Revisiting FACT Accreditation Standards for CAR-T Delivery

Tagline: The panel traces FACT accreditation's origins in transplant medicine and asks whether a decade of improved CRS and neurotoxicity management has outpaced the original rationale for its strict requirements.

In "Revisiting FACT Accreditation Standards for CAR-T Delivery," our experts turn to the history behind today's accreditation debate.

Dr. Graff acknowledges the need for a regulatory body to protect patients and ensure safe therapy delivery, but argues that times have changed since FACT accreditation's requirements were first established. She traces FACT's origins to the bone marrow transplant era, when rigorous guidelines were essential. When the first CAR-T products launched in 2017, toxicities were high and poorly understood, even at the most experienced centers, which justified strict documentation and oversight.

Nearly a decade later, she says, CRS and neurotoxicity rates have fallen enough to mirror what clinicians see with bispecific antibodies, aided by prophylactic medications and years of accumulated experience. She argues that practices like hers, which have safely managed bispecific antibody toxicities outpatient for four years without yet treating a CAR-T patient, deserve credit for that demonstrated capability. She questions why FACT would deny accreditation to a site whose cellular therapy team has already managed CRS and neurotoxicity in every form, when a CAR-T product would present nothing fundamentally different.

She describes this as a constant, daily fight: physicians within the Community Oncology Alliance are continually working to educate payers that accreditation requirements built for an earlier, riskier era should evolve alongside the therapies, the physicians, and the education supporting them. She is careful to note that she isn't singling out FACT itself as the problem; rather, she believes the standards it set years ago haven't kept pace with how far the field has come. The stakes are significant, she notes, citing that only about 20% of patients who need these therapies currently receive them. Depending on how advanced their disease is, that gap in access can fundamentally change a patient's life expectancy.

In "What FACT Accreditation Requires and Whether It's Necessary," the panel weighs what FACT accreditation actually requires against whether it should remain a gate to access.