CMS updates informed consent guidance for hospitals

The Centers for Medicare & Medicaid Services April 1 revised its Hospital Interpretative Guidelines for Informed Consent to clarify the need to obtain informed consent from patients before medical students or other students perform important surgical tasks or sensitive or invasive procedures or examinations.

“Based on increasing concerns about the absence of informed patient consent prior to allowing practitioners or supervised medical, advanced practice provider, or other applicable students to perform training- and education-related examinations outside the medically necessary procedure (such as breast, pelvic, prostate, and rectal examinations), particularly on anesthetized patients, we are reinforcing hospitals’ informed consent obligations,” the guidance states.

In an associated letter to teaching hospitals and medical schools, HHS officials said, “It is critically important that hospitals set clear guidelines to ensure providers and trainees performing these examinations first obtain and document informed consent from patients before performing sensitive examinations in all circumstances. Informed consent includes the 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.”

HHS’ Office for Civil Rights also will continue to work with HIPAA-covered entities to ensure that their policies and practices related to sensitive examinations do not discriminate against patients on the basis of sex, race, national original, age and disability, the letter notes.