Taking the Giant Leap Into CAR T: Managing Financial and Administrative Challenges

As Barry Russo, MBA, the longtime CEO of the Center for Cancer and Blood Disorders, described paying for the practice’s first shipment of chimeric antigen receptor (CAR) T-cell therapy, one thought of the astronauts on the recent Artemis II flight: with absolute precision, so much is possible. But anything less would bring disaster.

“It’s a little nerve wracking because it's a one-and-done thing,” Russo said, near the start of Wednesday’s session on access and administration of cellular therapy, held during the Community Oncology Alliance (COA) annual conference in Orlando, Florida. “It’s one drug, and I've just spent a half a million dollars of our practice’s money. You do have to have your ducks in a row around that. You have to have your payer negotiation nailed.”

Both before and after treatment, he said, it’s “all hands on deck” for the revenue cycle team to ensure the practice gets paid, not only for the therapy itself but also for other costs, which can exceed $1 million.

Russo joined moderator Lalan Wilfong, MD, the new chief medical officer of Navista, and panelists James Gilmore, PharmD, chief pharmacy and clinical services officer of American Oncology Network, and Aaron Lyss, MBA, senior director of payment and policy innovation at OneOncology, for a discussion of the business side of bringing cellular therapy to patients, or what one might call the art of getting paid.

As CAR T moves into the community setting, payers are still not accustomed to reimbursement for these therapies outside of an academic transplant center. And, as Wilfong explained, that means the stakes for practice leaders are enormous. “If you don't get reimbursed, that's a significant potential impact your physician compensation,” he said. “Because at the end of the day, physicians get whatever is left over in practice.”

“One hundred percent,” Russo replied. “Whenever comp goes down, your job gets less stable. Whenever the physician comp goes down, bad things happen,” he said, as laughter rippled through the audience.

But then Russo shared how everyone at his practice reacted when, after 45 days, test results showed that their first patient treated with CAR T had no evidence of disease.

“This is the whole reason that we want to do this,” he said.

Lyss said the OneOncology network has 6 practices ready to administer “at least 1 commercial CAR T-cell product," with more than 50 treatments administered across the network. AON is very close to administering its first commercially available CAR T treatment, Gilmore said.

Wilfong noted that practices are no longer handling the follow-up after the treatment is done in an academic center. "We're actually delivering the cellular therapy in our offices— not partnering with the hospital—and these therapies historically have only been given in health systems.”

Financial Barriers and Single-Case Agreements

Gilmore organized the financial challenges of each CAR T-cell episode into 3 buckets. First, there’s the upfront cost of therapy itself, which is approximately $500,000. Second, there are what he called “payer uncertainties,” which include whether things will be covered in a fair and timely way, as well as what patients will face in out-of-pocket costs. Third, there are the hard costs of standing up the program—equipment, staff training, policies, procedures, and accreditation, none of which are inexpensive.

Russo underscored the psychological and financial weight of the commitment. With each single-case agreement, “You're not working off your standard contract,” and there can be no room for the “clawbacks” that are often seen with self-funded employer coverage. “You can't get a clawback on a $600,000 drug. Make sure that language is in your single-case agreement."

Lyss, who has likely negotiated more single-case agreements for community CAR T than anyone in the country, said the heart of the problem is ancient contracting language: "The biggest challenge with the current state of these single-case agreements is this ingrained dogma that this has historically been done in transplant centers,” he said. “These agreements are written as if this is an [hematopoietic cell transplant]," and unwinding that history with payers is a tall order.

“When you've seen one, you've seen one—the variability at every step in the process, from a payment standpoint, is largely what accounts for why we don't have access to these therapies the way we have access to other therapies." To scale access to CAR T in community settings, Lyss continued, "We have to make this process more predictable and less risky for the practice.”

These kinds of challenges are the reason why only 2 out of 10 patients eligible for CAR T-cell therapy receive it, Russo said, and manufacturers hope they can gradually move that ratio to 4 out of 10 or 6 out of 10.

Lyss also identified a systemic coordination requirement that distinguishes CAR T from all other therapies. "Every clinical activity is actually a risk decision, because this has to flow through to ultimately getting approval for the case and getting reimbursed. The clinical teams, the [revenue cycle management] teams, and whoever's leading contracting all have to be in lockstep throughout the entire implementation journey—at a level of detail that isn't necessary in other therapies."

Operational Infrastructure

Russo urged practices considering CAR T to create a dedicated cell therapy committee that meets weekly and includes clinical, revenue cycle, authorization, and social services teams. His practice also invested in changes to phone systems and triage protocols and has explored wearable monitoring devices for remote patient management.

Because some specialized needs remain uncommon, they can also be expensive. “I had no idea how expensive apheresis is until you go price it, and then you realize there's usually one entity in your market who does it, and they can charge whatever they want."

He and Lyss both emphasized working closely with manufacturers. Understand just-in-time delivery. “Once you accept [T-cells], the clock starts ticking," Russo said. Manufacturers, he argued, have a financial incentive to bring treatment into the community setting. "They want to move from 2 out of 10, to 4 to 6 out of 10, and that's not going to happen anywhere except community oncology."

The group discussed the Foundation for the Accreditation of Cellular Therapy (FACT) certification. Lyss urged caution about front-loading the cost, and instead called for growing into FACT accreditation. “The more expensive we make it for community practices to administer these therapies, the less access we're going to have,” he said. In that vein, payers should not be requiring FACT accreditation as a medical necessity criterion. "These programs aren't going to be workable under those criteria."

Strategic Imperative

All 3 panelists positioned CAR T not as a niche add-on but as a core strategic priority. Gilmore pointed to the historical arc of community oncology, with therapies once confined to hospitals ultimately becoming standard in office settings, and said the mission is unchanged. “Providing these life-saving treatments to patients where they live, at a lower cost and a more convenient way,” he said.

Lyss said, “There are laws of physics here we can't avoid. These therapies are going to have to be accessible in the community setting.” He cited the coming expansion into autoimmune conditions—including type 1 diabetes, multiple sclerosis, lupus, and rheumatoid arthritis—as the moment that will "blow the lid off the current system." Russo said his practice is even reconsidering its branding. "We should be and could be treating all kinds of patients. What does our brand look like then?"

How Does the Total Cost of Care Compare?

Barbara McAneny, MD, a New Mexico-based oncologist, COA board member and former president of the American Medical Association, asked the panel whether data existed comparing total cost of care for CAR T in the community versus hospital settings. Lyss said this is hard to do because hospital-based programs “keep those numbers pretty well hidden from us." He argued that payers need to evolve into "more cooperative stakeholders" who reward the value community practices are creating.

Russo said that anecdotal data is emerging from employers in his area. AT&T and 7-Eleven, for example, have spoken publicly about paying between $3 million and $5 million for CAR T cases delivered in hospital settings, amounts much higher than the cost of treatment in the community setting. "It wouldn't surprise me if the delta is that large," he said.

For practices considering CAR T, the panelists recommended contacting payers early, developing a robust bispecific T-cell engager program as a foundation, and leaning heavily on manufacturers for help. Wilfong advised practices to look for guidance from COA’s newly formed cellular therapy working group.

Said Gilmore, "This isn't something you quickly get up to speed on when you have a patient. You start now."