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Coverage criteria for the annual Synagis® (palivizumab) distribution program

September 9, 2019

The Synagis® (palivizumab) distribution program for the 2019-2020 respiratory syncytial virus (RSV) season, which is November through March in the northeastern United States, begins next month. RSV is the most common cause of bronchiolitis and pneumonia among children younger than one year.

During the RSV season, Independence will approve the monthly administration of Synagis for infants and children in accordance with the current recommendations from the American Academy of Pediatrics (AAP). These recommendations are subject to change based on updates in the AAP policy statement and Red Book®.

Medical necessity criteria for coverage

Synagis is a humanized monoclonal antibody that provides passive immunity against RSV. It is intended to decrease the morbidity and mortality associated with RSV lower respiratory tract disease in high-risk infants and children. Synagis is not effective in the treatment of RSV disease, and it is not approved for this indication.

Immune prophylaxis using Synagis is considered medically necessary and covered for a maximum of five doses during the RSV season for infants and children who meet medical necessity criteria and who have any of the following high-risk conditions (according to the AAP criteria):

  • chronic lung disease (CLD) of prematurity;
  • history of preterm birth (born before 29 weeks, 0 days) for infants who are younger than 12 months at the start of the RSV season;
  • congenital heart disease;
  • congenital abnormalities of the airway or certain neuromuscular diseases;
  • cystic fibrosis with nutritional compromise and/or CLD;
  • immunocompromised status (e.g., due to transplantation or chemotherapy).

An additional postoperative dose of Synagis is considered medically necessary and covered for infants or children younger than 24 months who are medically stable, meet any of the AAP criteria for immune prophylaxis, and have undergone one of the following procedures during the RSV season:

  • surgical procedures that use cardiopulmonary bypass;
  • cardiac transplantation.

If an infant or child receiving monthly prophylaxis with Synagis experiences a breakthrough RSV hospitalization, continued monthly prophylaxis with Synagis is considered not medically necessary due to the low likelihood of a second RSV hospitalization during the same season.

How to obtain Synagis for office use

Synagis is covered under the member’s medical benefit. For the 2019-2020 RSV season, it is mandatory for all participating providers to obtain Synagis for Independence members through PerformSpecialty®, an independent company.

The following guidelines apply when ordering Synagis:

  • Providers should go to the Independence Direct Ship Drug Program webpage to download the new Synagis form. Our website now has a writeable form, which allows the information to be typed directly into the form online, rather than printing and faxing.
  • The RSV form must include sufficient clinical information to meet our Synagis medical policy criteria, which are based on current AAP recommendations.
  • If you opt to print, the completed form should be faxed to 1-855-851-4056, along with any necessary documentation to support the request. Incomplete forms may result in ordering delays.
  • Since Independence pays PerformSpecialty directly, providers neither pay for doses ordered through PerformSpecialty nor receive reimbursement for the actual pharmaceutical.
  • Synagis will generally be approved for office administration only, unless a patient is receiving home nursing services for a separate indication.
  • Upon approval of the request, Synagis will be shipped to the provider’s office monthly during the RSV season. Shipping for the 2019-2020 RSV season begins on Thursday, October 31, 2019, and continues through Tuesday, March 31, 2020. Up to five doses (one dose every 30 days) will be shipped per member.

Learn more

Review Medical Policy #08.00.22m: Immune Prophylaxis for Respiratory Syncytial Virus (RSV) to learn more. To view this policy, visit our Medical Policy Portal.

If you have questions about the Synagis distribution program, please call Customer Service at 1-800-ASK-BLUE.


This content was prepared for the Provider News Center and may not be reproduced in any way without the express written permission of Independence Blue Cross. Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association.
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