Obtain prior authorization for CPT 36522

Prior authorization is required for CPT 36522 (photopheresis; extracorporeal) when used for indications — coverage is limited to the medically necessary diagnoses listed in the policy (e.g., erythrodermic cutaneous T‑cell lymphoma, refractory transplant rejection, refractory GVHD).

• CPT code: 36522

CMS limits BOS coverage to qualifying clinical research

ECP to treat bronchiolitis obliterans syndrome (BOS) after lung allograft transplantation is covered by CMS only when provided under an approved clinical research study; absence of qualifying clinical research documentation may result in denial or noncoverage.

• CMS NCD (April 30, 2012): coverage limited to qualifying clinical research studies for BOS after lung transplant

Recommend prior authorization for investigational or limited‑evidence uses

Obtain prior authorization or pre-authorization documentation for indications supported primarily by small or inconclusive studies (for example, systemic sclerosis and other investigational uses); prior authorization is recommended to allow review of the evidence and justification.

• Policy recommends prior authorization for limited or investigational indications supported by small studies or meta-analyses

Confirm plan benefits and prior‑auth rules with the member’s plan

Verify the member’s plan provisions and prior authorization requirements with the payer; the Clinical Policy Bulletin provides review and effective dates but does not replace plan-specific benefit verification.

• Policy history: Effective 05/07/1998; Last review 03/29/2023; Next review 02/22/2024
• Clinical Policy Bulletins do not constitute a contract — confirm plan benefits

Document refractory‑to‑standard‑therapy status for transplant rejection

For transplant rejection indications, document that disease is refractory to standard immunosuppressive drug treatment (resistant or dependent to high‑dose steroids plus failure of ≥2 listed agents) before requesting ECP.

• Refractory requirement: resistant/dependent to high‑dose steroids plus refractory to ≥2 of azathioprine, cyclosporine, methotrexate, or polyclonal/monoclonal antilymphocyte agents (e.g., ALG, ATG)

Show failure of first‑line therapies in clinical documentation

Clinical reports and trials generally describe ECP as a later‑line therapy used after failure of first‑line treatments (e.g., systemic corticosteroids, topical agents, phototherapy) — include prior therapy history in the request.

• Studies report prior failure of first‑line therapies (topical steroids, calcineurin inhibitors, phototherapy) and sometimes second‑line agents

Use ECP after standard therapies have failed or are contraindicated

Consider ECP only after standard therapies have failed or are contraindicated for transplant rejection and immune‑related adverse events; requests for earlier use should include strong justification and supporting evidence.

• Policy states ECP generally considered after standard therapies have failed or are contraindicated; case reports exist for checkpoint‑inhibitor colitis

No formal step‑therapy program stated in this policy

There are no formal step therapy requirements specified in this policy; however, clinical criteria require prior failure of standard therapies for many covered indications.

• Policy: “No step therapy requirements are specified in this portion of the document.”
• Medically necessary indications specify refractory-to-treatment thresholds

Document procedure steps and usual treatment schedule

Photopheresis involves oral 8‑methoxypsoralen ingestion, leukapheresis with UVA exposure of collected leukocytes, and reinfusion; typical schedule is two consecutive days every 4 weeks with clinical evaluation at 6 months.

• Procedure: oral 8‑MOP followed ~2 hours later by leukapheresis, UVA exposure, reinfusion
• Treatment schedule: usually 2 consecutive days at 4‑week intervals with evaluation at 6 months

Include specific study‑based inclusion criteria in justification

When studies are cited, include the trial inclusion details in the authorization request (for example: disease duration ≥1 year, SCORAD >45, and prior failure of first‑line and second‑line therapies in atopic dermatitis trials).

• Atopic dermatitis trial inclusion: disease duration ≥1 year; SCORAD >45; resistance to first‑line therapy or one second‑line therapy

Provide comprehensive clinical documentation and objective measures

Include detailed clinical documentation: diagnosis, prior therapies and responses (e.g., steroid‑refractory GVHD or refractory colitis), objective measures when available (FEV1 decline for CLAD/BOS; baseline and follow‑up skin scores), and rationale for ECP given limited evidence.

• Required documentation examples: diagnosis, prior treatments and outcomes, objective measures (FEV1, SCORAD, skin scores), rationale for ECP use

Verify benefits — CPB is not a coverage guarantee

Refer to the Clinical Policy Bulletin and the member’s plan provisions for benefit details; the bulletin provides only a partial description of plan benefits and is not a substitute for plan verification.

• Clinical Policy Bulletins are developed to assist plan administration and do not constitute a contract

Avoid or justify non‑covered ICD‑10 diagnoses to prevent denial

If the submitted diagnosis is among the ICD‑10 codes listed as not covered for indications in this CPB (for example, L20.0–L20.9, G35, K50.00–K50.919), anticipate that claims may be denied and provide alternative supporting documentation or an appeal rationale.

• Examples of ICD‑10 codes listed as not covered: L20.0–L20.9 (atopic dermatitis); G35 (multiple sclerosis); K50.00–K50.919 (Crohn’s disease)

Provide clinical trial enrollment documentation for BOS after lung transplant

Document enrollment in an approved clinical research study for BOS after lung transplant (CMS NCD) when requesting coverage; lack of evidence of study participation may lead to denial under the CMS determination.

• CMS NCD (4/30/2012) requires ECP for BOS after lung transplant to be provided only within qualifying clinical research studies

Expect higher documentation burden for indications with limited evidence

Be prepared to supply additional justification or documentation for indications with insufficient or preliminary evidence (small/nonrandomized studies); such indications may be denied or require more evidence for approval.

• Policy notes evidence for some indications is preliminary and based on small or nonrandomized studies and may trigger noncoverage or requests for additional justification

CPB is administrative guidance — confirm coverage with the plan

Administrative notice: Clinical Policy Bulletins assist plan administration but do not guarantee coverage; providers remain responsible for treatment decisions and must verify member benefits and prior‑auth requirements.

• CPB is not a contract and does not guarantee coverage; participating providers are independent and responsible for member care