Centers for Medicare & Medicaid Service (CMS) revised hospital interpretive guidance in the State Operations Manual, Appendix A-Hospitals on April 1, 2024 in response to media stories of nation’s teaching hospitals and medical schools repeatedly performing sensitive examinations while under anesthesia without informed consent. Highlighted sensitive exams include but are not limited to pelvic, breast, prostate, and rectal examinations. The new guidance is effective immediately.

Additionally, U.S. Department of Health and Human Services (HHS) released a letter explaining HHS’ and CMS’ approach to address the issue. HHS stressed that all hospitals should 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 consent to any previously unagreed examinations to treatment while under anesthesia. HHS reminded providers that the Office of Civil Rights (OCR) investigates complaints concerning improper informed consent for sensitive procedures and directed to OCRs Frequently Asked Questions explaining patient’s right to restrict access to protected health information under the HIPAA privacy rule. The memo also noted the OCR will have continued focus on working with providers to bring practices and policies into compliance with HIPAA and ensure proper informed consent related to sensitive examinations. Lastly, HHS noted obtaining informed consent for sensitive examinations is the standard of care for many state regulators and that several enacted explicit legal protections echoing this as well.

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). Hospital surveyors will review facilities informed consent policies, processes, and forms against the CoPs and updated interpretive guidance released on April 1^st.

CMS revised that SOM Appendix A for hospitals at tag A-0955 under properly executed and well-designed informed consent forms examples and under the hospital’s policy and process for informed consent. The revision is below and notes additions in italics:

Whether physicians other than the operating practitioner, including, but not limited to, residents, medical, advanced practice provider (such as nurse practitioners and physician assistants), and other applicable students, will be performing important tasks related to the surgery, or examinations or invasive procedures for educational and training purposes, in accordance with the hospital’s policies. Important surgical tasks include: opening and closing, dissecting tissue, removing tissue, harvesting grafts, transplanting tissue, administering anesthesia, implanting devices, and placing invasive lines. Examinations or invasive procedures conducted for educational and training purposes include, but are not limited to, breast, pelvic, prostate, and rectal examinations, as well as others specified under state law.

The Joint Commission, a highly utilized accrediting and survey agency for hospitals, notes that an executed consent form alone is not sufficient to demonstrate informed consent and that providers should not assume patients understand medical terms in the consent form. Hospitals and other providers should review their informed consent policies, procedures, and forms to ensure it complies with the revised CMS guidance and specific state regulations. The Joint Commission notes that the following actions can help improve the informed consent process and ensure compliance with applicable requirements:

• Develop a list of procedures requiring written consent;
• Establish details on different professionals’ and support staffs’ roles in the informed consent process;
• Establish when qualified medical interpreters should be used;
• Document and explain the role of agents and/or substitute decision makers;
• Outline appropriate timing obtaining informed consent;
• Outline what constitutes the informed consent process;
• Detail required documentation and verification process for such document;
• Develop a list of resources available to assist in the informed consent process;
• Develop a formal training program for physicians and other qualified staff on effective communication and shared decision-making to gain informed consent in order to maintain patient safety;
• Streamline informed consent documents and patient education materials where possible;
• Develop policies and procedures for patients with limited health literacy, limited English proficiency, or visual or hearing impairments, and emphasize the use of qualified medical interpreters;
• Establish tool for physicians to evaluate patient understanding of procedures; and
• Establish required follow-up conversations to address miscommunications.