Recommendations For Synagis 2014-2015

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RECOMMENDATIONS FOR SYNAGIS
2014-2015
CPT Code 96372

The American Academy of Pediatrics (AAP) recommends the use of palivizumab (Synagis), an RSV monoclonal antibody vaccine, to prevent serious RSV illness in qualifying high-risk infants. The 2014 AAP recommendations (Red Book 29th edition) as well as the 2014 CCS Synagis Guidelines (NL: 13-0914) are incorporated into the following HPSJ and SJHA Synagis Qualification Criteria:

Who Qualifies for Synagis Prophylaxis?

Criteria eligible for coverage through HPSJ:

Patients meeting one of the following criteria during RSV season (Nov 1st – Mar 31st):
Infant born before 29 weeks gestation and less than 12 months of age at start of RSV season.

Up to 5 doses

Infant born at before 32 weeks gestation with Chronic Lung Disease (CLD) and require >21% oxygen for at least 28 days after birth

Up to 5 doses

Infants <12 months born with hemodynamically significant heart disease (i.e. acyanotic heart disease requiring cardiac surgery and receiving medication(s) to control congestive heart failure or moderate-severe pulmonary hypertension)

Up to 5 doses

Infants <12 months with pulmonary disorders or neuromuscular disease that lead to impaired clearing of upper respiratory secretions may be considered for prophylaxis.

Up to 5 doses

Children <24 months requiring oxygen for at least 28 days after birth and continue to require medical intervention (supplemental oxygen, chronic corticosteroid, or diuretics) during 6-month period prior to RSV season may be considered for prophylaxis.

Up to 5 doses

Children <24 months who are profoundly immunocompromised during RSV season may be considered for prophylaxis.

Up to 5 doses

Children <24 months who undergone cardiac transplant during RSV season may be considered for prophylaxis.

Up to 5 doses

Children <24 months who were receiving RSV prophylaxis and will continue to require RSV prophylaxis after cardiopulmonary bypass should be given a post-operative Synagis dose at the conclusion of the surgery.

1 post-operative dose

For infants less than 29 weeks estimated gestational age, prophylaxis should be administered as 15mg/kg monthly doses throughout the season to maximum of 5 doses. Prophylaxis occurs for between November to March. (This will provide protection until April.) Synagis should not be administered more frequently than monthly (every 28-30 days). Infants experiencing breakthrough RSV hospitalization while receiving prophylaxis should discontinue Synagis immediately.

Criteria eligible for coverage through CCS (CCS preauthorization is required).

Children with any CCS qualifying diagnosis should be referred to CCS for ongoing case management and Synagis authorization should be obtained through CCS. Please refer to CCS NL: 04-0509 for complete details (available at http://www.dhcs.ca.gov/services/ccs/Documents/ccsnl130914.pdf). CCS requires separate authorizations for outpatient administration. For inpatient administration, a separate authorization is not needed.

Palivizumab is a benefit for CCS clients, regardless of the eligible medical condition, who also meet one of the following criteria:

Patients meeting one of the following criteria during RSV season (Nov 1st – Mar 31st):
Children who meet the above criteria and have a CCS condition.
Children 24 months of age or younger at the start of RSV season with one of the following:

