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Plasma Exchange (Plasmapheresis)

Policy Number: MP-100

Latest Review Date: July 2024

Category: Therapy                                                       

POLICY:

Plasma exchange (plasmapheresis) may be considered medically necessary for ANY of the following conditions:

Autoimmune

  • Severe multiple manifestation of mixed cryoglobulinemia (MC) such as cryoglobulinemic nephropathy, skin ulcers, sensory motor neuropathy, and widespread vasculitis in combination with immunosuppressive treatment;
  • Catastrophic antiphospholipid syndrome

Hematologic

  • ABO incompatible hematopoietic progenitor cell transplantation;
  • Hyperviscosity syndromes associated with multiple myeloma or Waldenström’s  macroglobulinemia;
  • Idiopathic thrombocytopenic purpura in emergency situations;
  • Thrombotic thrombocytopenic purpura (TTP);
  • Atypical hemolytic-uremic syndrome;
  • Post transfusion purpura;
  • HELLP syndrome of pregnancy (a severe form of preeclampsia, characterized by hemolysis [H], elevated liver enzymes [EL], and low platelet [LP] counts);
  • Myeloma with acute renal failure

Neurological

  • Acute inflammatory demyelinating polyneuropathy (Guillain-Barre’ syndrome [GBS]; severity grade 1-2 within two weeks of onset; and children less than 10 years old with severe GBS);
  • Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP);
  • Multiple sclerosis with acute fulminant CNS demyelination;
  • Myasthenia gravis in crisis or as part of preoperative preparation;
  • Paraproteinemia polyneuropathy; IgA, IgG;
  • Neuromyelitis optica
  • N-methyl-d-aspartate receptor antibody encephalitis;
  • Progressive multifocal leukoencephalopathy associated with natalizumab;

Renal

  • Anti-glomerular basement membrane disease (Goodpasture’s syndrome);
  • ANCA-associated vasculitis [e.g., Wegener’s granulomatosis, also known as granulomatosis with polyangiitis (GPA)] with associated renal failure;
  • Dense deposit disease with factor H deficiency and/or elevated C3 Nephritic factor

Transplantation

  • ABO incompatible solid organ transplantation:
    • Kidney;
    • heart (infants);
  • Renal transplantation: antibody mediated rejection; HLA [human leukocyte antigen] desensitization;
  • Focal segmental glomerulosclerosis after renal transplant

Plasma exchange (plasmapheresis) is considered investigational in all other conditions, including, but not limited, to the following:

  • ABO incompatible solid organ transplant; liver
  • Acute disseminated encephalomyelitis
  • Acute inflammatory demyelinating polyneuropathy (Guillain-Barre syndrome) in children less than 10 years old with mild or moderate forms
  • Acute liver failure
  • Amyotrophic lateral sclerosis (ALS)
  • ANCA-associated vasculitis [e.g., Wegener’s granulomatosis, also known as granulomatosis with polyangiitis (GPA)] without associated renal failure
  • Aplastic anemia
  • Asthma
  • Autoimmune hemolytic anemia; warm autoimmune hemolytic anemia; cold agglutinin disease
  • Chronic fatigue syndrome
  • Coagulation factor inhibitors
  • Cryoglobulinemia; except for severe mixed cryoglobulinemia; as noted above
  • Dermatomyositis and polymyositis
  • Focal segmental glomerulosclerosis (other than after renal transplant)
  • Heart transplant rejection treatment
  • Hemolytic uremic syndrome (HUS); typical (diarrheal-related)
  • Hyperviscosity syndromes with renal failure (other than associated with multiple myeloma or Waldenström’s macroglobulinemia).
  • Idiopathic thrombocytopenic purpura; refractory or non-refractory
  • Inclusion body myositis
  • Lambert-Eaton myasthenic syndrome
  • Macular Degeneration (Age Related)
  • Multiple sclerosis with chronic progressive or relapsing remitting course
  • Mushroom poisoning
  • Myasthenia gravis with anti-MuSK antibodies
  • Obsessive compulsive disorder
  • Overdose and poisoning (other than mushroom poisoning)
  • Paraneoplastic syndromes
  • Paraproteinemia 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)
  • Psoriasis
  • Red cell alloimmunization in pregnancy
  • Regional enteritis (Crohn’s disease)
  • Rheumatoid arthritis
  • Scleroderma (systemic sclerosis)
  • Sepsis
  • Stiff-man syndrome
  • Sydenham’s chorea
  • Systemic lupus erythematosus (including SLE nephritis)
  • Thyrotoxicosis

