Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Immune Prophylaxis for Respiratory Syncytial Virus (RSV)

Policy #:08.00.22m

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin 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 Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

Immune prophylaxis using palivizumab (Synagis®) is considered medically necessary and, therefore, covered for a maximum of five doses in an annual respiratory syncytial virus (RSV) season for the prevention of serious lower respiratory tract infection caused by RSV in the following high-risk individuals, when the criteria for the indications listed below are met:
  • Chronic lung disease (CLD) of prematurity
    • Infants and children younger than 24 months of age with chronic lung disease (CLD) of prematurity who were born at a gestational age of less than 32 weeks, 0 days and required more than 21% oxygen for at least the first 28 days after birth:
      • During the first year of life
      • During the second year of life for individuals who require medical therapy for CLD within the six months before the start of the RSV season. (Medical therapy includes any of the following: a requirement for supplemental oxygen, or use of bronchodilators, diuretics, or corticosteroids)
  • Congenital abnormalities of the airway or certain neuromuscular diseases
    • Infants and children 12 months of age or younger at the start of the RSV season with either of the following indications:
      • Congenital abnormalities of the airway
      • Neuromuscular disease that compromises mobilization of respiratory secretions
  • Congenital heart disease (CHD)
    • Infants and children with congenital heart disease (CHD) younger than 12 months of age at the start of the RSV season who meet any of the following criteria:
      • Hemodynamically significant acyanotic CHD, when the individual is receiving medication to control congestive heart failure and will require cardiac surgical procedures
      • Hemodynamically significant cyanotic CHD, after consultation with a pediatric cardiologist
      • Diagnosis of moderate-to-severe pulmonary hypertension
  • Cystic fibrosis with nutritional compromise and/or chronic lung disease (CLD)
    • Infants and children younger than 24 months of age with cystic fibrosis who have nutritional compromise and/or manifestations of severe lung disease (previous hospitalizations for pulmonary exacerbation in the first year of life or abnormalities on chest radiography or chest computed tomography that persists when stable)
  • Immunocompromised status
    • Infants and children younger than 24 months of age who are profoundly immunocompromised (eg, due to transplantation or chemotherapy) during the RSV season
  • Prematurity
    • Infants and children born before 29 weeks gestation (29 weeks, 0 days) who are younger than 12 months of age at the start of the RSV season

An additional postoperative dose of palivizumab (Synagis®) is considered medically necessary and, therefore, covered for infants or children younger than 24 months of age who are currently receiving palivizumab (Synagis®) when they are medically stable, meet the above criteria for immune prophylaxis, and have undergone one of the following procedures during the current RSV season:
  • Surgical procedures that use cardiopulmonary bypass
  • Cardiac transplantation

Medical necessity criteria for immune prophylaxis for RSV in at-risk infants and young children are subject to change based on updated recommendations as outlined in the AAP policy statement and Red Book®.

NOT MEDICALLY NECESSARY

If an infant or child receiving monthly prophylaxis with palivizumab (Synagis®) experiences a breakthrough RSV hospitalization, monthly prophylaxis with palivizumab (Synagis®) is not medically necessary, and therefore not covered, due to the low likelihood of a second RSV hospitalization in the same season.

EXPERIMENTAL/INVESTIGATIONAL

All other indications for palivizumab (Synagis®) are considered experimental/investigational and, therefore, not covered.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.
Guidelines

The Company-Contracted providers must obtain palivizumab (Synagis®) through the Medical Benefit Direct Ship Program vendor, whereby a contracted vendor ships the agent directly to the Company-Contracted provider. A Medical Benefit Direct Ship vendor ships palivizumab (Synagis®) to the Company-Contracted provider's office as medically appropriate. The vendor submits the authorized claim and is reimbursed directly for the product. The Company-Contracted providers will not receive reimbursement for the actual pharmaceutical.

Administration of palivizumab (Synagis®) is eligible for reimbursement when administered in the professional provider's office. Administration of palivizumab (Synagis®) in the home setting is only eligible for reimbursement for members who are receiving skilled nursing services by a home health care agency for a separate indication.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, palivizumab (Synagis®) is covered under the medical benefits of the Company’s products when the medical necessity criteria in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Palivizumab (Synagis®) was approved by the FDA on June 15, 1998, for the use of prophylaxis of serious respiratory tract disease caused by RSV in pediatric individuals at high risk.

DOSING AND ADMINISTRATION

According to the Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics (AAP), a maximum of five doses of palivizumab (Synagis®) is generally sufficient to provide immune prophylaxis for RSV during the high-risk period (the beginning of November through the beginning of March) in all geographic areas. (Note: Infants born during the RSV season will be eligible for less than five monthly doses of palivizumab [Synagis®]). It may be eligible earlier than November or later than March, depending on seasonal and regional trends. These trends are concurrently reviewed based on information from public health authorities such as the National Respiratory and Enteric Virus Surveillance System (NREVSS) that monitors temporal and geographic patterns associated with the detection of RSV, among other infectious diseases. Participating laboratories report virus detections, isolations, and electron microscopy results on a weekly basis. NREVSS data is integrated with the CDC to help define the RSV season.

