ModifiedUnitedHealthcarePolicy CS004NE.R

Apheresis (for Nebraska Only)

Policy governing coverage and medical necessity criteria for therapeutic apheresis procedures (e.g., plasma exchange, photopheresis, LDL apheresis) for members in the state of Nebraska.

Policy Summary

PayerUnitedHealthcare

PolicyApheresis (for Nebraska Only)

Policy CodePolicy CS004NE.R

Change TypeScope expansion + documentation clarifications

Effective DateDec 1, 2025

Next Review Date

Key ActionObtain prior authorization when required and submit supporting documentation demonstrating the member meets medical necessity criteria, including relevant history, exam, and diagnostic test results.

SourceLink

POLICY UPDATE CHANGES

Replaced language limiting 'unproven and not medically necessary' to a listed set of conditions with a broader statement that therapeutic apheresis is unproven and not medically necessary for treating or managing any other conditions/diagnoses not listed as proven and medically necessary.

Added explicit medical record documentation requirements supporting medical necessity for requested services.

Updated Clinical Evidence, FDA, and References sections to reflect most current information.

~40+conditions listed (proven/unproven)

1state-specific policy (NE)

7procedure codes listed

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

coverage stance: insufficient evidence

Coverage Criteria for Therapeutic Apheresis

Covered Indications — Therapeutic Apheresis

Therapeutic apheresis is proven and medically necessary for the following conditions/diagnoses when policy-specific documentation and prior authorization (when required) criteria are met:

Acute inflammatory demyelinating polyneuropathy (Guillain–Barré syndrome), primary treatment

Acute liver failure requiring high-volume therapeutic plasma exchange (TPE-HV)

Anti-glomerular basement membrane disease (Goodpasture syndrome) in dialysis-independent patients or those with diffuse alveolar hemorrhage

Chronic acquired demyelinating polyneuropathies including IgG/IgA/IgM-related neuropathies and anti-myelin-associated glycoprotein neuropathy

Chronic inflammatory demyelinating polyneuropathy (CIDP)

Cryoglobulinemia, as second-line therapy when first-line treatments fail or are contraindicated

Cutaneous T-cell lymphoma: erythrodermic mycosis fungoides and Sézary syndrome

Erythrocytosis due to polycythemia vera when apheresis is indicated for acute management

Idiopathic dilated cardiomyopathy, NYHA class II-IV, when immunoadsorption is used as a therapeutic modality

Familial hypercholesterolemia: lipoprotein apheresis for homozygous familial hypercholesterolemia (first-line) and selected heterozygotes (second-line) when maximal tolerated medical therapy is insufficient

Focal segmental glomerulosclerosis (FSGS), recurrent in the transplanted kidney (second-line therapy)

Graft-versus-host disease (GVHD): acute GVHD (as indicated) and chronic GVHD as second-line therapy

Hereditary hemochromatosis when therapeutic apheresis (erythrocytapheresis) is indicated

Hypertriglyceridemic pancreatitis, severe, for rapid triglyceride reduction when clinically indicated

Hyperviscosity syndromes associated with hypergammaglobulinemia (e.g., Waldenström macroglobulinemia, multiple myeloma with hyperviscosity)

Inflammatory bowel disease (ulcerative colitis and selected Crohn's disease indications) via adsorptive cytapheresis or extracorporeal photopheresis where evidence supports use and other therapies fail

Covered Regimens and Modalities

Indication	Regimen
Cutaneous T-cell lymphoma — erythrodermic mycosis fungoides or Sézary syndrome
Extracorporeal photopheresis (or other apheresis modality as clinically appropriate)

Indication	Coverage stance	Notes / Rationale
Cutaneous T-cell lymphoma — mycosis fungoides, non-erythrodermic
Not medically necessary / Unproven
Listed among related/unproven indications; evidence insufficient for routine apheresis in non-erythrodermic MF per policy related-indications list

