State Law Restricting New Clinics May Limit Promising Cancer Treatment

Michigan health care regulators are set to meet on Sept. 19 to adopt restrictions on would-be providers of a new cancer treatment. The move, critics say, is redundant, expensive and designed to serve the interest of major hospital chains rather than patients.

The rule involves CAR T-cell therapy, an evolving treatment that uses a modified form of a patient’s own blood to attack his or her specific cancer. The Michigan Certificate of Need Commission, a government agency whose members are appointed by the governor, may end up requiring third-party accreditation for providers seeking to use the treatment.

The rule is backed by Michigan’s largest hospital systems. But it is opposed by cancer research organizations, patient advocates and pharmaceutical companies, who argue it would add an unnecessary level of regulation and deny many patients access to potentially life-saving treatment.

Michigan’s proposed cellular therapy rule could effectively limit the providers of the treatment to large hospital-based cancer centers, opponents said.

“That might not be a big problem for patients in Detroit,” said Dr. James Essell, an Ohio-based blood cancer specialist. “But for people removed from urban centers who don’t have the resources to move for treatment, it could be insurmountable.”

Essell, who filed an objection to the rule with the commission on behalf of The US Oncology Network, said it may be the first of its kind in the country. Opponents of the rule question whether the commission has the authority to regulate CAR T therapy. Its primary jurisdiction is in determining which facilties can obtain hospital beds and major diagnostic tools like imaging equipment, and in what quantities.

For the most part, drug treatments fall under the regulatory purview of the federal government, primarily the FDA.

Supporters of the proposed rule, such as administrators at the University of Michigan Health System, say it is necessary for patient safety. Given the complexity of gene therapy products, they told the commission in a letter, federal oversight is inadequate.

Bret Jackson is the director of the Economic Alliance, a Michigan coalition of business and labor interests. He said the very fact that CAR T and other cell-modification therapies are rapidly advancing is an argument for state intervention.

“The future of these (treatments) looks like it could be very broad,” Jackson said, “You want people (administering them) who know what they are doing.”

The controversy highlights long-standing questions about the validity of Michigan’s certificate of need law, commonly known as CON. It was was enacted in the 1970s under a since-repealed federal mandate, with the intent of controlling health care costs. Fifteen states have subsequently jettisoned the concept.

Michigan’s regulation remains among the most restrictive in the nation, and a 2015 study by the Mercatus Center at George Mason University found it limited the availability of hospital beds and diagnostic services. The law essentially requires prospective clinics, hospitals and certain other medical care service providers who want to open a new facility or expand an existing one to get permission from a commission comprised of existing providers.

Under the state law that created the commission, a new standard, such as the cell therapy regulation, is subject to a veto by elected officials. It can be rejected by the governor or by a concurrent resolution of the state Legislature during a 45-day window after the commission adopts it.

This latter point could mean trouble for the proposal. Among those who filed objections to the rule were three Republican leaders in the state Senate. Senate Leader Mike Shirkey and Sens. John Bizon and Curtis VanderWall said the new rule “will be an onerous barrier to access, create an onerous financial burden for providers, and limit the sites of care from offering cellular therapies to patients.”