Current Report Articles
CMS Revises Hospital Appendix A Interpretative Guidance for Informed Consent

CMS (May 3, 2024) – There are increasing concerns about the absence of informed patient consent for the traditional practice of allowing practitioners or supervised medical, advanced practice providers, or other applicable students to perform invasive examinations on patients who are under anesthesia. Patient advocates, physicians and students have expressed concern about whether patients, especially anesthetized patients, have been sufficiently informed about this practice and whether their full consent was obtained before these educational exams were performed.

While the Centers for Medicare & Medicaid Services recognizes these patient exams are often conducted as part of the vital skills clinical students must obtain during their training and education, CMS also firmly believes patients have the right to make informed decisions on the health care services they receive so they can give their full consent, especially if those patients will be under anesthesia at the time.

CMS is reinforcing hospitals' informed consent obligations in the interpretive guidance in the State Operations Manual, Appendix A for hospitals at tag A-0955, to properly execute a well-designed informed consent form, as well as the hospital's policy and process for informed consent to perform training- and education-related examinations outside the medically necessary procedure (such as breast, pelvic, prostate and rectal examinations), particularly on anesthetized patients.
--Ron Marshall