Provider Actions, Prior Authorization, and Documentation

Reference CPT/CPT-like Procedure CodesCPT

0342T	Therapeutic apheresis with selective HDL delipidation and plasma reinfusion
36511	Therapeutic apheresis; for white blood cells
36512	Therapeutic apheresis; for red blood cells
36513	Therapeutic apheresis; for platelets
36514	Therapeutic apheresis; for plasma pheresis
36516	Therapeutic apheresis; with extracorporeal immunoadsorption, selective adsorption or selective filtration and plasma reinfusion
36522	Photopheresis, extracorporeal

Prior Authorization

Prior authorization and coding reference — codes listed for reference; inclusion not guarantee of coverage

Codes are provided for billing and prior authorization reference only. Inclusion of a code in this policy does not guarantee coverage or payment and does not replace the need for prior authorization when required.

Verify member benefits and obtain prior authorization when indicated.
Submission of codes alone is insufficient — include supporting clinical documentation.

Prior Authorization

Prior authorization recommended for specialty apheresis — e.g., lipoprotein apheresis, granulocyte/monocyte apheresis; include clinical details

Prior authorization is recommended for specialty apheresis procedures (for example, lipoprotein apheresis, granulocyte/monocyte adsorptive apheresis, and other specialty cytapheresis procedures). Requests should include the specific apheresis modality, indication, prior medical therapies tried, treatment frequency, anticipated duration, and relevant laboratory or imaging data.

Include genetic confirmation for homozygous familial hypercholesterolemia when available.

Procedure Codes and Coding Notes

Procedure Codes ListedCPT

0342T	Therapeutic apheresis with selective HDL delipidation and plasma reinfusion.
36511	Therapeutic apheresis; for white blood cells.
36512	Therapeutic apheresis; for red blood cells.
36513	Therapeutic apheresis; for platelets.
36514	Therapeutic apheresis; for plasma pheresis.
36516	Therapeutic apheresis; with extracorporeal immunoadsorption, selective adsorption or selective filtration and plasma reinfusion.
36522	Photopheresis, extracorporeal

Note

Prior authorization and coding reminder

Reminder: procedure and CPT codes in the policy are for reference only; listing a code does not ensure coverage or payment. Authorization requirements and medical necessity determination are governed by the policy text and contract terms.

Codes listed include 0342T, 36511–36516, 36522

Definitions and Background on Apheresis Modalities

In summary, therapeutic apheresis (including plasma exchange, plasmapheresis, and photopheresis) is considered unproven and not medically necessary for numerous listed conditions due to insufficient or low‑quality evidence. The policy further clarifies that any condition not specifically listed as proven and medically necessary is likewise treated as unproven and not medically necessary; documentation must fully support any exception requests.

Therapeutic apheresis — key definitions for the group of procedures

DefinitionA group of extracorporeal procedures in which blood is collected, a specific component (plasma, cells, lipoproteins) is removed or treated and the remaining components are returned to the patient (includes plasmapheresis, immunoadsorption, photopheresis, LDL apheresis, RBC exchange, leukocytapheresis, etc.).

Typical setting and durationUsually performed in an outpatient facility and typically requires several hours per session; some plasma exchange regimens may be performed daily for at least 1 week in specific clinical situations.

Procedural variantsIncludes procedures that selectively remove components (e.g., adsorption columns, double-filtration plasmapheresis, erythrocytapheresis, thrombocytapheresis, rheopheresis).

Replacement fluids

Line of Therapy Considerations

second-line

Second-line — definition and operational note:

Second-line designation: 'Second-line' indicates apheresis is considered after initial/standard medical therapies have been tried and when used as an adjunct to those therapies (e.g., plasmapheresis with chemotherapy in myeloma cast nephropathy; recurrent FSGS in transplant).

Based on evidence summaries and line-of-therapy statements in policy.

second-line

Second-line — evidence-based operational note (alternate):

Second-line operational note: Clinical trials and systematic reviews indicate plasmapheresis alone did not show independent survival benefit in myeloma cast nephropathy; second-line use implies combination with effective chemotherapy and documentation of prior therapy is expected.

