What FACT Accreditation Requires and Whether It's Necessary

Tagline: Dr. Graff outlines exactly what FACT accreditation demands operationally, while Dr. Patt argues accreditation should support quality rather than function as a rate-limiting barrier to patient access.

"What FACT Accreditation Requires and Whether It's Necessary" takes up the question of whether accreditation and access can coexist.

Dr. Patt cites real-world data on patients treated at non-FACT-accredited sites, using it to ask whether FACT accreditation is truly necessary for safe CAR-T delivery. She credits FACT with pushing practices toward important quality standards and creating a more workable path for community oncology, but argues accreditation should never function as a rate-limiting step to access. She emphasizes that payers, not FACT itself, are the real barrier when they use accreditation status to justify coverage denials.

Dr. Graff walks through what FACT actually requires: rigorous documentation spanning apheresis and manufacturing through post-infusion follow-up, confirmation that a patient's histology matches their diagnosis, extensive staff training, and a program director who understands every step of the process. She describes it as far more detailed than routine clinical documentation, covering years of patient follow-up. She argues many community sites already manage comparable toxicity through bispecific antibody programs, some with higher CRS rates than CAR-T itself, using the same escalation protocols and trained teams. She asks why FACT can't create a probationary pathway for sites with a demonstrated safety record, rather than requiring a completed CAR-T patient before accreditation can even begin. Practices can apply for FACT while treating patients, she notes, but payers still lean on accreditation status alone to deny reimbursement.

Dr. Patt describes how Texas Oncology used a crawl-walk-run approach, building bispecific step-up dosing infrastructure, including a remote ePRO monitoring system covering roughly 100 nurses with a 3.5-minute average response time, as a foundation before expanding into CAR-T delivery. She credits Texas Oncology leader Nate Shumway with adapting that same monitoring model, adding biometric tracking, for lower-risk step-up dosing patients on the path toward CAR-T.

The next episode in this series, "The True Cost of Running a Community CAR-T Program," puts a dollar figure on what that infrastructure actually costs to build and maintain.