Revisions and clarifications to Hospital Interpretive Guidelines for Informed Consent

Memorandum Summary
• 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.