Premuzic et al.; Gupta et al.; Kalpakci et al.

Additional Provider Guidance

Prior Authorization

Policy prior authorization governance

Policy‑level prior authorization or governance notes should follow the policy’s prior authorization requirements and documentation rules; obtain authorization when required and ensure supporting records are available.

Documentation must be legible and maintained in the patient record
Authorizations are governed by the policy coverage determinations

Policy Summary

PayerUnitedHealthcare

PolicyApheresis (for Nebraska Only)

Policy CodePolicy CS004NE.R

Change TypeScope expansion + documentation clarifications

Effective DateDec 1, 2025

Next Review Date

SourceLink

On This Page

For GMA/CAP in ulcerative colitis, document prior therapies (steroids, thiopurines, biologics) and response history.

Prior Authorization

Prior authorization for chronic RCE — documentation requirements for pediatric SCD chronic automated RCE requests

For pediatric requests for chronic automated red cell exchange (RCE) in sickle cell disease, prior authorization should document underlying diagnosis, indication for chronic RCE (stroke prevention, recurrent acute chest syndrome, etc.), transfusion frequency, prior transfusion history, venous access plan, baseline hematocrit/HbS percentages, and individualized risk assessment.

Provide documentation of prior acute complications and rationale for chronic RCE (e.g., failure of alternative therapies).
If patient is <20 kg or low body weight, include device/priming plan and safety considerations.

Prior Authorization

Prior authorization for guideline-based indications — e.g., LDL apheresis for hoFH, leukapheresis in leukostasis; follow guideline criteria

For indications supported by guidelines (for example, LDL apheresis for homozygous familial hypercholesterolemia or leukapheresis for life-threatening leukostasis), prior authorization is required and requests must demonstrate alignment with guideline criteria and prior medical therapy attempts as applicable.

Document efforts to optimize lipid-modifying drug therapy before LDL apheresis when applicable.
For leukapheresis in leukostasis, document failure or contraindication of other urgent measures and current leukocyte count and clinical status.

Prior Authorization

Prior authorization for non-listed indications — governed by policy coverage determinations; services not listed require justification

Requests for apheresis to treat conditions not specifically listed as proven and medically necessary in this policy require prior authorization and will be reviewed against existing evidence. Absent compelling, peer-reviewed evidence and strong clinical rationale, such requests may be considered not medically necessary.

Include detailed clinical rationale, prior therapies tried, and objective measures of severity.
Non-listed indications lacking high-quality evidence are at increased risk of denial.

Denial Risk

HTG-induced acute pancreatitis — limited outcome benefit

Therapeutic plasma exchange for hypertriglyceridemia-induced acute pancreatitis results in faster triglyceride reduction but has not been shown to improve clinical outcomes or prognosis in available observational studies and meta-analysis. Authorizations for HTG-induced acute pancreatitis should include documentation of severity, timing relative to symptom onset, and rationale why conventional medical therapy is insufficient.

Document serum triglyceride levels and response (or lack of response) to conservative measures (insulin, heparin, aggressive IV fluids) prior to TPE.
Authorization may be limited when evidence does not demonstrate outcome benefit; provide strong justification for use.

Denial Risk

ANCA-associated vasculitis — inconclusive mortality benefit

Evidence for therapeutic plasma exchange in ANCA-associated vasculitis is mixed with meta-analyses and RCT data showing no consistent mortality benefit; there may be short-term reduction in ESRD in some early phases. Prior authorization should include disease severity, renal involvement details, timing, and explanation of how apheresis is expected to change management.

Document creatinine/trend, need for dialysis, and alternative induction therapies tried or planned.
Requests based solely on expected mortality reduction without clear renal/disease-specific rationale may be scrutinized or denied.

