BlueCross and BlueShield of Montana Medical Policy/Codes
Respiratory Syncytial Virus - Immune Prophylaxis
Chapter: Drugs - Medical Benefit
Current Effective Date: September 24, 2013
Original Effective Date: May 01, 1999
Publish Date: September 24, 2013
Revised Dates: November 13, 2002; February 11, 2004; September 14, 2010; November 09, 2012; July 29, 2013
Description

Respiratory syncytial virus (RSV) infections typically occur in the winter months, starting from October to December and ending from March to May. Considerable variation in the timing of community outbreaks is observed year to year. According to the Centers for Disease Control and Prevention (CDC), onset of the RSV season occurs when the median percentage of specimens testing positive for RSV is 10% or higher over a 2-week period. In the U.S., RSV is associated with approximately 75,000-125,000 pediatric hospitalizations annually. (1)

Chronic lung disease (CLD, [formerly known as bronchopulmonary dysplasia]) is a general term for long-term respiratory problems in premature infants. CLD results from lung injury to newborns that, consequently, requires use of a mechanical ventilator and supplemental oxygen for breathing. With injury, the lung tissues become inflamed and scarring can result. Some of the causes of the lung injury include prematurity, low amounts of surfactant, oxygen use, and/or mechanical ventilation. Risk factors for developing CLD include: birth at less than 34 weeks’ gestation, birth weight less than 2,000 grams (4 pounds 6.5 ounces), hyaline membrane disease, pulmonary interstitial emphysema (PIE), patent ductus arteriosus (PDA), Caucasian, male infants, maternal womb infection (chorioamnionitis), and family history of asthma.

In contrast to the well-documented beneficial effect of breastfeeding against many viral illnesses, existing data are conflicting regarding the specific protective effect of breastfeeding against RSV infection. Breastfeeding should be encouraged for all infants in accordance with recommendations of the American Academy of Pediatrics (AAP). High-risk infants should be kept away from crowds and from situations in which exposure to infected people cannot be controlled. Participation in group child care should be restricted during the RSV season for high-risk infants whenever feasible. Parents should be instructed on the importance of careful hand hygiene. In addition, all high-risk infants 6 months of age and older and their contacts should receive influenza vaccine, as well as other recommended age-appropriate immunizations.

This policy does not address therapies to treat RSV infection.

Regulatory Status

In June 1998, the biologic Synagis® (palivizumab; MedImmune, Inc, Gaithersburg, MA) was approved for marketing by the U.S. Food and Drug Administration (FDA) through the biologics licensing application for use in the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease. In July 2004, the FDA approved a liquid formulation of Synagis®, supplied as a sterile solution ready for injection, thus providing improved convenience for administration. This formulation is used in the physician office or home setting.

RespiGam® RSV-IVIG for intravenous use was available from 1993 to 2009. It is no longer manufactured.

In August 2010, Motavizumab (proposed to be marketed as Rezield™, MedImmune, Inc) received a complete response letter from the FDA requesting additional clinical data on its biologics license application. Subsequently, AstraZeneca suspended Motavizumab development and upon the manufacturer’s request, the FDA withdrew its biological license application.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Medically Necessary

Blue Cross and Blue Shield of Montana (BCBSMT) may consider respiratory syncytial virus (RSV) prophylaxis with palivizumab (Synagis) medically necessary in the following infants and children:

  1. Infants and children younger than 24 months of age with chronic lung disease (CLD) who have required medical therapy (supplemental oxygen, bronchodilator, diuretic or chronic corticosteroid therapy) within six months before the anticipated RSV season, to a maximum of five monthly doses.
  2. Infants born before 32 weeks’ gestation (31 weeks, 6 days or less) according to the following schedule, to a maximum of five monthly doses:
    • Infants born at 28 weeks, 6 days gestation or earlier, who are younger than 12 months of age at the start of palivizumab therapy for the RSV season; OR
    • Infants born at 29 weeks, 0 days to 31 weeks, 6 days of gestation, who are younger  than six months of age at the start of palivizumab therapy for the RSV season.
  3. Infants born between 32 weeks, 0 days and 34 weeks, 6 days gestation, who are younger than three months at the start of palivizumab therapy for the RSV season may receive monthly doses until age three months, to a maximum of three monthly doses (see *Exception), IF they have at least one of the following two risk factors, :
    • Attend child care; OR
    • Have at least one sibling younger than five years of age.
  4. Infants who have congenital abnormalities of the airway OR a neuromuscular condition that compromises handling of respiratory secretions, during the first year of life, to a maximum of five monthly doses.
  5. Infants and children, who are 24 months of age or younger, with severe immunodeficiencies (e.g. severe combined immunodeficiency, advanced acquired immunodeficiency syndrome, or severe immunodeficiency resulting from chemotherapy).
  6. Children who are 24 months of age or younger with hemodynamically significant cyanotic and acyanotic congenital heart disease (CHD) to a maximum of five monthly doses.
    • For children with CHD who meet the criteria in #6 above, an additional postoperative dose of palivizumab may be considered medically necessary after a surgical procedure requiring cardiopulmonary bypass.

