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Extracorporeal photopheresis (ECP) is a leukapheresis-based immunomodulatory procedure that involves the following steps:
ECP has been investigated for the treatment of patients with a variety of autoimmune diseases, graft-versus-host disease (GVHD), T-cell lymphoma (TCL), treatment for and prevention of organ rejection after solid organ transplant, and other miscellaneous conditions.
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.
Although 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 solid organ transplantation. 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.
FDA has approved via premarket application for two photopheresis systems manufactured by Therakos™ Inc. (West Chester, PA). Both systems are approved for use in ultraviolet A (UVA) irradiation, in the presence of the photoactive drug 8-MOP, of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of skin manifestations of cutaneous T-cell lymphoma (CTCL), in persons who have not been responsive to other forms of treatment. The two systems are:
8-MOP (UVADEX®) is approved by the FDA for extracorporeal administration with the UVAR XTS or CELLEX Photopheresis System in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma in persons who have not been responsive to other forms of treatment.
The use of either Therakos Photopheresis System or UVADEX® for other conditions is an off-label use of an 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, including acute 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 consecutive days for months 2 and 3, then monthly on 2 consecutive days for months 4-6.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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 policy statement. Updated Blue Cross Blue Shield Association policy # to 8.01.36.
09/25/2014: Policy reviewed; description updated. Medically necessary policy statement updated to add "including acute rejection." Policy guidelines updated.
08/27/2015: Code Reference section updated for ICD-10.
03/03/2016: Policy description updated regarding photopheresis systems. Policy statements unchanged. Policy guidelines updated to add medically necessary and investigative definitions.
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.