Documentation Required

Pediatric ABO-incompatible transplant documentation — document method used, transfusion volume, and contemporaneous data

For pediatric ABO-incompatible transplant apheresis (heart or kidney), include contemporaneous operative and transfusion details, method used (e.g., intraoperative immunoadsorption vs plasma exchange), volumes exchanged/transfused, isohemagglutinin titers pre- and post-procedure, and post-transplant monitoring and outcomes.

Specify age/weight of the child and whether RBC-primed techniques or intraoperative immunoadsorption were used.
Provide documentation of blood product utilization and any early rejection or antibody-mediated rejection (AMR) events.

Documentation Required

Recommended documentation for atypical/limited-evidence uses — document prior therapy failures and rationale for investigational use

When apheresis is requested for atypical or limited-evidence indications, prior authorization must include comprehensive supporting documentation: prior standard therapies tried and failed, literature or trial data supporting the request, expected benefit, and a monitoring plan. Requests lacking this information are at higher risk for denial.

Supply citations to peer-reviewed studies or guidelines that support the proposed use.
Describe measurable clinical objectives and duration/trial plan (e.g., number of treatments and reassessment points).

Step Therapy

Second-line therapy requirements — certain indications specify apheresis is second-line after standard treatments tried

For indications designated as second-line in this policy (for example, cryoglobulinemia, heterozygous familial hypercholesterolemia in many cases, refractory rheumatoid arthritis, focal segmental glomerulosclerosis recurrence, and others), prior authorization should document trials of standard first-line therapies and objective evidence of inadequate response or intolerance.

List medications/classes tried (doses, durations), biologic and disease-modifying therapy histories, and objective measures of treatment failure.
For transplant-related second-line uses, document prior graft-directed therapies and timing relative to rejection episode.

Documentation Required

Required medical record documentation — medical history, physical exam, diagnostic test results must be in chart to support request

Medical records must fully support medical necessity for any requested apheresis procedure. Documentation should include relevant medical history, physical examination findings, diagnostic test results, prior and current therapies, and a clear plan for treatment frequency and reassessment. Insufficient documentation may lead to denial.

Records must be legible and available upon request.
Lack of supporting documentation (including absence of prior therapy trials when required) is a common reason for denial.

Plasma exchange may use replacement fluids such as albumin or donor plasma depending on indication and protocol.

Exclusion noteDoes not include stem cell collection or harvesting for bone marrow/stem cell transplantation.

High-Volume Plasma Exchange (HVP) — definition / parameters

DefinitionHigh‑Volume Plasma Exchange (HVP) is defined as exchange of approximately 15% of ideal body weight plasma, representing about 8–12 L of plasma.

Exchange ratePatient plasma is removed at a rate of about 1–2 L per hour during HVP.

ReplacementReplacement with plasma in equivalent volume is performed during HVP.

Typical useUsed in settings requiring large-volume removal of plasma constituents (protocols vary by indication).

Extracorporeal Photopheresis (ECP) — definition

DefinitionExtracorporeal photopheresis (ECP) is a procedure in which the buffy coat is separated, treated extracorporeally with a photoactive compound (e.g., psoralens/UVADEX), exposed to UVA light, and reinfused during the same procedure.

MechanismTreatment combines leukocyte/buffy coat collection, photoactivation with a psoralen (such as UVADEX), and UVA irradiation before reinfusion to modulate immune response.

Regulatory contextAn FDA‑approved ECP system (Therakos CELLEX/UVAR XTS) and the photoactive drug UVADEX are approved for CTCL skin manifestations unresponsive to other therapies; UVADEX has multiple orphan designations.

Desensitization (HLA) — definition and transient antibody note

DefinitionDesensitization (HLA) refers to the use of plasmapheresis (or immunoadsorption) often combined with adjunctive therapies (e.g., low‑dose IVIG) to reduce anti‑HLA antibodies and enable transplantation.

Timing considerationAntibody reductions after plasmapheresis may be transient unless transplantation occurs within several days after the last treatment; rapid progression to transplant is often required for durable effect.