Individual case consideration for coverage of plasma exchange (plasmapheresis) will be given for patients with acute, life-threatening complications of chronic autoimmune diseases, such as rheumatoid arthritis and systemic lupus erythematosus. However, in these situations, treatment goal and duration of treatment with PE need to be clearly established prior to its initiation to ensure that short-term treatment of the acute complication does not evolve to a chronic use of PE with uncertain benefit.

For information regarding lipid apheresis, please refer to medical policy # 103 Lipid Apheresis

For information regarding ECP, please refer to medical policy # 028 Extracorporeal Photopheresis

DESCRIPTION OF PROCEDURE OR SERVICE:

Plasma exchange (PE) is a procedure in which the plasma is isolated, then discarded and replaced with a substitution fluid such as albumin. Plasma exchange is a nonspecific therapy, because the entire plasma is discarded. PE has been used in a wide variety of acute and chronic conditions, as well as in the setting of solid organ transplantation.

The terms therapeutic apheresis, plasmapheresis, and plasma exchange (PE) are often used interchangeably, but when properly used denote different procedures. The American Society for Apheresis (ASFA) definitions for these procedures are as follows:

  • Apheresis: A procedure in which blood of the patient or donor is passed through a medical device, which separates out one or more components of blood and returns remainder with or without extracorporeal treatment or replacement of the separated component.
  • Plasmapheresis: A procedure in which blood of a patient or the donor is passed through a medical device which separates out plasma from the other components of blood and the plasma is removed (i.e., less than 15% of total plasma volume) without the use of replacement solution.
  • Plasma exchange: A therapeutic procedure in which blood of the patient is passed through a medical device, which separates out plasma from other components of blood, the plasma, is removed and replaced with a replacement solution such as colloid solution (e.g., albumin and/ or plasma) or a combination of crystalloid/colloid solution.

This policy addresses only plasma exchange as a therapeutic apheresis procedure.

The rationale for PE is because circulating substances, such as toxins or autoantibodies, can accumulate in the plasma. In addition, it is hypothesized that removal of these factors can be therapeutic in certain situations. PE is essentially a symptomatic therapy, since it does not remove the source of the pathogenic factors. Therefore, the success of PE will depend on whether the pathogenic substances are accessible through the circulation and whether PE can adequately address their rate of production and transfer to the plasma component. For example, PE can rapidly reduce levels of serum autoantibodies; however, through a feedback mechanism, this rapid reduction may lead to a rebound overproduction of the same antibodies. This rebound production of antibodies is thought to render the replicating pathogenic clone of lymphocytes more vulnerable to cytotoxic drugs; therefore, PE is sometimes used in conjunction with cyclophosphamide.

Applications of PE can be broadly subdivided into two general categories: 1) acute self-limited diseases, in which PE is used to acutely lower the circulating pathogenic substance; and 2) chronic diseases, in which there is ongoing production of pathogenic autoantibodies. Because PE does not address underlying pathology, and, due to the phenomenon of rebound antibody production, its use in chronic diseases has been more controversial than in acute self-limited diseases.

In addition, plasmapheresis has been used in the setting of solid organ transplantation. It has been used as a technique to desensitize high-risk patients prior to transplant and as a treatment of antibody-mediated rejection reaction (AMR) occurring after transplant. Prior to transplant, plasmapheresis has been most commonly used to desensitize patients receiving an ABO mismatched kidney, often in combination with a splenectomy. As a treatment of AMR, plasmapheresis is often used in combination with intravenous immunoglobulin (IVIG) or anti-CD20 therapy (i.e., rituximab).

KEY POINTS:

This policy has been updated regularly with searches of the PubMed database. The most recent literature update was performed through July 7, 2024.

Summary of Evidence

In conclusion, due to data from published studies and/or clinical support, plasma exchange meets medical criteria for coverage for selected conditions. For conditions other than those selected, plasma exchange is considered investigational.

