BlueCross BlueShield of Tennessee Medical Policy Manual

Plasma Exchange

DESCRIPTION

Plasma exchange (PE) is an extracorporeal procedure in which blood of the patient is extracted and processed through a medical device which separates the plasma from other components of blood. This large volume of affected plasma (generally at least 1 plasma volume or approximately 3000ml) is discarded and replaced with allogeneic plasma or a plasma substitute.

The therapeutic use of PE is to rapidly remove toxins or autoantibodies which can accumulate in the plasma as a result of a disease process. PE is a non-specific therapy since the entire volume of plasma is discarded. It is essentially a symptomatic treatment since it does not remove the source of the pathogenic factors. Applications of PE can be broadly subdivided into two general categories: 1) acute self-limited diseases where PE is used to acutely lower the circulating toxic substance and 2) chronic diseases where there is ongoing production of pathogenic autoantibodies. The use of PE in chronic diseases has been more controversial than in acute self-limited diseases, due to the phenomenon of rebound antibody production and because it does not address underlying pathology. Although PE can rapidly reduce levels of serum autoantibodies; a feedback mechanism may lead to a rebound overproduction of the same antibodies. This rebound production of antibodies is thought to render the replicating pathogenic clone more vulnerable to cytotoxic drugs; therefore, PE is sometimes used in conjunction with cyclophosphamide.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION

Well-designed studies were not found in peer-reviewed published literature that validates the use of plasma exchange for the treatment of diseases/conditions listed as investigational.

SOURCES

American Academy of Neurology and the MS Council for Clinical Practice Guidelines. (July, 2008). Disease modifying therapies in multiple sclerosis. Retrieved November 10, 2010 from http://www.guideline.gov/content.aspx?id=4099.

American Academy of Neurology. (1996). Assessment of plasmapheresis. Retrieved November 15, 2010 from http://www.neurology.org/content/47/3/840.full.pdf.

BlueCross BlueShield Association, Medical Policy Reference Manual. (2:2010). Plasma exchange. (8.02.02). Retrieved October 29, 2010 from BlueWeb. (43 articles and/or guidelines reviewed)

British Committee for Standards in Haematology. (2006, February). Guidelines on the diagnosis and management of multiple myeloma 2005. Retrieved November 10, 2010 from http://www.guideline.gov/content.aspx?id=9555&search=british+multiple+myeloma.

Complete Guide to Medicare Coverage Issues [Computer software]. (July, 2009). Apheresis (therapeutic pheresis) (NCD 110.14, p. 2-57). The Ingenix Complete Guide to Medicare Coverage Issues.

Greenberg, B., Thomas, K., Krishnan, C., Kaplin, A., Calabresi, P., & Kerr, D. (2007). Idiopathic transverse myelitis. Neurology. 68 (19) 1614-1617. (Level 3 Evidence - Independent)

McPherson, R., & Pincus, M. (2006). Henry’s Clinical Diagnosis and Management by Laboratory Methods (21st ed., chapt. 36). Philadelphia: Elsevier Inc.

Szczepiorkowski, Z., Winters, J., Bandarenko, N., Kim, H., Linenberger, M., Marques, M., et al. Guidelines on the use of therapeutic apheresis in clinical practice – Evidence-based approach from the Apheresis Applications Committee of the American Society for Apheresis. Journal of Clinical Apheresis 2010, (25) 83-177.

U. S. Food and Drug Administration. (2002, November). Center for Devices and Radiological Health. 510(k) Pre-market Notification Database. K021615. Retrieved November 10, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf2/k021615.pdf.

U. S. Food and Drug Administration. (2004, July). Center for Devices and Radiological Health. 510(k) Pre-market Notification Database. K040041. Retrieved November 15,2010 from http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm078326.htm.

U. S. Food and Drug Administration. (2004, July). Center for Devices and Radiological Health. 510(k) Pre-market Notification Database. K040086. Retrieved November 10, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf4/K040086.pdf.

United Kingdom Blood and Tissue Services. (2005, October). Guideline for therapeutic plasma exchange. Retrieved November 10, 2010 from http://www.transfusionguidelines.org.uk/?Publication=HTM&Section=9&pageid=1137.

Winifred S. Hayes, Inc. Medical Technology Directory. (2006, April). Plasma exchange for multiple sclerosis. Retrieved November 10, 2010 from www.Hayesinc.com/subscribers. (47 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2007, December, last update search December 2009). Extracorporeal apheresis for conditions affecting the circulatory system and blood.  Retrieved November 10, 2010 from www.Hayesinc.com/subscribers. (46 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2007, July, last update search July 2010). Extracorporeal apheresis for autoimmune and connective tissue disorders. Retrieved November 10, 2010 from www.Hayesinc.com/subscribers. (60 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2007, March, last update search May 2010). Extracorporeal apheresis for gastroenterological indications. Retrieved November 10, 2010 from www.Hayesinc.com/subscribers. (41 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2007, September, last update search November 2010). Extracorporeal apheresis for neurological, visual, and auditory disorders. Retrieved November 10, 2010 from www.Hayesinc.com/subscribers. (59 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  5/1981

MOST RECENT REVIEW DATE:  5/14/2011

ID_BA

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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