Clinical implicationProtocols commonly combine apheresis with adjunctive immunomodulation and are most effective when transplant follows promptly after antibody reduction.

Myeloma cast nephropathy — definition

DefinitionMyeloma cast nephropathy (light chain cast nephropathy) is acute renal injury in multiple myeloma due to accumulation of free light chains causing tubular casts and kidney dysfunction.

Role of apheresisTherapeutic plasma exchange has been evaluated as an adjunct to chemotherapy to reduce serum free light chains and dialysis dependence, typically given for several sessions (mean 3–4 in published series).

Evidence summarySystematic review evidence has not demonstrated benefit of plasmapheresis independent of concomitant effective chemotherapy; benefit is described mainly when combined with chemotherapy in some studies.

TPE (therapeutic plasma exchange) — definition and common scheduling

DefinitionTherapeutic plasma exchange (TPE) is a series of single plasma‑volume exchanges in which plasma is removed and replaced (e.g., with 5% albumin or donor plasma) to eliminate pathogenic plasma components.

Common schedulingTPE regimens in case series often use exchanges every other day; some indications may require daily exchanges for at least 1 week depending on clinical need.

Replacement fluids and anticoagulationTypical replacement fluids include albumin or donor plasma; citrate anticoagulation is commonly used during procedures described in case series.

RCE / aRBX — definition and comparison to manual exchange

DefinitionRed cell exchange (RCE) / automated red blood cell exchange (aRBX) are procedures that remove and replace red blood cells to manage sickle cell disease complications, replacing patient RBCs with donor RBCs and colloid/solution as needed.

Automated vs manualAutomated RCE (aRBX) uses apheresis devices to exchange RBCs and is compared in studies to manual exchange transfusion (MET); meta‑analyses have not consistently shown clear superiority in all outcomes.

Clinical usesUsed acutely (e.g., acute chest syndrome, severe vaso‑occlusive complications) and chronically for stroke prophylaxis and iron management in SCD; pediatric low‑weight protocols may use RBC‑primed circuits.

TPE/PE — general definition and usage

DefinitionPlasma exchange (PE) / therapeutic plasma exchange (TPE) is a procedure that removes plasma and replaces it (e.g., with albumin or donor plasma) to eliminate pathogenic plasma components.

Common indicationsUsed across autoimmune, renal, neurologic, dermatologic, hematologic, and critical care contexts (indication‑specific guidance referenced elsewhere in policy).

Procedure variantsCan be performed by filtration or centrifugation methods and may be combined with immunoadsorption or double‑filtration techniques depending on target substances.

ASFA categories and grades — categorization explanation (I–IV)

Category IDisorders for which apheresis is accepted as first‑line therapy, either as a primary standalone treatment or in conjunction with other treatments.

Category IIDisorders for which apheresis is accepted as second‑line therapy, as a standalone treatment or with other treatments.

Category IIIDisorders where the optimum role of apheresis is not established; decision‑making should be individualized.

Category IVDisorders in which published evidence demonstrates or suggests apheresis is ineffective or harmful; IRB approval is desirable if undertaken.

Recommendation gradesASFA assigns recommendation grades (Grade 1A to 2C) to reflect strength and quality of evidence alongside categories.

Extracorporeal photopheresis / UVADEX — device/agent regulatory note

Regulatory noteAn ECP device (Therakos CELLEX / UVAR XTS) has received FDA premarket approval for palliative treatment of skin manifestations of cutaneous T‑cell lymphoma unresponsive to other therapies; UVADEX (8‑methoxsalen) is the photoactive drug used with these systems.

Device classificationDevices for therapeutic apheresis are regulated by the FDA as Class II or Class III devices depending on centrifugation vs filtration methods; filtration‑based separators are Class III.

UVADEX orphan statusUVADEX has been granted orphan drug status for several indications (diffuse systemic sclerosis, GVHD, prevention of acute cardiac allograft rejection).