Search:

  

accreditation statistics

April and May 2019 Accreditations

Cellular Therapy Entities

  • Accredited: 236
  • Applicants: 8

Cord Blood Banks

  • Accredited: 56
  • Applicants: 3

During April and May of 2019, 16 entities received FACT accreditation. For details regarding these accreditations, view the full accreditation report.

A complete list of accredited organizations can be found at www.factwebsite.org.

CMS Releases Final Decision on National Coverage Determination for CAR T-cell Therapy for Cancers

Posted in :: 2019 Volume 8 :: Thursday, August 29th, 2019

The United States Centers for Medicare & Medicaid Services (CMS) finalized its National Coverage Determination (NCD) for CAR T-cell Therapy for Cancers on August 7, 2019. Among other changes, the decision no longer requires Coverage with Evidence Development (CED) and now allows coverage for indications on FDA-approved indications and uses recommended by a citation in CMS-approved compendia. FACT appreciates CMS’s consideration of our comments and of those submitted by several of our stakeholders. Many of the changes will promote patient access to CAR T-cell therapy.

The American Society for Transplantation and Cellular Therapy (ASTCT), one of FACT’s parent organizations, indicated that it is also pleased with many of the changes from the proposed decision memo and responded with a comment letter about suggestions for continuing to improve reimbursement for this therapy.

We believe in the utility of FACT Standards to promote safety and efficacy of CAR T-cell therapies; increase harmonization across requirements of regulators, payers, and manufacturers; and reduce burden on hospitals. We will continue to work with all of these stakeholders to do our part to promote patient access.

View the CMS Decision Memo

View the ASTCT Letter to CMS