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Clinical research policy, take two

This article was originally published in The Gray Sheet

Executive Summary

Both federally funded and private trials would be affected by CMS's latest 1proposal to clarify its coverage of "usual patient care" for beneficiaries participating in clinical studies. Unlike the current policy, the proposal allows study sponsors and principle investigators to self-certify that their studies meet agency criteria in order to receive coverage. Standards require registration on, public release of study results within two years after the end of data collection, and discussion of how results are or are not expected to generalize to the Medicare population. CMS issued the proposal July 19. It addresses "confusion and ambiguity" that became apparent after the agency first proposed a revision to the original policy in April (2"The Gray Sheet" July 16, 2007, p. 8). Comments on the new proposal are due Aug. 18, and CMS hopes to finalize the policy in October...

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