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    OpenPayerPolicy UpdatesHematology/OncologyHarvard Pilgrim therapeutic apheresis Coverage | O…
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    Currentharvard pilgrim health carePolicy N/A

    Therapeutic apheresis (plasmapheresis/TPE) — Coverage Criteria

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    Defines medical necessity criteria and coding for therapeutic apheresis (including plasmapheresis, plasma exchange, and immunoadsorption) for Harvard Pilgrim Health Care commercial products. Applies to clinical requests for apheresis procedures and describes covered indications and limitations.

    Policy Summary
    Payerharvard pilgrim health care
    PolicyTherapeutic apheresis (plasmapheresis/TPE) — Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateJun 1, 2026
    Last ReviewFeb 18, 2026
    Next Review DateN/A
    Key ActionPrior authorization is not required for Harvard Pilgrim Health Care commercial products.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    42individual covered indications listed
    2

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    CPT codes specified
    No PAPA status
    CommercialProduct applicability

    Medical Necessity and Coverage Criteria

    Medically Necessary Indications

    Covered when documentation confirms diagnosis of ONE of the following:

    Covered indications list: Acute disseminated encephalomyelitis (ADEM): steroid refractory
    Covered indications list: Acute inflammatory demyelinating polyneuropathy; primary treatment
    Covered indications list: Acute liver failure requiring high-volume therapeutic plasma exchange
    Covered indications list: Anti-glomerular basement membrane disease — a. Dialysis independent; b. Diffuse alveolar hemorrhage
    Covered indications list: Catastrophic antiphospholipid syndrome
    Covered indications list: Chronic acquired demyelinating polyneuropathies — a. IgG/IgA/IgM related; b. Anti-myelin-associated glycoprotein
    Covered indications list: Chronic inflammatory demyelinating polyneuropathy
    Covered indications list: Cryoglobulinemia — second line therapy
    Covered indications list: Cutaneous T-cell lymphoma (erythrodermic mycosis fungoides; Sézary syndrome)
    Covered indications list: Erythrocytosis / polycythemia vera
    Covered indications list: Idiopathic dilated cardiomyopathy, NYHA class II–IV, via immunoadsorption
    Covered indications list: Familial hypercholesterolemia — a. Homozygotes, lipoprotein apheresis; b. Heterozygotes, lipoprotein apheresis (second line); c. All patients via therapeutic plasma exchange
    Covered indications list: Focal segmental glomerulosclerosis, recurrent in transplanted kidney — second line therapy
    Covered indications list: Graft-versus-host disease — a. Acute; b. Chronic, second line therapy
    Covered indications list: HELLP syndrome of pregnancy (hemolysis, elevated liver enzymes, low platelets)
    Covered indications list: Hereditary hemochromatosis
    Covered indications list: Hypertriglyceridemic pancreatitis, severe
    Covered indications list: Hyperviscosity in hypergammaglobulinemia
    Covered indications list: Inflammatory bowel disease (ulcerative colitis, Crohn's disease) via adsorptive cytapheresis
    Covered indications list: Lipoprotein(a) hyperlipoproteinemia
    Covered indications list: Multiple sclerosis, acute attack or relapse — second line therapy
    Covered indications list: Myasthenia gravis, acute
    Covered indications list: Myeloma cast nephropathy (light chain cast nephropathy) — second line therapy
    Covered indications list: Neuromyelitis optica spectrum disorders, acute or relapse — second line therapy
    Covered indications list: N-methyl D-aspartate (NMDA) receptor antibody encephalitis
    Covered indications list: Paraproteinemic demyelinating neuropathies associated with MGUS (IgA, IgG, or IgM) — excluding multiple myeloma
    Covered indications list: Pediatric autoimmune neuropsychiatric disorders (PANDAS/PANS) exacerbation
    Covered indications list: Peripheral vascular diseases
    Covered indications list: Post-transfusion purpura
    Covered indications list: Progressive multifocal leukoencephalopathy associated with natalizumab
    Covered indications list: Pruritus due to hepatobiliary disease, treatment resistant
    Covered indications list: Rheumatoid arthritis, refractory — second line therapy
    Covered indications list: Sickle cell disease — a. Acute stroke or multiorgan failure; b. Acute chest syndrome, severe (second line); c. Stroke prophylaxis; d. Individuals requiring chronic transfusion (every ≤5 weeks)
    Covered indications list: Thrombotic microangiopathy / thrombotic thrombocytopenic purpura (TTP)
    Covered indications list: Transplantation — heart, second line therapy (cellular rejection; recurrent rejection; desensitization; in children <40 months ABO incompatible; rejection prophylaxis via TPE)
    Covered indications list: Transplantation — hematopoietic stem cell, ABO incompatible, second line therapy (HPC(M) and HPC(A))
    Covered indications list: Transplantation — kidney, ABO compatible (antibody-mediated rejection; desensitization/prophylaxis living donor)
    Covered indications list: Transplantation — kidney, ABO incompatible, second line therapy (antibody-mediated rejection; desensitization, living donor)
    Covered indications list: Transplantation — liver, desensitization, ABO incompatible, living donor, via therapeutic plasma exchange
    Covered indications list: Transplantation — lung (bronchiolitis obliterans syndrome; chronic lung allograft dysfunction)
    Covered indications list: Vasculitis, ANCA-associated — a. Microscopic polyangiitis; b. Granulomatosis with polyangiitis
    Covered indications list: Voltage gated potassium channel antibody–related diseases
    Covered indications list: Wilson's disease, fulminant

    The Plan considers therapeutic apheresis as not medically necessary for all indications not specifically listed as covered in this policy. Requests for apheresis for indications outside the enumerated covered list should be denied as not medically necessary unless supporting documentation demonstrates the patient meets one of the policy's listed covered diagnoses and associated qualifiers.

