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New informed consent guidelines address surgery

Editor's note: Sue Dill-Calloway, RN, MSN, JD, director of hospital risk management for OHIC Insurance Company, The Doctor's Company, in Columbus, OH, is the CMS corner lead contributor. Submit a topic idea to her by contacting BOJ editor Kevin Moschella at This month, in the second of a three-part series, Dill-Calloway addresses the revised interpretive guidelines about informed consent issued on April 17 and effective immediately. This column focuses on surgical services. To access the full guidelines, go to

The second section of CMS' revised interpretive guidelines addressing informed consent looks at tag number 0392, which is found in the section about surgical services. The federal regulation, section 482.51 (b)(2) states, "A properly executed informed consent form for the operation must be in the patient's chart before surgery, except in emergencies."

Informed consent is a process in which information is provided to patients to enable them to evaluate a proposed surgery before agreeing to the procedure. CMS specifies that typically this information would contain the following:

  • Short- and longer-terms risks
  • Benefits
  • The likelihood of each of these based on the current clinical evidence and the physician's professional judgment

The surgery consent needs to be on the chart before the patient goes to surgery. An exception is made only in an emergency situation.

Defining surgery

Surgery is defined as any procedure that is listed as a surgical procedure in any of the various billing/coding systems used by CMS. This is true even if Medicare is not paying for the bill, according to the interpretive guidelines.

CMS now requires hospitals to ensure that the practitioner responsible for surgery obtains informed consent from patients in a manner consistent with the hospital's policy. This may be seen as problematic for many hospitals, especially those in states where informed consent was purely a physician issue unless the physician was an employee of the hospital. CMS also makes it clear that an informed consent form is obtained when anesthesia is provided to patients having surgery. CMS states that hospitals may wish to consider specifically extending their informed consent form to include the anesthesia component. Most anesthesiologists are already obtaining informed consent for anesthesia during surgical procedures.

Informed consent compliance

The hospital must comply with any specific state requirements for informed consent. In addition, CMS states that the surgery informed consent policy should describe:

  • Who may obtain the patient's informed consent
  • Which procedures require informed consent
  • The circumstances under which surgery is considered an emergency and may be undertaken without informed consent
  • The circumstances under which a patient's representative, rather than the patient, may give informed consent for a surgery
  • The content of the informed consent form and instructions for completing it
  • The process used to obtain informed consent, including how informed consent is to be documented in the medical record
  • Mechanisms that ensure that the informed consent form is properly executed and is in the patient's medical record prior to the surgery (except in the case of emergency surgery)

If the informed consent process and informed consent form are obtained outside the hospital, how the properly executed informed consent form is incorporated into the patient's medical record prior to the surgery

The surgical informed consent process

CMS also provides examples of what is contained in a well designed informed consent process. At first glance, hospitals may think that this represents a change in the previous CMS Conditions of Participation because the elements of informed consent were mandatory. However, even though CMS makes it sound permissive, hospitals are well advised to consider incorporating these elements into the informed consent process.

Hospitals should provide information about these new interpretive guidelines to all of their physicians and other practitioners who are performing procedures and surgery that require that an informed consent be given.

Editor's note: This article was adapted from an article Dill-Calloway wrote for the OHIC, The Doctors Company, publication Strategies.