Practice Guidelines and Position Statements

National Comprehensive Cancer Network

In the current National Comprehensive Cancer Network guidelines on multiple myeloma (v.4.2024), use of plasmapheresis to improve renal function is a category 2B recommendation. Plasmapheresis should also be used as adjunctive therapy for symptomatic hyperviscosity.

American Academy of Neurology

In 2011, the American Academy of Neurology issued evidence-based guidelines on plasmapheresis for the treatment of neurologic disorders. The primary conclusions, based on the evidence review, are provided in Table 1.

Table 1. Guidelines on Use Plasmapheresis to Treat Neurologic Disorders

Recommendation

Conclusion

Acute inflammatory demyelinating polyradiculoneuropathy(Guillain-Barré syndrome)

Established effective

Chronic inflammatory demyelinating polyneuropathy(CIDP), short-term treatment

Established effective

Relapses in multiple sclerosis

Probably effective

Fulminant demyelinating central nervous system disease

Possibly effective

Chronic or secondary progressive multiple sclerosis

Established ineffective

Myasthenia gravis

Insufficient evidence

Sydenham chorea

Insufficient evidence

Acute obsessive-compulsive disorder and tics in PANDAS

Insufficient evidence

PANDAS: pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections.

In 2003, the American Academy of Neurology published a practice parameter on Guillain-Barré syndrome (GBS). The following are the key findings: (1) treatment with plasma exchange (PE) or intravenous immunoglobulin hastens recovery from GBS; (2) combining the 2 treatments is not beneficial; and (3) steroid treatment given alone is not beneficial. The American Academy of Neurology’s recommendations are:

  • PE is recommended for adults with GBS who are nonambulant and who seek treatment within 4 weeks of the onset of neuropathic symptoms;
  • PE should be considered for ambulant patients examined within 2 weeks of the onset of neuropathic symptoms);
  • PE is a treatment option for children with severe GBS.

American Society for Apheresis

In 2023, the American Society for Apheresis updated its guidelines on the use of therapeutic apheresis (Ninth Special Issue). The following is a description of the Society categories (see Table 2).

Table 2. American Society for Apheresis Categories

Category

Description

I

Disorders for which apheresis is accepted as first-line treatment, either as a primary standalone treatment or in conjunction with other modes of treatment. 

II

Disorders for which apheresis is accepted as second-line treatment, either as a standalone treatment or in conjunction with other modes of treatment.

III

Optimum role of apheresis therapy is not established. Decision making should be individualized.

IV

Disorders in which published evidence demonstrates or suggests apheresis to be ineffective or harmful. IRB approval is desirable if apheresis treatment is undertaken in these circumstances.

IRB = Institutional Review Board

Table 3. American Society for Apheresis 2023 Key Recommendations

Indication

Modality

Category

Acute disseminated encephalomyelitis (ADEM): Steroid refractory

TPE

II

Acute fatty liver of pregnancy

TPE

III

Acute inflammatory demyelinating polyradiculoneuropathy (Guillain-Barré syndrome): Primary treatment

TPE
IA

I
I

Acute liver failure

TPE
TPE-HV

III
I

Age-related macular degeneration, dry, high-risk

DFPP

III

Alzheimer disease, mild or moderate

TPE

III

Amyloidosis, systemic, dialysis-related

Beta2 microglobulin adsorption

II

Anti-glomerular basement membrane disease (Goodpasture syndrome)

  • Diffuse alveolar hemorrhage (DAH)

TPE

I

  • Dialysis-independence

TPE

I

  • Dialysis-dependence, no DAH

TPE

III

Atopic dermatitis (atopic eczema), recalcitrant

ECP/IA/TPE/DFPP

III

Autoimmune dysautonomia

TPE

III

Autoimmune hemolytic anemia (AIHA), severe

  • Severe cold agglutinin disease

TPE

II

  • Severe warm AIHA

TPE

III

Babesiosis, severe

RBC exchange

III

Burn shock resuscitation

TPE

III

Cardiac neonatal lupus

TPE

III

Catastrophic antiphospholipid syndrome (CAPS)