* EXCEPTION: If an infant born between 32 weeks, 0 days and 34 weeks 6 days, is receiving palivizumab immunoprophylaxis and experiences a breakthrough RSV infection, monthly prophylaxis will be covered until a maximum of 3 doses have been administered.

Note: Decisions regarding prophylaxis with palivizumab for children with CHD should be made on the basis of the degree of physiologic cardiovascular compromise. Children younger than 24 months of age with CHD who are most likely to benefit from immunoprophylaxis include those:

  1. Receiving medication to control congestive heart failure; OR
  2. With moderate to severe pulmonary hypertension; OR
  3. With cyanotic heart disease

Not Medically Necessary

BCBSMT considers immune prophylaxis for RSV is considered not medically necessary for:

  1. 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, patent ductus arteriosus),
  2. Infants with lesions adequately corrected by surgery unless they continue to require medication for congestive heart failure, OR
  3. Infants with mild cardiomyopathy who are not receiving medical therapy.

Investigational

BCBSMT considers all other indications for immune prophylaxis for RSV (not otherwise addressed) are considered experimental, investigational and unproven, including but not limited to:

  • Children > 24 months at the initial request for immunoprophylaxis,
  • Adults with any diagnosis,
  • Patients undergoing stem cell transplantation,
  • Infants and children with cystic fibrosis.

Rationale

High-risk Infants

Several randomized clinical trials have demonstrated the success of immune prophylaxis of respiratory syncytial virus (RSV). A systematic review was conducted in the United Kingdom to evaluate the effectiveness of palivizumab for the prevention of RSV in children. (2) Two randomized controlled trials (RCTs) were identified in the review. (3, 4) In the 1998 Impact-RSV Study Group, prophylaxis with palivizumab for preterm infants without chronic lung disease (CLD) or children with CLD resulted in a 55% reduction in RSV hospital admission; 4.8% (48/1,002) in the palivizumab group and 10.6% (53/500) in the no prophylaxis group. (3) Similar reductions in other measures of RSV severity in breakthrough infections were also reported. In a 2003 double-blind, placebo-controlled randomized trial of 1,287 children with hemodynamically significant CHD, Feltes et al. reported prophylaxis with palivizumab was associated with a 45% reduction in hospitalization rate for RSV among children with congenital heart disease (CHD). (4) Hospitalization rates for RSV were 5.3% (34/639) in the palivizumab group and 9.7% (63/648) in the no prophylaxis group. The authors concluded that prophylaxis with palivizumab is clinically effective for reducing the risk of serious lower respiratory tract infection caused by RSV infection and requiring hospitalization in high-risk children.

In 1997, the PREVENT Study Group reported on a trial that randomly assigned 510 infants with prematurity or CLD to receive either placebo or RSV-intravenous immunoglobulin (IVIg) infusions monthly for 5 months. The authors reported a 41% reduction in hospitalization due to RSV infection and reductions in other measures of severity of RSV infection when it did occur. (5) Palivizumab eventually became the preferred product over the IVIg product due to the convenience of intramuscular administration, safety concerns regarding immunoglobulin pooled from multiple donors, and the unlimited supply of a bioengineered product.

In 1998, the American Academy of Pediatrics (AAP) published revised guidelines regarding the use of RSV-IVIg or palivizumab for RSV immune prophylaxis, which focused on infants with chronic lung disease and preterm infants. (6) In 2003, the AAP Red Book, which summarizes immunization recommendations and the AAP policy statement on the prevention of RSV, added indications for children with hemodynamically significant heart disease. (7)

Immune prophylaxis has also been suggested for patients 24 months of age or younger with congenital heart disease (CHD). The AAP guidelines note that children with cyanotic CHD who received RSV-IVIg and underwent cardiac surgery appeared to experience an increased surgical mortality rate. Therefore, according to the AAP guidelines, RSV-IVIg is contraindicated in children with cyanotic CHD. The AAP guidelines indicate the use of palivizumab in children with CHD should be based on the degree of cardiovascular compromise. Infants with CHD who are younger than 24 months may benefit from palivizumab if they are receiving medication for heart failure, have moderate-to-severe pulmonary hypertension, or have cyanotic heart disease.

