The Issue in Brief

CMS has adopted informed consent interpretive guidelines that pose significant implementation difficulties and will change hospital practice.

Background

Since their adoption almost twenty years ago, the federal regulations setting the Medicare Conditions of Participation for Hospitals have required hospitals to ensure that their medical records contain a “[p]roperly executed informed consent form for the operation * * * in the patient’s chart before surgery, except in emergencies.” 42 CFR § 482.51(b)(2). A similar requirement applies to all “procedures and treatments specified by the medical staff, or by Federal or State law if applicable, to require written patient consent.” 42 CFR § 482.24(c)(2)(v). But the regulations left the specific content of the informed consent form to physicians, hospitals and state law to define.

Effective January of 2005, the Centers for Medicare and Medicaid Services (“CMS”) issued detailed “guidance” delineating the content of a proper informed consent form. This guidance did not come in the form of a new regulation with appropriate notice and comment. Instead, the guidance took the form of “interpretative guidelines” given by CMS to state surveyors to ensure consistent interpretation of the federal regulations when surveying hospitals for compliance with Medicare regulations. Many hospitals were not aware of these new guidelines until state surveyors began to cite them for deficiencies.

Informed Consent Requirements Under the Interpretative Guidelines

The interpretative guidelines state that the responsible practitioner must provide information about treatment and alternatives sufficient to enable the patient to make intelligent choices from among the alternative courses of available treatment for their specific problem. “Informed consent must be given despite a patient’s anxiety or indecisiveness.” The guidelines define a properly executed informed consent form as one that contains at least the following:

• Name of patient, and when appropriate, patient’s legal guardian;
• Name of hospital;
• An explanation of the nature and purpose of the proposed procedure(s);
• Name of practitioner(s) performing the procedure(s) or important aspects of the procedure(s), as well as the name(s) and specific significant surgical tasks that will be conducted by practitioners other than the primary surgeon/practitioner. (Significant surgical tasks include: opening and closing, harvesting grafts, dissecting tissue, removing tissue, implanting devices, altering tissues).
• Risks and consequences of the procedure and the risks and consequences if no treatment is rendered;
• Alternative procedures and treatments;
• Signature of patient or legal guardian;
• Date and time consent is obtained;
• Statement that procedure was explained to patient or guardian;
• Signature of professional person witnessing the consent; and
• Name/signature of person who explained the procedure to the patient or guardian.

State Operations Manual (“SOM”) (Pub. 100-7), Interpretative Guidelines for § 482.51(b)(2) (A-0392) and § 482.24(c)(2)(v) (A- 0238).

Potential Problem Areas

For many hospitals, the most significant challenge raised by these new guidelines will be the requirement that the form include the name of the practitioners assisting the primary surgeon/practitioner and the specific surgical tasks that person will perform. Surgery is very often a team effort with surgeons being assisted by residents, surgical assistants and nurses in many different aspects of the surgical procedure within their scope of practice. As a practical matter, surgical consent forms are often filled out in the physician’s office several days or even weeks before the surgery. Staffing changes at the hospital can occur on the day of the surgery with little or no time for the form to be revised and re-signed by the patient. In teaching hospitals, schedule changes and duty hour restrictions for residents frequently cause unexpected changes in the surgical team.

In addition, questions have been raised about whether the informed consent form envisioned by CMS would require discussion of every conceivable risk or only those risks normally discussed with a patient applying the standard of care in the community. The requirement that a “professional person” witness the signing of the consent form has also raised questions. In particular, earlier this year, CMS was reportedly asserting that a registered nurse or physician assistant must witness the patient’s signing of the consent form.

Revisions to CMS Guidance Anticipated

As a result of these and other problems, stakeholders including the American Medical Association have provided critical comments to CMS about the new guidelines. In response to these comments, CMS is in the process of revising the interpretative guidelines to address some of the concerns that have been raised. According to David Eddinger at CMS, as currently envisioned, the revised guidelines will permit hospitals with teaching programs to omit the name of the specific resident who will assist the surgeon because CMS recognizes that it is too difficult to determine who will assist in advance. In addition, because the qualifications of the particular resident will frequently determine the type of surgical task the resident is able to perform, the revised guidelines will reportedly permit the consent form to say that the specific tasks to be performed by the resident will be left to the supervising surgeon’s discretion.