In accordance with FDA-approved labeling, palivizumab (Synagis®) is administered intramuscularly in a dose of 15 mg/kg every 30 days during the RSV season.

Palivizumab (Synagis®) is eligible for administration in the home setting by a home health care agency for individuals who are receiving skilled nursing services for a separate indication.

Description

Each year in the United States, respiratory syncytial virus (RSV) causes hospitalizations in 2-3% of infants in the first 12 months of life. Although RSV infection is largely self-limiting, certain populations may be at an increased risk for complications.

Palivizumab (Synagis®) (MedImmune; Gaithersburg, MD) is a humanized monoclonal antibody that is produced by recombinant DNA technology. Palivizumab (Synagis®) was licensed in June 1998 by the Food and Drug Administration and "is indicated for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease.” In the absence of a specific definition of “high risk” by the US Food and Drug Administration, the American Academy of Pediatrics (AAP) has endeavored to provide pediatricians and other professional providers with more precise guidance for determining who is at increased risk since palivizumab was first licensed.

Palivizumab (Synagis®) is indicated for use in high-risk infants and children younger than 24 months of age with chronic lung disease (CLD) of prematurity, which is defined by the AAP as an individual with a gestational age less than 32 weeks, 0 days who required more than 21% oxygen for at least the first 28 days after birth.

Infants with neuromuscular disease or congenital anomaly that impairs the ability to clear secretions from the upper airway because of ineffective cough are known to be at risk for a prolonged hospitalization related to lower respiratory tract infection and, therefore, may be considered for prophylaxis with palivizumab (Synagis®) during the first year of life.

Among the patient-specific parameters, the American Academy of Pediatrics (AAP) recommends the prophylactic use of palivizumab (Synagis®) in selected individuals under 12 months of age who are born within 12 months of onset of the RSV season and have hemodynamically significant CHD. The recommendation suggests that prophylactic use of palivizumab (Synagis®) should be administered for the following conditions:
  • Acyanotic CHD in individuals who are receiving medication to control congestive heart failure and will require cardiac surgical procedures
  • Moderate-to-severe pulmonary hypertension
  • Cyanotic CHD, after consultation with a pediatric cardiologist

The AAP also recommends a postoperative dose of palivizumab (Synagis®) for infants or children younger than 24 months who are currently receiving palivizumab (Synagis®) and have undergone cardiac transplantation or a surgical procedure that use cardiopulmonary bypass. This recommendation is based on evidence suggesting that there is a significant intraoperative loss of serum palivizumab (Synagis®) levels.

The following groups of infants with CHD are not at increased risk of RSV infection and generally should not receive 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 for the condition
  • Children in the second year of life

The AAP has stated that routine use of palivizumab (Synagis®) prophylaxis in patients with cystic fibrosis, including neonates diagnosed with cystic fibrosis by newborn screening, is not recommended unless other indications are present.

Palivizumab (Synagis®) prophylaxis has not been evaluated in randomized trials in the immunosuppressed population; however, the AAP suggests that children with severe immunodeficiencies may benefit from immune prophylaxis.

Lastly, the AAP recommends prophylaxis with palivizumab (Synagis®) for those born prematurely at less than 29 weeks gestational age.

There is limited data to suggest a slight increase in RSV hospitalization rates among children with Down syndrome. However, data are insufficient to justify a recommendation for routine use of prophylaxis with palivizumab (Synagis®) in children with Down syndrome unless qualifying heart disease, CLD, airway clearance issues, or prematurity (<29 weeks, 0 days gestation) is present.

Hospitalization rates attributable to RSV decrease during the second RSV season for all children. A second season of palivizumab prophylaxis is recommended only for preterm infants born at <32 weeks, 0 days gestation who required at least 28 days of oxygen after birth and who continue to require supplemental oxygen, chronic systemic corticosteroid therapy, or bronchodilator therapy within 6 months of the start of the second RSV season.

If any infant or young child receiving monthly palivizumab prophylaxis experiences a breakthrough RSV hospitalization, monthly prophylaxis should be discontinued because of the extremely low likelihood of a second RSV hospitalization in the same season (<0.5%).

RSV SEASON AND IMMUNE PROPHYLAXIS

According to peer-reviewed literature, 5 monthly doses of palivizumab at 15 mg/kg per dose will provide more than 6 months (>24 weeks) of serum palivizumab concentrations above the desired level for most children; therefore, administration of more than 5 monthly doses is not recommended within the continental United States. For qualifying infants who require 5 doses, a dose beginning in November and continuation for a total of 5 monthly doses will provide protection for most infants through April and is recommended for most areas of the United States. If prophylaxis is initiated in October, the fifth and final dose should be administered in February, which will provide protection for most infants through March. If prophylaxis is initiated in December, the fifth and final dose should be administered in April, which will provide protection for most infants through May.

Sporadic RSV infections occur throughout the year in most geographic locations. During times of low RSV prevalence (regardless of proportion of positive results), prophylaxis with palivizumab provides the least benefit because of the large number of children who must receive prophylaxis to prevent one RSV hospitalization.