  1. Chronic Lung Disease (CLD) in premature infants – those in the first year of life who had gestational age<32 weeks and requiring >21% supplemental oxygen for at least 28 days after birth. Those in the second year of life who had gestational age<32 weeks and required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) within 6 months before the start of RSV season.
  2. Hemodynamically significant Congenital Heart Disease (CHD) – those in the first year of life who have (a) acyanotic heart disease who receives medication to manage congestive heart failure and will require cardiac surgery; or (b) cyanotic heart disease if deemed warranted by the infant’s pediatric cardiologist. Requests for service should be from one of the following:
    • A CCS approved Cardiac Special Care Center (SCC)
    • A cardiologist from a CCS-approved SCC
    • CCS approved pediatrician authorized in conjunction with one of the above. Note: The approved cardiologist must be in agreement, if the pediatrician is requesting palivizumab and the cardiologist must explicitly indicate medical necessity.
  3. Severe congenital or acquired immunodeficiency – those younger than 24 months of age who are profoundly immunocompromised (e.g. severe combined immunodeficiency, acquired immunodeficiency syndrome, transplant recipients, or children who are immunocompromised due to chemotherapy) with request for service from one of the following:
    • CCS approved Infectious Disease and Immunologic Disorder SCC, Transplant SCC, or Hematology/Oncology SCC.
    • CCS Approved pediatrician authorized in conjunction with one of the above SCCs. Note: The approved SCC must be in agreement, if the pediatrician is requesting palivizumab and the SCC must explicitly indicate the medical necessity.
  4. Congenital airway abnormalities/neuromuscular disorder – those in the first year of life who have impaired ability to handle respiratory secretion.
  5. Cystic Fibrosis – in those in the first year of life with clinical heart disease and/or nutritional deficits. Prophylaxis may be considered in those in the second year of life with severe lung disease as evidenced by one of the following: previous hospitalization for lung exacerbation in the first year of life, persistent lung abnormalities on chest X-rays, or weight :length <10 percentile.

Please note: Premature infants who are currently only eligible for diagnostic services through the high-risk infant follow-up program are not eligible for authorization of Palivizumab through CCS and should be authorized through HPSJ.

** These criteria apply for SJHA participants. ** Authorizations for SJHA participants will be done through the health plan and should not be referred to CCS.


How do I Obtain Authorization and Medication?

Authorization:

Obtain the Synagis Authorization/Order Form on DRE or the website and submit by fax to (209) 942-6302. A single authorization is required for the series.

If approved, this authorization will be good for a maximum of 3 to 5 monthly (every 30 day) injections between November 1, 2014 and March 31, 2015 depending on the criteria met (listed above). The approval and order will be faxed by HPSJ to Diplomat Specialty Pharmacy to initiate the procurement process.

* If prophylaxis was initiated in December or if credible epidemiological evidence indicating new RSV infections extend into April 2015 exists, consideration will be given to add an April dose. Such determination will be made by March 31, 2015. Infants born during RSV season (i.e. January) will not require all 5 doses.

Procurement:

Synagis is provided through Diplomat Specialty Pharmacy. Once authorized by HPSJ, Diplomat Specialty Pharmacy will then contact your office to arrange/coordinate delivery of the approved medications to your office.

Administration Billing:

When billing for the Synagis injection please bill with the CPT Code 96372.

Ordering Synagis:

Diplomat Specialty Pharmacy, the Specialty Pharmacy serving members of Health Plan of San Joaquin (HPSJ) and San Joaquin Health Administrators (SJHA) provides Synagis. Diplomat Specialty Pharmacy has many positive features for you and your patients, including:

  • Delivery of medications directly to your infusion center or office within 24 business hours of approval
  • Reduced inventory management responsibility for your office
  • Refills and renewals coordinated by Diplomat Specialty Pharmacy, lessening the burden on your staff
  • Coordinated monthly scheduling of deliveries
  • Phone access to pharmacists, nurses, and trained staff to assist HPSJ and SJHA members
  • Patient monitoring and education program to improve adherence to prescribed regimens

Any questions regarding scheduling of the patients’ order should be directed to the Diplomat Specialty Pharmacy Customer service Monday through Friday 8:00 am until 11:00 pm, and Saturday 8:00 am until 4:00 pm (EST) at 1-877-319-6337.

Administration:

Synagis is to be given monthly from November through March, the peak RSV months, for a maximum total five doses for infants less than 29 weeks or for infants less than 32 weeks with CLD requiring >21% oxygen supplementation for at least the first 28 days after birth. A dose given in early March will provide protection into April.


Synagis Clinics:

Since 2010, San Joaquin General Hospital Clinics are no longer offering Synagis injection services

Thank you for caring for young, at risk infants. If you have any questions about the Synagis recommendations, please feel free to call HPSJ Utilization Management Department at (209) 942-6350.

Posted on November 21st, 2014 and last modified on July 27th, 2015.

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