CMS/NCI Collaboration Will Encompass Post-Approval Studies
This article was originally published in The Pink Sheet Daily
Executive Summary
Memorandum of understanding will create a mechanism to identify “high-priority clinical questions.” The collaboration also will examine off-label coverage of cancer drugs and reimbursement for new technologies.
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A collaboration between the Centers for Medicare & Medicaid Services and the National Cancer Institute to improve the delivery of cancer care will include an examination of ways to conduct post-approval studies. Under a memorandum of understanding that is being developed, the agencies will create "a joint process for identifying high-priority clinical questions about the optimal use of new cancer technologies and the creation of a process for conducting post-approval studies to address these priority questions," CMS said in a press release. NCI has outlined other aspects of the agencies' joint efforts over the past several months. The collaboration will include development of systems for rapid reimbursement of novel therapies and technology (1 (Also see "CMS/NCI Collaboration Will Use Cancer As Model For Evidence-Based Reimbursement" - Pink Sheet, 28 Apr, 2004.)), as well as consideration of off-label coverage for cancer drugs (2 (Also see "NCI/CMS Group Will Examine Coverage For Off-Label Cancer Drug Use" - Pink Sheet, 4 Jun, 2004.)). - M. Nielsen Hobbs |