Practitioners may see more activity from hospitals that are now expected to take steps to ensure compliance with consent rules.


  • Elizabeth Cushing, Esq.; CRICO/RMF; Cambridge, MA


In the Spring of 2007, the Center for Medicare and Medicaid Services, or CMS, issued revised Hospital Interpretive Guidelines for Informed Consent. Practitioners should expect to see more hospital activity in this area. Attorney Beth Cushing of CRICO/RMF reviews the new rules and how they may or may not change the informed consent process for practitioners and hospitals.

The goal of the new guidelines is to ensure that patients can exercise their right to make informed decisions regarding their care, including being informed of their health status, being involved in care planning and treatment, and being able to request or refuse treatment.

The CMS conditions of participation and its published guidelines for meeting those conditions are powerful tools to pursue this goal, because providers have to comply in order to get reimbursed. CMS then publishes guidelines to tell its surveyors how to determine if an institution is complying with the conditions of participation.

The new guidelines affect three conditions of participation, involving patient rights, medical records, and surgical services. The guidelines describe appropriate policies and forms, and now require the hospital to make certain efforts to ensure that the individual provider responsible for surgery obtain informed consent in a way that is consistent with hospital policy.

One of the existing conditions of participation is that all patient records contain a signed informed consent form before a procedure, except in emergencies. The new guidelines require that consent forms contain certain basic information, but also include:

  • a statement that the diagnosis and proposed procedure were explained to the patient or patient representative, and that the explanation included the patient’s prognosis without the procedure, the risks and benefits, and alternative therapies.

The new CMS guidelines also suggest what a well-designed form might include, such as:

  • an indication or listing of the material risks of the procedure that were discussed

  • and statements indicating whether someone other than the operating practitioner, such as a resident, will be performing important tasks.

In addition to the content of the forms, the guidelines suggest to the hospitals that their surgical informed consent policies describe who may obtain the patient’s consent, which procedures require informed consent, and the conditions under which surgery is considered an emergency that may go forward without informed consent.

One of the ways CMS can effect changes in health care practice is through the survey process. Hospitals are routinely monitored to determine whether they comply with various conditions of participation under Medicare and Medicaid.

So physicians will likely see some stepped up efforts by hospitals in the area of informed consent. Standardized forms and processes will get more emphasis. However, hospitals and practitioners who already have high-quality informed consent procedures will not be doing anything radically different as a result of these new changes.

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