The Centers for Medicare & Medicaid Services will produce a guidance document on Medicare coverage of products used in clinical trials or registries.

"One area for guidance development that...we will be putting on the agenda and spending a fair amount of time over the next few months working on is guidance related to our linkage of coverage decisions to participation in clinical trials and registries," Chief Medical Officer and Office of Clinical Standards & Quality Director Sean Tunis said during a CMS "open door" forum Jan. 13.

One example of such a linkage is CMS' "¹ Draft Decision Memo for Anticancer Chemotherapy for Colorectal Cancer." The draft proposes Medicare reimbursement for the "clinical and experimental" costs of four oncologics (Genentech's Avastin , Bristol-Myers Squibb/ImClone's Erbitux , Sanofi-Aventis' Eloxatin and Pfizer's Camptosar ) in nine National Cancer Institute trials evaluating off-label use of the products (² Also see "CMS Off-Label Coverage Decision For Colorectal Cancer Rx Coming Soon" - Pink Sheet, 4 October, 2004., p. 27).

In comments on CMS' proposal, the Pharmaceutical Research & Manufacturers of America and the Biotechnology Industry Organization both called for broader discussion of CMS' involvement in clinical trials and payment for off-label uses (³ Also see "PhRMA Proposes New Compendia To Guide Off-Label Rx Coverage" - Pink Sheet, 10 January, 2005., p. 17).

"Medicare coverage of clinical trials represents an important policy issue, and one that we think warrants a broader discussion than is possible within the context of a single national coverage decision for a specific item or service," PhRMA said.

"There's lots of general questions that have arisen about how we plan to implement" reimbursement for trials "in the future," Tunis noted, "including priority setting, issues of methodology, what sort of collaborations are going to be part of this process."

"We are going to be working through that and developing that process through the guidance development approach," he said.

"We'll have additional public meetings, open door forums, etc., be putting out draft proposals for how we plan to deal with this, getting additional feedback, and ultimately we'll have a guidance document explaining in detail where we're going with this approach in the future," Tunis said.

CMS had previously indicated that a guidance on off-label coverage of oncologics was not a near-term priority (⁴ Also see "Industry Seeks CMS Guidance On Preclinical Meetings, Trial Design" - Pink Sheet, 4 October, 2004., p. 26).

The draft guidance, which CMS expects to publish by March, will be one of the first created under the agency's new guidance development initiative that is being overseen by the Council for Technology & Innovation (⁵ Also see "CMS Innovation Council To Examine Pharmacogenomic Product Coverage" - Pink Sheet, 16 August, 2004., p. 8).

CMS plans to post the details of the guidance development process and a guidance agenda on CTI's website, which is expected to go live by the end of January. The guidance information will become available during the same timeframe.

The guidance development process is partly modeled on FDA's good guidance practices, Tunis noted.

"We believe this will be reflective of the long experience at the FDA as well as the input that we've received from you all."

In the case of the off-label colorectal cancer drug demo, CMS has clarified that Medicare will only cover drugs that are not otherwise free.

"Just to be clear, this coverage for the experimental treatments would apply only when these treatments are not provided for free through a manufacturer program or manufacturers to patients in the trial," CMS Administrator Mark McClellan said Jan. 12.

McClellan's remarks at an Alliance for Health Reform/ Health Affairs event serve as a response to the American Society of Clinical Oncology's comments questioning the initiative (⁶ Also see "CMS Off-Label Cancer Coverage Proposal Questioned By ASCO" - Pink Sheet, 10 January, 2005., p. 19).

"It is our understanding that many pharmaceutical companies typically provide the investigational drugs free of charge in cooperative group studies," ASCO's comments said.

"If the same holds true for these studies, the draft proposal amounts to little more than a transfer of the cost of clinical research from the participating companies to the taxpayers through Medicare payments," ASCO added.

CMS Developing Guidance On Coverage Decisions For Clinical Trials

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