On April 1, 2024, the U.S. Department of Health and Human Services (“HHS”), through the Centers for Medicare & Medicaid Services (“CMS”) released a memorandum to state survey agency directors highlighting revisions and clarification to the Hospital Interpretive Guidelines for Informed Consent (the “Guidance”). The Guidance clarifies informed consent requirements for the performance of pelvic, breast, prostate and rectal examinations (referred to in the Guidance as “sensitive exams”), particularly on patients under anesthesia.
In a letter addressed to the nation’s teaching hospitals and medical schools announcing the Guidance, HHS Secretary Xavier Becerra highlighted media reports and scientific literature on the practice of allowing medical students and residents to perform sensitive exams on patients under anesthesia for training purposes without first obtaining proper informed consent. The letter “recognize[s] that medical training on patients is an important aspect of medical education,” and states that the updates are intended to align CMS guidance with current medical education scholarship and best practices. The letter also notes that the HIPAA Privacy Rule allows patients the right to restrict who has access to their protected health information (“PHI”), including when a patient is unconscious during a medical procedure. The Guidance also builds on the longtime CMS focus in its rules and hospital conditions of participation (“CoPs”) for ensuring the broader rights of patients to be informed and provide consent in advance of the furnishing or discontinuing of patient care whenever possible, which includes informing patients of specific procedures to be conducted and the identities of performing individuals.
Background & Updated Guidance
Nearly half of all states have laws—the vast majority of which were passed over the last five years—specifically addressing informed consent requirements for the performance of sensitive exams in some circumstances. These laws vary widely in scope and enforcement but are generally geared toward ensuring that patients have an opportunity to provide informed consent before any provider, including a medical student or resident, performs a sensitive exam.
The Guidance more closely aligns CMS survey practices with these updates in state law. Specifically, the Guidance:
- Requires surveyors to confirm that a hospital’s informed consent policy and process, as well as the hospital’s informed consent forms, contain elements and information that allow for a patient, or the patient’s representative, to make fully informed decisions about their care.
- Clarifies that a properly executed informed consent form must include the name of the specific procedure or medical treatment for which consent is being given, as well as the name of the practitioner who is performing the procedure.
- Provides that a well-designed consent form, as well as hospital policy and process for informed consent, should alert patients to the following:
- Whether providers other than the operating provider, including other physicians, residents, medical students, advanced practice provider students and other applicable students will be performing important tasks related to surgery or examinations or invasive procedures for educational and training purposes.
- Clarifies that “examinations or invasive procedures” for which the above information should be provided include, but are not limited to, breast, pelvic, prostate and rectal examinations, as well as others specified by state law.
Practical Takeaways
Hospitals and health care providers should consider undertaking the following actions in response to the Guidance:
- Closely monitor ongoing developments in state law related to informed consent for sensitive exams, as this is an area of rapid change;
- Assess the processes by which medical students, residents, fellows and other medical learners are trained to conduct sensitive exams to ensure compliance with the Guidance, relevant state law and HIPAA;
- Review current medical staff and other policies and processes related to informed consent, and revise them as necessary to ensure compliance with the Guidance and relevant state law;
- Review informed consent forms and revise them as necessary to ensure compliance with the Guidance and relevant state law;
- Ensure that the operating room and other procedural area timeout processes include confirming whether the patient has provided informed consent to the performance of sensitive exams; and
- Educate educational leadership, teaching physicians, residents, fellows, medical students, other medical learners and staff on the requirements imposed by the Guidance and state law and on any necessary changes to the informed consent process.
If you have questions regarding the updated guidance, state law or would like assistance in reviewing and updating your informed consent policies and procedures, please contact:
- Jennifer Skeels at (317) 977-1497 or jskeels@hallrender.com;
- Scott Geboy at (414) 721-0451 or sgeboy@hallrender.com;
- Caitlin Bell-Butterfield at (919) 228-2408 or cbell-butterfield@hallrender.com;
- Or your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
