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Date Printed: October 23, 2017: 07:25 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J0000-28

Original Effective Date: 07/15/01

Reviewed: 05/10/17

Revised: 06/15/17

Subject: Palivizumab (Synagis®)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           

Dosage/ Administration

Position Statement

Billing/Coding

Reimbursement

Program Exceptions

Definitions

           

Related Guidelines

Other

References

Updates

 

Previous Version

           

DESCRIPTION:

Respiratory syncytial virus (RSV) is a viral respiratory infection characterized by an upper respiratory prodrome, increased respiratory effort, and wheezing in children less than two years of age. Several different types of laboratory tests are available for diagnosis of RSV infection. Many clinical laboratories currently use antigen detection tests or molecular diagnostic testing, such as reverse transcriptase-polymerase chain reaction (RT-PCR).

The incidence of RSV infection typically follows a seasonal pattern with most of the United States affected between November and March, with considerable regional and local variability. The duration of the RSV season remains five consecutive months for all geographic areas in the United States. Recent regional trends in the United States can be found at the Centers for Disease Control and Prevention (CDC) National Respiratory and Enteric Virus Surveillance System.

Palivizumab (Synagis) was approved by the U.S. Food and Drug Administration (FDA) June 1998 for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease. Conditions that increase the risk of severe RSV disease in young children include preterm birth, chronic lung disease of prematurity, and hemodynamically significant heart disease. Palivizumab exhibits neutralizing and fusion-inhibitory activity against RSV to interfere with the ability of RSV to replicate and infect cells.

The American Academy of Pediatrics (AAP) has provided guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for RSV infection. In 2014, the AAP updated their recommendations based on new data about which children are at highest risk of RSV hospitalization. Currently, the AAP recommends that palivizumab prophylaxis be limited to infants born before 29 weeks gestation and to infants with certain chronic illnesses (e.g., congenital heart disease, chronic lung disease).

POSITION STATEMENT:

 

Certificate of Medical Necessity

Submit a completed Certificate of Medical Necessity (CMN) along with your request for Palivizumab (Synagis®) to expedite the medical review process.

1. Click the link Palivizumab (Synagis®) - Certificate of Medical Necessity (MS Word) to open the form.

2. Complete all fields on the form thoroughly.

3. Print and submit a copy of the form with your request.

Note: Florida Blue regularly updates CMNs. Ensure you are using the most current copy of a CMN before submitting to Florida Blue. For a complete list of available CMNs, visit the Certificates of Medical Necessity page.

NOTE: Medical necessity criteria apply equally to all geographical locations in Florida and the United States. Because five (5) monthly doses of palivizumab (Synagis) will provide more than six (6) months of adequate serum concentrations for most infants, administration should be limited to peak respiratory syncytial virus (RSV) seasons in the continental United States.

Initiation of palivizumab (Synagis) meets the definition of medical necessity for prophylaxis of respiratory syncytial virus (RSV) during RSV season for members diagnosed with ANY of the following conditions when ALL associated criteria are met:

1. Prematurity

a. Member was born before 29 weeks, 0 days’ gestation

b. Member is younger than 12 months of age at the start of RSV season (see Other, Table 1)

c. Dose does not exceed 15 mg/kg/month

2. Chronic Lung Disease of Prematurity

a. Member was born before 32 weeks, 0 days’ gestation

b. Member required greater than 21% oxygen for the first 28 days after birth

c. Member is younger than 12 months of age at the start of RSV season (see Other, Table 1)

d. Dose does not exceed 15 mg/kg/month

3. Congenital Heart Disease

a. Member is 12 months of age or younger at the start of RSV season (see Other, Table 1)

b. Member’s congenital heart disease is hemodynamically significant

c. Member meets ANY of the following:

i. Member is diagnosed with acyanotic heart disease AND receives medication to control congestive heart failure AND will require (or previously required) cardiac surgical procedures

ii. Member is diagnosed with moderate to severe pulmonary hypertension

iii. Member is diagnosed with a cyanotic heart defect AND palivizumab prophylaxis is prescribed or supervised by a pediatric cardiologist

