Informed Consent Clarification from CMS

In April 2024, CMS communicated clarifying information related to the Informed Consent process. CMS Communication QSO-24-10- Hospitals shared the increasing concerns CMS has received regarding the absence or failure of hospitals to ensure that the informed consent process is utilized when practitioners or supervised medical, advanced practice provider, or other applicable students will be performing examinations as a component of their training and education.

The right to make informed decisions regarding care is based upon the foundation that the patient or surrogate decision maker has been provided all necessary information for them, or the decision maker, to make an informed decision.

Often times, organizations limit the scope of informed decision making to that of surgical/invasive/hi-risk procedures or treatments when in actuality the informed decision-making process is applicable to other components of the delivery of care such as the patient’s plan of care, their agreement with the plan of care, their right to refuse both medical and surgical/invasive interventions and the plan for discharge. The informed consent process is a subset of the informed decision process that sets forth specific requirements that must be met for hi-risk care procedures such as invasive procedures inclusive of surgery. The requirements of the informed consent documentation include:

1. Name of the hospital where the procedure or other type of medical treatment is to take place.
2. Name of the specific procedure, or other type of medical treatment for which consent is being given.
3. Name of the responsible practitioner who is performing the procedure or administering the medical treatment.
4. Statement that the procedure or treatment, including the anticipated benefits, risks, and alternatives, was explained to the patient or the patient’s legal representative in addition to the risks and benefits of the alternatives. Hospitals are permitted to delegate to the responsible practitioner, the selection of risks, benefits and alternatives that will be presented to the patient provided the selection is based upon the clinical evidence and patients’ medical history and presentation.
5. Signature of the patient or the patient’s legal representative.
6. Date and time the informed consent form is signed by the patient or the patient’s legal representative.

Core to the most recent QSO clarification is the requirement noted above as item #3- Name of the responsible practitioner who is performing the procedure or administering the medical treatment in addition to the patient’s right to refuse care. Recent articles in both the mainstream media as well as medical and scientific literature have brought public attention to the traditional practice of allowing practitioners or supervised medical, advanced practice providers, or other applicable students to perform pelvic and other invasive examinations on patients who are under anesthesia and whether the patient or decision maker is aware and willing to participate.

To assist surveyors and organizations in establishing compliant processes, CMS has embedded clarifying instructions into the interpretive guidance set forth in the State Operations Manual (SOM), Appendix A for hospitals at tag A-0955. This guidance now states “A written consent form is required for patients undergoing anesthesia procedures, but patients with the ability to verbally affirm consent for procedures that do not require anesthesia should have their medical record reflect that consent was given. In both instances there is written documentation of consent for any examinations.”

Reviewing your organization’s policies and procedures is essential to ensure that your care processes are designed to deliver services in a compliant manner. Organizations should expect that surveyors will be specifically looking at the Informed Consent policy and Informed Consent documentation forms to ensure that the consent process is designed to capture the patient’s agreement/consent or disagreement to having these additional healthcare professionals, deliver examinations outside of the scope of the procedure requiring informed consent.

Organizations are encouraged to work with their Legal Counsel to revise their informed consent documentation to include provisions to allow the decision maker to “opt-in” or “opt-out” in addition to developing appropriate documentation to capture the verbal consent given for the additional providers participation and additional examinations when this discussion is held while the patient is still able to provide verbal consent. Note: these changes are not designed to change the local organized medical staff’s determination as to what procedures require informed consent.

For questions or to learn more contact the C&A team at 704-573-4535 or email us at info@courtemanche-assocs.com.