The 2003 recommendation by the AAP (6) was based on the results of the Feltes RCT noted above. (4) In 2009, AAP updated its guidelines regarding the use of immune prophylaxis for RSV. The updated guidelines were published in the new AAP Red Book 2009 in the chapter on RSV. (8) The following is a summary, provided by the AAP, of the major changes to the guidelines:

  • “Recommendations for initiation and termination of prophylaxis are modified to reflect current CDC [Centers of Disease Control and Prevention] descriptions of RSV seasonality in different geographic locations within the United States.
  • The recommendations remain unchanged for infants with congenital heart disease, chronic lung disease of prematurity and birth before 32 weeks' gestation.
  • Regardless of the month when the first dose is administered, the recommendation for a maximum number of 5 doses for all geographic areas is emphasized for infants with hemodynamically significant congenital heart disease, chronic lung disease of prematurity or birth before 32 weeks' gestation and for a maximum number of 3 doses for infants with a gestational age of 32 to 35 weeks without hemodynamically significant congenital heart disease or chronic lung disease.
  • Risk factors for severe RSV lower respiratory tract disease among infants born between 32 to 35 weeks' gestation have been modified to include only:
  1. Infant attends child care
  2. Siblings living in the household are less than 5 years of age
  • Infants 32 to 35 weeks' gestation age who are born within the 3 months before the onset of RSV season and throughout the RSV season will qualify for prophylaxis if they have at least one [of the modified] risk factors. Earlier recommendations required 2 of 5 [different] risk factors.
  • Infants who qualify for prophylaxis in the 32 to 35 weeks' gestation age group should receive prophylaxis only until they reach 90 days of age or a maximum of 3 doses (whichever comes first). This is a change from the previous recommendation for 5 months of prophylaxis.
  • The AAP's definition of gestational age is used throughout this document. For example, 32 to 35 weeks' gestation is defined as 32 weeks, 0 days through 34 weeks, 6 days.”

In August 2009, AAP released a policy statement (including references and evidence grading) that supported their revised indications for the use of palivizumab for the prevention of respiratory syncytial virus infections. (9) In commenting on their 2009 recommendations, the AAP policy statement indicates, "they [the 2009 AAP recommendations] specifically target infants in this [32 to less than 35 weeks' gestational age] with consistently identified risk factors for RSV hospitalization during the period of greatest risk, which is the first 3 months of life.”

In 2008, Cohen and colleagues evaluated the characteristics of patients (n=19,548) enrolled in The Palivizumab Outcomes Registry with CHD over the 4 RSV seasons. (10) The Palivizumab Outcomes Registry prospectively collected data on patients who received RSV prophylaxis with palivizumab during the 2000–2004 RSV seasons. The percentage of registry subjects with CHD increased from 4.8% (102/2,116) in the first season to 11.4% (688/6,050) in the last season. Across all 4 seasons, 1,500 subjects with CHD were enrolled; 71% of whom had acyanotic CHD. The proportion with cyanotic CHD increased from 19.6% (20/102) in the 2000–2001 season to 37.5% (258/688) in the 2003–2004 season, while the proportion of all CHD in the registry more than doubled during this time. The cumulative RSV hospitalization rate was 1.9% among patients with CHD who received prophylaxis. Among subjects with cyanotic and acyanotic CHD, hospitalization rates were 2.6% and 1.6%, respectively. The authors concluded, “…the prospective data collected in the Palivizumab Outcomes Registry provides the largest published dataset available on infants with CHD receiving palivizumab; shows low hospitalization rates, use consistent with prelicensure clinical trial data and the revised American Academy of Pediatrics guidelines.”

