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Medical Policy: 05.01.08
Original Effective Date: September 1998
Reviewed: October 2011
Revised: August 2009
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Respiratory syncytial virus (RSV) causes acute respiratory tract illness in patients of all ages. In infants and children, RSV is the most important cause of bronchiolitis and pneumonia. Conditions that increase the risk of severe or fatal RSV infection are cyanotic or complicated congenital heart disease, especially conditions causing pulmonary hypertension; underlying pulmonary disease, especially bronchopulmonary dysplasia; prematurity; and immunodeficiency disease. Currently, only one FDA approved drug is available for RSV prophylaxis. Palivizumab, marketed under the trade name Synagis® is administered intramuscularly in a dose of 15 mg/kg once a month during the RSV season.
Palivizumab immunoprophylaxis begins just before the onset of RSV season, which typically occurs between October or November and March. Regional variance is known to occur. Spread among household members and child care contacts is common. The period of viral shedding is typically 3 to 8 days, but shedding may last as long as 3 to 4 weeks in young infants and immunosuppressed people. The most common incubation period is 4 to 6 days. RSV replicates to high titer in cells of the nasopharynx and can spread to the lower respiratory tract via secretions, but is generally confined to the respiratory tract in immunocompetent patients.
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Prior Approval:
Prior approval is recommended. Submit a prior approval/treatment request now.  (74 KB)
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Policy:
Palivizumab prophylaxis for RSV may be considered medically necessary for the following patients:
- Infants less than or equal to 28 weeks’ gestation and younger than 1 year of age at the start of RSV season. A maximum of 5 doses is recommended.
- Infants born at 29 to 32 weeks’ gestation (born before the 32nd week of gestation) and younger than 6 months of age at the start of RSV season. A maximum of 5 doses is recommended.
- Infants born at 32 to less than 35 weeks’ gestation (defined as 32 weeks 0 days through 34 weeks, 6 days) and younger than 3 months of age at the start of RSV season or born during the RSV season and have at least one of the following two risk factors:
- Infant attends child care, defined as a home or facility where care is provided for any number of infants or young toddlers
- Infant has a sibling younger than 5 years of age
Note: Infants in this gestational age category should receive prophylaxis only until they reach 3 months of age and should receive a maximum of 3 monthly doses; many will receive only 1 or 2 doses until they reach 3 months of age. Administration of palivizumab in this setting is not recommended after 3 months of age.
- Infants and children younger than 24 months of age with chronic lung disease of prematurity (CLD) who have required medical therapy (supplemental oxygen, bronchodilator, diuretic or corticosteroids) for CLD within 6 months before anticipated start of the RSV season. A maximum of 5 doses is recommended.
Note: The American Academy of Pediatrics suggests that patients with the most severe CLD who continue to require medical therapy may benefit from prophylaxis during a second RSV season, although data are limited regarding the effectiveness of palivizumab during the second year of life.
- Infants born before 35 weeks of gestation who have either congenital abnormalities of the airway or a neuromuscular condition that compromises handling of respiratory secretions. Infants and young children in this category should receive a maximum of 5 doses during the first year of life.
- Infants and children 24 months of age or younger with hemodynamically significant cyanotic and acyanotic congenital heart disease. This includes:
- Infants who are receiving medications to control congestive heart failure.
- Infants with moderate to severe pulmonary hypertension.
- Infants with cyanotic heart disease.
- For children with heart disease meeting any one of the above criteria for palivizumab, an additional postoperative dose of palivizumab may be considered medically necessary after a surgical procedure requiring cardiopulmonary bypass.
- If an infant or child who is receiving palivizumab immunoprophylaxis experiences a breakthrough RSV infection, monthly prophylaxis should continue until a maximum of 3 doses have been administered to infants in the 32 to less than 35 weeks’ gestation group (defined as 32 weeks, 0 days through 34 weeks, 6 days) or until a maximum of 5 doses for infants with congenital heart disease, CLD, or preterm birth before 32 weeks’ gestation. The American Academy of Pediatrics bases this recommendation on the observation that high-risk infants may be hospitalized more than once in the same season with RSV lower respiratory tract disease and the fact that more than one RSV strain often co-circulates in a community.
According to the American Academy of Pediatrics, the following groups of infants are not at increased risk of RSV and generally should not receive immunoprophylaxis:
- 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)
- Infants with lesions adequately corrected by surgery, unless they continue to require medication for congestive heart failure
- Infants with mild cardiomyopathy who are not receiving medical therapy
Other indications for immune prophylaxis for respiratory syncytial virus are considered investigational, including, but not limited to adults with any diagnosis, or children with immunodeficiencies or cystic fibrosis or children undergoing stem-cell transplant, not otherwise addressed by the above criteria.
Except as described above, immunization during a second RSV season is considered investigational because there is inadequate scientific evidence to permit conclusions about its effectiveness.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- 90378 for respiratory syncytial virus immune globulin (RSV-IgIM), for intramuscular use, 50 mg, each.
- 90379 for respiratory syncytial virus immune globulin (RSV-IgIV), human, for intravenous use.
- J1565 may be used to report respiratory syncytial virus immune globulin, intravenous, 50mg.
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Selected References:
- Silverman W. A Healthcare Management Company’s Experience with Palivizumab. Managed Care. January 2002 ©MediMedia USA.
- Sarah S. Long, Principles and Practice of Pediatric Disease, 3rd ed., Elsevier Inc., 2008, Chap 225, “Respiratory Syncytial Virus”.
- American Academy of Pediatrics. Respiratory Syncytial Virus. Red Book Online; 2009(1):560.
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Policy History:
Date Reason Action
September 2010 Annual review Policy renewed
October 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
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and, therefore, cannot guarantee any results or outcomes.
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advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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