According to Eddinger, with the exception of residents in a teaching program, CMS will continue to require the informed consent form to identify all other practitioners who will perform surgical tasks by name and to identify their specific tasks. But Eddinger says that CMS recognizes staff will sometimes change at the last minute. In fact, the current guideline for medical records acknowledges that “at the time of surgery, unforeseen circumstances may require changing which individual practitioners actually are involved in conducting the surgery.” SOM (Pub. 100-7), Interpretative Guidelines for § 482.24(c)(2)(v)(A-0238). Eddinger suggested that a new informed consent form might not be needed if the change was minor and would not be expected to make a difference to the patient. He also suggested that it might depend on the context, including timing. He stated that, at a minimum, last minute changes should be noted in the patient’s medical record after the operation is performed.

Eddinger confirmed that CMS will also clarify in its revised interpretation that not every possible risk must be noted in the consent form. He said that CMS’ intent was not to require an exhaustive list of every conceivable risk that might be associated with the procedure. He indicated that the risks that should be on the form are those risks that physicians typically discuss with patients related to a particular procedure. In addition, Eddinger anticipates that the revised interpretative guidelines will remove the requirement that the informed consent form be witnessed by a “professional.”

Eddinger would not commit to a date for the revised guidelines to issue but hoped it would be soon. We will keep you updated on those revisions.

Oregon Distinctions

The new interpretative guidelines represent a significant change for hospitals in Oregon. Hospital licensing rules in Oregon require hospitals to have a written policy specifying the requirements for informed consent. OAR 333-510-0070. But these rules do not specify the content of the informed consent form. The laws regulating physicians provide some guidance about the explanation a physician must give to obtain informed consent but do not require that these explanations appear a written t form. ORS 677.097 requires the physician to explain (1) in general terms the procedure or treatment to be undertaken; (2) that there may be alternative procedures or methods of treatment, if any; and (3) that there are risks, if any, to the procedure or treatment. ORS 677.097. After providing the general explanation, the physician must then ask the patient if the patient desires a more detailed explanation. If the patient requests a more detailed explanation, the physician must give it “unless to do so would be materially detrimental to the patient.” ORS 677.097(2).

From a review of the informed consent statute, one might conclude that the requirement to provide the patient the name of practitioners that will assist the surgeon is new to Oregon physicians. In fact, another statute, ORS 677.087(1) arguably requires that physicians do so. It states that “[a]ny physician * * * having agreed with a patient to perform any surgical operation or procedure, shall perform the surgery personally or, prior to surgery, shall inform the patient that the physician * * * will not be performing the surgery.” The statute does not define what is meant by performing a surgery “personally.” Thus, it has not been clear whether physicians violate this law by permitting another practitioner to perform parts of a surgical procedure under supervision without specifically informing the patient. Given this ambiguity, some careful surgeons likely are already informing patients when other practitioners will perform significant surgical tasks. Even so, the interpretative guidelines now clearly add this requirement that the patient be informed of the names of other practitioners who will participate and the tasks they will perform.

What To Do Now

Even assuming the interpretative guidelines are amended as anticipated, they put hospitals in the not unfamiliar position of attempting to comply with a regulation primarily directed at physicians. Physicians must obtain a patient’s informed consent. Hospitals are subject to negative survey findings if the proper informed consent form does not appear in the medical record. Because the risk of non-compliance falls on the hospital, at least for survey purposes, hospitals should review their informed consent policies and develop a standard informed consent form to be used by physicians and staff. If staffing changes are a routine problem, hospitals should consider inserting a provision in the form alerting the patient that the names of the individual practitioners who will assist in the surgery may change. If scheduling issues alter the practitioners that assist the surgeon, hospitals should err on the side of asking patients to sign an amendment to the form whenever possible. In all cases, staffing or other changes that are not reflected on the original form should be noted in the medical record for the surgery. Hospitals may wish to consider amending their bylaws or rules and regulations for medical staff to require physicians performing procedures at the hospital to use a form that complies with the interpretative guidelines.

The interpretative guidelines are contained in an appendix to the Medicare State Operations Manual. The SOM and appendix are available on CMS’ website at www.cms.hhs.gov/manuals/107_som.

While beyond the scope of this article, it should be noted that risks not disclosed may provide a basis for a claim where a patient who experiences a relatively remote risk asserts that it is common enough to have required disclosure.