Here are four findings from the updates:
1. Given the increasing concern over the lack of informed patient consent before training and education-related examinations outside of the medically required procedure — like pelvic, prostate, breast and rectal examinations, specifically on patients under anesthesia — HHS and CMS are reinforcing informed consent obligations at hospitals.
2. Surveyors must make sure that hospitals’ informed consent policies and processes, including informed consent forms, feature content that lets patients or their representatives make informed care decisions.
3. CMS’ hospital interpretive guidance is being revised regarding informed consent in the State Operations Manual’s Appendix A.
4. “While we recognize that medical training on patients is an important aspect of medical education, this guidance aligns with the standard of care of many major medical organizations, as well as state laws that have enacted explicit protections as well,” Xavier Becerra, secretary of HHS, said in a letter addressed to national teaching hospitals and medical schools. “Informed consent is the law and essential to maintaining trust in the patient-provider relationship and respecting patients’ autonomy.”
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