Respiratory Syncytial Virus (RSV) Prevention

POLICY NUMBER

L.5.01.468

Synagis (palivizumab)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Respiratory syncytial virus (RSV) is a virus that mainly affects the respiratory tract of children. This virus is most likely to infect children in the winter months. Some children are more at risk for getting this infection than others. For example, children who are born prematurely may be at higher risk for getting an infection with this virus during their first year of life. Another high risk group includes patients with chronic lung disease (CLD).

Synagis (palivizumab) is a monoclonal antibody developed to protect high risk infants against the worst effects of RSV, the most common cause of lower respiratory infections such as bronchitis and pneumonia in infancy and early childhood. Synagis (palivizumab) is a genetically engineered antibody against the RSV virus. Beyfortus (nirsevimab) is a long-acting monoclonal antibody product approved by the FDA in 2023 and is preferred over palivizumab for the prevention of RSV due to its efficacy, duration, and convenience. If nirsevimab is not available or not feasible to administer, high-risk infants who are recommended to receive palivizumab in the first or second year of life should receive palivizumab until nirsevimab becomes available. High-risk infants whose pregnant parent received a recommended RSV vaccine ≥14 days prior to delivery do not require palivizumab, except in rare circumstances when, based on the clinical judgment of the health care provider, the potential incremental benefit of administration is warranted.

Synagis (palivizumab) is indicated for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients:

• with a history of premature birth (<35 weeks gestational age) and who are 6 months of age or younger at the beginning of RSV season;

• with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season; and

• with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of RSV season.

Please note, Beyfortus (nirsevimab) is available without prior authorization.

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. 

Synagis (palivizumab) may be considered medicallynecessary when ALL of the following criteria are met:

1. ONE of the following:

   1. The individual is <12 months of age on November 1 and ONE of the following:

      1. The individual was born before 29 weeks, 0 days’ gestation;

      2. The individual has hemodynamically significant congenital heart disease (CHD);

      3. The individual has CLD of prematurity defined as both of the following:

         1. Gestational age <32 weeks, 0 days’ gestation; AND

         2. Requirement of >21% oxygen for at least 28 days after birth; OR

      4. The individual has a pulmonary abnormality or neuromuscular disease that impairs the ability to clear secretions from the upper airways; OR

   2. The individual is <24 months of age on November 1 and ONE of the following:

      1. The individual has CLD of prematurity and ALL of the following:

         1. Gestational age <32 weeks, 0 days’ gestation;

         2. Requirement of >21% oxygen for at least 28 days after birth; AND

         3. The individual continues to require medical support (i.e., chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) during the 6-month period before the start of the second RSV season; OR

      2. The individual is profoundly immunocompromised (i.e. recipient of solid organ transplant, chemotherapy, etc.) during the RSV season;

2. Documentation has been provided that Beyfortus (nirsevimab-alip) is not available or not feasible to administer; AND

3. The individual has not previously received treatment with Beyfortus (nirsevimab-alip) during or entering the current RSV season.

 Length of Approval: Maximum of 5 doses/season (For infants born during the RSV season, fewer than 5 monthly doses will be needed) 

Synagis (palivizumab) is considered not medically necessary for the following indications:

1. Children who receive monthly IVIG;

2. 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);

3. Infants with lesions adequately corrected with surgery, unless they continue to require medication for congestive heart failure;

4. Infants with mild cardiomyopathy who are not receiving medication therapy for the condition; AND

5. Treatment of RSV infection.

Services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary. BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

8/1998: RSV policy approved by Medical Policy Advisory Committee (MPAC).

11/1998: Synagis® criteria approved by MPAC; policy merged with RSV and renamed.

2/2/2001: Entire "Policy Section" revised.

10/26/2001: Infants <28 weeks of gestation up to 12 months of age "at the start of RSV season" added.

1/30/2002: Above statement added to Infants 29-32 weeks and 32-35 weeks.

2/14/2002: Investigational definition added.

5/2/2002: Type of Service and Place of Service deleted.

5/28/2002: Code Reference section updated, CPT 86756 added.

11/6/2002: Nova Factor new telephone and fax numbers added. Telephone # 1-800-235-8498 and fax # 1-888-355-6652 deleted.

9/17/2004: Code Reference section updated, CPT 86756, 90780, 90781, 90782 deleted, ICD-9 diagnosis code 460.0 invalid and deleted, ICD-9 diagnosis code range 460-466.0, 478.8-480.0, 493.0-493.1, 765.00-765.19, 770.0-770.9 listed separately, ICD-9 diagnosis code range 493.0-493.1 5th digit added, HCPCS J1565 description revised, HCPCS S9562 added.

9/30/2004: Code Reference section updated, ICD-9 diagnosis code 745.10, 745.11, 745.2, 745.4, 745.5, 745.60, 745.61, 745.69, 745.8, 746.02, 746.2, 746.7, 746.81, 746.83, 747.0, 747.10, 747.3, 747.49 added covered codes.

10/28/2005: Description section updated. FDA approved indications revised. Policy section updated: changed preferred provider to Accredo, changed telephone # from 1-866-591-9075 to 1-866-240-3373, changed fax # from 1-866-591-9094 to 1-877-369-3447. Sources updated; American Academy of Pediatrics Web Site, Synagis® and RespiGam® added.

11/4/2005: Code Reference section updated, ICD9 diagnosis codes 491.00-491.02, 491.20-491.22, 491.9, 493.20-493.22, 496, 765.20-765.27, V46.2 added; ICD9 procedure code 99.29 added.