TPE

I

Chronic acquired demyelinating polyneuropathies

  • IgG/IgA/IgM related

TPE

I

  • Anti-myelin-associated glycoprotein

TPE

III

  • Chronic ataxic neuropathy, ophthalmoplegia, IgM paraprotein, cold agglutinins, and disialosyl antibodies (CANOMAD)/Chronic ataxic neuropathy with disialosyl antibodies syndrome (CANDA)

TPE

III

Chronic focal encephalitis (Rasmussen encephalitis)

TPE/IA

III

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

TPE/IA

I

Coagulation factor deficiency and inhibitors

IA

III

TPE

III

Complex regional pain syndrome, chronic

TPE

III

Cryoglobulinemia, severe/symptomatic

TPE/DFPP
IA

II
II

Cutaneous T cell lymphoma (CTCL)

  • Erythrodermic mycosis fungoides/Sézary syndrome

ECP

I

  • Non-erythrodermic mycoses fungoides

ECP

III

Dilated cardiomyopathy, idiopathic, NYHA II-IV

IA
TPE

II
III

Erythrocytosis

  • Polycythemia vera

Erythrocytapheresis

I

  • Secondary erythrocytosis

Erythrocytapheresis

III

Erythropoietic protoporphyria, liver disease

TPE/RBC exchange

II

Familial hypercholesterolemia

  • Homozygous individuals

LA

I

  • Heterozygous individuals

LA

II

  • All patients

TPE

II

Focal segmental glomerulosclerosis (FSGS)

  • Recurrent in kidney transplant

TPE/IA

I

  • All types

LA

II

  • Steroid resistant in native kidney

TPE

III

Graft-versus-host disease (GVHD)

  • Acute

ECP

II

  • Chronic

ECP

II

Hemophagocytic lymphocytosis (HLH)

TPE

III

Heparin-induced thrombocytopenia and thrombosis

  • Pre-procedure

TPE/IA

III

  • Refractory or with thrombosis

TPE

III

Hereditary hemochromatosis

Erythrocytapheresis

I

Hyperleukocytosis

Leukocytapheresis

III

Hypertriglyceridemic pancreatitis

  • Severe

TPE/LA

III

  • Prevention of relapse

TPE/LA

III

Hyperviscosity in hypergammaglobulinemia

  • Symptomatic

TPE

I

  • Prophylaxis for rituximab

TPE

I

Idiopathic inflammatory myopathies

  • Anti-synthetase-syndrome

TPE

III

  • Clinically amyopathic dermatomyositis

TPE

III

  • Immune-mediated necrotizing myopathies

TPE

III

IgA nephropathy (Berger's disease)

  • Chronic progressive

TPE

III

  • Crescentic

TPE

III

Immune checkpoint inhibitors, immune-related adverse events

TPE

III

Immune thrombocytopenia (ITP), refractory

TPE/IA

III

Inflammatory bowel disease

  • Ulcerative colitis

Adsorptive cytapheresis

II

  • Crohn disease

Adsorptive cytapheresis/ECP

III

Lambert-Eaton myasthenic syndrome

TPE

II

Lipoprotein(a) hyperlipoproteinemia, progressive atherosclerotic cardiovascular disease

LA

II

Malaria, severe*

RBC exchange

III

Multiple sclerosis

  • Acute attack/relapse

TPE/IA

II

  • Chronic

TPE/IA

III

Myasthenia gravis

  • Acute, short-term treatment

TPE/DFPP/IA

I

  • Long-term treatment

TPE/DFPP/IA

II

Myeloma cast nephropathy

TPE

II

Nephrogenic systemic fibrosis

ECP/TPE

III

Neuromyelitis optical spectrum disorders (NMOSD)

  • Acute attack/relapse

TPE/IA

II

  • Maintenance

TPE

III

N-methyl-D-aspartate receptor antibody encephalitis

TPE/IA

I

Overdose, envenomation, and/or poisoning

  • Mushroom poisoning

TPE

II

  • Envenomation

TPE

III

  • Other

TPE/RBC exchange

III

Paraneoplastic autoimmune retinopathies

TPE

III

Paraneoplastic neurologic syndromes

TPE/IA

III

Pediatric autoimmune neuropsychiatric disorders

  • Pediatric autoimmune neuropsychiatric disorder associated with group A streptococci (PANDAS)/Pediatric acute-onset neuropsychiatric syndrome (PANS), exacerbation

