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
Plasma exchange for the following acute and chronic diseases is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Chronic inflammatory demyelinating polyneuropathy
Hyperviscosity syndrome
Mixed cryoglobulinemia with severe multiple manifestations
Severe Guillain - Barre
Myasthenia gravis
Thrombotic thrombocytopenia purpura
IgA or IgG paraproteinemia polyneuropathy
Anti-glomerular basement membrane disease (Goodpasture’s syndrome)
ABO incompatible solid organ transplants (kidney or heart)
ABO incompatible hematopoietic progenitor cell transplantation
Idiopathic thrombocytopenia purpura (ITP) in emergency situation
Atypical hemolytic uremic syndrome (HUS)
Post transfusion purpura
HELLP syndrome of pregnancy
Acute fulminant central nervous system demyelination (e.g., Acute Multiple Sclerosis, Acute Transverse Myelitis)
ANCA-associated vasculitis (e.g., Wegner’s granulomatosis)
Plasma exchange for all other conditions/indications including, but not limited to, the following is considered investigational:
Amyotrophic lateral sclerosis
ABO incompatible solid organ transplant; liver
Acute disseminated encephalopathy
Acute inflammatory demyelinating polyneuropathy (Guillain-Barré syndrome) in children younger than 10 with mild or moderate forms
Acute liver failure
Aplastic anemia
Asthma
Autoimmune hemolytic anemia; warm hemolytic anemia; cold agglutinin disease
Bullous pemphigoid
Cardiomyopathy, post transplant
Catastrophic antiphospholipid syndrome
Central pontine myelinolysis
Chronic fatigue syndrome
Coagulation factor inhibitors
Cryoglobulinemia; except foe severe mixed cryoglobulinemia, as noted below)
Focal segmental glomerulosclerosis
Heart transplant antibody mediated rejection
Hemolytic uremic syndrome (HUS) with typical presentation (diarrhea related)
Idiopathic thrombocytopenic purpura (ITP); refractory or non refractory
Inclusion body myositis
Lambert-Eaton myasthenic syndrome
Mild Guillain-Barré syndrome
Multiple sclerosis; chronic progressive or relapsing remitting
Mushroom poisoning
Myasthenia gravis with anti-MUSK antibodies
Myeloma kidney/acute renal failure to improve renal function
Obsessive-compulsive disorder and tic disorder of childhood
Overdose and poisoning (other than mushroom)
Paraneoplastic syndromes
Paraproteinemic polyneuropathy, (IgM)
Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS)
Pemphigus vulgaris
Phytanic acid storage disease (Refsum’s disease)
POEMS (polyneuropathy, organomegaly, endocrinopathy, M protein, skin changes)
Polymyositis and dermatomyositis
Psoriasis
Raynaud's phenomenon
Red cell alloimmunization in pregnancy
Regional enteritis (Crohn's disease)
Rheumatoid arthritis
Scleroderma (systemic sclerosis)
Severe late left ventricular failure
Stiff person syndrome
Sydenham’s chorea (SC)
Systemic lupus erythematosus; manifestations other than nephritis
Systemic Lupus nephritis
Systemic vasculitis to improve renal function
Thyrotoxicosis
MEDICAL APPROPRIATENESS
Plasma exchange is considered medically appropriate if ANY ONE of the following are met:
Chronic inflammatory demyelinating polyneuropathy (CIDP) with ALL of the following:
Severe or life-threatening symptoms
Failed response to conventional therapy with prednisone or intravenous immunoglobulins (IVIg)
Fulfillment of the mandatory diagnostic criteria for CIDP developed by the American Academy of Neurology AIDS task force which includes ALL of the following:
Progressive or relapsing motor and sensory, rarely on motor or sensory, dysfunction of more than one limb or a peripheral nerve nature, developing over at least 2 months
Nerve conduction studies including studies of proximal nerve segments in which the predominant process is demyelination
Must have THREE of the following four:
Reduction in conduction velocity (CV) in two or more motor nerves with ANY ONE of the following:
Less than 80% of lower limit of normal (LLN) if amplitude greater than 80% of LLN
Less than 70% of LLN if amplitude less than 80% of LLN
Partial conduction block or abnormal temporal dispersion in one or more motor nerves: either peroneal nerve between ankle and below fibular head, median nerve between wrist and elbow, or ulnar nerve between wrist and below elbow with ANY ONE of the following:
Criteria suggestive of partial conduction block: less than 15% change in duration between proximal and distal sites and greater than 20% drop in negative peak (-p) area or peak to peak (p-p) amplitude between proximal and distal sites
Criteria for abnormal temporal dispersion and possible conduction block: greater than 15% change in duration between proximal and distal sites and greater than 20% drop in -p area or p-p amplitude between proximal and distal sites and greater than 20% drop in -p or p-p amplitude between proximal and distal sites. These criteria are only suggestive of partial conduction block as they are derived from studies of normal individuals. Additional studies, such as stimulation across short segments or recording of individual motor unit potentials, are required for confirmation.
Prolonged distal latencies in two or more nerves with ANY ONE of the following:
Greater than 125% of upper limit of normal (ULN) if amplitude greater than 80% of LLN
Greater than 150% of ULN if amplitude less than 80% of LLN
Absent F-waves or prolonged minimum F-wave latencies (10 to 15 trials) in two or more motor nerves with ANY ONE of the following:
Greater than 120% of ULN if amplitude greater than 80% of LLN
Greater than 150% of ULN if amplitude less than 80% of LLN
Nerve biopsy showing unequivocal evidence of demyelination and remyelination.
Demyelination by either electron microscopy (greater than 5 fibers) or teased fiber studies (greater than 12% of 50 teased fibers, minimum of four internodes each, demonstrating demyelination/remyelination)
CSF study - cell count less than 10/mm3 if HIV-seronegative or less than 50/mm3 if HIV seropositive
CSF study - negative VDRL
Hyperviscosity syndrome with multiple myeloma or Waldenström's macroglobulinemia
Severe multiple manifestation of mixed cryoglobulinemia (e.g. cryoglobulimemic nephropathy, skin ulcers, sensory motor neuropathy and widespread vasculitis) used in conjunction with immunosuppressive treatment
Severe Guillain-Barré syndrome with ANY ONE of the following:
Inability to walk 5 meters without assistance
Confinement to bed / chair-bound
Ventilation assistance for at least part of the day or night
Myasthenia gravis in crisis or as part of a preoperative preparation
Anti-glomerular basement membrane antibodies (i.e., Goodpasture's syndrome) with progressive renal failure
Organ transplantation with ABO incompatibility or positive crossmatch demonstrated by high panel reactive antibody (PRA) screen, when a suitable nonreactive live or cadaveric donor is unavailable in ANY ONE of the following:
Kidney
Heart (infant)
ANCA-associated vasculitis (e.g., Wegner’s granulomatosis) with associated renal failure (serum CR above 5.8 mg/dl)
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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