Immune Prophylaxis for Respiratory Syncytial Virus (RSV) (ARCHIVED)

Policy ID: I-20-030

Section: Injections

Effective Date: July 01, 2018

Revised Date: October 16, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-20-030

Section: Injections

Effective Date: July 01, 2018

Revised Date: October 16, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

RSV causes acute upper respiratory tract infection in individuals of all ages and is one of the most common diseases of childhood. Most RSV-infected infants experience upper respiratory tract symptoms, and 20% to 30% develop lower respiratory tract disease with their first infection.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Immune prophylaxis with palivizumab (Synagis) for a maximum of five (5) doses within the local RSV season may be considered medically necessary for passive immunoprophylaxis against RSV when ANY the following criteria are met:

Infants with preterm birth less than 29 weeks zero (0) days gestation less than or equal to 12 months of age at the start of the RSV season; or
Certain infants less than or equal to 12 months of age, born at less than 32 weeks zero (0) days with chronic lung disease (CLD) defined as a greater than 21% oxygen requirement for at least the first 28 days after birth; or
Children younger than 12 months of age with hemodynamically significant acyanotic congenital heart disease who are most likely to benefit from immunoprophylaxis which include:
- Infants who are receiving medication to control congestive heart failure and will require cardiac surgical procedures; or
- Infants with moderate to severe pulmonary hypertension; or
- Infants with cyanotic heart disease in consultation with a pediatric cardiologist; or
Children less than or equal to 12 months of age born with congenital abnormalities of the airway or a neuromuscular condition that compromises handling of respiratory secretions; or
Children younger than 24 months of age who are profoundly immunocompromised during the RSV season; or
Children younger than 24 months of age who are undergoing cardiac transplantation; or
An infant with cystic fibrosis with clinical evidence of CLD or nutritional compromise in the first year of life; the continued use of palivizumab (Synagis) prophylaxis in the second year of life may be considered medically necessary for infants with cystic fibrosis for EITHER of the following:
- With symptoms of severe lung disease (e.g., previous hospitalization for pulmonary exacerbation in the first year of life or an abnormal chest radiograph, computed tomography scan that persist when stable); or
- Weight or length less than the 10th percentile.

NOTE:

NOTE: An additional dose of palivizumab (Synagis) may be considered medically necessary for children in approved course of treatment who undergo cardiopulmonary bypass (as soon as possible after surgery even if next dose is not due based upon standard schedule) if any other medically necessary criteria are present (for example, prematurity).

The use of palivizumab (Synagis) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

90378

The following groups of infants are not at increased risk of RSV and palivizumab (Synagis) is not considered medically necessary:

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); and
Infants with lesions adequately corrected by surgery, unless they continue to require medication for congestive heart failure; and
Infants with mild cardiomyopathy who are not receiving medical therapy for the condition; and
Children in second year of life who do not otherwise meet criteria above; and
Primary asthma or asthma prevention to reduce subsequent episodes of wheezing; and
Continued RSV prophylaxis children who experience breakthrough RSV hospitalization; and
For treatment in children or infants with known RSV disease; and
For all other indications not otherwise addressed as medically necessary, including, but not limited to, individuals with cystic fibrosis or Down syndrome who do not otherwise meet criteria above.

Procedure Code

90378

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

Primary Diagnosis code that must be billed with at least one of the Secondary Diagnosis Codes listed below: Z29.11

Secondary Diagnosis codes:

The following list of diagnosis codes is provided for reference purposes. Listing of a code does not imply that the code is covered without additional criteria being met as specified in policy language above. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.

