Immune prophylaxis is available with the use of intravenous immune globulin prepared from donors screened for high titers of respiratory syncytial virus (RSV) neutralizing antibody (RSV-IGIV), or Palivizumab, a humanized RSV monoclonal antibody that can be administered intramuscularly.

RSV-IGIV (RespiGam™)(90379) and Palivizumab (Synagis®)(90378) are eligible in accordance with the American Academy of Pediatrics guidelines for protection against lower respiratory tract infection with RSV in infants and children with either chronic lung disease or prematurity.

Prophylaxis should be initiated at the onset of the RSV season and terminated at the end of the RSV season. The usual time for the beginning of outbreaks is October to December, and termination is March to May, but regional differences may occur.

Typically, a total of 5 monthly dosages are given during the RSV winter season. Once a child qualifies for initiation of prophylaxis at the start of the RSV season, administration should continue throughout the season and should not stop at the point an infant reaches either 6 months or 12 months of age.

Patients with more severe chronic lung disease may benefit from prophylaxis during a second RSV season if they continue to require medical therapy for respiratory or cardiac dysfunction.

Monthly administration of immune prophylaxis for RSV with RSV-IGIV or palivizumab may be considered medically necessary in the following infants and children, based on guidelines from the American Academy of Pediatrics:

1. Infants and children younger than 2 years of age with chronic lung disease who have required medical therapy for their chronic lung disease within 6 months before the anticipated RSV season.
   
   
2. Infants born at 32 weeks of gestation or earlier without chronic lung disease or who do not meet the criteria in the above bullet according to the following schedule:
   
   
   • Infants born at 28 weeks of gestation* or earlier are candidates for prophylaxis during their first RSV season, whenever that occurs during the first 12 months of life; or
   • Infants born at 29 to 32 weeks of gestation* are candidates for prophylaxis up to 6 months of age.
     
     
3. Infants born between 32 weeks and 35 weeks of gestation (i.e., between 32 weeks, 1 day and 35 weeks, 0 days) and are younger than 6 months at the start of the RSV season, with at least 2 OR MORE of the following high-risk factors:
   
   
   • Child care attendance;
   • School-aged siblings;
   • Exposure to environmental air pollutants;
   • Congenital abnormalities of the airways; and
   • Severe neuromuscular disease.

Monthly administration of immune prophylaxis with only palivizumab (i.e., not RespiGam) may be considered medically necessary for children who are 24 months of age or younger with hemodynamically significant cyanotic and acyanotic heart disease.

Decisions regarding prophylaxis with palivizumab in children with congenital heart disease should be made on the basis of the degree of physiologic cardiovascular compromise. Infants younger than 12 months of age with congenital heart disease who are most likely to benefit from immunoprophylaxis include:

• Infants who are receiving medication to control congestive heart failure;
• Infants with moderate to severe pulmonary hypertension; and
• Infants with cyanotic heart disease.

For children with heart disease meeting the American Academy of Pediatrics criteria for palivizumab and any one (1) of the conditions described in the above bullets, an additional postoperative dose of palivizumab may be considered medically necessary after a surgical procedure requiring cardiopulmonary bypass.

Immune prophylaxis is considered not medically necessary and therefore not covered for infants and children with hemodynamically insignificant heart disease. This includes but is not limited to secundum atrial septal defect, small ventricular septal defect, pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation of the aorta, and patent ductus arteriosus. A participating, preferred, or network provider cannot bill the member for the denied service.

Other indications for immune prophylaxis for RSV are considered experimental/investigational and therefore not covered. This includes but is not limited to adults with any diagnosis, patients undergoing stem-cell transplantation, and immunocompromised children or children with cystic fibrosis, not otherwise addressed by the above criteria. A participating, preferred, or network provider can bill the member for the denied service.

*32 weeks gestation refers to an infant born on or before the 32nd week of gestation.

Synagis® is available in both a 50 mg and a 100 mg vial. Therefore, procedure code 90378-Respiratory syncytial virus immune globulin (RSV-IgIM) for intramuscular immunizations should be reported per 50 mg.

NOTE: See Medical Policy Bulletin I-8 on Immunizations.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

PRN References

02/1999, Synagis® 02/2000, Synagis® eligibility explained
04/2000, Reporting guidelines for Synagis® change
10/2000, Reminder: Synagis® may be eligible for reimbursement
12/2000, Eligibility criteria for RSV treatment changes
02/2001, Coverage expanded for Synagis®
08/2005, RSV treatment guidelines outlined

Prevention of Respiratory Syncytial Virus Infections: Indications for the Use of Palivizumab and Update on the Use of RSV-IGIV (RE9839), American Academy of Pediatrics, Policy Statement, Vol. 102, No. 5, November 1998

Palivizumab, USPDI-Vol. I, Edition 24, 2004 Micromedex, Inc.

Respiratory Syncytial Virus Immune Globulin, USPDI-Vol. I, Edition 24, 2004 Micromedex, Inc.

Immune Prophylaxis for Respiratory Syncytial Virus, National Blue Cross Blue Shield Association Medical Policy Reference Manual, Policy No. 5.01.10