BlueCross and BlueShield of Montana Medical Policy/Codes
Staphylococcal Vaccines
Chapter: Drugs - Pharmacy Benefit
Current Effective Date: July 18, 2013
Original Effective Date: July 18, 2013
Publish Date: July 18, 2013
Revised Dates: This medical document is no longer scheduled for routine literature review and update.
Description

The staphylococcus species are well-adapted parasites.  In humans, they colonize on the skin and in the nose.  These organisms are involved in common skin disorders including eczema, psoriasis, acne, boils and infections of cuts and burns.  They can invade and cause more serious infections of the skin, mammary glands, respiratory tree, blood, joints and bones.  Their toxins can cause food poisoning and toxic shock syndrome.  Those staphylococci that synthesize coagulase, including staphylococcus aureus, are more invasive.  By contrast coagulase negative species are particularly good at colonizing implanted materials such as long intravenous lines, heart valves and orthopedic prostheses. 

The theory behind the development of staphylococcal vaccines is to build a passive protective immunity against staphylococcus organisms.  With the increasing number of occurrences of hospital infections related to the staphylococcus species and an increasing number of resistant antibiotics in fighting staphylococcal organisms, interest in development of a vaccine has increased in the scientific community.

The United States Center for Disease Control and Prevention (CDC) has estimated that approximately two million people in the United States carry methicillin-resistant Staphylococcus aureus (MRSA) in their nasal passages.  MRSA has emerged as a growing problem, causing difficult-to-treat infections not only in hospitals but in the general community.  Staphylococcal vaccines are being developed to build a passive protective immunity against organisms.

Currently, there are two staphylococcal vaccines in phase III clinical trials by the FDA: Veronate® and Aurexis®.  Two other staphylococcal vaccines, StaphVAX™ and Altrastaph® were removed from phase III confirmatory trials when the trials failed to show that these vaccines could prevent staphylococcus aureus in kidney disease patients on hemodialysis.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Investigational

Staphylococcal vaccines have not been approved by the Federal Drug Administration (FDA) and are considered experimental, investigational and unproven.

Rationale

Since there are no current FDA approved staphylococcal vaccines, the administration of the vaccines is experimental and investigational and unproven.  An article published in the journal Trends of Immunology, by Colin A. Michie stated, “Vaccination has proved relatively unsuccessful against the common bacteria staphylococcus, despite almost a century of experimentation.” It is hoped that one day a vaccine will be developed to help combat the prevalence and incidence of staphylococcus infection.” 

In a search of the MEDLINE database through February 29, 2008 no new clinical trials were identified that would alter the conclusions reached above.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

99.55, 99.59

Procedural Codes: 90749
References
  1. Fattom, A.I. and R. Naso.  Staphylococcal vaccines:  a realistic dream.  Annuals of Medicine (1996 February) 28(1):43-46.
  2. McKenny, D., Pouliot, K. L., et al.  Broadly protective vaccine for Staphylococcus aureus based on an in vivo-expressed antigen.  Science (1999 May 28) 284(5419):  1523-7.
  3. Jones, T.  StaphVAX™ Current Opinion in Investigative Drugs (2002 January) 3(1): 48-50.
  4. Shinefield, H., Black, S., et al.  Use of a Staphylococcus aureus conjugate vaccine in patients receiving hemodialysis.  New England Journal of Medicine (2002 February 14) 346(7): 491-6.
  5. Michie, C.A.  Staphylococcal vaccines.  Trends in Immunology (2002 September) 23(9): 461-3.
  6. Robbins, J.B., Schneerson, R., et al.  Staphylococcus aureus types 5 and 8 capsular polysaccharide conjugate vaccines.  American Heart Journal (2004 April) 147(4): 593-8.
  7. Weisman, L.E.  Coagulase-negative staphylococcal disease:  emerging therapies for the neonatal and pediatric patient.  Current Opinions in Infectious Disease (2004 June) 17(3): 237-41.
  8. Jones, C.  Revised structures for the capsular polysaccharides from Staphylococcus aureus Types 5 and 8, components of novel glycoconjugated vaccines.  Carbohydrate Research (2005 May 2) 340(6): 1097-106.
  9. Fattom, A., Fuller, S., et al.  Safety and immunogenicity of a booster dose of Staphylococcus aureus types 5 and 8 capsular polysaccharide conjugate vaccine. (StaphVAX™) in hemodialysis patients.  Vaccine (2004 December) 23(5): 656-63.
  10. Maira-Litran, T., Kropec, A., et al.  Comparative opsonic and protective activities of Staphylococcus aureus conjugate vaccines containing native or deacetylated Staphylococcal Poly-N-acetyl-beta-(1-6)-glucosamine.  Infection and Immunity (2005 October) 73(10): 6752-62.
  11. Weems, J.J., Steinberg, J.F., et al.  Phase II, randomized, double-blind, multicenter study comparing the safety and pharmacokinetics of tefibazumab to placebo for treatment of Staphylococcus aureus bacteremia.  Antimicrobial Agents and Chemotherapy (2006 August) 50(8): 2751-5.
  12. DeJonge, M., Burchfield, D., et al.  Clinical trial of safety and efficacy of INH-A21 for the prevention of nosocomial staphylococcal bloodstream infection in premature infants.  Journal of Pediatrics (2007 September) 151(3): 260-5, 265 el.
History
May 2013  New 2013 Blue Cross and Blue Shield of Montana medical policy.  Staphylococcal Vaccines have not been approved by the Federal Drug Administration (FDA) and are considered experimental, investigational and unproven.    
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Staphylococcal Vaccines