The commission adopted the rule at the behest of several of Michigan’s established cancer treatment providers and on the advice of a panel of clinical experts it appointed to evaluate the need for the regulation.
The panel also recommended requiring providers to be accredited by the Foundation for the Accreditation of Cellular Therapy (FACT), a national nonprofit organization that inspects cellular therapy facilities.
Keeping Out Competition
CON laws, which in some states are called Certificate of Public Need laws, are designed to keep health care providers from engaging in unnecessary capital outlays that would ultimately be passed on to patients in the form of higher costs. In practice, this means hospitals and other health care providers must get the approval of a state agency before offering new services, expanding their operations, or implementing new medical technologies. Dominant providers frequently use CON laws to limit competition from smaller hospitals.
CAR-T therapy is different from most health care services, states Anna Parsons, a policy coordinator with the American Legislative Exchange Council, because it does not require a capital investment (see commentary).
“An FDA-certified hospital should be capable of offering these treatments, since all the high-tech bioengineering is done at other locations,” Parsons told Reason.com.
Michigan As Outlier
Michigan state Sen. Curt VanderWall (R-Ludington), who chairs the Senate Health Policy and Human Services Committee, says he opposes CON regulation of CAR-T.
“It is concerning to me that the CON commission expanded a requirement into a new clinical service area that goes well beyond the federal requirement,” VanderWall told Health Care News.
The Centers for Medicare and Medicaid Services makes no mention of FACT accreditation in its August 7 press release stating Medicare will cover the proceedure in “healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies for FDA-approved indications.”
“The new CON requirement to obtain third-party accreditation will be a barrier to access, create an unnecessary financial burden for providers, and limit the sites of care from offering cellular therapies to patients,” said VanderWall.
VanderWall says patients should be allowed to choose their own CAR-T provider.
“Patient choice and access are priorities for me,” said VanderWall. “Patients will be able to work with their doctors to find the best treatment site based on safety and access.
“Michigan should not be an outlier,” VanderWall said. “No other state has a CON standard for immune effector cell therapy (IECT), and safe treatment will be offered according to the established federal guidelines in the other 49 states.”
A Joint Legislative Committee and the governor were allowed 45 days from the September 19 decision to review the new language to regulate IECT, of which CAR-T is a form, and the FACT accreditation requirement.
AnneMarie Schieber ([email protected]) is managing editor of Health Care News.
Michigan State Senator Curt VanderWall, (R – Ludington): https://www.senatorcurtvanderwall.com