunization options, including vaccines that are given only to newborns: the Bayfoot vaccine and the hepatitis B vaccine.
The CDC also said doctors who only serve Medicaid-eligible patients do not have to purchase separate vaccine stores for privately insured children. It also lowered the minimum order size for Beyfortus so states can ship smaller doses in areas where demand for the vaccine may be lower.
Physicians can now borrow government doses of Beyfortus to paying patients as long as they replenish their supply within a month or after borrowing five doses.
O’Leary said these flexibilities will help, but they won’t remove all the barriers that prevent doctors and hospitals from offering Beyfortus.
In new guidance on childhood vaccine programs, the CDC said it recognizes that more steps may be needed to help doctors get Beyfortus to patients.
“CDC is continuing to explore operational policies that can help support these providers and will communicate any changes as soon as possible,” the guidance states.
Doctors urge patients to be patient
For now, doctors are urging parents to be patient.
“It’s a big improvement,” Creech said. The goal is to immunize all infants under 8 months of age and children under 2 years of age with certain risk factors, as well as the millions of infants not yet born this season. Approximately 4 million babies are born in the United States each year.
“It’s a lot of manufacturing. It’s a lot of distribution. There’s a lot of figuring out who’s going to pay what when,” Creech said.
Dr. Sharon Page, a pediatric cardiologist who lives in the Bay Area, isn’t satisfied with that answer. Paige was 37 weeks pregnant and was looking for any protection she could provide for her baby, who was due any day.
She had just missed the window for the new vaccine, which is given to pregnant women between 32 and 36 weeks of pregnancy. Antibodies produced by the vaccine can protect the baby in the first few months of life.
When she called her pediatrician and delivery hospital a few weeks ago to ask about Beyfortus, she was told they didn’t have it and didn’t know if they would ever get it.
“We know that RSV and COVID-19 and influenza hit kids so hard last year. So, again, it’s a head-scratcher. Like, what are the barriers?” Page said .
“It’s scary because, unfortunately, from my experience on the pediatric ward, I know that RSV can be really dangerous for little babies. It’s really upsetting to watch a baby with RSV struggle to breathe with a breathing tube down their throat. It’s heartbreaking,” she said.
Paige, who also has a 4-year-old in day care, wore a mask to school to protect her soon-to-be-born brother. Page said she and her husband considered taking her away from school for a while to protect their newborn during the upcoming respiratory virus season, but ultimately decided not to.
She said she was bombarded with ads on social media and elsewhere urging her to get her children the new RSV vaccine.
“When we hear from public health officials that we should get vaccinated … but we can’t actually go out and get that protection, even if we’re willing to pay for it, it’s just a confusing message that’s confusing. Frustrated,” she said.
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