    All indications that are not explicitly enumerated in the policy's covered indications list are considered not medically necessary. Providers should ensure the requested indication matches one of the covered diagnoses and include documentation of the clinical rationale; otherwise the service is not covered.

    CPT / HCPCS Codes

    CPT/HCPCS CodesCPTCovered
    36514Therapeutic apheresis; for plasma pheresis.
    36516Therapeutic apheresis; with extracorporeal immunoadsorption, selective adsorption or selective filtration and plasma reinfusion

    Provider Requirements and Authorization

    Prior Authorization

    Prior Authorization Required

    Prior authorization is not required for Harvard Pilgrim Health Care commercial products. If supporting clinical documentation is requested for a service, submit pertinent documentation to the plan when prior authorization or notification is required.

    • Harvard Pilgrim Health Care Commercial products: 800-232-0816
    • Prior authorization: No for Harvard Pilgrim commercial products
    Step Therapy

    Second-line requirements

    For multiple indications in this policy, therapeutic apheresis is specified as second-line therapy. Providers should ensure documentation demonstrates that first-line treatments were tried and either failed, were contraindicated, or not tolerated before apheresis is requested for these second-line indications.

    • Cryoglobulinemia — second-line therapy
    • Familial hypercholesterolemia (heterozygotes) — lipoprotein apheresis; second-line therapy

    Background

    Therapeutic apheresis is an extracorporeal blood processing technique in which whole blood is withdrawn and a targeted cellular or plasma component is selectively removed with reinfusion of the remaining blood constituents. It is used to remove abnormal cells or pathogenic plasma substances to prevent further injury or reverse toxic processes. The policy follows established clinical guidance in listing specific indications and qualifiers; any indication not listed is considered not medically necessary per the policy limitations.

    Definitions

    Therapeutic apheresis — definition and alternate terms
    DefinitionTherapeutic apheresis (also called pheresis): an extracorporeal blood‑processing technique in which whole blood is withdrawn, a targeted cellular or plasma component (e.g., platelets, leukocytes, or plasma) is selectively separated and removed, and the remaining blood constituents are reinfused into the patient.
    IncludesPlasmapheresis (PP), plasma exchange (PE), and therapeutic plasma exchange (TPE).
    PurposeTo remove abnormal cells or pathologic plasma substances associated with disease to prevent further damage or reverse toxic processes.
    Also calledPheresis; the term encompasses all therapeutic and collection procedures utilizing apheresis technology.
    Guideline sourceAmerican Society for Apheresis (ASFA) publishes categorical, evidence‑based recommendations (Categories I–IV) that guide indications and practice for therapeutic apheresis.
    Policy Summary
    Payerharvard pilgrim health care
    PolicyTherapeutic apheresis (plasmapheresis/TPE) — Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateJun 1, 2026
    Last ReviewFeb 18, 2026
    Next Review DateN/A
    Key ActionPrior authorization is not required for Harvard Pilgrim Health Care commercial products.
    SourceLink
    On This Page
    Medical Necessity and Coverage CriteriaCPT / HCPCS CodesProvider Requirements and AuthorizationBackgroundDefinitions
  1. Focal segmental glomerulosclerosis, recurrent in transplanted kidney — second-line therapy
  2. Graft-versus-host disease, chronic — second-line therapy
  3. Multiple sclerosis, acute attack or relapse — second-line therapy
  4. Myeloma cast nephropathy — second-line therapy
  5. Neuromyelitis optica spectrum disorders, acute or relapse — second-line therapy
  6. Rheumatoid arthritis, refractory — second-line therapy
  7. Sickle cell disease: acute chest syndrome, severe — second-line therapy
  8. Transplantation, heart — second-line therapy (cellular rejection, recurrent rejection, desensitization, rejection prophylaxis)
  9. Transplantation, hematopoietic stem cell, ABO incompatible — second-line therapy
  10. Transplantation, kidney, ABO incompatible — second-line therapy
    11. Documentation Required

    Supporting clinical documentation

    Submit supporting clinical documentation pertinent to the service request when prior authorization or notification is required. Documentation should include diagnosis, prior therapies tried (with dates and responses), relevant lab or imaging results, and rationale for therapeutic apheresis.

    • Include prior treatment history showing failure, contraindication, or intolerance for first-line therapy when apheresis is indicated as second-line
    • Provide relevant clinical notes, laboratory data, and consultation reports supporting the indication
    • Fax supporting documentation if requested by the plan
    Denial Risk

    Not covered indications

    Therapeutic apheresis is considered not medically necessary for indications not specifically listed in the Clinical Guideline Coverage Criteria. Requests for apheresis for other conditions are subject to denial unless sufficient evidence supports medical necessity.

    • Not medically necessary for all other indications not listed in the policy