State lawmakers are looking to set aside a panel’s decision that would require hospitals to earn third-party accreditation if they want to provide an emerging, complex and potentially lethal cancer treatment.
The Sept. 19 decision by the Michigan Certificate of Need Commission, made on the unanimous recommendation of an advisory committee that consisted largely of physicians, seeks to ensure care providers meet quality and safety standards if they perform or initiate what’s known as Immune Effector Cell Therapy (IECT).
Legislators who introduced a concurrent resolution in the state Senate on Tuesday believe the panel’s decision and proposed requirement “would limit patient access to innovative, new cancer treatments.” The resolution notes that the U.S. Food and Drug Administration “already requires comprehensive safety criteria and standards for facilities providing cell therapies.”
“It is unnecessary to require additional onerous and costly approvals and accreditations on facilities that go beyond federal government requirements. Additional requirements may discourage or prevent sites from providing IECT services in Michigan,” according to the resolution, which has 16 sponsors including Senate Majority Leader Mike Shirkey.
The state Senate this morning adopted the resolution on a voice vote and sent it to the House for consideration.
In a statement after the vote, the Midland-based Mackinac Center for Public Policy urged the House to act as well.
“We strongly encourage the House to follow suit, putting the best interests of cancer patients above the financial incentives of big hospitals,” Lindsay Killen, vice president for strategic outreach and communications at the Mackinac Center for Public Policy, said in a statement.
CON requires care providers to meet set standards, typically based on quality and volume metrics, in order to earn state regulatory approval to initiate a new diagnostic or medical procedure. State law gives the Legislature 45 days after the CON Commission adopts a standard to disapprove.
Action to overturn the standard on any form of IECT would represent the first time legislators exercised that authority. The law also gives the governor veto power over CON standards, which former Gov. Jennifer Granholm used in 2008 to halt a proposed standard on proton beam therapy.
In the case of IECT, a 15-member standard advisory panel “conducted a very thoughtful and deliberative process looking at all of the issues,” said CON Commission Chair James “Chip” Falahee.
The advisory committee, including several oncologists, was “very strong” in unanimously deciding to require hospitals to attain accreditation from the Foundation for the Accreditation of Cellular Therapy (FACT) to do IECT, a cellular therapy that modifies the body’s cells to attack and kill cancer cells.
Even after the federal Centers for Medicare and Medicaid Services lifted its own requirement for hospitals to have accreditation to receive reimbursement payments for IECT, the advisory committee stuck with its initial recommendation, Falahee said.
“At this early stage, in the interests of patient safety and quality, we want to maintain FACT accreditation,” he said. “This is an emerging embryonic technology. It’s a highly technical, highly dangerous therapy, and members of the committee said in these early stages we think it would be best to continue to require FACT accreditation.”
Bob Hughes, a CON commissioner and the owner of Advantage Benefits Group Inc. in Grand Rapids, argues that because of the toxicity of the drugs used in the therapy, “you have to make sure it’s done right.” Hughes notes the therapy costs $800,000 or more and cites research that shows one-year remission rates are about 50 percent.
“We just can’t just let these $800,000 drugs with limited success be administered by inexperienced providers. The consequences and costs are too severe,” said Hughes, who doubts the accreditation requirement poses an access barrier.
“It don’t think it’s too much for somebody to drive two hours to get a potentially life-saving drug that can potentially kill you if not done right,” he said.
ADJUST IF NEEDED
The CON Commission, after receiving public comment last summer for and against the standard, opted to “acknowledge the physicians’ expertise and go with it,” said Falahee, the senior vice president for legal and legislative affairs at Bronson Healthcare Group in Kalamazoo.
State law requires the CON Commission to review each standard every three years. The commission, if needed, can revisit the issue earlier and ease the standard, Falahee said.
“We think that recommendation is sound and supports and pays attention to patient safety and quality for the residents of Michigan that get this care,” he said. “Let’s make sure we get this right at the outset of this technology and, if after one year or 18 months or two years we know that it’s going well, we can cut back on the FACT accreditation or amend the standards.”
That’s also the view held by the Economic Alliance for Michigan, a business-labor coalition that supports the standard for IECT.
“Let’s keep the bar high to protect cancer patients” and make adjustments later as needed, said President Bret Jackson.
“No matter if it’s through regulation or legislative action, we want to make sure that cancer patients have the best possible opportunity for success and we think that having people trained and having the right equipment, which is what the FACT accreditation provides, allows for the best outcomes for patients,” he said. “However, as technology advances, I think the standard is going to have to be modified to meet the improvements that science will give us. Regulations are going to have to change as the technology advances.”
In addressing the CON Commission in September, Dr. Greg Yanik, an oncologist at CS Mott Children’s Hospital in Ann Arbor, called IECT “the most complex technology that I’ve ever seen in my career” of 30 years.
Yanik, a Catholic, said he does the sign of the cross every time before he treats a patient with IECT.
“The potential benefits are high (and) the risks are potentially even higher. We owe it to the citizens of our state to give them the optimal care with the optimal quality,” said Yanik, who supports requiring hospitals to earn accreditation to do IECT.
The advisory committee’s recommendation and the adopted standard “does not limit access to care to any health care system or any hospital,” but “simply mandated that those centers that provide that care provide quality care,” Yanik said.
IECT is now available at four hospitals in Michigan: Spectrum Health in Grand Rapids, Henry Ford Hospital and Barbara Ann Karmanos Cancer Center in Detroit, and the University of Michigan Hospital in Ann Arbor, all of which are FACT accredited.
Yanik told CON commissioners last month that he estimates about 300 cancer patients annually in Michigan would require IECT treatment and that 10 to 20 hospitals will eventually offer the therapy.
Still, access remains a concern for people who objected to the standard requiring accreditation to do the treatment.
State Sen. Curt Vanderwall, R-Ludington, the primary sponsor of the concurrent resolution introduced in the state Senate on Tuesday, told CON commissioners in September that he was particularly worried about access in rural markets.
“I just feel very strongly that the federal government has put some really strict standards in, especially on this therapy, and I feel that we are taking the option away from some facilities, potentially up north,” Vanderwall said.
The debate over requiring accreditation for hospitals that provide IECT therapies could offer a prelude to broader look at CON. A few weeks ago, a memo circulated in Lansing about repealing five areas currently under CON review: adult psychiatric beds, air ambulance, cardiac catheterization, critical access hospitals, and covered capital expenditures. The memo, multiple copies of which were obtained by MiBiz, also listed changes to the composition of the CON Commission’s membership.
Jackson said the Economic Alliance, which has been a strong supporter of CON, would “welcome the opportunity to have the dialogue” to improve the process. The Economic Alliance would support changes to expand the membership of the CON Commission, generate more public input, and improve the process of how standard advisory committees operate.
“There are opportunities to improve the program,” he said.
Members of the CON Commission are “not opposed to reform, as long as they are reforms that improve the CON program,” Falahee said.
EDITOR’S NOTE: This story has been updated from its original version.