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National Coverage Determination (NCD)

Extracorporeal Photopheresis

110.4

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Tracking Information

Publication Number
100-3
Manual Section Number
110.4
Manual Section Title
Extracorporeal Photopheresis
Version Number
2
Effective Date of this Version
12/19/2006
Ending Effective Date of this Version
04/30/2012
Implementation Date
04/02/2007
Implementation QR Modifier Date

Description Information

Benefit Category
Physicians' Services


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

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administration) but the drug can alternatively be administered directly to the patient before the white blood cells are withdrawn.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.
Indications and Limitations of Coverage

B. Nationally Covered Indications

The CMS has determined that extracorporeal photopheresis is reasonable and necessary under §1862(a)(1)(A) of the Social Security Act under the following circumstances:

1. Effective April 8, 1988, Medicare provides coverage for:

  • Palliative treatment of skin manifestations of CTCL 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.

C. Nationally Noncovered Indications

All other indications for extracorporeal photopheresis remain noncovered.

D. Other

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

(This NCD last reviewed December 2006.)
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
66
Revision History

04/1988 - Provided coverage when used in the palliative treatment of skin manifestations of cutaneous T-cell lymphoma that has not responded to other therapy. Effective date 04/08/1988. (TN 24)

Extracorporeal photopheresis is now covered for patients with acute cardiac allograft rejection or chronic graft versus host disease whose disease is refractory to standard immunosuppressive drug treatment. Effective date 12/19/2006 Implementation date 04/02/2007. (TN 66)
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Extracorporeal Photopheresis 3 04/30/2012 - N/A View
Extracorporeal Photopheresis 2 12/19/2006 - 04/30/2012 You are here
Extracorporeal Photopheresis 1 04/08/1988 - 12/19/2006 View
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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