Informed consent remains critical in healthcare, and over the last several years, there have been multiple updates from agencies and commissions providing clarifications. Most recently in April 2024, Centers for Medicare & Medicaid Services (CMS) updated its guidance for hospitals regarding informed consent issues. In April 2022, The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) issued an update as well. In essence, these updates are meant to clarify the nature of informed consent but also serve as a cautionary tale and reminder that informed consent is a critical component in the provision of healthcare.

With healthcare processes becoming more and more complex, the involvement of multiple providers, and patients often traveling for treatment, informed consent and keeping an accurate record of consent becomes critically important in the provision of patient care and mitigation of risk. Like many things in healthcare, such as HIPAA/HITECH, informed consent is a rule of notice. You generally cannot waive a risk, a right, or a limitation that you don’t know about.

As JCAHO previously indicated in its 2022 update, providers need to understand that informed consent in medical care “is a process of communication between a clinician and a patient” and that the need for consent is ongoing, emphasizing that informed consent “remains central to patient safety.” Between 2010-2021, there were more than 49 reports of informed consent-related sentinel events (events that resulted in patient death or severe or permanent harm). 

Informed Consent Barriers

Barriers to informed consent include, but are not limited to:

• Health literacy - Patients who are unable to understand the nature of the informed consent can create issues. This can be further complicated by patients who have compromised decision-making capacity, which also needs to be addressed in the informed consent process.
• Culture - Cultural concerns regarding who is an appropriate decision maker, who you may communicate with, whether or not patients are comfortable providing written notices of informed consent, and similar items must also be assessed. Communication is critical in this, particularly if a consent form may not fully discuss the entirety of the risks and benefits. Communication is not something that can be delegated to just anyone for consent to meet the standard of “informed.”
• Documented - The informed consent process needs to be a thoughtful, documented process with the appropriate communication points. At least one study determined that consent forms contained the appropriate information only 26.4 percent of the time, and the consent forms themselves often failed the basic test of telling the patient what the risks were.

CMS Update

In its April 2024 update, CMS was reacting to a reported patient concern. CMS clarified that a hospital must obtain consent from the patient if a medical student, intern, or another form of “learner” performs any important surgical task, sensitive or invasive procedures, or examinations. As mid-level practitioners take on more responsibilities and require additional training, CMS determined that it is critical to obtain patient consent for anyone in a training role to perform an invasive patient examination.

As part of the CMS process, surveyors have been instructed to assess a “hospital’s patient-informed policy and process as well as its informed consent forms...” This is to ensure that patients can make fully informed decisions about their care, including the people who participate in their care.

Why now?

CMS notes that various media stories and scientific literature highlighted cases of teaching hospitals and other entities allowing students to perform sensitive exams on patients who were under anesthesia when such exams were not necessary for medical care. Noting a growing number of states limiting non-consensual exams of this type, CMS chose to focus on consent requirements. Specifically, the new guidance requires that a consent form must include: 

Whether practitioners other than the operating practitioner, including but not limited to, other physicians, residents, advanced practice providers, and medical or other applicable students (such as nurse practitioner or physician assistant) will be performing important tasks related to the surgery, or examinations or invasive procedures for educational and training purposes…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. 

Bottom Line

Rules of notice require clear internal processes, accurate recordkeeping, several points of communication, and a periodic review of the barriers that patients may face. Facilities should review their policies and practices to ensure that both elements align with agency expectations.