HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
I-20-029
Topic:
Immune Prophylaxis for Respiratory Syncytial Virus (RSV)
Section:
Injections
Effective Date:
February 5, 2024
Issued Date:
February 5, 2024
Last Revision Date:
December 2023
Annual Review:
December 2023
 
 

Palivizumab (Synagis®)is a humanized monoclonal antibody produced by recombinant DNA technology directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV).

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.

Policy Position

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 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 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: Prophylaxis is not recommended in the second year of life on the basis of a history of prematurity alone. Prophylaxis may be considered medically necessary during the RSV season during the second year of life only for infants who meet the definition of chronic lung disease prematurity and continue to require medical support (chronic corticosteroid therapy, diuretic therapy or supplemental oxygen). 

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) not meeting the criteria as indicated in this policy is considered not medically necessary.

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.

The use of palivizumab (Synagis) not meeting the criteria as indicated in this policy is considered not medically necessary.

90378

 

 

 

 

 

 


NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Related Policies

 

 


Professional Statements and Societal Positions Guidelines

American Academy of Pediatrics 2021; 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, 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 5 monthly doses will be needed.
  • Prophylaxis is not recommended for otherwise healthy infants born at 29 weeks, 0 days’ gestation or later. Infants 29 weeks, 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 <32 weeks, 0 days and a requirement for >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 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 <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.
  • Because 5 monthly doses of palivizumab will provide more than 6 months (>24 weeks) of serum palivizumab concentrations above the desired level for most children, 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.
  • 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, 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 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 6 months.


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

D89.43

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


Place of Service: Outpatient

Immune Prophylaxis for RSV is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.




Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
    • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.