A review article discussed the development of a second-generation humanized monoclonal antibody (mAb), motavizumab, which is no longer under study in Phase III clinical trials, and most recently, a third generation mAb, Numax-YTE. (11)

Cystic Fibrosis

A Cochrane review was published in 2010 and updated in 2012, assessing the use of palivizumab in children with cystic fibrosis. (12, 13) One randomized comparative trial met the inclusion criteria of both reviews. In the study, 186 infants younger than 2 years with cystic fibrosis were randomly assigned to receive 5 monthly doses of palivizumab (n=92) or placebo (n=94). One member of each group was hospitalized for RSV within the 6-month follow-up period. The rate of adverse event noted in each group was relatively high, with serious adverse events not significantly different between the palivizumab and placebo groups (20.2% and 17.3%, respectively). The authors noted that it was not possible to draw conclusions on the tolerability and safety of RSV immune prophylaxis in cystic fibrosis. The single study reported similar adverse events but did not specify how adverse events were classified. No clinically meaningful outcome differences were noted at 6-month follow-up. The authors of the review called for additional randomized studies to establish both efficacy and safety of immune prophylaxis in children with cystic fibrosis.

Immunodeficiencies

The use of RSV-IVIg or palivizumab in patients with documented immunodeficiencies has also been suggested. The AAP guidelines note, "Palivizumab or RSV-IVIg has not been evaluated in randomized trials in immunocompromised children. Although specific recommendations for immunocompromised patients cannot be made, children with severe immunodeficiencies (e.g., severe combined immunodeficiency or severe acquired immunodeficiency syndrome) may benefit from prophylaxis. If these infants and children are receiving standard immune globulin intravenous monthly, physicians may consider substituting RSV-IVIg during the RSV season."

Immunocompromised patients undergoing stem-cell transplantation are also at risk for potentially lethal respiratory viral infections. Cortez and colleagues studied whether RSV-IVIg provided sufficient RSV immune prophylaxis to prevent RSV pneumonia in 54 patients undergoing stem-cell transplantation. (14) The authors reported a low incidence of RSV infection in the 54 RSV-IVIg patients, as well as in 31 patients not enrolled in the study, and could not determine the preventive effect of RSV-IVIg. In a literature review, Hynicka and Ensor found data are limited on RSV prophylaxis in immunocompromised adult patients. (15) The only prospective study identified in the review was by Kassis et al. (16) in which intravenous pavilizumab was given to 16 high-risk stem-cell transplant patients to prevent the nosocomial spread of RSV infection from 5 stem-cell transplant patients. After one week, no further RSV cases occurred, but whether controlling the spread of RSV on the stem-cell transplant unit was related to RSV prophylaxis versus implementation of strict quarantine and infection control practices cannot be determined.

Duration of Prophylaxis

The RSV season typically occurs from November to April. Within the United States, the inevitability of the RSV season is predicable, but the severity of the season and time of onset are variable from year to year and also between geographic areas within a given year. This has led to requests for either earlier or later immunoprophylaxis, or greater than 5 monthly doses. Nevertheless, as pointed out by Meissner and colleagues from the Centers of Disease Control and Prevention (CDC), “…this yearly and regional variation still occurs within the overall pattern of RSV outbreaks, usually beginning in November or December, peaking in January or February, and ending by March. Communities in the southern region tend to experience the earliest onset of RSV activity, and Midwestern states tend to experience the latest onset, but community to community variation in timing precludes using either national or regional data to precisely predict individual community RSV outbreaks. The duration of the season for western and northeast regions typically occurs between that noted in the South and the Midwest.” The authors point out that the recommendation for 5 monthly doses is derived from the randomized studies of palivizumab. A serum palivizumab concentration of greater than 30 μg/mL is the target level for protection, and in randomized studies, the trough level of palivizumab exceeded 30 μg/mL for at least 30 days after the fifth dose. This indicates that 5 monthly doses will provide substantially more than 20 weeks of protective serum antibody levels, covering most of the RSV season even with variation in season onset and end. (17)

Compliance

Frogel and colleagues reviewed the medical literature on compliance with palivizumab therapy and the relation between hospitalization rates in fully compliant and less compliant groups. (18) A total of 25 articles and abstracts met review inclusion criteria. Significant heterogeneity was detected due to between-study differences in the population studied and the definition of compliance used. Differences in compliance definitions led to a compliance rate range of 25% to as high as 100%, compared to rates in licensing studies of 92% and 93%. This led the authors to the conclusion that compliance in practice is far more variable. Minorities and patients on Medicaid were less likely to receive the full complement of palivizumab doses, while patients participating in a home health program tended to have higher compliance and less hospitalization. Home health programs were defined as nurse-delivered injections performed in the home setting.

Summary

RSV is the most common cause of lower respiratory infections in children. At highest risk are those younger than 2 years of age with prematurity, CLD [formerly known as bronchopulmonary dysplasia]), congenital heart disease, or multiple congenital anomalies. Immune prophylaxis against RSV is a prevention strategy to reduce the incidence of infection and its associated morbidity, including hospitalization, in high-risk infants.

