CMS Finally Issues Informed Guidance on Informed Consent: 2004 Interpretive Guidelines Revised

Last month, the Centers for Medicare and Medicaid Services (CMS) revised guidance issued in 2004 for the application of informed consent requirements under the Medicare Conditions of Participation for hospitals. The new guidance comes as a relief to hospitals and physicians alike, as it reverses burdensome requirements CMS had previously attempted to impose on the informed consent process.

Background

The Medicare Conditions of Participation require patient records to contain properly executed informed consent forms for those procedures and treatments that require written patient consent, and they specifically require that there be a properly executed informed consent form in the patient’s chart before surgery, except in emergencies. See 42 CFR § 482.51(b)(2), 42 CFR § 482.24(c)(2)(v). However, the Conditions of Participation leave the specific content of informed consent forms to be defined by hospitals or applicable law.

In May 2004, CMS issued Interpretive Guidelines for the Medicare Conditions of Participation, including detailed requirements for the content of informed consent forms. These Interpretive Guidelines created a considerable stir at the time as they imposed requirements on the informed consent process that exceeded the standard practice for documentation of consent. Under these guidelines, consent forms were to include, among other elements, the following information:

• The risks and consequences of the procedure and the risks and consequences if no treatment is rendered.
• Any alternative procedures and treatments.
• The names of all practitioners performing the procedure or important aspects of the procedure, including the names and specific significant surgical tasks to be conducted by practitioners other than the primary surgeon/practitioner. Significant surgical tasks were said to include opening and closing, harvesting grafts, dissecting tissue, removing tissue, implanting devices, altering tissues.
• The signature of the person witnessing the consent, who must be a “professional.”
• The name and signature of the person who explained the procedure to the patient.

The standard practice for most hospitals has been to rely on treating physicians to determine how best to provide information to their patients regarding the procedures they are to undergo. In many cases this information is provided orally and over time, often in the physician’s office. As a consequence, hospital consent forms are typically used to confirm that the exchange of information about the procedure has taken place rather than to contain all of that information. Hospital consent forms also do not typically contain the names of all the persons who would be involved in a procedure. The identities of those persons might not be known at the time the form is executed or might change. Such a requirement would be especially problematic for hospitals with resident training programs.

After the issuance of the 2004 Interpretive Guidelines, numerous hospital and physician organizations complained to CMS about the new requirements – not just that they were burdensome but that they failed to support or reflect actual and best practices in the consent process. Despite these protests, preliminary feedback from CMS had indicated that only minor adjustments in the Interpretive Guidelines could be expected.

The April 2007 Guidance

Given this background, there was considerable relief in the hospital and medical community when CMS released its latest guidance to state survey agency directors on April 13, 2007.¹ This new guidance revises the 2004 Guidelines as they apply to informed consent to make several significant changes:

• The Guidelines no longer require that hospital consent forms list the risks and consequences of the procedure and the risks and consequences if no treatment is rendered.
• The Guidelines no longer require that hospital consent forms list any alternative procedures and treatments.
• The Guidelines no longer require that hospital consent forms include the names of all practitioners performing the procedure or important aspects of the procedure, or the names and specific significant surgical tasks that will be conducted by practitioners other than the primary surgeon/practitioner.
• The Guidelines no longer require that a “professional” witness the consent.

Focus on policies, not forms

Instead of focusing on hospital consent forms, the new Guidelines focus on the need for hospital policies to support the informed consent process – to assure that patients receive adequate information, provided in a manner they can understand, so that they can effectively exercise the right to make informed decisions concerning treatment. The new Guidelines describe appropriate informed consent policies and “well designed” consent processes and forms.

With respect to consent forms themselves, the new Guidelines list the following minimum requirements for procedures or other types of medical treatment requiring informed consent:

• Name of the hospital where the procedure is to take place.
• Name of the specific procedure for which consent is being given.
• Name of the responsible practitioner who is performing the procedure.
• Statement that the procedure, 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 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.
• If there is applicable state law governing the content of the informed consent form, then the hospital’s form must also comply with those requirements.

The new Guidelines go on to state that a well-designed informed consent form might also include the following additional information:

• Name of the practitioner who conducted the informed consent discussion with the patient or the patient’s representative.
• Date, time, and signature of the person witnessing the patient or the patient’s legal representative signing the consent form.
• Indication or listing of the material risks of the procedure or treatment that were discussed with the patient or the patient’s representative.
• Statement, if applicable, that physicians other than the operating practitioner, including but not limited to residents, will be performing important tasks related to the surgery, in accordance with the hospital’s policies and, in the case of residents, based on their skill set and under the supervision of the responsible practitioner.
• Statement, if applicable, that qualified medical practitioners who are not physicians who will perform important parts of the surgery or administration of anesthesia will be performing only tasks that are within their scope of practice, as determined under state law, and for which they have been granted privileges by the hospital.

Recommended documentation

It is recommended that the physician carefully document in the hospital medical record that a discussion was held with the patient and that informed consent was obtained. This documentation can be accomplished in a variety of ways – through a chart note in the progress notes of the patient’s record, through a note in the patient’s history and physical, through a certification provision on the consent form itself (if the form contains one), or through documentation provided from the physician’s office (e.g., an informed consent form signed by both the patient and the physician).

Finally, CMS states in the new Guidelines that the medical staff at each health care facility “should” specify in the medical staff bylaws those procedures and treatments that require informed consent. In our view, the medical staff bylaws would not seem to be the best place for this information; the medical staff rules and regulations or a policy and procedure would seem to be better choices. However it is done, the description of those procedures requiring informed consent should be appropriately documented and approved by the medical staff’s executive committee.

1 See CMS memorandum dated April 13, 2007, “Revisions to the Hospital Interpretive Guidelines for Informed Consent,” available at: http://www.cms.hhs.gov/SurveyCertificationGenInfo/downloads/SCLetter07-17.pdf.