The National Cancer Institute's Interagency Council on Biomedical Imaging in Oncology has had 36 requests for meetings with manufacturers and researchers since its inception in June 2000.

"So far, the immediate and the annual feedback has been very encouraging, but at this point [the program is] not overutilized," council member Ellen Feigal, MD, deputy director of NCI's Division of Cancer Treatment and Diagnosis, remarked at the National Forum on Biomedical Imaging in Oncology Jan. 31 in Arlington, Virginia.

The interagency council's sixth meeting will take place March 20. The deadline for requests is Feb. 6. To date, requestors have ranged "from small to large companies to investigators from academia, who have products in various stages of development from a very early stage of development to a very mature stage of development," Feigal reported.

The interagency council features NCI, FDA and the Centers for Medicare and Medicaid Services representatives providing guidance on scientific, regulatory, coverage and reimbursement issues to sponsors as they develop cancer imaging products. Held three times a year, the meetings are closed to the public to protect proprietary information.

Meetings generally last three to four hours and include discussion of two or three topics. According to an interagency background document, the council "will give preference in scheduling meetings to promising new technologies that are viewed as important new developments in cancer imaging."

Regarding the open-forum meeting, Feigal expressed an interest in expanding its scope to "other areas of medicine, particularly to in vitro diagnostics."

NCI staffers have had initial meetings with industry reps who are considering the forum concept as "a potential way to productively interact with the government agencies," Feigal noted.

The National Forum on Biomedical Imaging in Oncology had its first meeting in September 1999 and includes representatives from industry, FDA, CMS and NCI.

Another example of potential interagency cooperation highlighted at the Jan. 31 meeting was between FDA and CMS. Overlap between the respective approval and coverage requirements of the two agencies has long been a concern within industry, particularly with regard to developing new technology.

A sticking point in collaborative review is that CMS covers a procedure based on evidence it is "reasonable and necessary," while FDA approves a product if it is deemed "safe and effective."

CMS' "reasonable and necessary" prerequisite is in need of clarification, Coverage & Analysis Group Director Sean Tunis, MD, acknowledged.

The agency is preparing a draft guidance, which tries "to take the principle[s] from our decision memorandum and put them into a single document in a more generalized way." The document should be completed within months, Tunis said.

In general, "we do recognize that regulatory and payment decisions need to be better coordinated," Tunis commented. "A serial process...is sometimes quite inefficient."

To this end, senior-level staff from CMS and FDA met Jan. 30 "to begin to talk about more formal avenues of collaboration," he said. Additionally, CMS is "working on a white paper [to] lay out how we can make this [collaboration] happen."

However, Tunis pointed out, differences will remain in the way the two agencies view a product. "The most likely places that FDA regulation and CMS policy are going to differ is technologies cleared under a 510(k) with no clinical data...or technologies that make no specific claim," he said. "If there [are not] any studies that demonstrate clinical utility, [the technology is] probably going to have a difficult time getting through CMS reimbursement."

Elsewhere in the department, the recently-formed HHS Secretary's Advisory Committee on Regulatory Reform has cited duplicative FDA and CMS requirements as an issue to be explored. A seven-member coordination subcommittee is charged with identifying HHS regulations and procedures that overlap or conflict with rules imposed by states, third-party payers and federal agencies inside and outside of HHS (¹ Also see "CMS Coverage, FDA Review Process Overlap Studied By HHS Secretary Panel" - Medtech Insight, 14 January, 2002., p. 8)

Cancer Imaging Tech Forum May Lead To Further FDA/CMS Collaboration

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