Prophylaxis is not recommended for primary asthma prevention or to reduce subsequent episodes of wheezing.
  • Palivizumab prophylaxis is not recommended for prevention of health care-associated RSV disease.

References


Actelion Pharmaceuticals. Pulmonary arterial hypertension (PAH). How is PAH diagnosed? [PAH-info Web site]. 08/2013. Available at: http://www.pah-info.com/How_is_PAH_diagnosed. Accessed July 27, 2016.

American Academy of Pediatrics. Committee on Infectious Diseases and Bronchiolitis Guidelines Committee. Technical Report: Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. Volume 134, Number 2, August 2014. Available at: http://pediatrics.aappublications.org/content/early/2014/07/23/peds.2014-1666.full.pdf+html . Accessed July 27, 2016.

American Academy of Pediatrics. Committee on Infectious Diseases and Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. Volume 134, Number 2, August 2014. Available at: http://pediatrics.aappublications.org/content/early/2014/07/23/peds.2014-1665.full.pdf+html . Accessed July 27, 2016.

American Academy of Pediatrics (AAP) Subcommittee on Diagnosis and Management of Bronchiolitis. Clinical practice guideline: Diagnosis and management of bronchiolitis. Pediatrics. 2006;118(4):1774-1793. Available at: http://pediatrics.aappublications.org/content/118/4/1774 . Accessed July 27, 2016.

American Hospital Formulary Service (AHFS). Drug Info 2016. palivizumab (Synagis). [Lexicomp Online Web site]. updated 06/2006. Available at: http://online.lexi.com/lco/action/doc/retrieve/docid/complete_ashp/414207 [via subscription only]. Accessed July 27, 2016.

Berger J. Pulmonary hypertension in congenital heart disease. [Medscape Web site]. 02/13/07. Available at: http://cme.medscape.com/viewarticle/551739 [via subscription only]. Accessed July 27, 2016.

Carbonell-Estrany X, Simoes EAF, Dagan R, et al. Motaizumab for prophylaxis of respiratory syncytial virus in high-risk children: a noninferiority trial. [AAP Web site]. Pediatrics.2010;125(1):e35-e51.

Centers for Disease Control and Prevention (CDC). The National Respiratory and Enteric Virus Surveillance System (NREVSS). Respiratory syncytial virus (RSV) surveillance. [CDC Web site]. Available at: http://www.cdc.gov/surveillance/nrevss/rsv/index.html . Accessed July 27, 2016.

Centers for Disease Control and Prevention. Respiratory syncytial virus infection (RSV). Prophylaxis and High-Risk Groups. updated 04/20/2015. Available at: http://www.cdc.gov/rsv/clinical/index.html. Accessed July 27, 2016.

Elsevier’s Gold Standard Clinical Pharmacology Compendium. palivizumab (Synagis). 03/19/15. [Clinical Key Web site]. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed July 27, 2016.

Lexi-Drugs Compendium. palivizumab (Synagis). 05/26/16. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed July 27, 2016.

Meissner HC, Anderson LJ, Pickering LK. Annual variation in respiratory syncytial virus season and decisions regarding immunoprophylaxis with palivizumab. Pediatrics.2004;114(4):1082-1084.

Nauser TD, Stites SW. Diagnosis and treatment of pulmonary hypertension. Am Fam Physician. 2001;63(9):1789-1798. Also available on the American Academy of Family Physicians Web site at: http://www.aafp.org/afp/20010501/1789.html. Accessed July 27, 2016.

Palivizumab (Synagis®) [prescribing information]. Gaithersburg, MD: MedImmune, Inc; updated 03/2014. Available at: https://www.synagis.com/. Accessed July 27, 2016.

Truven Health Analytics. Micromedex Healthcare Series. DrugDex®. palivizumab (Synagis). [Micromedex® 2.0 Web site]. 09/08/15. Available at:
http://www.micromedexsolutions.com/micromedex2/librarian/CS/BCB035/ND_PR/evidencexpert/ND_P/evidencexpert/DUPLICATIONSHIELDSYNC/A36FE9/ND_PG/evidencexpert/ND_B/evidencexpert/ND_AppProduct/evidencexpert/ND_T/evidencexpert/PFActionId/evidencexpert.GoToDashboard?docId=924765&contentSetId=100&title=Palivizumab&servicesTitle=Palivizumab&brandName=Synagis# [via subscription only]. Accessed July 27, 2016.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Synagis® (Palivizumab). [Product labeling]. [FDA Web site]. 03/21/14. Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103770s5185lbl.pdf . Accessed July 27, 2016.

US Food and Drug Administration (FDA). Department of Health and Human Services. Synagis® (Palivizumab). Product approval letter. [FDA Web site]. 03/21/14. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103770Orig1s5185ltr.pdf . Accessed July 27, 2016.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

90378


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

Z29.11 Encounter for prophylactic immunotherapy for respiratory syncytial virus (RSV)


HCPCS Level II Code Number(s)

S9562 Home injectable therapy, palivizumab, including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 08.00.22m
08/15/2018This policy has been reissued in accordance with the Company's annual review process.


Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date: 10/01/2016
Version Issued Date: 09/30/2016
Version Reissued Date: 08/16/2018

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.