Based on the weight of the clinical evidence from randomized clinical trials, systematic reviews and strong clinical consensus, immune prophylaxis for RSV has demonstrated reductions in RSV-related hospitalizations in select populations of susceptible infants and children; therefore, immune prophylaxis for RSV may be considered medically necessary for those patients, as listed in the Coverage section above. For all other uses of immune prophylaxis, the clinical evidence is not convincing that RSV hospitalizations will decrease. Therefore, the Coverage section above notes indications that are considered not medically necessary, or experimental, investigational and unproven. The Coverage statements are in agreement with the 2009 AAP Guidelines.

Practice Guidelines and Position Statements

In 2003, the AAP released a policy statement with revised indications for the use of palivizumab and RSV-IVIg for the prevention of RSV infections. (7)

In June 2009, the AAP released updated guidelines regarding the use of immune prophylaxis for RSV. The updated guidelines were published in the new AAP Red Book 2009 in the chapter on RSV. (8)

In August 2009, the AAP released a policy statement (including references and evidence grading) with revised indications for the use of palivizumab for the prevention of RSV infections. (9)

In 2012, the AAP released their 2012 Red Book; the 2012 Red Book does not have any changes that would alter the Coverage position of this policy. (19)

In 2008, Department of Public Health and Epidemiology, University of Birmingham, Birmingham, UK, released a Health Technology Assessment on immunoprophylaxis against RSV with palivizumab in children. (2) The authors concluded that prophylaxis with palivizumab is clinically effective for the reducing the risk of serious lower respiratory tract infection caused by RSV infection and requiring hospitalization in high-risk children.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

079.6, 99.29, 279.00, 279.01, 279.02, 279.03, 279.04, 279.05, 279.06, 279.09, 279.1, 279.10, 279.11, 279.12, 279.13, 279.19, 279.2, 279.3, 279.41, 279.49, 279.8, 279.9, 358.00, 358.01, 358.1, 358.2, 358.30, 358.31, 358.39, 358.8, 358.9, 396, 416.0, 416.1, 416.2, 416.8, 416.9, 417.0, 417.1, 417.8, 417.9, 424.0-424.99, 428.0, 491.0, 491.1, 491.2, 491.20, 491.21, 491.22, 491.8, 491.9, 493.20, 493.21, 493.22, 493.90, 493.91, 493.92, 496, 745.0, 745.10, 745.11, 745.12, 745.19, 745.2, 745.3, 745.4, 745.5, 745.60, 745.61, 745.69, 745.7, 745.8, 745.9, 746.00, 746.01, 746.02, 746.09, 746.1, 746.2, 746.3, 746.4, 746.5, 746.6, 746.7, 746.81, 746.82, 746.83, 746.84, 746.85, 746.86, 746.87, 746.89, 746.9, 747.0, 747.10, 747.11, 747.20, 747.21, 747.22, 747.29, 747.31, 747.32, 747.39, 747.40, 747.41, 747.42, 747.49, 747.5, 748.5, 748.60, 748.61, 748.69, 765.20, 765.21, 765.22, 765.23, 765.24, 765.25, 765.26, 765.27, 765.28, 770.7, V01.79, V04.82, V07.2

ICD-10 Codes

I08.0-I08.9, I28.0-I28.9, I34.0-I34.9, I35.0-I35.9, I36.0-I36.9, I37.0-I37.9, I42.0-I42.9, I43, I50.1-I50.9, J41.0-J42, J44.0-J44.9, P07.00-P07.32, P27.1-P27.9, P28.0-P28.9, Q20.0-Q28.9, 3E0234Z, 3E0334Z