TPE

II

  • Sydenham chorea, severe

TPE

III

Pemphigus vulgaris, severe

TPE
IA/ECP/DFPP

III
III

Peripheral vascular diseases

LA

II

Phytanic acid storage disease (Refsum disease)

TPE/LA

II

Post-transfusion purpura (PTP)

TPE

III

Progressive multifocal leukoencephalopathy (PML) associated with natalizumab

TPE

III

Pruritus due to hepatobiliary disease, treatment resistant

TPE

III

Psoriasis, disseminated pustular

ECP
Adsorptive cytapheresis

TPE

III
III
IV

Red blood cell alloimmunization, pregnancy complications

  • Hemolytic disease of the fetus and newborn

TPE

III

  • RhD alloimmunization prophylaxis after transfusion

RBC exchange

IV

Sepsis with multiorgan failure

TPE

III

Sickle cell disease

  • Acute stroke

RBC exchange

I

  • Acute chest syndrome, severe

RBC exchange

II

  • Other acute complications

RBC exchange/TPE

III

  • Stroke prophylaxis

RBC exchange

I

  • Pregnancy

RBC exchange

II

  • Recurrent vaso-occlusive pain

RBC exchange

II

  • Preoperative management

RBC exchange

III

Steroid-responsive encephalopathy associated with autoimmune thyroiditis (Hashimoto encephalopathy)

TPE

II

Stiff-person syndrome

TPE

III

Sudden sensorineural hearing loss

LA/DFPP/TPE

III

Systemic lupus erythematosus (SLE): Severe complications

TPE

II

Systemic sclerosis

ECP
TPE

III
III

Thrombocytosis

  • Symptomatic

Thrombocytapheresis

II

  • Prophylactic or secondary

Thrombocytapheresis

III

Thrombotic microangiopathy

  • Coagulation-mediated, due to pathogenic variants in THBDDGKE, or PLG

TPE

III

  • Complement-mediated, due to factor H autoantibodies

TPE

I

  • Complement-mediated, due to pathogenic variants in complement regulatory genes

TPE

III

  • Drug-associated: Ticlopidine

TPE

I

  • Drug-associated: Clopidogrel

TPE

III

  • Drug-associated: Gemcitabine

TPE

IV

  • Drug-associated: Quinine

TPE

IV

  • Infection-associated, from Shiga toxin-producing Escherichia coli (STEC-HUS), severe

TPE/IA

III

  • Infection-associated, from Streptococcus pneumoniae (pHUS)

TPE

III

  • Pregnancy associated, severe

TPE

III

  • Pregnancy associated, extremely preterm preeclampsia, severe

TPE/LA

III

  • Thrombotic thrombocytopenic purpura (TTP; immune, with ADAMTS13 deficiency)

