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Humanized respiratory syncytial virus (RSV) monoclonal antibody (e.g., palivizumab [Synagis®]) provides passive immunity to protect the lower respiratory tract from RSV infection. Palivizumab is administered by intramuscular injection on a monthly basis, during the RSV winter season, which is generally November through March. Each monthly dose provides protection for the following month.
In its most recent guidance on RSV prophylaxis, the American Academy of Pediatrics (AAP) states that approximately 2% to 3% of infants in the first 12 months of life are hospitalized with RSV infection each year in the United States. Although children with certain comorbidities are at increased risk of severe RSV infection compared with children without those comorbidities, chronologic age is the single most important risk factor for RSV hospitalization. The 2014 guidelines recommend up to 5 monthly doses of palivizumab during the first year of life for certain preterm infants and certain infants or children with specific chronic or congenital conditions. These guidelines were reaffirmed in 2019. Prophylaxis with palivizumab during the second year of life is recommended for certain children with specific pulmonary conditions.
Definitions
Congenital Heart Disease (CHD): Condition resulting from structural and/or functional defects of the heart at birth. CHD may be classified into acyanotic and cyanotic disease, depending on whether the patient clinically exhibits cyanosis (i.e.., blue or purple coloration of the skin or mucous membranes due to circulation of deoxygenated blood). Examples of acyanotic and cyanotic CHD include the following:
Immunocompromised Status: A state in which an individual's immune system is weakened or absent.
I. Use of immune prophylaxis (e.g., palivizumab [Synagis®]) for RSV may be considered MEDICALLY NECESSARY AND APPROPRIATE when ONE of the following criteria are met:
II. Use of immune prophylaxis (e.g.,palivizumab [Synagis]) for RSV is considered EXPERIMENTAL/INVESTIGATIVE for all other indications due to the lack of evidence demonstrating an impact on improved health outcomes.
Coverage
Administration of RSV Prophylaxis
No additional statements.
Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.
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Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.
Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement.
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Acknowledgements:
CPT® codes copyright American Medical Association® 2022. All rights reserved.
CDT codes copyright American Dental Association® 2022. All rights reserved.