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Coverage criteria policies

Synagis (palivizumab) injections for respiratory syncytial virus (RSV) prophylaxis

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Prior authorization is required for Synagis injections for RSV prophylaxis.


Synagis injections for RSV prophylaxis are generally covered subject to the indications listed below and per your plan documents.

Indications / Criteria for Coverage

HealthPartners’ coverage criteria of Synagis injections follows the American Academy of Pediatrics (AAP)1 updated recommendations and are used with permission from the AAP.

  1. For qualifying infants who require five doses, a dose beginning in November and continuation for a total of five monthly doses will provide protection for most infants through April and is recommended for most areas of the United States.
  2. Per AAP recommendations1, preterm infants without chronic lung disease of prematurity or congenital heart disease, palivizumab prophylaxis may be considered during the RSV season:
    1. Infants born before 29 weeks, zero days’ gestation who are younger than 12 months at the start of the RSV season (for infants born during the RSV season, fewer than five monthly doses will be needed).
    2. Infants 29 weeks, zero days’ gestation or later may qualify to receive prophylaxis on the basis of congenital heart disease (CHD), chronic lung disease (CLD), or another condition – see below.
  3. Per AAP recommendations1 for preterm infants with chronic lung disease (CLD), palivizumab prophylaxis may be considered during the RSV season:
    1. During the first year of life for preterm infants who develop CLD of prematurity - defined as gestational age <32 weeks, zero days and a requirement for >21% oxygen for at least the first 28 days after birth.
    2. During the second year of life, consideration of palivizumab prophylaxis is recommended only for infants who satisfy this definition of CLD of prematurity and continue to require medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) during the 6-month period before the start of the second RSV season. For infants with CLD who do not continue to require medical support in the second year of life prophylaxis is not recommended.
  4. Per AAP recommendations1 for infants with hemodynamically significant congenital heart disease (CHD), palivizumab prophylaxis may be considered during the RSV season:
    1. For children who are 12 months or younger with hemodynamically significant CHD, who are born within 12 months of onset of the RSV season. Infants most likely to benefit from palivizumab prophylaxis include:
      1. Infants with acyanotic heart disease who are receiving medication to control congestive heart failure and will require cardiac surgical procedures
      2. Infants with moderate to severe pulmonary hypertension
      3. Decisions regarding palivizumab prophylaxis for infants with cyanotic heart defects in the first year of life may be made in consultation with a pediatric cardiologist.
    2. For children who are receiving prophylaxis and who continue to require prophylaxis after a surgical procedure, a post-operative dose of palivizumab should be considered after cardiac bypass or at the conclusion of extra-corporeal membrane oxygenation for infants and children younger than 24 months.
    3. Children younger than two years who undergo cardiac transplantation during the RSV season may be considered for palivizumab prophylaxis.
  5. Per AAP recommendations1, children with anatomic pulmonary abnormalities or neuromuscular disorder:
    1. Infants with neuromuscular disease or congenital anomaly that impairs the ability to clear secretions from the upper airway because of ineffective cough are known to be at risk for a prolonged hospitalization related to lower respiratory tract infection and, therefore, maybe considered for prophylaxis during the first year of life.
  6. Per AAP recommendations1, immunocompromised children:
    1. Prophylaxis may be considered for children younger than 24 months of age who are profoundly immunocompromised during the RSV season.
  7. Per AAP recommendations3, children with Down syndrome:
    Limited data suggest a slight increase in RSV hospitalization rates among children with Down syndrome. However, data are insufficient to justify a recommendation for routine use of prophylaxis in children with Down syndrome unless:
    1. Qualifying heart disease, CLD, airway clearance issues, or prematurity (<29 weeks, zero days’ gestation) is present.
  8. Per AAP recommendations1, children with cystic fibrosis:
    Routine use of palivizumab prophylaxis in patients with cystic fibrosis, including neonates diagnosed with cystic fibrosis by newborn screening, is not recommended unless other indications are present:
    1. An infant with cystic fibrosis with clinical evidence of CLD and/ or nutritional compromise in the first year of life may be considered for prophylaxis.
    2. Continued use of palivizumab prophylaxis in the second year may be considered for infants with manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest radiography or chest computed tomography that persist when stable) or weight for length less than the 10th percentile.
  9. Per AAP recommendations1, Use of palivizumab in the second year of life:
    Hospitalization rates attributable to RSV decrease during the second RSV season for all children. A second season of palivizumab prophylaxis is recommended only for:
    1. preterm infants born at <32 weeks, zero days’ gestation who required at least 28 days of oxygen after birth and who continue to require supplemental oxygen, chronic systemic corticosteroid therapy, or bronchodilator therapy within 6 months of the start of the second RSV season.

