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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules state that extracorporeal photopheresis is a medical procedure in which a patients white blood cells 
are exposed first to a drug called 8-methoxypsoralen (8-MOP) and then to ultraviolet A (UVA) light. The 
procedure starts with the removal of the patients blood, which is centrifuged to isolate the white blood cells. 
The drug is typically administered directly to the white blood cells after they have been removed from the 
patient (referred to as ex vivo administration) but the drug can alternatively be administered directly to the 
patient before the white blood cells are withdrawn. After UVA light exposure, the treated white blood cells are 
then re-infused into the patient. 
Nationally Covered Indications:  
 
The Centers for Medicare & Medicaid Services has determined that extracorporeal photopheresis is reasonable 
and necessary under 1862(a)(1)(A) of the Social Security Act (the Act) under the following circumstances: 
1. Effective April 8, 1988, Medicare provides coverage for: Palliative treatment of skin manifestations of 
cutaneous T-cell lymphoma that has not responded to other therapy. 
2.  Effective December 19, 2006, Medicare also provides coverage for: 
Patients with acute cardiac allograft rejection whose disease is refractory to standard immunosuppressive drug 
treatment; and, 
Patients with chronic graft versus host disease whose disease is refractory to standard immunosuppressive drug 
treatment. 3. Effective April 30, 2012, Medicare also provides coverage for: 
Extracorporeal photopheresis for the treatment of bronchiolitis obliterans syndrome (BOS) following lung 
allograft transplantation only when extracorporeal photopheresis is provided under a clinical research study that 
meets the following conditions: 
The clinical research study meets the requirements specified below to assess the effect of extracorporeal 
photopheresis for the treatment of BOS following lung allograft transplantation. The clinical study must 
address one or more aspects of the following question: 
Prospectively, do Medicare beneficiaries who have received lung allografts, developed BOS refractory to 
standard immunosuppressive therapy, and received extracorporeal photopheresis, experience improved patient-
centered health outcomes as indicated by: 
a. improved forced expiratory volume in one second (FEV1); 
b. improved survival after transplant; and/or, 
c. improved quality of life? 
The required clinical study must adhere to the following standards of scientific integrity and relevance to the 
Medicare population: 
a. The principal purpose of the research study is to test whether extracorporeal photopheresis potentially 
improves the participants health outcomes. 
b. The research study is well supported by available scientific and medical information or it is intended to 
clarify or establish the health outcomes of interventions already in common clinical use. 
c. The research study does not unjustifiably duplicate existing studies. 
d. The research study design is appropriate to answer the research question being asked in the study. 
e. The research study is sponsored by an organization or individual capable of successfully executing the 
proposed study. 
f. The research study is in compliance with all applicable Federal regulations concerning the protection of 
human subjects found at 45 CFR Part 46. If a study is regulated by the Food and Drug Administration 
(FDA), it must also be in compliance with 21 CFR parts 50 and 56. 
g. All aspects of the research study are conducted according to appropriate standards of scientific integrity 
(see http://www.icmje.org). 
h. The research study has a written protocol that clearly addresses, or incorporates by reference, the 
standards listed here as Medicare requirements for coverage with evidence development. 
i. The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in 
healthy individuals. Trials of all medical technologies measuring therapeutic outcomes as one of the 
objectives meet this standard only if the disease or condition being studied is life threatening as defined 
in 21 CFR  312.81(a) and the patient has no other viable treatment options. 
j. The clinical research study is registered on the ClinicalTrials.gov website by the principal 
sponsor/investigator prior to the enrollment of the first study subject. 
k. The research study protocol specifies the method and timing of public release of all prespecified 
outcomes to be measured including release of outcomes if outcomes are negative or study is terminated 
early. The results must be made public within 24 months of the end of data collection. If a report is 
planned to be published in a peer-reviewed journal, then that initial release may be an abstract that 
meets the requirements of the International Committee of Medical Journal Editors 
(http://www.icmje.org). 
l. The research study protocol must explicitly discuss subpopulations affected by the treatment under 
investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion 
and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting 
of said populations on the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why 
these criteria are necessary. 
m. The research study protocol explicitly discusses how the results are or are not expected to be 
generalizable to the Medicare population to infer whether Medicare patients may benefit from the 
intervention. Separate discussions in the protocol may be necessary for populations eligible for 
Medicare due to age, disability or Medicaid eligibility. 
Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality supports clinical 
research studies that CMS determines meet the above-listed standards and address the above-listed research 
questions. 
Any clinical study under which there is coverage of extracorporeal photopheresis for this indication pursuant to 
this national coverage determination (NCD) must be approved by April 30, 2014. If there are no approved 
clinical studies on this date, this NCD will expire and coverage of extracorporeal photopheresis for BOS will 
revert to the coverage policy in effect prior to the issuance of the final decision memorandum for this NCD. 
Nationally Non-Covered Indications: 
All other indications for extracorporeal photopheresis not otherwise indicated above as covered remain non-
covered. 
You can find this rule at the Medicare National Coverage Determination (NCD) 110.4: Extracorporeal 
Photopheresis. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.