…What you need to know for the 2015-2016 RSV season
by Erika Goyer
On July 28, 2014, The American Academy of Pediatrics (AAP) released updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for RSV (Respiratory Syncytial Virus) infection. See the AAP’s press release.
These recommendations replace the guidelines in the 2012 Red Book that recommended monthly injections of Synagis (Palivizumab) for infants who were at high-risk for severe complications with RSV infection during their first two RSV seasons.
Under the new guidelines high-risk infants are now defined as:
- Babies born before 29 weeks gestational age (28 weeks, 6 days or less) who are less than 12 months (chronological age) at the beginning of the 2014-2015 RSV season (See why premature babies are at risk)
- Babies with Chronic Lung Disease (CLD) of Prematurity, also called bronchopulmonary dysplasia (BPD) who:
- Are younger than 12 months (chronological age) at the beginning of the 2014-2015 RSV season
- Were born at less than 32 weeks gestational age (31 weeks, 6 days or less)
- Required >21% oxygen (greater than 21%) for at least 28 days after birth
- Babies with lung or airway abnormalities or neuromuscular disorders that impair their ability to clear secretions from the upper airway who are less than 12 months (chronological age) at the beginning of the 2014-2015 RSV season
- Babies who are 12 months of age or younger with hemodynamically significant acyanotic congenital heart disease which is defined as:
- Infants who are receiving medication to control congestive heart failure and will require cardiac surgical procedures, including transplants
- Infants with moderate to severe pulmonary hypertension
- Most babies with cystic fibrosis
Under the new guidelines very few babies will receive Synagis after they turn one year old.
A second season of coverage for Palivizumab prophylaxis (i.e. Synagis injections) is now only recommended for patients with CLD who satisfied the above criteria during their first RSV season and continue to receive medical therapy (chronic corticosteroid therapy, diuretic therapy or supplemental oxygen) during the 6-month period before the start of the second RSV season and children who are profoundly immunocompromised (severe combined immunodeficiency or advanced acquired immunodeficiency syndrome).
While these new guidelines are controversial and severely limit the number of babies who will qualify for coverage compared to past years, many insurance providers are using them to decide who will and will not receive coverage for Synagis this RSV season.
As an alternative, families can advocate that their prescriber utilize the National Perinatal Association 2015 Respiratory Syncytial Virus (RSV) Guideline published in the November 2014 issue of Neonatology Today. Authors: Mitchell Goldstein, MD; T. Allen Merritt, MD; Raylene Phillips, MD; Gilbert Martin, MD; Sue Hall, MD; Rami Yogev, MD; Alan Spitzer, MD
It is more important than ever that you talk to your baby’s doctor and make a plan.
These new guidelines are restrictive and will make it harder for your baby to qualify for Synagis injections. But remember, you and your care team know your baby best. The AAP’s guidelines are not a replacement for clinical judgement. All of your baby’s health care needs should be decided by looking at their unique medical history. If you and your baby’s medical team think that your baby should receive Synagis during RSV season, that decision should be honored. Advocate for your baby. What you do makes a difference.
Learn more about protecting your baby.
Read Now I Know, an RSV Story by Kasey Mathews.
What You Can Do…
Learn about your baby’s health conditions.
Ask your neonatologist or pediatrician to look at your baby’s medical records with you and help you understand their medical history. If your child required breathing support like CPAP or was on a ventilator, find out for how long. Ask if they had respiratory distress syndrome or required surfactant therapy to help them breathe.
Get the right diagnosis.
If your child has been given a referral to see a pulmonologist or has received breathing treatments in the last few months, make sure that they have clearly been given the diagnosis – like CLD or BPD – that accurately describes their conditions and their risk factors. Consult the RSV ID Patient Risk Assessment Tool for guidance.
Contact your insurance provider to confirm your coverage.
Here are links to some insurers’ guidelines. (You can also get help with this process through MedImmune’s Access 360 Program.Call 1-877-778-9010.) You can often find information on your plan by Googling “Synagis” “Palivizumab” “RSV’ “2015 2016” and the name of your insurance plan.
