Prophylactic Treatment for Respiratory Syncytial Virus (RSV)*  Printer-Friendly Version
Medical Policy: 05.01.08
Original Effective Date: September 1998
Reviewed: December 2007
Revised: September 2006
This policy applies to all products unless specific contract
limitations, exclusions or exceptions apply. Please refer to the member's coverage
manual for benefit availability. Managed care guidelines related to referral authorization,
and precertification of inpatient hospitalization, home health, home infusion and
hospice services apply.
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 15mg/kg once a month during the RSV season.
Palivizumab is administered approximately once per month beginning just before the onset of RSV season, which typically begins in October or November. Generally, four subsequent monthly doses (for a total of five doses) are sufficient to provide protection during the entire RSV season. Regional variance is known to occur.
Policy:
Prior Approval is recommended for prophylactic treatment for RSV, which may be considered medically necessary for the following patients:
- Less than or equal to 28 weeks gestation and younger than 1 year of age at the start of RSV season.
- Greater than 28 weeks up to and including 32 weeks gestation and younger than 6 months of age at the start of RSV season.
- Greater than 32 weeks up to 35 weeks gestation and younger than 6 months of age at the start of RSV season and having two or more of the following risk factors:
- Child care attendance
- School aged siblings
- Exposure to environmental air pollutants
- Congenital abnormalities of the airways
- Severe neuromuscular disease
- 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.
- Infants and children younger than 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 immunoprophylaxis experiences a breakthrough RSV infection, monthly prophylaxis should continue through the RSV season. 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.
Prior Approval is recommended Submit a prior approval now
According to the American Academy of Pediatrics, the following groups of infants are not at increased risk of RSV and generally should not received immunoprophylaxis:
- Infants and children with hemodynamically insignificant heart disease (eg. 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.
 Top
Procedure Codes and Billing
Guidelines:
- To report provider services, use appropriate CPT** codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- CPT code 90378 for respiratory syncytial virus immune globulin (RSV-IgIM), for intramuscular use, 50 mg, each.
- CPT code 90379 for respiratory syncytial virus immune globulin (RSV-IgIV), human, for intravenous use.
- HCPCS code J1565 may be used to report; Injection, respiratory syncytial virus immune globulin, intravenous, 50mg.
Top
Selected References:
- American Academy of Pediatrics. Respiratory Syncytial Virus. Red Book Online; 2003(1):523.
- Silverman W. A Healthcare Management Company’s Experience with Palivizumab. Managed Care. January 2002 ©MediMedia USA.
- Pickering L.K., Ed. 2000 Red Book: Report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL. American Academy of Pediatrics; 2000:483-487.
- [Synagis® Guideline]. Letter issued by University of South Dakota School of Medicine, Dept. of Pediatrics and Adolescent Medicine, Sept. 11 1998.
- Zanga, J.R. Use of RSV-IGIV and Palivizumab (a humanized monoclonal antibody product) PedComm: AAP Member Alert. Academy of Pediatrics, Oct. 6, 1998. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. The Impact-RSV Study Group. Pediatrics 1998 Sept.; 102(3 pt 1):531-7.
- Subramanian, K.N. Shiva; Weisman, L.E.; Rhodes, T.; Ariango R., et al., for the MEDI-493 Study Group. Safety, tolerance, and pharmacokinetics of a humanized monoclonal antibody to respiratory syncytial virus in premature infants and infants with bronchopulmonary dysplasia. The Pediatric Infectious Disease Journal 1998; 17:110-115.
- Meissner HC, Long SS, et al. Revised indications for the use of palivizumab and respiratory syncytial virus immune globulin intravenous for the prevention of respiratory syncytial virus infections. Technical report. Pediatrics 2003 Dec;112(6 Pt 1):1447-52. (A practice Guideline from the American Academy of Pediatrics.)
- American Academy of Pediatrics. Respiratory Syncytial Virus. Red Book online; 2006 (1):560.
Top
New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
Wellmark Blue Cross and Blue Shield
Medical Policy Analyst
Station 304
636 Grand Ave.
Des Moines, IA 50309
*Prior Approval is recommended for this policy.
**Current Procedural Terminology © 2008 American Medical Association. All Rights Reserved.
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
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
|
 |