TPE

I

  • Transplantation-associated

TPE

III

Thyroid storm

TPE

II

Toxic epidermal necrolysis (TEN), refractory

TPE

III

Transplantation, heart

  • Cellular/recurrent rejection

ECP

II

  • Rejection prophylaxis

ECP/TPE

II

  • Desensitization

TPE

II

  • Antibody-mediated rejection

TPE

III

Transplantation, hematopoietic stem cell, ABO incompatible

  • Major ABO incompatible, hematopoietic cells obtained from bone marrow

TPE

II

  • Major ABO incompatible, hematopoietic cells obtained by apheresis

TPE

II

  • Minor ABO incompatible, hematopoietic cells obtained by apheresis

RBC exchange

III

  • Pure RBC aplasia

TPE

III

Transplantation, hematopoietic stem cell, HLA desensitization

TPE

III

Transplantation, intestine

  • Antibody mediated rejection

TPE

III

  • Desensitization

TPE

III

Transplantation, kidney, ABO compatible

  • Antibody mediated rejection

TPE/IA

I

  • Desensitization/prophylaxis, living donor

TPE/IA

I

Transplantation, liver

  • Desensitization, ABO incompatible, living donor

TPE

I

  • Desensitization, ABO incompatible, deceased donor

TPE

III

  • Antibody-mediated rejection

ECP/TPE

III

  • Immune suppression withdrawal

ECP

III

  • Desensitization, ABO incompatible

ECP

III

Transplantation, lung

  • Chronic allograft dysfunction

ECP

II

  • Bronchiolitis obliterans syndrome

ECP

II

  • Antibody-mediated rejection/desensitization

TPE

III

  • Desensitization

TPE

III

Vaccine-induced thrombotic thrombocytopenia, refractory

TPE

III

Vasculitis, ANCA-associated

  • Microscopic polyangiitis

TPE

III

  • Granulomatosis with polyangiitis

TPE

III

  • Eosinophilic granulomatosis with polyangiitis (EGPA; Churg-Strauss)

TPE

III

Vasculitis, IgA (Henoch-Schönlein purpura)

  • Crescentic rapidly progressive glomerulonephritis (RPGN)

TPE

III

  • Severe extrarenal manifestations

TPE

III

Vasculitis, other

  • Hepatitis B polyarteritis nodosa

TPE

II

  • Kawasaki disease

TPE

III

  • Multisystem inflammatory syndrome in children (MIS-C)

TPE

III

Voltage-gated potassium channel (VGKC) antibody-related disease

TPE/IA

II

Wilson disease, fulminant

TPE

I

TPE: therapeutic plasma exchange; IA: immunoadsorption; TPE-HV: high-volume therapeutic plasma exchange; ECP: extracorporeal photopheresis; DFPP: double filtration plasmapheresis; NYHA: New York Heart Association; RBC: red blood cell; LA: lipoprotein apheresis; Ig: immunoglobulin; HLA: human leukocyte antigen.

U.S. Preventative Services Task Force Recommendations

Not applicable

KEY WORDS:

Plasma exchange, plasmapheresis, apheresis, therapeutic apheresis, therapeutic plasma exchange, Rheo, Rheopheresis, focal glomerulosclerosis, FGS, focal segmental glomerulosclerosis, FSGS, Neuromyelitis optica, NMO, Devic syndrome

APPROVED BY GOVERNING BODIES:

The U.S. Food and Drug Administration has a compliance program to ensure that source plasma, source leukocytes, and therapeutic exchange plasma for further manufacture into products for human use are safe, pure, potent, and appropriately labeled. The compliance program covers products intended for use in both injectable drug products (e.g., immune globulin, albumin) and noninjectable products (e.g., in vitro devices such as blood bank reagents). Product Code for Therapeutic Exchange Plasma (TEP): 57DI-65.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply.  Refer to member’s benefit plan.  

CODING: 

CPT code:

36514

Therapeutic apheresis; for plasma pheresis

REFERENCES:

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  29. Lewis EJ. Hunsicker LG, Lan SP et al. A controlled trial of plasmapheresis therapy in severe lupus nephritis. The Lupus Nephritis Collaborative Study Group. N Engl J Med 1992; 326(21): 1373-1379.
  30. Liu J, Wang W, Zhao C et al. Comparing the autoantibody levels and clinical efficacy of double filtration plasmapheresis, immunoadsorption and intravenous immunoglobulin for the treatment of late-onset myasthenia gravis. Ther Apher Dial 2010; 14(2):153-160.
  31. Madore F. Plasmapheresis: Technical aspects and indications. Crit Care Clin 2002; 18 (2):375-92.
  32. Martin LK, Werth VP, Villaneuva EV, Murrell DF. A systematic review of randomized controlled trials for pemphigus vulgaris and pemphigus foliaceus. J Am Acad Dermatol. 2011 May;64(5):903-8.
  33. Matolon A, Markowitz GS, et al. Plasmapheresis treatment of recurrent FSGS in adult renal transplant recipients. Clin Nephrol 2001 Oct; 56(4):271-278.
  34. Mehndiratta MM, Hughes RA, Pritchard J. Plasma exchange for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. Aug 25 2015; 8(8):CD003906.
  35. Merle H, Olindo S, Jeannin S, et al. Treatment of optic neuritis by plasma exchange (add-on) in neuromyelitis optica. Arch Ophthalmol. Jul 2012; 130(7):858-862.
  36. Michael M, Elliott EJ, et al. Interventions for hemolytic uremic syndrome and thrombotic thrombocytopenic purpura: A systematic review of randomized controlled trials. Am J Kidney Disease, February 2009; 53(2): 259-272.
  37. Miller FW, Leitman SF, Cronin ME et al. Controlled trial of plasma exchange and leukapheresis in polymyositis and dermatomyositis. N Engl J Med 1992; 326(21): 1380-1384.
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  39. National Institute for Neurological Disorders and Stroke (NINDS). NINDS Neuromyelitis Optica Information Page. www.ninds.nih.gov/health-information/disorders/neuromyelitis-optica.
  40. Nicolson R. An open trial of plasma exchange in childhood-onset obsessive-compulsive disorder without poststreptococcal exacerbations. J Am Acad Child Adolesc Psychiatry 2000; 39 (10): 1313-1315.
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POLICY HISTORY:

