New Guidance from the HHS Regarding Hospital Interpretive Guidelines for Informed Consent
The Department of Health and Human Services (HHS) issued new guidance to the nation’s teaching hospitals and medical schools regarding Hospital Interpretive Guidelines for Informed Consent. Specifically, requiring written informed patient consent for breast, pelvic, prostate and rectal exams – especially if the patient is anesthetized – for educational and training purposes performed by medical students, nurse practitioners and/or physician assistants. Informed patient consent includes the patient’s right to “refuse consent for sensitive examinations conducted for teaching purposes and the right to refuse to consent to any previously unagreed examinations to treatment while under anesthesia.”
Requirements related to informed consent for hospitals are found throughout the Hospital Conditions of Participation (CoPs). According to HHS, this new guidance was released to reinforce hospitals’ compliance to obtain written informed patient consent relating to medical professionals performing sensitive examinations, especially those under anesthesia. Federal regulations previously identified obtaining consent for exams related to surgeries, but did not provide the level of detail pertaining to medical students.
CMS surveyors are required to make sure each hospital’s patient informed consent policy, processes and forms contain information to allow patients or their representatives to make fully informed decisions about their patient care. If hospitals do not obtain written informed patient consent, they may be ineligible for Medicare and Medicaid program participation. In addition, they may be subject to investigations and fines if they violate patient privacy laws under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule.
