New CMS Informed Consent Guidance for Sensitive Examinations of Unconscious Patients

On April 1, 2024, the U.S. Department of Health and Human Services (“HHS”), through the Centers for Medicare & Medicaid Services (“CMS”), Center for Clinical Standards and Quality/Quality, Safety & Oversight Group, issued new guidance (the “Guidance”), effective immediately, in the form of a memorandum to State Survey Directors, QSO-24-10 (the “Memorandum”).

The Guidance requires hospitals to ensure that medical professionals, residents, advanced practice providers (e.g., nurse practitioners and physician assistants), and other students (collectively, “Students”) performing sensitive examinations or invasive procedures for educational and training purposes on patients outside medically necessary procedures, including pelvic, breast, prostate, or rectal examinations, and particularly on patients under anesthesia, first obtain and document the patients’ informed consent before performing such examinations or procedures. The Memorandum describes revisions and clarifications to the Hospital Interpretive Guidelines for Informed Consent, which are found in the Patient’s Rights Condition of Participation (“CoPs”) 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) and to be further described in the State Operations Manual (SOM), Appendix A, once revised by HHS.

HHS released this Guidance based on increasing reports in the media, as well as in medical and scientific literature, highlighting instances where, as part of a Student’s clinical training, patients have been subjected to sensitive and intimate examinations or procedures while under anesthesia without their knowledge or prior informed consent. While HHS recognizes that the performance of these examinations and procedures has been necessary to teach Students vital clinical examination skills, it also believes that patient permission for these exams is an essential part of the informed consent process and necessary for compliance with the informed consent requirements of CMS’ Hospital Conditions of Participation.

HHS also acknowledged the growing number of states that have implemented legislation to address this situation, with at least 20 states having enacted laws regulating patient care with specific reference to the performance of sensitive examinations (See: Memorandum FN6; see also: Overview of State Statutes, cited in Memorandum, FN 1.)  Locally, Delaware was the first state to enact similar legislation (See: 16 Del. Code § 1221, as amended eff. November 9, 2019), with New Jersey following with a similar law in 2021 (See: N.J. Stat. § 45:1-74). More recently, Pennsylvania’s Governor signed Act 2023-31 on November 21, 2023, which amended the Medical Care Availability and Reduction of Error Act to add § 504.1, requiring informed consent in pelvic, rectal, and prostate examinations.

Finally, hospitals should note that HHS has specifically directed state surveyors to ensure that a hospital’s informed consent policy and process, as well as its informed consent forms, contain the necessary information to enable a patient, or his or her representative, to make fully-informed decisions about their care, including the right to consent (or not) to sensitive examinations or procedures for education purposes.

Takeaways:

• In order to set clear guidelines in this area, hospitals should work with their medical staffs to develop or amend their existing informed consent policies and procedures to ensure that providers and Students who wish to perform sensitive examinations or invasive procedures for medical education purposes first obtain and document the patient’s informed consent before performing those examinations or procedures.
• Revise the hospital’s existing surgical informed consent forms, or develop a separate form, to document the informed consent process and discussion with the patient, with the patient’s signature evidencing his or her consent to the sensitive examination or procedure.
• Because informed consent includes the right to refuse consent to sensitive examinations or procedures conducted for teaching purposes, patients should be informed of this right and not be subjected to retaliation or discrimination for refusing to consent.
• Medical staff members should be clearly informed about the new guidance and policy, and training should be provided to surgeons and other teaching physicians regarding changes to the practice and documentation requirements.
• When Students are involved, conversations between the surgeon and each Student should be encouraged to help mitigate possible concerns by the Students regarding whether the patient has consented to their involvement and examination for education purposes.
• Hospitals should develop processes to monitor and ensure transparency with respect to the consent process to ensure that each patient’s informed consent is obtained before a Student is permitted to perform a sensitive examination or procedure for education purposes while the patient is under anesthesia.