- Texas Medicaid & CHIP (most state Medicaid programs are only approving Synagis under the new AAP guidelines.)
- Blue Cross Blue Shield
- United Healthcare
Ask for a letter of medical necessity to be sent to your insurer.
A well-written letter of medical necessity is your most powerful tool for getting your baby’s care approved. Your doctor will use this letter to document why your baby is at risk and why Synagis is a critical part of their treatment plan. See “Writing a Letter of Medical Necessity: A Guide for Physicians.”
Get a pre-authorization.
This is also sometimes called prior authorization, prior approval, or pre-certification. Your health insurance plan will probably require pre-authorization for Synagis injections before your baby can receive them. However, pre-authorization isn’t a promise your insurer will cover the cost. It is just one step in the approval process. At this stage it may be useful to enlist your pharmacist’s help. Read Navigating Severe RSV Disease and Synagis: A guide for specialty pharmacy providers and share it with them.
Hear from fellow NICU mom Summer Hill-Vinson at Preemie Babies 101 and take her advice.
Submit your claim to the insurance provider.
Send everything your insurance provider needs to quickly approve your claim. But before you do, make an extra set of copies for your own records. Keep all these documents in your baby’s health care notebook. This will remind you what you have and can solve any problems that arise if the insurance company loses your paperwork. If you need additional support for your claim your health care provider may find the tools on MedImmune’s Access 360 site helpful. They can also access forms here that will help them coordinate the process.
If your claim is denied, appeal.
Advocate for your child. If you and your doctor think that your baby could benefit from receiving Synagis injections, resubmit the claim with all the information they will need to approve it. Use this sample letter from www.myaccess360.com as a guide.
Ask for help paying for Synagis from the manufacturer.
If your co-pays and out-of-pocket expenses are more than $30 for each injection or your insurance has denied coverage you can contact MedImmune’s Synagis Copay Savings Program 1-877-858-5452. If you have been denied coverage you can use the MedImmune Assistance Program (MAP). If you are without coverage MedImmune’s Patient Access Program can help.
Make sure your baby gets all five injections.
It is important that you understand how Synagis works. Synagis is not a vaccine. It will not prevent RSV infection. It is an injection of antibodies that will help your baby’s immune system fight the RSV infection if they catch the virus. But these antibodies only last for a short while. That is why Synagis injections must be given every 28-31 days. The protection your baby gets from the shots weakens over the course of the month.
Even if your baby gets Synagis, it is critically important that you do everything you can to keep your baby from getting infected. This means washing your hands often and staying away from people who might be sick and places where the virus is being spread. If you’d like more information read 5 Things Every NICU Parent Should Know… RSV. There are also tools you can sign up for through MedImmune at their Cradle with Care site that will help you manage your baby’s care during RSV season and beyond.
Hand to Hold’s response to the new AAP guidelines on Palivizumab prophylaxis
“Hand to Hold strives to provide meaningful support and education for families during and after a NICU stay to ensure parents are prepared to meet the needs of their medically fragile child and make informed decisions on their behalf.
“Unfortunately many of the families we serve each year face significant health challenges related to RSV. We are hopeful that the American Academy of Pediatrics new guidelines regarding further restrictions for the use of Synagis will not have an adverse effect on this very vulnerable population
“Hand to Hold will continue to educate parents about their child’s risks associated with RSV and other viruses by encouraging them to follow best practices for protecting their baby including offering breast milk, immunizing members of the household against influenza, practicing good hand and cough hygiene, avoiding smoke exposure, limiting attendance in large group child care during the first winter season whenever possible, and avoiding contact with anyone who is ill.”
Erika Goyer is the mother of three boys. Her oldest son Carrick Michael was born at 27 weeks gestation and weighed 1 pound, 14 ounces. Carrick died soon after his birth due to complications of prematurity. Erika went on to have two more high-risk pregnancies and two healthy sons.