CMS releases guidance on informed consent for teaching hospitals

Teaching hospitals must obtain informed consent prior to medical or other students performing important surgical tasks or sensitive or invasive procedures or examinations, according to Centers for Medicare & Medicaid (CMS) guidance published April 1, 2024. In a memorandum to State Survey Agency Directors entitled Revisions and clarifications to Hospital Interpretive Guidelines for Informed Consent, CMS announced revisions to the State Operations Manual, Appendix A for hospitals relating to “examinations or invasive procedures conducted for educational and training purposes, to “include, but not limited to, breast, pelvic, prostate and rectal examinations, as well as others under state law.”

The guidance acknowledges the importance of patient exams “as part of the vital skills clinical students must obtain during their training and education” but reiterates the importance of patients making informed decisions about the healthcare services they receive. CMS states that the guidance arises from articles that have brought increasing attention to “the traditional practice of allowing practitioners or supervised medical, advanced practice provider or other applicable students to perform pelvic and other invasive examinations on patients who are under anesthesia.”

In a corresponding Letter to teaching hospitals and medical schools, the Secretary of US Health and Human Services (HHS) Xavier Becerra, CMS Administrator Chiquita Brooks-Lasure and the Director of the Office for Civil Rights Melanie Fontes Rainer state that:

It is critically important that hospitals 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 to consent to any previously unagreed examinations to treatment while under anesthesia.

Requirements for hospitals related to informed consent may be found at 42 CFR sections 482.13(b)(2); 482.24(c)(4)(v); and 482.51(b)(2). A failure to comply with informed consent requirements may violate a hospital’s compliance with Medicare Conditions of Participation. The guidance also reminds teaching hospitals to consider additional state law requirements.

Finally, CMS reminds hospitals that the medical record is required to document the patient’s informed consent and provides minimum elements for a properly executed informed consent form:

• Name of the hospital where the procedure or other type of medical treatment is to take place.
• Name of the specific procedure, or other type of medical treatment for which consent is being given.
• Name of the responsible practitioner who is performing the procedure or administering the medical treatment.
• Statement that the procedure or treatment, including the anticipated benefits, material risks and alternative therapies, was explained to the patient or the patient’s legal representative. (Material risks could include risks with a high degree of likelihood, but a low degree of severity, as well as those with a very low degree of likelihood, but a high degree of severity. Hospitals are free to delegate to the responsible practitioner, who uses the available clinical evidence as informed by the practitioner’s professional judgment, the determination of which material risks, benefits and alternatives will be discussed with the patient.)
• Signature of the patient or the patient’s legal representative.
• Date and time the informed consent form is signed by the patient or the patient’s legal representative.

Norton Rose Fulbright lawyers will continue to monitor new education and guidance from CMS and HHS related to hospital operations and Conditions of Participation and are available to answer questions and assist hospitals.