Therapeutic Apheresis
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Defines medical necessity, indications, and administrative responsibility for therapeutic apheresis procedures (including therapeutic plasma exchange and extracorporeal photopheresis) for members of Geisinger Health Plan across applicable lines of business.
An exclusion for additional indications was added to the policy.
Medical Necessity and Covered Indications
Medically Necessary Indications
Therapeutic plasma exchange (TPE) and extracorporeal photopheresis (ECP) are considered medically necessary for the following specific conditions:
GBS severity and timing referenced (see policy for specifics).
ECP may be initiated when initial corticosteroid therapy fails for GVHD; initiate immediately for frank erythroderma or Sezary Syndrome; may be used for earlier stage CTCL when progression despite steroids or in steroid-dependent stable disease.
Extracorporeal Photopheresis (ECP) — Covered Indications
ECP is considered medically necessary for any of the following:
ECP may be initiated when initial corticosteroid therapy fails for GVHD; initiate immediately for frank erythroderma or Sezary Syndrome; may be used for earlier stage CTCL when progression despite steroids or steroid-dependent stable disease.
Lipid Apheresis — Covered Indications
Lipid apheresis is considered medically necessary for any of the following:
Preferred over TPE for FSGS due to higher remission rates with LA.
Erythrocytapheresis (RCE/RCR) — Covered Indications
RCE/RCR are considered medically necessary for the following conditions:
Plateletpheresis — Covered Indications
Plateletpheresis is considered medically necessary for:
No explicit exclusions are listed in this section of the policy text. The document separately defines therapeutic apheresis procedures and their medically necessary uses but does not enumerate any additional exclusion list here.
Any use of therapeutic apheresis that is not listed under the policy's Indications section is considered Unproven and therefore not covered. The policy provides a partial list of such unproven indications, which includes (but is not limited to) chronic Lyme disease, complex regional pain syndrome, psoriasis, amyotrophic lateral sclerosis, chronic multiple sclerosis, heavy metal intoxication, age-related macular degeneration, atopic dermatitis (recalcitrant), inflammatory bowel disease/Crohn's disease, stiff-person syndrome, sudden sensorineural hearing loss, burn shock resuscitation, cardiac neonatal lupus, coagulation factor deficiencies and inhibitors, idiopathic dilated cardiomyopathy NYHA II–IV (via TPE), erythropoietic protoporphyria liver disease, hemophagocytic lymphohistiocytosis, HIT with thrombosis, nephrogenic systemic fibrosis, pemphigus vulgaris, prophylactic RBC alloimmunization related to RhD, sepsis with multiorgan failure, steroid‑responsive encephalopathy associated with autoimmune thyroiditis, severe Sydenham's chorea, and thrombotic microangiopathy associated with gemcitabine or quinine.
The policy adopts the plan's definition of Medical Necessity: services must be appropriate for the symptoms and diagnosis, provided for direct care and treatment, consistent with current standards of good medical treatment, not primarily for convenience, and the most appropriate level of service. By implication, services that do not meet these criteria — including those provided mainly for convenience, not consistent with standard care, or not the most appropriate level of service — are not medically necessary and may be denied.
Therapeutic apheresis requests for indications listed in the policy's exclusions are considered unproven and therefore not medically necessary / not covered. Providers should expect denials for apheresis performed for those unlisted or explicitly identified unproven conditions unless convincing peer‑reviewed evidence is provided and the indication becomes accepted under the plan's evaluation process (see MP015).
Codes, Thresholds, and Coding Notes
| 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 |
| 38205 | Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection, allogeneic |
| 38206 | Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection, autologous |
| 38240 | Hematopoietic progenitor cell, allogeneic transplantation, per donor |
| 38241 | Hematopoietic progenitor cell, autologous transplantation, per donor |
Authorization, Documentation, and Billing Notes
Obtain prior authorization per member's plan
Prior authorization may be required for therapeutic apheresis across applicable lines of business (Commercial, Medicaid, Medicare, CHIP); verify and obtain prior authorization per the member's plan procedures before scheduling services.
- Policy applies to Commercial, Medicaid, Medicare, and CHIP lines of business; prior authorization requirements vary by plan and are listed in plan documents.
- Prior authorization and/or pre-certification requirements and instructions are available on the Geisinger provider policies page: https://www.geisinger.org/health-plan/providers/ghp-clinical-policies.
