Cancer therapy dispute highlights need to repeal CON laws


A cancer diagnosis is no longer the death sentence it once was. Five-year cancer survival rates have doubled since the 1950s. While one’s likelihood of survival varies by the type of cancer, the progression of the disease and the individual’s overall health, it is more likely that one will survive a cancer diagnosis today than die from it. Rapid advances in cancer diagnosis and treatments have transformed some types of cancer from terminal illnesses into chronic ones.

In a state that has a cancer death rate higher than the national average, Michigan’s Certificate of Need Commission — an unelected state board — recently attempted to limit the availability of one of the most promising FDA-approved therapies, known as CAR-T. This potentially lifesaving cancer therapy uses one’s own immune system cells, which have been reprogrammed to find and attack cancer cells in the body. In most cases, the treatment needs to be administered to the patient only once, allowing them to avoid more invasive treatments. Fortunately, the state’s legislature blocked this attempt to put hospital profits over patients.

Certificate of need (CON) laws require competitors’ stamp of approval before providers can offer more health care services, such as opening a new hospital or new medical service. These decades-old laws, established at a time when medical services were paid for by funding facilities rather than for services provided, long have been abandoned by most states. But these laws persist in Michigan and other states largely because they protect existing hospitals from new competitors.

The Michigan CON Commission’s attempt to require board approval for CAR-T cell therapy would have been an inappropriate use of the CON process. Since CAR-T can be administered through a routine blood transfusion — requiring no new capital investment for providers — and the process for altering the patient’s T-cells is done in a remote lab that is already governed by Food and Drug Administration (FDA) rules, it never should have been up for review by the commission.

However, Michigan’s largest hospitals, which are located primarily in the state’s urban centers, lobbied the commission to interfere and force would-be competitors through the CON process. The most harmful consequence would have been for rural patients. They would have been forced to travel hours to access the same potentially lifesaving treatment that others could access much more conveniently. Worse yet, they would have been forced to rely on less effective treatments if they were not healthy enough to travel, could not afford the trip, or did not have someone to accompany them.

Fortunately, Michigan law allows the state legislature to review a CON Commission ruling and reverse it within 45 days. Lawmakers acted in time, ensuring that more cancer patients can get access to this innovative treatment and putting these vulnerable cancer patients ahead of the big hospitals’ profits.

CON laws harm patient access, affordability and health outcomes. Allowing a bureaucratic board this breadth of authority over health care choices is unnecessary. Michigan lawmakers deserve kudos for reversing the CON Commission ruling on CAR-T.

There is, however, more work for state lawmakers across the country to do on this issue. CON laws are contributing to the shortage of in-patient psychiatric beds, meaning that the mentally ill are warehoused in jail or inappropriate hospital settings, rather than facilities that can better evaluate and meet their needs. Lawmakers should work to repeal CON laws so that patients aren’t forced into these harmful situations.

State lawmakers gearing up for their 2020 legislative sessions ought to put patients first, so that all patients, especially the most vulnerable, can have access to the care that best meets their needs and access to the best technology and innovation at the lowest cost. Repealing CON laws is a good place to start.

Lindsay Killen is vice president for strategic outreach and communications for the Mackinac Center for Public Policy in Midland, Mich.

Naomi Lopez is director of health care policy for the Goldwater Institute in Phoenix, Ariz., and an adjunct scholar with the Mackinac Center.

Tags Cancer Certificate of Need Health Medicine

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