D72.810

D80.0

D80.1

D80.2

D80.3

D80.4

D80.5

D80.6

D80.7

D80.8

D80.9

D81.0

D81.1

D81.2

D81.89

D81.9

D83.0

D83.2

D83.8

D83.9

D84.81

D84.822

D84.89

D84.9

D86.0

D86.1

D86.2

D86.3

D86.81

D86.82

D86.83

D86.84

D86.85

D86.86

D86.87

D86.89

D86.9

D89.0

D89.1

D89.2

D89.3

D89.40

D89.41

D89.42

D59.43

D89.49

D89.810

D89.811

D89.812

D89.813

D89.82

D89.89

D89.9

E84.0

E84.11

E84.19

E84.8

E84.9

I27.0

I27.1

I27.20

I27.21

I27.22

I27.23

I27.24

I27.29

I27.81

I27.82

I27.83

I27.89

I27.9

I42.9

I50.20

I50.21

I50.22

I50.23

I50.30

I50.31

I50.32

I50.33

I50.40

I50.41

I50.42

I50.43

I50.810

I50.811

I50.812

I50.813

I50.814

I50.82

I50.83

I50.84

I50.89

I50.9

P07.21

P07.22

P07.23

P07.24

P07.25

P07.26

P07.31

P07.32

P07.33

P07.34

P07.35

P07.36

P07.37

P07.38

P27.0

P27.1

P27.8

P27.9

Q20.0

Q20.1

Q20.2

Q20.3

Q20.4

Q20.5

Q20.6

Q20.8

Q20.9

Q21.0

Q21.10

Q21.11

Q21.12

Q21.13

Q21.14

Q21.15

Q21.16

Q21.19

Q21.20

Q21.21

Q21.22

Q21.23

Q21.3

Q21.4

Q21.8

Q21.9

Q22.0

Q22.1

Q22.2

Q22.3

Q22.4

Q22.5

Q22.6

Q22.8

Q22.9

Q23.0

Q23.1

Q23.2

Q23.3

Q23.4

Q23.8

Q23.9

Q24.0

Q24.1

Q24.2

Q24.3

Q24.4

Q24.5

Q24.6

Q24.8

Q24.9

Q25.0

Q25.1

Q25.21

Q25.29

Q25.3

Q25.40

Q25.41

Q25.42

Q25.43

Q25.44

Q25.45

Q25.46

Q25.47

Q25.48

Q25.49

Q25.5

Q25.6

Q25.71

Q25.72

Q25.79

Q25.8

Q25.9

Q26.0

Q26.1

Q26.2

Q26.3

Q26.4

Q26.5

Q26.6

Q26.8

Q26.9

Q32.1

Q33.0

Q33.2

Q33.3

Q33.4

Q33.6

Q33.9

Q34.9

Z48.21

Z94.0

Z94.1

Z94.2

Z94.3

Z94.4

Z94.81

Z94.84

Professional Statements and Societal Positions Guidelines

American Academy of Pediatrics2021; Red Book 2021-2014 Report of the Committee on Infectious Diseases 32 edition.

The American Academy of Pediatrics published updated guidelines on palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Relevant recommendations include:

Palivizumab prophylaxis may be administered to infants born before 29 weeks, zero (0) days' gestation who are younger than 12 months at the start of the RSV season. For infants born during the RSV season, fewer than five (5) monthly doses will be needed.
Prophylaxis is not recommended for otherwise healthy infants born at 29 weeks, zero (0) days' gestation or later. Infants 29 weeks, zero (0) days' gestation or later may qualify to receive prophylaxis on the basis of congenital heart disease (CHD), chronic lung disease (CLD), or another condition.
Palivizumab prophylaxis is not recommended in the second year of life on the basis of a history of prematurity alone.
Prophylaxis may be considered during the RSV season during the first year of life for preterm infants who develop CLD of prematurity defined as gestational age less than 32 weeks, zero (0) days and a requirement for greater than 21% oxygen for at least the first 28 days after birth.
During the second year of life, consideration of palivizumab prophylaxis is recommended only for infants who satisfy this definition of CLD of prematurity and continue to require medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) during the six (6)-month period before the start of the second RSV season.
For infants with CLD who do not continue to require medical support in the second year of life prophylaxis is not recommended.
Children with hemodynamically significant CHD who are most likely to benefit from immunoprophylaxis include infants with acyanotic heart disease who are receiving medication to control congestive heart failure and will require cardiac surgical procedures and infants with moderate to severe pulmonary hypertension.
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 less than 32 weeks, zero (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 six (6) months of the start of the second RSV season.
Because 5 monthly doses of palivizumab will provide more than six (6) months (greater than 24 weeks) of serum palivizumab concentrations above the desired level for most children, administration of more than five (5) monthly doses is not recommended within the continental United States. For qualifying infants who require five (5) doses, a dose beginning in November and continuation for a total of five (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.
Qualifying infants born during the RSV season may require fewer doses. For example, infants born in January would receive their last dose in March.
Hospitalized infants who qualify for prophylaxis during the RSV season should receive the first dose of palivizumab 48 to 72 hours before discharge or promptly after discharge. If an infant or child who is receiving palivizumab immunoprophylaxis experiences a breakthrough RSV infection, monthly prophylaxis should be discontinued because of the extremely low likelihood of a second RSV hospitalization in the same season.
On the basis of the epidemiology of RSV in Alaska, particularly in remote regions where the burden of RSV disease is significantly greater than the general US population, the selection of Alaska Native infants eligible for prophylaxis may differ from the remainder of the United States. Clinicians may wish to use RSV surveillance data generated by the state of Alaska to assist in determining onset and end of the RSV season for qualifying infants. Limited information is available concerning the burden of RSV disease among American Indian populations. However, special consideration may be prudent for Navajo and White Mountain Apache infants in the first year.
Limited data 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 in children with Down syndrome unless qualifying heart disease, CLD, airway clearance issues, or prematurity (29 weeks, zero (0) days' gestation).
With the shift in seasonality noted in 2021 and the current regional variability in interseason RSV cases, the AAP continues to support the use of palivizumab in eligible infants in any region experiencing rates of RSV activity at any time in 2022 similar to a typical fall-winter season. The AAP recommends initiating the standard administration of palivizumab, which consists of five (5) consecutive monthly doses. This regimen provides serum levels associated with protection for six (6) months, the length of a typical RSV season. The AAP will continue to monitor the interseasonal trends and update this guidance as needed if the RSV season extends longer than six (6) months.

ND Committee Review

Internal Medical Policy Committee 7-16-2019

Revised Criteria, and
Added information to Professional Statements and Societal Positions Guidelines

Internal Medical Policy Committee 7-22-2020 Annual review, no clinical content changes

Internal Medical Policy Committee 9-21-2020 No clinical content change, and

Updated Diagnosis codes

Internal Medical Policy Committee 3-17-2021 No clinical content change, and

Updated D iagnosis codes

Internal Medical Policy Committee 9-21-2021

Removed (typically November through April) and
Added local RSV season

Internal Medical Policy Committee 9-28-2022 - Effective October 01, 2022

Removed Diagnosis codes Q21.1 and Q21.2 and
Added 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

Internal Medical Policy Committee 1-26-2023 Effective March 01, 2023

Added ' acyanotic' to 'Children younger than 12 months of age with hemodynamically significant acyanotic congenital heart disease who are most likely to benefit from immunoprophylaxis which include:
Added 'in consultation with a pediatric cardiologist' to 'Infants with cyanotic heart disease in consultation with a pediatric cardiologist
Updated experimental/investigational statement
Added 'and palivizumab (Synagis) is not considered medically necessary' to The following groups of infants are not at increased risk of RSV and palivizumab (Synagis) is not considered medically necessary:
Added bullet point to Professional Statements and Societal Positions: 'With the shift in seasonality noted in 2021 and the current regional variability in interseason RSV cases, the AAP continues to support the use of palivizumab in eligible infants in any region experiencing rates of RSV activity at any time in 2022 similar to a typical fall-winter season. The AAP recommends initiating the standard administration of palivizumab, which consists of 5 consecutive monthly doses. This regimen provides serum levels associated with protection for 6 months, the length of a typical RSV season. The AAP will continue to monitor the interseasonal trends and update this guidance as needed if the RSV season extends longer than six (6) months'
Added additional statement under the Diagnosis codes: 'Primary Diagnosis code that must be billed with at least one of the Secondary Diagnosis Codes listed below: Z29.11; Secondary Diagnosis codes:; The following list of diagnosis codes is provided for reference purposes. Listing of a code does not imply that the code is covered without additional criteria being met as specified in policy language above. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply'

Internal Medical Policy Committee 1-16-2024 Effective March 01, 2024

Annual review no clinical content change

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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