Procedural Codes: 90378, 96372, S9562
References
  1. Respiratory syncytial virus--United States, July 2007-June 2011. MMWR Morb Mortal Wkly Rep 2011; 60(35):1203-6.
  2. Wang D, Cummins C, Bayliss S et al. Immunoprophylaxis against respiratory syncytial virus (RSV) with palivizumab in children: a systematic review and economic evaluation. Health Technol Assess 2008; 12(36):iii, ix-x, 1-86.
  3. 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; 102(3 Pt 1):531-7.
  4. Feltes TF, Cabalka AK, Meissner HC et al. Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. J Pediatr 2003; 143(4):532-40.
  5. Reduction of respiratory syncytial virus hospitalization among premature infants and infants with bronchopulmonary dysplasia using respiratory syncytial virus immune globulin prophylaxis. The PREVENT Study Group. Pediatrics 1997; 99(1):93-9.
  6. Prevention of respiratory syncytial virus infections: indications for the use of palivizumab and update on the use of RSV-IGIV. American Academy of Pediatrics Committee on Infectious Diseases and Committee of Fetus and Newborn. Pediatrics 1998; 102(5):1211-6.
  7. Meissner HC, Long SS. Revised indications for the use of palivizumab and respiratory syncytial virus immune globulin intravenous for the prevention of respiratory syncytial virus infections. Pediatrics 2003; 112(6 Pt 1):1447-52.
  8. 2009 Red Book. Report of the Committee on Infectious Disease. Respiratory Syncytial Virus. Vol 2009. Elk Grove Village, IL: American Academy of Pediatrics.
  9. From the American Academy of Pediatrics: Policy statements--Modified recommendations for use of palivizumab for prevention of respiratory syncytial virus infections. Pediatrics 2009; 124(6):1694-701.
  10. Cohen SA, Zanni R, Cohen A et al. Palivizumab use in subjects with congenital heart disease: results from the 2000-2004 Palivizumab Outcomes Registry. Pediatr Cardiol 2008; 29(2):382-7.
  11. Wu H, Pfarr DS, Losonsky GA et al. Immunoprophylaxis of RSV infection: advancing from RSV-IGIV to palivizumab and motavizumab. Curr Top Microbiol Immunol 2008; 317:103-23.
  12. Robinson KA, Odelola OA, Saldanha I et al. Palivizumab for prophylaxis against respiratory syncytial virus infection in children with cystic fibrosis. Cochrane Database Syst Rev 2010; 2:CD007743.
  13. Robinson KA, Odelola OA, Saldanha IJ et al. Palivizumab for prophylaxis against respiratory syncytial virus infection in children with cystic fibrosis. Cochrane Database Syst Rev 2012; 2:CD007743.
  14. Cortez K, Murphy BR, Almeida KN et al. Immune-globulin prophylaxis of respiratory syncytial virus infection in patients undergoing stem-cell transplantation. J Infect Dis 2002; 186(6):834-8.
  15. Hynicka LM, Ensor CR. Prophylaxis and treatment of respiratory syncytial virus in adult immunocompromised patients. Ann Pharmacother 2012; 46(4):558-66.
  16. Kassis C, Champlin RE, Hachem RY et al. Detection and control of a nosocomial respiratory syncytial virus outbreak in a stem cell transplantation unit: the role of palivizumab. Biol Blood Marrow Transplant 2010; 16(9):1265-71.
  17. Meissner HC, Anderson LJ, Pickering LK. Annual variation in respiratory syncytial virus season and decisions regarding immunoprophylaxis with palivizumab. Pediatrics 2004; 114(4):1082-4.
  18. Frogel MP, Stewart DL, Hoopes M et al. A systematic review of compliance with palivizumab administration for RSV immunoprophylaxis. J Manag Care Pharm 2010; 16(1):46-58.
  19. 2009 Red Book. Report of the Committee on Infectious Disease. Respiratory Syncytial Virus. Vol 2012. Elk Grove Village, IL: American Academy of Pediatrics.
  20.  Immune Prophylaxis for Respiratory Syncytial Virus. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2012 September) Prescription Drug 5.01.10.
History
November 2012  Policy updated with literature search. Policy statement number 4 modified with removal of “born before 35 weeks of gestation” to be consistent with the AAP guidelines. Deleted “congestive” from “congestive heart failure” in policy statements. Other policy statements are unchanged.  Rationale reorganized.  References 1, 13, and 15-16 added.
July 2013 Policy formatting and language revised.  Title changed from "Respiratory Syncytial Virus - Immune Prophylaxis" to "Respiratory Syncytial Virus (RSV) Immunoprophylaxis".  Added "Infants and children, who are 24 months of age or younger, with severe immunodeficiencies (e.g. severe combined immunodeficiency, advanced acquired immunodeficiency syndrome, or severe immunodeficiency resulting from chemotherapy)" to the Medically Necessary statement.  Added code S9562 and removed 96365, 96366, and J1565.
BCBSMT Home
®Registered marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. ®LIVE SMART. LIVE HEALTHY. is a registered mark of BCBSMT, an independent licensee of the Blue Cross and Blue Shield Association, serving the residents and businesses of Montana.
CPT codes, descriptions and material only are copyrighted by the American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS Restrictions Apply to Government Use. CPT only © American Medical Association.
Respiratory Syncytial Virus - Immune Prophylaxis