RetiredCareFirstPolicy 7.01.030

Therapeutic Apheresis

Defines medical necessity indications and experimental/investigational exclusions for therapeutic apheresis procedures; CareFirst adopts MCG Care Guidelines® for clinical criteria and requires checking member contract and prior authorization when applicable.

Policy Summary

PayerCareFirst

PolicyTherapeutic Apheresis

Policy CodePolicy 7.01.030

Change TypeRetired; adopted MCG criteria

Effective Date02/01/2026

Next Review DateN/A

Key ActionSubmit preauthorization requests when specified by contract and verify member benefits; reviewers will reference MCG Care Guidelines® for medical necessity.

POLICY UPDATE CHANGES

Update 2025: CareFirst adopted the position of MCG Care Guidelines® and retired the policy; literature review March 2025–October 2025 did not change conclusions.

Update 2024: MCG updates resulted in adding age-related macular degeneration and Refsum's disease as medically necessary indications and classifying other diagnoses as experimental/investigational.

Multiple prior updates (2019, 2017, 2015, 2013, 2010, 2008) modified or clarified medically necessary indications over time (examples: addition of NMDA receptor antibody encephalitis in 2019; ABO incompatible HPC transplantation and ANCA vasculitis in 2010).

~60Listed Medically Necessary Indications

MCGAdopted External Criteria Source

1Policy Status

Coverage Summary

Scope: Defines medically necessary indications and experimental/investigational exclusions for therapeutic apheresis (plasmapheresis, plasma exchange, cytapheresis, extracorporeal immunoadsorption) and requires checking member contract and prior authorization when applicable.

Coverage stance and status: CareFirst's stance is mixed (some indications are medically necessary; others are experimental/investigational). The policy is RETIRED and effective 02/01/2026; CareFirst has adopted the proprietary clinical criteria of MCG Care Guidelines® for medical necessity and clinical appropriateness.

High-level note: The policy references ~60 listed medically necessary indications and indicates adoption of external criteria from MCG (see provider guidance to use MCG criteria). Statistical/summary items in the brief (e.g., counts and adopted source) are noted here but not duplicated in the stats bar.

Policy Key Values

policy_number7.01.030

subjectTherapeutic Apheresis

statusRETIRED

effective_date02/01/2026

last_review10/08/2025

adopted_criteria_sourceCareFirst adopted MCG Care Guidelines® (Therapeutic Apheresis) for medical necessity guidance (2025).

serum_creatinine_threshold> 5.8 mg/dl (for ANCA-associated vasculitis with associated renal failure)

Medically Necessary Indications

Therapeutic apheresis is considered medically necessary for any of the conditions listed below:

ABO incompatible hematopoietic progenitor cell transplantation

acute inflammatory demyelinating polyneuropathy (Guillain-Barré syndrome); severity grade 1-2 within 2 weeks of onset; severity grade 3-5 within 4 weeks of onset; as an alternative to intravenous immunoglobulin (IVIG)

age-related macular degeneration

amanita mushroom poisoning

ANCA-associated vasculitis with associated renal failure (serum Cr > 5.8 mg/dl)> 5.8 mg/dl

Serum creatinine threshold per policy

anti-glomerular basement membrane disease (progressive renal failure due to anti-basement membrane antibodies) (Goodpasture's syndrome)

antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis

antiphospholipid syndrome (catastrophic)

autoimmune encephalitis

babesiosis (severe)

cardiac transplant

chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

cryoglobulinemia

cutaneous T-cell lymphoma (mycosis fungoides or Sezary syndrome) for stage III or stage IV disease

familial homozygous hypercholesterolemia

focal segmental glomerulosclerosis

graft vs host disease, steroid-dependent or steroid-refractory

HELLP syndrome of pregnancy (hemolysis, elevated liver enzymes, low platelets)

hemochromatosis (hereditary)

hemolytic uremic syndrome (HUS)

heterozygous familial hypercholesterolemia

homozygous familial hypercholesterolemia

hyperviscosity due to clonal thrombocytosis (e.g., essential thrombocythemia or other myeloproliferative disorder)

hyperviscosity due to erythrocytosis

hyperviscosity due to leukocytosis

hyperviscosity due to monoclonal gammopathy (e.g., Waldenstrom macroglobulinemia; multiple myeloma with IgA, IgG, or kappa light chains)

idiopathic thrombocytopenic purpura (ITP) in life-threatening situations

leukemia

lipoprotein(a) hyperlipoproteinemia

liver failure (acute)

liver transplant (ABO-incompatible)

lung allograft rejection

multiple sclerosis (acute, unresponsive to steroids) or other conditions such as transverse myelitis, acute fulminant CNS demyelination

myasthenia gravis

neuromyelitis optica spectrum disorder (acute), when high-dose intravenous steroids fail to resolve symptoms

N-methyl-D-aspartate receptor antibody encephalitis

paraproteinemia polyneuropathy, IgA, or IgG

pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS)

phytanic acid storage disease (Refsum disease)

polyarteritis nodosa associated with hepatitis B virus, in combination with glucocorticoids

polyneuropathy due to monoclonal gammopathy (paraprotein neuropathy) with IgA, IgG, or IgM

post-transfusion purpura

pure red cell aplasia unresponsive to steroid and immunosuppressive therapy (including sickle cell disease/sickle cell anemia)

Refsum's disease

renal transplant (ABO-compatible)

renal transplant (ABO-incompatible)

sickle cell disease (acute) with complications

sickle cell disease (nonacute) with complications

rheumatoid arthritis

solid organ transplant patients in acute antibody-mediated organ rejection or in those at high risk for antibody-mediated organ rejection

thrombotic microangiopathy (drug-related)

thrombotic thrombocytopenic purpura (TTP)

vasculitis associated with Human Immunodeficiency Virus (HIV)

Wilson disease

Experimental / Investigational Indications

Experimental/Investigational Indications

All other applications of therapeutic apheresis for conditions not listed in the medically necessary statement are considered experimental/investigational because they do not meet TEC criteria #2-5.

