Therapeutic Apheresis
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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.
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).
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.
Medically Necessary Indications
Medically Necessary Indications
Therapeutic apheresis is considered medically necessary for any of the conditions listed below:
Serum creatinine threshold per policy
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.
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 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
Use of MCG Criteria
CareFirst has adopted MCG Care Guidelines® (Therapeutic Apheresis) for medical necessity and clinical appropriateness; reviewers will reference those proprietary criteria.
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.
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
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.
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.
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).
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