**B. 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:

  1. improved forced expiratory volume in one second (FEV1);
  2. improved survival after transplant; and/or,
  3. improved quality of life?

The required clinical study must adhere to the following standards of
scientific integrity and relevance to the Medicare population:

  1. The principal purpose of the research study is to test whether extracorporeal photopheresis potentially improves the participants health outcomes.
  2. 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.
  3. The research study does not unjustifiably duplicate existing studies.
  4. The research study design is appropriate to answer the research question being asked in the study.
  5. The research study is sponsored by an organization or individual capable of successfully executing the proposed study.
  6. 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.
  7. All aspects of the research study are conducted according to appropriate standards of scientific integrity (see http://www.icmje.org).
  8. 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.
  9. 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.
  10. 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.
  11. 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).
  12. 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.
  13. 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](https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS018912).

(This NCD last reviewed April 2012.)