Plasmapheresis / Plasma Exchange
DESCRIPTION
The terms therapeutic apheresis, plasmapheresis and plasma exchange are often used interchangeably in the literature, but when properly used denote different procedures. Apheresis is a general term describing removal of blood from a subject. A portion of the blood is separated and retained while the rest is returned to the donor. However, leukapheresis or lymphocytapheresis also describes apheresis procedures in which the white blood cells are isolated and retained. As another example, peripheral stem cell collection, done in preparation for autologous bone marrow transplant, involves an apheresis procedure in which the critical stem cells are isolated and retained. Plasmapheresis involves the separation of affected plasma from the cellular components of the blood. After fractionation the cellular components are re-infused. This procedure is frequently performed in conjunction with plasma exchange.
Plasma exchange (PE) involves the removal of large volumes of affected plasma after which an allogeneic plasma or plasma substitute is re-infused. Plasma exchange is a nonspecific therapy, since the entire plasma is discarded. 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 pathogenic 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. Plasma exchange and plasmapheresis are conducted in outpatient settings. These include blood banks, dialysis centers, hospitals and physicians' offices.
POLICY
Plasmapheresis and/or plasma exchange for acute and chronic diseases is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Plasmapheresis and/or plasma exchange for all other conditions/disease/indications including, but not limited to, the following is considered investigational:
Amyotrophic lateral sclerosis
Bullous pemphigoid
Cardiomyopathy, post transplant
Central pontine myelinolysis
Chronic fatigue syndrome
Glomerulonephritis, rapidly progressive, excluding those related to anti-basement membrane immunoglobulins
HELLP (Hemolysis, Elevated Liver enzyme levels and a Low Platelet count) syndrome of pregnancy
Hemolytic uremic syndrome (HUS)
Idiopathic thrombocytopenic purpura (ITP)
Lupus nephritis to improve renal function
Mild Guillain-Barré syndrome
Multiple sclerosis
Myeloma kidney to improve renal function
Obsessive-compulsive disorder and tic disorder of childhood
Paraneoplastic syndromes including Eaton-Lambert syndrome
Paraproteinemic polyneuropathy, including monoclonal gammopathy of undetermined significance (MGUS)
Pemphigus
Polymyositis and dermatomyositis
Purpura, post-transfusion
Raynaud's phenomenon
Regional enteritis (Crohn's disease)
Rheumatoid arthritis
Scleroderma (systemic sclerosis)
Severe late left ventricular failure
Systemic lupus erythematosus
Systemic vasculitis to improve renal function
See also:
MEDICAL APPROPRIATENESS
Plasmapheresis and 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)
CFS study - cell count less than 10/mm-3 if HIV-seronegative or less than 50/mm-3 if HIV seropositive
CFS study - negative VDRL
Hyperglobulinemias with ANY ONE of the following:
Multiple myeloma
Hyperviscosity syndromes (Note: Waldenström's macroglobulinemia is marked by excess production of immunoglobulin M [IgM]. The excess IgM results in hyperviscose serum. This hyperviscosity syndrome responds well to plasmapheresis.)
Cryoglobulinemia
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
Thrombotic thrombocytopenic purpura (TTP)
IgA or IgG paraproteinemia polyneuropathy
Progressive renal failure due to anti-basement membrane antibodies (i.e., Goodpasture's syndrome).
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.
ADDITIONAL INFORMATION
Well-designed studies were not found in peer-reviewed published literature which validates the use of plasmapheresis and / or plasma exchange for the treatment of diseases/conditions listed as investigational.
SOURCES
BlueCross BlueShield Association, Medical Policy Reference Manual. (2:2006). Plasma exchange (plasmapheresis) (8.02.02). Retrieved October 29, 2009 from BlueWeb. (31 articles and/or guidelines reviewed)
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.
Dimopoulos, M. A., Merlini, G., Leblond, V., Anagnostopoulos, A., & Alexanian, R. (2005). How we treat Waldenström's macroglobulinemia. Haematologica, 90 (1), 117-125.
Hayes. Medical Technology Directory. (2006, April). Plasma exchange for multiple sclerosis. Retrieved October 29, 2009 from www.Hayesinc.com/subscribers. (47 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2007, December). Extracorporeal apheresis for conditions affecting the circulatory system and blood. Retrieved October 29, 2009 from www.Hayesinc.com/subscribers. (46 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2007, July). Extracorporeal apheresis for autoimmune and connective tissue disorders. Retrieved March October 29, 2009 from www.Hayesinc.com/subscribers. (60 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2007, March). Extracorporeal apheresis for gastroenterological indications. Retrieved March October 29, 2009 from www.Hayesinc.com/subscribers. (41 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2007, September). Extracorporeal apheresis for neurological, visual, and auditory disorders. Retrieved October 29, 2009 from www.Hayesinc.com/subscribers. (59 articles and/or guidelines reviewed)
National Cancer Institute. (2007, September). Fact Sheet: Waldenström's macroglobulinemia: Questions and answers. Retrieved March 20, 2008 from http://cis.nci.nih.gov/fact/pdfdraft/6_sites/fs6_4.pdf.
National Guideline Clearinghouse. (2006, February). Guidelines on the diagnosis and management of multiple myeloma 2005. Retrieved March 20, 2008 from http://www.guidelines.gov.
National Institute of Diabetes and Digestive and Kidney Disease. (2007, April). Goodpasture's syndrome. Retrieved March 20, 2008 from http://kidney.niddk.nih.gov/kudiseases/pubs/pdf/GoodpastureSyndrome.pdf.
U. S. Food and Drug Administration. (2002, November). Center for Devices and Radiological Health. 510(k) Pre-market Notification Database. K021615. Retrieved March 20, 2008 from http://www.fda.gov/cdrh/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 March 20, 2008 from http://www.fda.gov/cber/510k/K040041.htm.
U. S. Food and Drug Administration. (2004, July). Center for Devices and Radiological Health. 510(k) Pre-market Notification Database. K040086. Retrieved March 20, 2008 from http://www.fda.gov/cber/510k/k040086.htm.
ORIGINAL EFFECTIVE DATE: 5/1981
MOST RECENT REVIEW DATE: 12/10/2009
ID_BT
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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