Indications that are not covered

Per AAP recommendations1, the following groups of infants are not at increased risk of RSV and generally should not receive immunoprophylaxis:

  1. Preterm infants without CLD of prematurity or CHD born at 29 weeks, zero days’ gestation or later are not universally recommended to receive palivizumab prophylaxis.
  2. Palivizumab prophylaxis in the second year of life on the basis of a history of prematurity alone.
  3. Infants with CLD who do not continue to require medical support in the second year of life.
  4. Infants and children with hemodynamically insignificant heart disease (e.g., secundum atrial septal defect, small ventricular septal defect, pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation of the aorta, and patent ductus arteriosus).
  5. Infants with lesions adequately corrected by surgery, unless they continue to require medication for congestive heart failure.
  6. Infants with mild cardiomyopathy who are not receiving medical therapy for the condition.
  7. Children in the second year of life, unless criteria above are met.
  8. Passive antibody administration is not effective in the treatment of RSV disease and is not recommended.
  9. Palivizumab use in controlling outbreaks of health care-associated disease is not recommended unless criteria above are met for CLD, CHD or prematurity.
  10. Prophylaxis is not recommended for primary asthma prevention or to reduce subsequent episodes of wheezing.
  11. If any infant or young child receiving monthly palivizumab prophylaxis experiences a breakthrough RSV hospitalization, monthly prophylaxis is not covered and should be discontinued because of the extremely low likelihood of a second RSV hospitalization in the same season (<0.5%).


Respiratory syncytial virus (RSV) is a virus that causes upper respiratory symptoms along with some cough, wheezing and occasional pneumonia. RSV occurs mainly in the winter months. Although the illness is widespread, some small infants are at much greater risk of developing the severe complications of pneumonia. This may lead to hospitalization with oxygen and ventilation treatments. The infants at risk for RSV are small premature infants and young infants with chronic lung disease.

Synagis is an intramuscular medication given monthly to help prevent the serious lung complications of RSV.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all inclusive.




    Respiratory syncytial virus, monoclonal antibody, recombinant, for intramuscular use, 50 mg, each


    Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular


    Home injectable therapy, palivizumab, including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

CPT Copyright American Medical Association. All rights reserved.  CPT is a registered trademark of the American Medical Association.


This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.


  1. American Academy of Pediatrics Committee on Infectious Diseases and Bronchiolitis Guidelines Committee. (2014). Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics, 134(2), 415 – 420. doi:10.1542/peds.2014-1665
  2. American Academy of Pediatrics. (2015). Section 3: Summaries of infectious diseases, respiratory syncytial virus. In: Kimberlin, D. W., Brady, M. T., Jackson, M. A., & Long, S. S. (Eds.), Red Book: 2015 Report of the Committee on Infectious Diseases (pp. 667-676). 30th ed. Elk Grove Village, IL.
  3. Hayes, Inc. Hayes Medical Technology Directory Report. Palivizumab (Synagis) Prophylaxis for Respiratory Syncytial Virus Infection in Preterm Infants. Lansdale, PA: Hayes, Inc.; December, 2014. Reviewed November, 2017.

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Policy activity

  • 01/01/1997 - Date of origin
  • 09/01/2018 - Effective date
Review date
  • 09/2018

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