Indications lacking sufficient evidence include (but are not limited to): ALS, asthma, chronic fatigue syndrome (including Long COVID), paraneoplastic syndromes including Lambert-Eaton myasthenic syndrome, paraproteinemic peripheral neuropathy associated with POEMS syndrome and MGUS, pemphigus, polymyositis, dermatomyositis, scleroderma, systemic lupus erythematosus (SLE), Crohn's disease (except limited evidence for ulcerative colitis with GMA), and other diagnoses not listed as medically necessary.

The policy applies BlueCross BlueShield Association (BCBSA) Medical Policy Services (MPS)/TEC assessment criteria: all five criteria must be met for procedures to be considered non-experimental.

BCBSA/MPS (TEC) five criteria are listed in policy

See the Definitions entry for Experimental/Investigational for the formal description and the five BCBSA/MPS TEC criteria that must all be met for a technology to avoid that classification.

Implications: Therapeutic apheresis indications that are not included in the medically necessary list are considered experimental/investigational because they do not meet TEC criteria #2–5 and may be denied for not meeting policy criteria; providers should submit preauthorization requests and verify member contract benefits when applicable.

Provider Actions & Documentation

Prior Authorization

Prior Authorization Required When Specified By Contract

Some services, devices, drugs, and places of service require prior authorization; providers should submit preauthorization requests online or call 1-866-773-2884 (1-866-PRE-AUTH). Always check the member's contract for benefits.

Call 1-866-773-2884 (1-866-PRE-AUTH) for prior authorization
Always check the member's contract for benefits

Documentation Required

Use of MCG Criteria

CareFirst has adopted MCG Care Guidelines® (Therapeutic Apheresis) for medical necessity and clinical appropriateness; reviewers will reference those proprietary criteria.

Denial Risk

Experimental/Investigational Denial Risk

Therapeutic apheresis for indications not listed as medically necessary is considered experimental/investigational and may be denied as not meeting policy criteria.

Background & Evidence

Background: Therapeutic apheresis encompasses procedures that separate plasma or cellular blood components for treatment, including plasmapheresis, plasma exchange, cytapheresis, and extracorporeal immunoadsorption. Plasmapheresis/plasma exchange remove plasma which may be treated, returned, or replaced; cytapheresis selectively removes cellular elements (erythrocytapheresis, leukapheresis, thrombocytapheresis). Extracorporeal immunoadsorption uses filters (for example, Protein A columns) to selectively remove plasma components and return treated plasma to the patient.

Regulatory and guidance references: The FDA has approved specific LDL apheresis systems (Liposorber LA-15® and HELP®) and granted humanitarian device pathways and approvals for additional indications; the FDA also issued Emergency Use Authorizations during COVID-19 for Spectra Optia and Depuro D2000 adsorption cartridges. CareFirst references guidance from the American Society for Apheresis and has adopted MCG Care Guidelines® for medical necessity and clinical appropriateness.

Evidence note: A literature review covering March 2025–October 2025 found no change in conclusions; CareFirst's 2025 update states adoption of MCG criteria and that recent literature does not change prior conclusions regarding therapeutic apheresis. Prior evidence summaries note limited or weak data for many experimental/investigational indications and cite observational studies, case series, single-arm trials, and the need for robust randomized controlled trials and systematic reviews.

Evidence Items

MCG AdoptionCareFirst adopted MCG Care Guidelines® (Therapeutic Apheresis) for medical necessity and clinical appropriateness; reviewers will reference MCG proprietary criteria.

Literature Review 2025Search March 2025–October 2025 found no change in conclusions; policy retired.

Experimental/Investigational: Services or supplies that do not meet the five BCBSA/MPS assessment criteria (final U.S. regulatory approval, evidence permitting conclusions about health outcomes, demonstrated net health outcome improvement, parity with established alternatives, and attainability outside investigational settings) are considered experimental/investigational.

Revision History

2025retirement/adoptionLatest

Policy retired; CareFirst adopted MCG Care Guidelines® (Therapeutic Apheresis) and proprietary clinical criteria for medical necessity; literature search March–October 2025 found no change in conclusions.

2024revised indications

MCG updates resulted in adding age-related macular degeneration and Refsum's disease as medically necessary indications and updating the experimental/investigational statement to include all other diagnoses not listed as medically necessary.

historical (2019, 2017, 2015, 2013, 2010, 2008)historical updates

Multiple prior updates modified or clarified medically necessary indications over time (examples: addition of N-methyl-D-aspartate receptor antibody encephalitis in 2019; addition of ABO incompatible hematopoietic progenitor cell transplantation and ANCA-associated vasculitis in 2010; other incremental changes in 2017, 2015, 2013, and 2008).