TEC Assessment, November 1998

Medical Policy Group, March 2003 (2)

Medical Policy Administration Committee, March 2003

Available for comment April 1-May 16, 2003

Medical Policy Group, March 2005 (1)

Medical Policy Administration Committee, July 2005 (2)

Available for comment July 28-September 10, 2005

Medical Policy Group, January 2006 (2)

Medical Policy Administration Committee, February 2006

Available for comment March 4-April 17, 2006

Medical Policy Group, September 2006 (4)

Medical Policy Administration Committee, September 2006

Available for comment September 22-November 5, 2006

Medical Policy Group, September 2008 (1)

Medical Policy Administration Committee, October 2008

Available for comment October 4-November 17, 2008

Medical Policy Group, June 2009 (1)

Medical Policy Administration Committee, July 2009

Available for comment July 2-August 15, 2009

Medical Policy Group, September 2009 (2)

Medical Policy Administration Committee, October 2009

Available for comment October 3-November 17, 2009

Medical Policy Group, February 2010 (1): Updated policy for covered and non-covered conditions, reference list

Medical Policy Administration Committee, April 2010

Available for comment April 7-May 21, 2010

Medical Policy Group, January 2012 (3): Updated Key Points and References

Medical Policy Panel, May 2013

Medical Policy Group, May 2013 (1): Update to Policy with added coverage for CAPS, myeloma with renal failure, dense deposit disease with factor H and/or C3 Nephritic factor and focal segmental glomerulosclerosis after renal transplant. Serum creatinine threshold removed from ANCA-associated vasculitis criteria; updated Key Points and References

Available for comment May 22 through July 5, 2013

Medical Policy Panel, May 2014

Medical Policy Group, June 2014 (1): Update to Key Points and References; no change to policy statement

Medical Policy Panel, May 2015

Medical Policy Group, June 2015 (3): 2015 Updates to Key Points & References; no change in policy statement (only verbiage updates added clarifying some abbreviations of conditions listed.

Medical Policy Panel, September 2017

Medical Policy Group, October 2017 (7): Updates to Key Points and References. Policy Statement- added coverage for “N-methyl-d-aspartate receptor antibody encephalitis and Progressive multifocal leukoencephalopathy associated with natalizumab.”

Medical Policy Group, November 2020 (3): Update to Key Points and References; no change to policy statement.

Medical Policy Group, August 2021 (3): Updates to Key Points and References. Policy statement updated to remove “not medically necessary”, no other changes to policy statement or intent.

A peer reviewed literature analysis was completed and no new information was identified that would alter the coverage statement of this policy.

Medical Policy Group, August 2022 (3): 2022 Updates to Key Points, Practice Guidelines and Position Statements, and References. A peer reviewed literature analysis was completed and no new information was identified that would alter the coverage statement of this policy.

Medical Policy Group, July 2023 (11): 2023 Updates to Key Points, Benefit Application, and References. A peer reviewed literature analysis was completed and no new information was identified that would alter the coverage statement of this policy.

Medical Policy Group, July 2024 (11): 2024 Updates to Key Points, and References. A peer reviewed literature analysis was completed and no new information was identified that would alter the coverage statement of this policy.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.