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CMS Issues Revised Interpretive Guidelines for Informed Consent


Email Alert

April 20, 2007

The Centers for Medicare and Medicaid Services (CMS), issued revised Interpretive Guidelines for Informed Consent effective April 13, 2007. As readers may remember, the proposed guidelines caused concern by imposing requirements regarding identification of assistants at surgery.

The Interpretive Guidelines apply to Medicare Conditions of Participation (CoPs) for patients' rights, medical records, and surgical services. The guidelines discuss each CoP and the survey procedures used to determine compliance for that CoP. They also contain discussion and examples of practices which hospitals are encouraged to adopt, but which are not necessarily required by the CoPs. For instance, there is no specific requirement for informed consent for anesthesia services. However, because surgical procedures often involve the use of anesthesia, hospitals are encouraged to extend informed consent policies to include consent for the anesthesia component of the procedure.

The final guidelines do not include some requirements found in the draft version, including the need to identify in the consent form each assistant performing significant aspects of the planned surgery and requiring a "professional" to witness the informed consent discussion between patient and surgeon. Rather, the guidelines recommend that, as part of the informed consent discussion, providers inform patients of the possibility that residents or other assistants may participate in the surgery.

Access the Interpretive Guidelines for Informed Consent.

We would like to thank Leah Romano (Hall Render Killian Heath & Lyman PSC, Troy, MI) for submitting this email alert.

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