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DESCRIPTIONExtracorporeal photopheresis (ECP) is a leukapheresis-based immunomodulatory procedure that involves the following steps: the patient’s blood is collected and the leukocyte-rich portion (buffy coat) is separated, the photosensitizer agent 8-methoxypsoralen (8-MOP) is added to the lymphocyte fraction, which is then exposed to ultraviolet A light, and the light-sensitized lymphocytes are re-infused into the patient.
The standard of care for treatment of organ transplant rejection is immunosuppression, with the particular regimen dictated by the organ being transplanted. As organ transplantation success rates have improved more patients are facing the morbidity and mortality associated with immunosuppressive therapies developed to prevent rejection of the transplanted organ. Immunosuppressive therapies are used to lower the responsiveness of the recipient’s immune system, decreasing the chance of rejection. Unfortunately, portions of the immune system responsible for the prevention of viral, fungal and bacterial infection are also affected. This can in turn lead to serious infections, including opportunistic infections.
While first approved for the treatment of cutaneous T-cell lymphoma, ECP has more recently been used as a supplement to conventional therapies in the area of transplantation. Extracorporeal photopheresis (ECP) is a leukapheresis-based immunomodulatory procedure that involves the following steps:
Reports of the successful use of ECP in human cardiac transplant recipients were published in 1992 and use in other transplant patients followed. Although the specific mechanism of action of ECP is unknown, the reinfusion of treated leukocytes seems to specifically suppress the patient’s immune response to the donor organ, while maintaining the body’s ability to respond to other antigens. The specificity of ECP to target the immune response to the transplanted organ allows ECP to decrease organ rejection without an increased risk of infection, common with immunosuppressant drugs.
In the United States, the UVAR® XTS Photopheresis System was approved via premarket application (PMA) by the U.S. Food and Drug Administration (FDA) for use in the ultraviolet-A (UVA) irradiation (in the presence of the photoactive drug, methoxsalen) of extracorporeally circulating leukocyte-enriched blood in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) in persons who have not been responsive to other therapy.
8-MOP (UVADEX®) is approved by the FDA for use in conjunction with UVAR XTS Photopheresis System for use in the ultraviolet-A (UVA) irradiation in the presence of the photoactive drug methoxsalen of extracorporeally circulating leukocyte-enriched blood in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma in persons who have not been responsive to other therapy.
The use of the UVAR XTS photopheresis system or UVADEX for other conditions is an off-label use of a FDA-approved device/drug.
This policy only addresses the use of ECP for the treatment and prevention of organ rejection after solid organ transplant. Refer to the Extracorporeal Photopheresis as a Treatment of Graft-versus-Host Disease, Autoimmune Disease, and Cutaneous T-Cell Lymphoma for other applications.
POLICYExtracorporeal photopheresis (ECP) may be considered medically necessary to treat cardiac allograft rejection that is either recurrent or that is refractory to standard immunosuppressive drug treatment.
Extracorporeal photopheresis (ECP) is considered investigational in all other situations related to treatment or prevention of rejection in solid organ transplantation.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESA regimen of immunosuppressive therapy is standard of care for the treatment of solid organ rejection. Therefore, refractory rejection is defined as rejection that fails to respond adequately to a standard regimen of immunosuppressive therapy.
Recurrent allograft rejection is defined as having at least two rejection episodes that recurred after standard immunosuppressive therapy.
There is no standard schedule for extracorporeal photopheresis, and reported schedules vary by the organ type. However, most reported cardiac and lung schedules initiate therapy with 2 consecutive days of extracorporeal photopheresis for one month, followed by bi-weekly therapy on 2 successive days for months 2 and 3, then monthly on 2 consecutive days for months 4-6.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY07/22/2010: Approved by Medical Policy Advisory Committee
04/19/2011: Policy reviewed; no changes.
10/30/2013: Policy reviewed; no changes to polic statement. Updated Blue Cross Blue Shield Association policy # to 8.01.36.
SOURCE(S)Blue Cross Blue Shield Association policy # 8.01.36
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.