LANSING, Mich. — The Michigan Legislature approved a resolution introduced by Sen. Curt VanderWall Wednesday that will help ensure Michigan cancer patients have the same access to the most promising cancer treatment and facilities as cancer patients in any other state.
Senate Concurrent Resolution 14 rejects a recent standard issued by the state Certificate of Need Commission that would have regulated immune effector cell therapy (IECT) by requiring any facility administering treatments to be accredited by the Foundation for the Accreditation of Cellular Therapy (FACT).
“This new standard proposed by the commission would have placed bureaucratic hurdles and unnecessary regulation in the way of new cancer treatments providing patients hope and a new chance at life,” said VanderWall, R-Ludington. “Michigan does not need to add another layer of government bureaucracy at the state level; the current safeguards are more than enough.”
The Centers for Medicare and Medicaid Services (CMS) released a National Coverage Decision regarding coverage for chimeric antigen receptor T cancer therapy, a type of IECT. They specifically reviewed FACT accreditation and determined it was not necessary.
Instead, CMS and the Food and Drug Administration require risk evaluation and mitigation strategies (REMS).
“At FACT-accredited sites, REMS is still required to administer the cell therapy,” VanderWall said. “Requiring REMS and FACT simply creates redundancy and extra costs.”
VanderWall said immune effector cell therapy personalizes medicine at the molecular level to help save lives. Currently, there are 500 IECT clinical trials underway in a variety of settings across the country.
“If we had let the commission’s standard stand, not only would have Michigan been out of sync with the federal government and Medicare, we would have been the only state in the nation to require additional state-level government oversight of this procedure,” VanderWall said. “We would have been an outlier in restricting patient access to these exciting new cancer treatments.”
Sen. Curt VanderWall, R-Ludington, speaks on the Senate floor in support of Senate Concurrent Resolution 14, his measure that will help ensure Michigan cancer patients have access to treatment.