d. Dose does not exceed 15 mg/kg/month

4. Cardiac Transplantation

a. Member is younger than 2 years of age at the start of RSV season (see Other, Table 1)

b. Member underwent cardiac transplantation during the RSV season (see Other, Table 1)

c. Dose does not exceed 15 mg/kg/month

5. Anatomic Pulmonary Abnormality

a. Member is 12 months of age or younger at the start of RSV season (see Other, Table 1)

b. Member’s ability to clear secretions from the upper airway is impaired because of ineffective cough

c. Dose does not exceed 15 mg/kg/month

6. Neuromuscular Disorder

a. Member is 12 months of age or younger at the start of RSV season (see Other, Table 1)

b. Member’s ability to clear secretions from the upper airway is impaired because of ineffective cough

c. Dose does not exceed 15 mg/kg/month

7. Immunocompromised

a. Member is younger than 24 months of age at the start of RSV season (see Other, Table 1)

b. Member is profoundly immunocompromised (e.g., solid organ or hematopoietic stem cell transplantation, receiving chemotherapy, immunocompromised)

c. Dose does not exceed 15 mg/kg/month

8. Cystic Fibrosis

a. Member is 12 months of age or younger at the start of RSV season (see Other, Table 1)

b. Member meets either of the following:

iv. Member required greater than 21% oxygen for the first 28 days after birth

v. Member displays clinical evidence of nutritional compromise

c. Dose does not exceed 15 mg/kg/month

b. American Indian

a. Member is 12 months of age or younger at the start of RSV season (see Other, Table 1)

b. Member is a Navajo or White Mountain Apache American Indian

c. Dose does not exceed 15 mg/kg/month

Duration of approval: 5 consecutive months or until the end of RSV season (see Other, Table 1), whichever is sooner

Continuation of palivizumab (Synagis) meets the definition of medical necessity for prophylaxis of respiratory syncytial virus (RSV) during RSV season for members diagnosed with ANY of the following conditions when ALL associated criteria are met:

1. Chronic Lung Disease of Prematurity

a. Member was born before 32 weeks, 0 days’ gestation

b. Member required greater than 21% oxygen for the first 28 days after birth

c. Member is between 12 and 24 months of age at the start of RSV season (see Other, Table 1)

d. Member required medical support (i.e., chronic corticosteroid therapy, bronchodilator therapy, diuretic therapy, or supplemental oxygen) during the 6-month period before the start of the most recent RSV season (see Other, Table 1)

e. Dose does not exceed 15 mg/kg/month

2. Cystic Fibrosis

a. Member is between 12 and 24 months of age at the start of RSV season (see Other, Table 1)

b. Member meets either of the following:

i. Member has manifestations of severe lung disease (i.e., previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest radiography or chest computed tomography that persist when stable)

ii. Member’s weight for length is less than the 10th percentile

c. Dose does not exceed 15 mg/kg/month

Duration of approval: 5 consecutive months or until the end of RSV season (see Other, Table 1), whichever is sooner

A replacement dose of palivizumab (Synagis) meets the definition of medical necessity for prophylaxis of respiratory syncytial virus (RSV) during RSV season for members diagnosed with ANY of the following conditions when ALL associated criteria are met:

1. Cardiac Bypass

a. Member is younger than 24 months of age

b. Member is approved for palivizumab prophylaxis (initiation or continuation) by Florida Blue

c. Member is post-cardiac bypass

d. Member received at least one dose of palivizumab before undergoing cardiac bypass

e. Member has not received palivizumab since undergoing cardiac bypass

f. Member will continue to require palivizumab prophylaxis post-cardiac bypass

g. Dose does not exceed 15 mg/kg

2. Extracorporeal Membrane Oxygenation (ECMO)

a. Member is younger than 24 months of age

b. Member is approved for palivizumab prophylaxis (initiation or continuation) by Florida Blue

c. Member is post-ECMO

d. Member received at least one dose of palivizumab before undergoing ECMO

e. Member has not received palivizumab since undergoing ECMO

f. Member will continue to require palivizumab prophylaxis post-ECMO

g. Dose does not exceed 15 mg/kg

Duration of approval: 1 dose

Palivizumab (Synagis) is not considered a medical necessity for all other indications, including:

