HFMA NEWS

In a white paper released May 22 by the Food and Drug Administration (FDA), the agency describes plans for the Sentinel Initiative, which will include the development of a new electronic system that will enable FDA to query a broad array of information to identify possible post-market adverse events. The white paper, titled The Sentinel Initiative: A National Strategy for Monitoring Medical Product Safety, describes the proposed system and calls for a public-private collaboration to develop and implement it. The system will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in the nationwide effort.

The system would enable FDA to analyze significantly more information than it can currently by tapping into vast databases of health information to detect early signs of emerging safety problems. Creating an active surveillance system such as the Sentinel Initiative was one of the recommendations made by the Institute of Medicine in a 2006 report on ways to improve the safe use of drugs. Read the white paper.

Citing the complexity of the final rule and scope of public comments received in response to the proposed rule, the Centers for Medicare and Medicaid (CMS) has extended the timeline for publication of the hospice conditions of participation final rule. The notice appeared in the May 27, 2008, Federal Register.

Originally published May 27, 2005, the proposed rule would have established new conditions of participation for Medicare-participating hospices. The proposed revisions were intended to reflect an interdisciplinary, patient-centered approach to care planning and delivery and allowing hospices flexibility in meeting quality standards. CMS noted that extensive coordination has been needed to ensure that the provisions in the final rule follow guidelines of all administrative agencies that would be affected by the rule. Also, the final rule updates and revises policies, some of which were originally established in 1983; therefore, “the incorporation of these updates has required extensive time, outreach, and collaboration to ensure that the final rule’s provisions are consistent with current best practices in the provision of hospice services,” states the notice. Read the notice.