Large Hospitals Want State Monopoly On New Cancer Treatment

A new rule proposed by a state regulatory body to limit access to a new cancer treatment would be blocked under a resolution introduced Tuesday in the state Senate.

Senate Concurrent Resolution 14 would halt a proposed “final action” of a rule approved by the state Certificate of Need Commission in September. Its rule would require providers of immune effector cell therapy services to seek outside accreditation, in addition to getting approval under a federal drug safety process.

The requirement “would limit patient access to innovative, new cancer treatments,” the resolution states, calling it “unnecessary ... onerous and costly.”

The resolution would have to be approved by both the House and Senate by Nov. 7 to block the rule. It would be the first time that legislators blocked a rule from the commission, which was created in 1978 to limit capital expenditures by medical facilities on expansions and expensive technology.

State Rep. Hank Vaupel, R-Fowlerville, chairman of the House Health Policy Committee, said Tuesday he is inclined to support the resolution, but its fate is uncertain. Vaupel said that federal safety standards for cell therapy cancer treatments — in which the blood of a patient is extracted, modified in a laboratory to attack cancer and re-infused — are adequate. Michigan, he said, should not become the first state in the country to impose restrictions on it.

The CON commission rule is supported by the state’s largest hospital systems, which argue that the treatments currently available, known as CAR-T therapies, are so complex, expensive and potentially dangerous that rigorous oversight is required. Robert Hughes, president of Advantage Benefits Group and a CON commission member, said in an interview with Michigan Capitol Confidential that outside accreditation would help contain costs without unduly limiting access. Most importantly, he said, the new rule would ensure the safety of patients.

Hughes describes himself as a free-market conservative, “but health care is not a free market,” he said. “Half of all customers are covered by the government (Medicare and Medicaid).” While new cellular therapies using blood modified in a laboratory are promising, he said, they are also extremely expensive and perilous.

“The complexity of administering these drugs is off the charts,” Hughes said. “There is not much room for error.” Absent outside accreditation, providers could “select the wrong patients ... (or) administer (therapies) improperly, killing someone,” he said.

Dr. Mark Campbell, an oncologist and president of the Cancer and Hematology Centers of Western Michigan, strongly disagrees with that assessment. Campbell, whose centers employ 25 oncologists and serve nearly 8,000 patients a year at clinics at a half dozen clinics in Grand Rapids and rural communities to its north, said, “It is an insult to suggest we would select the wrong patients.”

Community clinics, like those run by his organization, provide a vital service to cancer patients who live and work far from urban centers, providing both effective and less expensive treatment, Campbell said.

“No one seems to care about the farmer (and cancer patient) who lives 20 miles north of Fremont, and can’t readily travel to Ann Arbor or Detroit,” Campbell said.

When the specific needs of a patient at his clinics require the services of a major hospital system, they get referred there, he said, just as the hospital systems refer patients to his facilities. The need for the new CON rule has not been demonstrated, Campbell said. “Why suddenly is this necessary?”