Pediatricians will be able to get paid for counseling families on nirsevimab in addition to administering the product to protect infants from respiratory syncytial virus (RSV), Centers for Disease Control and Prevention (CDC) Director Mandy K. Cohen, M.D., M.P.H., announced during an AAP town hall with members on Wednesday.
The American Medical Association approved new Current Procedural Terminology codes that include counseling. Federal officials are expected to finalize them in the coming days, according to Dr. Cohen.
The new codes will be a major step in reducing barriers to access. AAP President Sandy L. Chung, M.D., FAAP, said “the coding piece is obviously critical for this to work,” and AAP CEO/Executive Vice President Mark Del Monte, J.D., agreed.
“That’s fantastic, and I think that’s incredibly important,” he said. “The AAP has been working very closely with CMS (the Centers for Medicare & Medicaid Services) and CDC, and the team effort has really paid off in this case.”
During the town hall, Dr. Cohen and other CDC leaders answered pediatricians’ questions as they prepare to protect children from COVID-19, RSV and flu.
“It’s hard right now to be a practicing pediatrician,” Dr. Chung said. “… We see the promise of new opportunities to prevent another tripledemic, but we also have questions about new products and how do we use them, how can we carry them, how can we make sure all of our patients can access these equitably.”
RSV products to protect infants
Two new products are available this season to protect children from RSV — a vaccine for pregnant women given at 32-36 weeks’ gestation and a monoclonal antibody that can be given to children under 8 months old and some high-risk infants 8-19 months of age. Most infants need protection from only one of the products, and the CDC is not expressing a preference.
Nirsevimab is recommended for infants under 8 months instead of using 12 months as a cutoff age due to the CDC Advisory Committee on Immunization Practices’ risk-benefit analysis and because hospitalizations tend to peak in infants at 1 month of age, CDC leaders explained Wednesday.
Dr. Cohen suggested pediatricians talking to families about nirsevimab explain that it is an immunization that gives protective antibodies to a baby for six months.
Medicaid, the Children’s Health Insurance Program and the Vaccines for Children (VFC) program are covering nirsevimab. Dr. Cohen said the CDC is encouraging insurance companies to move quickly to cover it, since it can prevent the leading cause of infant hospitalization.
She acknowledged some of the logistical barriers pediatricians and hospitals are facing with a drug that costs $495 per dose in the private sector and $395 in the VFC program and the stringent rules that typically come with being a VFC provider. Only 10% of birthing hospitals participate in the VFC program.
The CDC will allow flexibilities in borrowing between private and VFC stock of nirsevimab this season.
A pediatrician may not know if a newborn baby will be covered by the VFC program. In those cases, Georgina Peacock, M.D., M.P.H., FAAP, director of the Immunization Services Division in the CDC’s National Center for Immunization and Respiratory Diseases, said if the child is likely to be covered by insurance, use private stock. If clinicians find out later the child is not covered, they can exchange it with a VFC dose. If the child is expected to be on Medicaid, the clinician should use VFC stock.
The CDC also is allowing hospitals and birthing centers participating in VFC to stock only nirsevimab and hepatitis B vaccine. CDC leaders are working to include nirsevimab as part of bundled hospital payments at birth, but that likely will not happen this season.
The AAP has called for continued access to palivizumab for high-risk children this season and has provided updated guidance. Palivizumab can be used for eligible children when nirsevimab is not available. Children who receive fewer than five doses of palivizumab in the 2023-’24 season can receive one dose of nirsevimab but should not receive any additional doses of palivizumab. Children who receive nirsevimab should not receive palivizumab later that season.
High-risk children who received palivizumab in their first RSV season should receive nirsevimab in their second season, if it is available and they remain eligible. If it is unavailable, they should receive palivizumab.
Updated COVID-19 vaccines
Updated COVID-19 vaccines from Moderna and Pfizer-BioNTech are available for people ages 6 months and older and from Novavax for those 12 years and older to better match circulating strains. The updated vaccines are the first to be sold commercially instead of distributed via the government as they were during the height of the pandemic.
As with nirsevimab, Dr. Cohen said the CDC will allow borrowing between private and VFC stock this season to ease the implementation.
“We don’t want to miss an opportunity to offer a vaccine to someone, so bidirectional borrowing is OK,” she said. Borrowing should not be done regularly, she added, and doses should be paid back appropriately.
The CDC also has decreased minimum VFC order quantities to help reduce waste, ease logistics and help with limited storage capacity.
In another move to improve logistics for pediatricians, Pfizer recently announced 100% returns for the three-dose COVID-19 vaccine vials authorized for children 6 months through 4 years.
Pediatricians asked Dr. Cohen about mixing and matching COVID vaccine brands for this young age group. She said the CDC recommends using the same vaccine brand throughout the primary series. However, children who previously received a primary series with one brand can switch to a different brand when getting an updated dose. Pediatricians will not need to report this to the Vaccine Adverse Event Reporting System.
Dr. Cohen also stressed the importance of children getting vaccinated. Half of children ages 6-23 months and one-third of those 2-4 years who were admitted to intensive care units with COVID-19 had no underlying conditions. She also pointed out COVID has higher death rates for children than other diseases did before vaccination became available, including rotavirus, varicella and meningococcal disease. Data from millions of doses show the vaccine is safe.
“The issue here is that no child should be dying from diseases that have a safe and effective vaccine and that’s what we have here,” she said.
Pediatricians can view a recording of the town hall here. The AAP also will hold a webinar on clinical considerations for prevention of RSV in children at 6 p.m. CDT Oct. 10 and a webinar on nirsevimab implementation strategies in outpatient practices at 7 p.m. CDT Oct. 17.
- AAP RSV resources, including information on ordering, dosing, coding and a visual guide for nirsevimab administration. Questions not answered on the site can be submitted here.
- Information for clinicians from the CDC on nirsevimab
- Information for parents from HealthyChildren.org on RSV symptoms and when to call a doctor
- HealthyChildren.org is holding a webinar for parents on RSV signs, symptoms and prevention at 9 a.m. CDT Oct. 6.
- Information from the AAP on COVID-19 vaccines, including a dosing guide and information on payment. Questions not answered on the site can be emailed to firstname.lastname@example.org.
- CDC interim clinical guidance on COVID-19 vaccines