1. 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)

2. Infants with heart conditions adequately corrected by surgery that no longer require medication for congestive heart failure

3. Infants with mild cardiomyopathy who are not receiving medical therapy for the condition

4. Children with passive exposure to tobacco smoke unless they meet other criteria as documented in the position statement

5. Treatment of active RSV infection

6. Down syndrome unless qualifying heart disease, chronic lung disease, or prematurity

7. Controlling outbreaks of health care-associated disease

8. Primary asthma prevention or to reduce subsequent episodes of wheezing

9. Children in the second year of life (except for those who meet palivizumab medical necessity criteria for the following conditions as outlined in the position statement above: cardiac bypass, cardiac transplantation, chronic lung disease (continuation only), cystic fibrosis (continuation only), extracorporeal membrane oxygenation (ECMO), or immunocompromised)

10. Use in adults

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

Dose Adjustments

None

Drug Availability

PRECAUTIONS:

Boxed Warning

None

Contraindications

Precautions/Warnings

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J3590

Unclassified biologics

CPT Coding:

90378

Respiratory syncytial virus, monoclonal antibody, recombinant, for intramuscular use, 50 mg, each

96372

Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular

ICD-10 Diagnoses Codes That Support Medical Necessity:

Z29.11

Encounter for prophylactic immunotherapy for respiratory syncytial virus (RSV)

REIMBURSEMENT INFORMATION:

The appropriate administration code is reported in addition to the immune globulin.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantages Products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

Antibody: a protein produced by the immune system.

Lower respiratory tract disease: infection of the lungs, such as pneumonia.

RELATED GUIDELINES:

None applicable.

OTHER:

The CDC National Respiratory and Enteric Virus Surveillance System (NREVSS) monitors the onset and end of RSV season. A documented trend of at least three consecutive weeks ≥ 10% positive RSV test from the regional RSV surveillance data may be indicative of active RSV in that region.

These reports can be accessed here: http://www.cdc.gov/surveillance/nrevss/rsv/state.html

A small number of sporadic RSV hospitalizations occur before or after the main season in many areas of the US (e.g., Central Florida, South Florida); however, maximum benefit from prophylaxis is derived during the peaks of the season and not when the incidence of RSV hospitalization is low. Additionally, administration of more than five monthly doses is not recommended within the continental United States.

Regional variations for RSV season within the state of Florida are based on historical data and outlined in Table 1 below:

Table 1

Florida RSV Season by Region

Region

Counties

Season Onset

Season End

North

Alachua

Baker

Bradford

Clay

Columbia

Dixie

Duval

Gilchrist

Hamilton

Lafayette

Levy

Madison

Nassau

Putnam

St. John's

Suwannee

Taylor

Union

September to October

January

Northwest

Bay

Calhoun

Escambia

Franklin

Gadsden

Gulf, Holmes

Jackson

Jefferson

Leon

Liberty

Okaloosa

Santa Rosa

Wakulla

Walton

Washington

September to October

January

Central

Brevard

Citrus

Flagler

Hernando

Hillsborough

Lake

Marion

Orange

Osceola

Pasco

Pinellas

Seminole

Sumter

Volusia

September to October

January

Southwest

Charlotte

Collier

DeSoto

Glades

Hardee

Hendry

Highlands

Lee

Manatee

Polk

Sarasota

July to August

January

Southeast

Broward

Indian River

Martin

Dade

Monroe

Palm Beach

St. Lucie

Okeechobee

July to August

January

REFERENCES:

  1. American Academy of Pediatrics, Committee on Infectious Diseases and Bronchiolitis Guidelines Committee. Policy statement: Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014; 134:415-20.
  2. 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. 2014; 134:e620-e638.
  3. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2014 [cited 2014 Aug 3]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  4. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2017 [cited 2017 April 3]. Available from: http://www.clinicalpharmacology.com/.
  5. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2017 April 3]. Available from: http://www.thomsonhc.com/.
  6. MedImmune. Synagis (palivizumab) injection, solution. 1998 [cited 2017 April 3]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8e35c4c8-bf56-458f-a73c-8f5733829788/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 05/10/17.

