CMS Pub. 100-03, ch. 1, § 110.4

A. General

Extracorporeal photopheresis is a medical procedure in which a patient’s 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 patient’s 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before the white blood cells are withdrawn.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.

B. Nationally Covered Indications

The Centers for Medicare & Medicaid Services (CMS) 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.

C. Nationally Non-Covered Indications

All other indications for extracorporeal photopheresis not otherwise indicated above as covered remain non-covered.

D. Other

Claims processing instructions can be found in chapter 32, section 190 of the Medicare Claims Processing

Manual.

(This NCD last reviewed April 2012.)