After Concerns over Intimate Exams HHS Clarifies Guidelines for Informed Consent

The U.S. Department of Health & Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), just released Revisions and Clarifications to Hospital Interpretive Guidelines for Informed Consent (Memo QSO-24-10-Hospitals).  The new guidance was announced in a 4/1/2024 “Letter to the nation’s teaching hospitals and medical schools.”  It specifies “surveyors must ensure that a hospital’s patient informed consent policy and process, as well as its informed consent forms, contain elements and information that allow for a patient, or his or her representative, to make fully informed decisions about their care.”  The new guidance action resulted from media reports and scientific literature highlighting “instances where, as part of medical students’ courses of study and training, patients have been subjected to sensitive and intimate examinations – including pelvic, breast, prostate, or rectal examinations – while under anesthesia without proper informed consent being obtained….”  To further address these concerns, CMS will also soon revise its hospital interpretive guidance about informed consent (see State Operations Manual, Appendix A-Hospitals).