The Gap Opens
Many doctors who participate in CCOPs commit money from their practices to this endeavor. Institutions, too, end up having to throw in subsidies.
Consider the Kalamazoo, Mich., CCOP. It receives about $550,000 a year from NCI and another $500,000 from the Western Michigan Cancer Center, said Joseph Mirro, the cancer center’s CEO and chief medical officer.
“Reimbursement per patient is less than it actually costs for us to conduct the research,” Mirro said to The Cancer Letter. “We do it, because we feel it’s extremely important to patient care and extremely valuable to our patients. It advances knowledge, which is good for our country, and it’s good for our docs, too.”
Historically, about 30 percent of patients who enter the NCI treatment, prevention, and control trials are accrued through CCOPs. When it comes to accrual of the underserved populations to prevention trials, CCOPs play a particularly important role, according to materials posted on the institute’s website.
The Kalamazoo CCOP embraced change. When NCORP was envisioned, it filed a joint application with the larger Grand Rapids CCOP, forming a single entity, which would serve the entire western part of Michigan.
Both Kalamazoo and Grand Rapids had ongoing funding for their CCOPs. The assumption at both places was that NCI would phase out the CCOPs program, but the money earmarked for their use would continue to flow.
“Our understanding was that these programs would dovetail into one another,” said Gilbert Padula, the principal investigator of the Grand Rapids CCOP.
On March 6, all the CCOPs received a letter from Crystal Wolfrey, chief grants management officer at the NCI Office of Grants Administration. “Beginning June 1, 2014, funding for participation in the NCI community research program will no longer be provided through a previously funded CCOP/MB-CCOP award,” the letter stated. The research sites will be informed about the outcome of their NCORP applications “in early summer for anticipated start dates in September 2014.”
The letter is posted on The Cancer Letter website. Wolfrey’s office is a component of the NCI Office of the Director.
Did Wolfrey’s letter mean that there would be no funding between June 1 and sometime in September?
Officials at CCOPs said that NCI officials acknowledged that this would be the case. At one conference call and in emails that included pasted-in explanations, institute officials said that the interruption in funding should be viewed as analogous to reapplication for competing continuation of their CCOP grants.
“Our recommendation is that sites approach this gap between CCOP and NCORP similarly,” said one email sent by a grants management official to multiple CCOPs. “If you are going to have activities ongoing that would be attributable to the CCOP, you may continue doing so and supporting them through other sources.
“If your NCORP application is selected and funded, you can then pre-access sources through the pre-award approval provided by NIH.
“Please understand that any pre-award activity when related expenses are incurred are at your own risk for your organization. The federal government is not obligated to support such expenses if award is not made.”
Where would this leave community investigators? Would this not amount to a 25 percent cut, assuming that NCORP funding remains constant?
Consider Michigan. In Grand Rapids, the CCOP would have had to find about $100,000 a month, $300,000 altogether, to get from June to September.
In Kalamazoo, its NCORP merger partner would need to find another $150,000 to get by. “I’ve got a shortfall at a minimum of about $150,000 for that period of time,” said Mirro. “That’s if I am very careful. It could be $300,000.”
In Ann Arbor, the shortfall would be $400,000.
The loss for the state’s clinical trials over three months would have been around $850,000. And that’s without knowing whether the NCORP grants would be approved—and at what level.
The message from NCI seemed clear to everyone who heard it.
“[NCI officials] reiterated that there will be this gap, and your parent institution would be expected to cover the cost,” Stella said to The Cancer Letter. “Of course, that’s ludicrous, because they already have their budgets for the year.”
CCOPs can’t just take a summer off.
“We have to find a way to follow those patients who are already on trials,” said Padula before Varmus’s open letter. “From the regulatory and compliance perspective, we have to continue to monitor those patients.”
Padula said he planned to reach out to local consortium hospitals to try to secure bridge funding. If that fails, “we would have to vastly limit the clinical trials that are presented to the IRB and we would have to activate significantly fewer trials during the summer months.”
In Kalamazoo, Mirro said he didn’t have much leeway. “This is critically important, and somehow I am going to have to figure out how to do it,” he said before receiving the letter from Varmus. “Because this is critically important to cancer patient care. I have patients on study now. I can’t just quit collecting data on those patients. It’s going to have to come out of somewhere else, and healthcare reform is squeezing most of healthcare providers in the U.S. We are seeing a severe degradation in reimbursement, even though we are doing more work. I am going to have to sit down and figure out where I cut, whom I cut, to make this work.”
Investigators in Michigan said they contacted their legislators. Stella said his institution has contacted Sen. Carl Levin (D-Mich.), and Mirro said his staff alerted Rep. Fred Upton (R-Mich).As chair of the House Committee on Energy & Commerce, Upton is positioned to exercise oversight over NCI.
“Upton knows his district, he knows we are here, he knows we have this grant, he knows Kalamazoo and Lakeland are also in his district, and he knows that Grand Rapids supports some of his district with patient care,” Mirro said.