11/2005: Approved by Pharmacy & Therapeutics (P&T) Committee.

2/7/2006: Code Reference table updated: The notes under CPT codes 90378 and 90379 and HCPCS code J1565 were updated to include the new intramuscular and IV infusion administration codes (90772, 90765-90766); ICD9 diagnosis codes 079.6, 079.89, 460.0-466.0, 466.11, 478.8-478.9, 480.0-480.9, 487.1, 519.8, 769, 770.0-770.9, 786.9 deleted, V58.65 added.

8/22/2006: Respigam deleted from policy due to discontinuation of medication.

11/14/2006: Code Reference section updated: ICD-9 code V04.82 added.

1/12/2006: Code reference section updated. ICD-9 codes 491.00, 491.01, and 491.02 deleted. ICD-9 codes 491.0 and 491.1 added.

01/01/2009: Accredo preferred provider information removed. BCBSMS information added.

8/17/2009: Policy updated: off label uses deleted. Policy statement section updated: deleted RSV season changed from September-March to October-February. Maximum of 5 doses/season added to infant age specifications. Infant age specifications revised.

12/15/2009: Coding Section revised with 2010 CPT4 and HCPCS revisions.

08/21/2013: Policy revised to change the RSV season from October - February to October 31 - March 31. Deleted procedure codes J1565 and 90379 from the Code Reference section.

08/28/2015: Code Reference section updated for ICD-10.

05/31/2016: Policy number L.5.01.468 added. Policy Guidelines updated to add medically necessary and investigative definitions.

08/09/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.

09/30/2016: Code Reference section updated to add new ICD-10 diagnosis code Z29.11.

08/15/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

07/01/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding FDA approved indications. Last policy statement updated to make the following correction: "IGIV" should be "IVIG." Sources updated.

10/01/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added statement to perform a formulary drug search on the patient's member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this policy may not be covered under a specific member's benefit plan. Policy description updated regarding indications for Synagis (palivizumab). Policy section updated to add that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Policy statement revised to state that Synagis (palivizumab) is considered medically necessary only during RSV season for patients who are 2 years of age and younger at the start of RSV season AND who meet the listed indications. Medically necessary criteria revised to change "2 years" to "24 months" and to add the following indications: hemodynamically significant congenital heart disease, bronchopulmonary dysplasia, and infants less than 6 months of age. Added treatment of RSV infection as a not medically necessary indication. Policy Exceptions updated to add State Health Plan and FEP. Sources updated.

02/18/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Medically necessary policy statement criteria revised. For length of approval, added statement that for infants born during the RSV season, fewer than 5 monthly doses will be needed. Not medically necessary policy statement updated to add additional criteria. Added statement that services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary. FEP removed from Policy Exceptions. Policy Guidelines updated regarding BCBSMS request for medical records. Sources updated.

12/21/2021: Code Reference section updated to revise code description for ICD-10 procedure code 3E0230M.

09/30/2022: Code Reference section updated to add new ICD-10 diagnosis codes Q21.10, Q21.11, Q21.12, Q21.13, Q21.14, Q21.15, Q21.16, Q21.19, Q21.20, Q21.21, Q21.22, and Q21.23, effective 10/01/2022.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

03/31/2023: Code Reference section updated to revise the code description for HCPCS code S9562, effective 04/01/2023.

07/01/2023: Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants.

07/01/2025: Effective 09/01/2025 - Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding Beyfortus (nirsevimab). Policy statement updated to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Medically necessary criteria revised regarding children <24 months of age on November 1. Added criteria regarding Beyfortus (nirsevimab-alip). Removed "severely immunocompromised infants" from the not medically necessary indications. Sources updated. Code Reference section updated to remove deleted ICD-10 diagnosis codes Q21.1 and Q21.2. Policy update effective 09/01/2025.

SOURCE(S)

1. American Academy of Pediatrics. AAP Recommendations for the Prevention of RSV Disease in Infants and Children. February 2024. Last accessed April 2025. https://publications.aap.org/redbook/resources/25379/AAP-Recommendations-for-the-Prevention-of-RSV

2. Beyfortus prescribing information. Sanofi Pasteur Inc. August 2024. Last accessed April 2025.

3. COMMITTEE ON INFECTIOUS DISEASES AND BRONCHIOLITIS GUIDELINES COMMITTEE, Michael T. Brady, Carrie L. Byington, H. Dele Davies, Kathryn M. Edwards, Mary Anne Jackson, Yvonne A. Maldonado, Dennis L. Murray, Walter A. Orenstein, Mobeen H. Rathore, Mark H. Sawyer, Gordon E. Schutze, Rodney E. Willoughby, Theoklis E. Zaoutis, Shawn L. Ralston, Allan S. Lieberthal, H. Cody Meissner, Brian K. Alverson, Jill E. Baley, Anne M. Gadomski, David W. Johnson, Michael J. Light, Nizar F. Maraqa, Eneida A. Mendonca, Kieran J. Phelan, Joseph J. Zorc, Danette Stanko-Lopp, Sinsi Hernández-Cancio; Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection. Pediatrics August 2014; 134 (2): 415–420. 10.1542/peds.2014-1665.

4. Mary T. Caserta, Sean T. O’Leary, Flor M. Munoz, Shawn L. Ralston, COMMITTEE ON INFECTIOUS DISEASES; Palivizumab Prophylaxis in Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection. Pediatrics July 2023; 152 (1): e2023061803. 10.1542/peds.2023-061803.

5. Synagis prescribing information. Swedish Orphan Biovitrum AB (publ). November 2021. Last accessed May 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.