FACT Announces Accreditations - October 2019 #

In October 2019, six entities received accreditation from the Foundation for the Accreditation of Cellular Therapy. For a complete list of programs achieving accreditation, review the full accreditation report.

FACT Announces Accreditations June - September 2019 #

From June through September 2019, 20 entities received accreditation from the Foundation for the Accreditation of Cellular Therapy. For a complete list of programs achieving accreditation, review the full accreditation report.

Updated Donor History Questionnaires Now Available #

HPC, Apheresis and HPC, Marrow DHQ Version 2.0, June 2019
The HPC, Apheresis and HPC, Marrow Donor History Questionnaire materials have been updated to version 2.0. A complete summary of the updates incorporated in this new version is in the chart detailing the changes from version 1.9.

HPC, Cord Blood DHQ Version 1.7, June 2019
The HPC, Cord Donor History Questionnaire materials have been updated to version 1.7. The changes update some FDA guidance document names, dates, and/or website links, located within the DHQ, to the current version. A complete summary of the updates incorporated in this new version is in the chart detailing the changes from version 1.6.

FACT Announces April and May 2019 Accreditations #

During April and May of 2019, 16 entities received accreditation from the Foundation for the Accreditation of Cellular Therapy. For a complete list of programs achieving accreditation, review the full accreditation report.

Feedback Requested: FACT-JACIE Standards #

Preparation of the Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration will commence this summer. Final publication is expected in March 2021.

FACT and JACIE invite you to complete a short survey focusing on general concepts of interest. You are also encouraged to promote this survey in your national or regional professional society. Responses will be accepted through June 15, 2019.

The results of this survey will be reported to the Standards Steering Committee for review and consideration.

Complete Survey

FACT Announces 2018 Fourth and 2019 First Quarter Accreditations #

During the fourth quarter of 2018 and first quarter of 2019, 40 entities received accreditation from the Foundation for the Accreditation of Cellular Therapy. For a complete list of programs achieving accreditation, review the full accreditation report.

FACT Submits Comments to CMS Regarding Proposed National Coverage Determination for CAR T-Cell Therapies for Cancer #

The United States Centers for Medicare & Medicaid Services (CMS) released a proposed decision memo that outlines coverage for CAR T-cell therapies for cancer using a National Coverage Determination (NCD) with Coverage with Evidence Development (CED). FACT responded to this proposal on March 15, 2019. Comments were a result of input from a variety of stakeholders, including the FACT Board of Directors and Immune Effector Cell Task Force, FACT-accredited programs, FACT inspectors, professional societies, data registries, manufacturers, and payers. We commend the cellular therapy field for its collaborative efforts to provide feedback that would be helpful to CMS as it seeks to provide beneficiaries access to CAR T-cells, and we appreciated this opportunity to provide feedback.

Highlights of FACT’s comments include:

• Suggestion that coverage is provided based on Food and Drug Administration (FDA)-approved product labels to allow coverage as therapies advance.
• Support for the use of the Center for International Blood and Marrow Transplant Research (CIBMTR) as the data registry, and suggestion to certify the registry prior to finalization of the proposed decision memo.
• Request for clarification on the utility of quality of life data for the stated purposes.
• Clarification regarding the scope of various sets of FACT Standards.
• Agreement that hospitals should meet FACT requirements to promote safety and efficacy of CAR T-cell therapies; increase harmonization across requirements of regulators, payers, and manufacturers; and reduce burden on hospitals.

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