Check plan prior‑auth/precertification details and codes
Prior authorization and/or pre-certification requirements may apply; use Geisinger’s online provider resources to confirm authorization rules and submit requests.
- Prior authorization requirements and precertification lists can be found on the Geisinger provider policies page.
- CPT codes listed in the policy are informational only; prior auth requirements may reference specific procedure codes when determining coverage.
Document steroid failure/intolerance before starting ECP
Initiate ECP when corticosteroid therapy fails or for steroid‑dependent/steroid‑refractory disease in covered indications (e.g., GVHD, CTCL); document prior steroid therapy and the clinical reason for initiating ECP.
- ECP may be initiated when initial corticosteroid therapy fails for GVHD.
- For CTCL, ECP should be initiated immediately for frank erythroderma/Sezary and may be used when progression occurs despite steroid therapy or in steroid‑dependent stable disease.
Document prior medical therapy failure for lipid apheresis
For lipid apheresis, document failure of or inadequate response to medical therapy (e.g., a 6‑month trial of diet and maximum tolerated combination drug therapy) prior to apheresis when indicated.
- Severe, refractory heterozygous familial hypercholesterolemia requires failure of a 6‑month trial of diet therapy and maximum tolerated combination drug therapy and meeting FDA LDL thresholds (LDL >300 mg/dL or LDL >200 mg/dL with documented CAD).
- Lipoprotein(a) hyperlipoproteinemia requires inadequate response to medical therapy before LA.
Document clinical rationale and prior therapies to support medical necessity
Maintain documentation demonstrating medical necessity: diagnosis, clinical rationale for removing plasma/cells (e.g., to remove autoantibodies, toxins, paraproteins), prior therapies tried and response, and that the service is the most appropriate level of care.
- Medical necessity must show the service is appropriate for the symptoms/diagnosis, provided for direct care, and consistent with current standards of good medical treatment.
- For apheresis, document the clinical rationale (e.g., removal of pathogenic plasma substances or treated WBCs), timing relative to other therapies, and plan for replacement fluids or cell handling as applicable.
Coding is informational — verify coverage and reimbursement
Use the CPT/HCPCS codes listed in the policy for informational purposes only; inclusion does not guarantee coverage — confirm member‑specific benefits and Medicare rules before billing.
- Codes included (e.g., 36511, 36512, 36513, 36514, 36516, 36522, 38205, 38206, 38240, 38241) are informational and may not be all‑inclusive.
- Coverage and reimbursement are determined by the member’s benefit plan and applicable Medicare rules; consult CMS or the local MAC for Medicare coverage specifics.
Risk of denial if not clinically appropriate or for convenience
Services that are not appropriate for the patient’s symptoms/diagnosis, inconsistent with standards of care, provided primarily for convenience, or not the most appropriate level of service may be denied; ensure documentation justifies medical necessity and level of care.
- The policy defines medical necessity criteria that must be met (appropriate for diagnosis, provided for direct care, consistent with standards, not primarily for convenience, and the most appropriate level of service).
- Any use of therapeutic apheresis not listed under Indication is considered unproven and may be denied as not covered.
Do not request apheresis for unlisted indications — likely denial
Requests for therapeutic apheresis for indications not listed as medically necessary are considered unproven and not covered; prior authorization requests for unlisted indications are likely to be denied.
- Policy exclusion: any use of therapeutic apheresis not listed under Indication is considered unproven and therefore not covered.
- A partial list of unproven conditions is provided in the policy; consult MP015 for the process addressing investigational/unproven services.
Use Within Treatment Lines
salvage
Procedural Definitions
Clinical Background
Therapeutic apheresis refers to a family of procedures in which whole blood is removed, separated into cellular elements and plasma by centrifugation or filtration, a component is removed or treated, and the remaining elements are returned to the circulation. Therapeutic plasma exchange (TPE) is a form of apheresis in which plasma is separated and discarded and replaced with a substitution fluid (for example, albumin or donated plasma) to remove harmful plasma-borne substances such as toxins or autoantibodies. Other apheresis techniques (e.g., extracorporeal photopheresis, lipid apheresis, red cell exchange, plateletpheresis) differ by the targeted component removed or processed and the specific clinical indications for which they are used.
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