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 THBD, DGKE, 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

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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.
41. Noris M and Remuzzi G. Atypical hemolytic-uremic syndrome. NEJM, October 2009; 361(17): 1676-1687.
42. Okamoto T, Ogawa, M, Lin Y, et al. Treatment of neuromyelitis optica: Current debate.  Therapeutic Advances in Neurological Disorders 2008; 1(43):43-52.
43. Owen RG, Pratt G, Auer RL, et al; British Committee for Standards in Haematology. Guidelines on the diagnosis and management of Waldenström macroglobulinaemia. Br J Haematol. 2014 May;165(3):316-333.
44. Padmanabhan A, Connelly-Smith L, Aqui N, et al. Guidelines on the Use of Therapeutic Apheresis in Clinical Practice –Evidence-Based Approach from the Writing Committee of the American Society for Apheresis: The Eighth Special Issue. J Clin Apher. Jun 2019; 34(3):171–354.
45. Pagano MB, Murinson BB, Tobian AA, et al. Efficacy of therapeutic plasma exchange for treatment of stiff-person syndrome. Transfusion. Jul 2014; 54(7):1851-1856.
46. Perlmutter SJ, Leitman SF, Garvey MA, et al. Therapeutic plasma exchange and intravenous immunoglobulin for obsessive-compulsive disorder and tic disorders in childhood. Lancet, October 1999; 354(9185): 1137-1138.
47. Pham HP, Williams LA, 3rd. Therapeutic plasma exchange in two patients with stiff-person syndrome. J Clin Apher. Oct 2016; 31(5):493-494.
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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.