GUIDELINE UPDATE INFORMATION:

07/15/01

Medical Coverage Guideline Reformatted.

11/15/01

Added info on RSV season.

10/15/03

Reviewed with changes to both "When Covered" and "When Non-Covered" sections.

12/04/03

Revised When Services are Not Covered to clearly define age criteria for children with congenital heart disease and immunodeficiencies.

06/15/04

Revised information on RSV season and moved from the When Services are Covered to the Informational section.

01/01/06

Annual HCPCS coding update: deleted expired codes 90780, 90781, 90782, 90784 added new codes 90765, 90766, and 90772.

08/15/06

Biennial review, reformatted, added HCPCS codes.

10/15/06

Expanded description of RSV season and added reference.

12/15/06

Revised by changing from medical “director” review to medical “necessity” review under Dosage and Administration. Added Medicare Part D statement under Program Exceptions.

09/15/07

Review and revision to guideline; consisting of changing the name since RespiGam® is no longer available, reformatted guideline, maintain current coverage and limitations, added note regarding RespiGam® not being available, added dosing for Synagis®, removed RespiGam® HCPCS code and CPT codes, removed Medicare Part D delegation, updated internet links and updated references.

01/01/08

Annual HCPCS coding update: changed description on CPT-4 code 90378.

04/15/08

Revision to guideline consisting of added the HCPCS code J1565 after RespiGam® in the note under Description, stating that this drug is no longer available.

09/15/08

Review and revision to guideline, consisting of adding statement under the “Dosage and Administration” section regarding a website to obtain epidemiology information regarding RSV season and updating references and links.

01/01/09

Annual HCPCS coding update: deleted code 90772; added code 96372; deleted code C9003.

03/15/09

Revision to guideline consisting of adding verbiage to allow south Florida counties to treat for a 9 month RSV season.

06/15/09

Revision to guideline; consisting of modifying southeast Florida RSV season and defining RSV season for the rest of Florida. Also modified risk factors for infants born between 32 and 35 weeks less than 6 months of age at the start of RSV season to be consistent with AAP guidelines.

08/01/09

Revision to guideline; consisting of changing position statement to be in line with AAP recommendations.

01/01/10

Annual HCPCS coding update: revised descriptor for code 90378.

07/15/10

Review and revision to guideline; consisting of updating RSV season and references.

10/01/10

Revision to guideline, consisting of formatting changes.

11/15/10

Revision to guideline; consisting of clarifying the end of RSV season.

07/01/11

Review and revision to guideline; consisting of updating the position statement and references.

07/01/12

Review and revision to guideline; consisting of updating description, position statement and references.

06/15/13

Review and revision to guideline; consisting of adding coverage for infants and children with severe immune deficiencies. Updated E/I by adding active RSV infection, children with tobacco smoke exposure and no other AAP identified risk factors, non-cyanotic heart disease, surgically corrected heart disease that no longer requires medication support, Updated the 2013-2014 season start and end dates.

06/15/14

Review and revision to guideline; consisting of generally defining regional seasons.

08/15/14

Revision to guideline; consisting of description, position statement, dosage/administration, precautions, program exceptions, other, references

09/15/14

Revision to guideline; consisting of update to position statement.

05/15/15

Revision: update to billing/coding and Other.

07/15/15

Review and revision to guidelines; consisting of updating references.

11/01/15

Revision: ICD-9 Codes deleted.

11/15/15

Revision to guidelines; consisting of updating ICD10 coding, revising position statement.

06/15/16

Review and revision to guideline; consisting of revising position statement, references.

10/01/16

Revision to guideline; consisting of updating ICD10 code

06/15/17

Review and revision to guideline; consisting of updating description and references.

Date Printed: October 23, 2017: 07:25 AM