On April 1, 2024, CMS released new guidance to reiterate and clarify hospital requirements for informed consent from patients with respect to medical professionals performing sensitive examinations, especially for patients under anesthesia. In addition to the new guidance, the Office for Civil Rights (OCR) recently issued an FAQs document that explains a patient’s right to restrict who has access to their Protected Health Information (PHI) when under anesthesia during a medical procedure.

CMS summarized its new guidance in a few points. First, the new guidance was issued in response to increasing concerns that practitioners, medical students, and supervised medical/advanced practice providers were not obtaining informed patient consent before performing sensitive examinations (e.g., breast, pelvic, prostate, and rectal examinations) on anesthetized patients in connection with training and education. Second, CMS noted that requirements related to informed consent for hospitals are located in the Hospital Conditions of Participation, including the Patient’s Rights Conditions of Participation, Medical Records Services Conditions of Participation, and Surgical Services Conditions of Participation. Finally, CMS stressed that a hospital’s patient informed consent policy and process, along with its forms, must allow a patient or the patient’s representative to make fully informed decisions about their care. CMS is revising its hospital interpretive guidance about informed consent to reflect the new guidance.

In addition to the new guidance, HHS Secretary Becerra and CMS Administrator Brooks-LaSure noted in an April 1, 2024 letter to teaching hospitals and medical schools that OCR investigates complaints alleging a patient’s PHI was used or disclosed in violation of HIPAA. The letter pointed out the FAQs document from OCR that explains a patient’s right to be protected against impermissible use and disclosure of PHI when under anesthesia during a medical procedure.

A copy of the new guidance is available here. A copy of the OCR FAQs document is available here. Secretary Becerra and Administrator Brooks-LaSure’s letter to teaching hospitals and medical schools is available here.