McCaskill-Stevens also noted the increasing role of molecular-based cancer care, and stressed that “the best laboratory in which care systems can be evaluated are the community settings,” where the majority of cancer patients are treated. Grubbs concurred, noting that historically, the majority of accruals for the cooperative group program have come from community-based practices. He said it is important to prepare these practices for the shift in emphasis within the NCTN to biomarker-driven phase II trials, “Without the community programs, [those trials] aren’t going to get done fast enough, so we have to make sure that program is strong as we do more phase II trials,” he said.

The CCOPs are “working to try to educate the advocacy community as well as other populations about biospecimens,” said McCaskill-Stevens. The program is evaluating infrastructure requirements at the local level for collecting and processing biospecimens, and hopes to strengthen that infrastructure accordingly by ensuring the availability of pathologists and other necessary personnel.

But Benz pointed out that reimbursement is lacking for tasks related to acquiring and testing specimens for patients in clinical trials, which go beyond routine clinical management. “Something needs to be built into the reimbursement system because the mechanisms for funding that in a community setting are almost non-existent unless they have some formal collaborative relationship with a big cancer center, which immediately shrinks down the number,” he said.

Grubbs added that not only is a reimbursement code required for acquiring and testing biospecimens, but that code also has to be recognized by the payer. A reimbursement code is also required to reimburse physicians for the time they spend offering and explaining clinical trial options to patients, he said. “Even if the patient doesn’t actually go on a trial, clinicians still can spend a tremendous amount of time reviewing the trial with the patient and their family,” Grubbs said. Doroshow said that the NCI continues to work with the NIH and other federal agencies to help define and shape national policy on clinical trials and reimbursement, as well as to educate patients and payers regarding the benefit of clinical trials.

McCaskill-Stevens reported that at the end of 2012, the NCI integrated the CCOPs, the Minority-Based CCOPs, and the NCI Community Cancer Centers Program (NCCCP), along with the research bases for those programs, into a new program called the NCI Community Oncology Research Program (NCORP). She said this consolidated program will expand the research scope in the community setting to include not just clinical trials,



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