The Michigan Legislature voted Wednesday morning to veto a unanimous vote by a state regulatory commission to regulate and limit the number of hospitals that could perform a promising but expensive cancer treatment.
The therapy, known as CAR T-cell cancer treatment, uses a patient's own immune cells to fight cancer. It's part of a class of treatments called "immune effector cell therapy," or IECT.
In Senate concurrent resolution No. 14, with the Michigan House concurring, legislators said a CON regulation on IECT would "limit patient access to innovative cancer treatment." It also said regulation could discourage additional health care facilities from offering the treatment.
On Sept. 19, the state Certificate-of-Need Commission in September approved a regulation that would require hospitals to achieve special accreditation to perform the somewhat dangerous treatment that currently has about a 40 percent initial success rate.
In a previous interview, James (Chip) Falahee Jr., chair of the CON Commission, said the commission respects whatever decision the state Legislature makes. "They have the ability under statute" to disapprove, he said. "We fulfilled our responsibility to review (the issue) and heard testimony" from oncologists and other experts before the commission made its decision.
"This is the first time (the state Legislature could issue a disapproval of a proposed CON regulation in a concurrent resolution) since language was put into effect in 2002," Falahee said. "There was one instance where the governor (Jennifer Granholm) vetoed" a proposed CON regulation (to limit proton beam therapy) in 2008.
Four hospitals in Michigan currently offer CAR T-cell therapy, an inpatient procedure that modifies the DNA in a person's T-cells with specific viruses to produce what are called chimeric antigen receptor (CAR) proteins. These proteins are specific to the patient's cancer. The modified T-cells are then multiplied in the laboratory before being reintroduced to the patient.
The hospital are Henry Ford Hospital and Barbara Ann Karmanos Cancer Center, both in Detroit, the University of Michigan Hospital in Ann Arbor and Spectrum Health in Grand Rapids. All four have FACT accreditation, which the regulation would have required.
"We had doctors speaking for the (bone marrow transplant hospital) sites and other doctors saying 'no,' (regulation) should not be limited to the BMT sites. It should be available at additional sites (outpatient oncology practices) as well," said Falahee. "I referred to them as the dueling physicians. It was a very professional discussion" at the Sept. 19 commission meeting.
In a Crain's story Wednesday, Falahee said the commission heard testimony for many oncologists and cancer researchers that IECT and CAR T-cell therapy is a new medical treatment and potentially dangerous, it should be conducted in an inpatient setting.
"We have to be safe for patient reasons," said Falahee, who also is senior vice president of legal and legislative affairs at Bronson Healthcare Group in Kalamazoo.
Falahee said Bronson is supporting the CON regulation, but hasn't discussed seeking a CAR T-cell program.
Experts estimate 300 patients annually in Michigan could be candidates for CAR T-cell at a total hospital, physician and pharmaceutical cost that ranges from $800,000 to $1 million. Most insurers, including Medicare and Medicaid, cover the procedure.
Arguing in favor of regulation, Greg Yanik, M.D., a pediatric hematologist-oncologist at Michigan Medicine in Ann Arbor, pointed out how few patients would qualify.
"We're not talking 3,000, we're not talking 30,000," Yanik said. "Do we want unregulated access where let's say 100 hospitals can each treat three patients? No. I really firmly believe that the SAC recommendations will probably end up with 10 to 20 hospitals and those with fairly large oncology group practices each treating 15 to 20 patients."
Yanik said in his 30 years as an oncologist, he has never seen such a toxic combination of agents involved in the therapy protocol. He said the potential benefits are great, but the risks are even higher.
"I'm Roman Catholic. Every patient I give CAR T or these IECT therapies to, right before I treat, I go like this (making the sign of the cross and saying a prayer)," he said. "That tells you how serious I feel about this therapy."
This article was originally published in Crain's Detroit Business.