CMS Announces Revisions and Clarifications to Hospital Interpretive Guidelines for Informed Consent

According to an April 1 announcement, 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.

Requirements related to informed consent for hospitals are found throughout the Hospital Conditions of Participation (CoPs): the Patient’s Rights CoP at 42 CFR 482.13(b)(2); the Medical Record Services CoP at 482.24(c)(4)(v); and the Surgical Services CoP at 482.51(b)(2).

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.

CMS is revising its hospital interpretive guidance about informed consent in the State Operations Manual, Appendix A-Hospitals, to address this.

CMS has more information.