NCD 110.4: Extracorporeal Photopheresis

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administration) but the drug can alternatively be administered directly to the patient before the white blood cells are withdrawn.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 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:

• improved forced expiratory volume in one second (FEV1);

• improved survival after transplant; and/or,

• improved quality of life?

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

• The principal purpose of the research study is to test whether extracorporeal photopheresis potentially improves the participants’ health outcomes.

• 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.

• The research study does not unjustifiably duplicate existing studies.

• The research study design is appropriate to answer the research question being asked in the study.

• The research study is sponsored by an organization or individual capable of successfully executing the proposed study.

• 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.

• All aspects of the research study are conducted according to appropriate standards of scientific integrity (see http://www.icmje.org).

• 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.

• 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.

• 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.

• 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).

• 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.

• 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.)

10/2024 - The purpose of the Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations(NCDs). No policy is being changed as a result of these updates. ( TN 12903 ) (CR13818)

01/2024 - Transmittal 12318 issued October 19, 2023, is being rescinded and replaced by Transmittal 12441, dated January 3, 2024, to add FISS to BR 13390.11 and to add clarifying verbiage to business requirement 13390.12. All other information remains the same. ( TN 12441 ) (CR13390)

10/2023 - The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations (NCDs). No policy is being changed as a result of these updates. ( TN 12318 ) (CR13390)

02/2020 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html , along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. ( TN 2427 ) (CR11491)

05/2017 - This change request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html , along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. ( TN 1854 ) (CR10086)

02/2017 - This change request (CR) is the 10th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates as follows: CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, CR9540, CR9631, and CR9751, as well as in CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. ( TN 1792 ) (CR9861)

04/2016 - Transmittal 1630, dated February 26, 2016, is being rescinded and replaced by Transmittal 1658 to (1) remove duplicate spreadsheet NCD210.3, (2) add missing spreadsheet NCD20.33, (3) add B/MAC to requirement 3 at request of WPS/B, (4) rename the spreadsheet titles, and, (5) provide a link to the attached spreadsheets for more efficient ease of reference and accessibility. All other information remains the same. ( TN 1658 ) (CR9540)

12/2015 - This change request (CR) is the 3rd maintenance update of ICD-10 conversions/updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, & CR9087. Some are the result of revisions required to other NCD-related CRs released separately that included ICD-10 coding. Implementation date: 01/04/2016 Effective date: 10/1/2015. ( TN 1580 ) (CR9252)

08/2015 - This change request (CR) is the 3rd maintenance update of ICD-10 conversions/updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, & CR9087. Some are the result of revisions required to other NCD-related CRs released separately that included ICD-10 coding.

These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 01/04/2016 Effective date: 10/1/2015. ( TN 1537 ) (CR 9252)

05/2014 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 07/01/2013 Effective date: 07/01/2013. ( TN 1388 ) ( TN 1388 ) (CR 8691)

03/2013 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 07/01/2013 Effective date: 07/01/2013. ( TN 1199 ) ( TN 1199 ) (CR 8197)

09/2012 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy.Implementation date: 01/07/2013 Effective date: 10/1/2015. ( TN 1122 ) ( TN 1122 ) (CR 7818)

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)

Effective for claims with dates of service on or after April 30, 2012, CMS will cover 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 specific requirements to assess the effect of extracorporeal photopheresis for the treatment of BOS following lung allograft transplantation. Effective date 04/30/2012 Implementation date 10/01/2012. ( TN 143 ) (CR7806)