CAR T on Main Street: COA Session Dives Into Details on Expanding Access to Care

Since 2017, when the FDA approved the first engineered T-cell therapies to silence cancer, the quest has been to bring these miracle treatments to as many patients as possible.

Nearly a decade later, the prospect of scaling chimeric antigen receptor (CAR) T-cell therapy across community oncology practices seems possible. Early adopters have learned to manage the adverse effects of the first generation of bespoke therapies, and now allogeneic or “off-the-shelf” treatments are in the pipeline, which would eliminate much of the time, uncertainty, and cost of that first wave.

These opportunities were the theme of “CAR T on Main Street: Expanding Access, Empowering Care,” held April 28, 2026, at the Community Oncology Alliance’s annual Community Oncology Conference. Four oncologists gathered for a panel discussion moderated by Eve Stahl, MHA RT(R), of McKesson/The US Oncology Network. They were Gary Simmons, MD, of Virginia Oncology Associates; Michael Byrne, DO, FACP, of Tennessee Oncology/OneOncology; Ralph Boccia, MD, FACP, of the Center for Cancer and Blood Disorders/American Oncology Network (AON); and Ameet Patel, MD, MMHC, of Florida Cancer Specialists & Research Institute.

The panel explored how CAR T-cell therapy is moving from the academic transplant centers where it got its start into the community oncology setting—and what it will take to reach more patients at scale.

Boccia emphasized that this starts with having a robust clinical research program in the practice. “One of our goals has always been to keep our patients in the community, [to] try to provide the care that you were trained to give when you were at academic centers, and to maintain that care in your community,” he said. “So that’s why we are so dedicated to clinical research.”

Why Offer CAR T in the Community?

What drives physicians to take on the management and financial challenges of CAR T? In a word, it’s access. Simmons said his practice serves roughly 2.5 million people, with the nearest academic center more than 100 miles away. "Data from [the American Society for Transplantation and Cellular Therapy] show, and our data just in our practice show that that's just a barrier to getting patients cellular therapy," he said.

Byrne said more than 50% of patients with cancer in Tennessee are seen in his practice’s clinics, giving Tennessee Oncology a responsibility to keep those patients close to home. Patel said if community oncology fails to take on CAR T, some patients won’t be treated. “A quarter of patients, if not more, don’t make it to authorized treatment centers for these curative cell therapies.”

He invoked the story of Emily Whitehead, the first patient treated with CAR T in 2012, to note that, despite a decade of clinical progress, the market and access landscape have changed little.

“How can we reinvent the wheel? How can we improve access, retain quality, and, most importantly, how can we do it in a sustainable manner, a manner that society as a whole benefits [from]?” Patel asked. “Can we do it with the consensus of payers, quality, governance, and, most importantly, efficiency and cost?”

Patient Selection and Care Delivery

All 4 physicians run fully outpatient CAR T programs. Byrne described a rigorous approach to patient selection, emphasizing the need to assess caregiver availability and to provide meticulous bridging therapy to keep patients stable enough to reach infusion. “We’ve lost zero patients along the way,” he noted.

Simmons highlighted that community oncologists’ close relationships with patients—combined with total control over the care timeline—can produce superior outcomes. Both physicians agreed that patient preference to remain with their own care team is nearly universal. Complex cases require intense focus: Simmons described a patient with central nervous system myeloma on dialysis for whom navigating outpatient infusion logistics required exceptional coordination.

Having a strong hospital partner is essential, but it’s not a given that anyone will see an incentive to cooperate. Patel warned, “Having a good hospital partner that is engaged and motivated to be able to pick up the panel if a patient does require management in the hospital is very, very important.” Boccia said the best approach is to engage hospital clinicians directly rather than rely on hospital administration.

Payer Barriers and Patient Stories

Reimbursement and payer policy emerged as perhaps the most consequential barrier. Simmons shared the story of a patient, a former government official with severe myeloma, whose primary commercial insurer denied outpatient CAR T and insisted the therapy could not be safely administered outside a hospital setting. This patient did not want to travel for treatment, and she ultimately dropped her primary insurance so that Medicare became her primary coverage. This allowed her to stay with the practice and closer to home.

“How does that make sense?” Simmons asked. Fortunately, he reported, the patient is now minimal residual disease–negative and in remission.

Boccia described a current patient with follicular lymphoma whose payer directed him to an outdated Centers of Excellence network that he said was built for a time when only academic centers administered CAR T. After 4 weeks of negotiations, his team secured an out-of-network authorization. The payer’s own medical director acknowledged that the policy needed to change. “Give me another couple of months, and I think we can figure out how to break apart this Center of Excellence group.” Boccia noted a structural inequity in Medicare reimbursement for community practices compared with academic centers—a gap he attributed in part to 340B status—and called on community providers to work together to address it through policy channels.

Infrastructure, Economics, and Sustainability

Building a community CAR T program requires a huge up-front investment, which Byrne described as a “7-figure” commitment to staffing, freezers, liquid nitrogen, and quality infrastructure. Patel emphasized the need to carefully map operational workflows, assess whether a hub-and-spoke model fits the geography, and build payer relationships before the first patient is infused. “There’s no point in getting into CAR T cell therapy unless you have a good system in place to be able to sustain yourself,” he said.

Simmons was candid about the economic strain, calling financial sustainability his biggest concern. "There’s a very low to negative margin right now in CAR T cells.” Because the FDA-approved CAR T indications skew heavily toward Medicare populations, and because community practices lack the 340B advantages of academic centers, many programs operate at a loss. He called on manufacturers to rethink community pricing and delivery models. “You’re going to have to develop different models if you want to see these numbers expand, because what you're doing is not working.”

Byrne added that another underappreciated cost is time—the countless unreimbursed meetings required to coordinate care that traditional productivity-based models do not reward.

“I just want to add 1 thing,” Simmons said. “No one up here said that physicians don’t want to do this. You're not hearing that.”

Accreditation and Quality Standards

FACT (Foundation for the Accreditation of Cellular Therapy) accreditation is a major topic in the field, panelists said. Boccia noted that his center is pursuing FACT certification in part to demonstrate quality to peer practices within AON. "We can establish that we can show what quality looks like, and people can then pattern themselves with those quality measures."

Stahl noted that Texas has passed a law explicitly affirming that FACT accreditation is not required to receive these therapies in any health setting, including community oncology.

Patel, whose practice is also pursuing provisional FACT accreditation, described the decision as highly context dependent—tied to goals around quality, future services such as autologous stem cell transplant, and local payer requirements. He emphasized that quality must be enforced on both the practice and hospital sides. “There’s a codependency between access and quality, and you have to find the right mix for both.”

Advice for Getting Started

“Ask for help early—don’t be proud," Byrne said. No resource should be off limits, whether it’s manufacturers, conference networks, or experienced peers. Patel recommended that practices start with bispecific antibodies as a stepping stone to offering CAR T. “Bispecifics is a good stress test in terms of your operational workflow, proof of concept, and feasibility,” he said. “That is an important way to be able to onboard things like CAR T-cell therapy over time.”

Simmons counseled caution and self-assessment. “Know how deep the water is before you jump in.” He also urged manufacturers to rethink pricing models for the community setting, and like Patel, called on payers to recognize that high-quality outpatient CAR T is both clinically sound and cost-effective. Boccia urged practices to enter clinical trials as an on-ramp, as this will offer access to a manufacturer-provided playbook, build team experience with T-cell–redirected toxicity, and establish a foundation for future commercial programs.

Stahl closed by praising the panel’s “pioneering spirit to bring access to these important therapies into the community where it needs the most."